Examination of Myriad-Mayo Guidance Comments -- ACLU


USPTO SealOn March 4, the U.S. Patent and Trademark Office issued a guidance memorandum entitled "Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products" (or "Myriad-Mayo Guidance") to implement a new procedure for determining the subject matter eligibility of claims under 35 U.S.C. § 101 in view of the Supreme Court's decisions in Association for Molecular Pathology v. Myriad Genetics, Inc. (2013), and Mayo Collaborative Services v. Prometheus Laboratories, Inc. (2012).  At a biotechnology/chemical/pharmaceutical (BCP) customer partnership meeting in April, the Office announced that it would be hosting a public forum in May to receive public feedback on the Guidance, and at that forum encouraged shareholders to submit written comments on the Guidance.  The original "end of June" deadline for submitting comments on the Guidance was subsequently extended to July 31.  With that extended deadline now passed, Patent Docs will focus on selected comments in a series of posts.

The Office has posted the comments that were submitted on the USPTO website.  The comments are divided into five groups (with the number of submissions in each group also provided):  Intellectual property organizations and other associations (18), academic and research institutions (7), law firms (6), companies (9), and individuals (42).  Today, we examine the comments submitted by the American Civil Liberties Union (ACLU).

ACLUThe ACLU begins its comments letter by noting the organization's role in the sequence of events that led to the creation of the Guidance -- i.e., as petitioners in the Association for Molecular Pathology v. Myriad Genetics, Inc. case.  While "commend[ing] the PTO for releasing guidance that synthesizes the Supreme Court case law on Section 101 of the Patent Act," the ACLU offers two recommendations for amendments to the Guidance and spends the last page of its letter addressing the Office's "Preliminary Examination Instructions in view of the Supreme Court Decision in Alice Corporation Pty. Ltd. v. CLS Bank International, et al.," which were issued on June 25.

Before outlining its recommendations, the ACLU indicates its support for the Office's "expansive" view of the subject matter to be assessed under the Guidance -- i.e., encompassing more than the nucleic acid molecules at issue in Myriad.  Stating that "[t]he Guidance correctly recognizes that the PTO must apply the Supreme Court's decisions to all patent applications that may claim products and laws of nature," the ACLU argues that "[w]hile Myriad examined nucleic acids, the reasoning of the Court was not limited to nucleic acids."  Noting that the Myriad Court "relied heavily on the standards it previously articulated in Diamond v. Chakrabarty, 447 U.S. 303 (1980), and Funk Bros. Seed. Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948) -- namely, that the claimed composition must have 'a distinctive name, character, and use,' 'markedly different characteristics from any found in nature,' and that the 'invention' must be more than 'the discovery of the natural principle itself,'" the ACLU contends that "the body of Supreme Court case law on Section 101 must be examined together, as each case often relies on and further elaborates on earlier cases."

In the ACLU's opinion, however, the Guidance is not without fault, and the organization offers two recommendations for amendments the Office could make to the Guidance.  First, the ACLU suggests that "Section 101 patent eligibility must turn on both the structure and function of a claimed composition."  In particular, the ACLU argues that "[t]he Guidance examines only the structure of a claimed product, but a close reading of the Court's decisions lays out the requirement that the composition must have markedly different characteristics from any found in nature in both structure and function" (emphasis in original). Looking to past Supreme Court decisions, the letter contends that:

[T]he Funk Bros. bacteria arguably had a different "character," as the strains of bacteria did not appear together in nature.  But the function -- their ability to fix nitrogen without inhibiting each other -- was not invented by the patentee.  The fruit in American Fruit Growers had a different structure -- borax in the rind -- but not a different function; it was still intended for human consumption.  . . .  The Chakrabarty bacterium had both a markedly different structure and function than any found in nature.

Second, the ACLU indicates that the organization is "concerned that the factor-weighing analysis laid out in the Guidance does not comport with the Supreme Court's Section 101 decisions and will only confuse the analysis."  Explaining that "[t]he [Supreme] Court generally makes its Section 101 determinations by evaluating whether what is claimed has markedly different characteristics from any found in nature, or whether there is an inventive concept," the ACLU argues that "[t]here may be different components to each of these evaluations, but they should not be parsed out as individual elements of the Section 101 question," adding that "[w]eighing multiple factors on each side of the Section 101 threshold introduces the likelihood that a claim will meet several competing factors for or against eligibility and muddle the analysis."

The ACLU letter closes by turning to the Office's Preliminary Examination Instructions, noting that "[a]s the PTO revisits its guidance on abstract ideas, we provide some thoughts to help inform its analysis."  Among those thoughts are the following:  (1) agreement with the Office's position that the Court's case law does not set up different Section 101 standards for abstract ideas versus laws of nature (or products of nature); (2) guidance on abstract ideas should not permit any patents that claim mental thought or steps; (3) the Office should not rely on the inclusion of a machine in patent claims.

The ACLU concludes its letter by declaring that "Section 101 issues are of particular significance to the wider public as they are at the heart of the constitutional mandate that patents 'promote the progress of Science and useful Arts,' rather than impede it."

Patent Docs will examine other Guidance comments in subsequent posts.


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