Ex Parte Furst et alDownload PDFPatent Trial and Appeal BoardDec 17, 201311337225 (P.T.A.B. Dec. 17, 2013) 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. 11/337,225 01/20/2006 Joseph G. Furst ICON 200037US01 2177 27885 7590 12/18/2013 FAY SHARPE LLP 1228 Euclid Avenue, 5th Floor The Halle Building Cleveland, OH 44115 EXAMINER BUI, VY Q ART UNIT PAPER NUMBER 3773 MAIL DATE DELIVERY MODE 12/18/2013 PAPER 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. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte JOSEPH G. FURST and WILLIAM G. BRODBECK ____________ Appeal 2012-002213 Application 11/337,225 Technology Center 3700 ____________ Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and SHERIDAN K. SNEDDEN, Administrative Patent Judges. ADAMS, Administrative Patent Judge. DECISION ON APPEAL1 This appeal under 35 U.S.C. § 134 involves claims 54, 56-59, 61, 62, 64-68, 71, 72, 78, and 81-88 (App. Br. 2; see also October 12, 2011 Second Reply Br. 1 (acknowledging the cancellation of “[c]laims 74, 76, 79 and 80”)).2 Examiner entered rejections under 35 U.S.C. § 102(b)/103 and 35 U.S.C. § 103(a). We have jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part. 1 The Real Party in Interest is ICON Medical Corp. (App. Br. 1.) Appeal 2012-002213 Application 11/337,225 2 STATEMENT OF THE CASE The claims are directed to a method of reducing stent strut fracture problems that can result from repeated bending a stent that is located in, inter alia, a treatment site in a body passageway. Claims 54, 81, and 85 are representative and are reproduced in the Claims Appendix of Appellants’ Brief. Claims 54, 57-59, 61, 62, and 65-68 stand rejected under 35 U.S.C. § 102(b) as anticipated by or, in the alternative, under 35 U.S.C. § 103 as obvious over Reed.3 Claims 81 and 85 stand rejected under 35 U.S.C. § 102(b) as anticipated by or, in the alternative, under 35 U.S.C. § 103 as obvious over Datta.4 Claim 64 stands rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Reed and Kunz.5 Claims 82-84 and 86-88 stand rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Reed, Datta, and Kuntz. The rejections over Reed or Datta alone: ISSUE Does the preponderance of evidence on this record support Examiner’s finding that: (1) Reed teaches or makes obvious the subject matter of Appellants’ claims 54, 61, 62, and 68; or (2) Datta teaches or makes obvious the subject matter of Appellants’ claim 81? 3 Reed et al., US 6,197,013 B1, issued March 6, 2001. 4 Datta et al., US 6,338,739 B1, issued January 15, 2002. 5 Kunz et al., US 6,515,009 B1, issued February 4, 2003. Appeal 2012-002213 Application 11/337,225 3 FACTUAL FINDINGS (FF) FF 1. Reed teaches a stent that is “partially or wholly made of a biodegradable/dissolvable polymer such as polylactide (PLA) [or] polyglycolide (PGA)” to “release therapy over an extended period” (Ans. 3; Reed, col. 11, ll. 48-52). FF 2. Reed’s Figure 7 is reproduced below: “FIG. 7 is a schematic representation of a balloon-expandable probe stent” (Reed, col. 4, ll. 26-27). FF 3. Reed’s stent comprises “micro-needles/micro-structures/probes 5 [comprising lumens containing a drug reservoir] . . . to penetrate a plaque layer of a blood vessel wall for an effective delivery of . . . treatment drugs” (Ans. 3-4; Reed, col. 11, ll. 53-55; col. 12, l. 48 – col. 13, l. 9). FF 4. Examiner finds that while Reed [D]oes not explicitly disclose a method of reducing a problem of fractured stent struts and accelerating degradation of the stent. . . . Reed’s stent must fracture at various locations over time, especially at locations of stress concentration [and] [t]hese fractured locations of the stent will provide extra surfaces for the body fluid in the blood vessel to degrade the material of the stent, th[ereby] . . . accelerat[ing] the biodegradation as recited in . . . [Appellants’] claims. (Ans. 4.) Appeal 2012-002213 Application 11/337,225 4 FF 5. Reed’s Figures 10a-c are reproduced below: FIG. 10a shows a probe, 5 (without a lumen) pierces the vessel [9], when balloon, 15, expands to the left . . . [thereby] provid[ing] a pathway for the drug . . . coating the probe, to enter the vessel. . . . FIG. 10b . . . show[s] a probe which contains a lumen 11, which holds the drug . . . 14, by surface tension. . . . Additional therapy is in reserve in a liquid or gel reservoir between the probe and expansion balloon. When the balloon, 15, is expanded, this forces therapy from the reservoir through the lumen. In the embodiment shown in FIG. 10c, the reservoir is inside the expansion balloon, 15. The probe lumen extends through the balloon so that fluid forces used to expand the balloon also force additional therapy through the lumen. (Reed, col. 13, ll. 1-17; see also id. at col. 6, l. 55 (“the reservoir is the inflation balloon”); id. at col. 11, ll. 9-10; see id at col. 5, ll. 25-30 (the drug coated stent “is coated with a biocompatible material which provides a protective coating to prevent the drug . . . from being washed away, and allows for the release of the drug . . . over a period of time”)). FF 6. Datta suggests “stent[s] made of a biodegradable polymer, such as a PLA or PGLA . . . deployed in a blood vessel” (Ans. 5; see Datta, Abstract (“A biodegradable stent for implantation into a lumen in a human body”)). FF 7. Datta suggests that A proper selection of degradation rates will cause the inner core to fracture into small pieces in vivo, while a portion, or all, of the outer layer remains intact, thereby producing unique "soft" fragments or filaments. That is, after the inner core has degraded and effectively been removed from the stent structure by body fluids, the remaining outer layer degrades to a soft, Appeal 2012-002213 Application 11/337,225 5 pliable, fibrillar filament, which may remain intact or degrade into several sections. (Datta, col. 9, ll. 55-62.) FF 8. Examiner finds that Datta’s stent . . . “deployed in a blood vessel inherently will fracture over time when the stent in the body passage flexes and fracture at locations of stress concentration of the stent . . . [and] therefore will provide newly exposed surfaces of the stent for the body fluid in a blood vessel to degrade the biodegradable material of the stent, and accelerate the biodegradation as recited in . . . [Appellants’] claims. (Ans. 5.) ANALYSIS The rejection over Reed: Examiner finds that Reed teaches a stent that is formed of a biodegradable polymer that will inherently “fracture at various locations over time, . . . [thereby,] provid[ing] extra surfaces for the body fluid in the blood vessel to degrade the material of the stent, [and] . . . accelerat[e] the biodegradation as recited in . . . [Appellants’] claims” (FF 1-4; see App. Br. 11 (Appellant acknowledges that Reed discloses that 1) a stent could be formed of a biodegradable material, 2) the stent can include micro-needles, and 3) the stent can deliver drugs to a treatment site”)). Claim 54: Appellants contend that Reed does not disclose the step of allowing the body portion of the stent to flex in the body passageway such that continual flexing of the body portion results in at least one fracture in the body portions, and wherein the fracturing of the body portion results in accelerated degradation of the body portion at the site Appeal 2012-002213 Application 11/337,225 6 of the fracture thereby causing accelerated absorption of the body portion in the body passageway. (App. Br. 12; First Reply Br.6 4.) We are not persuaded. Appellants fail to explain why a person of ordinary skill in this art would not have expected Reed’s stent to flex, or how Reed does not allow the body portion of the stent to flex, in a body passageway in the same manner that Appellants’ stent flexes in a body passageway (see FF 4; Cf. Appellants’ claim 54 (“allowing said body portion of said stent to flex in said body passageway”)). As Examiner explains, such flexing will inherently result in stent fractures which “will provide extra surfaces for the body fluid in the blood vessel to degrade the material of the stent, th[ereby] . . . accelerat[ing] the biodegradation” of the stent (id.). Further, dependent claim 65 makes it clear that two embodiments encompassed by claim 54, the PLA and PGA polymers, are identical polymers to those taught in Reed (FF 1) and would therefore reasonably have been expected to inherently have the same properties. Once a prima facie case of anticipation has been established, the burden shifts to the Appellant to prove that the prior art product does not necessarily or inherently possess the characteristics of the claimed product. In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (“Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product.”). 6 Received May 31, 2011. Appeal 2012-002213 Application 11/337,225 7 Reed teaches a stent that is “wholly made of a biodegradable/ dissolvable polymer,” therefore, we are not persuaded by, Appellants’ contention regarding “a metal stent” (FF 1; Cf. App. Br. 12). Claims 61 and 62: Appellants’ claims 61 and 62 depend ultimately from and further limit the stent of Appellants’ claim 54 to include, inter alia, (1) a plurality of micro-structures that extend from the body of the stent and (2) that the body portion includes at least one cavity that is at least partially filled with a biological agent (Appellants’ claims 61 and 62). While Reed teaches that a biological agent may be (a) coated onto the microstructures or (b) contained within a reservoir located within the microstructures or a balloon, Examiner failed to identify a portion of Reed that teaches or suggests a biological agent is located within a cavity of the body portion (FF 3 and 5; App. Br. 12-13 (“Reed does not teach that the body of the stent includes cavities and biological agent in the cavity”); First Reply Br. 5). Claim 68: Appellants’ claim 68 depends ultimately from and further limits the stent of Appellants’ claim 54 to include, inter alia, a plurality of micro- structures that extend from the body of the stent, wherein the microstructures include a cavity at least partially formed of a biodegradable polymer that is at least partially filled with a biological agent, wherein the polymer coats a portion of the microstructures to encapsulate the biological agent in the cavity (Appellants’ claim 68). Appeal 2012-002213 Application 11/337,225 8 Appellants contend that “[t]he concept of coating micro-needles with any type of polymer is absent from the teachings of Reed . . . [and] Reed does not teach that a polymer coating on a micro-needle is used to encapsulate a biological agent in a cavity of the micro-needle” (App. Br. 13). We are not persuaded. Reed’s biodegradable stent includes micro-needle micro-structures that contain lumens comprising a biological agent (FF 1-3 and 5). The rejection over Datta: Claim 81: We recognize, but are not persuaded by, Appellants’ contention that “Datta is absent any teaching regarding how the degradation of the stent can be accelerated by fracturing . . . the stent” (App. Br. 15; First Reply Br. 5-6). As Examiner explains, Datta’s stent is formed of a biodegradable polymer that will inherently “fracture at various locations over time, . . . [thereby,] provid[ing] newly exposed surfaces of the stent for the body fluid in the blood vessel to degrade the material of the stent, and accelerate the biodegradation as recited in . . . [Appellants’] claims” (FF 6-8). Dependent claim 84 makes it clear that two embodiments, the PLA and PGA polymers, encompassed by claim 81, are identical polymers to those taught in Datta (FF 6) and would therefore reasonably have been expected to inherently have the same properties. We find no error in Examiner’s finding. Best, 562 F.2d at 1255. Appeal 2012-002213 Application 11/337,225 9 Claim 85: Appellants’ contention regarding claim 85 are the same as that presented for claim 81 (App. Br. 14-18; First Reply Br. 6). Therefore, Appellants’ claim 85 falls with claim 81. CONCLUSION OF LAW The preponderance of evidence on this record supports Examiner’s finding that Reed teaches Appellants’ claimed invention. The rejection of claims 54 and 68 under 35 U.S.C. § 102(b) as anticipated by or, in the alternative, under 35 U.S.C. § 103 as obvious over Reed is affirmed. Claims 57-59 and 65-68 fall with claim 54. The preponderance of evidence on this record supports Examiner’s finding that Datta teaches Appellants’ claimed invention. The rejection of claim 81 under 35 U.S.C. § 102(b) as anticipated by or, in the alternative, under 35 U.S.C. § 103 as obvious over Datta is affirmed. Claim 85 falls with claim 81. The preponderance of evidence on this record fails to support Examiner’s finding that Reed teaches Appellants’ claimed invention. The rejection of claims 61 and 62 under 35 U.S.C. § 102(b) as anticipated by or, in the alternative, under 35 U.S.C. § 103 as obvious over Reed is reversed. Obviousness: ISSUE Does the preponderance of evidence relied upon by Examiner support a conclusion of obviousness? Appeal 2012-002213 Application 11/337,225 10 FACTUAL FINDINGS (FF) FF 9. Examiner finds that Reed suggests the subject matter of Appellants’ claim 64 with the exception of “a trapidil or GM-CSF or combination thereof as a biological agent” (Ans. 6). FF 10. Examiner finds that the combination of Reed and Datta suggest the subject matter of Appellants’ claims 82-84 and 86-88 with the exception of a “a trapidil or GM-CSF or combination thereof as a biological agent” (Ans. 6). FF 11. Examiner relies on Kunz to make up for this deficiency in Reed alone or in combination with Datta, wherein Kunz suggests “trapidil as a favorable cystostatic agent for inhibiting cell growth and division” (id.). ANALYSIS The rejection over Reed and Kunz: Based on the combination of Reed and Kuntz, Examiner concludes that, at the time Appellants’ invention was made, it would have been prima facie obvious “to provide trapidil to a Reed . . . stent as this agent will inhibit[] cell growth and division in a blood vessel” (Ans. 6). Appellants do not dispute Examiner’s reliance on Kunz in combination with Reed, but instead content that “Reed does not make obvious the method of fracturing the body of the stent to accelerate the degrading of the stent” (App. Br. 15; First Reply Br. 6-7). We are not persuaded for the reasons set forth above. The rejection over Reed, Datta, and Kuntz: Based on the combination of Reed, Datta, and Kuntz, Examiner concludes that, at the time Appellants’ invention was made, it would have Appeal 2012-002213 Application 11/337,225 11 been prima facie obvious “to provide trapidil as taught by Kuntz to a combined stent of Reed [and] . . . Datta . . . as . . . trapidil will inhibit[] cell growth and division in a blood vessel” (Ans. 6). Claim 82: Appellants contend that the combination of Reed and Datta fails to “make obvious the method of fracturing the body of the stent to accelerate the degrading of the stent” (App. Br. 16; First Reply Br. 7). We are not persuaded for the reasons set forth above. Claim 83: Appellant contends that the combination of Reed, Datta, and Kunz fails to make obvious a stent that includes a [P]lurality of micro-structures [that] are coated with a coating material, wherein the coating material includes a bioabsorbable or biodegradable material, and that the coating material at least partially delays the biological agent in the plurality of microstructures from being delivered to penetrated regions of the body passageway at the treatment site after the body portion is expanded to the expanded cross-sectional area. (App. Br. 17; First Reply Br. 7.) We are not persuaded (see FF 5 (the drug coated on Reed’s stent “is coated with a biocompatible material which provides a protective coating to prevent the drug . . . from being washed away, and allows for the release of the drug . . . over a period of time”)). CONCLUSION OF LAW The preponderance of evidence relied upon by Examiner support a conclusion of obviousness. The rejection of claims 82 and 83 under Appeal 2012-002213 Application 11/337,225 12 35 U.S.C. § 103(a) as unpatentable over the combination of Reed, Datta, and Kuntz is affirmed/reversed. Claim 88 falls with claim 83. TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED-IN-PART lp Copy with citationCopy as parenthetical citation