Ex Parte Karabey et alDownload PDFPatent Trial and Appeal BoardDec 29, 201613556260 (P.T.A.B. Dec. 29, 2016) 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. 13/556,260 07/24/2012 Halil I. Karabey H-KN-01532 (10) 7920 11100 7590 Covidien (Klein) Attn: IP Legal Department 15 Hampshire Street Mansfield, MA 02048 EXAMINER HOUSTON, ELIZABETH ART UNIT PAPER NUMBER 3731 NOTIFICATION DATE DELIVERY MODE 01/03/2017 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): iplegalus@covidien.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte HALIL I. KARABEY, ANNA G. PRESTEZOG, MICHAEL S. MIRIZZI, BRIAN FARLEY, JOHN W. RODRIGUEZ, and RUSSELL B. THOMPSON Appeal 2014-009997 Application 13/556,260 Technology Center 3700 Before ANNETTE R. REIMERS, JILL D. HILL, and LISA M. GUIJT, Administrative Patent Judges. GUIJT, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Appellants1 seek our review under 35 U.S.C. § 134 of the Examiner’s decision2 rejecting claims 1-6, 9—15, 18—28, and 30-32. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM and designate our affirmance as a NEW GROUND OF REJECTION pursuant to our authority under 37 C.F.R. § 41.50(b). 1 Appellants identify the real party in interest as Covidien LP. Appeal Br. 1. 2 Appeal is taken from the Final Office Action dated March 14, 2014 (the “Final Act.”). Appeal 2014-009997 Application 13/556,260 CLAIMED SUBJECT MATTER Claims 1 and 24 are independent. Claims 1 is reproduced below and is illustrative of the subject matter on appeal. 1. Apparatus for occluding a hollow anatomical structure (HAS), the apparatus comprising: an implant sized for insertion into the HAS, the implant comprising a fibrous mass of loose, non-knit, non-woven, radially bulky fibers formed form one or more bioabsorbable materials; wherein the radially bulked fibers are self-expanding, such that the implant is deliverable in a compressed, low-profile state through the HAS, and self-expandable in the radial direction at a treatment site in the HAS to occlude the HAS at the treatment site. REJECTIONS I. Claims 1—6, 10-12, 14, 15, 18—22, 24—28, 30, and 32 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Callister (US 2005/0209633 Al; pub. Sept. 22, 2005) and Galdonik (US 2005/0085847 Al; pub. Apr. 21, 2005). II. Claim 9 stands rejected under 35 U.S.C. § 103(a) as unpatentable over Callister, Galdonik, and Pavcnik (US 2001/0039450 Al; pub. Nov. 8, 2001). III. Claims 13 and 31 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Callister, Galdonik, and Hyodoh (US 2003/0040772 Al; pub. Feb. 27, 2003). IV. Claim 23 stands rejected under 35 U.S.C. § 103(a) as unpatentable over Callister, Galdonik, and Damis (US 2004/0254589 Al; pub. Dec. 16, 2004). 2 Appeal 2014-009997 Application 13/556,260 ANALYSIS Rejection I Analogous Art “The analogous-art test requires that the Board show that a reference is either in the field of the applicant’s endeavor or is reasonably pertinent to the problem with which the inventor was concerned in order to rely on that reference as a basis for rejection.” In re Kahn, 441 F.3d 977, 986-87 (Fed. Cir. 2006) (citing In re Oetiker, 977 F.2d 1443, 1447 (Fed. Cir. 1992)). The “field of endeavor” prong asks if the structure and function of the prior art is such that it would be considered by a person of ordinary skill in the art because of the similarity to the structure and function of the claimed invention as disclosed in the application. In re Bigio, 381 F.3d 1320, 1325- 27 (Fed. Cir. 2004). “A reference is reasonably pertinent if, even though it may be in a different field from that of the inventor’s endeavor, it is one which, because of the matter with which it deals, logically would have commended itself to an inventor's attention in considering his problem.” In re Clay, 966 F.2d 656, 659 (Fed. Cir. 1992). Appellants argue that Galdonick is not analogous art and therefore, improperly relied on by the Examiner. Appeal Br. 3—9; Reply Br. 2-4. In particular, Appellants submit that the field of endeavor of Galdonik, namely, “embolism protection devices... deployed for filtering of flow within a vessel,” is not the same as the field of endeavor as the claimed subject matter, namely, “occluding a hollow anatomical structure.” Appeal Br. 4 (citing Spec. 12; Galdonik, Abstract). Appellants also argue that Galdonik is not reasonably pertinent to the problem faced by Appellants, in that Appellants “were trying to solve problems such as occluding hollow 3 Appeal 2014-009997 Application 13/556,260 anatomical structures by ‘treating] structures near nerves or the skin without concern for heat damage, paresthesia, skin bum or damage to other adjacent anatomical structures,’” whereas Galdonik’s embolism protection device “generally do[es] not involve the application of heat or tumescent anesthesia to the body.” Id. at 5. We determine that the field of endeavor is more broadly defined as “intravascular devices,” such as stents, filters, and occluders (see e.g., Hyodoh 1209), and therefore, Galdonik is analogous art to Appellants’ claimed invention. Additionally, we determine that Appellants’ invention addresses the problem of how to occlude (or block) an HAS (Spec. 1 6), and that Galdonik is reasonably pertinent to the problem of occluding (or blocking) an HAS, because Galdonik discloses fibers for filtering, which is at least partially occluding or blocking a lumen of a patient’s vessel. See, e.g., Galdonik, Abstract. Thus, Galdonik’s device logically would have commended itself to an inventor’s attention in considering Appellants’ problem. Accordingly, we determine that Galdonik is analogous art properly relied on by the Examiner. Motivation to Combine Appellants argue claims 1—6, 10-12, 14, 15, 18—22, 24—28, 30, and 32 as a group. Appeal Br. 20-22. We select claim 1 as a representative claim, and claims 2—6, 10-12, 14, 15, 18—22, 24—28, 30, and 32 stand or fall with claim 1. 37 C.F.R. § 41.37(c)(l)(iv). Regarding independent claim 1, the Examiner finds, inter alia, that Callister discloses the fibrous mass, as claimed, except that Callister does not explicitly disclose that the fibers are formed from one or more 4 Appeal 2014-009997 Application 13/556,260 bioabsorbable materials. Final Act. 4 (citing Callister, Figs. 1—4 (fibrous member 15), Figs. 10, 11 (fibrous mass 42). The Examiner relies on Galdonik for teaching “similar fibers intended to impede a vessel lumen comprising bioabsorbable materials.” Id. (citing Galdonik || 87, 164, 166). The Examiner finds that Galdonik “specifically teaches a fibrous body that is bioabsorbable to release ‘growth factors’ . . . that are well-known to improve ‘cellular growth.’” Ans. 4 (citing Galdonik|| 180, 183). The Examiner determines that “one of ordinary skill in the art. . . would understand that bioabsorbable materials are well-known materials to provide temporary scaffolding to ‘facilitate cellular growth.’” Id. The Examiner further determines that “selecting a known material on the basis of its suitability for the intended use [is] a matter of obvious design choice . . . within the general skill of a work in the art.” Id. The Examiner reasons that it would have been obvious to “modify the fibers of Callister with the bioabsorbable material as taught by Galdonik ... to provide favorable material properties and to facilitate the release of biologically active agents and facilitate cellular growth.” Final Act. 4—5 (citing Galdonik || 87, 164). First, Appellants argue that “[t]here is no suggestion that Callister would not work for its intended purpose, or that modifying Callister by adding bioabsorbable materials as taught by Galdonik would improve Callister’s device, or even work.” Appeal Br. 9. Appellants also argue that “Callister overcame the deficiencies in the prior devices by using two different metallic materials to cause electrical activity, thereby causing tissue ingrowth,” and that “modifying Callister with the device of Galdonik would change the method of operation of the Callister device.” Id. at 10. Appellants maintain that “there is no suggestion that choosing a 5 Appeal 2014-009997 Application 13/556,260 bioabsorbable material, which disappears over time, would overcome the deficiency in the prior art identified by Callister,” and that “[bjioabsorbable materials were known at the time Callister filed his application, yet Callister does not mention any bioabsorbable materials.” Id. at 9. Callister discloses an occluding contraceptive device including a stent-like occluding structure 11 containing wire elements 16 and 17 that “generate sufficient galvanic activity to stimulate tissue growth when disposed within a patient’s body lumen.” Callister || 39-40. Callister also discloses that “a fibrous member 15 is transversely disposed in the occluding structure 11” {id. 140), and that “fibrous member 15 is permeable to facilitate epithelialization or other tissue ingrowth, and the complex comprising the fibrous member with the tissue ingrowth occludes the reproductive lumen sufficiently to prevent the passage of reproductive cells therethrough” {id. 142); see also id. 1 50 (“The fibrous material of the fibrous body 42 . . . [is] permeable to allow for tissue ingrowth.”). Thus, we agree with Appellants that regarding the embodiments in Callister relied on by the Examiner, Callister discloses tissue ingrowth on or within the fibrous mass to occlude the HAS, and it is speculative to determine that a fibrous mass that bioabsorbs would allow these embodiments of Callister’s device to work for its intended purpose. However, Callister also discloses “alternative occluding device 60,” which comprises helically shaped coils 62, 64 “to generate galvanic activity to enhance tissue growth into and/or on the occluding component 61.” Callister | 52. With respect to device 60, Callister discloses that “[a]s previously described, a fibrous body . . . may be disposed within the inner lumen 65 of the occluding component 61 ... to further enhance tissue 6 Appeal 2014-009997 Application 13/556,260 growth.” Id. (emphasis added). In other words, Callister’s fibrous body is not required for Callister’s occluding component 61 to perform its intended purpose, but is only used to improve its function by adding to the stimulation of tissue growth provided by coils 62, 64. See also Callister 140. Therefore, the Examiner’s proposed modification of the fibrous body within Callister’s occluding component 61 to be bioabsorbable would not frustrate the purpose or efficacy of Callister’s occluding component 61, or even change its method of operation, which would continue to primarily rely on the galvanic activity of coils 62, 64. We also do not agree with Appellants that Callister’s failure to mention that the fibrous body may be bioabsorbable is evidence that Callister deemed such a modification would not work. Second, Appellants argue that Callister “teaches away from using a device that does not occlude the hollow anatomical structure, and specifically teaches away from using fibrous material, which Galdonik discloses, even if it promotes tissue ingrowth.” Appeal Br. 9. We disagree, in that the Examiner relies on Galdonik for bioabsorbability alone, and Appellants do not point to any passage in Callister that “criticize[s], discredits] or otherwise discourage[s]” the use of a bioabsorbable fibrous mass. In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004) (prior art does not teach away from claimed subject matter merely by disclosing a different solution to a similar problem unless the prior art also criticizes, discredits or otherwise discourages the solution claimed). Third, Appellants argue that Galdonik does not teach or suggest that bioabsorbable materials provide favorable material properties, such as facilitating the release of biologically active agents and cellular growth. Appeal Br. 10. 7 Appeal 2014-009997 Application 13/556,260 Notably, Galdonik discloses that “a biologically active agent can be released by way of the embolism protection device,” for example, “the biologically active agent is eluted gradually by diffusion out of the material from which the device is formed or released gradually by degradation of the material from which the device is formedGaldonik 193 (emphasis added). Galdonik further discloses that “the device can release growth factor, which could improve healing or create new vessels.” Id. 196. To the extent one of ordinary skill in the art would not understand Galdonik as teaching bioabsorbable (as opposed to degradable) fibers for releasing agents, and specifically, agents for promoting cellular growth, we note that Hyodoh3 supports the Examiner’s Official Notice by disclosing that [b]oth the straight and the tapered stents of the present invention (as well as the filters and occluders discussed below). .. may be formed with filaments made of biodegradable material so as to form self-expanding, bioabsorbable, biodegradable stents that may, in addition to functioning as stents, function as drug or nutrient delivery systems as a result of the material used. Many factors may be considered in choosing material from which to form the biodegradable stents . . . [which] may be formed from materials of minimal thickness so as to minimize blood flow blockage and facilitate bioabsorbtion. Hyodoh H 209, 210. Callister itself also teaches the benefits of coating the occluding component with epithelialization promoter agents, or other agents. See, e.g., Callister 110 (“the occluding component can be coated with a polymer having impregnated therein an agent such as a drug, enzyme 3 The Examiner relies on Hyodoh in the rejection of claims 13 and 31 for teaching “a similar vascular occlusive implant having fibers with a bioabsoprtion time of 2-24 weeks after implantation.” Final Act. 8 (citing Hyodoh 1218). 8 Appeal 2014-009997 Application 13/556,260 or protein, for inducing or promoting tissue growth.”). Moreover, claim 1 does not require the fibrous mass to release any agents, but simply to be bioabsorbable, and Appellants do not challenge the Examiner’s alternative reasoning that it would have been obvious to modify Callister’s fibers with bioabasorbable materials, as taught by Galdonik and/or as is well-known in the art, “to provide favorable material properties” and “to facilitate the release of biologically active agents,” apart from “facilitating] cellular growth.” Final Act. 4—5. Finally, Appellants argue that “the diametrically-opposed purposes of the fibers in Galdonik (non-occluding filtration) and the fibers of Callister (occlusion) would necessarily mean that modifying Callister with the teachings of Galdonik would result in a device that does not occlude blood flow, which would render Callister unsuited for its intended purpose.” Reply Br. 4. However, Appellants’ argument does not address the rejection articulated by the Examiner, which proposes modifying the fibers of Callister, which are ancillary to the metallic fibers that generate galvanic energy for facilitating tissue growth, as explained supra, such that Callister’s device would continue to be suited for use as an occlusion device. Accordingly, we sustain the Examiner’s rejection of independent claim 1 and claims 2—6, 10-12, 14, 15, and 18—22 stand with claim 1. We designate our affirmance as a new ground of rejection to provide Appellants with a full and fair opportunity to respond to the rejection, to the extent we have relied on passages from the prior art which were not relied upon by the Examiner in support of the rejection. 9 Appeal 2014-009997 Application 13/556,260 Rejections II and III Appellants chose not to present separate arguments for the patentability of dependent claims 9, 13, 23, and 31, arguing only that Pavcnik, Hyodoh, and/or Damis do not cure the deficiencies in the Examiner’s findings and reasoning with respect to Callister and Galdonik. Appeal Br. 10—12. Because we sustain the Examiner’s rejection of claim 1 as unpatentable over Callister and Galdonik, as discussed supra, we also sustain the Examiner’s rejection of claims 9, 13, 23, and 31. We designate our affirmance of the rejection of claims 9, 13, 23, and 31 as a new ground of rejection. DECISION The Examiner’s rejections of claims 1-6, 9-15, 18—28, and 30-32 are AFFIRMED, and we designate our affirmance as a NEW GROUND OF REJECTION. This decision contains a new ground of rejection pursuant to 37 C.F.R. §41.50(b). 37 C.F.R. § 41.50(b) provides “[a] new ground of rejection pursuant to this paragraph shall not be considered final for judicial review.” 37 C.F.R. § 41.50(b) also provides: When the Board enters such a non-final decision, the appellant, within two months from the date of the decision, must exercise one of the following two options with respect to the new ground of rejection to avoid termination of the appeal as to the rejected claims: (1) Reopen prosecution. Submit an appropriate amendment of the claims so rejected or new Evidence relating to the claims so rejected, or both, and have the matter reconsidered 10 Appeal 2014-009997 Application 13/556,260 by the Examiner in which event the prosecution will be remanded to the Examiner. The new ground of rejection is binding upon the examiner unless an amendment or new Evidence not previously of Record is made which, in the opinion of the examiner, overcomes the new ground of rejection designated in the decision. Should the examiner reject the claims, appellant may again appeal to the Board pursuant to this subpart. (2) Request rehearing. Request that the proceeding be reheard under § 41.52 by the Board upon the same Record. The request for rehearing must address any new ground of rejection and state with particularity the points believed to have been misapprehended or overlooked in entering the new ground of rejection and also state all other grounds upon which rehearing is sought. Further guidance on responding to a new ground of rejection can be found in the Manual of Patent Examining Procedure § 1214.01. AFFIRMED; 37 C.F.R, $ 41.50(b) 11 Copy with citationCopy as parenthetical citation