From: Aidan Toombs [mailto:redacted] Sent: Wednesday, July 30, 2014 9:08 PM To: myriad-mayo_2014 Subject: Comments on the Guidance COMMENTS on the Guidance for Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws Of Nature, Natural Phenomena, & Natural Products of March 4, 2014 (the “Guidance”). July 29, 2014 I am a registered patent attorney, responding to the invitation to submit written comments on the Guidance. Particularly, I believe the Supreme Court’s decisions in Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. __ (2013) (“Myriad”) and Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. __ (2012) (“Mayo”) could be implemented in an alternative manner from the Guidance, and I provide herein an alternative. The U.S. Patent and Trademark Office (the “Office”) coins a new term as the standard for patent eligibility of claims reciting a judicial exception, and that is “significantly different.” See Guidance, pages 2 (flowchart), 3 (Question 3), et seq. Specifically, Question 3 asks whether the claim recites something “significantly different” than a judicial exception. The Guidance then instructs the Examiner how to analyze “significantly different” using various factors. See factors (a)-(l) in the Guidance, pages 4-5. A review of several Office Actions mailed since imposition of the Guidance shows that claims are already being rejected under the “significantly different” standard, with Examiners providing a reason such as that the claims “do not recite something significantly different than a judicial exception.” Response taken from an actual Office Action mailed March 24, 2014 in the public record (emphasis added). I posit that the term “significantly different” is not an accurate synthesis of the outcomes of Myriad and Mayo, and claims should not be evaluated under a “significantly different” standard. First, the term appears nowhere in either Myriad or Mayo. Apparently it is the Office’s conflation of the “marked difference” standard of Myriad (as applied to products of nature), with the “significantly more” standard of Mayo (as regards process claims reciting a law of nature). Factors (a)-(l) are then a shuffling together of concepts from Myriad and Mayo into one pile, along with factors already in use by the Office. For example, factors (a) and (g) reflect the “markedly different” standard of Myriad, factors (c) and (d) reflect the “significantly more” standard of Mayo, and factor (e) reflects the machine or transformation “clue.” The court in Myriad, decided after Mayo, could have conflated the terms into a new standard had it wished; indeed, it cited Mayo several times. However, it did not do this. The court was addressing a different concept in each case. The “significantly more” standard of Mayo primarily relates to the recitation of a law of nature recitation in a claim (the claim must recite “significantly more” than the principle itself; e.g., the correlation between thiopurine metabolite levels and response to treatment). Likewise, the “markedly different” standard of Myriad primarily relates to the recitation of a product in a claim (the product must possess characteristics “markedly different” from those found in nature; e.g., cDNA v. DNA). The test for patent eligibility articulated by the court as a result of Myriad and Mayo is not whether a claimed product is “significantly different” from that found in nature, nor whether a claimed process is “significantly different” from the recitation of a law of nature. That, however, is the new standard created by the Office. This confuses the issue of patent eligibility by creating a single new standard where none was intended and forcing Examiners to evaluate claims with a grab bag of factors drawn from the two cases. I propose removing Question 3 from the Guidance flowchart (“Does the claim as a whole recite something significantly different than the judicial exception(s)?”), as this is not a legal standard of patent eligibility under current case law. I propose replacing it with a new question such that the Examiner is directed to analyze each claim according to the Mayo or Myriad standards separately, depending on the type of claim and which judicial exception(s) it contains. Accordingly, questions downstream from Question 2 (judicial exception) could be, for example: “Does the claim recite a process? – (if yes, then) –> Does the claim recite a law of nature? – (if yes, then) –> Analyze under the “significantly more” factors, as well as those currently used by Examiners; e.g., machine or transformation. If the claim is deemed not patent eligible, the Examiner may state in the rejection, “The [process] claims do not recite something significantly more than a law of nature, and is thus a judicial exception to patent eligibility. See Mayo ... .” “Does the claim recite a composition of matter? – (if yes, then) –> Does the claim recite a product of nature? – (if yes, then) –> Analyze under the “markedly different” factors, as well as any currently used by Examiners. If the claim is deemed not patent eligible, the Examiner may state in the rejection, “The [composition] claims do not demonstrate that the claimed subject matter is markedly different from what exists in nature, and is thus a judicial exception to patent eligibility. See Myriad ... .” Some benefits to analyzing claims in this manner are that it provides the Examiner a firmer legal basis for claim rejections in light of Myriad and Mayo, which in turn should provide the Office a better defense in the event of appeals than its “significantly different” creation; analyzing process vs. composition claims separately under the two distinct standards provides cleaner and less confusing instructions to Examiners, instead of lumping all judicial exception claims under the “significantly different” standard; and, it provides clearer advance instructions to applicants to facilitate drafting of patent eligible process or composition claims in view of recent case law. T. Aidan Toombs Palo Alto, California