November 2008

Survey results: Would Metabolite’s claim 13 be found patentable under the reasoning of Bilski?

Earlier in the week, I wrote about Bilski in relation to the recent diagnosis patent case of LabCorp v. Metabolite. Metabolite’s claim 13 reads as follows:

13. A method for detecting a deficiency of cobalamin or folate in warm-blooded animals comprising the steps of: assaying a body fluid for an elevated level of total homocysteine; and correlating an elevated level of total homocysteine in said body fluid with a deficiency of cobalamin or folate.

I asked the following question to Patently-O readers and received a response from about 200 readers: It reads as follows:

Would Metabolite’s claim 13 be found patentable under the reasoning of Bilski?

The response can be broken down as follows: 31% of responses would find the claim to include patentable subject matter while the remaining 69% would reject the claim under Section 101. Of those who would find the claim patentable, the vast majority (89%) reason that the claim includes a transformation. In my discussion of the case, I indicated one argument for showing how the assay step could be considered a transformation. The remaining 11% of those who would find the claim patentable say that it is tied to a particular machine or apparatus. None of the responses indicated that the claim satisfied both the machine and transformation prongs of the test.

Of the 69% of “unpatentable” responses, the majority (72%) saw the claim unpatentable as neither a machine nor a transformation. 43% of those asserting unpatentability saw the claim as unpatentable under the revived mental steps doctrine of bilski. Included in these figures is the 16% who saw the patent violating both the revived mental steps doctrine and the machine-or-transformation test.

The survey did not ask demographic data. However, of those responses using a USPTO IP address, 86% would find the claim unpatentable under Section 101.

Post-Bilski BPAI Approves of Beauregard Claims

Ex parte Bo Li, Appeal 2008-1213 (BPAI 2008)

Li’s patent application claims a computer program product stored on a computer readable memory adapted be executed to implement a report generation method. The computer program product is a typical Beauregard claim. In what appears to be the first decision to cite the new Bilski machine-or-transformation test of patentable subject matter, the BPAI overturned the examiner’s Section 101 rejection – finding that the product claim includes statutory subject matter.

Here, the examiner argued that the claimed computer program product could not be patentable because it did not produce “a useful, concrete and tangible result.” On appeal, the BPAI held that Bilski expressly rejected that statement from State Street. However, because Li’s claim was for a product, the BPAI did not apply the Bilski machine-or-transformation test to determine patentability. Rather, the court merely relied on the notion of that claimed products – even when written as Beauregard claims – are patentable.

“It has been the practice for a number of years that a “Beauregard Claim” of this nature be considered statutory at the USPTO as a product claim. (MPEP 2105.01, I). Though not finally adjudicated, this practice is not inconsistent with In re Nuijten. Further, the instant claim presents a number of software components, such as the claimed logic processing module, configuration file processing module, data organization module, and data display organization module, that are embodied upon a computer readable medium. This combination has been found statutory under the teachings of In re Lowry, 32 F.3d 1579 (Fed. Cir. 1994). In view of the totality of these precedents, we decline to support the rejection under 35 U.S.C. § 101.”

Li won the Section 101 battle, but still lost the war – the BPAI affirmed the examiner’s contention that the claim was also unpatentable as obvious.


  • Thanks to Amber Rovney of Weil’s Austin office for first noting the opinion.  
  • Assignee is IBM, but originally filed as a Korean Application.
  • The approved-of claim is drafted as follows:

42. A computer program product, comprising a computer usable medium having a computer readable program code embodied therein, said computer readable program code adapted to be executed to implement a method for generating a report, said method comprising:

  • providing a system, wherein the system comprises distinct software modules, and wherein the distinct software modules comprise a logic processing module, a configuration file processing module, a data organization module, and a data display organization module;
  • parsing a configuration file into definition data that specifies: a data organization of the report, a display organization of the report, and at least one data source comprising report data to be used for generating the report, and wherein said parsing is performed by the configuration file processing module in response to being called by the logic processing module;
  • extracting the report data from the at least one data source, wherein said extracting is performed by the data organization module in response to being called by the logic processing module;
  • receiving, by the logic processing module, the definition data from the configuration file processing module and the extracted report data from the data organization module; and
  • organizing, by the data display organization module in respone to being called by the logic processing module, a data display organization of the report, wherein said organizing comprises utilizing the definition data received by the logic processing module and the extracted report data received by the logic processing module.

Trends in patent complaints

Prof. Paul Janicke at the University of Houston Law Center is an expert on patent litigation statistics. He recently sent me a note about some recent trends in the filing of patent complaints.

Over the last three years, patent lawsuit filings have been fairly steady at around 2,700 annually. This year to date they seemed on track to stay at that level or a little higher, with filings through Oct. 31 standing at 2,327.

However, filings in recent months are down about 20%, possibly due to the general financial conditions of September and October.

Patent Suits filed in September and October (all districts):


Filings in Sept.-Oct. 







Eastern District of Texas patent suit filings in September and October:


ED Tex Filings in Sept.-Oct.







Firm Disqualified from Representing Patentee in Malpractice Suit After Defending Deposition of Prosecuting Attorney

Touchcom v. Bereskin & Parr (Fed. Cir. 2008)(non-precedential order)

This is an attorney malpractice case. The Canadian firm Bereskin & Parr prepared and prosecuted Touchcom’s US patents relating to fuel pumps. Touchcom then sued Dresser, Inc, but lost when the district court granted summary judgment of invalidity under 35 USC 112 (indefiniteness). After that loss, Touchcom sued the B&P for malpractice in preparing and filing the patent application.

Wildman Harrold represented Touchcom in the original infringement action and also in the malpractice case. During the original litigation, Wildman Harrold had also defended the deposition of the B&P patent agent who had filed the case.  Based on that conflict, B&P asked that Wildman firm be disqualified from arguing the appeal, and the Federal Circuit agreed.

In a non-precedential order, the Federal Circuit agreed to disqualify the Wildman Harrold firm. Because the malpractice case arose in the Eastern District of Virginia, the court applied Virginia Professional Conduct Rule 1.9.  That rule prohibits (without consent) an attorney from being adverse to a former client in a matter substantially related to the prior representation.

“A lawyer who has formerly represented a client in a matter shall not thereafter represent another person in the same or a substantially related matter in which that person’s interests are materially adverse to the interests of the former client unless both the present and former client consent after consultation.” Rule 1.9.

Wildman agreed that it had represented the patent agent and that the matter was substantially related. However, Wildman argued that it could turn against its former client because the firm was representing both Touchcom and the B&P patent agent.  And, the nature of the litigation meant that the B&P patent agent had no expectation that Wildman would keep any secrets from Touchcom.

Following the only Virginia case on point (an unpublished opinion), the Federal Circuit disqualified the Wildman Firm — finding that Rule 1.9 establishes broad “standards of attorney loyalty” that go beyond client confidences.

Holding: The motion to disqualify is granted to the extent that attorneys from Wildman Harrold are disqualified from representing Touchcom in this case. Replacement counsel for Touchcom is directed to file an entry of appearance within 30 days of the date of filing of this order.


Patent Demand – A Simple Path to Patent Reform

[Read Tim Wilson’s Paper] Tim Wilson (Senior IP Counsel at SAS US) has been concerned about patent quality for some time. In part, the sheer number of patent applications being filed creates a host of problems. Wilson’s solution is to raise patent fees – he says the fees should go as high as $50,000 for large corporate applicants. The result – according to natural tendencies of supply and demand – is that fewer applications will be filed and fewer patents will issue. In all likelihood, however, those that are filed will be better applications covering higher quality inventions.

Wilson did not simply pull his $50,000 figure out of his ear. Using the powerful computing resources of SAS, Wilson calculated an estimated demand curve for patent applications using both (1) historical filing reactions to increases in PTO fees and (2) an assumption that the budgets of corporate patent departments is fairly inelastic. Wilson then created his Figure 5 – showing the demand curve for patent applications drawn with respect to the patent application fees.

Wilson’s approach is admittedly only an estimate, but his intuition has to be correct that a dramatic increase in PTO fees would lead to a dramatic decrease in PTO filings.

An average high technology patent contains a minor improvement on a small portion of a product and the patent application is typically written using outside counsel working for a flat fee of a few thousand dollars. Imagine what would happen to the high technology company’s patent process if each patent application cost $50,000 just to file. The high technology company would file far fewer, but more important patent applications and they would spend more time and effort doing so. The pharmaceutical company’s process probably would not change much because a billion dollar decision depends on the outcome of the patent process.

What would happen to non-practicing entities, sometimes derisively referred to as patent trolls? I believe that these entities will change to patent market facilitators, or cease to exist. When the value of all patents is increased substantially, it is very unlikely that any patent will be available to fall to these non-practicing entities. First, each individual patent will be more valuable to the current owner of that patent, so it will be less likely that an owner would be willing to part with it to a troll. Second, if a company does fail, competitors of that company may be more willing to buy that patent rather than allow it to fall to a company that may sue the competitor. Finally, fewer issued patents mean that it will be easier for companies to monitor patents issuing in their product space and less likely that they will allow those patents to fall into the hands of a troll.

DDC Comment: Wilson’s proposal has some merit, and his work on the demand curve is especially interesting. However, the proposal suffers from three fundamental problems: First, the proposal implicitly equates economic value with technologic value – the two are related but different. Many important technical advances have only limited economic value, but still serve as building blocks for future advances. (i.e., standing on the shoulders of giants). Second, the proposal greatly favors technologies where the economic value is well known up front. Again, many important technologies are eventually found valuable – but the very high up-front price will greatly limit those applications – and consequently, the upstream incentive to innovate in that area. Third, the proposal favors firms with cash – i.e., those that have performed well in the past and have saved their money. However, many innovation experts believe that most of the breakthrough work comes from these mainstream companies. To his credit, Wilson addresses this problem by stating that the high-price only applies to large companies. However, that approach would tend to allow the “non-practicing entities” to continue to obtain patents (against one of Wilson’s primary goals). In addition, the prospect of small entities paying only $500 while large entities pay $50,000 would surely lead to other political and practical problems.


Applying Bilski to Metabolite’s Diagnosis Claim

Metabolite’s broadest method claim has two steps: First, assay a body fluid to determine its homocysteine level. Second, correlate the homocysteine level to a vitamin deficiency. It reads as follows:

13. A method for detecting a deficiency of cobalamin or folate in warm-blooded animals comprising the steps of: assaying a body fluid for an elevated level of total homocysteine; and correlating an elevated level of total homocysteine in said body fluid with a deficiency of cobalamin or folate.

In 2006, the Supreme Court almost took the time to reject this claim under Section 101, but decided that the issue had not been properly raised on appeal. Dissenting from the last minute denial of certiorari were Justices Breyer, Stevens and Souter. In a dissenting opinion drafted by Justice Breyer, the three would have held the invention as claimed an unpatentable “law of nature.” The same anti-preemption theme of Bilski also runs through the Breyer opinion. The courts are concerned with the potential (but unidentified) problems of having a patent that

There can be little doubt that the correlation between homocysteine and vitamin deficiency set forth in claim 13 is a “natural phenomenon.” . . . .

Claim 13 . . . tells the user to use any test at all. Indeed, to use virtually any natural phenomenon for virtually any useful purpose could well involve the use of empirical information obtained through an unpatented means that might have involved transforming matter.

I thought it would be interesting to attempt to apply the Bilski decision to Claim 13 to judge its patentability.


Bilski offers two avenues for showing that a claimed process is patentable. First, the process will be patentable if it is tied to a particular machine or apparatus. Alternatively, the process will be patentable if it “transforms a particular article into a different state or thing.” According to the court, “particular article” does not necessarily need to be physical, but it must at least be “representative of physical objects or substances.”

Machine: Metabolite’s Claim 13 easily fails the first prong of the machine-transformation test because the claimed method is not tied to any particular machine.

Transformation: The “correlating” step could be performed in a human mind and consequently cannot serve as the basis for finding patentable subject matter. As the court noted in Bilski – a process step that “may be performed entirely in the human mind is obviously not tied to any machine and does not transform any article into a different state or thing.”

The “assay” step could follow the same analysis – if it is possible to “assay a body fluid for an elevated level of total homocysteine” only using the human mind then no there is no credible transformation. The mental step potential may be true if, for example, the body fluid’s homocysteine level is visually apparent. [Interesting timing issues here, at the time of the invention, the assay involved extensive lab work, but later-invented technology has dramatically changed the process.]

Assuming that “assaying a body fluid for an elevated level of total homocysteine” cannot be done in the mind, we must then ask whether the claim requires a transformation of a particular physical object or substance or at least transformation of a particular article that is “representative of physical objects or substances.” Perhaps the best physically related transformation involves transforming the “body fluid” into an indication of elevated homocysteine level and then into an indication of vitamin deficiency. Under Abele, both homocysteine level and vitamin deficiency do represent physical substances – consequently their ‘creation’ may be “sufficient to render that … process patent-eligible.” [Of course, this analysis may apply a loose definition of ‘transformation.’]


Constitutionality of the Marking Statute

Pequignot v. Solo Cup (E.D.Va. 2008)

Earlier this year, I discussed patent attorney Matthew Pequignot’s two “false marking” lawsuits pending in the Eastern District of Virginia. 35 U.S.C. § 292 is a penal statute and calls for damages of “not more than $500” for each false marking offense.

In an interesting turn, Solo Cup recently moved to dismiss the case based on its argument that Section 292 is unconstitutional. Now, the US Government has filed a motion to intervene and will argue (in support of the plaintiff) that the false marking statute is valid. 

On the other side, Solo Cup argues that the statute gives the courts extraconstitutional power. The statute allows any party to sue and collect half of the statutory reward, but the statute does not explicitly provide that the private lawsuit be filed on “behalf of the US Government.” These two facts lead to Solo’s argument that the court lacks Article III jurisdiction. (And that Congress had no power to enact the statute – leading to separation of power problems). 

Pequignot response will likely win the day: “given that qui tam statutes are older than the Republic, Solo fails to cite even one judicial decision holding that such provisions, including § 292, violate the Separation of Powers doctrine.”

According to the USDOJ brief, the same issue has been raised in two other pending cases: Harrington v. CIBA Vision Corp., No. 3:08cv00251 (W.D. N.C.) and North Carolina Farmers’ Assistance Fund, Inc. v. Monsanto Co., et al., No. 1:08-cv- 409 (M.D. N.C.).

“Barack,” “Obama,” and the Trademark Office

By Mark Reichel. Mark Reichel is a patent attorney at the Ice Miller firm and writes the “daily dose of IP.”

After such an exciting election, I thought I’d have some fun with a blog post and highlight a few attempts to register trademarks pertaining to our President-elect that, for reasons shown below, were unsuccessful:

BARACK STAR” – U.S. Trademark Application Serial No. 78/471,745 in IC 016 and 025 – This application was abandoned after the USPTO refused registration for false association because “the proposed mark consists of or comprises matter which may falsely suggest a connection with U.S. Senator Barack Obama” and “[a]lthough not connected with the goods or services applicant provides under the proposed mark, the name BARACK is so famous that consumers would presume a connection with Senator Obama.”

DO YOU SMELL WHAT BARACK IS COOKING” – U.S. Trademark Application Serial No. 77/406,936 in IC 025 – This application was abandoned after the USPTO refused registration “under Section 2(c) of the Trademark Act, for the record does not include the written consent of Barack Obama, the name of the living individual identified in the proposed mark.”

PET BARACK” – U.S. Trademark Application Serial No. 77/408,020 in IC 020 – This application was abandoned after the USPTO refused registration using the same lack of consent argument as described above.

OBAMA — O BABY!” – U.S. Trademark Application Serial No. 78/745,546 in IC 026 – This application was abandoned after the USPTO refused registration using a false connection argument similar to the false association argument described above.

OBAMA SO PHAT” – U.S. Trademark Application Serial No. 77/135,294 in IC 040 – This application was abandoned after the USPTO refused registration using the same lack of consent argument as described above.

OBAMA NOT YOUR MAMA FOR PRESIDENT IN 2008” – U.S. Trademark Application Serial No. 77/037,088 in IC 040 – This application was abandoned after the USPTO refused registration for false association and lack of consent as described above.

In addition to the foregoing, I note one additional trademark application (77/086,418) that I will not describe here due to its sensitive and offensive nature, and of which I am personally pleased to see rejected for a multitude of reasons.

* * * * *

Following Mark’s lead, I also found this mark for Gov. Palin [also offensive] and a host “joe the plumbers” including several actual plumbers.

California Malicious Prosecution Charges Based on PTO Interference

Plumley v. Mockett, 79 Cal. Rptr. 3d 822 (California Ct. App. 2008) 79 Cal.Rptr.3d 822

Interesting case from California state court. Plumley won an interference proceeding and then sued Mockett and Mockett’s attorney for “malicious prosecution.” The allegation was that Mocket and his patent attorney “filed the federal interference action with malice and without probable cause. In the malicious prosecution charges were dismissed, but case raises important cautions to third parties intending to request interference proceedings; request reexamination; or potentially even oppose European patent grants. In this case, both parties were located in California, and the court there did not appear concerned that the interference (the alleged malicious prosecution) was filed in a non-Californian administrative agency.


  • The facts from the case are intriguing and detailed. Mockett originally sued Plumley in California court alleging that Plumley had stolen his idea. The California court, however, held that Mockett was lying and had fabricated evidence. Parallel to the original state court action, the PTO found for Mockett in the interference (noting that it was not bound by the California court’s holding). On appeal, the district court flipped BPAI’s holding – finding no evidence of derivation. Subsequently, the BPAI awarded the patent to Plumley. At that point, Plumley sued Mocket for malicious prosecution.

The patent at issue is a design patent covering a grommet for a desk that allows wires to pass through. U.S. Design Patent No. D 361711.

Responding to Examiner’s Charge of Burying Reference

In another recent first office action, the Examiner complained of the “voluminous references” submitted by the applicant. In this case just over 75 references were submitted.

[T]he cloaking of a clearly relevant reference by inclusion in a long list of citations may not comply with the Applicant’s duty of disclosure. Penn Yan Boats, Inc. v. Sea Lark Boats, Inc., 359 F. Supp. 948 (S.D. Fla. 1972). . . . accord with dicta from Molins PLC v. Textron, Inc., 48 F.3d 1172 (Fed. Cir. 1995), stating that forcing the Examiner to find “a needle in a haystack” is “probative of bad faith.” Id. [The Molins] case presented a situation where the disclosure was in excess of 700 pages and contained more than fifty references.

Therefore, it is recommended that if any information that has been cited by Applicants in the previous disclosure statements is known to be material for patentability as defined by 37 C.F.R. § 1.56, applicant should present a concise statement as to the relevance of that/those particular documents therein cited.

The Examiner here appears to only recommend more detailed statements about the submissions. Under 37 C.F.R. § 1.105 and Star Fruits, the Examiner could have instead officially requested such information.

Earlier in the year Shell Oil proposed an alternative rule that would allow an Examiner to “decline consideration of [a] reference” when the reference’s relevance could not be determined. In response, the “attorney could concisely point out the section or portion of the reference believed to be relevant or submit a concise statement of the relevance of the reference as a whole.” [Link]

Canadian Supreme Court Confirms Plavix Patent Despite Evergreening Charges

Apotex Inc. v. Sanofi-Synthelabo Canada Inc., 2008 SCC 61 (Canada Supreme Court 2008)

The Supreme Court of Canada has upheld Sanofi’s “selection patent” (the ‘875 patent) covering the blockbuster anti-clotting drug Plavix. A broader “genus” patent (the ‘777 patent) – also held by Sanofi – discloses over 250,000 different compounds. The narrower patent does have some additional patent scope. In particular, while ‘875 patent claims a particular dextro-rotatory isomer, the prior ‘777 patent only describes a racemate of that compound that includes two different isomers.

As an apparent “evergreening” strategy, Sanofi did not claim priority to its earlier patent filing. This allows for an additional decade of patent term. Looking at the case, the Supreme Court determined that it should simply follow the law of novelty and obviousness and not create any special ‘evergreening’ exception:

[97] Evergreening is a legitimate concern and, depending on the circumstances, strategies that attempt to extend the time limit of exclusivity of a patent may be contrary to the objectives of the Patent Act. The Act aims to promote inventiveness by conferring exclusivity for a limited period of time while providing for public disclosure of the invention to enable others to make or use it after expiry of the period of exclusivity.

[98] However, a generalized concern about evergreening is not a justification for an attack on the doctrine of selection patents for two reasons. First, a selection patent may be sought by a party other than the inventor or owner of the original genus patent. In such a case, anticipation or obviousness may be an issue, but evergreening does not arise.

On obviousness, the court found “a significant difference” between the claimed patent and the prior genus patent, and that the “difference was not obvious.”

Junk Patents

In 2007, Haliburton filed for patent protection – claiming a method of “patent acquisition and assertion by a (non-inventor) first party against a second party.” It looks like the company wants to be able to sue non-inventing entities who try to patent and assert technology against a company who has been using the technology as a trade secret. Bilski wipes cleanly out the claims – except for those claiming the step of “performing research using a computer.” The inventor Clive D. Menezes is a Halliburton patent attorney. The prosecuting attorney is Howard Speight.

Obligation to point out the inventor and invention dates of each claim not commonly owned

In a recent first office action rejection, the examiner wrote the following:

“This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 C.F.R. 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).

I’m confused by this examiner statement. (Otherwise, this particular office action is exceptionally well written). What I don’t understand is the “obligation.” After receiving this (or even before) are the patent applicants under a duty to describe the ownership structure and invention dates?

Federal Government’s Contracting Quota for Small (Racially) Disadvantaged Businesses Found Unconstitutional

Rothe Development Corp. v. Department of Defense (Fed. Cir. 2008)

Although not a patent case, Rothe raises an important Federal Constitutional issue. In Rothe, the Federal Circuit has held that the statutory quota for governmental contracts with “small disadvantaged business” is facially unconstitutional as a race-based violation of the right to equal protection (through the Due Process Clause of the Fifth Amendment).

10 U.S.C. § 2323 (“Section 1207”) sets a goal that “five percent of federal defense contracting dollars” be awarded to small businesses owned and controlled by “socially and economically disadvantaged individuals.” Under the Small Business Act, Black Americans, Asian Americans, Hispanic Americans, and Native Americans are presumptively socially disadvantaged individuals.

Statutes that that include explicit racial classifications are reviewed with “strict scrutiny.” Such provisions are only valid if they “serve a compelling governmental interest, and [are] narrowly tailored to further that interest.” In the race setting, general efforts “to alleviate the effects of societal discrimination” are not considered compelling interests under the Supreme Court’s 1996 Shaw decision. Congress reauthorized Section 1207 in 2006. Thus, to be constitutional, the evidence of a compelling governmental interest at that time.

On appeal, the Federal Circuit found that older Congressional evidence (from the original enactment of the provision) was “stale” by 2006 and thus not reliable. Additionally, the record did not reflect that newer evidence was officially considered by Congress.

Although we are mindful that Congress has broad discretion to regulate its internal proceedings, we are hesitant to conclude that the mere mention of a statistical study in a speech on the floor of the House of Representatives or the Senate is sufficient to put the study “before Congress” for purposes of Congress’ obligation to amass a “strong basis in evidence” for race-conscious action.

Finally, the Federal Circuit found that the newer studies – even if considered by Congress – were inadequate because of the many methodology defects.

Upon these findings, the Federal Circuit held that congress did not have a compelling governmental interest in enacting Section 1207 and that the statute therefore is invalid as unconstitutional.


  • Opinion written by Chief Judge Michel and joined by Circuit Judge Mayer and District Court Judge Stearns from Massachusetts sitting by designation. These judges were appointed by Presidents Reagan, Reagan, and Clinton, resptively.


BPAI Appointments Clause Argument Waived

In re DBC (Fed. Cir. 2008) (

The primary issue in DBC began with Professor Duffy’s 2007 administrative law article in the Patently-O Patent L.J. In that article, Duffy noted a constitutional problem with the appointment of BPAI judges. Notably, the 1999 statute required that BPAI judges be appointed by the PTO Director while constitution requires such ‘inferior officers’ be appointed by either the President or a ‘Head of Department’ such as the Secretary of Commerce. Later, I found that the vast majority of recent BPAI decision included at least one illegally appointed judge (using Duffy’s standard). [LINK] Following these findings, Congress passed an amendment placing the appointment duty in the hands of the Secretary of Commerce. The Bill – now signed into law – includes a retroactive saving clause that would bless prior improperly appointed judges as properly acting as “de facto officer[s]” [Link] The retroactive savings clause is, however, considered constitutionally suspect.

During reexamination, the patentee (DBC) lost its BPAI appeal. At the Federal Circuit, the DBC argued that the BPAI decision should be vacated because two of the three BPAI panel members were ‘illegally appointed.’ Citing Duffy’s Patently-O article, Judge Linn noted the potential appointment problems. However, rather than addressing the issue directly, the Federal Circuit dismissed DBC’s argument as waived because the patent applicant had failed to raise the issue before the BPAI panel itself.

If DBC had timely raised this issue before the Board, the Board could have evaluated and corrected the alleged constitutional infirmity by providing DBC with a panel of administrative patent judges appointed by the Secretary. Of course, the Board may not have corrected the problem, or even acknowledged that the problem existed. But in that case, DBC would have preserved its right to appeal the issue.

In exceptional circumstances, the Federal Circuit will consider previously waived arguments. Here, however, the court declined its discretion to do so: “We do not view the circumstances of this case to warrant such an exceptional measure.”

Although this case focuses on the particular appointments clause issue, its discussion of waiver may be especially important for those preparing BPAI arguments.

DBC’s patent focuses on uses of the mangosteen fruit – apparently one of the ugliest and most delicious fruits around. In the appeal the Federal Circuit also found (1) a substantial question of patentability had been raised [this has become a very low bar] and (2) that the patent claims were properly found obvious based on the prior art despite evidence of commercial success.

Applying Bilski to Biotechnology and the Life Sciences

By Professor Christopher M. Holman (University of Missouri at Kansas City School of Law and author of Holman’s Biotech IP Blog)

The Bilski majority characterizes its machine-transformation test as "the governing test for determining patent eligibility of a process under section 101." Under this test, a claim is patent-eligible if (and as applied in Bilski apparently only if): (1) it is tied to a particular machine or apparatus, or (2) it transforms a particular article into a different state or thing." As explained by the Court, the test serves as a proxy for assessing the more fundamental concern – ensuring that the claim does not seek to impermissibly "preempt the use of a fundamental principle." This might make sense in the context of so-called business method patents, where the fundamental principle implicated is typically characterized as an abstract idea or mental process. But it is unclear to what extent this test will prove applicable to patent claims arising out of the life sciences, where patentable subject matter challenges more often allege preemption of a natural phenomena or law of nature, rather than an abstract idea or mental process.

For example, although Bilski states that a process claim is "surely" patent-eligible under section 101 if it complies with the machine-transformation test, this cannot be literally correct with respect to a naturally occurring biological process. Photosynthesis transforms carbon dioxide and water into sugar, and in Bilski the Court specifically points to chemical reactions as the sort of physical transformation that will render a process patentable, but a claim directed to photosynthesis would clearly violate Supreme Court precedent which bars the patenting of natural phenomena.

Bilski acknowledge that the machine-transformation test might require refinement or augmentation in the future, and I think this refinement will likely be necessary when the court addresses patentable subject matter challenges based on allegations that a patent claim preempts a biological natural phenomenon. Three such cases are currently on appeal to the Federal Circuit – Ariad v. Lilly, Classen v. Biogen, and Prometheus v. Mayo. Nevertheless, since for the time being the machine-transformation test is apparently the governing test, it is worth considering how the claims at issue in these case, and some other controversial biotechnology patent claims, might fare under this approach.

Ariad’s claims essentially recite methods of altering the activity of a regulatory protein (NF-kB) in a cell, which would seem to satisfy the transformation prong of the test. This outcome would be consistent with the District Court’s determination that the claims comply with section 101, albeit for an entirely different reason. But Lilly argues (reasonably I think) that the claims wholly preempt the use of a natural biological phenomenon, and since Bilski acknowledges that the machine-transformation test is really just a proxy for weeding out patent claims that preempt "fundamental principles," this argument might prevail even though the claim does recite a physical transformation.

The claims at issue in Classen, on the other hand, are directed to methods for determining an optimal immunization schedule based on comparing the observed incidence of immune-mediated disorders in treatment groups subjected to different vaccination schedules. Determining an immunization schedule does not appear to satisfy either prong of the machine-transformation test. The claims do include an additional step of immunizing patients, but under Bilski this step would likely be classified as "insignificant extra-solution activity." For example, the majority particularly points to data collection steps as insufficient to render patentable a claim that is essentially directed to a process of analyzing the data. Notably, the majority strongly suggests that the inclusion of a data-gathering step in the claim at issue in LabCorp v. Metabolite is insufficient to confer patentability on that claim, the essence of which is directed to the non-tranformative step of observing a correlation between homocysteine and vitamin B levels in a body fluid. In this regard, Bilksi appears to be consistent with the approach suggested by Justice Breyer in his dissent from the Supreme Court’s decision not to decide LabCorp.

Similarly, the claims at issue in Prometheus essentially target observing the level of a drug metabolite in a patient, and based on that observation recognizing that an adjustment in dosage may be required. The claims recite the administration of the drug to a patient and determining the level of metabolite in the patient’s body, but under Bilski these might well be treated as an insignificant extra solution data-gathering steps, analogous to the assay step in the claim challenged in LabCorp. If we disregard these steps, the claims would appear to fail machine-transformation test.

Note that at the core, the reason the claims in Prometheus and Classen might fail the machine-transformation test has little to do with any underlying natural phenomenon, but rather because they preempt an abstract idea/mental process without tying that process to a specific machine or apparatus. In contrast, the challenge to Ariad’s claims is fundamentally different, being based on preemption of a natural phenomenon rather than preemption of an abstract idea that could be implemented mentally without the use of a machine. In my view, the machine-transformation test just does not work for claims such as Ariad’s.

Some of the most controversial biotechnology patents are so-called human gene patents, particularly those relating to genetic diagnostic testing. For example, Myriad has been widely criticized for its perceived aggressive enforcement of patents relating to the BRCA breast cancer genes. Some of these patents broadly claim methods of identifying mutations, with no apparent extra-solution step that transforms a particular article or is tied to a particular machine or apparatus. For example, U.S. Patent No. 5,753,441 claims a "method for screening germline of a human subject for an alteration of a BRCA1 gene which comprises comparing germline sequence of a BRCA1 gene . . . with germline sequences of wild-type BRCA1 gene . . ., wherein a difference in the sequence of the BRCA1 gene . . . of the subject from wild-type indicates an alteration in the BRCA1 gene in said subject.

Similarly, U.S. Patent No. 6,432,644 claims "a method for diagnosing the presence of a polymorphism in human KCNE1 . . . wherein said method is performed by means which identify the presence of said polymorphism . . .."

Arguably, these sorts of claims are merely directed to "comparing" naturally occurring genetic sequences, or "diagnosing" the presence of natural mutations, and lack the significant extra-solution step necessary for patent-eligibility under Bilski.

Finally, note that Bilski in effect treats the patentable subject matter doctrine as a mechanism for policing claim scope, a role more commonly associated with the enablement and written description requirements. For example, the majority points to its earlier decision in Abele as an example where a broad claim is invalid for encompassing patent-ineligible subject matter, but an appropriately narrowed dependent claim complies with Section 101. Similarly, genetic diagnostic testing claims might be fine if limited to a specific test or tests, but patent-ineligible if drafted so broadly as to effectively encompass any method for observing a genetic variation.

Gardner: Patent Bar Should Use Its High Priced Skills to Overcome Bilski et al.

In my last post on Bilski, I added my Comiskey ‘fear factor’ to Paul Gardner’s analysis of post-Bilski claim strategies. In response, Mr. Gardner first notes that the Comiskey language I quoted is “dicta, supported only by arguably inapposite precedent, and presumably uninformed by any discourse in the briefing.” Beyond that, however, Gardner explains that the Patent Bar should stand-up and explain to the PTO and courts that “the application of novel and nonobvious software to otherwise computer hardware is neither ‘routine’ nor ‘typical.'”

Paul Gardner: The verbiage in Comiskey from which you opine in the September 20, 2007 issue of Patently O that “Comiskey could be read to indicate that any portion of an invention that constitutes nonstatutory subject matter will be considered de facto obvious” is dicta, supported only by arguably inapposite precedent (n. 16 in Comiskey), and presumably uninformed by any discourse in the briefing (given the fact that the court remanded the case to the Patent Office for ruling on the Section 103 issue). Moreover, the opinion says only that “[t]he routine addition of modern electronics to an otherwise unpatentable invention typically creates a prima facie case of obviousness.” (Emphasis added.) I can’t help but wonder whether such gratuitous, patent-negative dicta is in large part the unintended but predictable consequence of the patent bar too often capitulating to rejections rather than aggressively asserting their clients’ rights to protection (caused, perhaps, by clients’ limited funding of patent prosecution). By “aggressively asserting,” I mean arguing forcefully in a given case that the application of novel and nonobvious software to otherwise conventional computer hardware is neither “routine” nor “typical,” and that labeling it “routine” or “typical” at the front end is to prejudge the 103 issue and forestall reasoned analysis.

I submit that a compelling argument can and should be made that the application of nonobvious software to conventional hardware renders the combination patentable, in much the same way that purification of a naturally-occurring substance renders the purified substance patentable if its therapeutic value is nonobvious. The discovery of the therapeutic value of the naturally-occurring substance makes the purified substance nonobvious notwithstanding the fact that the purification process itself is old and well known. It seems to me that the same logic applies to nonobvious software implemented by old and well known hardware.

One of the two questions you posed last Friday was whether skilled patent attorneys will be able to alter their claim strategies to fit within Bilski’s pronouncements. I believe that it is more important than ever for the patent bar to use their high priced skills to argue against the kind of short-sighted rejections that are coming out of the Patent Office and being affirmed by the courts. The balance has clearly shifted against inventors and patentees in recent years, and only the skills of the advocate can move the balance back to the appropriate position.

Please understand that I do not take issue with your statement that “Comiskey could be read to indicate that any portion of an invention that constitutes nonstatutory subject matter will be considered de facto obvious.” My concern is that, left without countervailing exposition, such commentary may discourage the patent bar from advocating the contrary.

I have posted a reprint of my Patently-O post from the first Tuesday of November, 2004. There were no comments added to that original post

Chicago still uses punch-cards for voting. Despite the risk of hanging chads or dimpled marks, the benefit of this system is the paper trail. Many voters, including myself, are reassured by the paper trail. Patent No. 4,445,731 (shown above) was invented by John Ahmann in the early 1980’s. The patent covers the type of portable voting booths used in my precinct. Ahmann is still recognized as an expert in voting technology and testified in the Bush v. Gore controversy of 2000. According to the BBC, about 30% of U.S. voters will use electronic voting (e-voting) machines in today’s election. *2008 NOTE – that number is up to 32% for 2008*

Problems and praise Opponents highlight the problems that have already occurred with the machines – pointing for instance to a congressional race in Ohio in which votes were incorrectly registered due to a problem with the memory cartridges. At the same time however, Georgia’s entirely electronic system appears to have few naysayers after two years in operation – although it is widely believed that the [2004] presidential election will prove the greatest test. The principal criticism remains the lack of paper audit trails. Nevada is the only state using machines that provide voters with the kind of receipt which would, if necessary, allow for a manual recount. But in order to accommodate some of the concerns, a number of states – including California – will give voters the opportunity to vote using electronic machines or a paper ballot form.

Here is a picture of my neighbor and senate hopeful Barack Obama and his daughter casting his vote.

Bilski: Adding Obvious but Meaningful Limitations

Paul Gardner is PRG’s Academic Director. In an e-mail, I asked him whether claim drafting techniques and strategies can be effectively tailored to satisfy Bilski’s requirements without sacrificing valuable claim scope. Mr. Gardner says yes it can be done most of the time (and PRG is developing the CLE to tell you how). For Gardner, an important consideration in Bilski is between “meaningful limits” versus “nonobvious limits.”

While Bilski requires that process claims recite machine or transformation limitations that “impose meaningful limits on the claim’s scope,” such limitations need not themselves be new or nonobvious. In other words, “meaningful limits” is not to be equated with “nonobvious limits,” and the “meaningful limits” requirement may be satisfied – insofar as Section 101 patent-eligibility is concerned – by machine or transformation limitations which, standing alone, are old or obvious. Once Section 101 patent-eligibility is found to be present, novelty and nonobviousness of the claim as a whole may be satisfied by a novel and nonobvious algorithm in combination with the structural machine or transformation recitations.

This difference is seen in the Federal Circuit’s discussion of Abele.

As Chief Judge Michel points out in Bilski, in Abele the CCPA found a broad method claim reciting only data manipulation steps (calculating the difference between two values and displaying the value of the difference) to be patent-ineligible, but found a dependent claim adding only that the data is “X-ray attenuation data produced in a two dimensional field by a computed tomography scanner” to be patent-eligible, because the data represented physical and tangible objects.

My own caution comes from the CAFC’s nonobviousness analysis in the 2007 Comiskey decision. In describing that case, I led with the headline “35 USC 101 Finds its Teeth (Biting into Nonobviousness)” because Comiskey could be read to indicate that any portion of an invention that constitutes nonstatutory subject matter will be considered de facto obvious. Under this reading of Comiskey, obvious but meaningful limitations may overcome §101, but leave the claim extremely vulnerable under §103(a). The Supreme Court’s 1978 Parker v. Flook decision follows this same line of thinking – treating a non-statutory (but previously unknown) algorithm “as though it were a familiar part of the prior art.”





Written Description: Single Embodiment Insufficient

This decision is nothing new. Broad claims must either be supported by multiple embodiments or some general principles describing how the single embodiment is applicable to other configurations. Failing that, a broad claim may fail the enablement prong. As seen here, even when enabled, a broad claim without sufficient support will be invalid under the written description requirement.

In re Alonso (Fed. Cir. 2008)

The PTO Board of Appeals (BPAI) rejected claim 92 of Kenneth Alonso’s for failing the written description requirement of Section 112. “To satisfy this requirement, the specification must describe the invention in sufficient detail so that one skilled in the art can clearly conclude that the inventor invented the claimed invention as of the filing date sought.” (quoting case). In an opinion written by Judge Stearns (D.M.A.) sitting by designation, the Federal Circuit affirmed.

Claim 92 of the Alonso patent application claims a “method of treating neurofibrosarcoma in a human by administering an effective amount” of an idiotypic monoclonal antibody (mAb) secreted in a human-human cell hybridoma.

In his application, Alonso only described the preparation of a single mAb, but claimed essentially all Mab’s that bind to neurofibrosarcoma, and the PTO found that a “skilled artisan would reasonably conclude that applicant was clearly not in possession of the claimed genus of compounds. Applicant should direct the claim language toward the only described embodiment (e.g., a mAb produced by hybridoma HB983).”

Standard of Review: The PTO’s factual determinations are reviewed for “substantial evidence.” Thus, the Federal Circuit will affirm when “a reasonable mind might accept [the evidence] as adequate to support a conclusion.” Even if the Federal Circuit might ultimately have seen the facts differently, it will affirm if the PTO’s position is reasonable.

Predictability: The Federal Circuit acknowledged that disclosure of a single embodiment can be sufficient for a broader genus claim. However, more disclosure is necessary when the composition and effectiveness of members of the genus is heterogeneous or unpredictable.

We have previously held in a similar context that “a patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated.” Noelle v. Lederman, 355 F.3d 1343, 1350 (Fed. Cir. 2004).

Alonso argued that his single embodiment should be given more weight because he had actually reduced it to practice (unlike the Rochester COX-2 case). The Federal Circuit rejected that argument because Alonso had not provided the necessary predictive information – “nothing about the structure, epitope characterization, binding affinity, specificity, or pharmacological properties common to the large family of antibodies implicated by the method.”


  • The court gives the following justification for the written description requirement: “The requirement ‘serves a teaching function, as a quid pro quo in which the public is given meaningful disclosure in exchange for being excluded from practicing the invention for a limited period of time.'” quoting Univ. of Rochester, 358 F.3d 916 (Fed. Cir. 2004) (in turn quoting Enzo Biochem, 323 F.3d 956 (Fed. Cir. 2002)).
  • In his 2005 book on Electronic and Software Patents, Steve Lundberg, et al. include the understatement: “The purpose of the written description requirement has been in flux recently.”