CORNING INCORPORATEDDownload PDFPatent Trials and Appeals BoardJul 29, 202014899394 - (D) (P.T.A.B. Jul. 29, 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. 14/899,394 12/17/2015 David Henry SP13-194 1063 22928 7590 07/29/2020 CORNING INCORPORATED SP-TI-3-1 CORNING, NY 14831 EXAMINER VISONE, THOMAS J ART UNIT PAPER NUMBER 1651 NOTIFICATION DATE DELIVERY MODE 07/29/2020 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): usdocket@corning.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte DAVID HENRY, MARTIAL HERVY, and CORINNE WALERACK Appeal 2020-000130 Application 14/899,394 Technology Center 1600 Before ERIC B. GRIMES, LINDA M. GAUDETTE, and FRANCISCO C. PRATS, Administrative Patent Judges. GAUDETTE, Administrative Patent Judge. DECISION ON APPEAL1 The Appellant2 appeals under 35 U.S.C. § 134(a) from the Examiner’s decision finally rejecting claims 1 and 3–8.3 We AFFIRM. 1 This Decision includes citations to the following documents: Specification filed December 17, 2015 (“Spec.”); Final Office Action dated February 8, 2019 (“Final”); Appeal Brief filed June 4, 2019 (“Appeal Br.”); and Examiner’s Answer dated July 29, 2019 (“Ans.”). 2 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. The Appellant identifies the real party in interest as Corning Incorporated. Appeal Br. 3. 3 We have jurisdiction under 35 U.S.C. § 6(b). Appeal 2020-000130 Application 14/899,394 2 CLAIMED SUBJECT MATTER The invention relates to “a wholly synthetic cell culture article that enables cell culture in chemically defined medium or serum free medium, and allows for the harvest of the cultured cells without using any protease.” Spec. ¶ 6. Claim 1, reproduced below, is illustrative of the claimed subject matter: 1. A cell culture article, comprising: a substrate comprising an ionically cross-linked polygalacturonic acid compound selected from at least one of: pectic acid; partially esterified pectic acid having a degree of esterification from 1 to 40 mol%, or salts thereof; and an adhesion polymer on the surface of the polygalacturonic acid compound, wherein the substrate comprises a microcarrier particle. Appeal Br. 19 (Claims Appendix). REFERENCES The Examiner relies on the following prior art as evidence of unpatentability: Name Reference Date Ma US 6,497,902 Dec. 24, 2002 Darvari US 2010/0009007 A1 Jan. 14, 2010 Martin US 2011/0183418 A1 Jul. 28, 2011 John F. Robyt, Essentials of Carbohydrate Chemistry, Springer Advanced Texts in Chemistry (Springer-Science+Business Media, LLC 1998) Appeal 2020-000130 Application 14/899,394 3 Jean-François Thibault, Gelation of Pectinic Acids in the Presence of Calcium Counterions, BRITISH POLYMER JOURNAL, Vol. 17, No. 2, pp. 181– 184 (1985). REJECTION Claims 1 and 3–8 are rejected under 35 U.S.C. § 103 as unpatentable over Ma in view of Robyt, Thibault, Martin, and Darvari. CLAIM CONSTRUCTION The claim 1 language reasonably could be construed as encompassing either (1) an adhesion polymer coated substrate, the substrate being selected from pectic acid and partially esterified pectic acid or salts thereof, or (2) a substrate selected from pectic acid, partially esterified pectic acid or salts thereof, and an adhesion polymer coated polygalacturonic acid compound. Having reviewed the dependent claims and the written description, we determine that the scope of claim 1 is limited to the first alternative: an adhesion polymer coated substrate, the substrate being selected from at least one of pectic acid and partially esterified pectic acid having a degree of esterification from 1 to 40 mol%, or salts thereof. See, e.g., Spec. ¶¶ 39, 63 (disclosing that the synthetic microcarriers can be selected from pectic acid, partially esterified pectic acid, or salts thereof, or a mixture thereof); id. ¶ 84 (“PGA [polygalacturonic acid] beads, due to their hydrogel nature and negative charge, do not readily support cell attachment without specific treatment. The PGA beads can be functionalized with moieties promoting cell adhesion, for example, with peptides.”). Appeal 2020-000130 Application 14/899,394 4 OPINION The Examiner made the following, undisputed findings: (1) “Ma teaches a cell culture article comprising an ionically crosslinked pectin or D- galactopyranuronic acid (the pyranose form of D-galacturonic acid) substrate useful, e.g., in cell culture applications” and “Ma further teaches that bioactive agents can be incorporated into the cell culture article”; (2) Robyt teaches that pectins are divided into two categories (pectinic acids which are polygalacturonic acids that are partly esterified with methanol and pectic acids which are polygalacturonic acids with no or only a negligible amount of methyl ester); (3) “Thibault teaches [that] pectinic acid . . . readily forms a gel in the presence of calcium ions if the degree of esterification is lower than 40%”; (4) Martin teaches that “cell culture articles can be coated with adhesion polymers such as poly(HEMA-co-MAA-PEG-VN) copolymers”; and (5) “Darvari teaches [that] microparticles can be coated with polygalacturonic acid.” Final 2–4. The Appellant does not dispute these findings. See generally Appeal Br. 12–16. Nor does the Appellant dispute the Examiner’s finding that one of ordinary skill in the art at the time of filing would have produced Ma’s hydrogel using “pectinic acid, with a degree of esterification below 40%, or pectic acid, with no or only a negligible amount of methyl ester,” based on the teachings of Robyt and Thibault. See Final 3 (finding that “the prior art recognizes that a high degree of methyl esterification prevents gel formation”); see generally Appeal Br. 12–16. The Appellant argues, however, that the Examiner reversibly erred in finding that one of ordinary skill in the art would have “modif[ied] the teachings of Ma, Robyt, and Thibault in view of Martin to advantageously Appeal 2020-000130 Application 14/899,394 5 enhance attachment of anchorage-dependent cells using an adhesion polymer[]” (Final 3). See Appeal Br. 13–15. The Appellant also argues that the Examiner reversibly erred in finding that one of ordinary skill in the art would have “modif[ied] Ma, Robyt, Thibault, and Martin in view of Darvari in order [to] advantageously produce polygalacturonic acid coated microcarriers for cell culture applications” (Final 4). See Appeal Br. 15–16. The Appellant’s arguments are not persuasive for the reasons discussed below. The Appellant argues that Martin’s cell culture surfaces and articles do not include hydrogel or polysaccharide materials such as those disclosed by Ma, and that the Examiner did not identify “any disclosure or demonstration of including . . . an adhesion polymer on the surface of a polygalacturonic acid substrate.” Appeal Br. 14. These arguments are unpersuasive because, as the Examiner finds (Ans. 5), Martin explicitly states that “the substrate may be any material suitable for culturing cells” (Martin ¶ 61 (emphasis added)). The Appellant argues that the Examiner’s explanation of why the ordinary artisan would have coated polygalacturonic acid substrates with cell adhesion polymers—to enhance attachment of anchorage-dependent cells— relies on impermissible hindsight. Appeal Br. 15. This argument is not convincing because the Examiner’s finding is supported by Martin’s teaching that “a cell adhesive peptide is a peptide or polypeptide, an amino acid sequence (which terms are interchangeable) which contains a sequence known or after-identified to enhance cell binding, either to a surface in [a] cell culture, or to other cells or extracellular matrix in vivo.” Martin ¶ 31 (emphasis added). Appeal 2020-000130 Application 14/899,394 6 The Appellant further argues that the ordinary artisan would not have had a reasonable expectation of success in including an adhesion polymer on the surface of a polygalacturonic acid substrate because “it is known that absorption of such adhesion polymers on materials, such as those discussed in Martin, relies on hydrophobic interactions which do not exist for polygalacturonic acid substrates.” Appeal Br. 14. We agree with the Examiner that this argument is not persuasive because it is based on unsupported, attorney argument. See Ans. 6. The Appellant argues that the Examiner failed to explain sufficiently why the ordinary artisan “would selectively ignore the substrates and materials disclosed in Martin . . . and . . . instead choose the microcarrier taught in [Darvari].” Appeal Br. 16. As found by the Examiner, Darvari teaches that surface-modified microparticles are capable of altered binding interactions with molecules, cells, and tissues, as compared to microparticles not carrying such surface modifications (Final 4 (citing Darvari Abstract)), thus “provid[ing] a clear motivation to specifically select polygalacturonic acid coated microcarrier particles as the substrate for the cell culture article” (Ans. 10). The Appellant has not explained persuasively why this finding is erroneous or unreasonable. See Appeal Br. 16. The Appellant also argues that “Ma suggests several disadvantages related to the forming of beads or microcarriers and therefore teaches away from forming beads or microcarriers.” Appeal Br. 16. The Appellant directs us to Ma column 1, lines 42–59, in support of this argument. Id. at 15. We are not persuaded that the ordinary artisan, upon reading Ma’s disclosure, would have been discouraged from using a microcarrier particle as a substrate in Ma’s cell culture article. See In re Gurley, 27 F.3d 551, 553 Appeal 2020-000130 Application 14/899,394 7 (Fed. Cir. 1994) (“A reference may be said to teach away when a person of ordinary skill, upon reading the reference, would be discouraged from following the path set out in the reference, or would be led in a direction divergent from the path that was taken by the applicant.”). In response to the Appellant’s argument, the Examiner finds that the disclosure in Ma column 1, lines 42–59, “is limited to sodium alginate hydrogels produced using specific procedures.” Ans. 8 (citing Ma 2:12–17). The Appellant has not provided persuasive argument or evidence to refute this finding. Any arguments made by the Appellant, but not discussed in this Decision, have been fully addressed by the Examiner and are unpersuasive for the reasons stated in the Final Office Action and the Answer. CONCLUSION For the reasons discussed above, we are not persuaded of reversible error in the Examiner’s determination that the claim 1 cell culture article is obvious over the combined teachings of Ma, Robyt, Thibault, Martin, and Darvari. Because the Appellant’s arguments in support of patentability are directed to the claims as a group, we sustain the rejection as to all appealed claims. See 37 C.F.R. § 41.37(c)(iv) (2018). DECISION SUMMARY Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1, 3–8 103 Ma, Robyt, Thibault, Martin, Darvari 1, 3–8 Appeal 2020-000130 Application 14/899,394 8 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). 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