Tag Archives: Enablement

Linking Pigs and Humans through the Enablement Doctrine

Patent,

By Dennis Crouch

Edwards Lifesciences AG v. CoreValve, Inc. (Fed. Cir 2012)

In an opinion by Judge Newman, the Federal Circuit has sided with the patentee – rejecting the challenger’s argument that the patent lacked an enabling disclosure under 35 U.S.C. § 112(1). The claims (and accused infringer activity) are all seemingly focused on using the claimed cardiac valve prosthesis in a human. However, at the time of the patent application, the invention had only been tested in a pig and the human link in the specification was only the statement that “the cardiac valve prosthesis for use in human beings has a corresponding form.” (In its brief, CoreValue also notes that none of the pigs survived more than five hours.). See U.S. Patent No. 5,411,552. The real question was whether the conversion to a human prosthesis would require undue experimentation. If not, then the specification is sufficient.

The court writes:

CoreValve [the accused infringer] argues that in no event does testing in pigs enable use in humans. However, it has long been recognized that when experimentation on human subjects is inappropriate, as in the testing and development of drugs and medical devices, the enablement requirement may be met by animal tests or in vitro data. See MPEP §2164.02 (“An in vitro or in vivo animal model example in the specification, in effect, constitutes a ‘working example’ if that example ‘correlates’ with a disclosed or claimed method invention.”). This general rule has been elaborated in various situations, e.g., In re Brana, 51 F.3d 1560, 1566 (Fed. Cir. 1995) (“one who has taught the public that a compound exhibits some desirable pharmaceutical property in a standard experimental animal has made a significant and useful contribution to the art, even though it may eventually appear that the compound is without value in the treatment in humans”); Scott v. Finney, 34 F.3d 1058, 1063 (Fed. Cir. 1994) (“Testing for the full safety and effectiveness of a prosthetic device is more properly left to the Food and Drug Administration. Title 35 does not demand that such human testing occur within the confines of Patent and Trademark Office proceedings.”).

Rather than following any bright-line rule requiring human testing, the court refocused attention on the so-called “Wands factors” of undue experimentation summarized by the court in the case of In re Wands, 858 F.2d 731 (Fed. Cir. 1988). These factors include:

  1. the quantity of experimentation necessary,
  2. the amount of direction or guidance presented,
  3. the presence or absence of working examples,
  4. the nature of the invention,
  5. the state of the prior art,
  6. the relative skill of those in the art,
  7. the predictability or unpredictability of the art, and
  8. the breadth of the claims.

In this vein, so to speak, the patentee had provided expert trial testimony as to how someone skilled in the art would be able to take the pig results and use them for a human version without undue experimentation. Based upon that testimony, the court was able to confirm that the jury conclusion was based on substantial evidence.

Validity judgment confirmed.

Construing Claims for Enablement: From a doctrinal standpoint, the question of whether a claim is sufficiently enabled should not depend upon the accused infringing activity. In practice that link is regularly found in the caselaw where courts focus the enablement question on activities related to the accused infringement. This case is no different. It turns out that the asserted claims are not expressly limited to a product for use with humans. Rather, the claims are directed toward “a valve prosthesis for implantation in a body channel.” Now, the specification does suggest that the problem being addressed deals with people and that suggestion cold potentially limit the claim scope. However, the court does not deal with the real reality that the claims are drafted in a way that would encompass use of the device in a variety of animals – many of them vastly different from a pig. In mind, this comes together to mean that we have a de facto special claim construction for enablement purposes that is used to understand the “full scope” of the claims.

Note:

  • The case has an important remedies discussion that will be included in a future post.
  • The parallel patent has been already litigated in both Germany and the UK with both cases resulting in non-infringement determinations. The key difference here is that the US courts have more broadly interpreted the claim term “cylindrical” to include shapes that are not really cylindrical. (The relevant portion of the accused device does not have a uniform diameter along its axis). That construction was confirmed on appeal since the specification does not explicitly require constant diameter.
  • In regards to the image accompanying this post, do you read from left-to-right or right-to-left?

Overkill of the Best Mode

Patent, ,

By Dennis Crouch

Joy Mining Machinery v. Cincinnati Mine Machinery (Fed. Cir. 2012) (nonprecedential)

In what may well be its final decision on the best mode requirement of 35 U.S.C. §112(1), the Federal Circuit has reversed a district court judgment invalidating claim 2 of Joy MM's asserted Patent No. 6,662,932. However, the decision will provide additional legal foundation for patent applicants to keep important or sensitive information regarding their invention as a trade secret rather than including that information as part of the patent disclosure.

Here, the court confirms that the best mode requirement does not require actual disclosure of the best mode, but rather only adequate disclosure to enable one of skill in the art to practice the best mode without undue experimentation. Citing See Ajinomoto Co. v. Int'l Trade Comm'n, 597 F.3d 1267 (Fed. Cir. 2010); and Young Dental Mfg. Co. v. Q3 Special Prods., Inc., 112 F.3d 1137 (Fed. Cir. 1997).

In this case, the inventors had apparently decided that the best mechanism for its claimed drive-pin retainer was a press-fitting. However, the applicant failed to identify that particular mechanism in the specification and instead suggested welding. At the time, a press-fitting mechanism was already known to those of skill in the art as one way to construct a drive-pin retainer. As such, the federal circuit found that the failure to disclose that best mode did not qualify as an actionable concealment.

Accordingly, CMM cannot point to any clear and convincing evidence upon which a reasonable jury could rely to find that the omission of press-fitting from the written description of the '932 patent "concealed" its use as a drive pin retaining means from the public.

It is unclear to this author how "concealment" can be read into the statute. Rather, Section 112 affirmatively requires that the applicant "set forth the best mode" not simply avoid concealment. The America Invents Act of 2011 (AIA) substantially alters best mode jurisprudence. Although the statutory change leaves the requirement in place without amendment, the new law prevents any post grant action (either in court or the PTO) that would challenge a patent as invalid or unenforceable based upon failure to disclose the best mode.

In reality, this decision will not have much impact beyond putting another hole in a doctrine whose obituary has already been read.

Notes:

110812_1633_Overkilloft2

Apple v. Samsung: Adding Elements to Avoid Infringement

Patent, , ,

By Dennis Crouch

Apple Inc. v. Samsung Electronics Co., Ltd., — F.3d —, 2012 WL 4820601, App. No. 2012-1507 (Fed. Cir. 2012) (N.D.Ill. 12-CV-0630) (APPLE II)

This is my second post on the appellate decision that I term Apple II. [Read the First Apple II Post.] In Apple II, the Court of Appeals for the Federal Circuit vacated N.D. California District Court Judge Koh’s preliminary injunction order that would have forced Samsung’s Galaxy Nexus smartphone off the market pending conclusion of the infringement lawsuit. The appellate court provided two independent reasons for vacating the preliminary injunction order: (1) that Apple had failed to provide proof of irreparable harm due to Samsung’s continued use of the particular invention covered by the patent; and (2) that a finding of infringement is unlikely based upon the claim construction as corrected by the Federal Circuit. This post focuses on the claim construction issue.

The patent at issue in this case is U.S. Patent No. 8,086,604. That patent issued in December 2011 but stems from upon an application originally filed in January 2000 and appears to be largely directed to aspects of Apple’s Siri application (although the original invention is not tied to a mobile device). After construing claim 6 of the patent, the district court found that Samsung’s product likely infringes. On appeal, the Federal Circuit has reversed that claim construction in a way that substantially narrows claim scope and thus negates any likelihood that Samsung infringes. Although the claim-at-issue uses open-ended “comprising” language, the appellate panel held that an apparatus that includes additional similar (but non-infringing) elements would not be covered by the patent.

Claim 6 is directed to an “apparatus for locating information in a network” comprising various software elements. The basic idea is that the system has a set of heuristic modules corresponding to different search areas. We all use heuristics for searching. For example, if you want to find prior art relating to a chemical compound, you might hire an expert chemistry searcher. On the other hand, if your search area is airplane seat design, you might hire someone else. Under the language of the patent, these search strategies could be defined as two different heuristic modules each corresponding to their respective search area. In the lawsuit itself, Apple identified the three heuristic modules as (1) a Google Search Module; (2) a Module that allows for Search of Internet Browsing History; and (3) a Search of a user’s Contacts List. One difficulty with considering this case is that this invention appears in hindsight to be ridiculously obvious. However, obviousness is not the topic of the appeal.

The patent claim requires “a plurality of heuristic modules … wherein: each heuristic module corresponds to a respective area of search and employs a different, predetermined heuristic algorithm corresponding to said respective area.” Samsung’s product allegedly uses a plurality of heuristic modules corresponding to different search areas. However, the accused product does not use “different, predetermined heuristic algorithm” for each and every different search area. I have modeled this below with a diagram of the Galaxy Nexus Search System associated with five different Search Areas (A,B,C,D,E) but only three different Heuristic Modules (X,Y,Z). Although some of the Heuristic Modules are re-used by the system, Apple argues that the system still infringes under standard patent law that would find the addition of non-infringing elements to an infringing core does not negate infringement. See CIAS, Inc. v. Alliance Gaming Corp., 504 F.3d 1356, 1360 (Fed. Cir. 2007) (infringing device may include additional, unrecited elements).

Writing for the unanimous panel, Judge Prost (joined by Judge Moore and Reyna) rejected Apple’s argument and instead agreed with Samsung that the claim “requires that [each and] every heuristic module within the accused device use a unique heuristic algorithm.”

[D]espite the use of “comprising,” claim 6 is not amenable to the addition of other modules that do not use different heuristic algorithms because such addition would impermissibly wipe out the express limitation that requires every module to have a unique heuristic algorithm.

It appears from the court’s remarks that a simple claim amendment might have saved Apple’s case:

  • Original: “a plurality of heuristic modules … wherein: each heuristic module corresponds to a respective area of search and employs a different, predetermined heuristic algorithm …”
  • Proposed: “a plurality of heuristic modules … wherein: each of the plurality of heuristic module corresponds to a respective area of search and employs a different, predetermined heuristic algorithm …”

However, Apple might not have been able to obtain patent protection if it had clarified that the system might use the same heuristic algorithm for a variety of search areas. In particular, during prosecution Apple used the limitation in question to avoid prior art. The company argued “Andreoli does not describe … that each of the local and remote search operations employs a different heuristic algorithm.” Although the appellate panel based its decision on what I see as odd linguistics, this prosecution history argument is probably the most damning evidence.

Apple has at least one continuation application pending and thus has the opportunity to further shape its claims in a way that captures the market while avoiding prior art. See U.S. Patent Application Pub. No. 2012-0166477. The USPTO is also in the early stages of conducting an inter partes reexamination that was filed in August 2012 by Motorola Mobility (Google). See Inter Partes Reexamination No. 95/000,685.

THOSITA: Obvious to a Team Having Ordinary Skill in the Art

Patent, ,

By Dennis Crouch

Inventors Per Patent: The number of inventors per patent has risen fairly steadily for the past 40 years. Today, most patents are directed toward inventions created by teams of two or more inventors working in a collaborative environment. When done well, teamwork can add tremendous value to the creative process and can also provide a combined depth of knowledge beyond most individuals.

Individual PHOSITA: From its inception, the 1952 Patent Act allowed for joint inventors. However, the question of obviousness focuses on a single hypothetical individual: "a person having ordinary skill in the art to which said subject matter pertains." 35 U.S.C. § 103. The AIA slightly amends this portion of Section 103 to clarify that the "said subject matter" is "the claimed invention." This is a change made throughout the statute and puts-to-rest ongoing arguments for identification of a "core" invention for each patent.

PHOSITA as a Team: In its most recent decision, the UK Royal Court of Justice appellate panel took a different path – finding that question of obviousness should be judged from the viewpoint of a "skilled team." MedImmune v. Novartis, [2012] EWCA Civ 1234 (Kitchen, LJ). For the case in question, the court found that the "patent is addressed to a team of scientists with differing backgrounds in areas such as immunology, in particular antibody structural biology, molecular biology and protein chemistry, but with a common interest in antibody engineering."

The skilled team construct is not entirely new to UK case law. See, for example, Schlumberger Holdings Ltd v Electromagnetic Geoservices AS, [2010] EWCA Civ 819 (Jacob LJ), and Halliburton Energy Services, Inc. v. Smith International (North Sea) Limited, [2006] EWCA Civ 1715 (Jacob LJ). The starting point for these UK courts is essentially identical to that of US courts. In particular, the UK Patents Act 1977 defines "inventive step" as being "not obvious to a person skilled in the art." The corresponding language is found in Article 56 of the European Patent Convention (defining inventive step with reference to being obvious to a person skilled in the art). In building the notional teams, the UK courts have been somewhat careful to avoid hindsight bias in the process. Dyson Appliances Ltd v Hoover Ltd [2001] EWCA Civ 1440. Despite the progress, it is clear to me that the UK courts are still working out what it means to be obvious to a team as opposed to obvious to an individual person.

What is added by a Team Analysis?: In 2011, I questioned whether obviousness analysis should reflect some nuances of teamwork:

As compared to a solo worker, teams often have an overall broader depth of knowledge, but are often plagued by communication difficulties. In the obviousness analysis, this shift could be reflected in a broader scope of potential prior art but a more rigorous analysis of whether the ordinary team would make leaps of analysis necessary to combine disparate prior art.

Despite providing arguments on both-sides, I suspect that a notional team would tend to make an obviousness conclusion more likely. The knowledge of those of skill in the art is considered in other areas of patent law such as claim construction, enablement, and definiteness.

THOSITA under US Law: One statutory question moving forward is whether a section 103 "person" can be interpreted to encompass a team of persons. The answer is almost certainly yes. Perhaps the greatest driving factor for this conclusion is found in Section 102 that begins with the statement that "A person shall be entitled to a patent unless…" For that statute, the term person certainly apply to teams of joint inventors.

One major problem with my starting point of increased-team-size is the reality that the obviousness question is not designed around a "skilled inventor" threshold but that of a skilled craftsman of "ordinary skill." This means that there is not really any statutory hook for pushing the obviousness analysis to track the culture of innovation and creative experimentation. Rather, the focus is merely on ordinary craftsmen and what would have been common sense at the time. By design, this creates a low inventiveness threshold intentionally does not consider the particular inventive path taken. "Patentability shall not be negated by the manner in which the invention was made." 35 U.C.C. 103 (post-AIA).

See:

  • Dennis Crouch, Person(s) Skilled in the Art: Should the Now Established Model of Team-Based Inventing Impact the Obviousness Analysis?, Patently-O (2011)
  • Jonathan J. Darrow, The Neglected Dimension of Patent Law's PHOSITA Standard, 23 Harvard JOLT 227 (2009)

Did the AIA Eliminate Secret Prior Art?

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In many ways, prior art is the core of the US patent system. Patentability requires that any invention-to-be-patented be “new” as defined by 35 U.S.C. §§ 101, 102, and 103. Prior art serves as the underlying evidence to prove that the invention is not new. As implied by its name, prior art has a temporal aspect in that the “prior art date” must come before (i.e., be prior-in-time to) the critical patentability date of the invention in question. Sometimes, the identical invention is found within a single prior art reference. In that case, the newness doctrine of “novelty” as defined by 35 U.S.C. § 102 will do the invalidating work. However, more often than not, a prior art reference will only teach a portion of the purported invention. In that case, the prior art may still serve a useful roll when applying the obviousness doctrine defined by 35 U.S.C. § 103.

We’ve talked about two key features of prior art: (1) being earlier in time and (2) teaching some aspect of the invention being claimed. Those two elements are never sufficient to satisfy the evidentiary requirements of prior art. Rather, the law always requires one additional element to take this information from being merely prior private knowledge to being prior art. As part of the America Invents Act move to a first-to-file regime, this additional step will always involve (3) transferring knowledge.

One argument favoring a first-to-file regime is its focus on publicly available information rather than privately held knowledge. And, in most cases, the step of transferring of knowledge highlighted above is a public act. Thus, prior art may be created through publication, patenting, or public use. 35 U.S.C. § 102(a)(1) (post-AIA). The AIA retains one form of temporally-secret prior art in that the prior filing of a patent application by “another inventor” will be deemed prior art as of its filing date. 35 U.S.C. § 102(a)(2) (post-AIA; formerly defined by § 102(e)). This is secret prior art because patent applications are typically kept secret by the USPTO for 18-months after they are filed. However, I term § 102(a)(2) prior-art-as-of-filing-date as only temporally (or temporarily) secret because such a reference cannot be used as prior art unless and until the prior-filed application is made public through either publication or patenting. Perhaps because of the unfairness of associated with its secrecy, most other countries besides the US only allow this type of prior art for novelty arguments and not for questioning obviousness (inventive step).

The AIA did eliminate several types of secret of prior art, including prior secret invention by another inventor under pre-AIA § 102(g) and prior knowledge transferred from another to the patent applicant under pre-AIA § 102(f). The individualized secrecy of these prior art references created two main problems: (1) that patentability could not be fully evaluated with going through the arduous process of obtaining additional information from interested parties and (2) that the secrecy gave interested parties more of an opportunity to fraudulently create (or destroy) documents after-the-fact. Making patentability based upon publicly available information can hypothetically lead to some unjust outcomes, but it has the enormous benefit of providing clear(er) notice to anyone who cares to look.

Two important secret prior art questions remain — namely whether either (1) secret commercial uses (by the patentee) or (2) secret on-sale activity (by anyone) create prior art that can invalidate a patent on novelty grounds and contribute to invalidation on obviousness grounds. The Patent Act never expressly authorized the first type of prior art and has arguably now rejected the second. Advocates for a transparent prior art system argue that the AIA should be interpreted as eliminating both.

Secret Sales: One type of prior art that is traditionally thought of as potentially secret is created by what is known as the on-sale bar. An invention that is on sale before the critical patenting date will result in prior art that renders any patent invalid. There are a few ways that a sale or offer-to-sell could be secret: for example, (1) it might be an offer between two individuals that is subject to a (formal or informal) confidentiality agreement or (2) it might be an offer that does not fully disclose the scope of the invention.

The AIA retains the identical language of its predecessor statute regarding on sale activity that occurs prior to the defined critical date. Compare 35 U.S.C. § 102(a)(1) (post-AIA) with 35 U.S.C. § 102(b) (pre-AIA). Although the “on sale” term itself is identical, the context of the new statute is arguably different. In particular, the new statute has added a catchall phrase “otherwise available to the public” that suggests that the on-sale activity must also be available to the public. The new statute reads as follows:

A person shall be entitled to a patent unless — 1. the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention; or …

The open question is whether the language here creates a legally cognizable implication that the “on sale” activity must be available to the public as well.

Secret Commercialization by the Patentee: In his 1946 decision in Metallizing Engineering, Judge Learned Hand explained that a patentee’s commercial use of its process (even if done secretly behind factory walls) counted as a “public use” sufficient to invalidate the later-filed patent application. The court wrote “That it is a condition upon an inventor’s right to a patent that he shall not exploit his discovery competitively after it is ready for patenting; he must content himself with either secrecy, or [a patent].” Under the rule, secret commercial uses of an invention by a third party does not count as a public use. This distinction is found nowhere in the patent statute, but has been judicially recognized for many years. While the new statute retains the “public use” language, many suggest that a strong congressional intent that the new statute eliminate the Metallizing rule.

USPTO Proposed Interpretation: In a set of proposed examination guidelines, the USPTO indicated its interpretations that the statute has altered these provisions in favor limiting the application of secret prior art. In particular, the USPTO’s position is that, while the statute is not entirely clear on these points, the legislative history indicates that that prefiling secret sales and commercial uses do not qualify as prior art under the revised Section 102. The PTO writes: “The legislative history of the AIA indicates that the inclusion of this clause in AIA 35 U.S.C. 102(a)(1) should be viewed as indicating that AIA 35 U.S.C. 102(a)(1) does not cover non-public uses or nonpublic offers for sale.

For the most part, patent attorneys appear to agree with the USPTO’s proposals. The American Bar Association’s IP Law Section writes:

ABA IPL respectfully submits that the passage “otherwise available to the public” reflects the touchstone of what constitutes prior art under the AIA under section 102(a)(1). This section requires availability to the public or public accessibility is an overarching requirement. Such accessibility is critical to provide a simpler, more predictable and fully transparent patent system. As such, for a “public use,” for a determination that an invention is “on sale,” as well as to assess whether an offer for sale has been made, the statutory requirements under the AIA require a public disclosure. Thus, non-public offers for sale (and non-public uses) would not qualify as prior art under the AIA.

The AIPLA agrees, writing:

AIPLA believes that an offer for sale needs to be public to qualify as “on sale” prior art under §102(a)(1). . . . AIA §102(a)(1), unlike pre-AIA 35 U.S.C. §102(b), contains the residual clause “or otherwise available to the public.” This is a major policy change achieved by the new legislation, which would further the goal of increasing objectivity in the identification of prior art. . . .

[T]he legislative history of the AIA indicates that the inclusion of this clause in §102(a)(1) should be viewed as indicating that §102(a)(1) does not cover non-public uses or non-public offers for sale. AIPLA believes that such an interpretation reflects the clear intent of Congress. It is also consistent with the broad goal of global harmonization under a first-inventor-to-file system.

The IPO agrees as well – arguing in its comments to the USPTO that the AIA “overrules Metallizing Engineering by excluding ‘secret’ commercial activity from the ‘on sale’ provision” and that the only on sale activity relevant to patentability under the AIA is when an invention is “publicly on sale.” LES is also on board with this interpretation.

Several individuals disagreed, including Lawrence Pope who wrote:

Certainly, any change in patent law which abandoned a long established policy and allowed inventors to engage in secret commercial exploitation of their inventions for as long as they liked without forfeiting their right to obtain valid patent protection on the same, would require quite explicit statutory language. In addition, it would be expected that any such major change would be reflected in a more extensive legislative history than the mere comments of two members. One would at least expect to see it reflected in the Committee Report reporting on the legislation to the House of Representatives.

Mark Lemley also argued that the PTO’s interpretation is quite problematic:

[T}he proposed Guidelines take the position that the AIA has reversed an unbroken line of precedent of both the Federal Circuit and the regional circuits tracing back to Judge Learned Hand’s decision in the Metallizing case. Those cases hold — for impeccable policy reasons — that the term “public use” in old section 102(b) should be interpreted to prevent an applicant from making a secret commercial use for more than a year while delaying the filing of a patent application. A contrary conclusion, as the PTO now proposes, will enable inventors to keep their process inventions secret for years or even decades, and then surface and file a patent application. That is directly contrary to the goals of first-inventor-to-file in the AIA, which encourage early filing of patent applications.

Concluding that Metallizing and the cases that follow it were abrogated will have another, even more pernicious effect. Metallizing, Gore v. Garlock, and other cases interpret the term “public use” in the old statute. One might reasonably conclude that those cases stretch the meaning of that term, but what the courts said they were doing was interpreting “public use.” The term “public use” appears unchanged in new section 102 under the AIA. For the PTO to conclude that the new law opens the door to reinterpretation of the settled meaning of terms present in both the old and new statutes opens a dangerous door. Parties and courts might be expected to try to revisit the meaning of “on sale,” “patented,” “printed publication,” and many other settled statutory provisions, creating enormous uncertainty. To take just one example, the inherency doctrine, like the Metallizing rule, is not articulated expressly in either the old or new statute. If the reenactment of the term “public use” opens the door to revisiting Metallizing, it also opens the door to revisiting inherency, the “ready for patenting” rule in on sale bar, and a host of other settled cases. The PTO, patent applicants, and litigants would be much better served by leaving existing precedent interpreting unchanged statutory terms in place.

Read more comments here: http://www.uspto.gov/patents/law/comments/. (Note, the equally major issue is the USPTO’s interpretation of the disclosure grace period that is also part of the commentary).

What’s the Big Deal?: The USPTO does not have substantive authority to shape the interpretation of 35 U.S.C. § 102. In the end, this issue will be resolved by the courts or else clarified by Congress in a technical amendment. In many ways, the arguments above are simply a preview for a Federal Circuit and Supreme Court ruling on the issue. One problem with the USPTO’s narrow view of the prior art is that it delays the eventual resolution of this issue since it gives patent applicants nothing to challenge. In any event, this is a debate that will continue for at least the next decade and likely beyond.

Supreme Court Questions Whether Patent Law Malpractice Claims “Arise Under” the US Patent Laws (And Thus Are Amenable to Federal Jurisdiction).

Patent, , , ,

By Dennis Crouch

Gunn v. Minton (Supreme Court 2012)

Over the past few years we have seen an ongoing subject matter jurisdictional battle between state courts, regional federal circuit courts of appeal, and the Court of Appeals for the Federal Circuit. The issue as raised in various context is when a complaint stating a non-patent cause of action should be considered to “arise under” the patent laws so as to ensure that the case is heard by a federal district court and subsequently by the Court of Appeals for the Federal Circuit. These non-patent / patent cases can arise in a variety of disputes, including disputes over legal malpractice, contracts and licenses, employment disputes, bankruptcy, challenges to arbitrations, and antitrust disputes.

The issue in the present case is whether state courts in Texas properly have jurisdiction over legal malpractice claims against patent attorneys (or patent litigators). Legal malpractice is generally a state law tort claim, but the Federal Courts have jurisdiction over claims arising under the patent laws. Although there is Federal Circuit precedent on point, this case actually arises from a Texas state court dismissal of Mr. Minton’s malpractice claim based upon the state court’s interpretation of federal law.

Now, the Supreme Court has agreed offer its final view on the question of when the Federal Courts (and the Court of Appeals for the Federal Circuit) have jurisdiction here. Although nominally a patent case, the case could have much broader impact because it will essentially be interpreting the generic constitutional and statutory limitation of “arising under” jurisdiction.

Background on the Dispute: The case started several years ago when Mr. Vernon Minton developed a set of software that he leased to the Texas Int’l Stock Exchange (TISE). That lease to TISE occurred more than one year before he filed a provisional patent application on the invention embodied by the product. The USPTO granted Minton U.S. Patent No. 6,014,643. However, in a later lawsuit against NASDAQ, the patent was invalidated via the on-sale bar of 35 U.S.C. § 102(b) and that invalidity finding was upheld by the Federal Circuit on appeal. Minton v. Nat’l Ass’n of Sec. Dealers, Inc., 336 F.3d 1373 (Fed. Cir. 2003). In that decision, the Federal Circuit confirmed that the lease to TISE constituted a “sale” for 102(b). In a post-judgment motion, Minton asked the district court to consider whether the use by TISE was an experimental use. However, the district court refused to consider that issue because of its untimely introduction.

The present lawsuit arose when Minton sued his patent litigation counsel (who have now joined the Fulbright & Jaworski firm). The crux of the malpractice claim is that the litigation counsel failed to timely plead the experimental use question. Minton filed the lawsuit in Texas state court and lost on a pretrial motion based upon the trial court’s judgment that Minton had failed to present “a scintilla of proof . . . to support his claims.” That no-damages judgment was affirmed by the Texas court of appeals. However, the Supreme Court of Texas took an orthogonal view and held that Texas courts actually lacked subject matter jurisdiction over case. In particular, the Texas Supreme Court held that Minton’s malpractice claim required resolution of a substantial question of patent law and therefore fell within the exclusive “arising under” jurisdiction of the federal courts and, eventually, the Court of Appeals for the Federal Circuit. This ruling gives Minton another shot at winning the case – this time in federal district court. The Texas court wrote:

This case arises out of patent infringement litigation. We consider whether federal courts possess exclusive subject-matter jurisdiction over state-based legal malpractice claims that require the application of federal patent law. The federal patent issue presented here is necessary, disputed, and substantial within the context of the overlying state legal malpractice lawsuit. Additionally, the patent issue may be determined without creating a jurisdictional imbalance between state and federal courts. We conclude that exclusive federal jurisdiction exists in this case. Accordingly, without reaching the merits of the legal malpractice claim, we reverse the court of appeals’ judgment and dismiss this case.

The 5-3 Texas Supreme Court decision follows the lead set by the Court of Appeals for the Federal Circuit in Air Measurement Tech., Inc. v. Akin Gump Strauss Hauer & Feld, L.L.P., 504 F.3d 1262 (Fed. Cir. 2007) and Immunocept, L.L.C. v. Fulbright & Jaworski, L.L.P., 504 F.3d 1281 (Fed. Cir. 2007). In those cases the Federal Circuit gave a broad interpretation to arising under jurisdiction based upon the court’s congressionally mandated goal of national uniformity in the patent system. Both the Akin Gump and the Fulbright Jaworski cases were decided on the same day by the same panel and both penned by then Chief Judge Paul Michel. (Judges Lourie and Rader joined). Although the Texas court did not treat the Federal Circuit decisions as binding precedent, the Court chose to adopt the logic of those decisions. The dissent argued that the State of Texas has a strong interest in (and a regulatory scheme in place for) ensuring that Texas attorneys maintain a high level of quality and that federalism concerns suggest that many of these cases should be adjudged at the state court level. In a non-patent case, the Supreme Court approved of this more nuanced analysis of arising under jurisdiction in the case of Grable & Sons Metal Products, Inc. v. Darue Eng’g & Mfg., 545 U.S. 308 (2005). In 2012, the Federal Circuit has decided at least three other jurisdictional disputes over attorney malpractice. In each case, Judge O’Malley argued against federal circuit jurisdiction based upon her reading of Grable. See Landmark Screens, LLC v. Morgan Lewis & Bockius, LLP (Fed. Cir. 2012)(O’Malley, J., concurring); Byrne v. Wood, Herron & Evans, LLP (Fed. Cir. 2012)(O’Malley, J., joined by Wallach, J., dissenting from denial of the petition for en banc rehearing); and USPPS, Ltd. v. Avery Dennison Corp. (Fed. Cir. 2012)(O’Malley, J., joined by Mayer, J., concurring).

Question Presented: The attorneys challenging federal jurisdiction raised the following questions:

Did the Federal Circuit depart from the standard this Court articulated in Grable & Sons Metal Products, Inc. v. Darue Eng’g & Mfg., 545 U.S. 308 (2005), for “arising under” jurisdiction of the federal courts under 28 U.S.C. § 1338, when it held that state law legal malpractice claims against trial lawyers for their handling of underlying patent matters come within the exclusive jurisdiction of the federal courts? Because the Federal Circuit has exclusive jurisdiction over appeals involving patents, are state courts and federal courts strictly following the Federal Circuit’s mistaken standard, thereby magnifying its jurisdictional error and sweeping broad swaths of state law claims – which involve no actual patents and have no impact on actual patent rights – into the federal courts?

In his responsive brief, Minton reframed the question as follows:

Minton filed a legal malpractice claim against the Attorneys arising from a patent infringement lawsuit. Do federal courts have exclusive “arising under” jurisdiction where the sole substantive issue is the application of a patent law doctrine which is an essential element of Minton’s malpractice claim?

Underlying Law: As suggested by both questions presented, the underlying law on federal court jurisdiction over patent cases begins with the federal statute – 28 U.S.C. § 1338(a).

The district courts shall have original jurisdiction of any civil action arising under any Act of Congress relating to patents, plant variety protection, copyrights and trademarks. Such jurisdiction shall be exclusive of the courts of the states in patent, plant variety protection and copyright cases.

28 U.S.C. § 1338(a). There are two key phrases here. First, federal jurisdiction only exists when the civil action is considered to be “arising under [an] Act of Congress relating to patents.” Second, if federal circuit exists then it is exclusive of state jurisdiction.

Not a Constitutional Question: The statutory “arising under” language is intended to reflect the parallel language found in Article III, Section 2 of the U.S. Constitution that limits federal judicial power to cases “arising under this Constitution, the Laws of the United States, and Treaties made, or which shall be made, under their Authority…” However, the two sources have been interpreted somewhat differently. The constitutional “arising under” limits have been broadly interpreted to allow courts to hear cases even when the federal claim is only raised in a defense or counterclaim. See Osborn v. Bank of the United States, 22 U.S. 738 (1824). On the other hand, the “arising under” language in sections 1338 and 1331 have been more narrowly interpreted under the well pleaded complaint rule. In his 2004 article on Holmes Group, Professor Cotropia writes:

The phrase “arising under” originated from Article III of the Constitution, defining the jurisdiction of the federal court system. The Supreme Court interpreted this phrase, as it appears in Article III, to extend the constitutional grant of federal judiciary power to every case where federal law potentially forms an ingredient of a claim. Article III allowed “[t]he mere existence of a latent federal ‘ingredient’ that might in theory be dispositive of the outcome of a case . . . to bring the entire case, including ancillary nonfederal issues, within the jurisdiction of the federal courts.” An implementing statute is needed, however, for lower federal courts to exercise the powers conferred by Article III. With such an implementing statute, lower federal courts could enjoy some or all of the constitutional “arising under” grant of jurisdiction.

Christopher Cotropia, Counterclaims, the Well-Pleaded Complaint, and Federal Jurisdiction, 33 Hofstra L. Rev. 1 (Fall 2004); See also Donald L. Doernberg, There’s No Reason for It; It’s Just Our Policy: Why the Well-Pleaded Complaint Rule Sabotages the Purposes of Federal Question Jurisdiction, 38 Hastings L.J. 597 (1987).Because the Constitutional limitation has been so broadly interpreted, all of the practical discussion is focused on the meaning of “arising under” as it is found in the statutory context.

In Grable (following a long line of precedent), the Supreme Court confirmed that – under the statute – a case may “arise under” federal law even when the cause of action is purely a non-federal state-law claim. However, when the cause of action is not based on a federal claim, Grable requires (1) a substantial underlying contested federal issue and (2) that federal jurisdiction over the case “be consistent with congressional judgment about the sound division of labor between state and federal courts.” Grable interpreted the “arising under” language of 28 U.S.C. § 1331 rather than the patent jurisdictional statute of section 1338. However, in Christianson v. Colt Industries Operating Corp., 486 U.S. 800 (1988), the Supreme Court recognized that those two statutes should be interpreted in parallel.

Is Patent Law Different?: Although I wrote above that the case has non-patent implications, patent law presents some particulars that might not exist in other areas of law. These involve the particular exclusive jurisdictional statute for patent law. Thus, although state courts have jurisdiction to also decide most federal claims, they cannot decide patent claims. In addition, Congress has spoken regarding its desire for uniformity in the application of the patent laws. These stated federal interests could be sufficient to explain a difference between federal jurisdiction over patent law malpractice claims and not over say trademark law malpractice claims. The malpractice is a relatively minor question compared with jurisdiction over contract claims that involve patent rights (such as a patent license or sale). It would be a big deal if the Supreme Court opened the door to greater federal jurisdiction over these claims. As I explain in the next paragraph, I think it is unlikely that this case would be a vehicle for expanding federal jurisdiction and instead will more likely be a vehicle for contracting federal jurisdiction – at least when compared with the holdings in Akin Gump and Fulbright jurisdictional decisions discussed above.

Grable is the Supreme Court’s most recent pronouncement on this issue and that case the court tempered federal arising under jurisdiction by requiring courts to be mindful of the appropriate balance of power between state and federal courts. Despite Grable, both the Federal Circuit and now the Texas Supreme Court have continued to maintain broad jurisdictional reach over these malpractice cases. In these cases, the minority dissenting viewpoint has argued for less expansive jurisdiction. In this setup, the Supreme Court is more likely to resolve the conflict between these ranges than it is to identify a result to the extreme. In addition, in the years since Grable, there has been a continued focus and recognition of legitimizing State’s rights. This notion of the importance of State’s rights places an additional thumb the scale of reduced federal jurisdiction over these types of cases.

AIA Expands Arising Under Jurisdiction: Although not applicable for this case, the Leahy-Smith America Invents Act (AIA) has altered federal court jurisdiction in a way that overrules the Supreme Court decision in Holmes Group, Inc. v. Vornado Air Circulation Systems, Inc., 535 U.S. 826 (2002). In that case, the Supreme Court interpreted the applied the well pleaded complaint rule to the Federal Circuit appellate jurisdiction statute (28 U.S.C. § 1295) in holding that patent issues raised only in counterclaims do not “arise under” the patent law in a way that creates Federal Circuit jurisdiction. The AIA amends the statute to clarify that Federal Circuit jurisdiction includes cases where the patent issue is first raised in a compulsory counterclaim. In addition, the new law indicates that “No State court shall have jurisdiction over any claim for relief arising under any Act of Congress relating to patents” and also provides a right of removal from state court if either party raises a claim for relief “arising under any Act of Congress relating to patents.”

USPTO Press Release on Preissuance Submissions

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USPTO Encourages Third Parties to Participate in Review of Pending Patent Applications

Crowdsourcing Initiative with Stack Exchange Enables Experts to Introduce Prior Art and Improve Quality of 
Examination Process

WASHINGTON — The U.S. Department of Commerce's United States Patent and Trademark Office (USPTO) encourages subject-matter experts to take advantage of a new rule implemented under the Leahy-Smith America Invents Act (AIA) that—for the first time in the history of U.S. patent law—allows third parties to submit relevant materials to patent examiners in any given examination. Submission of proposed prior art helps examiners determine whether the innovation in the application is patentable. The new provision, 35 U.S.C. 122(e), was implemented by the USPTO on Sunday, Sept. 16, and applies to any pending application.

Today, efforts are already underway in the private sector to crowdsource the identification of prior art.  One such initiative, utilizing input from the USPTO, is a newly launched social network known as Ask Patents by Stack Exchange, in which subject-matter experts volunteer to suggest prior art for given applications, as well as to offer their input on the proposed value of those suggestions from others.

"By introducing third party input into the examination process for the first time since the inception of our nation's intellectual property system, we're able to expand the scope of access to prior art in key areas like software patents. This will improve the examination process and advance the Administration's ongoing commitment to transparency and open government," said Under Secretary of Commerce for Intellectual Property and Director of the USPTO David Kappos. "We encourage our nation's innovators to follow Stack Exchange's example and assist us as we improve the examination process and resulting patent quality that will drive our economy and create jobs and exports."

The submission by third parties of prior art—the library of published patents, applications, or other publications in a specific technology area—allows the USPTO to tap directly into the U.S. innovation community. Submissions provide a fuller, more exhaustive scope of materials for examiners to review in determining the novelty of a given application. This new mechanism will help ensure that truly novel, useful, and non-obvious innovations obtain the intellectual property protection they deserve.

Stay current with the USPTO by subscribing to receive email updates. Visit our Subscription Center atwww.uspto.gov/subscribe.

The America Invents Act: One Year Later (Pt. 4)

Academic Studies, Patent, , , ,

By Jason Rantanen

Liveblogging the America Invents Act: One Year Later conference at the Indiana University Mauer School of Law. Warning and disclaimer: Quality may vary and these don't necessary reflect my opinions.

Keynote speaker – Director David Kappos

Director Kappos – Going to talk about what the USPTO is working on. 

Satellite offices – USPTO has been around since around 1790; always had only one location.  First satellite office: Detroit.  That office now up and running, and first class of examiners is examining applications.  Hired about 12 judges there.  On time, below budget.

Opening up three more offices.  Dallas-Fort Worth, Denver, Silicon Valley.  Denver location has been chosen already; doing site surveys for the other two locations.  Have vacancy notifications for hiring requests for judge out now; will be putting out hiring announcements for examiners soon.  Love to hire law school graduates.  In addition to hiring in Alexandria, there are going to be hiring opportunities in these areas.  Great place to start your career; but also a good place for a long term career.

IP Critical to GDP and Jobs – conducted a recent study called "Industries in Focus" that reports on the importance of innovation/IP rights for the GDP.  Also a recent study by BIO that reports on the enormous contribution of universities to GDP through Bayh-Dole.

AIA- AIA is a lot about balance between first inventors and follow-on competitors.  On Sunday, the first major piece of the AIA goes into effect.  Follow-on competitors are great – produce great products at great prices; produce innovations of their own.  The AIA isn't about advantaging anyone; it's about balancing both sides.

Major tenets of AIA: enabling the patent system to work for everyone, in every industry. 

Increase certainty of patent rights – includes backstop provisions, such as post-grant review;

Remove or prevent low quality patents- no way, consistent with any cost-effective business methodology, that you can do a perfect job.  Also, courts have consistently not chosen the easy way out in terms of flexibility rather than hard, categorical rules.  PTO promulgates a lot of guidelines – useful, but not perfect. This is why post-grant is so important – when the PTO gets it wrong in the first instance, there's a backstop.

Build a 21st century patent system – this leads to the world's first 21st century patent system.  This is not the most-cautious approach.  It's not a Swiss watch, it's innovation friendly.

More than halfway done with implementing provisions of the AIA.  After Sunday, just the 18-month rules to go into effect. 

Challenging fee-setting process is in progress.  Started this process with the academy, with IP-law economists.  They helped design a system that sets fees that are consistent with policy.  It will take several iterations, but he's serious about listening to the academy on this issue.

2012 Fall Roadshow in progress this month.  Lots of good feedback from these. Notes that new forms (not samples) that are to be used starting Monday are now available on the USPTO website.

Track One statistics – fast tracking of applications accompanied by a petition.  Now almost a year out from creation.  Average days to final disposition is 153.8 days.  About 5,500 applications so far.  Petition gets granted 96% of the time; 47 days to first office action. Of the 1716 final dispositions mailed, 867 allowances mailed.  Not a fast way to get a rejection; a fast way to get a patent if you should be getting a patent. Also, examiners want to pick up Track One first, because (1) it shows the applicant is serious; (2) probably an important innovation; and (3) applicant will be willing to engage with the examiner to get the job done.

Unexamined patent application backlog – backlog is going down.  New narrative is "optimal inventory" – want to come to the right level of backlog/inventory.  What about unintentional consequences: when they changed a lot of the incentives, it sent backlog numbers in the right direction.  However, the consequence was that doing this unintentionally sent a message to examiners to sit on RCE's; this is what they're working on now.  Soon, the RCE backlog will go like the unexamined patent application backlog. 

What is "inventory"?  The about of applications available fluctuates, but there needs to be work available to everyone to work on every day.  If the inventory gets too low, there are days when some people don't have enough work and others have too much.  So now the PTO needs to make sure that the inventor doesn't crash through the optimal inventory level.

Forward looking pendency – now down in the 16 month range.  Goal is 10 months; not that far off from that goal.  Less than two years from now they'll be at the optimal level. 

IP Awareness Assessment Tool – enables a non-lawyer to navigate a number of questions that adjusts the question to understand whether they might have possible issues in patent/trademark/trade secret areas.  Idea is to help small businesses understand when and how they need legal advice, and to navigate IP-issues before talking to a lawyer.

The H-Word: Harmonization.  Of forms of IP, patent laws are the laggard in terms of harmonization.  Working with patent systems of other countries to continue moving towards harmonization, especially grace period.  This is an area where further industry and academy support would be very welcome.  Trading partners need to change their laws to adopt the grace period. 

Social Enterprises: 2010-2011 – green tech pilot.  Totally maxed out.  This was the prototype for Track One.  Now they're working on the pro bono program.  A year into the program – have already issued patents, have inventors with products in the marketplace.  Launching in other cities.  By 2014, plan to have every region of US covered so that if you have a great idea, but not the resources to hire a patent attorney, you can get one through this system.  "No Invention Left Behind."  Looking to expand globally, with modifications.

Patents for Humanity – currently running.  Lot of applications coming in; closes in mid-October.  Involves patents that are being used for humanitarian purposes.  http://patentsforhumanity.challenge.gov.  Gives access to accelerated PTO processes, including appeals.

Education outreach – Put in place an education outreach to all kids in America.  Want to get positive, age-appropriate information out to kids of all ages so that they view themselves as innovators, they respect their innovations, they respect the innovations of others.

Software patents – came to the PTO to try and help with this.  Been working on making sure the agency doesn't issue patents that it shouldn't.  Championed stronger disclosure requirements; 112 guidelines specifically directed to software; trained examiners on using these guidelines; rise in 112 rejections on software patents.  This is a specific area where they're trying to improve patent quality. 

Question – how do you sort the good examiners from bad examiners?

Answer: USPTO has a LOT of data.  They track the data down to the individual examiner level.  Allowance rates – too high/too low.  Prosecution efficiency – have a new measure called compact prosecution that looks at whether the prosecution gets done.  Quality – check when they grant and reject cases.  Some of the best examiners are taken off the line and used as quality assurance supervisors.  What they've been finding is that even as you improve throughput and quality, there will be pockets (art units, departments, examiners) who need some help.  Data is also being given to the examiners on a monthly basis.  Also focusing on art units that exhibit significant deviations to see if there's an issue. Seeing improvement.

Bob Armitage – Thanked Director Kappos for the America invents Act.

The America Invents Act: One Year Later (conference)

Patent, , , ,

By Jason Rantanen

Liveblogging the America Invents Act: One Year Later conference at the Indiana University Mauer School of Law.   Warning and disclaimer: Quality may vary and these don't necessary reflect my opinions.

Session 1:

Mark Janis – opening remarks.  Hard to believe it's been a year act since AIA was signed.  Still at the beginning of understanding the AIA provisions.  Exciting times.  Lots of patent law thought leaders here today – Bob Armitage, Director K appos. 

Come back in ten days for the next conference.

Bob Armitage – wants to the the upbeat, inspirational speaker that we all need at 8:30 am. 

Some things that need to be done with the AIA in terms of legislative correction of errors.  Suggests that different constituencies in patent law work together on this goal in the immediate future – before the next election.

The AIA is the most profound change to the patent system since 1836 patent statute.  He's been involved in the process of patent reform for the last 30 years.  Shortly after he left law school, he realized that we had a law school that we had a patent system that didn't work very well.  Some of the things that we needed to do to improve the patent system was to eliminate first to invent, have a more transparent grace period, and eliminate recurring patent terms. 

Sees the AIA as major constituencies coming together to move the patent system in the direction of transparency and objectivity.  If the implementation of the AIA goes well, this is the patent system we'll have.  A more predictable patent system.  Much of this comes down to invalidity defenses – under the AIA these are much simpler. 

We were the last to the table in terms of modernizing our patent system.  Prior 1999, we really had a secret patent system. With the AIA, the patent system was opened up even further.  After AIA, there's no-fault correction of misnaming of inventors; the technical filing of an affidavit that mis-names the inventor is no longer a worry; best mode is no longer a concern for patent applicants; patent prosecutors are better off because of supplemental examination.  If they're deposed, and things arise, the patent holder can, in a pre-litigation context, go back to the patent office. (me: Query how this is viable, since depositions often arise during litigation.  Could make sense for a sequential litigant).

Other big changes: deceptive intent removed throughout the application process; patent owner can seek the patent as the applicant; no more supplemental oaths. 

Post-grant review: patents are now open to more challenges after the patent issues.  It's any issue of patentability that you can raise in court, you can raise in the PTO.  Why is this important?  This lets parties challenge patents the day patents issue, not six years down the road.  Challenging patents in court is expensive.  Post-grant review allows parties to resolve these issues in the matter of months, not years, at a fraction of the cost.

Sees the AIA as increasing transparency, objectivity, predictability, simplification of patent system.  Patent validity is reduced to just four objective legal standard: sufficient differentiation from prior public disclosures and earlier patent filings of others; sufficient disclosure to identify the claimed embodiments and enable them to be put to a specific practical, and substantial use; sufficient definiteness to differentiate subject matter; sufficient concreteness to avoid excessively conceptual or otherwise abstract subject matter.  That's all there is to the patent law.  These are objective standards that don't require you to know anything about what the inventor did, thought, etc. 

The national embarrassment of the first-to-invent system will now end. Example Gore-Tex case of why this was a problem.  Interference count practice was problematic.  It was an embarrassment and it's gone. 

The AIA is an attempt to be a codification of the way Congress wants the law, not a codification of what the law is. 102(b) was a colossal mess because of the attempt to codify existing law.  Under the AIA, there are no new AIA patent law doctrines.  Legislative history says "apply as written."  Example: 102 – only new phrase is "available to public."  Apply as written – this means that prior art is that art which is publicly accessible (comment: this issue is one of the most debated issues in the new AIA).

Who benefits from the AIA?  Those with the least resources, capital available.  It's a patent system optimized for small inventors, universities.  For those engaged in commerce of patents, supplemental examination allows for due diligence to be more effective, since it will allow the curing of inequitable conduct.

Beyond Question: RMail Challenges the Use of Subject Matter Eligibility as an Invalidity Defense

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RMail v. Amazon.com and PayPal (E.D.Tx 2012)

Over the past few weeks we have been having an interesting debate over whether subject matter eligibility under 35 U.S.C. § 101 constitutes as valid defense to patent infringement that may be raised in litigation. Section 282 of the Patent Act defines defenses available to an accused infringer and that statute has been interpreted to limit defenses available only to those that fit the statutory list. Thus, because improper revival of an abandoned patent application does not fit on the list, the Federal Circuit ruled that mistake by the patentee and USPTO could not be used to later invalidate the patent during litigation. One problem with Section 282 is that it is not a simple list of references, but is instead really a pointer to other sections of the Patent Act. Thus, an accused infringer can assert an invalidity defense based upon "any ground specified in [Sections 100-188] as a condition for patentability" as well as "any requirement of section 112, except that the failure to disclose the best mode." Now, we normally think of the doctrines of invalidity deriving from Sections 102 (anticipation); 103 (obviousness); 112 (written description; enablement; indefiniteness); and 101 (utility and subject matter eligibility). Now, Section 112 is clearly identified as a defense, and the patent act particularly identifies section 102 and 103 as creating the "conditions for patentability" required under Section 282. The lone outsider then is Section 101 whose status as creating conditions for patentability has not been established. Professor Hricik introduced this argument and began the statutory analysis in a post titled Are the Courts Correct in Their Assumption that a Patent Issued on Non-patentable Subject Matter is Invalid?. I continued the argument by considering its application to the new post grant review program in a post titled Can a Third Party Challenge Section 101 Subject Matter Eligibility in the USPTO's new Post-Grant Review Procedure?. Now, in RMail, lawyers are asking Judge Gilstrap (E.D.Tx.) to decide the issue.

RMail's asserted patents are directed to a new way to authenticate service of electronic messages – i.e., to prove that an e-mail was actually sent and received without relying upon key encryption. U.S. Patent Nos. 6,182,219 and 6,571,334. Many of the claims are not limited to any particular "technology" except for various simple data structures. Instead, the claims simply focus on the sending and receiving of the various data elements in ways that could all seemingly be done offline using pencil and paper.

After being sued, PayPal filed a motion for partial summary judgment – asking the court to rule those claims invalid under 35 U.S.C. § 101 as lacking subject matter eligibility.

In response, RMail has argued that subject matter eligibility is not a proper invalidity defense permitted to be raised under Section 282 (in addition to providing arguments on the merits).

VI. CONGRESS DID NOT PERMIT SECTION 101 TO SUPPLY A LITIGATION DEFENSE

Rmail closes by asking the Court to recognize and apply all appropriate statutory barriers against entertaining Defendants' Section 101 defense. The entire jurisprudential "murky morass" of subject matter eligibility need not arise again in any litigation. Myspace, 672 F.3d at 1260 (using "murky morass" label). Rmail acknowledges that this argument is for the good faith extension or modification of existing caselaw. Courts until now have uniformly overlooked Congressional will on this question.

Namely, while Section 101 analyses are appropriate in Patent Office application proceedings, this Court lacks any statutory basis for analyzing Section 101 issues as a litigation defense. Patent defenses are statutory. Under the Patent Act of 1952, only enumerated patent defenses exist. Aristocrat Tech. v. Int'l Game Tech., 543 F.3d 657, 661-63 (Fed. Cir. 2008). If an issue is not denominated an infringement defense within the Patent Act, then the Court lacks jurisdiction to address it. Id.

. . . .

It does not matter that the statutory misinterpretation has lasted so long, or so pervades conventional thinking. Even a long-term statutory misconstruction will not bar restoring the patent system to its statutory limits. See Central Bank of Denver v. First Interstate Bank of Denver, 511 U.S. 164, 177, 191 (1994). . . . Four recent Supreme Court cases arose in the USPTO administrative context, and are thus consistent with Rmail's argument: Benson, Flook, Diehr, Bilski. A fifth, Prometheus, admittedly arose within an infringement defense context. However, no one seems to have pointed out to the Supreme Court this important threshold issue of statutory construction, and statutory limitations on the powers of the federal courts. Prometheus thus does not bar this Court from issuing a correct ruling in the present adversarial context.

PayPal's response is fairly weak – that the dicta of Aristocrat identifies Section 101 as a condition for patentability. (To be clear, the PayPal briefs are quite good – they just lightly treat this particular issue).

The landmark 1996 Supreme Court case of Graham v. John Deere is interesting and sends somewhat mixed signals in its dicta describing the patent act. In that case, the court wrote that "The [Patent] Act sets out the conditions of patentability in three sections. An analysis of the structure of these three sections indicates that patentability is dependent upon three explicit conditions: novelty and utility as articulated and defined in § 101 and § 102, and nonobviousness, the new statutory formulation, as set out in § 103." The odd element of the Supreme Court statement is that it does not identify subject matter eligibility as a defense created by § 101. In Aristocrat, the Federal Circuit explained away the gap by noting "it is beyond question that section 101's other requirement, that the invention be directed to patentable subject matter, is also a condition for patentability." I guess that question is no longer unaskable.

Docs:


CLS Bank v. Alice Corp: Patenting Software Ideas

Patent, , , , ,

By Dennis Crouch

"Settlement risk" is real in almost every transaction. When a lawyer does legal work, how does she know that she'll get paid. Conversely, if a client pays up-front, how does he know that the work will actually be performed. There is always a possibility of filing a lawsuit to demand fulfillment. However, most businesses would prefer a system that better guarantees a more immediate positive result. A trusted (and bonded) escrow agent can help relieve the problem, but even an escrow agent needs assurances. Further, in the age of electronic funding of transactions, we should be able to take advantage of features of a computer network that might not have been available in an offline world.

The recent Federal Circuit decision in CLS Bank v. Alice Corp. focuses on the subject matter eligibility of Alice's claim to a computer system for assisting with closing financial transactions in a way that avoids settlement risk. The system includes two elements: (1) data storage with various "shadow" variables stored therein; and (2) a computer that is programmed to conduct the transaction. Basically, the transaction is initially conducted in the shadow (i.e., mock) system and then, if the shadow system shows that the parties have sufficient funds to conduct the transaction, post the obligation to the real exchange institution.

The claim reads as follows:

1. A data processing system to enable the exchange of an obligation between parties, the system comprising:

a data storage unit having stored therein information about a shadow credit record and shadow debit record for a party, independent from a credit record and debit record maintained by an exchange institution; and

a computer, coupled to said data storage unit, that is configured to (a) receive a transaction; (b) electronically adjust said shadow credit record and/or said shadow debit record in order to effect an exchange obligation arising from said transaction, allowing only those transactions that do not result in a value of said shadow debit record being less than a value of said shadow credit record; and (c) generate an instruction to said exchange institution at the end of a period of time to adjust said credit record and/or said debit record in accordance with the adjustment of said shadow credit record and/or said shadow debit record, wherein said instruction being an irrevocable, time invariant obligation placed on said exchange institution.

The district court initially ruled that the patent claim lacked subject matter eligibility. I wrote about that decision in a 2011 post entitled Bilski Applied to Invalidate Computer System Claims. In 2012, a divided Court of Appeals for the Federal Circuit revered – holding that that, when considered as a whole, the claim is patent eligible. Judge Linn wrote the majority opinion that was joined by Judge O'Malley. In many ways, Judge Linn's opinion follows the advice that Professor Rob Merges and I gave in our paper titled Operating Efficiently Post-Bilski by Ordering Patent Doctrine Decision-Making. Judge Linn's approach is to only reach Section 101 issues when subject matter ineligibility is "manifestly evident". Judge Prost wrote in dissent and argued that the majority improperly ignored the Supreme Court's most recent statements on the topic found in Prometheus. Professor Jason Rantanen wrote a nice post on the Federal Circuit decision titled CLS Bank v. Alice: The "Nothing More Than" Limitation on Abstract Ideas.

When I consider this claim, a few thoughts arise:

  1. This is a system claim rather than a method claim. However, the structure of the claim is such that the system is designed around the method that it is intended to perform. This makes me think that the teaching of Bilski and Mayo v. Prometheus cannot be ignored here even though those cases were focused on the eligibility of method claims.
  2. The claim requires computer hardware as an integral portion of the invention. However, the particularly claimed computer hardware is entirely conventional and being used in an unsurprisingly conventional manner. Further, if we relax the claim requirements of a computer and "electronic" communications then this same transaction could be fully conducted offline with paper as the data storage unit and contracts creating the time invariant obligation.
  3. Use of the system does not require any physical transformation recognized by the courts (unless you interpret the claim to be limited to only include data storage units that work by physical transformation). The claim does require changes in bank account values and legal obligations, but those have not traditionally been seen as qualifying transformations in the patent eligibility context.
  4. Finally, and most importantly for me, the invention is designed to solve a particular problem in industry and claims a system that operates by performing a series of identified steps to address that particular problem.

Many of you know that, in my view, the Supreme Court precedent on subject matter eligibility has not been internally reconciled. That ongoing precedential conflict coupled with the fuzziness of boundary lines continue to fuel debate on the topic both within and outside of the courthouse. On balance, both sides of this debate have strong arguments based upon patent law history and precedent and I can understand why someone versed in Supreme Court patent eligibility precedent could end up with a conclusion on either side.

Despite the Federal Circuit opinion, this case has not gone away. In recent days, the accused infringer (CLS Bank) has filed a request for rehearing and that request is supported by three amicus briefs. CLS Bank's main point in its brief is that the CLS Bank computer system claim is unpatentable when fully analyzed against Bilski and Prometheus. The brief asks two questions:

  1. Whether the new test for patent-eligibility articulated by the panel majority is inconsistent with Bilski's and Mayo's approach to 35 U.S.C. § 101; and
  2. Whether the method, system, and media claims at issue are patent ineligible because, albeit computer-implemented, they recite no more than an abstract fundamental mechanism of financial intermediation with no inventive concept.

The CLS Bank brief was filed by Mark Perry and his team at Gibson Dunn in DC. This is a change from the Kaye Scholer firm that represented CLS Bank at the district court and in the original appeal.

An amicus brief filed on behalf of a diverse group of five companies including British Airways and LinkedIN (and who all tend to be defendants in patent cases) spelled out how the "course filter" approach used by Judge Linn went against both recent and old Supreme Court precedent. That brief asks two additional questions:

  1. Should courts enforce the patent eligibility requirement evenhandedly without imposing a "manifestly evident" or "coarse filter" hurdle on the patent challenger?
  2. Is patent eligibility a threshold requirement well suited for decision on the pleadings and on early summary judgment?

John Vandenberg of Klarquist Sparkman filed the BA/LinkedIN brief.

Daryl Joseffer of King & Spalding filed a second amicus brief on behalf of Google, HP, Red Hat and Twitter. The brief explains how Mayo identifies four "guideposts" for determining whether an invention lacks subject matter eligibility under the prohibitions of abstract ideas and laws of nature. The four clues all begin with the notion that a patentable invention must be "significantly more than an abstract idea." Thus, if you begin with an abstract idea, "(1) adding steps that are conventional or obvious is insufficient to confer patentable subject matter (Mayo at 1294, 1298, 1299); (2) adding steps that are so general and non-specific that they do not significantly limit the claim's scope is insufficient (id. at 1300, 1302); (3) limiting an idea to a particular technological environment is insufficient (id. at 1294, 1297); and (4) claims that fail the machine-or-transformation test are likewise dubious (id. at 1296, 1303). Explaining the first point, the brief argues that a claim must contain an "inventive concept" apart from the identified law of nature or abstract idea.

The EFF brief filed by Julie Samuel reminds the court of the extensive literature concluding that software patents are bad – especially when in the hands of "patent trolls."

The patentee's responsive brief is due later this month.

*****

*****

At least two additional software patent cases are pending at the Federal Circuit. In Bancorp v. Sun Life, a different panel of Federal Circuit judges considered software patents similar to those in CLS Bank but found the claims ineligible under Section 101. In WildTangent v. Ultramercial, the Federal Circuit initially ruled that patented method of distributing copyrighted media was eligible. However, that case was vacated and remanded by the Supreme Court following its decision in Mayo and with instructions to reconsider the holding based upon the new Supreme Court precedent. WildTangent has also requested an en banc hearing. WildTangent's petition asks: "When does a patent's reference to the use of a general purpose computer or an Internet website transform an otherwise unpatentable abstract concept into a process that satisfies the subject-matter eligibility requirement of 35 U.S. C. § 101?" Arguing from the other side (asking for its patent to be revalidated), Bancorp identifies the conflict with CLS Bank and argues that the "manifestly abstract" standard should be applied to its case.

*****

Judge Linn, author of the CLS Bank decision has announced his move to Senior Status in November 2012. Senior judges ordinarily do not decide whether to hear cases en banc and do not sit en banc. The one significant exception to that rule is that a senior judge will be a part of the en banc panel if that judge was a part of the original panel that heard the case. For this particular contentious issue, Judge Linn's status may well impact the results.

*****

Counting votes is always difficult and may not be worthwhile, but I pulled-up seven recent software patent eligibility decisions and classified the results based upon how the various panel member voted on the eligibility question. If I leave out judges Schall and Plager (Senior judges), the result is that three of the judges sit on the "claims eligible" side (Chief Judge Rader and Judges O'Malley and Newman); five of the judges are on the "claims ineligible" side (Judges Prost, Bryson, Dyk, Moore, and Wallach); two have decisions on both sides (Judges Linn and Lourie); and one is not in my sample (Judge Reyna).

Case

Claims Eligible

Claims Ineligible

WildTangent

Rader, Lourie, O'Malley

  

CLS Bank

Linn, O'Malley

Prost

Bancorp

  

Lourie, Prost, Wallach

RCT v. Microsoft

Rader, Newman, Plager

  

Cybersource

  

Bryson, Dyk, Prost

Dealtracker*

Plager

Linn, Dyk

Fort Properties

  

Prost, Schall, Moore


 

Continuations-in-Part (CIPs) and Priority Claims

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By Dennis Crouch

This post considers the meaning of priority in a continuation-in-part application and, in particular, when the claimed priority document can serve as prior art against the child.

Yesterday, I wrote about the majority opinion in Santarus v. Par Pharma (Fed. Cir. 2012). In that case, the patentee was fighting for the validity of its continuation-in-part (CIP) patent. A CIP is a patent filing that claims priority to a previously filed parent patent document but that also adds some amount of new material to the disclosure and/or claims. In CIP applications, priority date is determined on a claim-by-claim basis. Of course the priority date is important because it largely defines the scope of prior art available to potentially invalidate the patent claims.

In its decision, the Court of Appeals for the Federal Circuit ruled that some of the disputed claims were sufficiently disclosed in the parent filing and therefore properly claimed priority to that original filing date. Another set of claims, however, included matter that was added in the CIP. Those claims with new matter were not given priority to the original filing and thus had to rely on the filing date of the CIP application. Thus, for the claims with new matter any patent issued or document published more than one-year before the CIP filing date would count as prior art under 35 U.S.C. 102(b). See Paperless Accounting v. Bay Area Rapid Transit System, 804 F.2d 659, 665 (Fed. Cir. 1986).

At this point in the analysis, there is a major point of contention between the judges on one particular alleged prior art reference – whether the original patent filing counts as prior art against the child. The parent patent (really, the great grandparent patent) was filed in 1996 and issued as a patent in 1998. The descendent patent in being litigated in this case was not filed until 2003 but claims priority back to the original 1996 filing through a series of continuations and CIPs. Under normal circumstances, a 1998 patent would clearly serve as prior art against a 2003 filing under Section 102(b) as discussed above. However the system of priority claiming to parent applications is designed to overcome that problem by treating the child applications as if they had been filed on the same day as the original ancestor – so long as the procedures of 35 U.S.C. § 120 are followed. Interesting for the purposes of this discussion, Section 120 discusses priority at the patent level rather than claim-by-claim and asks whether the “application for patent” satisfies the written description and enablement requirements.

35 U.S.C. 120 Benefit of earlier filing date in the United States.

An application for patent for an invention disclosed in the manner provided by the first paragraph of section 112 of this title in an application previously filed in the United States . . . shall have the same effect, as to such invention, as though filed on the date of the prior application. . .

In Santarus, the invention of only some of the claims were sufficiently disclosed in the original specification. For those claims that lack priority, the big question is whether and to what extent the original patent can be used as 102(b)/103(a) prior art as part of an obviousness rejection.

In a per curiam opinion, the majority (Chief Judge Rader and Judge Moore) held that – since priority is determined on a claim-by-claim basis – that the original patent was prior art against the claims that lacked priority. Writing in dissent, Judge Newman argued that the priority should be given with regard to material disclosed in the priority document. Judge Newman’s approach also breaks the patent apart but divides priority more precisely according to which material was found in the original disclosure. Under Judge Newman’s approach, the original filing cannot be used as a priority document.

Newman writes:

The panel majority forgets that “matter disclosed in the parent application is entitled to the benefit of the filing date of the parent application.” Waldemar Link, GmbH & Co. v. Osteonics Corp., 32 F.3d 556 (Fed. Cir. 1994); see Litton Sys., Inc. v. Whirlpool Corp., 728 F.2d 1423 (Fed. Cir. 1984) (“The earlier filing date of the parent application pertains to material in the C-I-P application also disclosed in the prior application. 35 U.S.C. §120.”). Instead, the panel majority relies upon the common subject matter from the ‘737 [original] patent disclosure to invalidate the ‘885 claims supported by that subject matter. This is incorrect, for the common subject matter in the ‘885 patent is entitled to the ‘737 filing date. That entitlement is not lost by issuance of the ‘737 patent.

Of course, majority did not “forget” as Judge Newman suggested. Rather, the majority found that the patentee had “waived any argument that the ‘737 patent is not prior art to the other claims” by failing to appeal that point.

+ + + + +

Although distinguishable, the most on-point decision relating to this issue may well be In re Chu, 66 F.3d 292 (Fed. Cir. 1995). In that case (and with Judge Newman on the panel), the Federal Circuit ruled that the asserted priority document could be used as prior art because all of the claims included added limitations not found in the priority document. The court wrote:

Chu is entitled to the benefit of the Doyle patent filing date only if the Doyle patent discloses the subject matter now claimed by Chu. This, however, is admitted by Chu not to be the case. In fact, Chu states that “the invention as now claimed[ ] was not described in the [Doyle] patent.” Specifically, Chu concedes that “nothing in Doyle suggests that SCR catalyst be placed inside the bag filter.” Therefore, independent claim 1, which includes this limitation, and dependent claims 2, 4, and 14, are not supported by the Doyle patent disclosure. Accordingly, Chu cannot obtain the benefit of the Doyle patent filing date for these claims and the Doyle patent was properly relied on as prior art.

The obvious difference between the present case and Chu is that some of the claims are supported by the priority document.

MPEP 2106 Patent Subject Matter Eligibility [R-9]

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There are two criteria for determining subject matter eligibility and both must be satisfied. The claimed invention (1) must be directed to one of the four statutory categories, and (2) must not be wholly directed to subject matter encompassing a judicially recognized exception, as defined below. The following two step analysis is used to evaluate these criteria.

I.   THE FOUR CATEGORIES OF STATUTORY SUBJECT MATTER

Step 1: Is the claim directed to one of the four patent-eligible subject matter categories: process, machine, manufacture, or composition of matter? The subject matter of the claim must be directed to one of the four subject matter categories. If it is not, the claim is not eligible for patent protection and should be rejected under 35 U.S.C. 101 , for at least this reason. A summary of the four categories of invention, as they have been defined by the courts, are:

  • i. Process – an act, or a series of acts or steps. See Gottschalk v. Benson, 409 U.S. 63, 70, 175 USPQ 673, ___ (1972) ("A process is a mode of treatment of certain materials to produce a given result. It is an act, or a series of acts, performed upon the subject-matter to be transformed and reduced to a different state or thing." (emphasis added) (quotingCochrane v. Deener, 94 U.S. 780, 788, 24 L. Ed. 139, 1877 Dec. Comm'r Pat. 242 (1876)); NTP, Inc. v. Research in Motion, Ltd., 418 F.3d 1282, 1316, 75 USPQ2d 1763, ___(Fed. Cir. 2005) ("A process is a series of acts." (quoting Minton v. Natl. Ass'n. of Securities Dealers, 336 F.3d 1373, , 336 F.3d 1373, 1378, 67 USPQ2d 1614, ___ (Fed. Cir. 2003))). See also 35 U.S.C. 100(b); Bilski v. Kappos, 130 S. Ct. 3218, 95 USPQ2d 1001 (2010).
  • ii. Machine – a concrete thing, consisting of parts, or of certain devices and combination of devices. Burr v. Duryee, 68 U.S. (1 Wall.) 531, 570, 17 L. Ed. 650 (1863). This includes every mechanical device or combination of mechanical powers and devices to perform some function and produce a certain effect or result. Corning v. Burden, 56 U.S. 252, 267, 14 L. Ed. 683 (1854).
  • iii. Manufacture – an article produced from raw or prepared materials by giving to these materials new forms, qualities, properties, or combinations, whether by handlabor or by machinery. Diamond v. Chakrabarty, 447 U.S. 303, 308, 206 USPQ 193, ___ (1980) (emphasis added) (quoting Am. Fruit Growers, Inc. v. Brogdex Co., 283 U.S. 1, 11, 51 S. Ct. 328, 75 L. Ed. 801, 1931 (Dec. Comm'r Pat. 711 (1931))).
  • iv. Composition of matter – all compositions of two or more substances and all composite articles, whether they be the results of chemical union, or of mechanical mixture, or whether they be gases, fluids, powders or solids, for example. Chakrabarty, 447 U.S. at 308.

    Non-limiting examples of claims that are not directed to one of the statutory categories:

  • i. transitory forms of signal transmission (for example, a propagating electrical or electromagnetic signal per se), In re Nuijten, 500 F.3d 1346, 1357, 84 USPQ2d 1495, ___ (Fed. Cir. 2007);
  • ii. a naturally occurring organism, Chakrabarty, 447 U.S. at 308;
  • iii. a human per se, The Leahy-Smith America Invents Act (AIA), Public Law 112-29, sec. 33, 125 Stat. 284 (September 16, 2011);
  • iv. a legal contractual agreement between two parties, see In re Ferguson, 558 F.3d 1359, 1364, 90 USPQ2d 1035, ___ (Fed. Cir. 2009) (cert. denied);
  • v. a game defined as a set of rules;
  • vi. a computer program per se, Gottschalk v. Benson, 409 U.S. at 72;
  • vii. a company, Ferguson, 558 F.3d at 1366; and
  • viii. a mere arrangement of printed matter, In re Miller, 418 F.2d 1392, 1396, 164 USPQ 46, ___ (CCPA 1969).

    A claim that covers both statutory and non-statutory embodiments (under the broadest reasonable interpretation of the claim when read in light of the specification and in view of one skilled in the art) embraces subject matter that is not eligible for patent protection and therefore is directed to non-statutory subject matter. Such claims fail the first step and should be rejected under 35 U.S.C. 101 , for at least this reason.

    For example, machine readable media can encompass non-statutory transitory forms of signal transmission, such as, a propagating electrical or electromagnetic signal per se. See In re Nuijten, 500 F.3d 1346, 84 USPQ2d 1495 (Fed. Cir. 2007). When the broadest reasonable interpretation of machine readable media in light of the specification as it would be interpreted by one of ordinary skill in the art encompasses transitory forms of signal transmission, a rejection under 35 U.S.C. 101 as failing to claim statutory subject matter would be appropriate. Thus, a claim to a computer readable medium that can be a compact disc or a carrier wave covers a non-statutory embodiment and therefore should be rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.

    If the claimed invention is clearly not within one of the four categories, it is not patent eligible. However, when the claim fails under Step 1 and it appears from applicant's disclosure that the claim could be amended to be directed to a statutory category, Step 2 below should still be conducted.

    II.   JUDICIAL EXCEPTIONS TO THE FOUR CATEGORIES

    Step 2: Does the claim wholly embrace a judicially recognized exception, which includes laws of nature, physical phenomena, and abstract ideas, or is it a particular practical application of a judicial exception? See Bilski v. Kappos, 561 U.S. ___, 130 S. Ct. 3218, 3225, 95 USPQ2d 1001 (2010) (stating "The Court's precedents provide three specific exceptions to § 101's broad patent-eligibility principles: 'laws of nature, physical phenomena, and abstract ideas.'") (quoting Diamond v. Chakrabarty, 447 U.S. 303, 309, 206 USPQ 193, ___ (1980)).

    Determining whether the claim falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter) does not end the analysis because claims directed to nothing more than abstract ideas (such as mathematical algorithms), natural phenomena, and laws of nature are not eligible for patent protection. Diamond v. Diehr, 450 U.S. 175, 185, 209 USPQ 1, 7 (1981); accord, e.g., Chakrabarty, 447 U.S. at 309, 206 USPQ at 197; Parker v. Flook, 437 U.S. 584, 589, 198 USPQ 193, 197 (1978); Benson, 409 U.S. at 67-68 , 175 USPQ at 675. "A principle, in the abstract, is a fundamental truth; an original cause; a motive; these cannot be patented, as no one can claim in either of them an exclusive right." Le Roy v. Tatham,, 55 U.S. (14 How.) 156, 175 (1852). Instead, such "manifestations of laws of nature" are "part of the storehouse of knowledge," "free to all men and reserved exclusively to none." Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130, 76 USPQ 280, 281 (1948).

    Thus, "a new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter" under Section 101. Chakrabarty, 447 U.S. at 309, 206 USPQ at 197. "Likewise, Einstein could not patent his celebrated law that E=mc2; nor could Newton have patented the law of gravity." Ibid. Nor can one patent "a novel and useful mathematical formula," Flook, 437 U.S. at 585, 198 USPQ at 195; electromagnetism or steam power, O'Reilly v. Morse, 56 U.S. (15 How.) 62, 113-114 (1853); or "[t]he qualities of … bacteria, … the heat of the sun, electricity, or the qualities of metals," Funk, 333 U.S. at 130, 76 USPQ at 281; see Le Roy, 55 U.S. (14 How.) at 175.

    While abstract ideas, physical phenomena, and laws of nature are not eligible for patenting, methods and products employing abstract ideas, physical phenomena, and laws of nature to perform a real-world function may well be. In evaluating whether a claim meets the requirements of 35 U.S.C. 101 , the claim must be considered as a whole to determine whether it is for a particular application of an abstract idea, physical phenomenon, or law of nature, and not for the abstract idea, physical phenomenon, or law of nature itself. Diehr, 450 U.S. at 188-178.

    In addition to the terms laws of nature, physical phenomena, and abstract ideas, judicially recognized exceptions have been described using various other terms, including natural phenomena, scientific principles, systems that depend on human intelligence alone, disembodied concepts, mental processes and disembodied mathematical algorithms and formulas, for example. The exceptions reflect the courts' view that the basic tools of scientific and technological work are not patentable.

    The claimed subject matter must not be wholly directed to a judicially recognized exception. If it is, the claim is not eligible for patent protection and should be rejected under 35 U.S.C. 101 . However, a claim that is limited to a particular practical application of a judicially recognized exception is eligible for patent protection. A "practical application" relates to how a judicially recognized exception is applied in a real world product or a process, and not merely to the result achieved by the invention. When subject matter has been reduced to a particular practical application having a real world use, the claimed practical application is evidence that the subject matter is not abstract (e.g., not purely mental) and does not encompass substantially all uses (preemption) of a law of nature or a physical phenomenon. See, e.g., Ultramercial v. Hulu, 657 F.3d 1323, 1329, 100 USPQ2d 1140,1145 (Fed. Cir. 2011)(stating that the patent "does not claim a mathematical algorithm, a series of purely mental steps, or any similarly abstract concept. It claims a particular method . . . a practical application of the general concept.").

    A.   Practical Application of Machines, Manufactures, and Compositions of Matter (Products)

    If the claimed product falls within one of the three product categories of invention and does not recite judicially excepted subject matter, e.g., a law of nature, a physical phenomenon, or an abstract idea, it qualifies as eligible subject matter. If a judicial exception is recited in the claim, it must be determined if the judicially excepted subject matter has been practically applied in the product.

    Eligible machines, manufactures, and compositions of matter are non-naturally occurring products typically formed of tangible elements or parts that embody a particular or specific, tangible practical application of the invention. Thus, for these product categories, a particular practical application is often self-evident based on the claim limitations that define the tangible embodiment. This is because an idea that is tangibly applied to a structure is no longer abstract, and a law of nature or physical phenomenon that is practically applied to a structure is limited to that particular application of the concept. For example, a cup is the tangible application of the abstract idea of containing a liquid and is one limited embodiment of that idea (which is no longer abstract). As another example, a magnetic door latch is the tangible application of the concept of magnetism and does not wholly embrace the concept of magnetism but, rather, is one limited application of the concept.

    A claim that includes terms that imply that the invention is directed to a product, for instance by reciting "a machine comprising…", but fails to include tangible limitations in accordance with its broadest reasonable interpretation is not limited to a practical application, but rather wholly embraces or encompasses the concept upon which the invention is based. This is impermissible as such claim coverage would extend to every way of applying the abstract idea, law of nature or physical phenomenon.

    A claim that includes judicially excepted subject matter and whose broadest reasonable interpretation is directed to a man-made tangible embodiment (i.e., structure) with a real world use is limited to a practical application (the subject matter has been practically applied). The reason is that the claim as a whole must be evaluated for eligibility in the same manner that a claim as a whole is evaluated for patentability under 35 U.S.C. 102, 103 and 112.

    Once a practical application has been established, the limited occurrence of preemption must be evaluated to determine whether the claim impermissibly covers substantially all practical applications of the judicially excepted subject matter. If so, the claim is not patent-eligible. If the claim covers only a particular practical application of the judicially excepted subject matter, it is patent eligible.

    The following examples show the difference between a tangible embodiment that is evidence of a particular practical application and an abstract concept that has no practical application.

  • (a) A claim that is directed to a machine comprising a plurality of structural elements that work together in a defined combination based on a mathematical relationship, such as a series of gears, pulleys and belts, possesses structural limitations that show that it is a tangible embodiment, providing evidence that the mathematical relationship has been applied (a practical application). Additionally, that tangible embodiment is limited by the claimed structure and would not cover all substantial practical uses of the mathematical relationship. The claim would be eligible for patent protection.
  • (b) On the other hand, a claim that is directed to a machine ("What is claimed is a machine that operates in accordance with F=ma.") and includes no tangible structural elements under the broadest reasonable interpretation, covers the operating principle based on a mathematical relationship with no limits on the claim scope. Thus, as no tangible embodiment is claimed, there would be no evidence of a practical application. The claim would wholly embrace the mathematical concept of F=ma and would not be eligible subject matter.
  • (c) As another example, a claim to a non-transitory, tangible computer readable storage medium per se that possesses structural limitations under the broadest reasonable interpretation standard to qualify as a manufacture would be patent-eligible subject matter. Adding additional claim limitations to the medium, such as executable instructions or stored data, to such a statutory eligible claim would not render the medium non-statutory, so long as the claim as a whole has a real world use and the medium does not cover substantially all practical uses of a judicial exception. The claim as a whole remains a tangible embodiment and qualifies as a manufacture. As explained above, the additional claim limitations would be evaluated in terms of whether they distinguish over the prior art.

    B.   Practical Application of Processes (Methods)

    The Supreme Court in Bilski v. Kappos, 561 U.S. ___, 130 S. Ct. 3218, 95 USPQ2d 1001 (2010), clarified the requirements for a claim to be a statutory process. Not every claimed method qualifies as a statutory process. A process claim, to be statutory under 35 U.S.C. 101 , must be limited to a particular practical application. This ensures that the process is not simply claiming an abstract idea, or substantially all practical uses of (preempting) a law of nature, or a physical phenomenon. See MPEP § 2106.01 for further guidance regarding subject matter eligibility determinations during examination of process claims that involve laws of nature/natural correlations.

    A claim that attempts to patent an abstract idea is ineligible subject matter under 35 U.S.C. 101 . See Bilski, 130 S. Ct. at 3230 (''[A]ll members of the Court agree that the patent application at issue here falls outside of § 101 because it claims an abstract idea.''). The abstract idea exception has deep roots in the Supreme Court's jurisprudence. See Bilski, 130 S. Ct. at 3225 (citing Le Roy v. Tatham, 55 U.S. (14 How.) 156, 174–175 (1853)).

    Bilski reaffirmed Diehr's holding that ''while an abstract idea, law of nature, or mathematical formula could not be patented, 'an application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection.''' See Bilski, 130 S. Ct. at 3230 (quoting Diamond v. Diehr, 450 U.S. 175, 187 (1981)) (emphasis in original). The recitation of some structure, such as a machine, or the recitation of some transformative component will in most cases limit the claim to such an application. However, not all such recitations necessarily save the claim: ''Flook established that limiting an abstract idea to one field of use or adding token postsolution components did not make the concept patentable.'' See Bilski, 130 S. Ct. at 3231. Moreover, the fact that the steps of a claim might occur in the ''real world'' does not necessarily save it from a 35 U.S.C. 101 rejection. Thus, the Bilski claims were said to be drawn to an ''abstract idea'' despite the fact that they included steps drawn to initiating transactions. The ''abstractness'' is in the sense that there are no limitations as to the mechanism for entering into the transactions.

    Consistent with the foregoing, Bilski holds that the following claim is abstract:

    1. A method for managing the consumption risk costs of a commodity sold by a commodity provider at a fixed price comprising the steps of:

    • (a) Initiating a series of transactions between said commodity provider and consumers of said commodity wherein said consumers purchase said commodity at a fixed rate based upon historical averages, said fixed rate corresponding to a risk position of said consumer;
    • (b) Identifying market participants for said commodity having a counter-risk position to said consumers; and
    • (c) Initiating a series of transactions between said commodity provider and said market participants at a second fixed rate such that said series of market participant transactions balances the risk position of said series of consumer transactions.

    Specifically, the Court explains:

    The concept of hedging, described in claim 1 and reduced to a mathematical formula in claim 4, is an unpatentable abstract idea, just like the algorithms at issue in Bensonand Flook. Allowing petitioners to patent risk hedging would preempt use of this approach in all fields, and would effectively grant a monopoly over an abstract idea.

    Bilski also held that the additional, narrowing, limitations in the dependent claims were mere field of use limitations or insignificant postsolution components, and that adding these limitations did not make the claims patent-eligible. Claims 1–9 in Bilski are examples of claims that run afoul of the abstract idea exception. The day after deciding Bilski, the Supreme Court denied certiorari in Ferguson v. Kappos, U.S. Supreme Court No. 09–1501, while granting, vacating, and remanding two other Federal Circuit 35 U.S.C. 101 cases. The denial of certiorari left intact the rejection of all of Ferguson's claims. Although the Federal Circuit had applied the machine-or-transformation test to reject Ferguson's process claims, the Supreme Court's disposition of Ferguson makes it likely that the Ferguson claims also run afoul of the abstract idea exception. A representative Ferguson claim is:

    1. A method of marketing a product, comprising:

    • Developing a shared marketing force, said shared marketing force including at least marketing channels, which enable marketing a number of related products;
    • Using said shared marketing force to market a plurality of different products that are made by a plurality of different autonomous producing company [sic], so that different autonomous companies, having different ownerships, respectively produce said related products;
    • Obtaining a share of total profits from each of said plurality of different autonomous producing companies in return for said using; and
    • Obtaining an exclusive right to market each of said plurality of products in return for said using.

    The following guidance presents factors that are to be considered when evaluating patent-eligibility of method claims. The factors include inquiries from the machine-or-transformation test, which remains a useful investigative tool, and inquiries gleaned from Supreme Court precedent. See In re Bilski, 545 F.3d 943, 954 (Fed. Cir. 2009) (stating that "[a] claimed process is surely patent-eligible under § 101if: (1) it is tied to a particular machine or apparatus, or (2) it transforms a particular article into a different state or thing."); and Bilski, 130 S. Ct. at 3227 (stating, "This Court's precedents establish that the machine-or-transformation test is a useful and important clue, an investigative tool, for determining whether some claimed inventions are processes under § 101. The machine-or-transformation test is not the sole test for deciding whether an invention is a patent-eligible 'process.'").

    While the Supreme Court in Bilski did not set forth detailed guidance, there are many factors to be considered when determining whether there is sufficient evidence to support a determination that a method claim is directed to an abstract idea. The following factors are intended to be useful examples and are not intended to be exclusive or limiting. It is recognized that new factors may be developed, particularly for emerging technologies. It is anticipated that the factors will be modified and changed to take into account developments in precedential case law and to accommodate prosecution issues that may arise in implementing this new practice.

    Where the claim is written in the form of a method and is potentially a patentable process, as defined in 35 U.S.C. 100(b), the claim is patent-eligible so long as it is not disqualified as one of the exceptions to 35 U.S.C. 101 's broad patent-eligibility principles; i.e., laws of nature, physical phenomena, and abstract ideas.

    Taking into account the following factors, the examiner should determine whether the claimed invention, viewed as a whole, is disqualified as being a claim to an abstract idea. Relevant factors—both those in favor of patent-eligibility and those against such a finding—should be weighed in making the determination. Factors that weigh in favor of patent-eligibility satisfy the criteria of the machine-or-transformation test or provide evidence that the abstract idea has been practically applied. Factors that weigh against patent-eligibility neither satisfy the criteria of the machine-or-transformation test nor provide evidence that the abstract idea has been practically applied. Each case will present different factors, and it is likely that only some of the factors will be present in each application. It would be improper to make a conclusion based on one factor while ignoring other factors.

    With respect to the factors listed below, a "field-of-use" limitation does not impose actual boundaries on the scope of the claimed invention. A field-of-use limitation merely indicates that the method is for use in a particular environment, such as "for use with a machine" or "for transforming an article", which would not require that the machine implement the method or that the steps of the method cause the article to transform. A field-of-use limitation does not impose a meaningful limit on the claimed invention. Insignificant "extra-solution" activity means activity that is not central to the purpose of the method invented by the applicant. For example, gathering data to use in the method when all applications of the method would require some form of data gathering would not impose a meaningful limit on the claim.

    1.   Factors To Be Considered in an Abstract Idea Determination of a Method Claim

    (a)   Whether the method involves or is executed by a particular machine or apparatus

    "The machine-or-transformation test is a useful and important clue, and investigative tool, for determining whether some claimed inventions are processes under § 101." Bilski v. Kappos, 561 U.S. ___, ___, 130 S. Ct. 3218, 3227, 95 USPQ2d 1001, ___ (2010). If so, the claims are less likely to be drawn to an abstract idea; if not, they are more likely to be so drawn. With respect to these factors, a "machine" is a concrete thing, consisting of parts, or of certain devices and combination of devices. This includes every mechanical device or combination of mechanical powers and devices to perform some function and produce a certain effect or result. This definition is interpreted broadly to include electrical, electronic, optical, acoustic, and other such devices that accomplish a function to achieve a certain result. An "apparatus" does not have a significantly different meaning from a machine and can include a machine or group of machines or a totality of means by which a designated function or specific task is executed.

    Where a machine or apparatus is recited or inherent in a patent claim, the following factors are relevant:

    (a) The particularity or generality of the elements of the machine or apparatus; i.e., the degree to which the machine in the claim can be specifically identified (not any and all machines). Incorporation of a particular machine or apparatus into the claimed method steps weighs toward eligibility.

    For computer implemented processes, the "machine" is often disclosed as a general purpose computer. In these cases, the general purpose computer may be sufficiently "particular" when programmed to perform the process steps. Such programming creates a new machine because a general purpose computer, in effect, becomes a special purpose computer once it is programmed to perform particular functions pursuant to instructions from program software. In re Alappat, 33 F.3d 1526, 1545, 31 USPQ 1545, ___ (Fed. Cir. 1994); see alsoUltramercial v. Hulu, 657 F.3d 1323, 1329, 100 USPQ2d 1140, 1145 (Fed. Cir. 2011) (stating "a programmed computer contains circuitry unique to that computer"). However, "adding a 'computer-aided' limitation to a claim covering an abstract concept, without more, is insufficient to render [a] patent claim eligible" where the claims "are silent as to how a computer aids the method, the extent to which a computer aids the method, or the significance of a computer to the performance of the method." DealerTrack v. Huber, ___ F.3d ___, ___, 101 USPQ2d 1325, 1339-40 (Fed. Cir. 2012). To qualify as a particular machine under the test, the claim must clearly convey that the computer is programmed to perform the steps of the method because such programming, in effect, creates a special purpose computer limited to the use of the particularly claimed combination of elements (i.e., the programmed instructions) performing the particularly claimed combination of functions. If the claim is so abstract and sweeping that performing the process as claimed would cover substantially all practical applications of a judicial exception, such as a mathematical algorithm, the claim would not satisfy the test as the machine would not be sufficiently particular.

    (b) Whether the machine or apparatus implements the steps of the method. Integral use of a machine or apparatus to achieve performance of the method weighs toward eligibility, as compared to where the machine or apparatus is merely an object on which the method operates, which weighs against eligibility. See Cybersource v. Retail Decisions, 654 F.3d 1366, 99 USPQ2d 1960 (Fed. Cir. 2011) ("We are not persuaded by the appellant's argument that claimed method is tied to a particular machine because it 'would not be necessary or possible without the Internet.' . . . Regardless of whether "the Internet" can be viewed as a machine, it is clear that the Internet cannot perform the fraud detection steps of the claimed method").

    (c) Whether its involvement is extrasolution activity or a field-of-use, i.e., the extent to which (or how) the machine or apparatus imposes meaningful limits on the execution of the claimed method steps. Use of a machine or apparatus that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would weigh against eligibility. See Bilski, 138 S. Ct. at 3230 (citing Parker v. Flook, 437 U.S. 584, 590, 198 USPQ 193, ___ (1978)), and Cybersource v. Retail Decisions, 654 F.3d 1366, 99 USPQ2d 1690 (Fed. Cir. 2011) ("while claim 3 requires an infringer to use the Internet to obtain that data . . . [t]he Internet is merely described as the source of the data. We have held that mere '[data-gathering] step[s] cannot make an otherwise nonstatutory claim statutory.'" In re Grams, 888 F.2d 835, 840, 12 USPQ2d 1824, ___ (Fed. Cir. 1989) (quoting In re Meyer, 688 F.2d 789, 794, 215 USPQ 193, ___ (CCPA 1982)))…

    (b)   Whether performance of the claimed method results in or otherwise involves a transformation of a particular article

    "Transformation and reduction of an article 'to a different state or thing' is the clue to patentability of a process claim that does not include particular machines." Bilski v. Kappos, 561 U.S. ___, 130 S. Ct. 3218, 3227, 95 USPQ2d 1001 (2010)(quoting Gottschalk v. Benson, 409 U.S. 63, 70, 175 USPQ 673, ___ (1972). If such a transformation exists, the claims are less likely to be drawn to an abstract idea; if not, they are more likely to be so drawn.

    An "article" includes a physical object or substance. The physical object or substance must be particular, meaning it can be specifically identified. An article can also be electronic data that represents a physical object or substance. For the test, the data should be more than an abstract value. Data can be specifically identified by indicating what the data represents, the particular type or nature of the data, and/or how or from where the data was obtained.

    "Transformation" of an article means that the "article" has changed to a different state or thing. Changing to a different state or thing usually means more than simply using an article or changing the location of an article. A new or different function or use can be evidence that an article has been transformed. Manufactures and compositions of matter are the result of transforming raw materials into something new with a different function or use. Purely mental processes in which thoughts or human based actions are "changed" are not considered an eligible transformation. For data, mere "manipulation of basic mathematical constructs [i.e,] the paradigmatic 'abstract idea'," has not been deemed a transformation. Cybersource v. Retail Decisions, 654 F.3d 1366, 1372 n.2, 99 USPQ2d 1690, 1695 n.2 (Fed. Cir. 2011)(quoting In re Warmerdam, 33 F.3d 1354, 1355, 1360 (Fed. Cir. 1994). However, transformation of electronic data has been found when the nature of the data has been changed such that it has a different function or is suitable for a different use. In re Bilski, 545 F.3d 943, 962-63 (Fed. Cir. 2009)(aff'd sub nom Bilski v. Kappos, 130 S. Ct. 3218 (2010)).

    Where a transformation occurs, the following factors are relevant:

    (a) The particularity or generality of the transformation. The Supreme Court has stated that an invention comprising a process of "'tanning, dyeing, making waterproof cloth, vulcanizing India rubber [or] smelting ores' . . . are instances . . . where the use of chemical substances or physical acts, such as temperature control, changes articles or materials [in such a manner that is] sufficiently definite to confine the patent monopoly within rather definite bounds." Gottschalk v. Benson, 409 U.S. 63, 70, 175 USPQ 673, ___ (1972) (discussing Corning v. Burden, 15 How.(56 U.S.) 252, 267-68). A more particular transformation would weigh in favor of eligibility.

    (b) The degree to which the recited article is particular; i.e., can be specifically identified (not any and all articles). A transformation applied to a generically recited article would weigh against eligibility.

    (c) The nature of the transformation in terms of the type or extent of change in state or thing, for instance by having a different function or use, which would weigh toward eligibility, compared to merely having a different location, which would weigh against eligibility.

    (d) The nature of the article transformed, i.e., whether it is an object or substance, weighing toward eligibility, compared to a concept such as a contractual obligation or mental judgment, which would weigh against eligibility.

    (e) Whether its involvement is extrasolution activity or a field-of-use, i.e., the extent to which (or how) the transformation imposes meaningful limits on the execution of the claimed method steps. A transformation that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would weigh against eligibility.

    (c)   Whether performance of the claimed method involves an application of a law of nature, even in the absence of a particular machine, apparatus, or transformation

    An application of a law of nature may represent patent-eligible subject matter even in the absence of a particular machine, apparatus, or transformation. See, e.g., Bilski v. Kappos, 561 U.S. ___, 130 S. Ct. 3218, 3227, 95 USPQ2d 1001 (2010)(citing Diamond v. Diehr, 450 U.S. 175, 187, 209 USPQ 1, ___ (1981)) (stating that the Court had previously "explicitly declined to 'hold that no process patent could ever qualify if it did not meet [machine or transformation] requirements.") (quoting Gottschalk v. Benson, 409 U.S. 63, 67, 175 USPQ 673, ___ (1972)). If such an application exists, the claims are less likely to be drawn to an abstract idea; if not, they are more likely to be so drawn. See MPEP § 2106.01 for further guidance regarding subject matter eligibility determinations during examination of process claims that involve laws of nature/natural correlations.

    Where such an application is present, the following factors are relevant:

    (a) The particularity or generality of the application. Application of a law of nature having broad applicability across many fields of endeavor weighs against eligibility, such as where the claim generically recites an effect of the law of nature or claims every mode of accomplishing that effect, such that the claim would monopolize a natural force or patent a scientific fact. See O'Reilly v. Morse, 56 U.S. 62 (1853)(finding unpatentable a claim for "the use of electromagnetism for transmitting signals at a distance"); The Telephone Cases, 126 U.S. 1, 209 (1888)(discussing a method of "transmitting vocal or other sound telepgraphically … by causing electrical undulations, similar in form to the vibrations of the air accompanying the said vocal or other sounds," stating "[Bell] had detected a secret of nature . . . .[H]e proceeded promptly to patent, not only a particular method and apparatus for availing of that law, but also the right to avail of that law by any means whatever. Thus considered he has been able to monopolize a natural force, and patent a scientific fact.").

    (b) Whether the claimed method recites an application of a law of nature solely involving subjective determinations; e.g., ways to think about the law of nature. Application of a law of nature to a particular way of thinking about, or reacting to, a law of nature would weigh against eligibility. See The Telephone Cases, 126 U.S. at 210 (stating "[counsel for defendant] argued, that in all the cases upholding a claim for a process, the process was one capable of being sensually perceived, verified and proved by oath — not as a matter of opinion, but as a matter of fact."), id. at 211 (discussing Tilghman v. Proctor, 102 U.S. 707 (1880) ("[t]here was a process, all of which lay within ordinary means of observation and verification.").

    (c) Whether its involvement is extrasolution activity or a field-of-use, i.e., the extent to which (or how) the application imposes meaningful limits on the execution of the claimed method steps. An application of the law of nature that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would weigh against eligibility.

    (d)   Whether a general concept (which could also be recognized in such terms as a principle, theory, plan or scheme) is involved in executing the steps of the method

    The presence of such a general concept can be a clue that the claim is drawn to an abstract idea. Where a general concept is present, the following factors are relevant:

    (a) The extent to which use of the concept, as expressed in the method, would preempt its use in other fields; i.e., that the claim would effectively grant a monopoly over the concept.Bilski v. Kappos, 561 U.S. ___, ___, 130 S. Ct. 3218, 3231, 95 USPQ2d 1001, ___ (2010).

    (b) The extent to which the claim is so abstract and sweeping as to cover both known and unknown uses of the concept, and be performed through any existing or future-devised machinery, or even without any apparatus. Gottschalk v. Benson, 409 U.S. 63, 68, 175 USPQ 673, ___ (1972) (stating "[h]ere the process' claim is so abstract and sweeping as to cover both known and unknown uses of the BCD to pure binary conversion. The end use may (1) vary from the operation of a train to verification of drivers' licenses to researching the law books for precedents and (2) be performed through any existing machinery or future-devised machinery or without any apparatus").

    (c) The extent to which the claim would effectively cover all possible solutions to a particular problem; i.e., that the claim is a statement of the problem versus a description of a particular solution to the problem. See The Telephone Cases, 126 U.S. 1, 161-162 (1888) (discussing Tilghman v. Proctor, 102 U.S. 707 (1880)("'The claim of the patent [in Tilghman] is not for a mere principle.' . . . In that case there was a problem. Find a way, if you can, to combine each atom of water with an atom of acid. If you can do that, then you can reach this important result of resolving the neutral fats into glycerine and acids. And Tilghman's solution of it was: Heat the water under such pressure that the water shall not pass into steam. This was his process; and he claimed, and the court justly allowed, great latitude in its application.")).

    (d) Whether the concept is disembodied or whether it is instantiated; i.e., implemented, in some tangible way. A concept that is well-instantiated weighs in favor of eligibility.

    See, e.g., Bilski, 138 S. Ct. at 3230 (stating that the Court in Diehr "concluded that because the claim was not 'an attempt to patent a mathematical formula, but rather [was] an industrial process for the molding of rubber products,' it fell within § 101's patentable subject matter." (citing Diehr, 450 U.S. at 192-193)). Accord Research Corp. Technologies v. Microsoft Corp., 677 F.3d 859, 868-869, 97 USPQ2d 1274, ___ (Fed. Cir. 2010) (stating that the claims here "'do not seek to patent a mathematical formula'" but rather a process of halftoning in computer applications, presenting "functional and palpable applications in the field of computer technology" such that applicant's claimed invention requires instantiation (in some claims) through "a 'high contrast film,' 'a film printer,' 'a memory,' and 'printer and display devices'"); Ultramercial v. Hulu, 657 F.3d 1323, 1328, 100 USPQ2d 1140, 1144(Fed. Cir. 2011)(stating that the patent "does not simply claim the age-old idea that advertising can serve as currency, [but instead] a practical application of this idea.").

    A concept that is not well-instantiated weighs against eligibility. See DealerTrack v. Huber, ___ F.3d ___, 101 USPQ2d 1325 (2012) where in the court stated:

    The claims are silent as to how a computer aids the method, the extent to which a computer aids the method, or the significance of a computer to the performance of the method. The undefined phrase "computer-aided" is no less abstract than the idea of a clearinghouse itself. Because the computer here "can be programmed to perform very different tasks in very different ways," it does not "play a significant part in permitting the claimed method to be performed." Simply adding a "computer aided" limitation to a claim covering an abstract concept, without more, is insufficient to render the claim patent eligible… "In order for the addition of a machine to impose a meaningful limit on the scope of a claim, it must play a significant part in permit-ting the claimed method to be performed, rather than function solely as an obvious mechanism for permitting a solution to be achieved more quickly, i.e., through the utilization of a computer for performing calculations."

    Dealertrack, ___ F.3d at ___, 101 USPQ2d at 1339-40 (citations omitted). Furthermore, limiting an abstract idea to one field of use or adding token postsolution components does not make the concept patentable.

    (e) The mechanism(s) by which the steps are implemented; e.g., whether the performance of the process is observable and verifiable rather than subjective or imperceptible. Steps that are observable and verifiable weigh in favor of eligibility. The Telephone Cases, 126 U.S. at 211 (discussing Tilghman v. Proctor, 102 U.S. 707 (1880) ("[t]here was a process, all of which lay within ordinary means of observation and verification").

    (f) Examples of general concepts include, but are not limited to:

  • • Basic economic practices or theories (e.g., hedging, insurance, financial transactions, marketing);
  • • Basic legal theories (e.g., contracts, dispute resolution, rules of law);
  • • Mathematical concepts (e.g., algorithms, spatial relationships, geometry);
  • • Mental activity (e.g., forming a judgment, observation, evaluation, or opinion);
  • • Interpersonal interactions or relationships (e.g., conversing, dating);
  • • Teaching concepts (e.g., memorization, repetition);
  • • Human behavior (e.g., exercising, wearing clothing, following rules or instructions);
  • • Instructing ''how business should be conducted.''

    See, e.g., Bilski, 138 S. Ct. at 3231 (stating "[t]he concept of hedging, described in claim 1 and reduced to a mathematical formula in claim 4, is an unpatentable abstract idea."), In re Ferguson, 558 F.3d 1359, 90 USPQ2d 1035 (2009) (cert. denied Ferguson v. PTO, June 29, 2010)(finding ineligible "methods . . . directed to organizing business or legal relationships in the structuring of a sales force (or marketing company);" Benson, 409 U.S. at 67 (stating "mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work."); Bilski, 130 S. Ct. at 3231 (quoting Le Roy v. Tatham, 14 How. (55 U.S.) 156, 175 ("[a] principle, in the abstract, is a fundamental truth; an original cause; a motive; these cannot be patented, as no one can claim in either of them an exclusive right")). See also Bilski, 130 S. Ct. at 3259 (Breyer, J. concurring).

    2.   Making the Determination of Eligibility

    Each of the factors relevant to the particular patent application should be weighed to determine whether the method is claiming an abstract idea by covering a general concept, or combination of concepts, or whether the method is limited to a particular practical application of the concept. The presence or absence of a single factor will not be determinative as the relevant factors need to be considered and weighed to make a proper determination as to whether the claim as a whole is drawn to an abstract idea such that the claim would effectively grant a monopoly over an abstract idea and be ineligible for patent protection.

    If the factors indicate that the method claim is not merely covering an abstract idea, the claim is eligible for patent protection under 35 U.S.C. 101 and must be further evaluated for patentability under all of the statutory requirements, including utility and double patenting (35 U.S.C. 101 ); novelty (35 U.S.C. 102); non-obviousness ( 35 U.S.C. 103 ); and definiteness and adequate description, enablement, and best mode (35 U.S.C. 112). 35 U.S.C. 101 is merely a coarse filter and thus a determination of eligibility under 35 U.S.C. 101 is only a threshold question for patentability. 35 U.S.C. 102, 103 , and 112 are typically the primary tools for evaluating patentability unless the claim is truly abstract, see, e.g., Bilski v. Kappos, 561 U.S. ___, ___, 130 S. Ct. 3218, 3229, 95 USPQ2d 1001, ___ (2010). (''[S]ome business method patents raise special problems in terms of vagueness and suspect validity.'').

    If the factors indicate that the method claim is attempting to cover an abstract idea, the examiner will reject the claim under 35 U.S.C. 101 , providing clear rationale supporting the determination that an abstract idea has been claimed, such that the examiner establishes a prima facie case of patent-ineligibility. The conclusion made by the examiner must be based on the evidence as a whole. In making a rejection or if presenting reasons for allowance when appropriate, the examiner should specifically point out the factors that are relied upon in making the determination. If a claim is rejected under 35 U.S.C. 101 on the basis that it is drawn to an abstract idea, the applicant then has the opportunity to explain why the claimed method is not drawn to an abstract idea. Specifically identifying the factors used in the analysis will allow the applicant to make specific arguments in response to the rejection if the applicant believes that the conclusion that the claim is directed to an abstract idea is in error.

    III.   Establish on the Record a Prima Facie Case

    USPTO personnel should review the totality of the evidence (e.g., the specification, claims, relevant prior art) before reaching a conclusion with regard to whether the claimed invention sets forth patent eligible subject matter. USPTO personnel must weigh the determinations made above to reach a conclusion as to whether it is more likely than not that the claimed invention as a whole either falls outside of one of the enumerated statutory classes or within one of the exceptions to statutory subject matter. "The examiner bears the initial burden … of presenting a prima facie case of unpatentability." In re Oetiker, 977 F.2d 1443, 1445, 24 USPQ2d 1443, 1444 (Fed. Cir. 1992). If the record as a whole suggests that it is more likely than not that the claimed invention would be considered a practical application of an abstract idea, physical phenomenon, or law of nature, then USPTO personnel should not reject the claim.

    After USPTO personnel identify and explain in the record the reasons why a claim is for an abstract idea, physical phenomenon, or law of nature with no practical application, then the burden shifts to the applicant to either amend the claim or make a showing of why the claim is eligible for patent protection. See, e.g., In re Brana, 51 F.3d 1560, 1566, 34 USPQ2d 1436, 1441 (Fed. Cir. 1995); see generally MPEP § 2107 (Utility Guidelines).

    Under the principles of compact prosecution, each claim should be reviewed for compliance with every statutory requirement for patentability in the initial review of the application, even if one or more claims are found to be deficient with respect to the patent-eligibility requirement of 35 U.S.C. 101 . Thus, Office personnel should state all non-cumulative reasons and bases for rejecting claims in the first Office action.

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    2106.01    ** > Subject Matter Eligibility Analysis of Process Claims Involving Laws of Nature [R-9]

    I.   SUMMARY

    The following guidance is intended for use in subject matter eligibility determinations during examination of process claims that involve laws of nature/natural correlations, such as the claims in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. __, 132 S.Ct. 1289, 101 USPQ2d 1961 (2012) (Mayo). Process claims that are directed to abstract ideas, such as the claims in Bilski v. Kappos, 561 U.S. ___, 130 S. Ct. 3218, 95 USPQ2d 1001 (2010), should continue to be examined using the guidance set forth in MPEP § 2106.

    The guidance set forth in this section should be followed for examination of process claims in which a law of nature, a natural phenomenon, or a naturally occurring relation or correlation (collectively referred to as a natural principle in the guidance) is a limiting element or step. In summary, process claims having a natural principle as a limiting element or step should be evaluated by determining whether the claim includes additional elements/steps or a combination of elements/steps that integrate the natural principle into the claimed invention such that the natural principle is practically applied, and are sufficient to ensure that the claim amounts to significantly more than the natural principle itself. If the claim as a whole satisfies this inquiry, the claim is directed to patent-eligible subject matter. If the claim as a whole does not satisfy this inquiry, it should be rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.

    II.   ESSENTIAL INQUIRIES FOR SUBJECT MATTER ELIGIBILITY UNDER 35 U.S.C. 101

    After determining what applicant invented and establishing the broadest reasonable interpretation of the claimed invention, conduct the following three inquiries on the claim as a whole to determine whether the claim is drawn to patent-eligible subject matter. Further details regarding each inquiry are provided below.

  • 1. Is the claimed invention directed to a process, defined as an act, or a series of acts or steps?

    If no, this analysis is not applicable. For product claims see MPEP § 2106. If yes, proceed to Inquiry 2.

  • 2. Does the claim focus on use of a law of nature, a natural phenomenon, or naturally occurring relation or correlation (collectively referred to as a natural principle herein)? (Is the natural principle a limiting feature of the claim?)

    If no, this analysis is complete, and the claim should be analyzed to determine if an abstract idea is claimed (see MPEP § 2106). If yes, proceed to Inquiry 3.

  • 3. Does the claim include additional elements/steps or a combination of elements/steps that integrate the natural principle into the claimed invention such that the natural principle is practically applied, and are sufficient to ensure that the claim amounts to significantly more than the natural principle itself? (Is it more than a law of nature plus the general instruction to simply "apply it"?)

    If no, the claim is not patent-eligible and should be rejected. If yes, the claim is patent-eligible, and the analysis is complete.

    III.   DETAILED GUIDANCE FOR USING THE INQUIRIES

    A.   

    Determining What Applicant Invented and the Broadest Reasonable Interpretation

    Review the entire specification and claims to determine what applicant believes that he or she invented. Then review the claims to determine the boundaries of patent protection sought by the applicant and to understand how the claims relate to and define what the applicant has indicated is the invention.

    Claim analysis begins by identifying and evaluating each claim limitation and then considering the claim as a whole. It is improper to dissect a claimed invention into discrete elements and then evaluate the elements in isolation because it is the combination of claim limitations functioning together that establish the boundaries of the invention and limit its scope.

    Establish the broadest reasonable interpretation of the claims when read in light of the specification and from the view of one of ordinary skill in the art. This same interpretation must be used to evaluate the compliance with each statutory requirement. SeeMPEP § 2111 and § 2173 et seq. for further details of claim construction and compliance with 35 U.S.C. 112, second paragraph, respectively.

    B.   

    INQUIRY 1: Process

    Under this analysis, the claim must be drawn to a process. A process is defined as an act, or a series of acts or steps. Process claims are sometimes called method claims.

    C.   

    INQUIRY 2: Natural Principle

    Does the claim focus on use of a natural principle, i.e., a law of nature, a natural phenomenon, or naturally occurring relation or correlation? (Is the natural principle a limiting feature of the claim?)

    A natural principle is the handiwork of nature and occurs without the hand of man. For example, the disinfecting property of sunlight is a natural principle. The relationship between blood glucose levels and diabetes is a natural principle. A correlation that occurs naturally when a man-made product, such as a drug, interacts with a naturally occurring substance, such as blood, is also considered a natural principle because, while it takes a human action to trigger a manifestation of the correlation, the correlation exists in principle apart from any human action. These are illustrative examples and are not intended to be limiting or exclusive.

    For this analysis, a claim focuses on a natural principle when the natural principle is a limiting element or step. In that case, the claim must be analyzed (in Inquiry 3) to ensure that the claim is directed to a practical application of the natural principle that amounts to substantially more than the natural principle itself. So, for instance, a claim that recites a correlation used to make a diagnosis focuses on a natural principle and would require further analysis under Inquiry 3.

    If a natural principle is not a limitation of the claim, the claim does not focus on the use of a natural principle and requires no further analysis under this procedure. If the claim focuses on an abstract idea, such as steps that can be performed entirely in one's mind, methods of controlling human activity, or mere plans for performing an action, refer to MPEP § 2106 to evaluate eligibility.

    D.   

    INQUIRY 3: Practical Application and Preemption

    Does the claim include additional elements/steps or a combination of elements/steps that integrate the natural principle into the claimed invention such that the natural principle is practically applied, and are sufficient to ensure that the claim amounts to significantly more than the natural principle itself? (Is it more than a law of nature plus the general instruction to simply "apply it"?)

    A claim that focuses on use of a natural principle must also include additional elements or steps to show that the inventor has practically applied, or added something significant to, the natural principle itself. See Mayo, 101 USPQ2d at 1966. To show integration, the additional elements or steps must relate to the natural principle in a significant way to impose a meaningful limit on the claim scope. The analysis turns on whether the claim has added enough to show a practical application. See id. at 1968. In other words, the claim cannot cover the natural principle itself such that it is effectively standing alone. A bare statement of a naturally occurring correlation, albeit a newly discovered natural correlation or very narrowly confined correlation, would fail this inquiry. See id. at 1965, 1971.

    It is not necessary that every recited element or step integrate or relate to the natural principle as long as it is applied in some practical manner. However, there must be at least one additional element or step that applies, relies on or uses the natural principle so that the claim amounts to significantly more than the natural principle itself. Elements or steps that do not integrate the natural principle and are merely appended to it would not be sufficient. In other words, the additional elements or steps must not simply amount to insignificant extra-solution activity that imposes no meaningful limit on the performance of the claimed invention. See id. at 1966. For example, a claim to diagnosing an infection that recites the step of correlating the presence of a certain bacterium in a person's blood with a particular type of bacterial infection with the additional step of recording the diagnosis on a chart would not be eligible because the step of recording the diagnosis on the chart is extra-solution activity that is unrelated to the correlation and does not integrate the correlation into the invention.

    Along with integration, the additional steps must be sufficient to ensure that the claim amounts to significantly more than the natural principle itself by including one or more elements or steps that limit the scope of the claim and do more than generally describe the natural principle with generalized instructions to "apply it." See id. at 1965, 1968. The additional elements or steps must narrow the scope of the claim such that others are not foreclosed from using the natural principle (a basic tool of scientific and technological work) for future innovation. Elements or steps that are well-understood, purely conventional, and routinely taken by others in order to apply the natural principle, or that only limit the use to a particular technological environment (field-of-use), would not be sufficiently specific. See id. at 1968. A claim with steps that add something of significance to the natural laws themselves would be eligible because it would confine its reach to particular patent-eligible applications of those laws, such as a typical patent on a new drug (including associated method claims) or a new way of using an existing drug. See id. at 1971; see also 35 U.S.C. 100(b). In other words, the claim must be limited so that it does not preempt the natural principle being recited by covering every substantial practical application of that principle. The process must have additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself. See id. at 1968.

    A claim that would fail this inquiry includes, for example, a claim having a limitation that describes a law of nature and additional steps that must be taken in order to apply the law of nature by establishing the conditions under which the law of nature occurs such as a step of taking a sample recited at a high level of generality to test for a naturally occurring correlation. See id. at 1970. Adding steps to a natural biological process that only recite well-understood, routine, conventional activity previously engaged in by researchers in the field would not be sufficient. See id. at 1966, 1970. A combination of steps that amounts to nothing significantly more than an instruction to doctors to "apply" applicable natural laws when treating their patients would also not be sufficient. See id. at 1970.

    Claims that do not include a natural principle as a limitation do not raise issues of subject matter eligibility under the law of nature exception. For example, a claim directed to simply administering a man-made drug that does not recite other steps or elements directed to use of a natural principle, such as a naturally occurring correlation, would be directed to eligible subject matter. Further, a claim that recites a novel drug or a new use of an existing drug, in combination with a natural principle, would be sufficiently specific to be eligible because the claim would amount to significantly more than the natural principle itself. However, a claim does not have to be novel or non-obvious to qualify as a subject matter eligible claim. Moreover, a claim that is deemed eligible is not necessarily patentable unless it also complies with the other statutory and non-statutory considerations for patentability under 35 U.S.C. 101 (utility and double patenting), 102, 103, 112, and non-statutory double patenting.

    The weighing factors used in MPEP § 2106 are useful tools for assisting in the evaluation. For convenience, these factors and how they may assist in the analysis are summarized below.

    E.   

    RELEVANT FACTORS USEFUL FOR INQUIRY 3

    The following factors can be used to analyze the additional features in the claim to determine whether the claim recites a patent-eligible practical application of a natural principle and assist in answering Inquiry 3 above. Many of these factors originate from past eligibility factors, including the 'Machine-or-Transformation' (M-or-T) test. However, satisfying the M-or-T factors does not ensure eligibility if the claim features that include a particular machine or transformation do not integrate the natural principle into the claimed invention to show that the natural principle is practically applied, and are not sufficient to ensure that the claim amounts to significantly more than the natural principle itself.

  • • Appending conventional steps, specified at a high level of generality, to a natural principle does not make the claim patent-eligible.
  • • Steps that amount to instructions that are well-understood, routine, conventional activity, previously engaged in by those in the field add nothing specific to the natural principle that would render it patent-eligible.
  • • A claim that covers known and unknown uses of a natural principle and can be performed through any existing or future-devised machinery, or even without any apparatus, would lack features that are sufficient for eligibility.
  • • A particular machine or transformation recited in more than general terms may be sufficient to limit the application to just one of several possible machines or just one of several possible changes in state, such that the claim does not cover every substantial practical application of a natural principle. This can be contrasted with only adding features that limit the application to a certain technological environment (e.g., for use in catalytic conversion systems), which would cover every substantial practical application in that field.
  • • Additional limitations that are necessary for all practical applications of the natural principle, such that everyone practicing the natural principle would be required to perform those steps or every product embodying that natural principle would be required to include those features, would not be sufficient.
  • • A particular machine or transformation recited in a claim can show how the natural principle is integrated into a practical application by describing the details of how that machine and its specific parts implement the natural principle (e.g., the parts of an internal combustion engine apply the concept of combustion to produce energy) or how the transformation relates to or implements the natural principle (e.g., using ionization in a manufacturing process).
  • • A machine or transformation that is merely nominally, insignificantly, or tangentially related to the steps or elements, e.g., data gathering or data storage, would not show integration. For example, a machine that is simply incidental to execution of the method (using a computer as a counter balance weight and not as a processing device) rather than an object that implements the method or a transformation that involves only a change of position or location of an object rather than a change in state or thing does not show that these additional features integrate the natural principle into the invention as they are incidental to the claimed invention.
  • • Complete absence of a machine-or-transformation in a claim signals the likelihood that the claim is directed to a natural principle and has not been instantiated (e.g., is disembodied or can be performed entirely in one's mind.)
  • • A mere statement of a general concept (natural principle) would effectively monopolize that concept/principle and would be insufficient. This can be contrasted with a tangible implementation with elements or steps that are recited with specificity such that all substantial applications are not covered. Such specificity may be achieved with observable and verifiable steps, for example, rather than subjective or imperceptible steps.

    IV.   

    SAMPLE ANALYSIS

    A.   

    Sample Claim Drawn to a Patent-Eligible Practical Application - Diamond v. Diehr

    1. A method of operating a rubber-molding press for precision molded compounds with the aid of a digital computer, comprising:

    providing said computer with a data base for said press including at least, natural logarithm conversion data (ln), the activation energy constant (C) unique to each batch of said compound being molded, and a constant (x) dependent upon the geometry of the particular mold of the press,

    initiating an interval timer in said computer upon the closure of the press for monitoring the elapsed time of said closure,

    constantly determining the temperature (Z) of the mold at a location closely adjacent to the mold cavity in the press during molding, constantly providing the computer with the temperature (Z),

    repetitively calculating in the computer, at frequent intervals during each cure, the Arrhenius equation for reaction time during the cure, which is ln v = CZ + x where v is the total required cure time,

    repetitively comparing in the computer at said frequent intervals during the cure each said calculation of the total required cure time calculated with the Arrhenius equation and said elapsed time,

    and opening the press automatically when a said comparison indicates equivalence.

    The above claim was found to be a patent-eligible practical application in Diamond v. Diehr, 450 U.S. 175 (1981). Recently, the Supreme Court looked back to this claim as an example of a patent-eligible practical application as explained in the following excerpt from Mayo:

    The Court pointed out that the basic mathematical equation, like a law of nature, was not patentable. But it found the overall process patent eligible because of the way the additional steps of the process integrated the equation into the process as a whole. Those steps included "installing rubber in a press, closing the mold, constantly determining the temperature of the mold, constantly recalculating the appropriate cure time through the use of the formula and a digital computer, and automatically opening the press at the proper time." [ ] It nowhere suggested that all these steps, or at least the combination of those steps, were in context obvious, already in use, or purely conventional. And so the patentees did not "seek to pre-empt the use of [the] equation," but sought "only to foreclose from others the use of that equation in conjunction with all of the other steps in their claimed process." [ ] These other steps apparently added to the formula something that in terms of patent law's objectives had significance—they transformed the process into an inventive application of the formula. See Mayo at 1969 (emphasis added).

    This claim would pass Inquiries 1-3 in the above analysis as it is a process that includes the Arrhenius equation as a limitation, with additional steps that integrate the Arrhenius equation into the process and are sufficient to narrow the scope of the claim so that others are not foreclosed from using the Arrhenius equation in different applications.

    B.   

    Sample Claim Drawn to Ineligible Subject Matter - Mayo v. Prometheus

    1. A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:

    (a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and

    (b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder,

    wherein the level of 6-thioguanine less than about 230 pmol per 8×108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and

    wherein the level of 6-thioguanine greater than about 400 pmol per 8×108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

    The above claim was found to be ineligible in Mayo. The Supreme Court determined that the claim focused on use of a law of nature that was given weight during prosecution of the claim – specifically the relationships between concentrations of certain metabolites in the blood and the likelihood that a dosage of a thiopurine drug will prove ineffective or cause harm. See id.at 1967. The Court analyzed the claim as follows:

    The question before us is whether the claims do significantly more than simply describe these natural relations. To put the matter more precisely, do the patent claims add enough to their statements of the correlations to allow the processes they describe to qualify as patent-eligible processes that apply natural laws? We believe that the answer to this question is no. See id. at 1968.

    The upshot is that the three steps simply tell doctors to gather data from which they may draw an inference in light of the correlations. To put the matter more succinctly, the claims inform a relevant audience about certain laws of nature; any additional steps consist of well understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately. For these reasons we believe that the steps are not sufficient to transform unpatentable natural correlations into patentable applications of those regularities. See id. at 1968.

    This claim would pass Inquiries 1-2 and fail Inquiry 3. It is a process claim that includes a natural principle that was construed as a limiting feature of a claim during prosecution – the natural principle being the naturally occurring relationships noted above, which are a consequence of the ways in which thiopurine compounds are metabolized by the body. The Court emphasized that while it takes a human action to trigger a manifestation of this relation in a particular person, the relation itself exists in principle apart from any human action. See id. at 1967. The additional steps integrate the relationship into the process as the administering step involves the thiopurine drug, the determining step establishes the thiopurine drug level and the wherein clauses set forth the critical levels. The steps are not sufficient, however, to narrow the application such that others could still make use of the naturally occurring relationship in other practical applications. The claim essentially sets forth a law of nature with generalized instructions to apply it.

    C.   

    Making a Rejection

    After performing the appropriate Inquiries, a claim that fails Inquiry 3 should be rejected under 35 U.S.C. 101 as not being drawn to patent-eligible subject matter. When making the rejection, identify the natural principle, identify that the claim is effectively directed to a natural principle itself, and explain the reason(s) that the additional claim features or combination of features, when the claim is taken as a whole, fail to integrate the natural principle into the claimed invention so that the natural principle is practically applied, and/or fail to be sufficient to ensure that the claim amounts to significantly more than the natural principle itself.

    A sample rejection of the following claim could read as follows:

    Claim 1. A method of determining effective dosage of insulin to a patient, comprising the steps of administering a dose of insulin to a patient, testing the patient's blood for the blood sugar level, and evaluating whether the insulin dosage is effective based on the blood sugar level.

    Analysis:

    The claim passes Inquiry 1 because it is drawn to a process.

    The claim passes Inquiry 2 because a naturally occurring correlation between insulin and blood glucose levels is a limitation of the claim.

    The claim does not pass Inquiry 3 because, although the additional steps integrate or make use of the correlation in the process by administering insulin in one step and testing for the correlation in another step, the steps are not sufficient to ensure that the claim amounts to significantly more than the correlation itself since every application of the correlation would require an administration of insulin and testing of blood to observe the relationship between insulin and blood glucose levels.

    The rejection:

    Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter because it is not a patent-eligible practical application of a law of nature. The claim is directed to a naturally occurring correlation between insulin and blood glucose levels. The combination of steps recited in the claim taken as a whole, including the steps of administering insulin to a patient and testing blood sugar levels, are not sufficient to qualify as a patent-eligible practical application as the claim covers every substantial practical application of the correlation.

    D.   

    Evaluating a Response

    A proper response to a rejection based on failure to claim patent-eligible subject matter would be an amendment adding additional steps/features or amending existing steps/features that integrate the natural principle into the process (by practically applying or making use of the principle) and are sufficient to limit the application of the natural principle to more than the principle itself + steps that do more than simply "apply it" at a high level of generality. Examples of both eligible and ineligible hypothetical claims follow. It would also be proper for the applicant to present persuasive arguments that the additional steps add something significantly more to the claim than merely describing the natural principle. A showing that the steps are not routine, well-known or conventional could be persuasive.

    For example, a claim that uses the natural disinfecting properties of sunlight would require additional steps beyond exposing an item requiring disinfection to sunlight. The additional steps could involve constructing a sanitizing device that uses ultraviolet light for disinfection with steps that integrate the ultraviolet light into the device and are sufficient to confine the use of the ultraviolet light to a particular application (not so broad as to cover all practical ways of applying ultraviolet light). A claim that sets forth the relationship between blood glucose levels and the incidence of diabetes would require additional steps that do significantly more to apply this principle than conventional blood sample testing or diagnostic activity based on recognizing a threshold blood glucose level. Such additional steps could involve a testing technique or treatment steps that would not be conventional or routine.

    See the 2012 Interim Procedure for Laws of Nature guidance memo issued July 3, 2012 and posted on the USPTO web site (http://www.uspto.gov/patents/law /exam/2012_interim_guidance.pdf) for additional examples. <

Logical Conclusion?: Claimed Open-Ended Ranges Lack Enablement

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By Dennis Crouch

Magsil Corp. and MIT v. Hitachi (Fed. Cir. 2012)

In a unanimous opinion, the Federal Circuit has affirmed a district court summary judgment holding that the asserted claims of MIT's patent are invalid for a lack of enablement. The patent covers read-write sensors for computer hard disk drive storage systems and relies upon quantum tunneling in operation.

The courts have derived an enablement requirement from Section 112 of the patent statute. Under the doctrine, after studying the patent specification, a person of skill in the relevant art should be able to (theoretically) make and use the full scope of the claimed invention without undue experimentation. Patents ordinarily include many different claims that identify various legal rights given to the patentee. Enablement is judged independently on a claim-by-claim basis. Any claim that lacks enablement will be deemed invalid and thus unenforceable.

One of the murkiest areas of the doctrine is determining whether the "full scope" of the claim is enabled. The commonly used open ended "comprising" claim language allows for an infinite number of potential variants to be embodied within the scope of a single claim. In almost every case, it is possible to theoretically define an embodiment that falls within the claim scope but that is not fully enabled by the specification. Obviously, the fact that a particular theoretical covered embodiment is not enabled can't be sufficient to invalidate a claim. The difficult legal issue then is finding when a patent claim crosses the threshold from legitimately having a few non-enabled potential embodiments to illegitimately failing to enable the full scope of the claim.

Unbounded Range: Here, the patent claims that the device switch has a change in resistance of "at least 10%." Although it is desirable to have a device with a greater ΔR, the inventors best pre-filing device only reached 11.8%. The accused infringing devices had a greater ΔR and thus the patentee argued that the "at least 10%" claim scope could cover a ΔR of 100% or even 1,000%." The defendant (Hitachi) was able to prove that those ΔR levels could not have been achieved at the time of the patent filing without undue experimentation. The Federal Circuit found this sufficient to find the claim lacking enablement.

In sum, this field of art has advanced vastly after the filing of the claimed invention. The specification containing these broad claims, however, does not contain sufficient disclosure to present even a remote possibility that an ordinarily skilled artisan could have achieved the modern dimensions of this art. Thus, the specification enabled a marginal advance over the prior art, but did not enable at the time of filing a tunnel junction of resistive changes reaching even up to 20%, let alone the more recent achievements above 600%.

This case follows in re Fisher (CCPA 1970). In that case the court ruled that a claimed potency of "at least 1 International Unit of ACTH per milligram" was invalid as lacking enablement after the patentee attempted to enforce the patent against products with potentials of much greater than the 2.3 IUs disclosed in the specification.

The court particularly addressed the comprising issue discussed above. One key distinction is that the high ΔR range here is an explicit element of the claimed invention rather than being a mere latent vestige of the claim structure.

Not a Groundbreaking Invention: In both Fisher and here, the patentees' actual experiments were at ranges just above that already known in the art. That seeming small advance reflected in claiming a range that barely avoided the prior art at the lower bound but then attempted to claim an infinite range at the upper bound. In this case, the court identifies the advance as "marginal over the prior art." The suggestion from the court is that a marginal advance such as this is deserving of a much narrower scope than would be given a groundbreaking invention. The court is on the right track with this approach however, the language of the opinion can also be read to limit potentially broad scope of even groundbreaking inventions when the accused infringer (or others) have spent significant time and energy on developing a particular embodiment covered by the invention.

Whither Open-Ended Ranges and a Plurality of Members?: The opinion can also be read to eliminate the potential for open-ended ranges. The court writes that "the '922 patent specification only enables an ordinarily skilled artisan to achieve a small subset of the claimed range." Of course, a mathematician will explain that any claim with a range that potentially reaches to infinity (e.g., "a plurality of members") will suffer from this same defect – that only a small subset of the claimed range will be enabled (assuming that infinity is not enabled).

Transformative Research to Avoid Infringement: As mentioned above, the opinion relies somewhat heavily on the fact that extensive post-patent-filing research was conducted; and that the research eventually led to a new state-of-the-art that is much more advanced than that imagined by the inventors (even though still literally covered by the claims). This opens the door to manufacturing companies to offer testimony related to their extensive research and development programs and offer an argument akin to transformative copying in copyright law. If the research is sufficiently transformative (and took sufficient effort) then the patent will be deemed invalid for failing to enable that covered embodiment.

Enablement Doctrine Allows Follow-on Research: The court is straightforward in stating that a strong enablement requirement will help prevent over broad patent claims and thus allow room (and incentives) for "follow-on or improvement inventions."

Invalidity affirmed.

Director Kappos: Some Thoughts on Patentability

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The following is a reprint from USPTO Director Kappos’ recent statement on patentable subject matter:

+ + + + +

The recent Federal Circuit decision CLS Bank International v. Alice Corporation raises some important points that offer insight on advancing prosecution of patent applications. In CLS Bank, the claims to a computer-implemented invention were found to fall within an eligible category of invention and not to mere abstract ideas. In answering the question of eligibility under § 101, I found it interesting that the court looked at the different roles of the various statutory provisions, § 101, 102, 103, and 112. Sections 102, 103 and 112 do the substantive work of disqualifying those patent eligible inventions that are “not worthy of a patent”, while § 101 is a general statement of the type of subject matter eligible for patenting. The court notes that, while § 101 has been characterized as a threshold test and certainly can be addressed before other matters touching on patent validity, it need not always be addressed first, particularly when other sections might be discerned by a trial judge as having the promise to resolve a dispute more expeditiously or with more clarity or predictability. The court in CLS Bank also recognized that the exceptions to eligibility—laws of nature, natural phenomenon, and abstract ideas—should arise infrequently.

Based on my experience, I appreciate the wisdom of the court’s discussion relating to resolving disputed claims by focusing initially on patentability requirements of § 102, 103, and 112, rather than § 101. I have found that when claims are refined to distinguish over the prior art, recite definite boundaries, and be fully enabled based on a complete written description, they do not usually encounter issues of eligibility based on reciting mere abstract ideas or broad fundamental concepts. Put another way, every business looks for opportunities to sequence workflow so that the first issues addressed are the ones that can simplify or completely resolve other issues. This is good basic management for businesses, and for patent offices.

While courts can resolve patent disputes in the most expeditious manner given the facts of the case, the Office has the unique duty of ensuring that all patentability requirements are met before issuing a patent. Applications that are presented in the best possible condition for examination with clear and definite claims that are believed to distinguish over the prior art and are supported by a robust disclosure will most likely not encounter rejections based on eligibility. Avoiding issues under § 101 can have a very positive effect on pendency and help examiners focus on finding the closest prior art, leading to strong patent protection. Hopefully, the guidance supplied by the Federal Circuit in CLS Bank can help us as we continue to work on reducing pendency and enhancing quality of issued patents.

Prior Art Enablement: Burden on Patent Applicant to Prove Non-Enablement

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by Dennis Crouch

In re Antor Media Corp (Fed. Cir. 2012)(Lourie, J.)

As part of an ex parte reexamination process, the Board of Patent Appeals (BPAI) found Antor’s patent claims invalid as both anticipated and obvious based upon the combination of four prior art references.  The patent under reexamination – No. 5,734,961 – covers a fairly simple network-based data transfer method. 

On appeal to the Federal Circuit, Antor challenged the anticipation holding.  Its argument was that the examiner had not provided any evidence that the asserted prior art was sufficient to enable anyone to practice the Antor invention.  The Federal Circuit agreed that prior art must provide an enabling disclosure (for anticipation), but still rejected Antor’s argument by holding that the USPTO need not even consider the enablement question unless the applicant first presents prima facie evidence of non-enablement.

The court held

“that, during patent prosecution, an examiner is entitled to reject claims as anticipated by a prior art publication or patent without conducting an inquiry into whether or not that prior art reference is enabling.  As long as an examiner makes a proper prima facie case of anticipation by giving adequate notice under § 132, the burden shifts to the applicant to submit rebuttal evidence of nonenablement.”

Thus, prior art references are presumed to be sufficiently enabled. Here, the court affirmed that Antor had not rebutted this presumption of enablement because the patentee did “not show[] that undue experimentation would be needed to practice the claimed invention” based upon the disclosure in the prior art.  

Enablement is normally treated as a question of law. Here, however, enablement of the prior art is a subset of the factual inquiry into anticipation. As such, it appears that the court has treated enablement of the prior art as an underlying question of fact and applied the substantial evidence rule to its review of the BPAI decision. 

To be clear, the prior art enablement question looks to whether the arguably anticipatory prior art sufficiently enables the invention now being patented.  You’ll notice that the above discussion focused on anticipation rather than obviousness. The conclusion that a prior art reference lacks enablement does not exclude the reference from consideration during an obviousness challenge.  Thus, Antor mounted (and lost) a separate argument against the obviousness rejections that had been affirmed by the BPAI. See Amgen Inc. v. Hoechst Marion Roussel, Inc. (Fed. Cir. 2003) (“Under § 103 … a reference need not be enabled; it qualifies as a prior art, regardless, for whatever is disclosed therein”).

Making Pre-Grant Submissions More Efffective

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by Dennis Crouch

The America Invents Act (AIA) expands the opportunity for third-party pre-issuance submissions in patent cases. Beginning September 16 of this year (2012), anyone will be permitted to submit published documents ('printed publications') that are relevant to the examination of a pending application along with a concise explanation of the importance of the documents submitted. 

In a recently issued set of final rules, the USPTO outlines the procedures that it has put in place to handle the new filings. Changes To Implement the Preissuance Submissions by Third Parties Provision of the Leahy-Smith America Invents Act, 77 F.R. 42150 (2012).

Targeted preissuance submissions offer an extremely inexpensive mechanism for limiting competitor patent scope. The process has little downside (in most cases) but does require additional competitor monitoring.  The effectiveness of the process has not been tested.  Although the process has major limitations, I believe that it will serve as an effective tool in the hands of skilled practitioners.  I have spoken with several attorneys who are already preparing their preissuance submissions to be filed in late September.

Key points: 

  • Implementation: Although the pre-grant submissions cannot be filed before September 16, once that date passes, they may be filed in applications that were already on file with the USPTO. I know of some individuals who are already preparing materials for pre-grant submissions against competitor applications. Presumably they will file those sometime on or after September 16, 2012. 
  • Deadlines: During the legislative process, the PTO supported these third-party submissions, but offered some concern that late-stage submissions could create problems for both patent applicants and for the USPTO examination process.  Thus, for most cases the preissuance submission must be filed before the first office action rejection is mailed.  In cases where there is no office action rejection or where the PTO works quickly, submissions will be allowed if within an alternative deadline of within six-months of publication.  The PTO will not consider any submissions submitted after the notice of allowance.
  • Requirements: Submissions may be done anonymously and electronically, but must include (1) A list identifying the items being submitted; (2) a concise description of the relevance of each item listed; (3) a legible copy of each non-U.S. patent document listed; (4) an English language translation of any non-English language item listed; (5) a statement by the party making the submission that the submission complies with the statute and the rule; and (6) the required fee ($0 if fewer than three-documents submitted).
  • Results: The patent examiner is required to consider compliant third-party submissions in preparation for the next office action.  The submitted documents will be listed on the face of the patent as considered.

How to make preissuance submissions more effective?: Some may have a more nuanced or longer-term strategy, but the usual realistic goal of a third-party submission is to limit the scope of a competitor's pending application.  Barring retaliatory competitor action, the only downside is that a broad patent may still issue with a prosecution history reflecting that the examiner considered the submitted documents.  No estoppel is created by the submissions.  The identical argument will not be available during a later post grant review and may be more difficult to prove at trial than it would have been if never considered at the USPTO.

  1. Quality Art: The best preissuance submissions will begin with on-point prior art.  Examiners will not likely be tolerant of submissions that lack prima facie credibility.
  2. Concise and Well Drafted: There is a large risk of examiners ignoring submissions that appear as a large stack of dense documents.  The concise explanation should be designed to quickly lead examiners to a rejection based upon the submitted documents.   
  3. Explaining Known Art: Rather than submitting new prior art, applicants may re-submit art already in the file along with an explanation of how the art should be applied.   
  4. Reputation: Certain practitioners and entities will earn reputations as filing credible/incredible. 
  5. Protect Potential Space: Remember that the patent applicant is still likely to receive a patent. The pre-issuance submission is useful for limiting and defining patent scope.  The record will reflect that the patent definitely does not cover X.  With the normal unpredictability of claim construction, this defining role result can be quite helpful down the road if the patent is ever litigated.  Practicing entities should use the process to clear a path for their own current and potential technology usage.  As discussed below, a third party may be satisfied with the applicant adding a definition to a claim term rather than actually amending the claim. 
  6. Internal Prior Art: Remember that e-mails and other correspondence can potentially serve as printed publications under the patent laws.  (See caselaw on 35 USC 102(a) & 102(b)).
  7. Other Questions of Patentability: The statute calls for the submission of documents “of potential relevance to the examination” and is certainly not restricted to issues of novelty and nonobviousness.  The rules do not allow an applicant to simply submit an argument without an underlying published document. For a definiteness issue, a dictionary definition may serve as the hook.  For a new-matter question, the document could be the related parent application. For a patentable subject matter issue, the document might be Mayo v. Prometheus.

Arguments Serving as Published Evidence: A third-party challenging enablement might want to hire an expert to study the application; publish an expert report; and then submit the report (along with a concise explanation) following these new procedures.  This approach appears to fit within the statute that allows the submission of “any … printed publication of potential relevance.”  However, in its notice of final rules, the USPTO has indicated that it will not accept materials created and published merely for the purpose of challenging the pending application in question.  The USPTO appears to understand that the statute is broadly written and thus does not directly prohibit the filing of such documents.  The Office instead concludes that the submission would be rejected because the required concise explanation of such a document “would likely be deemed an improper attempt by the third party to impermissibly participate in the examination of the application because the relevance of the document being described is its discussion of the patentability of the application.”  In this sense, the Office seems to be setting up a conflict between these new submission procedures found in 35 USC 122(e) and the prohibition on protests and pre-grant oppositions left unamended in 35 USC 122(c). 

I believe that the USPTO is probably wrong on its analysis of the law here — in many (if not most) cases, this type of evidence should be allowed under the law.  The statute does not provide a particular mechanism for challenging the PTO's refusal to consider these submissions, but the Office is unlikely be convinced on petition without resorting to the filing of a federal case. As an aside, the filing of a non-compliant submission will likely trigger the applicant's duty of disclosure.  In that case, the applicant will likely re-file the submission as part of an information disclosure statement.

Note: Some of these ideas came from reading Hal Wegner's useful report on Third Party Submissions: The Final Rule.

CLS Bank v. Alice: The “Nothing More Than” Limitation on Abstract Ideas

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By Jason Rantanen

CLS Bank International v. Alice Corporation Pty. Ltd. (Fed. Cir. 2012) Download 11-1301
Panel: Linn (author), O'Malley, Prost (dissenting)

Despite two recent opinions by the Supreme Court, the issue of patent eligible subject matter continues to sharply divide the Federal Circuit.  CLS Bank v. Alice Corporation illustrates this point neatly, even going a step further.   Unlike other recent opinions involving questions of patent eligible subject matter that have approached the issue in a relatively narrow, case-specific manner, here the majority implements a sweeping rule with significant implications for future cases – a rule that the dissenting judge criticizes as being irreconcilable with Supreme Court's precedent.

Background: Alice sued CLS for infringement of four patents covering, in the majority's words, "a computerized trading platform for exchanging obligations in which a trusted third party settles obligations between a first and second party so as to eliminate 'settlement risk'.  Settlement risk is the risk that only one party's obligation will be paid, leaving the other party without its principal."  Slip Op. at 2.  The patents included method, system, and computer program product claims. Claim 1 of Patent No. 7,149,720 is representative of the system claims:

1. A data processing system to enable the exchange of an obligation between parties, the system comprising:
a data storage unit having stored therein information about a shadow credit record and shadow debit record for a party, independent from a credit record and debit record maintained by an exchange institution; and

a computer, coupled to said data storage unit, that is configured to (a) receive a transaction; (b) electronically adjust said shadow credit record and/or said shadow debit record in order to effect an exchange obligation arising from said transaction, allowing only those transactions that do not result in a value of said shadow debit record being less than a value of said shadow credit record; and (c) generate an instruction to said exchange institution at the end of a period of time to adjust said credit record and/or said debit record in accordance with the adjustment of said shadow credit record and/or said shadow debit record, wherein said instruction being an irrevocable, time invariant obligation placed on said exchange institution.

The district court granted summary judgment of invalidity based on a failure to claim patent eligible subject matter.  Alice appealed.

The majority's "nothing more than" limitation: In reversing the district court, the majority focused on the "abstract ideas" exception to patent eligible subject matter.  Examing the concept of "abstract ideas," the majority concluded that despite substantial precedent and commentary, its meaning remains unclear and its boundary elusive.  There is, of course, some guidance in the precedent, notably the machine or transformation test and concerns about preempting an entire field of innovation.  There are also computer-specific opinions, which the majority distilled down into the rule that "a claim that is drawn to a specific way of doing something with a computer is likely to be patent eligible whereas a claim to nothing more than the idea of doing that thing on a computer may not."  Slip Op. at 18 (emphasis in original). But even this rule allows for "great uncertainty" as to the meaning of "abstract ideas."

Against this backdrop, the majority did not attempt to define the concept of "abstract ideas."  Instead, it implemented a new rule that minimizes the need to make such a determination and strongly favors a conclusion of patentable subject matter when claims involve anything that might be characterized as an abstract idea.  The majority's rule:

"this court holds that when—after taking all of the claim recitations into consideration—it is not manifestly evident that a claim is directed to a patent ineligible abstract idea, that claim must not be deemed for that reason to be inadequate under § 101…Unless the single most reasonable understanding is that a claim is directed to nothing more than a fundamental truth or disembodied concept, with no limitations in the claim attaching that idea to a specific application, it is inappropriate to hold that the claim is directed to a patent ineligible “abstract idea” under 35 U.S.C. § 101."

Slip Op. at 20-21 (emphasis added).  Applying this rule, the majority concluded that Alice's claims were directed to patent eligible subject matter.  In reaching this conclusion, it emphasized the need to look at the claim as a whole rather than to generalize the invention as the district court did.  Applying this approach, the majority concluded that the computer limitations "play a significant part in the performance of the invention" and that the claims are "limited to a very specific application of the concept of using an intermediary to help consummate exchanges between parties." Id. at 26. 

The majority also emphasized a theme previously discussed on PatentlyO: that district courts have the discretion to determine the order in which to assess questions of validity, and may execise that discretion in the interests of judicial efficiency: "Although § 101 has been characterized as a “threshold test,” Bilski II, 130 S. Ct. at 3225, and certainly can be addressed before other matters touching the validity of patents, it need not always be addressed first, particularly when other sections might be discerned by the trial judge as having the promise to resolve a dispute more expeditiously or with more clarity and predictability."  Slip Op. at 13 (emphasis added).

Judge Prost's Dissent: Writing in dissent, Judge Prost sharply criticized the majority for "responding to a unanimous Supreme Court decision against patentability with even a stricter subject matter standard."  Dissent at 8.    "The majority resists the Supreme Court’s unanimous directive to apply the patentable subject matter test with more vigor. Worse yet, it creates an entirely new framework that in effect allows courts to avoid evaluating patent eligibility under § 101 whenever they so desire."  Id. at 1.  Judge Prost was equally critical of the majority's departure from the Supreme Court's case-specific approach to questions of patent eligible subject matter.  "The majority has failed to follow the Supreme Court’s instructions—not just in its holding, but more importantly in its approach."  Id. at 3.

Central to Judge Prost's dissent is the view that the Supreme Court in Prometheus required that to be patent eligible the subject matter must contain an "inventive concept."  "Now there is no doubt that to be patent eligible under § 101, the claims must include an “inventive concept.”  Dissent at 3. Finding nothing inventive in the claims – they consist of the abstract and ancient idea together with its implementation via a computer – the dissent concludes that they cannot constitute patent eligible subject matter.

The Heart of the Dispute: One interpretation of the divide between majority and dissent is that it flows from fundamentally different approaches to the question of what the "invention" is for purposes of § 101.  The majority sees the "invention" as rigidly defined by the claims: "ignoring claim limitations in order to abstract a process down to a fundamental truth is legally impermissible," and accuses the dissent of doing just that.  Slip Op. at 23.  In contrast, the dissent, while recognizing the importance of the claims, strips them of jargon in order to ask "So where is the invention"?  Dissent at 5.  The majority's approach resembles the standard patent law approach to dealing with the concept of the invention; the dissent's is much more similar to how the Supreme Court analyzes questions of patentable subject matter. 

In any event, given the fundamental disagreement between the majority and dissent, this will be a case to keep a close eye on.

Correction to original post: Judge Lourie was joined by Judge O'Malley, not Judge Moore.

Proposed Rules for Micro Entities

Patent,

By Jason Rantanen

As part of the America Invents Act, Congress created the new "micro entity" category of patent applicants.  See Public Law 112-29, 125 Stat. 283, Section 10(g) (2011).  Similar to small entity status, micro entities are entitled to a reduction of patent application fees (75% for micro entities versus 50% for small entities).  "Micro entity" is a bit of a misnomer: an applicant can qualify as a micro entity either by having an income of less than three times the median household income (approximately $50,000 based on 2010 incomes) or by being under an obligation to assign or license the application to an institution of higher education.  The latter route might be particularly attractive to universities, as it enables micro entity status for most university-affiliated researchers.  

The USPTO recently published a set of proposed regulations for establishing micro entity status.  In large part, these regulations would implement the micro entity status requirements set out in the AIA, while providing some further clarification in a few areas, such as multi-inventor applications (all must meet the micro entity requirements).

The Federal Register publication also notes some complications arising due to the severance of "applicant" from "inventor."  Prior to the AIA, the two terms were synonymous.  After September 16, 2012, however, it is possible for an application to be made by someone other the inventor.  The micro entity section of the AIA uses the term "applicant;" however, as part of the proposed rulemaking the PTO is seeking comments on whether "inventor" should be used in place of "applicant" at any point in the rules for establishing micro entity status.

Finally, keep in mind that even once these proposed rules are finalized, the discount will not be available until the PTO sets or adjusts patent fees under the fee setting authority provision of the AIA, something that it indicates will not formally occur until around March 2013. 

The proposed rules are available here:  Download 2012-12971  The comment deadline date is July 30, 2012.

Book Discussion: Frischmann Predicts Prometheus

Patent, , , , , ,

Guest post by Professor Michael Burstein.  This review is cross-posted on the Concurring-Opinions blog.

In his new book Infrastructure: The Social Value of Shared Resources (OUP 2012), Brett Frischmann explores how infrastructural resources contribute to social welfare. He defines a set of resources — infrastructure — in terms of the manner in which they create value and then examines the conditions under which such resources ought to be managed as a commons. He develops a framework for understanding the demand for infrastructure and the advantages and disadvantages of managing infrastructure in a nondiscriminatory manner. Prof. Frischmann then applies this framework to a variety of infrastructural resources — roads, telecommunications networks, the environment, and, of particular interest to readers of this blog, cultural resources including those which are protected by patent and copyright law.

I'm going to focus my comments on Frischmann's theory of intellectual infrastructure and how it relates to the structure of intellectual property law. Just a few days after the release of Infrastructure, the Supreme Court handed down its decision in Mayo Collaborative Services v. Prometheus Laboratories. That case presented the question whether certain diagnostic claims were within the scope of patentable subject matter under section 101 of the Patent Act. The Court held that they were not, in a manner that is strikingly consistent with Frischmann's theory. Hence the title of my post. But Frischmann's theory may also go a long way toward bringing some order to an area of patent law that has long been confused.

Let's start with the concept of intellectual infrastructure. Frischmann explains that intellectual or cultural resources can be infrastructural in the same manner as physical goods. So long as the resource is a "nonrival input into a wide variety of outputs" (275), it satisfies the characteristics of infrastructure that Frischmann so richly describes. In turn, that suggests that the case for managing the resource as a commons is strong. Frischmann then explains how this concept applies to ideas. Ideas, he writes, often are infrastructure (subject to a number of complications that I'll put to the side). So in his view, intellectual property should protect implementations of ideas but not the ideas themselves (286). To sort one from the other, Frischmann turns to the concept of abstraction in copyright law and argues that patent law should follow a similar path.

Now consider Prometheus. The inventors in that case discovered a correlation between the effectiveness of a drug and the amount of certain metabolites of that drug in a patient's blood. Their patent claimed a method of optimizing the dosage of the drug based on that correlation. The method was simple: (1) administer the drug; (2) determine the amount of metabolites in the patient's blood; (3) make an inference about drug dosage based on the correlation. Doctrinally, the question before the Court was whether this amounted to a claim on a "natural law" – the correlation between drug dosage and metabolism that happens in the human body – which would be unpatentable under a long-standing exception to the scope of patentable subject matter, or a patentable application of that law.

Substitute "idea" for "natural law" and the analogy to Frischmann's analysis becomes clear. Indeed, there is no reason why a "natural law" cannot be an "idea" as Frischmann describes it. A natural law is the articulation of a principle; whether that principle is an infrastructural idea turns on its characteristics, not its origins. In Prometheus, the Court, with Justice Breyer authoring the unanimous decision, held that the patent claimed the natural law itself and not an application of that law. The Court held that the the patent claims did not "add enough to their statements of the correlations . . . to qualify as patent-eligible processes that apply" those correlations (slip op. 8). The "administering" and "determining" steps, in the Court's view, comprised "well-understood, routine, conventional activity already engaged in by the scientific community" and so were "not sufficient to transform unpatentable natural correlations into patentable application of those regularities" (slip op. 11). Or, in Frischmann's terms, the patent claims did not amount to an implementation of an idea; they claimed the idea itself.

The rationale underlying the Court's decision also resonates with Frischmann's argument. Justice Breyer cast the decision in expressly functional terms. The danger, he wrote, is that because natural laws are "the basic tools of scientific and technological work," patents on natural laws "foreclose[] more future invention than the underlying discovery could reasonably justify" (slip op. 17). So too, the rationale for managing infrastructural resources as commons turns on the demand-side benefits: the spillovers and externalities that non-rival consumption of infrastructure resources enables. In this way, Prometheus is quite consistent with Frischmann's injunction against propertizing ideas.

Frischmann's theory also suggests some provocative solutions to problems that have long plagued the doctrine of patentable subject matter. Section 101 of the Patent Act defines as patentable any "new and useful process, machine, manufacture, or composition of matter." But the Supreme Court has long carved out from those categories several broad exceptions. They are usually described by the terms "laws of nature, natural phenomena, and abstract ideas," but at times appear also to encompass "products of nature," "mental processes," "mathematical formulae," "algorithms," and the like. Infrastructure may offer a unifying principle for choosing to exclude these things from the scope of patentable subject matter. Frischmann writes that "[t]he Supreme Court should stop referring to abstract ideas" in its patentable subject matter jurisprudence and should instead "make clear that ideas are not patentable" (300). Viewed through the lens of infrastructure, Prometheus is a step in this direction. The correlations at issue in that case were actually quite narrow. At the very least, they were not "abstract" in the sense that the "concept of hedging risk" found to be unpatentable in Bilski v. Kappos was abstract. Yet the correlations in Prometheus and the concept of hedging in Bilski are both ideas. And they are ideas that have the characteristics of infrastructure — nonrival inputs into a wide range of outputs. The Court's functional analysis suggests that the problem in both cases was that granting exclusive rights to ideas that have the characteristics of infrastructure might foreclose future innovation.

I would go even further. The next big patentable subject matter case is likely going to be the Public Patent Foundation's ongoing challenge to gene patents held by Myriad Genetics. Doctrinally, the question raised in that case — whether the patents claim "products of nature" – is different than the question whether a patent claims an idea. But to the extent that genes can be characterized as infrastructure — and I think there is a reasonable case that they can be — the functional analysis described above should apply. The exclusion of products of nature from the scope of patentable subject matter may therefore be consistent with the exclusion of ideas from the scope of patentable subject matter.

It has also been a matter of debate among academics and practitioners whether and to what extent the inquiry into patentable subject matter serves a function different from other requirements of patentability like novelty or nonobviousness. To the extent that infrastructural resources ought to lie beyond the scope of patent protection for functional reasons, the patentable subject matter screen will capture this insight in a way that other patentability doctrines will not. But this is a topic for further exploration.

Frischmann's book is an important contribution across a wide range of fields. It is a terrific achievement and I think its influence will continue to grow as we grapple with the implications of its analysis.

Concurring Opinions has been hosting a symposium to discuss Prof. Frischmann's book and includes posts by Marvin Ammori, Adam Thierer, Barbara A. Cherry, Frank Pasquale, Michael Burstein, Timothy B. Lee, Tim Wu, Laura DeNardis, Andrew Odlyzko, Deven Desai, and Brett Frischmann himself.