TERUMO KABUSHIKI KAISHA

Patent Trials and Appeals Board

Feb 23, 2022

2021000755 (P.T.A.B. Feb. 23, 2022)

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. 16/207,546 12/03/2018 Takao ANZAI 1027550-001920 1030 21839 7590 02/23/2022 BUCHANAN, INGERSOLL & ROONEY PC 1737 KING STREET SUITE 500 ALEXANDRIA, VA 22314-2727 EXAMINER FALKOWITZ, ANNA R ART UNIT PAPER NUMBER 1617 NOTIFICATION DATE DELIVERY MODE 02/23/2022 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): ADIPDOC1@BIPC.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte TAKAO ANZAI1 Appeal 2021-000755 Application 16/207,546 Technology Center 1600 Before ULRIKE W. JENKS, TAWEN CHANG, and CYNTHIA M. HARDMAN, Administrative Patent Judges. HARDMAN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134(a) involving claims to an anithrombotic coating material comprising polyalkoxyalkyl (meth)acrylate containing 100 mol% of a certain structural unit. The Examiner rejected the claims as obvious over the prior art. We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. 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 Terumo Kabushiki Kaisha. Appeal Br. 2. Appeal 2021-000755 Application 16/207,546 2 CLAIMED SUBJECT MATTER Claims 1-10 are on appeal, of which claims 1 and 10 are independent. Claim 1 is representative and reads as follows: 1. An antithrombotic coating material, comprising: polyalkoxyalkyl (meth)acrylate that contains a structural unit (A) represented by formula (2): wherein in formula (2), R1 represents a hydrogen atom or a methyl group, R2 represents an alkylene group having 1 to 4 carbon atoms, and R3 represents an alkyl group having 1 to 4 carbon atoms, wherein the polyalkoxyalkyl (meth)acrylate has a weight average molecular weight of 200,000 or more, wherein the polyalkoxyalkyl (meth)acrylate is dissolved in methanol or a mixture comprising water and methanol, wherein the polyalkoxyalkyl (meth)acrylate is not a block copolymer, and wherein the polyalkoxyalkyl (meth)acrylate is composed of 100 mol% of the structural unit (A). Appeal Br. (Claims Appendix 1-2). Appeal 2021-000755 Application 16/207,546 3 REFERENCE The Examiner relies upon the following prior art reference: Name Reference Date Tanaka US 6,590,054 B2 July 8, 2003 REJECTION Claims Rejected 35 U.S.C. § Reference(s)/Basis 1-10 103 Tanaka OPINION The Examiner rejects the claims as obvious over Tanaka, finding in relevant part that Tanaka discloses an antithrombotic coating comprising a copolymer comprising meth(acrylic) ester monomers of formula (1), reproduced below: wherein (a) R1 and R2 are alkylene groups having from 1 to 4 carbons and R3 is a hydrogen or methyl, and (b) the monomers of formula (1) are from 85- 99.9 mol% of the copolymer. Final Act. 4 (citing, e.g., Tanaka Abstract, 4:30-35, 6:50-55, 11:10-15). The Examiner finds that it would have been obvious to combine Tanaka’s copolymer comprising monomers of formula (1) into an antithrombotic coating because Tanaka already discloses such a coating. Id. at 8. “[T]he examiner bears the initial burden, on review of the prior art or on any other ground, of presenting a prima facie case of unpatentability.” In Appeal 2021-000755 Application 16/207,546 4 re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). We conclude that, on this record, the Examiner has not satisfied this burden. We agree with Appellant that Tanaka does not disclose or suggest a polyalkoxyalkyl (meth)acrylate that is composed of 100 mol% of the structural unit (A), as recited in independent claims 1 and 10. Appeal Br. 6. In the Final Action, the Examiner fails to acknowledge that Tanaka’s copolymer comprises not only the meth(acrylic) ester monomers of formula (1) reproduced above, but also a monomer having a basic functional group (referred to herein as Tanaka’s “second monomer”) copolymerized with monomers of formula (1). See Appeal Br. 7 (citing Tanaka 3:8-25, 4:12-18, 4:59-65, 6:49-62, Abstract). As such, Tanaka’s copolymer is necessarily composed of less than 100 mol% of structural unit (A), due to the presence of Tanaka’s second monomer. Id. In the Advisory Action, the Examiner recognizes Tanaka’s second monomer, but asserts that Tanaka discloses that up to 99.9 mol% of its copolymer is the monomer of formula (1). Advisory Action 2. The Examiner asserts that “a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close,” and that Appellant “has not provided evidence of criticality of the 100 mol% of the polyalkoxyalkyl (meth)acrylate as compared to 99.9 mol%.” Id. The Examiner, however, provides no rationale for why a person of ordinary skill in the art would have modified Tanaka’s copolymer to exclude the second monomer. Indeed, we agree with Appellant that Tanaka teaches that the second monomer is an essential part of the disclosed invention, whereby the benefits of the invention, such as improved hydrophilicity, flow Appeal 2021-000755 Application 16/207,546 5 from the presence of the second monomer. Appeal Br. 9-14 (citing, e.g., Tanaka 3:8-25, 6:49-62). In view of Tanaka’s disclosure, it is not apparent why a person of ordinary skill in the art would have modified Tanaka’s copolymer to exclude the second monomer, and the Examiner has not articulated a rationale as to why a person of ordinary skill in the art would have done so. As such, the burden has not shifted to Appellant to demonstrate criticality of the claimed mol% of polyalkoxyalkyl (meth)acrylate. The Examiner asserts that the open-ended transitional phrase “comprising” in the preamble of Appellant’s claim 1 leaves the claimed polyalkoxyalkyl (meth)acrylate open to structural units other than the recited structural unit (A). Ans. 3-4. We disagree. As Appellant explains, the transition phrase “comprising” in the preamble opens the claimed antithrombotic coating material to additional components beyond the recited polyalkoxyalkyl (meth)acrylate, but does not open the recited polyalkoxyalkyl (meth)acrylate to other structural units beyond structural unit (A). Appeal Br. 3. This is because claims 1 and 10 recite “wherein the polyalkoxyalkyl (meth)acrylate is composed of 100 mol% of the structural unit (A).” This language excludes from the claimed polyalkoxyalkyl (meth)acrylate any structural unit that is not structural unit (A). Id. The Examiner also asserts that the lines on both ends of formula (2) indicate that structural unit (A) “is not intended to be sole type of [structural unit]” of the polyalkoxyalkyl (meth)acrylate. Ans. 4. We disagree. As Appellant explains, structural unit (A) is a repeating unit, and a person of ordinary skill in the art would understand the lines to represent bonding sites for the repeating unit. Appeal Br. 4. Appeal 2021-000755 Application 16/207,546 6 The Examiner also asserts that “it is not possible to make a polymer that [is] composed of 100 mol% of the structural unit (A) as any units that begin or end the polymer would not read on the claimed formula (2).” Ans. 4. Again, we disagree. As stated by Appellant, “[t]he Examiner misapprehends the phrase ‘polyalkoxyalkyl (meth)acrylate that is composed of 100 mol% of the structural unit (A)’ as excluding end points of the polymer.” Reply Br. 5. We agree with Appellant that a person of ordinary skill in the art would understand that the claimed polyalkoxyalkyl (meth)acrylate would include end points because it is impossible for a polymer to not have end points. Id. at 5-6. In sum, the Examiner has not established that a person of ordinary skill in the art would have been motivated to modify Tanaka’s copolymer to exclude the second monomer. As such, the Examiner has not established that Tanaka teaches or suggests the subject matter of Appellant’s claims 1- 10. Accordingly, we reverse the Examiner’s rejection. CONCLUSION We reverse the rejection of claims 1-10 under 35 U.S.C. § 103 as unpatentable over Tanaka. DECISION SUMMARY Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1-10 103 Tanaka 1-10 REVERSED