2020006584 (P.T.A.B. May. 18, 2021)

Erika Hoffmann et al.

Patent Trials and Appeals BoardMay 18, 2021

2020006584 (P.T.A.B. May. 18, 2021)

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. 13/700,175 11/27/2012 Erika Hoffmann 1344.0002-US1 1009 65770 7590 05/18/2021 Thrive IP Jeremy Stipkala 5401 NETHERBY LANE SUITE 1201 NORTH CHARLESTON, SC 29420 EXAMINER MERCIER, MELISSA S ART UNIT PAPER NUMBER 1615 NOTIFICATION DATE DELIVERY MODE 05/18/2021 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): JEREMY.STIPKALA@Thrive-IP.COM docket@thrive-ip.com rebecca.seaman@thrive-ip.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte ERIKA HOFFMANN, MICHAEL HOFFMANN, and ROLAND HORRES __________ Appeal 2020-006584 Application 13/700,175 Technology Center 1600 __________ Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and TAWEN CHANG, Administrative Patent Judges. FREDMAN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal1,2 under 35 U.S.C. § 134 involving claims to a catheter balloon coated with an antirestenotic agent and a coating of the compound of formula I. The Examiner rejected the claims as failing to comply with the written description requirement. 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 Hemoteq AG (see Appeal Br. 3). 2 We have considered and refer to the Specification of Nov. 27, 2012 (“Spec.”); Non-Final Office Action of Dec. 5, 2019 (“Final Action”); Appeal Brief of April 16, 2020 (“Appeal Br.”); Examiner’s Answer of July 22, 2020 (“Ans.”); and Reply Brief of Sept. 21, 2020 (“Reply Br.”). An oral hearing was held on May 6, 2021. Appeal 2020-006584 Application 13/700,175 2 Statement of the Case Background “After introducing short-term as well as long-term implants (stents or catheter balloons) into blood vessels reocclusion of vessels frequently occurs as a complication, which is known as restenosis” (Spec. 1:14–16). “Drug eluting catheter balloons offer an alternative to conventional stent coated with agent,” but a problem “is that not sufficient antirestenotic agent can be transmitted to the affected vessel section” (id. at 1:28–37). “Other problems of the prior art are low transmission amounts of the agent or agents into the vessel wall, no control over the dosage, [and/or] problems with the balloon material” (id. at 2:4–6). The Specification teaches “a coating system that reduces effectively the premature release of agents from the surface of the catheter balloons and ensures the drug delivery from the balloon surface on the vessel wall in a shorter period than a minute with the most highly effective form” (Spec. 2:13–16). The Claims Claims 16, 18, 29, 30, 34, and 35 are on appeal. Independent claim 16 is representative and may be found in the Claims Appendix (see Appeal Br. 27:2–31:6) The Rejection The Examiner rejected claims 16, 18, 29, 30, 34, and 35 under 35 U.S.C. § 112(a) as failing to comply with the written description requirement (Non-Final Act. 4–5). The Examiner finds “only 3 of the species [in Table I of the Specification] meet the limitations recited in claim 16, which is not a Appeal 2020-006584 Application 13/700,175 3 representative cross section to the scope of compounds recited in formula (I)” (Non-Final Act. 5). The Examiner finds “the instant claims do not particularly recite said compounds are ‘transport promoting molecular dispersants’, the instant specification discloses the compounds have the function” (id.). The Examiner concludes that: The skilled artisan would not be able to correlate any of the chemical structures and physical properties to the functionality in the instant specification. Therefore, the specificity does not provide adequate written description for the entire genus of a catheter balloon comprising a coating of an anti-restenotic agent and the compound of formula (I). (id.). Appellant contends “the claimed subject matter is precisely defined by the combination of the chemical structures of the groups attached to the central carbon atom and the physical properties of the compound of general formula (I), as well as by multiple species taught in the specification” (Appeal Br. 24). Appellant contends that “the specification describes a total of 19 different compounds suitable for use in a coating of the claimed catheter balloon” (id. at 23). And Appellant contends that while “the claims have been amended to focus on a claim scope that now includes fewer than all of the examples . . . a showing of three species in the specification is still sufficient to show that Appellant was in possession of the claimed subject matter” (id. at 23). We find that Appellant has the better position. The written description requirement can be met by disclosing “complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics.” Enzo Appeal 2020-006584 Application 13/700,175 4 Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 964 (Fed. Cir. 2002). These claims disclose complete structures of the recited molecules and therefore describe those molecules. It is unclear whether Enzo requires a correlation between the function and structure in this situation (i.e., in which complete structures are recited in the claims), or if such a correlation is necessary only when the claims rely upon functional characteristics. In either case, Appellant provides both a complete structure, a representative showing of nineteen specific structural examples that share a function of reducing restenosis (see Spec. 15–18, Table 1 and 24, Table 2), and detailed disclosures regarding the particular functional characteristics recited in the claims (see Spec. 12:19 to 14:32). While we are sympathetic to the Examiner’s concern that when the genus of disclosed molecular structures becomes enormous, there is less certainty that any particular species will satisfy the function required for the claimed molecules, the Examiner provides no evidence of any molecule that falls within the scope of the claim but fails to have a required function. In contrast, Appellant has shown reduced restenosis for nineteen different molecules with about eleven different base linker structures (see Spec. 15– 18, Table 1 and 24, Table 2). Even if, as the Examiner and Appellant seem to agree, only three of these molecules remain within the scope of the claims currently at issue (see Ans. 5; Appeal Br. 23), the only evidence of record still supports Appellant’s position that these three structures satisfy the functional requirements, not the position of the Examiner. We therefore reverse the written description rejection. Appeal 2020-006584 Application 13/700,175 5 DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 16, 18, 29, 30, 34, 35 112(a) Written Description 16, 18, 29, 30, 34, 35 REVERSED