Ex Parte Parenteau et al

Patent Trial and Appeal BoardAug 21, 2018

13774644 (P.T.A.B. Aug. 21, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 13/774,644 02/22/2013 23579 7590 08/22/2018 Pabst Patent Group LLP 1545 PEACHTREE STREET NE SUITE 320 ATLANTA, GA 30309 FIRST NAMED INVENTOR Nancy L. Parenteau UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www .uspto.gov ATTORNEY DOCKET NO. CONFIRMATION NO. IBT 100 7841 EXAMINER BEL YA VSKYI, MICHAIL A ART UNIT PAPER NUMBER 1644 MAIL DATE DELIVERY MODE 08/22/2018 PAPER Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte NANCY L. PARENTEAU, JOSEPH C. LANING, and JANETH. YOUNG (APPLICANT: INGENIUM BIOTHERAPY CORPORATION) Appeal2017-002191 Application 13/774,644 1 Technology Center 1600 Before DONALD E. ADAMS, RYAN H. FLAX, and DAVID COTTA, Administrative Patent Judges. ADAMS, Administrative Patent Judge. DECISION ON APPEAL This Appeal under 35 U.S.C. Â§ 134(a) involves claim 17 (see Final Act. 2 2). Examiner entered rejections under 35 U.S.C. Â§Â§ 101 andÂ§ 103(a). We have jurisdiction under 35 U.S.C. Â§ 6(b ). We REVERSE. 1 Appellants identify "INGENIUM BIOTHERAPY CORPORATION" as the real party in interest (App. Br. 2). 2 Office Action mailed November 19, 2015. Appeal2017-002191 Application 13/774,644 STATEMENT OF THE CASE Appellants' disclosure relates to "personalized T cell therapy that eliminates or substantially reduces the number of cells capable of tumor propagation and cancer progression" (Spec. 1: 6-7). Claim 17, the only claim presented on Appeal, is reproduced below: 17. An isolated tumor C-RC cell population prepared by (a) obtaining a tumor sample from an individual; (b) cultivating the tumor sample under conditions that induce a stress response in non-C-RC differentiating and differentiated cells leading to apoptosis and necrosis but permit C-RC cells to propagate through the activation of a regenerative response; ( c) isolating the dominant actively expanding, most rapidly dividing population of cells from step (b ); and ( d) culturing the cells to obtain a population of 51 % to 100% C- RC, in a serum-free, defined cell culture medium containing agents selected from the group consisting of agents inducing the apoptosis and/or necrosis of the cells, cAMP elevating agents, agents inhibiting cell-cell adhesion, nitric oxide, tumor necrosis factor-alpha (TNF- a), interleukin I-beta (ILI-a), interferon- gamma (IFN-y), agents disrupting cell adhesion, agents interfering with survival of more differentiated cells, and calcium in a concentration of less than about 1 mM calcium, wherein 80-100% of the C-RC population consists of actively expanding and dividing VSEC, SDEC and SCEC cells and abnormal transit amplifying cells. (App. Br. 29--30.) 2 Appeal2017-002191 Application 13/774,644 Claim 17 stands rejected under 35 U.S.C. Â§ 103(a) as unpatentable over any one of Maenhaut, 3 Weissman, 4 Clarke, 5 and Gutova. 6 Claim 17 stands rejected under 35 U.S.C. Â§ 101. Obviousness: ISSUE Does the preponderance of evidence relied upon by Examiner support a conclusion of obviousness? ANALYSIS Examiner finds that each of Maenhaut, Weissman, Clarke, and Gutova disclose an isolated tumor C-RC cell population in culture medium (Final Act. 4 ). Examiner recognizes, however, that none of Maenhaut, Weissman, Clarke, and Gutova discloses that "80-100% of [the] C-RC population consists of VSEC,[ ]SDEC and SCEC cells" as required by Appellants' claim 17 (Ans. 7). Nonetheless, Examiner asserts that "VSEC, SDEC and SCEC are all naturally occurring subsets of C-RC cells" that would have necessarily resulted from "culturing and expanding ... C-RC cells in serum- free, defined culture medium comprising for example TNF-[a] or interferon- gamma" (Ans. 7). Examiner recognizes, however, that none of Maenhaut, Weissman, Clarke, and Gutova discloses "a serum-free defined cell culture medium" as set forth in Appellants' claim 17 (Final Act. 5). Nonetheless, Examiner asserts that, notwithstanding the express disclosures of Maenhaut, 3 Maenhaut et al., Cancer stem cells: a reality, a myth, a fuzzy concept or a misnomer? An analysis, 31 Carcinogenesis 149--158 (2010). 4 Weissman et al., US 7,781,179 B2, issued Aug. 24, 2010. 5 Clarke et al., US 7,713,710 B2, issued May 11, 2010. 6 Gutova et al., US 8,569,055 B2, issued Oct. 29, 2013. 3 Appeal2017-002191 Application 13/774,644 Weissman, Clarke, and Gutova ( which do not teach the culture medium required by Appellants' claim 17), at the time of Appellants' claimed invention, a person of ordinary skill in this art would have selected a serum- free defined cell culture medium as characterized and required by Appellants' claim 1 7 for use in any of Maenhaut, Weissman, Clarke, and Gutova because such media is "conventional" and it was "within the skill of the art to determine the optimum cell culture medium" ( Ans. 7; see also Final Act. 5). We are not persuaded. Examiner appreciates that the culture media required by Appellants' claim 1 7 is required to achieve the cell population required by Appellants' claim 1 7, which requires [that] "80-100% of [the] C-RC population consists of actively expanding and dividing VSEC, SDEC and SCEC cells and abnormal transit amplifying cells" (Ans. 7). Because none of Maenhaut, Weissman, Clarke, and Gutova disclose a population of cells grown in the culture media required by Appellants' claim 1 7, there can be no inherent or latent property in any of Maenhaut, Weissman, Clarke, and Gutova that could be discovered or would give rise to Appellants' claimed invention ( cf Ans. 7-8). Thus, as Examiner concedes, in order to achieve Appellants' claimed invention, the disclosures of Maenhaut, Weissman, Clarke, and Gutova must be modified (Ans. 7). Examiner asserts that such a modification would be to use a media that was conventionally known in the art at the time of Appellants' claimed invention (id.). In this regard, 4 Appeal2017-002191 Application 13/774,644 Examiner directs attention to Yamazaki 7 for a disclosure of "serum-free, define[d] culture medium comprising for example TNA-alpha or interferon- gamma ... used for culturing and/or maintaining [] isolated cancer stem cells" (see id.). As Appellants point out, however, Yamazaki "claims priority to a PCT application filed on October 16, 2012, 8 months after the priority date of [Appellants'] application," thus Examiner failed to establish that the culture medium required by Appellants' claimed invention to produce the cell population required by Appellants' claimed invention was known in the art at the time of Appellants' claimed invention (Reply Br. 8). Stated differently, Examiner failed to provide an evidentiary basis on this record to establish that a person of ordinary skill in this art would have been capable of optimizing the culture media in any of Maenhaut, Weissman, Clarke, and Gutova to arrive at Appellants' claimed cell population, even if there would have been a reason to make such a modification in the first instance (see App. Br. 18 (Examiner does not identify the defined cell culture media ... required by claim 17 which enable[ s] one to derive VSEC, SDEC and SCEC from explants")). CONCLUSION The preponderance of evidence relied upon by Examiner fails to support a conclusion of obviousness. The rejection of claim 17 under 35 U.S.C. Â§ I03(a) as unpatentable over any one of Maenhaut, Weissman, Clarke, or Gutova is reversed. 7 Yamazaki et al., US 2016/0159904 Al, published June 9, 2016. Yamazaki is a "[c]ontinuation of [A]pplication No. 14/354,517, filed on Apr. 25, 2014, now abandoned, filed as [A]pplication No. PCT/JP2012/077714 on Oct. 26, 2012" (Yamazaki). 5 Appeal2017-002191 Application 13/774,644 Subject Matter Eligibility: ISSUE Does the evidence of record support Examiner's finding that Appellants' claimed invention is directed to patent ineligible subject matter? ANALYSIS The Supreme Court articulated a two-step test for patent eligibility under Â§ 101 that "distinguish[ es] patents that claim laws of nature, natural phenomena, and abstract ideas from those that claim patent-eligible applications of those concepts." Alice Corp. Pty. Ltd. v. CLS Bankint'l, 134 S. Ct. 2347, 2355 (2014) (citing Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. at 1296-97). "First," Alice instructs a court to "determine whether the claims at issue are directed to one of those patent- ineligible concepts." Id. (citation and quotations omitted). If the claims are directed to a patent-ineligible concept then the court must proceed to the second step of the test - the "search for an inventive concept-i.e., an element or combination of elements that is sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the ineligible concept itself." Id. ( quotations and alterations omitted). On this record, Examiner finds that Appellants' claim 1 7 is directed to a product of nature and "[ t ]he recitation that the cells are in defined cell culture medium does not recite something significantly different []and thus does not add 'enough' to make the claims as a whole patent-eligible" (Final Act. 3). Thus, Examiner finds that Appellants' claimed invention is directed to patent ineligible subject matter (see Final Act. 2--4). We are not persuaded. 6 Appeal2017-002191 Application 13/774,644 As Appellants explain, "Examiner asserts that the recitation in [] claim 1 7 that the cells are in defined culture media does not recite something significantly different, because at the time the invention was made, serum- free, defined culture medium comprising for example, TNF alpha or interferon-gamma was well known and routinely used for culturing and/or maintaining [] isolated cancer stem cells" (Reply Br. 6). As discussed above, however, Examiner failed to establish an evidentiary basis on this record to support a finding that that such culture media was well known, routine and conventionally used in the art at the time of Appellants' claimed invention. See Berkheimer v. HP Inc., 881 F.3d 1360, 1369 (Fed. Cir. 2018) ("[ w ]hether something is well-understood, routine, and conventional to a skilled artisan at the time of the patent is a factual determination"). CONCLUSION The evidence of record fails to support Examiner's finding that Appellants' claimed invention is directed to patent ineligible subject matter. The rejection of claim 17 under 35 U.S.C. Â§ 101 is reversed. REVERSED 7