On May 9, the U.S. Patent and Trademark Office held a four-hour long forum to receive public feedback on the Myriad-Mayo Guidance, which was issued by the Office on March 4.  According to the Office's Guidance webpage, the forum was intended to provide an opportunity for stakeholders to present their interpretation of the impact of Supreme Court precedent on the complex legal and technical issues involved in subject matter eligibility analyses during patent examination.

Last week, we reported on the opening remarks provided by Drew Hirshfeld, Deputy Commissioner for Patent Examination Policy, the overview of the Guidance provided by Raul Tamayo, Senior Legal Advisor for the Office of Patent Legal Administration (Part I), and the first two groups of public presentations (Part II and Part III).  Today, we conclude the series by reporting on the third group of public presenters as well as the open participation/question and answer session that concluded the forum.  The third group of presenters consisted of Barbara Fiacco of Foley Hoag, representing the American Intellectual Property Law Association (AIPLA); Duane C. Marks of Roche Diagnostics Operations, Inc.; and Gregory A. Cox of Eli Lilly and Company, representing the American Bar Association Section of Intellectual Property Law (ABA-IPL).

Ms. Fiacco (at left) began her presentation by noting, as a number of presenters before her had, that the standard set forth in Chakrabarty was whether a naturally occurring product recited in a claim exhibits markedly different characteristics.  She also contended that the Guidance "ignored Chakrabarty" with respect to the analysis of combinations of naturally occurring products.  Ms. Fiacco further asserted that the Guidance conflicted with Diehr because it does not focus on the claim as a whole, and in support pointed to the Guidance's firework example.

The second presenter, Mr. Marks used his allotted time to propose a framework for analyzing diagnostic method claims.  Before discussing that framework, however, he explained that the impact of the Guidance on diagnostic method claims was important because 70% of all medical decisions made by physicians rely on diagnostic assay results, and noted that the use of companion diagnostics leads to decreased health care spending by reducing the use of pharmaceuticals that might be ineffective.  With respect to his proposed framework, Mr. Marks contended that "[t]he Supreme Court's decision in Mayo [v. Prometheus] must be analyzed in view of the specific claims at issue" (emphasis in presentation), and cited the Mayo opinion in support of this assertion ("Our conclusion rests upon an examination of the particular claims before us in light of the Court's precedents [which] warn us against upholding patents that claim processes that too broadly preempt the use of a natural law.").

Turning to the claim at issue in that case, Mr. Marks (at right) reviewed the Court's statements regarding the administering and determining steps and the wherein clause, as well as the Court's comments regarding the claim as a whole.  He next discussed the "useful clues" that can be found in the Mayo decision, noting first that the Court's decision relies on "established general legal rules," and "[s]pecifically, the judicial rule that prevents too broadly preempting the use of a law of nature" (emphasis in presentation).  Mr. Marks emphasized that in Mayo, the Court "does not recite a new rule for biotech or diagnostic patents," and that changes to the MPEP were not needed to address diagnostic claims (emphasis in presentation).  He also noted that the Mayo Court did not change the machine or transformation test, but rather the Court pointed out that the Federal Circuit's analysis and application of the test was wrong.  In particular, Mr. Marks explained that neither the administering step nor the determining step requires a transformation.  According to Mr. Marks, Justice Breyer's "big, blinking roadmap" for understanding Mayo is his contrasting of Prometheus' claims with a new way of using an existing drug:

Unlike, say, a typical patent on . . . a new way of using an existing drug, the patent claims [at issue in Mayo] do not confine their reach to particular applications of those laws [of nature].  . . .  [T]hese patents tie up too much future use of laws of nature.

Mr. Marks next suggested ways in which the Prometheus claims could be fixed.  With respect to the administering step, the claim could be amended to recite the specific drug being administered (i.e., a specific compound and not just any 6-­thioguanine producing drug), the specific dosage of the drug (e.g., dosage range), the specific time points for administration (e.g., once daily for a full week), or the specific form of administration (e.g., I.V. or oral).  According to Mr. Marks, such amendments would "[i]mpose[] meaningful limits/actual boundaries" on the administering step, which would then "[c]ompl[y] with precedent which Mayo was based on that 'warns against too broadly preempting a use of a law of nature'!"

With respect to the determining step, Mr. Marks suggested that the claim could be amended to recite specific analytic methods for "determining" (e.g., ELISA, PCR, HPLC, flow cytometry, Mass spectrometry), or specific compositions used in these analytic methods (e.g., antibodies or primers).  As with the proposed amendments to the administering step, Mr. Marks argued that such amendments would "[i]mpose[] meaningful limits on the execution of the claimed steps, and "[c]ompl[y] with precedent which Mayo was based on that 'warns against too broadly preempting a use of a law of nature'!"

Finally, for the wherein clause, Mr. Marks suggested that the claim could be amended to introduce active steps such that the overall claim encompasses, for example, a method of treatment, in which the dosage of drug is actively altered based on the metabolite level, or a method of diagnosis, in which a diagnosis is provided based on the metabolite level.  He contended that by amending the wherein clause in such a way, "[c]laim scope is limited by altering dosage or by reciting positively [the] providing [of] a diagnosis," and that the claim would recite "steps that require steps to be performed."  Putting all of the proposed amendments together, Mr. Marks presented a version of the claim that he asserted was "fixed":

After briefly touching on claim 20 from U.S. Patent No. 5,747,282 (a claim involved in AMP v. Myriad), Mr. Marks presented a table of areas in which he believed the Office got it right in the Guidance and areas in which he believed the Office got it wrong (at least with respect to diagnostic method claims):

A copy of Mr. Marks' presentation can be found here.

The final presenter of the group (and the forum), Mr. Cox (at left), indicated that "[t]he ABA-IPL is reviewing the newly issued guidelines carefully and will provide written comments to the Office."  Despite the ABA-IPL's ongoing analysis of the Guidance, Mr. Cox did outline the ABA's current policy position on subject matter eligibility.  He noted first that the ABA "supports the principle that laws of nature, physical phenomena, and abstract ideas are not eligible for patenting under 35 U.S.C § 101, even if they had been previously unknown or unrecognized."  Next, he indicated that in analyzing process claims for subject matter eligibility, the claim must be read as a whole and be "limited to a specific application of a law of nature, natural phenomenon, or abstract idea" or "require[] or involve[] a transformation of matter."  Finally, Mr. Cox pointed out that the ABA opposed the importing of §§ 102, 103, or 112 criteria into a patent eligibility analysis, and instead:

[S]upports the principle that the inquiry into subject matter eligibility for patenting under 35 U.S.C. § 101 is a separate and distinct requirement for patent eligibility which should be resolved independently from the conditions of patentability under Sections 102 and 103, and the requirements for obtaining a valid patent under Section 112.

(emphasis in presentation).

A copy of Mr. Cox's presentation can be found here.

The forum concluded with an hour-long open participation/question and answer session.  In response to a question regarding the patent eligibility of fusion proteins, June Cohan (at right), a Legal Advisor with the USPTO's Office of Patent Legal Administration (who readers may recall presented on the Guidance at the most recent biotechnology/chemical/pharmaceutical (BCP) customer partnership meeting) indicated that fusion proteins were analogous to the cDNA molecules addressed in Myriad in that the former consists of separate proteins fused together and the latter consists of exons joined together.

Another commenter argued that correlations should be patent eligible, asking "did nature create the correlation between a marker and a disease," and then responding "no."  Following up on that assertion, the next commenter asked the USPTO representatives how they would amend Prometheus' claim to make it patent eligible.  Ms. Cohan responded that the Office could not get into specifics because there were pending applications in the family.  However, she did suggest that the commenter "should come back with a claim that is more like [the claim in] Diehr."  When another commenter suggested that a diagnostic method claim could be fixed by adding a treatment step, Ms. Cohan stated that "I don't think you need to transform a diagnostic claim to a treatment claim" to make the claim patent eligible, and pointed to Examples F and G in the Guidance.  She did concede that the Office was "considering another example" as a way to clarify the issue.

When one commenter asked whether the Office had the "right or responsibility to harmonize conflicting Supreme Court jurisprudence on patent eligibility," Mr. Hirshfeld (at left) responded that "we have the responsibility."

In response to another commenter's assertion that the Guidance lacked a clear test for assessing whether the claim as a whole recites something significantly different, Mr. Hirshfeld pointed out that the Office "realize[s] that we have said structural differences [can establish that something is significantly different], but you can also have functional differences."  Mr. Hirshfeld conceded, however, that "whether we have adequately conveyed this is another question."

Stating that she was "not optimistic" that examiners could be convinced to withdraw rejections made under the Guidance, Ms. Brinckerhoff asked the Office representatives how applicants could respond to such rejections, especially for composition claims.  She noted that "we'll have to take that [rejection] to the Board," and argued that "clients are going to give up" and "investors are going to go elsewhere."  She asked the panel "what can we do in the short term, noting that "we can't wait this out."  One Office representative suggested that applicants seek telephonic or video interviews with examiners (with the latter apparently gaining popularity at the Office).

Another commenter declared that the Guidance is "damaging to our clients," and implored the Office to withdraw the Guidance.  Mr. Hirshfeld responded that it was "highly unlikely" that the Guidance would be withdrawn, but indicated that "there may be iterative changes."  Mr. Hirshfeld concluded the forum by reminding attendees that "we very much value your feedback," and noting that the Office was seeking additional written comments from the public.  While no firm deadline has been set for submitting such comments, he asked attendees to try to submit their comments by the end of June.

For additional information regarding this topic, please see:

• "USPTO Holds Forum on Subject Matter Eligibility -- Part III," May 15, 2014
• "USPTO Holds Forum on Subject Matter Eligibility -- Part II," May 14, 2014
• "Guest Post: How to Patent Grapefruit Juice -- The New USPTO Guidance for Patent Eligible Subject Matter Is Both Sticky and Sour," May 13, 2014
• "USPTO Holds Forum on Subject Matter Eligibility -- Part I," May 12, 2014
• "USPTO Tries to Address Public Misunderstandings Regarding Myriad-Mayo Guidance," April 16, 2014
• "USPTO Issues Guidance for Analyzing Subject Matter Eligibility of Claims Reciting Laws of Nature/Natural Principles, Natural Phenomena or Natural Products," March 4, 2014