Arena Pharmaceuticals, Inc.

Patent Trials and Appeals BoardMar 11, 2021

2020004614 (P.T.A.B. Mar. 11, 2021)

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. 15/238,014 08/16/2016 Antonio Garrido Montalban 20750-0159004 179.US5.CON 8363 26204 7590 03/11/2021 FISH & RICHARDSON P.C. (ARENA PHARMACEUTICALS) P.O. BOX 1022 MINNEAPOLIS, MN 55440-1022 EXAMINER BARKER, MICHAEL P ART UNIT PAPER NUMBER 1655 NOTIFICATION DATE DELIVERY MODE 03/11/2021 ELECTRONIC 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. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): PATDOCTC@fr.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte ANTONIO GARRIDO MONTALBAN, DANIEL J. BUZARD, JOHN A. DEMATTEI, TAWFIK GHARBAOUI, STEPHEN R. JOHANNSEN, ASHWIN M. KRISHNAN, YOUNG MI KUHLMAN, YOU-AN MA, MICHAEL JOHN MARTINELLI, SUZANNE MICHIKO SATO, and DIPANJAN SENGUPTA ____________ Appeal 2020-004614 Application 15/238,014 Technology Center 1600 ____________ Before DONALD E. ADAMS, RICHARD M. LEBOVITZ, and ROBERT A. POLLOCK, 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 claim 78 (see Br. 1).2 We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 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 “Arena Pharmaceuticals, Inc.” (Appellant’s March 27, 2019 Appeal Brief (Br.) 1). 2 Examiner finds Appellant’s claims 1, 2, 4–10, 65–67, and 71–77 allowable (see Examiner’s March 30, 3018 Final Office Action (Final Act.) 2; see also Appeal 2020-004614 Application 15/238,014 2 STATEMENT OF THE CASE Appellant discloses “processes for preparing an L-arginine salt of (R)- 2-(7-(4-cyclopentyl-3-(trifluoromethyl)benzyloxy)-1,2,3,4-tetrahydro- cyclopenta[b]indol-3-yl)acetic acid of Formula (Ia): comprising” a step that involves a compound of Formula (IIg): wherein R1 and R2 are each independently C1-C6 alkyl, or R1 and R2 together with the nitrogen atom to which they are both bonded form a 5-member or 6-member heterocyclic ring, and R3 is C1-C6 alkyl. (Spec. 2–3.) Appellant’s claim 78 is reproduced below: 78. A compound of Formula (IIg): Br. 1). We do not address the objection of Appellant’s claims 79 and 80, which is a petitionable, rather than appealable, issue (see Final Act. 2; see also Br. 1). Appeal 2020-004614 Application 15/238,014 3 wherein R1 and R2 are each independently C1-C6 alkyl, or R1 and R2 together with the nitrogen atom to which they are both bonded form a 5-member or 6-member heterocyclic ring, and R3 is C1-C6 alkyl. (Br. 28–29.) Claim 78 stands rejected under 35 U.S.C. § 102(b) as anticipated by STN/CAPLUS.3 ISSUE Does the preponderance of evidence on this record support Examiner’s finding that STN/CAPLUS anticipates the compound recited in clam 78? ANALYSIS Examiner finds that STN/CAPLUS teaches a compound having the following formula: , which anticipates Appellant’s claim 78, “wherein R1 and R2 together with the nitrogen atom to which they are both bonded form a 6-member heterocyclic ring, and R3 is C2 alkyl (ethyl)” (Ans. 4). We find no error in Examiner’s prima facie case of anticipation. [A]ll that is required of the office to meet its prima facie burden of production is to set forth the statutory basis of the rejection and the reference or references relied upon in a sufficiently 3 STN/CAPLUS Registry No. 380350-42-5 (2002). Appeal 2020-004614 Application 15/238,014 4 articulate and informative manner as to meet the notice requirement of [35 U.S.C.] § 132. See In re Jung, 637 F.3d 1356, 1363 (Fed. Cir. 2011). We find that Examiner met his burden of production and, thus, properly shifted the evidentiary burden to Appellant. Appellant contends that STN/CAPLUS does not provide an enabling description of Appellant’s claimed compound. We are not persuaded. [D]uring patent prosecution, an examiner is entitled to reject claims as anticipated by a prior art publication or patent without conducting an inquiry into whether or not that prior art reference is enabling. As long as an examiner makes a proper prima facie case of anticipation by giving adequate notice under [35 U.S.C.] § 132, the burden shifts to the applicant to submit rebuttal evidence of nonenablement. In re Antor Media Corp., 689 F.3d 1282, 1289 (Fed. Cir. 2012) (emphasis added). The requirement that a [§] 102(b) reference be an enabling disclosure was discussed . . . In re LeGrice, 301 F.2d 929, 49 CCPA 1124, 133 USPQ 365 (1962). . . . The following excerpt continues to be the proper standard for determining whether there is enablement. * * * the proper test of a description in a publication as a bar to a patent as the clause is used in section 102(b) requires a determination of whether one skilled in the art to which the invention pertains could take the description of the invention in the printed publication and combine it with his own knowledge of the particular art and from this combination be put in possession of the invention on which a patent is sought. Unless this condition prevails, the description in the printed publication is inadequate as a statutory bar to Appeal 2020-004614 Application 15/238,014 5 patentability under section 102(b). (Emphasis ours.) See In re Samour, 571 F.2d 559, 197 USPQ 1 (Cust. & Pat. App. 1978). Whether those skilled in the art already possessed the necessary precursors is an issue subject to a shifting burden of proof. To explain, when the PTO cited a disclosure which expressly anticipated the present invention, . . . the burden was shifted to the applicant. [Appellant then] had to rebut the presumption of the operability of . . . [the reference] by a preponderance of the evidence. In re Jacobs, 50 CCPA 1316, 318 F.2d 743, 137 USPQ 888 (1963). In re Sasse, 629 F.2d 675, 681 (CCPA 1980). With the foregoing in mind, we note that “[a]ttorney’s argument in a brief cannot take the place of evidence.” In re Pearson, 494 F.2d 1399, 1405 (CCPA 1974). Because Examiner met the burden, we are not persuaded by the contentions asserted by Appellant’s Attorney that STN/CAPLUS is not enabling and, therefore, is not an anticipatory reference (see Br. 4–13). For the foregoing reasons, we are not persuaded by Appellant’s contentions that Examiner improperly shifted the evidentiary burden on this record, because STN/CAPLUS is not a patent document (see Br. 8–13). Accordingly, we are not persuaded by Appellant’s contentions regarding In re Sasse, 629 F.2d 675 (CCPA 1980) and In re Donohue, 766 F.2d 531 (Fed. Cir. 1985) (see Br. 8–9 and 12–13). We are also not persuaded by Appellant’s contentions regarding In re Wiggins, 488 F.2d 538, 543 (Fed. Cir. 1973) (Br. 10–12). In Wiggins “the evidence of record suggest[ed] that a method suitable for [the] preparation [of the claimed compound] was not developed until a date later than that of the reference” relied upon. In re Wiggins, 488 F.2d 538, 543 (Fed. Cir. Appeal 2020-004614 Application 15/238,014 6 1973) (footnote omitted, emphasis added). We find no such evidence on this record. See Pearson, 494 F.2d at 1405 (“Attorney’s argument in a brief cannot take the place of evidence.”). Thus, we are not persuaded by Appellant’s contentions regarding Wiggins (see Br. 10–12). In sum, the proper test of a description in a publication as a bar to a patent as the clause is used in section 102(b) requires a determination of whether one skilled in the art to which the invention pertains could take the description of the invention in the printed publication and combine it with his own knowledge of the particular art and from this combination be put in possession of the invention on which a patent is sought. Sasse, 629 F.2d at 681 (emphasis added). On this record, Examiner presented a prima facie case of anticipation and, thus, properly shifted the evidentiary burden to Appellant (see Ans. 3–5). Appellant, however, failed to carry its evidentiary burden. We recognize Appellant’s contentions regarding an alleged second rejection of the claimed compound as “in public use or on sale in this country, more than one year prior to the date of application for patent in the United States” (Br. 3). As Examiner makes clear, however, no such rejection was made on this record (Ans. 5). Therefore, we are not persuaded by Appellant’s contentions regarding a second rejection on this record. CONCLUSION The preponderance of evidence on this record supports Examiner’s finding that STN/CAPLUS teaches Appellant’s claimed invention. The rejection of claim 78 under 35 U.S.C. § 102(b) as being anticipated by STN/CAPLUS is affirmed. Appeal 2020-004614 Application 15/238,014 7 DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 78 102(b) STN/CAPLUS 78 TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED