Cadena Bio, Inc.Download PDFPatent Trials and Appeals BoardMay 4, 20202019004453 (P.T.A.B. May. 4, 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. 14/795,720 07/09/2015 John M. GEREMIA 51169-007003 1070 21559 7590 05/04/2020 CLARK & ELBING LLP 101 FEDERAL STREET BOSTON, MA 02110 EXAMINER GEORGE, PATRICIA ANN ART UNIT PAPER NUMBER 1793 NOTIFICATION DATE DELIVERY MODE 05/04/2020 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): patentadministrator@clarkelbing.com smmichaud@clarkelbing.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte JOHN M. GEREMIA, ANASTASIA V. MURPHY, SCOTT HAN, BENJAMIN A. SEIGAL, ALICIA LANDRY, KYLE SHERRY, STEPHEN PANOS, DEVIN CHURCHMAN, and ANDREW O’CONNOR ____________ Appeal 2019-004453 Application 14/795,720 Technology Center 1700 ____________ Before ADRIENE LEPIANE HANLON, JAMES C. HOUSEL, and MONTÉ T. SQUIRE, Administrative Patent Judges. Opinion for the Board filed by Administrative Patent Judge SQUIRE. Opinion Concurring filed by Administrative Patent Judge HOUSEL. SQUIRE, Administrative Patent Judge. DECISION ON APPEAL1 1 In this Decision, we refer to the Specification filed July 9, 2015 (“Spec.”); Final Office Action dated Dec. 28, 2017 (“Final Act.”); Appeal Brief filed Dec. 31, 2018 (“Appeal Br.”); Examiner’s Answer dated Mar. 8, 2019 (“Ans.”); and Reply Brief filed May 8, 2019 (“Reply Brief”). Appeal 2019-004453 Application 14/795,720 2 Appellant2 appeals under 35 U.S.C. § 134(a) from the Examiner’s final decision rejecting claims 18–24, 27–31, and 35–46.3 We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. CLAIMED SUBJECT MATTER The invention relates to oligosaccharide compositions and methods of producing such oligosaccharide compositions. Spec. ¶ 2; Abstract. According to one embodiment, the oligosaccharide composition includes monosaccharide monomers connected by glycosidic bonds, wherein the monosaccharide monomers are independently selected from the group consisting of C5 monosaccharides and C6 monosaccharides. Spec. ¶ 20. Claim 18 illustrates the subject matter on appeal and is reproduced below from the Claims Appendix (Appendix A) to the Appeal Brief: 18. An oligosaccharide composition, comprising: monosaccharide monomers connected by glycosidic bonds; wherein: the monosaccharide monomers are C5 monosaccharides or C6 monosaccharides; at least 15% of the oligosaccharide composition has a degree of polymerization (DP) of at least four monosaccharide monomers; 2 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42(a). Appellant identifies Kaleido Biosciences, Inc. and Cadena Bio, Inc. as the real parties in interest. Appeal Br. 3. 3 Claims 1–17 and 26 are withdrawn and claims 25 and 32–34 are cancelled. Appeal Br. 3. Appeal 2019-004453 Application 14/795,720 3 the mean DP of the oligosaccharide composition is 5–10 monosaccharide monomers; and at least a portion of the glycosidic bonds in the oligosaccharide composition comprises β-1,2 bonds and α-1,3 bonds. Appeal Br. 16 (key disputed claim language italicized and bolded). REFERENCES The Examiner relies on the following prior art references as evidence in rejecting the claims on appeal: Name Reference Date Fichert et al. (“Fichert”) US 2013/0005684 A1 Jan. 3, 2013 Katsumi JP 2012-158526A Aug. 23, 2012 REJECTIONS On appeal, the Examiner maintains (Ans. 2) the following rejections:4 1. Claims 18–24, 27–29, and 35–46 are rejected under 35 U.S.C. § 103 as unpatentable over Fichert (“Rejection 1”). Ans. 4; Final Act. 4. 2. Claims 30 and 31 are rejected under 35 U.S.C. § 103 as being unpatentable over Fichert, as applied to claims 18–24, 27–29, and 35–46 above, further in view of Katsumi5 (“Rejection 2”). Ans. 11; Final Act. 11. 4 The Examiner’s rejections of claim 18 and the claims that depend on claim 18 for lack of written description and indefiniteness are withdrawn at page 2 of the Answer. 5 The Examiner refers and cites to the English translation of the Katsumi reference provided in the record. Appeal 2019-004453 Application 14/795,720 4 OPINION Rejection 1 The Examiner rejects claims 18–24, 27–29, and 35–46 under § 103 as obvious over Fichert. Ans. 4–10. The Examiner determines that Fichert teaches or suggests an oligosaccharide composition satisfying the limitations of claim 18 and concludes the reference would have rendered the claim obvious. Ans. 4–6 (citing Fichert ¶¶ 1, 22, 25, 43, 44, 77, 78, 80, 182, 339, 343). Regarding the “mean DP of the oligosaccharide composition is 5–10 monosaccharide monomers” recitation of claim 18, the Examiner relies principally on paragraphs 43 and 44 of Fichert for teaching that limitation of the claim. Ans. 5. In particular, based on the equation provided at paragraph 44 of the reference, the Examiner finds Fichert teaches that the degree of polymerization (DP) is equal to the molecular weight of the final product made, an oligosaccharide copolymer, divided by the molecular weight of the monomers therein. Id. (citing Fichert ¶ 44). The Examiner further finds and explains that [t]his equation describes how the DP of the oligosaccharides copolymer made . . . as discussed in the prior paragraph (0043) is determined, wherein the final product has a DP of less than 2 to 10, which encompasses the claim of at least 15% of the oligosaccharide composition has a degree of polymerization (DP) of at least four; and further encompasses a mean DP of the oligosaccharide composition of five to ten. Id. at 5 (citing Fichert ¶ 43). Appellant argues the Examiner’s rejection of claim 18 should be reversed because Fichert does not teach or suggest “the mean DP of the oligosaccharide composition is 5–10 monosaccharide monomers,” as recited in the claim. Appeal Br. 5–8; Reply Br. 1–2. Appellant contends the Appeal 2019-004453 Application 14/795,720 5 Examiner erred reversibly by equating the “degree of polymerization (DP)” recited in claim 18 to the degree of polymerization described in Fichert because they are not the same. Appeal Br. 5. In particular, Appellant contends that, in contrast to the degree of polymerization recited in the claim, which represents the number of monosaccharide monomers in the claimed composition, the degree of polymerization Fichert describes represents the number of cyclodextrin monomers in its copolymer composition. Id. at 5 (citing Fichert ¶¶ 44, 45). Appellant further contends that because Fichert teaches its copolymer composition comprises at least two cyclodextrin monomers and the smallest cyclodextrin structure having six glucose monosaccharide monomers, Fichert’s composition would have at least 12 monosaccharide monomers and, therefore, the mean DP of Fichert’s composition would necessarily fall outside the claimed range of “5–10 monosaccharide monomers.” Id. at 6–8 (citing Fichert ¶¶ 16, 21, 22, 25, 43–45); see also id. at 5 (arguing the mean DP of Fichert’s copolymers “does not encompass” and “does not overlap” the mean DP of the claimed oligosaccharide compositions); Reply Br. 1 (arguing “[c]yclodextrin copolymers alone have a mean DP of at least 12 monosaccharide monomers”). The weight of the evidence supports Appellant’s arguments. Thus, for principally the same reasons Appellant provides at pages 5–8 of the Appeal Brief and pages 1–2 of the Reply Brief, we are not persuaded the Examiner has established by a preponderance of the evidence that Fichert teaches or suggests “the mean DP of the oligosaccharide composition is 5–10 monosaccharide monomers” recitation of claim 18. In re Oetiker, 977 F.2d Appeal 2019-004453 Application 14/795,720 6 1443, 1445 (Fed. Cir. 1992) (holding the examiner bears the initial burden of establishing a prima facie case of obviousness). We are not persuaded the portions of Fichert the Examiner cites and relies upon in the rejection teach or suggest the “mean DP of the oligosaccharide composition is 5–10 monosaccharide monomers,” as recited in the claim. See Fichert ¶¶ 43, 44, 77, 78, 80. Rather, as Appellant notes (Appeal Br. 5–7), the degree of polymerization Fichert teaches represents and relates to the number of cyclodextrin monomers and not the number of monosaccharide monomers, as recited in the claim. Fichert ¶ 43, ¶ 44, ¶ 45 (disclosing “M(CDM) stands for the average molecular weight of the cyclodextrin monomer”). As Appellant further notes (Appeal Br. 7–8), Fichert teaches that its copolymer composition comprises at least two cyclodextrin monomers and the smallest cyclodextrin structure having six glucose monosaccharide monomers. Fichert ¶ 16 (disclosing “[t]he subject matter of this invention is copolymers containing at least two cyclodextrin”), ¶ 22 (disclosing “α-cyclodextrin contains six glucosyl units in the cyclodextrin ring structure, β-cyclodextrin contains seven glucosyl units, γ-cyclodextrin contains eight and δ-cyclodextrin contains nine”). As Appellant explains and illustrates at pages 7–8 of the Appeal Brief, because Fichert teaches its copolymer composition comprises at least two cyclodextrin monomers and the smallest cyclodextrin structure having six glucose monosaccharide monomers (Fichert ¶¶ 16, 21, 22, 25), we find a preponderance of the evidence supports that Fichert’s composition would have at least 12 monosaccharide monomers and, therefore, the mean DP of Appeal 2019-004453 Application 14/795,720 7 Fichert’s composition would necessarily fall outside the claimed range of “5–10 monosaccharide monomers.” The Examiner’s comments at pages 18–20 of the Answer are not persuasive because they do not meaningfully address Appellant’s argument that Fichert’s disclosure regarding the degree of polymerization relates to and is measured in cyclodextrin monomers comprising at least 12 monosaccharide monomers. In particular, the Examiner does not identify sufficient evidence or persuasively explain how or why one of ordinary skill in the art would have been led to an oligosaccharide composition having a mean DP of “5–10 monosaccharide monomers,” as recited in the claim, based on Fichert’s disclosure regarding a cyclodextrin copolymer composition necessarily having at least 12 monomers. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007) (requiring “reasoning with some rational underpinning to support the legal conclusion of obviousness”) (quoting In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)). The Examiner’s assertion that “Fichert teaches the use of glycosyls . . . wherein the glycosyls have from 4 to 9 monomers” (Ans. 19) is not persuasive because, as Appellant correctly points out (Reply Br. 1), Fichert teaches that the glycosyls are actually attached to cyclodextrin polymers. See Fichert ¶ 77 (disclosing that “the bond to the cyclodextrin monomers may involve any ring member of the glycosyl”), ¶ 80 (“The bonding of the glycosyl to the cyclodextrin monomers and compounds may take place via any possible ring member of the glycosyl.”). As Appellant explains (Reply Br. 1–2), because, as discussed above, Fichert’s cyclodextrin copolymers alone have a mean DP of at least 12 monosaccharide monomers, the cyclodextrin copolymers with glycosyls attached would, likewise, have a Appeal 2019-004453 Application 14/795,720 8 mean DP of at least 12 monosaccharide monomers, and fall outside the claimed range. We, therefore, do not sustain the Examiner’s rejection of claim 18. Because claims 19–24, 27–29, and 35–46 depend from claim 18, we also do not sustain the Examiner’s rejection of those claims. Accordingly, we reverse the Examiner’s rejection of claims 18–24, 27–29, and 35–46 under 35 U.S.C. § 103 as obvious over Fichert. Rejection 2 The Examiner’s rejects claims 30 and 31 under § 103 as obvious over the combination of Fichert and Katsumi. Ans. 11–12. Claims 30 and 31 each depends from claim 18. Appeal Br. 18 (Appendix A). The foregoing deficiencies in the Examiner’s findings and analysis regarding the Fichert reference and “the mean DP of the oligosaccharide composition is 5–10 monosaccharide monomers” recitation of claim 18 discussed above in reversing the Examiner’s Rejection 1 are not remedied by the Examiner’s findings regarding the additional Katsumi reference or combination of references cited in support of the second ground of rejection. Accordingly, for principally the same reasons discussed above for reversing Rejection 1, we reverse the Examiner’s rejection of claims 30 and 31 under 35 U.S.C. § 103 as obvious over the combination of Fichert and Katsumi. Appeal 2019-004453 Application 14/795,720 9 CONCLUSION In summary: Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 18–24, 27–29, 35–46 103 Fichert 18–24, 27–29, 35–46 30, 31 103 Fichert, Katsumi 30, 31 Overall Outcome 18–24, 27–31, 35–46 REVERSED Appeal 2019-004453 Application 14/795,720 10 HOUSEL, Administrative Patent Judge, concurring. Although I concur completely with the majority that the Examiner has not established a prima facie case of obviousness for the claimed subject matter, I write to raise several matters which neither the Examiner nor Appellant address. To begin with, I note that claim 18 recites an oligosaccharide composition comprising: 1) C5 or C6 monosaccharide monomers connected by glycosidic bonds; 2) at least 15% of the composition has a DP of at least four monosaccharide monomers; 3) a mean DP of 5–10 monosaccharide monomers; and 4) at least a portion of the glycosidic bonds in the composition comprise α-1,3 bonds and β-1,2 bonds. Fichert refers to “cyclodextrin monomers” (Fichert ¶ 16) which the Examiner misinterpreted to be monosaccharide monomers. However, cyclodextrin is actually an oligosaccharide comprising either six glucose monomers (α-cyclodextrin), seven glucose monomers (β-cyclodextrin), eight glucose monomers (γ-cyclodextrin), or nine glucose monomers (δ-cyclodextrin), connected by glycosidic bonds. Fichert ¶ 22. Further, glucose is a C6 monosaccharide monomer. Thus, a composition of cyclodextrin is an oligosaccharide composition meeting limitations (1)–(3) of claim 18. With regard to limitation (4), Appellant discloses that an oligosaccharide composition having at least some α-1,3 and β-1,2 glycosidic bonds is produced by combining a feed sugar with a catalyst. Spec. ¶¶ 16, 286–288, 440–447. Cyclodextrin typically has α-1,4 bonds. Fichert ¶ 22. However, Fichert further teaches that the monosaccharide monomers may be linked with other glycosidic linkages including 1,2; 1,3; and 1,6 bonds, and, specifically with regard to glucose and galactose, teaches that “[t]he bonding Appeal 2019-004453 Application 14/795,720 11 of the glycosyl to the cyclodextrin monomers and compounds may take place via any possible ring member of the glycosyl.” Id. ¶ 80. Therefore, in my view, it would have been well within the ordinary skill in the art, to prepare a cyclodextrin having at least some α-1,3 bonds and β-1,2 bonds, as Fichert suggests absent a persuasive showing of unexpected results. Copy with citationCopy as parenthetical citation