Last Friday, 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.
After USPTO Deputy Director Michelle Lee welcomed attendees and viewers to the forum, Drew Hirshfeld, Deputy Commissioner for Patent Examination Policy, provided opening remarks on the Guidance, and then Raul Tamayo, Senior Legal Advisor for the Office of Patent Legal Administration, provided an overview of the Guidance. Following Mr. Hirshfeld and Mr. Tamayo were several public presenters, who were divided into three groups, with each presenter being given 10 minutes to provide feedback on the Guidance. The first group of presenters consisted of Dr. Hans Sauer, Deputy General Counsel for Intellectual Property for the Biotechnology Industry Organization; Suzannah K. Sundby of Smith, Gambrell & Russell, LLP; Dr. Anthony D. Sabatelli of Dilworth IP LLC; and Dr. Kenneth H. Sonnenfeld of King & Spalding LLP. The second group of presenters consisted of Courtenay C. Brinckerhoff of Foley & Lardner LLP; Dr. Leslie Fischer of Novartis Pharmaceuticals Corp.; and Dr. Warren D. Woessner of Schwegman Lundberg & Woessner, P.A. The final 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). Following the public presentations, the forum concluded with a hour of open participation, where USTO representatives answered questions from attendees and viewers and accepted public statements from those in attendance.
In his opening remarks, Mr. Hirshfeld (at left) noted that the process of crafting examination guidance is an iterative one in which the Office responds to significant decisions (such as Myriad) by moving as quickly as possible to get guidance to examiners, and then going back and developing further guidance, if needed, following public input and feedback. Anticipating a question that he sensed was on the minds of most attendees, Mr. Hirshfeld indicated that he did not know what (if anything) would change in the Guidance as a result of public input and feedback, but suggested that "everything is on the table." However, Mr. Hirshfeld declared that the Office strongly believes that the Guidance is based on principles mandated by case law (although he acknowledged that the challenge was in applying these principles).
For those who had attended the April 16 biotechnology/chemical/pharmaceutical (BCP) customer partnership meeting, Mr. Tamayo's (at right) overview of the Guidance was probably quite familiar. In addition to reviewing the new examination procedure set forth in the Guidance for determining the subject matter eligibility of claims under 35 U.S.C. § 101, Mr. Tamayo also raised and answered several questions regarding the Guidance.
With respect to the question of why, in view of Myriad, the Guidance concerns anything more than DNA, Mr. Tamayo noted that the Guidance is not limited to Myriad, but considers a number of other Supreme Court decisions dealing with subject matter eligibility. Mr. Tamayo also explained that the Guidance was so comprehensive because the relevant case law was so woven (as shown in the slide below).
In response to the query about why the Guidance gives short shrift to the word "discovery" in 35 U.S.C. § 101 ("Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter . . . ."), Mr. Tamayo noted in his presentation that "[o]ver the last 65 years, the Supreme Court has repeatedly explained that a mere discovery of nature’s handiwork is not eligible" (emphasis in original). In support of the proposition that "discovery" is not enough for eligibility, he cited to four of the Court's decisions:
Mr. Tamayo next addressed the origin of the Guidance's "significantly different" standard, indicating that the phrase is meant to capture the two pathways to eligibility described in Association for Molecular Pathology v. Myriad Genetics, Inc. (2013), and Mayo Collaborative Services v. Prometheus Laboratories, Inc. (2012).
Noting that the Court's decision in Myriad had changed the Office's understanding of the law, he explained that isolation or purification of an otherwise unchanged naturally occurring product could no longer be viewed as eligible subject matter. According to Mr. Tamayo, the Federal Circuit's recent decision in In re Roslin added another data point that the proper test for all natural products -- and not just DNA -- was the "markedly different" standard of Chakrabarty. With respect to the question of why the Office limited the marked difference analysis to structure, he explained in his presentation that the "Supreme Court has never held a claim reciting a natural product eligible unless it was structurally different than what exists in nature," citing to four of the Court's decisions (as shown in the slide below).
As to whether a functional difference could be used to establish a marked difference, Mr. Tamayo stated that the Office's response was "no." In support of the Office's conclusion, he noted that while briefs submitted in the Myriad case had argued that the claimed DNA at issue in that case performed functions that native DNA could not, such arguments "did not alter the Court’s decision that eligibility hinged on a markedly different structural change." That being said, Mr. Tamayo indicated that the Office was "open to hearing alternative interpretations and considering examples."
In lieu of convincing the Office to consider functional differences, and in the event that an applicant's claims recite molecules that are identical to naturally-occurring products, Mr. Tamayo suggested two ways to make such claims eligible: (1) by excluding embodiments from the claim that do not possess markedly different characteristics, or (2) by combining the natural product with something that adds significantly more to the natural product (as shown in slide below).
Mr. Tamayo next addressed what he called the Guidance's most "explosive" example, Example C.
He explained that the example was intended to emphasize the important role of using the broadest reasonable interpretation (BRI) when analyzing claims for subject matter eligibility. Mr. Tamayo noted that the Office's assertion in the Guidance that "calcium chloride and gunpowder as recited in the claim are not markedly different from what exists in nature" had drawn feedback in the patent community ranging from "disagreement to vociferous disagreement (with more of the latter)." As in the Office's BCP presentation, Mr. Tamayo described the four types of gunpowder (simple mixture, corned gunpowder, glazed powder, and white powder) and explained that the simple mixture is not markedly different because none of the components (potassium nitrate, sulfur and charcoal) have been structurally changed. He then explained that as a result of BRI, examiners and applicants might look at gunpowder differently (as shown in the slide below).
Mr. Tamayo concluded his presentation by answering one last question: whether gunpowder was per se ineligible. His response was "no," but only because, as he reminded everyone, the new examination procedure did not establish bright line rules. He pointed out, for example, that an applicant might expressly disclaim a broad interpretation of gunpowder in the specification or use claim language that demonstrates that the particular claimed gunpowder is markedly different.
In a subsequent post, we will examine the response of public presenters.
For additional information regarding this topic, please see:
• "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