WANG, RongfuDownload PDFPatent Trials and Appeals BoardFeb 26, 202014663470 - (D) (P.T.A.B. Feb. 26, 2020) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE 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 APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 14/663,470 03/20/2015 Rongfu WANG 55533-00001 5756 39290 7590 02/26/2020 Duane Morris LLP Duane Morris LLP 505 9th Street N.W. Suite 1000 Washington, DC 20004 EXAMINER DENT, ALANA HARRIS ART UNIT PAPER NUMBER 1643 MAIL DATE DELIVERY MODE 02/26/2020 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 RONGFU WANG ____________ Appeal 2019-003856 Application 14/663,470 Technology Center 1600 ____________ Before DONALD E. ADAMS, ERIC B. GRIMES, and RICHARD M. LEBOVITZ, Administrative Patent Judges. ADAMS, Administrative Patent Judge. DECISION ON APPEAL Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from Examiner’s decision to reject claims 1, 5, 6, 10, and 13 (see Appeal Br. 2).2 We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real party in interest as “Dr. Rongfu WANG” (Appellant’s December 7, 2017 Appeal Brief (Appeal Br.) 2). 2 Claims 2–4, 7–9, 11, 12, and 14–[19] stand withdrawn from consideration and claim 20 is cancelled (see Examiner’s April 21, 2017 Final Office Action 2; see also Appeal Br. 11–13). Appeal 2019-003856 Application 14/663,470 2 STATEMENT OF THE CASE Appellant claims a method of inducing interferon-gamma release in T cells and inducing T cells that recognize PSGR-expressing cells in an HLA-class dependent manner in a prostate cancer patient comprising administering to the patient an effective amount of a peptide selected from the group of peptides consisting of PSGR3 having the amino acid sequence of SEQ ID NO:3, PSGR4 having the amino acid sequence of SEQ ID NO: 4 and PSGR14 having the amino acid sequence of SEQ ID NO: 11, or combinations of two or more of the peptides. (Appeal Br. 4.) Appellant discloses that PSGR3 has the sequence ILANIYLLV (SEQ ID NO: 3), PSGR4 has the sequence WLAFPLCSL (SEQ ID NO: 4), and PSGR14 has the sequence VILANIYLLV (SEQ ID NO: 11) (see Spec. 15, Table 1). Appellant’s claim 1 is reproduced below: A method of inducing interferon-gamma release in T cells and inducing T cells that recognize PSGR-expressing cells in a HLA-class dependent manner in a patient in need thereof comprising administering to the patient an effective amount of a peptide selected from the group of peptides consisting of PSGR3 having the amino acid sequence of SEQ ID NO: 3, PSGR4 having the amino acid sequence of SEQ ID NO: 4 and PSGR14 having the amino acid sequence of SEQ ID NO: 11, or combinations of two or more of the peptides, wherein the patient is suffering from prostate cancer, and wherein interferon-gamma release in T cells is induced and T cells that recognize PSGR-expressing cells in a HLA-class dependent manner are induced in said patient. (id. at 11 (emphasis added).) Appellant’s claims 5, 6, 10, and 13 depend directly or indirectly from Appellant’s claim 1. Appeal 2019-003856 Application 14/663,470 3 Grounds of rejection before this Panel for review: Claims 1, 5, and 6 stand rejected under 35 U.S.C. § 102(a)(1) as anticipated by Jakobovits ’842.3 Claims 1, 5, and 6 stand rejected under 35 U.S.C. § 102(a)(1) as anticipated by Jakobovits ’562.4 Claims 1, 5, 6, 10, and 13 stand rejected under 35 U.S.C. § 103 as unpatentable over the combination of Jakobovits ’842 and Li.5 Claims 1, 5, 6, 10, and 13 stand rejected under 35 U.S.C. § 103 as unpatentable over the combination of Jakobovits ’562 and Li. Anticipation: ISSUE Does the preponderance of evidence on this record support Examiner’s finding that either of Jakobovits ’842 or Jakobovits ’562 teaches Appellant’s claimed invention? FACTUAL FINDINGS (FF) FF 1. Jakobovits ’842 “relates to a gene and its encoded protein, termed 101P3A11 or PHOR-1, expressed in certain cancers, and to diagnostic and therapeutic methods and compositions useful in the management of cancers that express 101P3A11” (Jakobovits ’842 1; see also Jakobovits ’562 ¶ 2 (Jokobovits ’562 “relates to a novel gene and its encoded protein, termed 101P3A11, and to diagnostic and therapeutic methods and compositions 3 Jakobovits et al., WO 02/092842 A2, published Nov. 21, 2002. 4 Jakobovits et al., US 2003/0091562 A1, published May 15, 2003. 5 Li et al., US 8,287,856 B2, issued Oct. 16, 2012. Appeal 2019-003856 Application 14/663,470 4 useful in the management of various cancers that express 101P3A11 (also referred to as PHOR-1)”)). FF 2. Jakobovits ’842 and Jakobovits ’562 both disclose that “[t]he use of a tumor antigen in a vaccine that generates humoral and/or cell-mediated immune responses as anti-cancer therapy is well known in the art and has been employed in prostate cancer using human PSMA and rodent PAP immunogens” (Jakobovits ’842 61; Jakobovits ’562 ¶ 301). FF 3. Jakobovits ’842 and Jakobovits ’562 both disclose that prostate cancer expresses 101P3A11 (Jakobovits ’842 8; Jakobovits ’562 ¶ 43). FF 4. Jakobovits ’842 “provides cancer vaccines comprising a 101P3A11- related protein” (Jakobovits ’842 61; see id. (Jakobovits ’842 discloses that “[t]he entire 101P3A11 protein, immunogenic regions or epitopes thereof can be combined and delivered by various means”); see also Jakobovits ’562 ¶ 232 (Jakobovits ’562 discloses the use of 101P3A11 proteins to generate cancer vaccines); Jakobovits ’562 ¶ 209 (Jakobovits ’562 discloses the use of one or more immunoreactive eiptopes of 101P3A11, including those peptides set forth in, inter alia, Table XI); see Ans.6 3–4)). FF 5. Jakobovits ’842 discloses that “representative embodiments of [its] invention comprise peptides/proteins having any . . . 9 . . . contiguous amino acids of a 101P3A11 protein” (Jakobovits ’842 33; Jakobovits ’562 ¶ 27 (Jakobovits ’562 discloses the use of peptides having, inter alia, 9 contiguous amino acids of a 101P3A11 protein)) FF 6. Jakobovits ’842 discloses a number of 9 contiguous amino acid peptides of 101P3A11 including a peptide having the sequence ILANIYLLV 6 Examiner’s March 8, 2018 Answer. Appeal 2019-003856 Application 14/663,470 5 (SEQ ID NO: 901) (Jakobovits ’842 166, Table XI; see also Jakobovits ’562 ¶ 766 (Jakobovits ’562 discloses a number of 9 contiguous amino acid peptides of 101P3A11 including a peptide having the sequence ILANIYLLV (SEQ ID NO: 72); see Ans. 3–4). FF 7. Jakobovits ’842 and Jakobovits ’562 both disclose that pharmaceutical compositions for therapeutic treatment are intended for parenteral, topical, oral, nasal, intrathecal, or local (e.g. as a cream or topical ointment) administration. Preferably, the pharmaceutical compositions are administered parentally, e.g., intravenously, subcutaneously, intradermally, or intramuscularly. Thus, the invention provides compositions for parenteral administration which comprise a solution of the immunogenic peptides dissolved or suspended in an acceptable carrier, preferably an aqueous carrier. (Jakobovits ’842 74; Jakobovits ’562 ¶ 384; see also Ans. 3–4.) FF 8. Jakobovits ’842 and Jakobovits ’562 both disclose that: In vivo, the effect of a 101P3A11 therapeutic composition can be evaluated in a suitable animal model. For example, xenogenic prostate cancer models can be used, wherein human prostate cancer explants or passaged xenograft tissues are introduced into immune compromised animals, such as nude or SCID mice (Klein et al., 1997, Nature Medicine 3: 402-408). (Jakobovits ’842 81; Jakobovits ’562 ¶ 424.) FF 9. Examiner finds that the ILANIYLLV peptide disclosed by both Jakobovits ’842 and Jakobovits ’562 is the same as Appellant’s PSGR3 peptide (Ans. 3–4). FF 10. Appellant discloses a study testing twenty-one of the peptides disclosed by Jakobovits (specifically, for their ability to induce “peptide- specific T-cell responses in [peripheral blood mononuclear cells (PBMCs) of] at least one of 10 healthy subjects,” wherein Appellant found that 13 of Appeal 2019-003856 Application 14/663,470 6 the “peptides were capable of inducing peptide-specific T-cell response in at least one of 10 healthy subjects” (see Spec. ¶ 68–70; cf., e.g., Jakobovits ’842 Tables V, VI, VIII, IX, X, and XI (SEQ ID NOs: 37, 586, 901, 579, 587, 61, 700, 742, 153, 420, 213, 223, 757, 711, 822, 210, 417, 203, 221, 425, and 426)). ANALYSIS Examiner finds that both Jakobovits ’842 and Jakobovits ’562 teach Appellant’s claimed invention (Ans. 3–4; see FF 1–9). We are not persuaded. On this record, Appellant claims a method of inducing interferon- gamma release in T cells and inducing T cells that recognize PSGR- expressing cells in a HLA-class dependent manner in a patient in need thereof, wherein the patient is suffering from prostate cancer, and wherein interferon-gamma release in T cells is induced and T cells that recognize PSGR-expressing cells in a HLA-class dependent manner are induced in said patient (see Appeal Br. 11). Examiner established, and Appellant recognizes, that Jakobovits ’842 and Jakobovits ’562 each disclose a number of different peptides of varying lengths, including Appellant’s PSGR3 peptide, for use, inter alia, in a method of treating cancer in a patient, including prostate cancer (see generally FF 1–9; see generally Appeal Br. 7). Examiner did not, however, establish that either of Jakobovits ’842 and Jakobovits ’562 teach methods of inducing interferon-gamma release in T cells or inducing T cells that recognize PSGR-expressing cells in a HLA- class dependent manner, i.e., the functional requirements of Appellant’s claimed invention. Examiner, instead, relies on inherency to reach the functional requirements of Appellant’s claimed invention (see Ans. 8). Appeal 2019-003856 Application 14/663,470 7 Specifically, Examiner reasons that “[p]roducts of identical chemical composition cannot have mutually exclusive properties. A chemical composition and its properties are inseparable” and, “[t]herefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present” (Ans. 8 (citing In re Spada, 911 F.2d 705, 708–09 (Fed. Cir. 1990))). Stated differently, Examiner reasons that because the references disclose one peptide, among many, that falls within the scope of Appellant’s claimed invention, the administration of this peptide, to a patient in need thereof, will inherently produce the functional requirements of Appellant’s claimed invention. We find that the evidence of record fails to support Examiner’s finding of anticipation. “[A] claim is anticipated if each and every limitation is found either expressly or inherently in a single prior art reference.” Celeritas Techs. Ltd. V. Rockwell Intl. Corp., 150 F.3d 1354, 1360 (Fed. Cir. 1998). Inherent anticipation requires that the missing descriptive material is “necessarily present,” not merely probably or possibly present, in the prior art. In re Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999) (citing Continental Can Co. USA, Inc. v. Monsanto Co., 948 F.2d 1264, 1268 (Fed. Cir. 1991)). In addition, we note that “[t]o anticipate, the reference must also enable one of skill in the art to make and use the claimed invention.” In re Donohue, 766 F.2d 531, 533 (Fed. Cir. 1985). On this record, Appellant established that the peptides disclosed by Jakobovits ’842 and Jakobovits ’562 have different properties as they relate to the functional properties of Appellant’s claimed invention (see FF 10; see generally Appeal Br. 7). Thus, Appellant’s evidence essentially establishes different classes of peptides among those listed in the prior art tables. Appeal 2019-003856 Application 14/663,470 8 Examiner failed, however, to establish an evidentiary basis on this record to support a finding that either of Jakobovits ’842 or Jakobovits ’562 provided a disclosure directing, i.e. enabling, those of ordinary skill in this art to select, from the genus, or different classes, of peptides disclosed in the references, those peptides that exhibit the functional properties required by Appellant’s claimed invention. See, e.g., Bristol–Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368 (Fed. Cir. 2001): The record in this case does not establish whether the general class of premedicants that are suitable to prophylactically treat hypersensitivity reactions before administration of a cancer drug such as paclitaxel is small enough such that Kris’s disclosure of premedicants effectively described the specific classes of premedicants in [the] claims. Id. at 1380. For the foregoing reasons, we find that Examiner failed to establish an evidentiary basis on this record to support a finding of anticipation. CONCLUSION The preponderance of evidence on this record fails to support Examiner’s finding that either of Jakobovits ’842 or Jakobovits ’562 teaches Appellant’s claimed invention. The rejection of claims 1, 5, and 6 under 35 U.S.C. § 102(a)(1) as anticipated by Jakobovits ’842 is reversed. The rejection of claims 1, 5, and 6 under 35 U.S.C. § 102(a)(1) as anticipated by Jakobovits ’562 is reversed. Appeal 2019-003856 Application 14/663,470 9 Obviousness: ISSUE Does the preponderance of evidence relied upon by Examiner support a conclusion of obviousness? FACTUAL FINDINGS (FF) FF 11. Examiner relies on Jakobovits ’842 or Jakobovits ’562 as discussed above (see FF 1–9). FF 12. Examiner finds that Jakobovits ’842 or Jakobovits ’562 do not disclose a “method, wherein an inhibitor of human Programmed Death 1 (PD-1) is administered with PSGR3” and relies on Li to teach “an antibody that specifically binds to PD-1” (Ans. 5–6 (citing Li, Abstract and Col. 16)). ANALYSIS Based on Jakobovits ’842 or Jakobovits ’562 in combination with Li, Examiner concludes that, at the time Appellant’s invention was made, it would have been prima facie obvious to “combine the therapeutic agents” of Li and either of Jakobovits ’842 or Jakobovits ’562 “. . . for enhanced generation of an immune response to tumor cells in a patient” (Ans. 6 (citing Li, col. 1: 13–19; Jakobovits ’842, Abstract; Jakobovits ’562, Abstract) (alteration original)). Examiner, however, failed to establish that Li makes up for the deficiency discussed above with respect to either of Jakobovits ’842 or Jakobovits ’562 (see Appeal Br. 9; see also Ans. 8). Therefore, we are not persuaded by Examiner’s assertion that “the validity of Jakobovits has been established herein, hence this reference in combination with Li is proper” (Ans. 8). Appeal 2019-003856 Application 14/663,470 10 CONCLUSION The preponderance of evidence relied upon by Examiner fails to support a conclusion of obviousness. The rejection of claims 1, 5, 6, 10, and 13 under 35 U.S.C. § 103(a) as unpatentable over the combination of Jakobovits ’842 and Li is reversed. The rejection of claims 1, 5, 6, 10, and 13 under 35 U.S.C. § 103(a) as unpatentable over the combination of Jakobovits ’562 and Li is reversed. DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1, 5, 6, 20 102(a)(1) Jakobovits ’842 1, 5, 6 1, 5, 6, 20 102(a)(1) Jakobovits ’562 1, 5, 6 1, 5, 6, 10, 13, 20 103 Jakobovits ’842, Li 1, 5, 6, 10, 13 1, 5, 6, 10, 13, 20 103 Jakobovits ’562, Li 1, 5, 6, 10, 13 Overall Outcome 1, 5, 6, 10, 13 REVERSED Copy with citationCopy as parenthetical citation