Ex Parte Sharma et al

Patent Trial and Appeal BoardFeb 21, 2019

13532013 (P.T.A.B. Feb. 21, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 13/532,013 06/25/2012 121159 7590 02/25/2019 Kacvinsky Daisak Bl uni PLLC-Boston Scott T. Bluni 50 Doaks Lane Marblehead, MA 01945 FIRST NAMED INVENTOR UpmaSharma 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 ATTORNEY DOCKET NO. CONFIRMATION NO. 8140.7300174002 6102 EXAMINER SCHALL, MATTHEW WAYNE ART UNIT PAPER NUMBER 3774 NOTIFICATION DATE DELIVERY MODE 02/25/2019 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): docketing@kdbfirm.com bbonneville@kdbfirm.com ehysesani@kdbfirm.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte UPMA SHARMA, GREGORY ZUGATES, RANY BUSOLD, and TOBY FREYMAN 1 Appeal2018-002775 Application 13/532,013 Technology Center 3700 Before DANIEL S. SONG, MICHELLE R. OSINSKI, and WILLIAM A. CAPP, Administrative Patent Judges. SONG, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE The Appellant appeals under 35 U.S.C. Â§ 134(a) from the Examiner's Final Office Action ("Final Act.") rejecting claims 1-14, 16, 17, and 26-29 in the present application. App. Br. 1. We have jurisdiction under 35 U.S.C. Â§Â§ 6(b) and 134(a). We REVERSE. 1 Collectively referred to as "Appellant" herein. The Appellant identifies the real party in interest as Arsenal Medical Inc. Appeal Brief ("App. Br.") 3. Appeal2018-002775 Application 13/532,013 Claim 1, the sole independent claim on appeal, reads as follows: 1. A method for treating an aneurysm within a patient, the aneurysm characterized by a first end, a second end, and a surface between the first and second ends, said method comprising the steps of: placing a medical device within said aneurysm, said medical device comprising a structure having a first end, a second end, and an exterior surface between said first and second ends; delivering, with a catheter, a material between the exterior surface of said medical device and the surface of the aneurysm; and forming a foam from said material upon delivery between the exterior surface of said medical device and the surface of the aneurysm; wherein (a) said foam is formed by the reaction of said material with blood in situ and (b) the reaction includes the generation of a gas, said gas expanding a portion of the material into an interstitial area. App. Br. 12 (Claims App.). REJECTIONS 1. The Examiner rejects claims 1, 2, 9--14, 16, 17, and 26-292 under 35 U.S.C. Â§ 103 as obvious over Carrison (US 2003/0171773 2 The Examiner lists claim 15 as also being rejected but we are informed by the Appellant that claim 15 has been canceled. App. Br. 1. The Examiner also omits claim 17 in the listing of the claims subject to the rejection, but this appears to be a typographical error, claim 17 having been finally rejected and appealed by the Appellant. Final Act. Office Action Summary; App. Br. 1, 13 (Claims App.). Accordingly, we omit the Examiner's reference to claim 15, and add reference to claim 1 7. 2 Appeal2018-002775 Application 13/532,013 Al, pub. Sept. 11, 2003) in view of Kim et al. (US 2007/0005140 Al, pub. Jan. 4, 2007 ("Kim")). Final Act. 3. 2. The Examiner rejects claims 3-8 under 35 U.S.C. Â§ I03(a) as obvious over Carrison and Kim, in view of Hissink et al. (US 2006/0008419 Al, pub. Jan. 12, 2006 ("Hissink")). Final Act. 4. ANALYSIS Rejection 1 The Examiner rejects claims 1, 2, 9-14, 16, 17, and 26-29 as obvious over Carrison in view of Kim, finding that Carrison discloses a method for treating an aneurysm as claimed, but also finding that it "does not specifically disclose the foam is formed upon delivery of the material into the patient." Final Act. 3. The Examiner further finds that Kim "teaches a method of delivering in-situ forming foam (paragraphs [0017] and [0057]), in the same field of endeavor, for the purpose of treating a diseased area by expanding to fill the area (paragraph [0042])." Final Act. 3. The Examiner concludes that it would have been obvious to a person of ordinary skill in the art to have "modif[ied] the method of Carrison with the method of Kim, in order to expand a foam to treat a diseased area as described in Kim in paragraph [0042]." Final Act. 4. In that regard, the Examiner further finds that "Kim discloses the foam material releasing a gas in paragraph [0057] and reacting with blood in paragraph [0059]." Ans. 2. The Appellant argues, inter alia, that "Kim only teaches forming a foam and then compressing and implanting the pre-formed foam at the target site." App. Br. 8. Accordingly, the Appellant argues that while Kim 3 Appeal2018-002775 Application 13/532,013 discloses an injectable foam, it does not disclose the foam being formed by the reaction of the delivered material and blood in situ at the target site, or the recited generation of a gas as required by claim 1. App. Br. 7. The Appellant is correct. It is not apparent where Kim discloses formation of foam in situ within the patient. Kim discloses compressing the already formed foam and implanting the same such that the implanted foam expands. See, e.g., Kim Fig. 3A-3B; ,r,r 14, 42, 58, 168. Accordingly, we agree with the Appellant that Kim teaches forming a foam, compressing the foam and delivering the preformed foam into the body where it ( 1) re- expands and (2) may absorb blood and blood components. This is not a teaching or suggestion of reacting a foam-forming material with blood in situ to generate a gas and form a foam, as purported in the Examiner's Answer. Reply Br. 6; see also Reply Br. 5. The Examiner responds that "[t]he term 'in situ,' according to Merriam-Webster Dictionary means 'in the natural or original position or place.' The broadest reasonable interpretation of this recitation does not require the reaction to take place within the body of a patient." Ans. 2. However, we agree with the Appellant that "it is clear error to interpret the term 'in situ' as not requiring the foaming reaction to take place within the body of the patient." Reply Br. 4. Firstly, a person of ordinary skill in the art would understand the term "in situ" as used in the Appellant's Specification to mean that forming the foam and generation of gas occurs within the body of a patient. See, e.g., Spec. 23, 30; Figs. 2-3. Secondly, the limitations of claim 1 recites "delivering, with a catheter, a material between the exterior surface of said medical device and the surface of the aneurysm," "forming a foam from said material upon 4 Appeal2018-002775 Application 13/532,013 delivery," and that "said foam is formed by the reaction of said material with blood in situ." App. Br. 12 (Claims App.). Thus, the Appellant is correct that [ s ]ince the claim requires that the foam is formed upon delivery to a site within the body and forms by reaction with blood, the term "in situ" in the context of these method steps necessarily means that the foam forms within the aneurysm and cannot previously have been formed in the catheter or elsewhere. Reply Brief 4 ( emphasis omitted). Therefore, in view of the above considerations, we reverse the Examiner's rejection of independent claim 1, and the rejection of claims 2, 9--14, 16, and 26-29 that ultimately depend from claim 1. The Appellant also submits various arguments with respect to Carrison. App. Br. 7; Reply Br. 5. While we do not find these arguments directed to Carrison persuasive, they are nonetheless moot in view of the above discussed deficiency in the Examiner's claim construction, and findings with respect to Kim upon which the rejection is based. Rejection 2 The Examiner rejects claims 3-8 as obvious over Carrison and Kim, in view of Hissink, the Examiner relying on Hissink for disclosing a foam made from a poly (urethane urea) or multifunctional isocyante and polyethers. Final Act. 4. However, as the Appellant argues (App. Br. 9), the deficiencies of the rejection discussed above relative to claim 1 are not remedied by the Examiner's application of Hissink. Accordingly, this rejection is also reversed. The Appellant's further argument relative to Hissink (App. Br. 10) is moot. 5 Appeal2018-002775 Application 13/532,013 CONCLUSION Rejections of claims 1-14, 16, 17, and 26-29 are REVERSED. REVERSED 6