Ex Parte Colman et al

Patent Trial and Appeal BoardOct 11, 2016

10080713 (P.T.A.B. Oct. 11, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 10/080,713 02/25/2002 20786 7590 10/13/2016 KING & SPALDING 1180 PEACHTREE STREET, NE ATLANTA, GA 30309-3521 FIRST NAMED INVENTOR Alan Colman 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. 10758.105015CON 9155 EXAMINER TON, THAIAN N ART UNIT PAPER NUMBER 1632 NOTIFICATION DATE DELIVERY MODE 10/13/2016 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): ATLIPDOCKETING@kslaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte ALAN COLMAN, ANGELIKA E. SCHNIEKE, ALEXANDER J. KIND, DAVID L. A Y ARES, and YIP AN DAI Appeal2016-006371 Application 10/080,713 Technology Center 1600 Before FRANCISCO C. PRATS, JEFFREY N. FRED MAN, and TA WEN CHANG, Administrative Patent Judges. FREDMAN, Administrative Patent Judge. DECISION ON REQUEST FOR REHEARING Appellants have requested rehearing (reconsideration) of the Decision mailed July 22, 2016. That decision affirmed the Examiner's anticipation and obviousness rejections. We deny the requested relief. DISCUSSION Appellants contend that "the Board made a factual error" (Req. Reh' g 8). Specifically, Appellants contend that: Appeal2016-006371 Application 10/080,713 Capecchi 1 clearly teaches that microinjection can be used to knock-in genes by random integration. See page 37, column 4, last two paragraphs. Specifically, Capecchi states that microinjection (''use of extremely small glass needles to insert DNA directly into the nuclei") can be used to produce random integration ("the DNA molecules were randomly inserted"). This is in direct contrast to the Board's position that microinjection is merely an auxiliary process that facilitates homologous recombination. (Req. Reh'g 9). Appellants further contend that "Campbell, the reference cited for inherent disclosure of homologous recombination, uses the term 'knock-in' only once and does not define it" and that "nothing of the record teaches that 'knock-in' necessarily means homologous recombination and to the contrary, both Capecchi and the Appellant's specification teach that it is possible by random integration" (Req. Reh' g 10). We find these arguments unpersuasive. The preponderance of evidence does not support 1A~ppellants' position for at least t\~10 reasons. Appellants conflate "gene knock-ins" with "random integration." Campbell '6692 specifically lists two techniques: "gene additions" and "gene knock-ins" (Dec. 6; FF 9). Campbell '669 teaches "techniques may include gene additions, gene knock-outs, gene knock-ins, and other gene modifications" (Dec. 6; FF 9). Campbell '669's use of both techniques indicates that the techniques differ and the terms have different meanings, with "gene additions" reasonably interpreted as representing insertion of 1 Capecchi M., Targeted Gene Replacement, 270 Scientific American 34--41 (1994). 2 Campbell et al., WO 97/07669 Al, published Mar. 6, 1997 (hereinafter "Campbell '669"). 2 Appeal2016-006371 Application 10/080,713 complete genes randomly into the genome, i.e., "random integration," and with "gene knock-ins" reasonably interpreted as representing targeted replacement of complete genes, i.e., "targeted gene replacement." This interpretation is also consistent with the term "gene knock-outs" as an opposite of "gene knock-ins" where even the Specification recognizes "gene knock-outs" as meaning the targeted removal of a gene (see, e.g., Spec. 65:21-22 "The knockout vector was designed as a replacement-type vector"). The ordinary artisan would understand that if a "gene knock-out" is a targeted removal of a gene, then a "gene knock-in" is the targeted insertion or replacement of a gene, while "gene additions" represents non- targeted random integration of genes. Therefore, when Campbell '669 teaches "gene knock-ins," Campbell '669 is referring to targeted gene replacement, a process Capecchi teaches operates by homologous recombination (Dec. 7; FF 16). Even if this interpretation, supported by a preponderance of the evidence, were incorrect, Appellants' reliance on "random integration" as distinguishing the "homologous recombination" limitation in claim 62 is misplaced. The portion of Capecchi identified by Appellants specifically teaches that "random integration" operates by homologous recombination. Thus, even if the "gene knock-ins" of Campbell '669 are interpreted to refer to random integration rather than targeted gene replacement, Capecchi teaches that the underlying biological mechanism by which the gene is inserted in random integration is by homologous recombination. Specifically, Capecchi teaches that "[a ]pparently, before cells performed random insertion, some mechanism in the cell nucleus stitched 3 Appeal2016-006371 Application 10/080,713 virtually all the introduced DNA molecules together in the same orientation. We went on to demonstrate that cells used a process called homologous recombination to achieve such linkages" (Capecchi 38, col. 1; see Dec. 8; FF 17). Thus, Capecchi teaches that random insertion also uses the process of homologous recombination in order to introduce the DNA molecules encoding genes into the genome. In their Appeal Brief, Appellants' substantive argument regarding claim 62 was that Campbell '669 "does not expressly disclose homologous recombination" (App. Br. 8). However, as discussed above, even if "gene knock-ins" are understood to operate by random insertion, rather than targeted gene replacement, Capecchi provides evidence that random insertion operates by homologous recombination (Dec. 8; FF 17), satisfying the requirement of claim 62. Appellants provide no convincing evidence to the contrary. Consequently, the preponderance of the evidence supports the Examiner's position that Campbell '669's "gene knock-ins" necessarily operate by homologous recombination. Appellants have not identified persuasive evidence that rebuts the Examiner's position. CONCLUSION We have carefully reviewed the original opinion in light of Appellants' request, but we find no point of law or fact which we overlooked or misapprehended in arriving at our decision. Therefore, Appellants' request is denied with respect to making any modifications to the decision affirming the Examiner's rejection. 4 Appeal2016-006371 Application 10/080,713 No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. Â§ 1.136(a). REHEARING DENIED 5