Commonwealth Scientific and Industrial Research OrganisationDownload PDFPatent Trials and Appeals BoardMay 20, 202015197541 - (D) (P.T.A.B. May. 20, 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. 15/197,541 06/29/2016 Tara D. Sutherland RICE-088CON 6906 24353 7590 05/20/2020 BOZICEVIC, FIELD & FRANCIS LLP BOZICEVIC, FIELD & FRANCIS 201 REDWOOD SHORES PARKWAY SUITE 200 REDWOOD CITY, CA 94065 EXAMINER BURKHART, MICHAEL D ART UNIT PAPER NUMBER 1633 NOTIFICATION DATE DELIVERY MODE 05/20/2020 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): docket@bozpat.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte TARA D. SUTHERLAND, VICTORIA SHIRLEY HARITOS, HOLLY TRUEMAN, ALAGACONE SRISKANTHA, SARAH WEISMAN, and PETER M. CAMPBELL ____________ Appeal 2019-005436 Application 15/197,541 Technology Center 1600 ____________ Before DONALD E. ADAMS, ERIC B. GRIMES, and TAWEN CHANG, 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 54–58, 64, 65, and 70–75. 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 “Commonwealth Scientific and Industrial Research Organization” (Appellant’s October 8, 2018 Appeal Brief (Br.) 3). Appeal 2019-005436 Application 15/197,541 2 STATEMENT OF THE CASE Appellant’s disclosure “relates to silk proteins, as well as nucleic acids encoding such proteins,” methods of making silk proteins, and “to recombinant cells and/or organisms which synthesize silk proteins” (Spec.2 1:4–6). Claim 54 is representative and reproduced below: 54. A recombinant host cell comprising a polynucleotide which encodes a silk polypeptide, wherein at least a portion of the polypeptide has a coiled coil structure, and wherein the silk polypeptide comprises an amino acid sequence which is at least 40% identical to at least any one or more of SEQ ID NO:40, SEQ ID NO:41, SEQ ID NO:5, SEQ ID NO:6, SEQ ID NO:26, or SEQ ID NO:27; and wherein a) the polynucleotide is operably linked to a heterologous promoter, and/or b) the recombinant host cell is a bacterial, yeast or plant cell. (Br. 16.) Grounds of rejection before this Panel for review: Claims 54–58, 64, 65, and 70–75 stand rejected under the written description provision of 35 U.S.C. § 112, first paragraph. Claims 54–58, 64, 65, and 70–75 stand rejected under the enablement provision of 35 U.S.C. § 112, first paragraph. Written Description: ISSUE Does the preponderance of evidence on this record support Examiner’s finding that Appellant’s Specification fails to provide written descriptive support for the claimed invention? 2 Appellant’s June 29, 2016 Specification. Appeal 2019-005436 Application 15/197,541 3 ANALYSIS Examiner finds that Appellant’s “claims read on a broad genus of potential DNA and protein sequences (not limited to any particular source or sequence) and variants, such as any variant with as little as 40% homology to the recited SEQ ID NOs” (Ans. 4). Examiner further finds that Appellant’s disclosure fails to provide a correlation between a polypeptide’s structure and function, i.e. silk polypeptide and variants thereof that are commensurate in scope with Appellant’s claimed invention may be reasonably identified. In this regard, Examiner finds that although one of skill in the art can readily envision numerable [sic] species of nucleic acid or protein sequences that are at least a given % identity to a reference sequence and that encode a polypeptide at least a given % identity to a recited reference amino acid sequence, one cannot envision which of these also encode a polypeptide with a specified activity or function. (Ans. 6.) As Examiner explains, if one skilled in the art were to make a synthetic sequence that encoded a polypeptide with 90% identity to the reference amino acid sequence, he would be no more able to say whether it encoded a silk protein than if the nucleotide sequence encoded a polypeptide that was only 10% identical to the reference polypeptide sequence. (Id.; see id. at 12 (Examiner finds that Appellant’s Specification fails to provide “guidance to vary the disclosed sequences such that the claimed invention is produced, i.e. silk polypeptides. The fact remains there is no predictable way to vary the claimed nucleotides/polypeptides such that a silk polymer or polypeptide is produced”).) In response, Appellant contends “that the unifying feature of [its] claims is a tertiary structure of the silk polypeptide –– namely, the coiled- coil structure” (Br. 4; see also id. at 4–5 (Appellant contends that “[t]he Appeal 2019-005436 Application 15/197,541 4 sequences recited in . . . [its] claims are explicitly limited by their structure which confers their biological function)). In this regard, Appellant directs attention to, inter alia, Kohn3 to support Appellant’s contention “that the coiled-coil structure is simple, well understood, easy to predict and can be generated by sequences that are completely different to one another. Thus, a skilled person would have been able to design or envision variants across the entire scope of the claims at the time of filing” (id. at 5). Appellant’s contention is not persuasive. As Examiner explains, with reference to Kohn: It is stipulated that the coiled-coil structure found in proteins is reasonably well-studied, however, such coiled-coils are found in proteins as diverse as the HIV gp41 envelope protein and well-known DNA-binding motifs (zinc fingers) and DNA- binding proteins (oncoproteins such as c-Fos). . . . The situation is thus not as simple as [Appellant] assert[s]: merely forming a coiled-coil does not lead to a silk polypeptide, but could be any one of many unrelated possibilities known in the art. (Ans. 12 (emphasis added).) We agree with Examiner’s finding that Appellant’s Specification fails to provide an adequate written description of Appellant’s claim 1 (see Ans. 4). “[T]he test for sufficiency [of the written description] is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.” Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). A “sufficient description of a genus . . . requires the disclosure of either a representative number of species falling within the 3 Kohn et al., α-Helical Protein Assembly Motifs, 272 J. Biol. Sci. 2583–86 (1997). Appeal 2019-005436 Application 15/197,541 5 scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Ariad, 598 F.3d at 1350. “[A]n adequate written description requires a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials.” Id. Although “functional claim language can meet the written description requirement when the art has established a correlation between structure and function,” “merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species.” Id. In addition, as the Rochester Court made clear: Regardless whether a compound is claimed per se or a method is claimed that entails the use of the compound, the inventor cannot lay claim to that subject matter unless he can provide a description of the compound sufficient to distinguish infringing compounds from non-infringing compounds, or infringing methods from non-infringing methods. University of Rochester v. G.D. Searle & Co., 358 F.3d 916, 926 (Fed. Cir. 2004). As discussed above, the evidence on this record refutes Appellant’s contention that its disclosure’s “unifying feature,” specifically a “coiled-coil structure,” is sufficient to establish a correlation between the structure and function so that one of skill in this art can visualize or recognize the members of Appellant’s claimed genus (see, e.g., Ans. 12; see id. at 14 (Examiner finds that Appellant’s “rebuttals are completely directed to coiled-coils when the relevant issue is silk polypeptides”); cf. Br. 4 (Appellant contends “that the unifying feature of [its] claims is a tertiary Appeal 2019-005436 Application 15/197,541 6 structure of the silk polypeptide –– namely, the coiled-coil structure”); see generally Br. 5–14). CONCLUSION The preponderance of evidence on this record supports Examiner’s finding that Appellant’s Specification fails to provide written descriptive support for the claimed invention. The rejection of claim 54 under the written description provision of 35 U.S.C. § 112, first paragraph is affirmed. Claims 55–58, 64, 65, and 70–75 are not separately argued and fall with claim 54. Enablement: ISSUE Does the evidence of record support Examiner’s conclusion that undue experimentation would be required to practice the claimed invention? ANALYSIS “[T]o be enabling, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation.”’ In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993). The enablement requirement ensures that the public knowledge is enriched by the patent specification to a degree at least commensurate with the scope of the claims. The scope of the claims must be less than or equal to the scope of the enablement. The scope of enablement, in turn, is that which is disclosed in the specification plus the scope of what would be known to one of ordinary skill in the art without undue experimentation. National Recovery Techs. Inc. v. Magnetic Separation Sys., Inc., 166 F.3d 1190, 1195–96 (Fed Cir. 1999). Appeal 2019-005436 Application 15/197,541 7 Examiner and Appellant agree that although “the written description and enablement requirements are separate and . . . separable requirements, the instant application fails to meet either requirement for essentially the same reasons” (Ans. 4; see Br. 4 (Appellant “understand[s] that although two distinct and separate rejections are made under 35 U.S.C. §112, first paragraph, the issues that underpin both of the rejections are essentially the same, and largely relate to the structural and functional characteristics of the polypeptides and polynucleotides recited in the claims,” thus “Appellant believes that both rejections can be addressed by a single discussion”)). On this record, Examiner finds that although Appellant’s Specification provides an enabling disclosure of “methods and compositions comprising the biomolecules set forth in SEQ ID NOs: 40, 41, 5, 6, 26 and 27,” Appellant’s Specification fails to provide an enabling disclosure of “variants” of these biomolecules falling within the scope of Appellant’s claims (see Ans. 3). In this regard, Examiner finds that Appellant’s “[S]pecification discloses only a few putative functional amino acid sequences with little to no sequence homology for a polypeptide having the necessary activity, and provides no guidance on determining which polypeptide variants would have an activity or structure as recited in [Appellant’s] claims” (id. at 10). Thus, finding “the number of possible sequences having 81 substitutions (i.e. 80% homology as recited in [Appellant’s] claim 57) is 3.6 x 10187,” Examiner finds that Appellant’s “claimed genus of potential silk polypeptides to be produced or encoded by the claimed cell lines is impossibly broad, and . . . [Appellant’s] [S]pecification lacks any link between the recited function (a silk Appeal 2019-005436 Application 15/197,541 8 polypeptide) and a structure which would allow predictable variation to the degree claimed” (Ans. 11). We find no error in Examiner’s findings. For the reasons discussed above, with respect to the written description requirement, we are not persuaded by Appellant’s contention its disclosure of a “coiled-coil structure” “provides the skilled artisan with an enormous amount of information to enable them to design variants encompassed by” Appellant’s claims (see Br. 14; see also id. at 4 (Appellant contends “that the unifying feature of [its] claims is a tertiary structure of the silk polypeptide –– namely, the coiled-coil structure”); see generally Br. 5– 14; cf. Ans. 14 (Examiner finds that Appellant’s “rebuttals are completely directed to coiled-coils when the relevant issue is silk polypeptides”)). CONCLUSION The evidence of record supports Examiner’s conclusion that undue experimentation would be required to practice the claimed invention. The rejection of claim 54 under the enablement provision of 35 U.S.C. § 112, first paragraph is affirmed. Claims 55–58, 64, 65, and 70–75 are not separately argued and fall with claim 54. DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 54–58, 64, 65, 70–75 112, first paragraph Written Description 54–58, 64, 65, 70–75 54–58, 64, 65, 70–75 112, first paragraph Enablement 54–58, 64, 65, 70–75 Overall Outcome 54–58, 64, 65, 70–75 Appeal 2019-005436 Application 15/197,541 9 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 Copy with citationCopy as parenthetical citation