Rakesh N. Chettier

Patent Trials and Appeals BoardAug 19, 2019

15421186 - (R) (P.T.A.B. Aug. 19, 2019)

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. 15/421,186 01/31/2017 Rakesh N. Chettier CHT-008U 2859 52966 7590 08/19/2019 Schramm-Personal-ACT Michael R. Schramm 350 West 2000 South Perry, UT 84302 EXAMINER LEAVITT, MARIA GOMEZ ART UNIT PAPER NUMBER 1633 NOTIFICATION DATE DELIVERY MODE 08/19/2019 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): mike@schrammpatent.com mikeschramm@besstek.net PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte RAKESH N. CHETTIER ____________ Appeal 2018-004583 Application 15/421,1861 Technology Center 1600 ____________ Before DONALD E. ADAMS, DEMETRA J. MILLS, RICHARD M. LEBOVITZ, Administrative Patent Judges. ADAMS, Administrative Patent Judge. DECISION ON REQUEST FOR REHEARING Appellant requests rehearing of the Decision entered July 26, 2019 (“Decision”) reversing the rejections under the written description and enablement provisions of 35 U.S.C. § 112(a) and entering a New Ground of Rejection under 35 U.S.C. § 112(b). We DENY the requested relief. 1 Appellant identifies “Rakesh N. Chettier and Michael R. Schramm” as the real party in interest (Appellant’s January 8, 2018 Appeal Brief (App. Br.) 2). Appeal 2018-004583 Application 15/421,186 2 STATEMENT OF THE CASE Appellant’s disclosure “relates to methods for use in preparing stem cell [(SC)] compositions and for use in administering such compositions to patients” (Spec. ¶ 2). Claim 1 is representative and reproduced below: 1. A treatment method comprising obtaining at least one SC from a patient determined to have or be predisposed to at least one genetic condition, identifying at least one marker associated with an increased risk of said condition in said at least one SC, editing the genetic sequence of said at least one SC via CRSP such that at least one of the following is performed comprising elimination of said condition increased risk associated marker from said at least one SC and introduction of a condition decreased risk associated marker to said at least one SC, causing said at least one SC to initiate differentiation into a predetermined tissue, administering said edited at least one SC to said patient. (App. Br. 32.) Claim 1 stands rejected as indefinite under 35 U.S.C. § 112(b). As the Decision explains, “although we exercised our discretional authority under 37 C.F.R. § 41.50(b) to reject Appellant’s claim 1, we leave it to Examiner to determine the appropriateness of any further rejections of Appellant’s claimed subject matter. See Manual of Patenting Examining Procedure § 1213.02” (Decision 8). ANALYSIS Appellant contends that “the Board committed reversible error . . . [because] [t]he Board indicated that claim 1 was amenable to various Appeal 2018-004583 Application 15/421,186 3 interpretations when in fact claim 1 is not amenable to various interpretations” (Req. Reh’g2 2). We are not persuaded. We recognize Appellant’s contentions regarding a distinction between autogenic and allogenic (see id. at 4 (“[A]ppellant respectfully urges that . . . neither the instant specification teaches nor does claim 1 . . . claim either or both of the allogeneic treatment of a genetic disease and the autogeneic treatment of a genetic disease”); id. at 2 (“Appellant’s position is that claim 1 can only be interpreted consistent with an autogeneic administration of stem cells (aka the . . . ‘second embodiment’ [set forth in Appellant’s Specification])”); id. at 3 (“Appellant is neither advocating that claim 1 reads on the allogenic treatment of a genetic disease nor the autogeneic treatment of a genetic disease (the specification and the claims –– especially claim 1 –– do neither), but rather that the treatment was applied to the SCs that are subsequently administered to a patient”); see id. at 5 (Appellant contends “that it is inherently impossible to interpret claim 1 as anything other than the patient from whom the at least on SC is obtained is the selfsame patient to whom the at least on SC is administered, which of course is the very definition of an autogenic administration of stem cells”)). To be clear, the indefiniteness issue on this record does not concern whether the SCs are from an allogenic or autogenic source. To the contrary, the indefiniteness issue on this record is whether Appellant’s claim is limited solely to a method of preparing a SC, or alternatively to both a method of preparing a SC and treating a genetic disease in a patient with such a SC (see Decision 6–7). See generally, In re Zletz, 893 F.2d 319, 322 (Fed. Cir. 2 Appellant’s August 7, 2019 Request for Rehearing. Appeal 2018-004583 Application 15/421,186 4 1989) (“[D]uring patent prosecution when claims can be amended, ambiguities should be recognized, scope and breadth of language explored, and clarification imposed.”). Appellant’s claim 1 recites a treatment method (Spec. ¶¶ 7–8; cf. App. Br. 32)” (Decision 5). As the Decision explained, the second disclosed embodiment of Appellant’s invention “describes a method of preparing a SC composition and administering this composition to a patient” (Decision 4 (citing Spec. ¶ 8); see Req. Reh’g 2 “Appellant’s position is that claim 1 can only be interpreted consistent with . . . the . . . ‘second embodiment’ [set forth in Appellant’s Specification]”). This method recites that “a patient is determined to be genetically predisposed to degenerative disk disease (DDD) or to have clinical indications of DDD or both” (Decision 4 (citing Spec. ¶ 8)). SCs are obtained from this patient and modified to, inter alia, “no longer include a marker associated with the existence or predisposition to DDD” (id.). These SCs are then “caused to initiate differentiation into the tissue of choice, namely disk tissue, and . . . [are] then administered to the patient via injection into at least one disk of the patient . . . [to] stimulate regeneration of disk material that is not predisposed to DDD” (id. at Decision 4–5). Thus, although there is no doubt that Appellant is preparing SCs, Appellant’s Specification discloses that these SCs are taken from a patient genetically predisposed to DDD or having clinical indications of DDD, modified, and reintroduced into the same patient to stimulate regeneration of disk material that is not predisposed to DDD. Thus, a patient with a genetic disease, i.e. DDD, is treated by this method. Appellant’s enumerated contentions in the Rehearing Request only serve to support that the claims Appeal 2018-004583 Application 15/421,186 5 may be read in two different ways, and do not clearly support one claim interpretation over the other. For the foregoing reasons, we are not persuaded by Appellant’s intimation that the Board did not understand or misinterpreted the term “treatment” (see Req. Reh’g 2–4). Therefore, we are not persuaded by Appellant’s contention that “contrary to the Board’s erroneous assertion there are ‘no two ways’ to interpret claim 1 and therefore claim 1 is not indefinite” (Req. Reh’g 5). Appellant has not convinced us that there are not two possible interpretations of claim 1, and therefore we agree with our original determination that claim 1 is indefinite. The rejection of claim 1 under 35 U.S.C. § 112(b) is maintained. Appellant’s requested relief is denied (see Req. Reh’g 6). 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). REHEARING DENIED