Recent USPTO Developments on Subject Matter Eligibility Presentation for Massachusetts Association of Technology Transfer Offices April 25, 2018 Elizabeth Spar Sunstein Kann Murphy & Timbers LLP © 2018 Sunstein Kann Murphy & Timbers LLP

USPTO Response to 101 Decisions Since the Supreme Court decided Alice v. CLS Bank in June 2014, the USPTO regularly issues new memoranda explaining its implementation of the § 101 framework.

USPTO Revisions to MPEP Incorporate Guidance from USPTO Memorandum In late January, the USPTO incorporated each of its earlier memoranda into the MPEP. The sections that the USPTO amended to include its Mayo/Alice guidance are in chapter 2100.

Updates to MPEP The new cases and examples follow from the Mayo/Alice line of cases. 2106.04 repeats the guidance of the Enfish memo: Examiners should accordingly be careful to distinguish claims that recite an exception (which require further eligibility analysis) and claims that merely involve an exception (which are eligible and do not require further eligibility analysis).

Patent Examiners are citing to these decisions ... mere physical or tangible nature of additional elements such as the obtaining and detecting steps does not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)). ... this type of correlation is a consequence of natural processes, similar to the naturally occurring correlation found to be a law of nature by the Supreme Court in Mayo). ... just as PCR was identified in Ariosa v. Sequenom as “well-known, routine and conventional” ... the methods encompassed by the instant claims are well-known, routine and conventional. Representative claim: 1. A method of producing a desired preparation of multi-cryopreserved hepatocytes, said hepatocytes being capable of being frozen and thawed at least two times, and in which greater than 70% of the hepatocytes of said preparation are viable after the final thaw, said method comprising: (A) subjecting hepatocytes that have been frozen and thawed to density gradient fractionation to separate viable hepatocytes from nonviable hepatocytes, (B) recovering the separated viable hepatocytes, and (C) cryopreserving the recovered viable hepatocytes to thereby form said desired preparation of hepatocytes without requiring a density gradient step after thawing the hepatocytes for the second time, wherein the hepatocytes are not plated between the first and second cryopreservations, and wherein greater than 70% of the hepatocytes of said preparation are viable after the final thaw.

Recently Issued Diagnostic Claims U. S Recently Issued Diagnostic Claims U.S. 9,939,449 – Issued April 10, 2018 1. (Original) A method for diagnosing and treating an anxiety disorder in a female subject, comprising: a. analyzing pituitary adenylate cyclase-activating polypeptide (PACAP) expression levels in a tissue sample collected from a female subject; b. diagnosing the anxiety disorder in the female subject having elevated tissue PACAP expression levels as compared to a control tissue sample obtained from a subject who does not have an anxiety disorder; and c. treating the anxiety disorder in the female subject diagnosed in (b).

The Office Action. Step (c) requires treating the disorder The Office Action ... Step (c) requires treating the disorder. However, for such treatment to add significantly more, it must practically apply the judicial exception ... In this case, step (c) does not relate to the judicial exception. It does not require practically applying steps (a) and (b). Step (c) is no more than instructions to treat a disorder, including using known, conventional therapies. Since step (c) is in no way reliant on the judicial exception, it does not add significantly more than the judicial exception.

U.S. 9,939,449- Claim Amendments 1. (Amended) A method for diagnosing and treating post traumatic stress disorder (PTSD) an anxiety disorder in a female subject, comprising: a. analyzing pituitary adenylate cyclase-activating polypeptide (PACAP) expression levels in a tissue sample collected from a female subject; b. diagnosing PTSD the anxiety disorder in the female subject having elevated tissue PACAP expression levels as compared to a control tissue sample obtained from a subject who does not have PTSD an anxiety disorder; and c. treating the anxiety disorder in administering to the female subject diagnosed in (b) a therapeutically effective amount of an antibody that binds specifically to an epitope at the carboxy-terminal end of PACAP.

The Office Action The rejection under 101 is withdrawn in light of the amendments. The treatment step now practically applies the judicial exception and is considered to elevate the claim as a whole to significantly more than the judicial exception itself.

Recently Issued Diagnostic Claims US 9,939,449 – Issued April 10, 2018 1. (Original) A method of determining an increased likelihood of prostate cancer cells in a subject to metastasize, comprising detecting in a sample comprising prostate cancer cells from the subject over-expression of a nucleic acid of ABCD3 compared to expression levels of a nucleic acid of ABCD3 from a control, the over-expression of a nucleic acid of ABCD3 in prostate cancer cells being indicative of an increased likelihood of prostate cancer cells in the subject to metastasize.

The Office Action The claims do not recite something “significantly more than the judicial exception(s); rather, the claims “simply inform” the natural phenomenon to one performing routine active method steps and do not amount to significantly more than the judicial exceptions.

US 9,939,449 Claim Amendments 1. (Amended) A method of determining an diagnosing and treating an increased likelihood of prostate cancer cell metastasis in a subjectcells in a subject to metastasize, the method comprising: a. obtaining a sample comprising prostate cancer cells from a subject; b. detecting expression of a nucleic acid of ABCD3 in the sample and determining whether the expression of a nucleic acid of ABCD3 is overexpressed in a sample comprising prostate cancer cells from the subject over expression of a nucleic acid of ABCD3 compared to expression levels of a nucleic acid of ABCD3 from a control; c. diagnosing the subject with, the overexpression of a nucleic acid of ABCD3 in prostate cancer cells being indicative of an increased likelihood of prostate cancer cell metastasis when the nucleic acid ABCD3 is overexpressed; and d. administering an aggressive treatment of prostate removal, radiation, chemotherapy or a combination thereof to the subject cells in the subject to metastasize.

The Office Action In an effort to expedite prosecution, it is noted the following amendment to claim 1 would obviate this rejection by adding a step that would result in a claimed combination of steps that would not be considered conventional or routine:” ...b. detecting expression of nucleic acid ABCD3 in the sample by amplifying ABCD3 nucleic acid using a primer pair that specifically amplifies ABCD3 nucleic acid and determining whether...

1. (Amended) A method of diagnosing and treating an increased likelihood of prostate cancer cell metastasis in a subject, the method comprising: a. obtaining a sample comprising prostate cancer cells from a subject; b. detecting expression of a nucleic acid of ABCD3 in the sample by amplifying ABCD3 nucleic acid using a primer pair that specifically amplifies ABCD3 nucleic acid and determining whether the expression of a nucleic acid of ABCD3 is overexpressed compared to expression levels of a nucleic acid of ABCD3 from a control; c. diagnosing the subject with an increased likelihood of prostate cancer cell metastasis when the nucleic acid ABCD3 is overexpressed; and d. administering an aggressive treatment of prostate removal, radiation, chemotherapy or a combination thereof to the subject.

Conclusion There is some hope for diagnostic claims. It may be useful to modify claim language based on claims that have been allowed, although there is inconsistency between examiners. Take advantage of the Revised MPEP and use the examples provided. Interview.

Elizabeth N. Spar espar@sunsteinlaw.com Thank you. Elizabeth N. Spar espar@sunsteinlaw.com