DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of Claims
Currently, claims 1, 16, and newly added claims 185-187 are pending in the instant application. Claim 16 and 185 are withdrawn from consideration as being drawn to a non- elected species. Claims 1 and 186-187 are currently under examination. All the amendments and arguments have been thoroughly reviewed but are deemed insufficient to place this application in condition for allowance. The following rejections are either newly applied, as necessitated by amendment, or are reiterated. They constitute the complete set being presently applied to the instant Application. Response to Applicant's arguments follow. This action is FINAL.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Any rejection not reiterated is hereby withdrawn in view of the amendments to the claims.
Claim Rejections - 35 USC § 101
Claims 1 and 186-187 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural correlation/law of nature and an abstract idea without significantly more. This judicial exception is not integrated into a practical application and the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons set forth below.
35 U.S.C. § 101 requires that to be patent-eligible, an invention (1) must be directed to one of the four statutory categories, and (2) must not be wholly directed to subject matter encompassing a judicially recognized exception. M.P.E.P. § 2106. Regarding judicial exceptions, “[p]henomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work.” Gottschalk v. Benson, 409 U.S. 63, 67 (1972); see also M.P.E.P. § 2106. The unpatentability of abstract ideas was confirmed by the U.S. Supreme court in Bilski v. Kappos, 561 U.S. 593, 601 (June 28, 2010) and Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 134 S. Ct. 2347, 2354 (2014). See also Myriad v Ambry, CAFC 2014-1361, -1366, December 17, 2014. The unpatentability of laws of nature was confirmed by the U.S. Supreme Court in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66, 71 (2012). “[L]aws of nature, natural phenomena, and abstract ideas” are not patentable. Dia-mond v. Diehr, 450 U. S. 175, 185 (1981); see also Bilski v. Kappos, 561 U. S. at 601 (2010).
Claims Analysis:
As set forth in MPEP 2106, the claims have been analyzed to determine whether they are directed to one of the four statutory categories (STEP 1).
The instant claims are directed to methods and therefore are directed to one of the four statutory categories of invention.
The claims are then analyzed to determine if they recite a judicial exception (JE) (STEP 2A, prong 1) [Mayo Collaborative Services v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1293 (2012), Alice Corp. Pry. Ltd. v. CLS Bank Int'l, 134 S. Ct. 2347 (2014)].
The claimed invention recites a method of prognosing prostate cancer by determining the expression level of SEQ ID NO: 380, which is a fragment of the INHBA gene. However, the relationship between expression levels of this gene and cancer prognosis is a natural correlation which, as in Mayo, is itself a natural process that exists apart from any human action. Additionally, the claimed recitation of prognosing and determining whether the subject is likely to have biochemical recurrence are recitations of abstract ideas because they encompass observations, conclusions and determinations which can occur entirely within the mind. It is therefore determined that the claims are directed to judicial exceptions.
The claims are then analyzed to determine whether they recite an element or step that integrates the JE into a practical application (STEP 2A, prong 2) [Vanda Pharmaceuticals Inc., v. West-Ward Pharmaceuticals, 887 F.3d 1117 (Fed. Cir. 2018)].
The claims recite steps of assaying gene expression, however this does not integrate the JE into a practical application because it is a mere data gathering step to use the correlation and does not add a meaningful limitation to the method. While the claims have been amended to recite “administering a prostate cancer treatment to the subject based on the prognosis that the subject is likely to have a biochemical recurrence of the prostate cancer, or not administering a prostate cancer treatment…” when the subject is not likely to have biochemical recurrence of the prostate cancer. However, the recitation of administration of a “prostate cancer treatment” is a generalized treatment limitation. Additionally, the limitation of “not administering” prostate cancer treatment requires that the practitioner do nothing (it is noted that this claim interpretation also applies to claims 186 and 187 because they further limit the possible treatment, but do not actually require that such treatment be administered due to the alternative embodiments recited in claim 1). Therefore, these limitations do not integrate the JEs into a practical application because the conditional, generalized recitation does not recite or require any particular therapeutic. This recitation has no more than a nominal relationship to the exceptions recited, and is so general as to be mere instructions to apply the JE’s in a generic way. The Supreme Court does acknowledge that it is possible to transform an unpatentable law of nature, but one must do more than simply state the law of nature while adding the words "apply it.” CLS BankInt’l, 134 S.Ct. at 2358; Prometheus, 132 S. Cl, at 1294.
In the absence of steps or elements that integrate the JE into a practical application, the additional elements/steps are considered to determine whether they add significantly more to the JE either individually or as an ordered combination, to “’transform the nature of the claim’ into a patent eligible application” [Mayo Collaborative Services v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1293 (2012), Alice Corp. Pry. Ltd. v. CLS Bank Int'l, 134 S. Ct. 2347 (2014)] (STEP 2B).
In the instant situation, the step of assaying an expression level is generally recited and does not provide any particular reagents that might be considered elements that transform the nature of the claims into a patent eligible application because no specific elements/steps are recited. This step is not only a mere data gathering step, but the general recitation of detection of known nucleic acids is well understood, routine, and conventional activity (See MPEP 2106.05(d)(II)). Furthermore, the instant specification teaches that the expression levels were determined using Affymetrix arrays that were available and used by practitioners in the field well before applicants effective filing date. The administering steps are also generally recited and require what amounts to generalized instructions to treat prostate cancer which are well understood routine and conventional. Applicant is reminded that in Mayo, the Court found that “[i]f a law of nature is not patentable, then neither is a process reciting a law of nature, unless that process has additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself." Further "conventional or obvious" "[pre]solution activity" is normally not sufficient to transform an unpatentable law of nature into a patent-eligible application of such a law”. Flook, 437 U. S., at 590; see also Bilski, 561 U. S., at ___ (slip op., at 14) (“[T]he prohibition against patenting abstract ideas ‘cannot be circumvented by’ . . . adding ‘insignificant post-solution activity’” (quoting Diehr, supra, at 191–192)). The Court also summarized their holding by stating “[t]o put the matter more succinctly, the claims inform a relevant audience about certain laws of nature; any additional steps consist of well understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately.” Therefore these limitations/steps do not “‘transform the nature of the claim’ into a patent-eligible application.’” Alice, 134 S. Ct. at 2355 (quoting Mayo, 132 S. Ct. at 1297).
When viewed as an ordered combination, the claimed limitations are directed to nothing more than the determination that a natural correlation/phenomena exists. Any additional element consists of using well understood, routine and conventional activity, and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately.
Accordingly, it is determined that the instant claims are not directed to patent eligible subject matter.
Response to Arguments
The response traverses the rejection and asserts that the claims have been amended to integrate the JEs into a practical application of treating a subject. This argument has been thoroughly reviewed but was not found persuasive for the reasons made of record in the rejection above. Specifically, the recitation of administration of a “prostate cancer treatment” is a generalized treatment limitation. Additionally, the limitation of “not administering” prostate cancer treatment requires that the practitioner do nothing. Therefore, these limitations do not integrate the JEs into a practical application because the conditional, generalized recitation does not recite or require any particular therapeutic. This recitation has no more than a nominal relationship to the exceptions recited, and is so general as to be mere instructions to apply the JE’s in a generic way. The Supreme Court does acknowledge that it is possible to transform an unpatentable law of nature, but one must do more than simply state the law of nature while adding the words "apply it.” CLS BankInt’l, 134 S.Ct. at 2358; Prometheus, 132 S. Cl, at 1294. The rejection is maintained and applied to the newly added claims.
Claim Rejections - 35 USC § 103
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1 and 186-187 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Nakagawa (Nakagawa et al; PLOS One; vol 3; May 2008, e2318 pages 1-14) and Gorlov (Gorlov et al; BMC Cancer, 2010, vol 10, pages 1-8).
It is noted that claim 1 has been amended to recite “i) determining that the subject is likely to have biochemical recurrence of the prostate cancer or ii) determining that the subject is not likely to have a biochemical recurrence of the prostate cancer”. The specification does not appear to define the phrase “biochemical recurrence”, however at paragraph 0085, the specification teaches that biochemical relapse includes a disease state where patients present with elevated PSA but no other disease symptoms as well as elevated PSA with system cancer disease or recurrence. At paragraph 0086, the specification teaches that METS, SYS, systemic event, systemic progression, CR, or clinical recurrence are used interchangeably to refer to patients that experience biochemical recurrence (BCR) and develop metastases. The specification does not provide any guidance as to whether any difference in scope is present for the terms “biochemical relapse” vs “biochemical recurrence”. Therefore, the phrase has been given its broadest reasonable interpretation, consistent with the teachings of the specification, to include patients who have been treated for prostate cancer, including by surgery, and develop elevated PSA levels with or without additional symptoms.
With regard to claim 1, Nakagawa teaches assaying the expression level of genes including INHBA (SEQ ID NOS: 380) in patients with PSA recurrence and prostate cancer systemic progression. Nakagawa teaches that INHBA expression was one of 68 genes significantly correlated with prostate cancer systemic progression (table 3) in patients with PSA recurrence. Gorlov also teaches assaying expression levels of genes including INHBA and teaches that upregulated expression was associated with tumor progression after surgery. Gorlov teaches that this gene was also found to be upregulated in prostate cancer progression in the study of Nakagawa and teaches that it, among other genes, can be used to predict tumor progression after surgery. Therefore, it would have been prima facie obvious to the ordinary artisan at the time the invention was made to assay expression levels of genes in patients with prostate cancer, including the IHNBA gene, and to predict PSA recurrence and prostate cancer system progression using these gene expression levels. It is noted that the claims do not provide any limitations as to how the expression levels of the plurality of targets is “utilized”. Therefore, the claims have been broadly interpreted to encompass analysis of gene expression of the a panel of targets, including INHBA, and using the information to develop models that predict tumor progression after surgery, as suggested by Gorlov, to include PSA recurrence and prostate cancer systemic progression, as taught by Nakagawa.
With regard to claims 1, 186 and 187, Nakagawa teaches that treatments for men with PSA recurrence include adjuvant hormonal ablation, local radiation therapy, or simple observation (not administering a prostate cancer treatment).
Response to Arguments
The response traverses the rejection and asserts that “as far as Applicant is aware”, none of the cited references, alone or in combination, teach the limitations of claim 1. This argument has been thoroughly reviewed but was not found persuasive for the reasons made of record in the rejection at section 8, set forth above.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/JEHANNE S SITTON/Primary Examiner, Art Unit 1682