Tag Archives: First to Invent

Billups-Rothenberg v. ARUP: The Dangers of FIling Too Early…Or Too Late

By Jason Rantanen

Billups-Rothenberg, Inc. v. Associated Regional and University Pathologists, Inc. (Fed. Cir. 2011) Download 10-1401
Panel: Gajarsa (author), Linn, and Moore

Billups is a classic example of the difficulties companies face when engaging in patent races.  Patent races occur when two or more entities are in competition to be the first to develop and patent a new technology.  In these sitautions, companies race to file patent applications, hoping to gain a competitive advantage.  Sometimes, however, the applications are filed before the inventors have really developed a patentable invention; othertimes, the applications are filed too late, after a competitor has filed its own application or published crucial information. In this case, Billups filed Patent No. 5,674,681 too early and Patent No. 6,355,425 too late, losing on both ends.

The patents-in-suit relate to a genetic test for Type I hereditary hemochromatosis that involves the detection of specific mutations in genes involved in regulating iron absorption.  The district court granted summary judgment of no written description for the '681 patent and anticipation of the '425 patent.

Lack of Written Description of Earlier Patent
On appeal, the CAFC first affirmed the district court's ruling that the '681 patent lacked written description, applying its customary approach to biotechnology inventions.  Here, Billups disclosed only the approximate location of the relevant mutation in the '681 patent, a disclosure that it argued was sufficient to place the inventor in possession of the invention (which in this case included the step of detecting the mutation) when combined with the knowledge that existed at the time of invention.  The CAFC disagreed.  "Given the lack of knowledge of sequences for the hemochromatosis gene and its mutations in the field, the limited extent and content of the prior art, and the immaturity and unpredictability of the science when the '681 patent was filed, Billups cannot satisfy the written description requirement merely through references to later-acquired knowledge."  Slip Op. at 11. 

The panel also, unnecessarily in my opinion, addressed the problem in genus-disclosure terms.  After quoting the relevant case law regarding disclosure of genus claims, the court concluded that the the patent failed because it "does not not identify even a single species that satisfies the claims.  In this case, the eventual discovery of only one species…within the claimed genus does not constitute adquate written description of that genus."  It is opaque to me what relevance a post-filing discovery of a species, let alone one by a third party, has to a species-genus analysis.

Anticipation of Later Patent
At the same time that Billups was conducting its  research, another group of scientists isolated and sequenced the hemochromatosis gene, published their results, and obtained Patent No. 6,025,130, filed nearly three years before the '425 patent.  The CAFC agreed with the district court that the '130 patent was anticipatory.

The inquiry focused on whether the '130 patent disclosed the diagnosis of an iron disorder using a specific mutation, the S65C mutation.  The '130 patent reports the genetic sequence of the S65C mutation, among with others that the inventors believed relevant to hemochromatosis, and describes techniques for conducting genetic assays that it states can be used to design a diagnostic device and method for screening the mutations.  Billups argued that this disclosure was not anticipatory because the '130 patent did not conclude that the S65C mutation was related to a hemochromatosis disease state, merely that there was a correlation and thus, Billups argued, the S65C mutation may have been only  a clinically insignificant polymorphism. 

Relying on the doctrine that a "reference is no less anticipatory if, after disclosing the invention, the reference then disparages it" (Slip Op. at 15), the CAFC rejected BIllups argument.  Here, "the '130 patent disclosed using the S65C mutation when diagnosing hemochromatosis, but qualifies that disclosure with the obseravation that the mutation "may only be a polymorphic variant."  Id., quoting '130 patent (emphasis in opinion).  Although the prior art questioned the utility of the application of the disclosed invention, it nevertheless disclosed it, thus rendering the '425 patent anticipated. 

Ex Parte Contact with USPTO Examiners

Radio Systems Corp. v. Accession, Inc. (Fed. Cir. 2011)

Accession is a small private New Jersey corporation. Its owner, Thomas Sullivan, is also the sole employee and named inventor of the company’s patent. Accession makes and sells a pet door (the “Wedget”) that installs within a sliding glass patio door. Accession’s Patent No. 7,207,141 issued in April 2007 and claims this “portable pet portal insert for use with a sliding patio door.” Radio Systems is headquartered in Tennessee and makes pet-related products, including a patented electronic pet access door (the “SmartDoor”).

The personal jurisdiction holding in this case will be discussed in a different post, but here I wanted to bring up the interesting facts regarding Accession’s ex parte contact with the USPTO regarding Radio System’s pending patent application. Judge Bryson explains the facts as follows:

On August 20, 2009, Accession’s counsel left a voice message with the PTO examiner for the [Radio Corp] SmartDoor application, alerting the examiner to the existence of Accession’s ‘141 patent. On the same day, Accession’s counsel telephoned Radio Systems’ counsel and stated his position that the SmartDoor infringed the ‘141 patent and that interference proceedings would be warranted between the ‘141 patent and the SmartDoor application. Later that day, Accession’s counsel left a voice message with Radio Systems’ counsel indicating that Mr. Sullivan should be named as a co-inventor on the SmartDoor application. On August 25, 2009, Accession’s counsel sent an e-mail to Radio Systems’ counsel asking whether Radio Systems had brought the ‘141 patent to the attention of the PTO. The next day, the PTO examiner returned the phone call of Accession’s counsel. As a result of that conversation, the PTO withdrew the notice of allowance previously issued for the SmartDoor application. On August 28, 2009, Accession’s counsel sent an e-mail to Radio Systems’ counsel informing him of the communication with the examiner.

Of course, third-party contact with an examiner is expressly prohibited under the Manual of Patent Examining Procedure unless expressly authorized by the applicant. Further violating procedure, the USPTO Examiner then returned the telephone call and based upon the information learned issued a “Notice of Withdrawal from Issue.”

Once an examiner learns of important prior art it, that examiner should use the prior art. Here, the examiner cited the Sullivan patent as prior art against claim 17 of the SmartDoor application and indicated that the “pertinent prior art document” had been disclosed in a telephone conversation with Accession’s patent attorney on August 26, 2009. In response, Radio Corp cancelled claim 17.

In its brief, Accession attempted to rebut the argument that its attorney had done anything wrong – writing that:

Nothing in the record could establish that the Patent Office considered Accession’s contacts to be “wrongful.” Indeed, after the first contact, a voicemail left by Accession’s counsel with the patent examiner, the Patent Office reached out to Accession’s counsel and subsequently took action it believed appropriate. That action did not include sanctions against Accession. There is nothing in this record (or elsewhere) suggesting that the Patent Office found Accession’s counsel’s actions to have violated any rule, policy, or law. Further, the record demonstrates that the sole purpose of the contacts was to alert the Patent Office to the fact that the Radio Systems pending application was deficient.

What should happen here?

Crown Packaging v. Ball Metal Beverage Container: The Problem-Solution Approach to Written Description Issues

By Jason Rantanen

Crown Packaging Technology, Inc. v. Ball Metal Beverage Container Corporation (Fed. Cir. 2011) Download 10-1020
Panel: Newman, Dyk (dissent), Whyte (author)

For the past decade, the Federal Circuit has struggled to reconcile the the written description rules announced in its biotechnology-related opinions with the patentability requirements for patents in other technological fields.  Particularly challenging for the court are the implications of a strong written description doctrine for mechanical inventions, which historically were subject to little scrutiny under the broad approach to the written description requirement.

Crown Packaging presents the latest iteration of the court's thinking on this issue.  Penned by the highly regarded Judge Ronald M. Whyte of the Northern District of California, the opinion firmly lays to rest one possible argument for challenging mechanical patents on written description ground and confirms that the Problem-Solution approach to analyzing written description issues applied in Revolution Eyewear is alive and well post-Ariad.  Given the depth of its treatment of the issue, this is an opinion that should go into every attorney's toolbag for addressing non-biotech related written description issues.

The patents at issue in Crown disclose a beverage can end that reduces the amount of metal wasted during the process of seaming the can end to the can body.  (Picture a can of soda.  The can end is the top portion that one drinks from.  The can body is the part that contains the beverage.)  The patents (which share a specification) solve the problem of reducing metal waste in two ways: first, by changing the angle of the vertical portion of the inside wall from nearly perpendicular to significantly angled, and second, by reducing width of the reinforcing bead (the little channel that runs along the inside of the can lip that tends to fill up with soda).  Because simply reducing the width of the reinforcing bead can present structural challenges and result in unsightly scuffing, the patent also discloses a particular type of chuck (the portion of the seaming machinery that sits inside the top of the can against which the lip is rolled) that does not drive deeply into the reinforcing bead.

Figure 2 illustrates the prior art; Figure 5 is an embodiment of the invention.  In the prior art can end, the peripheral walls are nearly vertical and the chuck (element 17) fully enters the reinforcing bead (element 15); in the embodiment of the invention, the walls are closer to 45 degrees and the chuck (element 31) does not enter the reinforcing bead (element 25).

Crown Fig 2
Crown Fig 5
Crown's two patents, one for a product and the other a method of manufacturing, include claims covering just the use of an angled wall without mentioning the narrow bead or penetration of the chuck. During the district court proceedings, Ball argued that these claims lacked written description support because they covered embodiments both in which the chuck was driven inside the reinforcing channel as well as embodiments in which the chuck was driven outside the bead despite only describing embodiments showing the latter in the specification.  The district court agreed with Bell, granting summary judgment of invalidity.

Judge Whyte and Judge Newman disagreed with the district court.  After dismissing the species-genus approach to these types of situations, the majority framed the issue in problem-solution terms.  Relying on Revolution Eyeware, Inc. v. Aspex Eyewear, Inc., 563 F.3d 1358 (Fed. Cir. 2009), the court agreed with Crown that "[i]nventors can frame their claims to address one problem or several, and the written description requirement will be satisfied as to each claim as long as the description conveys that the inventor was in possession of the invention recited in the claim." Slip Op. at 13, quoting Revolution Eyewear at 1367.  Here, there were two separate, clearly described solutions to the problem of improving metal useage: modifying the slope of the wall or limiting the width of the reinforcing bead.  Nor does it matter that both solutions relate to the same problem: "we specifically held in Revolution Eyewear that it is a 'false premise that if the problems addressed by the invention are related, then a claim addressing only one of the problems is invalid for lack of sufficient written description."  Slip. Op. at 14, quoting Revolution Eyewear at 1367. And the majority distinguished the issue of enablement from that of written description, concluding that Ball's argument relating to whether one of ordinary skill in the art could not seam a can with an increased sloped chuck wall without also avoiding contact with the reinforcing bead presented an issue of enablement, not written description. 

One possible limitation on the majority's holding, however, is where the specification mandates that the prior art problems must always be solved together.  Here, the specification did not so require – rather, "the specification supports the asserted claims that achieve metal savings by varying the slope of the chuck wall alone."  Slip Op. at 15.  Yet this will likely be an argument raised by future parties.

The Dissent
Although agreeing with the majority on the reversal of the district court's grant of summary judgment of anticipation, Judge Dyk disagreed with its treatment of the written description issue.  Judge Dyk's dissent rested on a different reading of Revolution:

Relying on Revolution Eyewear, the majority holds that the claims are valid. However, Revolution Eyewear, in holding that a claim may address only one of the purposes disclosed in the specification, still requires explicit disclosure of the embodiments in the claims: “Inventors can frame their claims to address one problem or several, and the written description requirement will be satisfied as to each claim as long as the description conveys that the inventor was in possession of the invention recited in that claim.” Revolution Eyewear, Inc. v. Aspex Eyewear, Inc., 563 F.3d 1358, 1367 (Fed. Cir. 2009) (emphasis added). Therefore, the claims, whether directed to solving a single problem or multiple problems, must still be grounded in the specification.

Thus in Judge Dyk's view, the claims lack written description:

There is no question that the specification does not teach combining the sloped can end wall together with the wider, prior art bead and driving the chuck into the bead instead of the sloped can end wall. That combination is a new and distinct invention, and our written description jurisprudence requires that it be described in the specification. The fact that the claims are broad enough to cover such an invention or imply that the claims cover such an invention is not sufficient when the invention itself is not described either in the claims or elsewhere in the specification. The failure of the specification to describe the invention requires invalidation of claims 50 and 52.

Commentary:
I find it difficult to agree with Judge Dyk's distinguishing of Revolution Eyewear, which was decided on strikingly similar facts, or his deeper view of what constitutes an invention.  In Revolution, the patent addressed two problems presented by prior-art magnetic sunglasses that attached to the frame of a pair of glasses: a frame strength problem, which the inventor solved by placing the magnets on protrusions extending from the primary and auxiliary frames, and a stability problem, which the inventor solved by having the protrusions extending from the auxiliary frame rest on top of protrusions extending from the primary frame.  The asserted claim covered only the former: placing the magnets on protrusions, and did not include any limitations directed to the stability problem.

In rejecting the written description defense, the Revolution court pointed specifically to Figure 3 of the original patent, reproduced below:

Revolution Eyeware Figs 3 and 4
This figure discloses only the combination embodiment: a primary frame with magnet-containing protrusions designed so that the auxiliary frame protrusions will rest on top (element 13/14 on the primary, 21/22 on the auxiliary).  The court's opinion did not rely on any embodiments showing only magnet-containing projections without the stability component.  Yet, under Judge Dyk's reasoning, such an embodiment could not provide the necessary written description support. 

Moving into the abstract, Judge Dyk's view of the nature of an invention also seems problematic to me.  Judge Dyk seems to be expressing the Louriean idea that "the invention" must be limited to the identical embodiments disclosed in the patent.  Any alteration of those embodiments, such as combining one particular inventive idea disclosed in the patent with the prior art, renders the claim invalid.  But this bright line rule ignores one of the underlying tensions in patent law, namely, that it is impossible to describe every single possible permutation of the invention.  Patents don't need to specify, for example, that a particular device may be painted every color of the rainbow to provide written description support for a claim that contains no limitations as to color.  Yet this seems to be the logical extension of the embodiment-only approach, and one that continues to be trouble me. 

American Piledriving v. Geoquip: Resolving Different Courts’ Constructions

By Jason Rantanen

American Piledriving Equipment, Inc. v. Geoquip, Inc. and American Piledriving Equipment, Inc. v. Bay Machinery Corporation (Fed. Cir. 2011) Download 10-1283
Panel: Bryson, Gajarsa, and Linn (author)

One of the Federal Circuit's primary purposes is to ensure consistent claim construction results.  American Piledriving v. Geoquip highlights this role. 

American Piledriving holds Patent No. 5,355,964, which relates to counterweights for "vibratory pile drivers."  By rapidly rotating these unevenly weighted counterweights in opposite directions, vibratory forces are generated that force the pile into the ground.  Early counterweights possessed several drawbacks that the invention of the '964 purport to solve.

The district court proceedings on appeal involved two suits brought by American Piledriving, one in the Eastern District of Virginia and the other in the Northern District of California, against distributors of vibratory pile drivers manufactured by Hydraulic Power Systems, Inc. (These two suits were part of a set of seven brought by American Piledriving, all in different districts).  The crucial portion of representative claim 1 reads:

a counterweight rotatably carried in said receiving means for rotation about a rotational axis, said counterweight having a cylindrical gear portion and an eccentric weight portion integral with said cylindrical gear portion, said eccentric weight portion having at least one insert-receiving area formed therein, said counterweight being made of a first metal;

At issue were the district courts' constructions of three claim terms, two of which the courts construed differently: "eccentric weight portion" and "insert receiving area." (The courts reached the same contruction for "integral," a construction the appellate court affirmed).  Based on their constructions of these terms, the two district courts granted summary judgment of noninfringement.

On appeal, the CAFC agreed fully with the Virgina court, affirming its constructions and grant of summary judgment.  The Calfornia court fared slightly less well: the panel disagreed with the additional limitations the trial court added but nonetheless affirmed summary judgment of noninfringement for the two products that were also involving in the Virginia litigation, reversing and remanding for further proceedings on a third product at issue only in the California litigation. 

Although much of American Piledriving comes across as a typical claim construction opinion concluding that well-established principles of claim construction supported the district courts' interpretations, the portions of American Piledriving addressing the two courts' different interpretations of "eccentric weight portion" and "insert receiving area" are somewhat noteworthy.  All three courts determined that some structure provided by the specification was required; however, the CAFC concluded that the California court's constructions went beyond what the rules permitted:

While both district courts indicated that the term should be defined as extending from the face of the gear, the California court also required that the “eccentric weight portion” extend from a particular portion of the gear, extend in a specific direction, and include a receiving area formed to receive a tungsten rod. This court agrees with American Piledriving that nothing in the specification compels the reading of these additional limitations into the construction of “eccentric weight portion.”

Unfortunately, the CAFC's discussion of the differences between these two courts' analyses of the use of the structure in the specification to limit the functional claim elements is limited to this brief passage and a similar passage in its section on "insert receiving area."  This is disappointing given the court's build-up at the beginning of the opinion, which held promise for a thorough dissection of where the cutoff might be in terms of how much structure from the specification should be part of the claim constuction.  See Slip Op. at 10 ("In the course of construing the claims in this case, the Virginia district court carefully avoided redefining the claims and reading limitations into the claims from the written description. The California district court, however, inappropriately added several limitations not contained in the inventor’s claimed definition of the scope of his invention. This disparate treatment of the same issues before two competent and capable district courts is thus instructive."

Federal Circuit Rejects Narrow View of Analogous Arts Test

by Dennis Crouch

Innovation Toys v. MGA Entertainment and Wal-Mart (Fed. Cir. 2011) Download 10-1290

Panel Judges Rader, Lourie, and Whyte

The patent in suit are directed to a strategy board game that uses lasers and movable mirrored playing pieces. The winner is the first to illuminate opponent’s “key playing piece.”  See U.S. Patent No.  7,264,242. Defendant MGA’s Laser Battle board game seemed to fit the bill, and the district court granted summary judgment of literal infringement.

On summary judgment, the district court also held the patent non-obvious.  The keystone of the district court’s analysis was that  element of the district court judgment to exclude prior art related to the 1989 Atari Laser Chess video game. In particular, the district court held that the video game was not analogous art to the patented board game.

Analogous Art: Prior art is not considered in the obviousness analysis unless it can be classified as analogous art. In his treatise, Donald Chisum defines analogous art as “prior art [that] includes both references in the art in question and references in such allied fields as a person with ordinary skill in the art would be expected to examine for a solution to the problem.”  The Federal Circuit has traditionally followed a two step analysis to determine whether a reference is analogous: “(1) whether the art is from the  same field of endeavor, regardless of the problem addressed, and (2) if the reference is not within the field of the inventor’s endeavor, whether the reference still is reasonably pertinent to the particular.”  In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004).  The court treates the question of whether art is analogous as a question of fact.

In KSR v. Teleflex, the Supreme Court ruled that “any need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining [prior art] elements in the manner claimed.”  While that holding addressed a slightly different doctrinal aspect of the nonobviousness analysis, the bases for the Supreme Court’s ruling in KSR would apply for the analogous arts test. This appellate decision does not discuss KSR. However, in Wyers v. Master Lock, 616 F.3d 1231 (Fed. Cir. 2010) (Dyk, J.), the Federal Circuit opined that KSR “directs [the court] to construe the scope of analogous art broadly.”  In Wyers, Judge Dyk points to the KSR statement that “familiar items may have obvious uses beyond their primary purposes, and a person of ordinary skill often will be able to fit the teachings of multiple patents together like pieces of a puzzle.”

Here, the court did not need to use KSR to expand upon the traditional doctrinal limits of analogous arts. In reviewing the lower court decision, the Federal Circuit held that the lower court

failed to consider whether a reference disclosing an  electronic, laser-based strategy game, even if not in the same field of endeavor, would nonetheless have been reasonably pertinent to the problem facing an inventor of a new,  physical, laser-based strategy game.  In this case, the district court clearly erred in not finding the Laser Chess references to be analogous art based on this test as a matter of law.

On remand, the district court will be asked to reconsider the obviousness question after including the Laser Chess video game reference.

America Invents Act – First to Invent and a Filing Date Focus

Earlier this week, the Senate overwhelmingly passed (95–5) the America Invents Act (S.23 or AIA) which represents a major patent reform initiative.  Many are saying this is the largest patent reform measure since the 1952 Patent Act.  I would argue that two reforms from the 1980’s are at least as important as the AIA: Federal Courts Improvement Act of 1982 (establishing the Court of Appeals for the Federal Circuit) and the 1984 Hatch-Waxman Act (establishing the modern generic drug system). 

Of course, neither of those 1980’s reforms rewrote the core patent law fundamentals of novelty and nonobviousness. In this post, I look at how the AIA re-defines these doctrines.

Filing Date Prior Art: Under the new law, Sections 102 and 103 of the patent act would be largely rewritten.  The new Section 102(a) defines novelty and eliminates invention-date rights (with the exceptions noted below).  The new focus a patent applicant’s “effective filing date” and whether prior art existed before that date. As a general matter, this shift expands the scope of potential prior art and therefore should make it more difficult to obtain patent protection.  In addition to the date change, the statute adds a new catch-all phrase to the scope of prior art. Courts will be asked to consider what it means to be “otherwise available to the public.”  Under the new provision classifies prior art as items “patented, described in a printed publication, or in public use, on sale, or otherwise available to the public.”  Section 102(a)(1).  In addition, a third-party application on file at the PTO will count as prior art as of its effective filing date once that application is published or patented. Section 102(a)(2).  Of course, the effective filing date allows for priority claims

Narrow Grace Period: The new law would substantially narrow the current one-year pre-filing grace period so that that it only applies to negate pre-filing disclosures (1) by the inventor, (2) derived from the inventor, or (3) after the inventor had already publicly disclosed.  A technical problem with the new Section 102(b) provision is that the key term –  “disclosure” – is left undefined. The grace period provision is written as an exception to the filing-date prior art provision discussed above. However, it is unclear whether the exception applies to all types of prior art including “on sale” activities. 

Patent Races and First-to-File: In a patent race with two or more entities seeking protection for the same invention, the patent would be awarded to the first-to-file a patent application rather than the first-to-invent.  This eliminates current Section 102(g), interferences, and questions of conception, diligence, reduction to practice, abandonment, suppression, and concealment.  Except that the new law would allow for a derivation action (court) or proceeding (USPTO) when the first-filer “derived” their claimed invention from another. An oddity of the statute is that the derivation action may only be filed when the patent office issues two patents that claim the same invention. An important aspect of the derivation proceedings before the USPTO is that they allow the parties to settle their case.

One problem with the derivation provision that will be left to the PTO and courts is that the key term – “derived” – is not defined.  If given a broad meaning, the derivation proceedings could offer inventors something akin to the copyright doctrine of derivative works. 

This invention-date focus will likely drive more provisional patent application filings for US entities.  The prior-disclosure grace period limitation may drive a revival in formal invention disclosure publications.  However, because this narrowed grace period is still broader than that available in most countries, a pre-filing disclosure may negate foreign patent rights.

No Prior User Rights: The Senate Bill does not include any provision for prior user rights.  Although current law only has limited prior user rights, a prior user who is sued for infringement may be able to invalidate that patent by claiming prior invention under Section 102(g).  That option is eliminated in a first-to-file system leaving a prior user potentially liable for infringement.  

Nonobvious Subject Matter: The new law would rewrite Section 103 as follows

A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.

One shift in the nonobviousness statute merely codifies the current law’s focus on “claims” rather than the “subject matter sought to be patented.”   We’ll hope that courts will not interpret the phrase “the claimed invention as a whole” as requiring the courts to examine the entire claim-set as a whole.

The most important change is that the new provision considers obviousness as of the “effective filing date” of the patent claims being considered rather than “at the time the invention was made.” Of course, the courts already ignore the language of the statute and allow post-invention 102(b) prior art to be used for obviousness analysis.

Comparison of the Current U.S. First-to-Invent System with the First-Inventor-To-File System Proposed in the Patent Reform Act of 2011 (S.23)

Guest Post By Prof. Ann McCrackin, Stephen Brodsky, and Amrita Chiluwal. Prof. McCrackin is Director of the Patent Prosecution Program at the Univ. of New Hampshire School of Law (formerly Franklin Pierce Law Center). Mr. Brodsky and Ms. Chiluwal are both 2011 JD Candidates at the Univ. of New Hampshire School of Law.

The Patent Reform Act of 2011 ("S.23") is now being considered by the full U.S. Senate. One of the provisions of S.23 would replace the current first-to-invent ("FTI") system with a first-inventor-to-file ("FITF") system. Some of the differences between these two systems are outlined below in order to help understand the changes in Sec. 2 of the S.23 Bill. For simplified illustrative purposes, Parties ("A" and "B") and their invention ("Widget") will be used below.

First-to-Invent

The current U.S. system is a first-to-invent ("FTI") system. Under the FTI system, the first party to invent is entitled a patent on that invention upon filing for a patent application (as long as all of the other patentability requirements are met). Even if the first party to invent is not the first to file, that party could still be entitled to the patent rights. In situations where there are multiple inventors of the same invention, the determination as to who is entitled to the patent rights is made during an interference proceeding. Interference proceedings are administrative proceedings held at the USPTO that legally determine the first inventor. However, there are time constraints on interference proceedings, e.g., typically a party cannot bring an interference proceeding on an invention after a patent has issued on that patent. Therefore, the first person to file would get the patent unless another person is able to prove prior invention in an interference proceeding.

The following examples involve two parties who claim the same invention in an FTI system:

(more…)

Centocor v. Abbott: Written Description and Antibody Claims

By Jason Rantanen

Centocor Ortho Biotech, Inc. v. Abbott Laboratories (Fed. Cir. 2011) Download 10-1144
Panel: Bryson, Clevenger, Prost (author)

Centocor, the holder of Patent No. 7,070,775, which claims fully human antibodies to human necrosis factor α ("TNF-α"), sued Abbott for infringement by the therapeutic antibody Humira®.  A jury rejected Abbott's defenses and awarded Centocor $1.67 billion in damages.  After the district court granted Abbott's JMOL of no willful infringement, but denied JMOL on invalidity, noninfringement and damages, Abbott appealed. 

Later Added Claims Lacked Written Description
On appeal, the CAFC reversed, focusing solely on the issue of written description.  In many ways this is a prototypical written description case.  Centocor's approach to developing a TNF-α antibody involved first identifying a mouse antibody to human TNF-α, then changing the less critical portions of the antibody to make it more human – thus producing a chimeric antibody.  Abbott followed a different path, setting out from the start to develop a fully human antibody, a process that ultimately led to Humira®.  Both Centocor and Abbott obtained patents on their antibodies.

In 2002, after Abbott obtained regulatory approval to market Humira®, Centocor filed claims to fully human antibodies as part of an ongoing continuation of the chimeric antibody patent family. These claims later issued as part of the '775 patent.  In responding to Abbott's argument that the fully human antibody claims lacked adequate written description, Centocor relied on a 1994 CIP in the chain that predated the 1996 filing date of Abbott's patent application.

In its opinion, the CAFC honed in on the lack of disclosure of any human variable regions (the portion of the antibody that binds to TNF-α) in the 1994 CIP.  Examining the "four corners" of the 1994 CIP application, the court concluded that "[t]here is nothing in the specification that conveys to one of skillin the art that Centocor possessed fully-human antibodies or human variable regions that fall within the boundaries of the asserted claims."

"while the patent broadly claims a class of antibodies that contain human variable regions, the specification does not describe a single antibody that satisfies the claim limitations. See Eli Lilly, 119 F.3d at 1566-69. It does not disclose any relevant identifying characteristics for such fully-human antibodies or even a single human variable region. See id. Nor does it disclose any relationship between the human TNF-α protein, the known mouse variable region that satisfies the critical claim limitations, and potential human variable regions that will satisfy the claim limitations."

Slip Op. at 16-17.  Essentially, the claims constituted a wish list of properties for a fully-human, therapeutic TNF-α antibody would possess – but a mere wish or plan for obtaining the invention is not sufficient to satisfy the written description requirement. 

Disclosure of a Protein Does Not Necessarily Suffice to Support Claims to All Associated Antibodies
Centocor also suggested that it satisfied the written description requirement by fully disclosing the human TNF-α protein.   It based that suggestion on the current PTO written description guidelines, together with Noelle v. Lederman, 355 F.3d 1343 (Fed. Cir. 2004).  One example in the PTO guidelines indicates that "'an isolated antibody capable of bding to [protein] X' is adequately described where the specification fully characterizes protein X-even if there are no working or detailed prophetic examples of actual antibodies that bind to protein X."  Slip Op. at 17-18.  In other words, simply disclosing the "lock" is suffient to support a claim to the key fitting into that lock.  This view was reinforced by Noelle, in which the CAFC held that:

"as long as an applicant has disclosed a “ fully characterized antigen,” either by its structure, formula, chemical name, or physical properties, or by depositing the protein in a public depository, the applicant can then claim an antibody by its binding affinity to that described antigen."

Noelle, 355 F.3d at 1349. 

Accepting that while this may be true in some cases, the CAFC rejected its application to the multi-part claims at issue.  "While our precedent suggests that written description for certain antibody claims can be satisfied by disclosing a well-characterized antigen, that reasoning applies to disclosure of newly characterized antigens where creation of the claimed antibodies is routine."  Slip Op. at 19.  Here, the creation of the claimed antibodies – which possessed a number of characteristics beyond their relationship with the antigen – was anything but routine.  "Claiming antibodies with specific properties, e.g., an antibody that binds to human TNF-α with A2 specificity, can result in a claim that does not meet written description even if the human TNF-α protein is disclosed because antibodies with those properties have not been adequately described."  Id. at 20.  As Centocor "failed to support its contention that generating fully-human antibodies with he claimed properties would be straightforward for a person of ordianry skill in the art" at the time, possession of the known antigen did not place it in possession of the claimed antibodies. 

For those who are interested in reading further, PatentDocs has a detailed write-up of the decision.

 

Arlington Industries v. Bridgeport Fittings: “The specification is the heart of the patent”

By Jason Rantanen

Arlington Indus., Inc. v. Bridgeport Fittings, Inc. (Fed. Cir. 2011)
Panel: Rader (author) Lourie (concurring in part and dissenting in part), Moore

At first glance, Arlington v. Bridgeport presents a seemingly typical claim construction opinion, as the majority opinion reads like any another decision addressing the perpetual question of whether the district court improperly imported a limitation from the specification or instead correctly interpreted the claims in light of the specification and prosecution history.  In an eloquent dissent, however, Judge Lourie reveals his deepest beliefs as to what patents should really be about: permitting the patent holder to claim what is disclosed in the specification – and nothing more.

 
Bac
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2010-1025The claim construction issue in this appeal involved the term "spring metal adaptor," a key component in the invention: a new fitting for an electrical junction box.  Prior to the invention of Patent No. 5,266,050, held by Arlington, most junction box connectors used a threaded nut that was screwed into the junction box – a tricky operation.  The '050 patent solved this problem by using a fitting with a spring metal adaptor (20) containing two types of outward pointing tangs (22 and 23).  The new fitting could simply be snapped into place rather than needing to be screwed.

During the district court proceedings, the court construed the claim term "spring metal adaptor" to mean a "*split* spring adaptor," commenting that "a necessary feature of the "spring" metal adaptor is that it is 'split.'  Without the split, it would not spring."  Summary judgment of non-infringement was granted in Bridgeport's favor based on this construction.

Majority: The District Court Imported a Limitation from the Specification
Treating the appeal as a standard question of claim construction, Judge Rader, writing for the majority, held that the district court erred by importing a "split" limitation into its constructions of "spring steel adaptor."  The majority first dismissed Bridgeport's argument that "spring" should be construed to mean that the metal adaptor performs a "springing" function, and instead held that it refers to the type of steel used in the adaptor. It then rejected the argument that "spring metal adaptor" should be defined by implication to require a split, considering both the specification and prosecution history, as well as the doctrine of claim differentiation, before concluding that the intrinsic evidence "reveals no intent to lit the term 'spring metal adaptor' by using it in a manner that excludes unsplit adaptors."  Slip Op. at 15.

Judge Lourie's Dissent: "The specification is the heart of the patent"
Bringing to the boil an ideological disagreement that last eruped in Ariad, Judge Lourie's dissent takes issue less with the outcome of this particular appeal than with the CAFC's entire approach to claim construction.  Expanding upon his discussion of claim construction in Phillips v. AWH Corp., 415 F.3d 1303, 1328 (Fed. Cir. 2005) and before, Judge Lourie writes: "the basic mandate is for claims to be interpreted in light of the specification of which they are a part because the specification describes what the inventors invented….The specification is the heart of the patent.  In colloquial terms, you should get what you disclose."  Arlington dissent at 2 (internal citation omitted).  In his view, the problem is that the CAFC has gotten bogged down in its "focus on our muddy, conflicting, and overly formulaic rules…when the real task of claim interpretation is to read the specification and determine what the inventors meant when they used the language they did." Id. (internal citation omitted).

"Obviously the claims define the scope of protection accorded the owners of a patent. Phillips, 415 F.3d at 1312. But in construing the claims we should avail ourselves of the knowledge we glean from the patent specification to see what the inventors disclosed as their invention. The bottom line of claim construction should be that the claims should not mean more than what the specification indicates, in one way or another, the inventors invented."

Id. Thus, Judge Lourie would have ruled differently:

"In this case, the inventors made clear in the specification of the ‘050 patent that the spring metal adapters in their invention have an opening that prevents the adap-tors from forming a complete circle. The result that the panel majority arrives at here, on remand, could be that Bridgeport might be held to be an infringer of a patent that clearly indicates that there is a split in the adaptor, by making or selling an adaptor lacking such a split. That is not a result that the patent law ought to protect."

Id. (emphasis added).

Judge Lourie's articulated ideology of claim construction offers a window into a deeper worldview: that fundamentally, patents should be narrow, limited to only that which the inventor actually contemplated at the time of filing.  If an inventor invents a circular tanged clip with a slot, the inventor should not be able to claim circular tanged clips that lack slots, period.  Following Judge Lourie's reasoning a bit further, if an inventor contemplates a circular tanged clip made out of steel, the inventor should not be able to claim circular tanged clips made out of aluminum.  Perhaps aluminum clips might be held to infringe under the doctrine of equivalents, but they are not within the literal claim scope.

This view has merit.  By placing a heavy onus on the patent applicant to think of all the possible permutations of the invention, applicants would need to think more carefully about their disclosures and patent scope would be limited to only present ideas.  Of course, inventors would necessarily be penalized because it may be impossible to imagine all permutations, especially those that rely on not-yet-envisioned technologies.   But Judge Lourie seems willing to pay this cost because of the greater certainty and narrower scope that he believes flows from limiting the inventor to only what he or she invented.   

Procedural note: There were actually two separate district court proceedings at issue, both arising in the same district.  In the first proceeding, the district court declined to adopt a "split" construction and Bridgeport was found to infringe; that appeal was stayed while the appeal of the second proceeding (in which the court did adopt a "split" construction) was pending.  The second proceeding also involved a related patent, No. 6,521,831, that contained an essentially identical term ("spring steel adapter").  The CAFC reversed the district court's construction of that term as well, a ruling Judge Lourie joined because the district court relied only on its construction of the term in the '050 patent and did not separately construe the term of the '831 in light of that specification.

Additional Commentary: In a recent article on IP Frontline, Hal Wagner offers a perspective on the ongoing discussion between Chief Judge Rader and Judge Lourie about the proper scope of claim construction.  See Wagner, "Arlington Indus. v. Bridgeport Fittings: The 20 Year Claim Construction Debate."

 

Centillion Data v. Qwest Communications: Getting Around Joint Infringement Problems

By Jason Rantanen

Centillion Data Systems, LLC v. Qwest Communications International, Inc. (Fed. Cir. 2011)
Panel: Lourie, Linn, Moore (author)

Joint patent infringement remains a hot topic as the Federal Circuit continues to tinker with the doctrine.  Centillion Data v Qwest adds a new twist, allowing joint infringement issues to be avoided altogether when dealing with system claims if a customer "puts the system as a whole into service, i.e., controls the system and obtains benefit from it" – even if the customer does not physically possess or own elements of the system.

Background
Centillion Data Systems sued Qwest for infringement of Patent No. 5,287,270, which relates to a system for collecting, processing, and delivering information from a service provider to a customer.  As described by the CAFC, claim 1 requires:

“a system for presenting information . . . to a user . . . com-
prising:” 1) storage means for storing transaction records, 2) data processing means for generating summary reports as specified by a user from the transaction records, 3) transferring means for transferring the transaction records and summary reports to a user, and 4) personal computer data processing means adapted to perform additional processing on the transaction records.

Slip Op. at 2-3.  Centillion conceded that the claim concludes both components maintained by the service provider (elements 1-3) and an element maintained by an end user (element 4), but contended that Qwest's billing systems (which contain two parts: the "back office" systems and front-end client applications) nevertheless infringe the '270 patent. 

On Qwest's motion, the trial court granted summary judgment of noninfringement, concluding that under BMC Resources Inc. v. Paymentech, L.P., 498 F.3d 1373 (Fed. Cir. 2007) and Cross Medical Products v. Medtronic Sofamor Danek, Inc. 424 F.3d 1293 (Fed. Cir. 2005), Qwest could not be liable for infringement because it did not "use" every element of the claim, nor did it direct or control the fourth element.  The trial court also held that Qwest's customers did not "use" the system, nor did they direct or control elements 1-3.

Meaning of "use"
On appeal, the CAFC focused on the meaning of the word "use" in the context of a system claim, concluding that under NTP, Inc. v. Research in Motion, Ltd., 418 F.3d 1282 (Fed. Cir. 2005), Qwest's customers "use" the system as required under 271(a).  In reaching its conclusion, the court drew upon its definition of the term in NTP.  Based on that prior definition, the CAFC held that "to 'use' a system for purposes of infringement, a party must put the invention into service, i.e., control the system as a whole and obtain benefit from it."  Slip Op. at 8.  While the district court correctly recognized that this was the proper definition to apply, it erred "by holding that in order to 'use' a system under § 271(a), a party must exercise physical or direct control over each individual element of the system. The 'control' contemplated in NTP is the ability to place the system as a whole into service." Id.

Applying this rule, the CAFC concluded that although Qwest itself does not "use" the system, its customers do.  Those customers put the system into operation by initiating a demand for the service that causes the back-end system to generate the requested reports.  "This is 'use' because, but for the customer's actions, the entire system would never have been put into service."  Id. at 11. On the other hand, Qwest does not "use" the system because it never "puts into service the personal computer data processing means.  Supplying the software for the customer to use is not the same as using the system."  Id. at 13.

Comment: Dennis predicted this outcome a year ago.

Whither BMC?
While both the district court and Qwest relied heavily on BMC and Cross Medical, any substantive discussion of those cases, or joint infringement theory more generally, is conspicuously absent from the CAFC's ruling concerning Qwest's customers.  Rather, underlying the court's analysis is the conclusion that BMC and Cross Medical are irrelevant to primary issue before the court: the meaning of the term "use" in 271(a).  This court thus relegates BMC and Cross to the limited context of vicarious liability analyses.  "The customer is a single “user” of the system and because there is a single user, there is no need for the vicarious liability analysis from BMC or Cross Medical."  Slip. Op. at 10.  Of course, the court's ruling is limited to system claims; method claims (the type of claims at issue in BMC) might produce a different result.

Other holdings:
The CAFC addressed two other issues in its opinion, first concluding that Qwest does not "make" the infringing system because it does not provide the "personal computer data processing means" or install the client software, and then ruling that summary judgment of no anticipation was improper due to the existence of disputed issues of fact.

Don’t File a Patent: A Book by John Smith

011811_0237_DontFileaPa1 John Smith starts his book thanking "Examiner Ms. E.P." of the USPTO for giving him inspiration for his book. "Without your three absurd Office Action rejections, this book would not have been possible." Smith's book is titled Don't File a Patent with the headline caption "the book that the Patent Office doesn't want you to read." Smith is not a lawyer, but rather an entrepreneur and inventor. Smith had no trouble obtaining two patents that covered his relatively worthless invention (designer wheel covers). Then, for his invention with real market value (hurricane window protectors), the PTO refused to issue a patent. (Smith apparently gave-up after three rejections.)

The book is directed toward individual inventors and small companies with little or no budget for intellectual property or litigation. Although the book takes an overly-extreme position, Smith suggests the valid argument that the limited resources of a small entity is often better spent on other business development activities. His "Reason #5 not to file a patent" explains this point:

The patent process costs tens of thousands of dollars. This is a waste of your money. A better investment is making your product first in the mind of your customer. . . . Back in 2005 when I filed my original patent application, I didn't have all this knowledge. At the time, some attorneys suggested that inventors "should wait and not market your product until you have a patent." I'm glad I never listened to that advice. Good thing I started marketing Storm Stoppers right away! Had I waited until getting a patent, I'd have nothing now. No awesome name brand, no millions of dollars in past sales, no thousands of customers, no appearances on CNBC & CNN, no Goodwill donation trips to the Bahamas and no learning and improving my product. Marketing your product right away is the only way to demonstrate that you have a good product.

About one-half of the book is dedicated to explaining why patenting is a waste of time and money for folks in his situation. The other half is devoted to providing some guidance on marketing and manufacturing.

At times throughout the book, Mr. Smith appears so burned by his past experience that he is blinded to the potential that patents can add in certain situations. With that major caveat, I think that the book is a good read and could be a useful tool for containing over-exuberance of innovators.

 

 

Design Patents and the Fashion Industry

The chart above shows a histogram of design patent application pendency based on patents issued April-November 2010. The majority of design patents issue within one year of the application filing. When there is a delay in prosecution, it is typically due to informalities in the application submitted. In an earlier study, I found that a very low percentage of design patent applications were ever challenged on novelty or obviousness grounds. For a large entity, a design application and issue fees total to $1,320 (half that for a small-entity).

Fashion Industry: In property law, I teach the case of Cheney Bros. v. Doris Silk Corp. (2nd Cir. 1930). In that 80-year-old case, a silk designer filed suit to stop a free-riding copycat. The appellate court rejected the plea based on the general rule that mere product imitation is not actionable at common law. Rather, a successful plaintiff must have some statutory right to protection – such as a patent or copyright – before copying can be pejorized as counterfeiting. At the time, copyright was not available for fabric designs (it is now) and patents were arguably impractical because of the prosecution cost and invention requirement. For the past eighty-years, the fashion industry has been asking for additional protections. During that time, the potential for copyright and trademark protections have been greatly expanded and enforcement of criminal counterfeiting has increased. However, there are still calls for expanded protection for fashion.

Fashion & Design Patent Rights: Some fashion industry markets have found design patents as valuable. These include eyewear, shoes, handbags, and jewelry. Despite widespread and growing use, fashion industry leaders have continued to push additional forms of protection that are easier to obtain.

The Innovative Design Protection and Piracy Prevention Act (S.3728) was recently passed through the Senate Judiciary Committee. That bill would provide protection for new fashion designs that are unique, distinguishable, non-trivial, and non-utilitarian variation over the prior art. No registration of rights would be required. Rather, protection is automatic for newly publicized clothing, footware, bags, and eyeglass frames. At trial, plaintiff would have the burden of proving rights and infringement. Under the proposed system, rights would persist for three years from the date of publication or first distribution.

Cancer Research Technology v. Barr Laboratories: Prosecution Laches and Inequitable Conduct

By Jason Rantanen

Cancer Research Technology Ltd. v. Barr Laboratories, Inc. (Fed. Cir. 2010)
Panel: Newman, Lourie (author), Prost (dissenting)

Although overshadowed by the en banc Federal Circuit arguments in TheraSense v. Becton Dickinson this morning, Cancer Research Technology v. Barr Laboratories may provide a preview of what the opinions in TheraSense could look like – although it doesn't necessarily indicate which view of inequitable conduct will ultimately prevail.  In Cancer Research, Judges Lourie and Newman reversed a district court finding of prosecution laches and inequitable conduct, while dissenting Judge Prost would have reached the opposite result.

The patent at issue (the '291 patent) involved a set of thirteen tetrazine derivatives that the original 1982 specification identified as possessing anticancer activities based on animal studies.  During the first nine years of prosecution, the examiner repeatedly rejected the claims due to lack of utility; rather than file a response to the office actions, the applicant instead filed continuation after continuation.  In 1991, Cancer Research obtained ownership of the patent application and shortly thereafter responded to the examiner's arguments.  The patent issued in 1993 and expires in 2014. 

Following Cancer Research's clinical testing, the FDA approved one of the compounds covered by the '291 patent (marketed as TEMODAR) for the treatment of one type of cancer in 1999 and a second in 2005.  In 2007, Barr Laboratories filed an Abbreviated New Drug Application ("ANDA") for a generic form of TEMODAR.  Cancer Research sued Barr for infringement four months later.  During the district court proceedings, the parties stipulated to validity and infringement and, after a bench trial, the court found that the patent was unenforceable due to prosecution laches and inequitable conduct. 

Prosecution Laches
Given the nearly ten-year delay before any meaningful response to the examiner's rejection was filed, Barr contended that the patent was unenforceable due to prosecution laches.  The district agreed, concluding that the delay in prosecution was unreasonable and unexplained.

On appeal, the majority reversed the finding of prosecution laches, holding that the doctrine requires not just unreasonable delay, but also a showing of prejudice.  The majority further held that "to establish prejudice, an accused infringer must show evidence of intervening rights, i.e., that either the accused infringer or others invested in, worked on, or used the claimed technology during the period of delay."  (Slip Op. at 9).  Here, there was no evidence of intervening rights during the prosecution period, such as evidence showing that someone other than the patent holder attempted to develop the claimed compounds.  Even Barr itself waited until 2007 – four years later than required – before filing its ANDA.  The majority also noted that there was no public harm: in the absence of the patent, Cancer Research likely would not have been incentivized to develop TEMODAR at all. 

Writing in dissent, Judge Prost rejected the notion that prosecution laches requires prejudice, let alone intervening rights; rather, under her reading of the precedent such a requirement is not part of the laches determination.  Furthermore, in her opinion, both Barr and the public were harmed by Barr's inability to market a generic version of TEMODOR.

Comment: I'm unconvinced by Judge Prost's argument on this point.  If she is correct, then the '291 patent was never enforceable – be it in 2007, when Barr filed its ANDA, or 1993, when it issued.  Yet without an enforceable patent, Cancer Research would never have developed TEMODOR, let alone engaged in the expensive Phase III clinical studies necessary to demonstrate its safety and efficacy.  Thus, the "harm" to the public would been greater in the absence of the '291 patent, not less.

Inequitable Conduct
The majority also rejected the district court's finding of inequitable conduct, while the dissent reached the opposite conclusion.  Both opinions focused on the subject of intent to deceive. 

The inequitable conduct issue in this case revolved around an extensive series of articles by an inventor on the '291 patent that presented data from post-application clinical trials of the claimed compounds.  These articles included conclusions indicating that some of the claimed compounds demonstrated high toxicity and low anticancer activity, which the district court found to be highly material to the patent claims because it directly contradicted statements in the '291 patent regarding the compounds' utility in treating cancers, as well as the patentability of a broadly written claim.

The majority, following the "intent cannot be inferred from materiality" line of thought, concluded that the district court's only basis for finding intent was its determination that the withheld articles were highly material.  "Because the district court did not rely on any other evidence to support its finding of deceptive intent beyond that used to find the withheld data material, the court in effect relied solely on its materiality finding to infer intent to deceive."  Slip Op. at 17.  The majority also concluded that the inference of deceptive drawn by the district court about the inventor's publication of data was not the only reasonable inference; rather, the broad publication of this data in multiple articles is inconsistent with an inference of intent to deceive.  Thus, an equally reasonable inference is that the inventor did not appreciate the potential importance of the published data to the patentability of the patent claims.

Judge Prost, again writing in dissent, would have affirmed the district court's determinations.  In contrast to the majority, which required independent evidence of intent, her view of inequitable conduct is that it does not require separate evidentiary bases for materiality and intent; rather it is appropriate to cite to the same evidence for materiality and intent.  Furthermore, here there was additional evidence of intent in the form of the district court's credibility findings, "which are virtually unreviewable by this court."  Thus, under her approach to intent in inequitable conduct, "[w]e should not draw inference that the district court has already excluded based on its own credibility findings."

Comment: The majority and dissent's views on intent can be partially reconciled under the position that, although an intent to deceive may be partially based on evidence of materiality, materiality cannot be the sole basis for the finding of intent to deceive.  Here, in the majority's opinion, the finding of materiality was the sole basis for the intent to deceive determination, because the only additional factor – the credibility determination – was based on an erroneous inference.  On the other hand, in the dissent's view credibility determinations are unreviewable and are sufficient to provide the "beyond the materiality" support for an intent to deceive finding.

Constitutional Inventors, First-Possession, and the Confusion of Bayh-Dole

Property law courses generally begin with the concept of first-possession as an originator of property rights. In patent law, the first-possession principle leads to a rule that potential patent rights are owned by the inventors unless and until they are assigned to another entity. See Crown Die & Tool Co. v. Nye Tool & Machine Works, 261 U.S. 24, 35-37 (1923). The legal basis for inventor rights is derived from constitutional principles that give Congress power to enact patent laws that grant exclusive rights "to inventors." US Constitution, Article I, § 8, cl. 8.

In Stanford v. Roche, Both Stanford and the US Government argue that that the Bayh-Dole Act of 1980 alters this original formula in the special case where an invention was either "conceived or first actually reduced to practice" with the use of US federal funding received by a university, non-profit, or small business. In that situation, the Bayh-Dole Act suggests that the funded-entity, the "contractor", automatically holds patent rights with a right to "elect to retain title to any subject invention." 35 U.S.C. § 202(a). If the contractor decides not to retain title, then, the funding federal agency "may receive title" or "may … grant requests for retention of rights by the inventor." 35 U.S.C. § 202(d). The Bayh-Dole Act includes a comparative-law clause making its provisions superior to those found in any other Act. "This chapter shall take precedence over any other Act which would require a disposition of rights in subject inventions of small business firms or nonprofit organizations contractors in a manner that is inconsistent with this chapter."

The Bayh-Dole language is somewhat confusing when examined through a first-possession framework. Namely, the statute indicates that the university might "retain title" and also that inventors can request "retention of rights." It is unclear from these provisions whether it is the university or the inventor that first holds rights. The US Constitution helps break this seeming conflict by focusing on inventors as the original recipient of rights. With this Constitutional backstop, there is no way that the university can be the original rights-holder. Rather, that designation must remain with the inventors.

This result may be important for the Stanford v. Roche case that was recently granted a writ of certiorari. Under a Constitutionally limited Bayh-Dole Act, Stanford cannot automatically claim first-possession rights to every invention & first reduction-to-practice that was materially supported by federal funding obtained by Stanford. At most, the Bayh-Dole law requires a transfer of rights from the inventor to the university. In the property framework, the question then focuses on the timing of the Bayh-Dole transfer (is it immediate or does it only occur upon the university's election of rights?) and on its impact on a prior transfer of patent rights to a third party.

A First Look at USPTO Petitions Data

Earlier this week, one of my excellent patent law students (Lawrence Higgins) plowed through 64 sets of recent USPTO petitions decisions. The decisions came from a group of randomly selected patent applications with application serial numbers 11/900,000 –  11/999,999. The vast majority of petitions were granted (78%) although about 20% were first rejected before being later granted after the applicant provided further information or argument. 

I categorized the petitions into groups.  The largest group consisted of petitions requesting revival of an abandoned application. 25% of the petitions were revival petitions with 94% being granted. 22% of the petitions involved the applicant attempting to establish a priority date. The next largest category of petitions were petitions to make special. In this group, all nine of the petitions to make special were based on the inventor's age (over 65 years) and all were granted. The remaining petitions involved a hodgepodge collection of issues such as attorney requests to withdraw representation, patent term adjustment corrections, refunds, corrections, and republication.  None of the petitions in our sample challenged a restriction requirement.

  • I'm working on a more complete study of the petitions decisions data.
  • Petitions are Available for Download Here

 

Board of Patent Appeals

Although the Board of Patent Appeals (BPAI) is working harder than ever, its backlog continues to rise. The first chart below shows the BPAI’s inventory of undecided appeals in ex parte cases. This only includes fully-briefed appeals whose dockets have been transferred to the BPAI and does not include the thousands of other applications where awaiting briefing. The average timing from notice-of-appeal to appellate decision is 29 months.

PatentLawPic1141

I spoke with BPAI officials who identified the jump in early 2009 as a one-time issue involving the bulk transfer of cases that had been previously delayed.

The next chart shows the number of Ex Parte cases decided each month. The average number of cases being decided each month continues to rise. However, the chart also reveals a high month-to-month variability. That variability is explained by the BPAI judge quota system. BPAI judge performance is primarily judged two times per year, and that process is reflected in a systematic incentive for the judges to do more work in Feburary and August and then less work in March and September.

PatentLawPic1142

Although the BPAI is deciding more cases than ever, inventory continues to rise because more appeals are being filed than ever.

Adams Respiratory Therapeutics v. Perrigo – construction of pharmacokinetic claim terms

Adams Respiratory Therapeutics, Inc. v. Perrigo Company (Fed. Cir., August 5, 2010)
Panel: Linn, Moore (author), Friedman

By Jason Rantanen

Adams holds patent number 5,372,252, which covers an extended release formulation containing guaifenesin (an expectorant used to thin, loosen, and help expel mucus that causes congestion).  Perigo sought FDA approval for a generic version of Adams' product, Mucinex®.  After construing the claims, the district court granted summary judgment of noninfringement.  Adams appealed that decision.

The claim terms in dispute related to pharmacokinetic parameters.  These parameters are used to characterize the rate and extent of absorption of the active pharmaceutical ingredient ("API").  The primary term at issue, Cmax, indicates the maximum concentration of the API following dosing.

"Equivalent Cmax"
The parties' main dispute was over the meaning of the term "equivalent" in the context of "provides a Cmax in a human subject equivalent to the Cmax obtained when the first of three doses of a standard immediate release formulation having one third the amount of guaifenesin is dosed."  For purposes of FDA approval, a formulation is considered to be bioequivalent if, among other things, its Cmax is within 80% to 125% of the value with which it is being compared at a 90% confidence interval. The district court agreed with Perrigo that "equivalent" should be construed to mean equivalent under the FDA bioequivalence guidelines.

On appeal, Adams challenged the requirement of a 90% confidence interval, arguing that it makes sense when seeking FDA approval, but not when proving infringement. 

The Federal Circuit agreed with Adams.  In doing so, it rejected Perrigo's argument that the inventors had expressly defined "equivalent" as te FDA's bioequivalence guidelines.  Rather, the court construed Adams' reference to the FDA guidelines as referring specifically to the 80-125% range, not to the requirement of a 90% confidence interval.  According to the court:

Requiring a 90% confidence interval would inappropriately raise the bar for establishing infringement.  Adams must show that it is more likely than not that Perrigo's ANDA product will have a Cmax within the 980-125% range. Adams is not required to show that Perrigo's product will meet this requirement 9 times out of 10.

Slip Op. at 8.

Comment: This interpretation opens up a box of statistical worms, and I suspect that down the line the court may regret its venture into probability theory.  For the time being, however, it gives parties useful language to quote when attempting to prove infringement (and perhaps invalidity) via clinical results. 

A ≈ B ≈ C therefore A ≈ C
Adams also appealed the district court's ruling that it  impermissibly compared the accused product to Mucinex.  Adams' argument was that because the accused product was bioequivalent to Mucinex, and Mucinex was bioequivalent to a standard immediate release ("IR") product, then the accused product had a Cmax equivalent to the IR product. 

The Federal Circuit agreed that, under the circumstances of this case, Adams' argument was sufficient to preclude summary judgment of noninfringement.  The court cautioned, however, that "[i]f Adams had relied on the mere fact of bioequivalence of the two sets of products (and no PK data or Cmax values, that would not be enough to survive summary judgment."  Slip Op. at 11.  Here, however, Adams presented actual PK data and Cmax values, which a fact-finder could look at when assessing equivalence between the accused product and an IR product. 

"Bioavailable"
The court also addressed the meaning of the term "bioavailable" in the context of the '252 patent.  The dispute hinged on whether the phrase "fully bioavailable in the subject's stomach" meant "both release and availability in the stomach for absorption, wherever that absorption might occur." 

Perrigo argued that because "bioavailable" is commonly understood to mean absorption, thus requiring the guaifenesin to be absorbed in the stomach.  Because guaifenesin is primarily absorbed in the small intestine, this construction would preclude a finding of infringement.

The court rejected the proposed construction as inconsistent with the specification: "Although the specification never expressly defines bioavailable, it uses the term when describing the availability of the drug for absorption, not the actual absorption."  Slip Op. at 14.  The court further noted that Perrigo's construction would exclude the preferred embodiment, which "is rarely, if ever, correct and would require highly persuasive evidentiary support."

Doctrine of Equivalents
Finally, Adams argued that the district court erroneously precluded it from relying on the doctrine of equivalents with respect to a dependant claim requiring that the total amount of guaifenesin released in to the patient be at least 3500 hr*ng/mL.  The panel concluded that the use of a numerical limit did not preclude Adams from arguing that an amount of 3494.38 hr*ng/mL was equivalent to 3500 hr*ng/mL. 

Divorce and Patents

Enovsys v. Nextel (Fed. Cir. 2010)

Mundi Fomukong is a co-inventor of the patents-in-suit. At the time of the invention, Fomukong was married to Fonda Whitfield. Sometime after the first patents issued, Fomukong and Witfield divorced. Later, the second patent issued; Fomukong formed Enovsys; and he (along with his co-inventor) assigned their rights to the new company. Later, when Enovsys sued Sprint-Nextel, the defendant challenged the case on standing. Sprint's argument is based on the rule that any patent infringement actions must be brought jointly by all co-owners of the patent. Specifically, Sprint argued that Ms. Whitfield retained an interest in the patent rights even after the divorce and, without Ms. Whitfield's support, Enovsys lacked standing. (Ms. Whitfield assigned her rights to Sprint.)

In the US, patent ownership rights are primarily controlled by state laws. At times, patent attorneys are called to understand their local laws of contracts, employment, inheritance, and (here) divorce. Thus, in deciding this case, the court looked first to the law of California — the site of the marriage, invention, and divorce.

California is a "community property" state and “all assets acquired during a marriage are presumptively community property.” In their divorce filings, however, Fomukong and Whitfield checked the box next to the statement that “We have no community assets or liabilities.” Without citing specific California law, the Federal Circuit held that that the final divorce decree coupled with this box-checking stripped Whitfield of her community property rights in the patent. "[A]lthough the final divorce decree was silent as to particular property, it nevertheless adjudicated the parties’ rights with respect to that property because it was based on an uncontested complaint which alleged that there was no community property."

With the issue of ownership settled, the court then affirmed the lower court's claim construction and infringement verdict.

 

Federal Circuit Splits on Validity of Means Plus Function Claim

Telcordia Technologies, Inc. v. Cisco Systems pic-100.jpg (Fed. Cir. 2010)

Chief Judge Rader and Judge Prost sparred over the level of explanation necessary to ensure that a means plus function (MPF) claim is found definite. The Patent Act (35 U.S.C. 112 p6) permits claim limitations written as a "means or step for performing a specified function." The statute provides that an MPF "claim [limitation] shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof." However, the claim will be found indefinite and therefore invalid if the specification fails to include at least some structure that is clearly linked or associated with the claimed function. “The question is not whether one of skill in the art would be capable of implementing a structure to perform the function, but whether that person would understand the written description itself to disclose such a structure.” (Quoting Tech. Licensing Corp. v. Videotek, Inc., 545 F.3d 1316, 1338 (Fed. Cir. 2008)).

Telcordia's patent in this case is directed to a double-ring network that is designed to withstand either a line-cut or a failed node. One element of the claim requires a "monitoring means, associated with the first ring and the second ring, for evaluating the integrity of the multiplexed subrate communications on the first ring and the second ring."

Writing for the majority, Chief Judge Rader (joined by Judge Lourie) held that the claimed "monitoring means" had been properly described in the specification. The dissent cited the same precedent but could not find anything in the specification that links disclosed structures to the claimed function. In discussing the opinion, Foley's Hal Wegner described the opinion as "pitting the leader of the older generation [of Federal Circuit Judges] against a contender from the next generation."

Stats: About 15% of newly issued patent included at least one claim having an MPF limitation. And, of those patents that include an MPF limitation, about half recite fewer than five such limitations. It appears that attorneys are using MPF claim language primarily as a back-up. Longer claim-sets are more likely to include means-plus function language. Thus 21% of patents with above-average-sized claimsets (by character count) include a means-plus-function limitation while only 11% of patents with below-average-sized claimsets include an MPF limitation. Looking claim-by-claim, I found that only 3% of the recently issued patents include means-plus-function limitations in every independent claim. Patents with MPF terms are more frequently associated with non-assigned patents (usually individual inventors). Patents arising from certain countries are much more likely to include MPF limitations. The chart below looks at the most common foreign filing jurisdiction for priority claims and reports the percentage of US patents arising from those foreign filings that include MPF limitations. [More Data]

 

Bilski, Kenny Rogers and Supreme Court Rule 46

by Professor John F. Duffy, George Washington University Law School

You got to know when to hold 'em, know when to fold 'em
Know when to walk away, know when to run                       
               
                                       — Kenny Rogers in The Gambler
_____________________________

Kenny Rogers’ hit song The Gambler provides some wise strategic advice, valid not only in cards and but also in law and perhaps in life generally:   If “fold ’em” is an option, sometimes it is the best one. Supreme Court Rule 46 on “Dismissing Cases” provides petitioners in Supreme Court cases the opportunity to “fold ’em,” and in the days remaining before the Supreme Court delivers an opinion in its Bilski v. Kappos case, the most puzzling question in the case has become this: Why won’t the petititoners in Bilski fold?

From the perspective of the petitioners, the case for seeking dismissal seems overwhelmingly strong. In the months since the oral argument in Bilski, every Justice save Justice Stevens has delivered an opinion from the set of cases argued in the November sitting. Bilski remains the only case not decided from that sitting. Because only one case remains undecided and only one Justice has yet to deliver an opinion from that month, there is widespread agreement among those familiar with Supreme Court practice that Justice Stevens is writing the Court’s opinion in Bilski. Thus, the petitioners are now reduced to hoping that Justice Stevens, who once argued in dissent that all software should be outside patentable subject matter, will author an opinion that will be more pro-patent than the positions taken by all but one of the Federal Circuit judges.

But there’s more. Not only do petitioners have no realistic hope of winning anything in the case, they also have much to lose by persisting in the appeal. Petitioners—the named inventors in the application, Bernard Bilski and Rand Warsaw—and their firm WeatherWise have other patent claims, some issued and some pending, that pass the machine-or-transformation test but that may not pass whatever test Justice Stevens is busy constructing.

That’s a quick summary of the case for the petitioners seeking dismissal of Bilski. The details only make the case stronger. Then again, there is also a distinct possibility that petitioners’ side of the case may want to lose.

The Petitioners’ Chances for Victory: Nil.

Any rational consideration of persisting in a legal case should begin with a frank assessment of the chances for gain and loss.   I’ll begin with the chances for gain, for they are as close to zero as can be imagined.

Good poker players learn to read other players’ “tells,” subtle clues which give hints about the likely outcomes if the hand is played to completion. In Bilski, the Supreme Court has also given some awfully clear “tells” that do not bode well for the petitioners.

Most importantly, the assignment pattern of the Court’s opinions strongly suggests that Justice Stevens is writing the opinion. The assignment of opinions in the Court is typically done with two goals in mind: (1) to give each Justice the chance to author at least one majority opinion from each sitting; and (2) to average out the number of majority opinions written by each Justice. Twelve separate cases were argued in the November sitting, including Bilski. (This counts two cases—Graham v. Florida and Sullivan v. Florida—as effectively one case, as the two cases involved the same issue and were eventually decided the same day.) Every Justice has delivered a majority opinion from that month, with the exception of the Justice Stevens. Thus, most Supreme Court watchers would predict that the one remaining opinion from the month—Bilski—was assigned to Justice Stevens.

There is some uncertainty about this result, however. Pursuant to Supreme Court Rule 46, one of those twelve cases (Pottawattamie County v. McGhee) was dismissed two months after the oral argument, so the Justice assigned to write the opinion in that case is not publicly known. Still, Stevens still remains the most likely candidate to have been assigned the Bilski opinion because of the larger pattern of assignments from the Court’s first three sittings (September, October and November). During those three months, 26 cases were argued. If the Court were trying to average out the workload among the Justices, then every Justice save one should have been assigned three majority opinions to write.

By now, all Justices have delivered three majority opinions from those first sittings with the exception of Justices Stevens and Sotomayor. Justice Stevens has delivered only one majority opinion (a case argued in October); Justice Sotomayor has delivered two majority opinions (one each from October and November). It seems highly likely that Justice Stevens was assigned only two majority opinions to write from the first three sittings because Stevens was also writing the principal dissent in Citizens United v. FEC, the hugely important campaign finance case to which the Court gave expedited consideration.   (If, however, Justice Stevens was originally assigned three majority opinions, then he would have definitely been assigned Bilski.) Assuming Justice Stevens was assigned only two majority opinions, then the assignments to write majority opinions in Bilski and the now-dismissed Pottawattamie County case would have been distributed to Stevens and Sotomayor. Sotomayor would seem like the natural for Pottawattamie County, which involved the immunity of state prosecutors from civil liability, because Sotomayor served as a state criminal prosecutor under New York City’s Robert Morgenthau. Stevens, by contrast, was an antitrust lawyer before becoming a judge, and he has shown significant interest in patentable subject matter.

Another clue to the authorship of Bilski comes from the lengthy delay in announcing the opinion. As previously mentioned, Justice Stevens wrote the principal dissent in the Citizens United case, which was heard and decided on an expedited basis by the Court because of the case’s importance to the spring primary season. Stevens’ impassioned dissent in that case ran for 90 pages, and that opinion seems to have delayed the release Stevens’ other majority opinions. Indeed, for two months after the January decision in the Citizens United case, Justice Stevens was the only Justice on the Court not to have delivered any majority opinion during the entire Term.

If, as seems likely, Justice Stevens is writing the majority opinion in Bilski, that is an awful omen for the petitioners. Justice Stevens wrote the majority opinion for the Court in Parker v. Flook (1978), which created the enigmatic rule that certain forms of “post-solution activity” cannot transform an unpatentable principle into a patentable process. Justice Stevens is also one of the few Justices ever to attempt to draw bright-line rules for excluding whole fields from the patent system. His dissent in Diamond v. Diehr, 450 U.S. 175, 193 (1981), sought to promulgate “an unequivocal holding that no program-related invention is a patentable process under § 101 unless it makes a contribution to the art that is not dependent entirely on the utilization of a computer.” 450 U.S. at 219.

In addition to the Court’s fairly clear “tell” that Justice Stevens will deliver the opinion of the Court, there are other signs that the petitioners’ chances for ultimate success are nil. The oral argument did not go well at all for petitioners’ counsel (to put it mildly), and a significant portion of the government’s argument was devoted to arguing that the Court should not impose a more restrictive rule than that sought by the PTO (e.g., a complete ban on business method patents, whether machine implemented or not). See Transcript of Argument at 40-50. In addition, at the Federal Circuit, even Judge Rader—one of the two judges willing to take a more comprehensive view of patentable subject matter—stated explicitly that he would agree the petitioners’ claims were unpatentable as abstract ideas.

Finally, if more evidence were needed, there is the PTO’s extraordinary record of success at the Supreme Court in patent cases. Two recent articles, one by Colleen Chien of Santa Clara University and one of my own, have independently noted that, since the creation of the Federal Circuit, the government’s substantive positions on patent law have always prevailed at the Supreme Court. See Colleen Chien, Patent Amicus Briefs: What the Courts’ Friends Can Teach Us About the Patent System (2010); John F. Duffy, The Federal Circuit in the Shadow of the Solicitor General, 78 G.W.U. L. Rev. 518 (2010).   The petitioners in Bilski must hope that the Supreme Court will finally rule against the government, and in an opinion by Justice Stevens, stake out a much more pro-patent position than every judge on the Federal Circuit save one.

The Value of Dismissal.

The impossibly slim odds of winning would not matter to the petitioners if they had nothing to lose from persisting in the appeal. But petitioners Bilski and Warsaw have at least two pending patent applications on business methods for hedging risk. See U.S. Pat. App. 200030233323 A1 (Dec. 18, 2003); U.S. Pat. App. 20040122764 A1 (June 24, 2004). Furthermore, Petitioner Warsaw also is the named inventor on several issued claims in a patent assigned to the firm WeatherWise.   See U.S. Pat. No. 6,785,620 (2004). Many of the claims in that patent would seem to pass the machine-or-transformation test, as the claims cover “system[s]” that include various modules for storing and manipulating data. Some claims are also directed to a “computer-readable medium having stored thereon instructions,” which is a form of claim for covering business software that the government currently views as permissible but that could be jeopardized by an unfavorable Supreme Court opinion in Bilski.   

If the Bilski case were dismissed, a decision about patentable subject matter would be left for the future. From the standpoint of petitioners, the future would better for two reason. First, Justice Stevens would be replaced by a new Justice, likely Elana Kagan. That change has to favor those on the side of the petitioners since Justice Stevens takes a more restrictive view of patentable subject matter than many of the other Justices on the Court. By contrast, the Solicitor General’s Office under Kagan expressly endorsed the position (stated during the Bilski oral argument) that the Federal Circuit had correctly decided State Street Bank v. Signature Financial. See Transcript of Oral Argument at 44. The future also presents the possibility of a different case, with perhaps more attractive facts.

Dismissal: Still Time?

Supreme Court Rule 46.1 allows any case to be dismissed, even after the oral argument, by agreement of the parties. The Rule directs that, upon filing of such an agreement, the Clerk of the Court, “without further reference to the Court, will enter an order of dismissal.” Furthermore, Rule 46.2 allows petitioners unilaterally to seek dismissal by agreeing to pay all the court costs and fees due. (Such costs and fees are not attorneys’ fees but merely the minor costs associated with the appeal that are paid by the losing party in any case.) The grounds on which respondents may object to such a filing are strictly “limited to the amount of damages and costs in this Court alleged to be payable or to showing that the moving party does not represent all petitioners or appellants.” The Clerk of the Court is directed “not [to] file any objection not so limited.”

The Rule reflects a very clear policy that the Court will not plunge ahead to decide a case if the petitioners have decided to “fold ’em,” and that policy makes perfect sense from the Court’s perspective. The Supreme Court has plenty of cases to decide, and important issues eventually percolate back up to the Court if they really need to be decided. Indeed, in the November sitting alone, the Pottawattamie County case was dismissed even though argument had been heard two months earlier and the case involved an important issue about the scope of prosecutors’ immunity.

True, if the Solicitor General’s Office were unwilling to agree to the dismissal, it is unclear what would happen. At oral argument, however, the advocate for the Solicitor General’s Office emphasized that the government thought the Court should never have taken the case because it was an “unsuitable vehicle” to decide questions of patentable subject matter. Transcript of Argument at 48. Moreover, the Solicitor General’s Office is very much a repeat player at the Supreme Court, and thus the Office tends to be willing to follow not just the letter but also the spirit of the Court’s rules. Since those rules reflect a fairly clear policy that petitioners’ dismissals should not be opposed unless the petitioner either is not willing to pay costs or does not represent all petitioners, the Solicitor General’s Office seems unlikely to attempt to thwart dismissal where the petitioners comply with the conditions of Rule 46.

A Final Point: A Desired Defeat?

All of the above makes the crucial assumption that the petitioners in Biski want to sustain the patentability of business method patents such as their own. But that assumption may be wrong. The patent application at issue is no longer owned by Bernard Bilski, Rand Warsaw or even WeatherWise, the small start-up company that holds similar patent claims on hedging energy consumption risks and is merely a licensee of the patent application at issue in the case (see Paul Schaafsma news article noting the licensing relationship). As the petitioners’ briefs in the Supreme Court disclose, the real party in interest in the case is Equitable Resources Inc., renamed EQT Inc. during the pendency of the case. See Petitioners’ Reply Brief at (i). That corporation has market capitalization of $5.4 billion (see EQT Financial Report). A quick search of the PTO’s database does not show any issued patents owned by this corporation, and the company’s most recent annual report filed with the SEC makes no mention of patents or intellectual property. It is not at all clear that such a company really wants to have patent protection for innovative ways to manage energy costs or risks, or for any other form of business method. Large companies are often the targets of patent infringement litigation, and start-ups often see patents as a means to compete against established firms. Indeed, the Warsaw patent on hedging risk—which is assigned to WeatherWise, not EQT—could itself provide a reason why the petitioners’ side of the case would welcome defeat.

It remains a puzzle why the petitioners in this case are persisting in an appeal that seems not only doomed but also capable of establishing new and unpredictable restrictions to the scope of patentable subject matter. I had previously thought that “irrational exuberance” provided the best answer—that the Bilski petitioners were likely to remain unrealistically optimistic about their chances for success right up to the end. But the presence of a multibillion-dollar corporation controlling the litigation decreases the chances that the strategy is due to simple inventor over-optimism. Perhaps the entity controlling the petitioners’ side of the case is really quite wily, for there would be no cause to “fold ’em,” if the petitioners’ side would view thorough defeat as victory. That would explain much.