Ex Parte Sikes et al

Patent Trial and Appeal BoardJan 18, 2013

12056689 (P.T.A.B. Jan. 18, 2013)

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. 12/056,689 03/27/2008 Courtney Sikes 06-0011US2 (4010/212) 9994 106953 7590 01/18/2013 Mayer & Williams 251 North Avenue West Suite 201 Westfield, NJ 07090 EXAMINER CRAIGO, WILLIAM A ART UNIT PAPER NUMBER 1615 MAIL DATE DELIVERY MODE 01/18/2013 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 COURTNEY SIKES and MARK STECKEL ____________ Appeal 2011-011358 Application 12/056,689 Technology Center 1600 ____________ Before DONALD E. ADAMS, DEMETRA J. MILLS, and ERIC GRIMES, Administrative Patent Judges. ADAMS, Administrative Patent Judge. DECISION ON APPEAL This appeal under 35 U.S.C. § 134 involves claims 1-14 and 16-25 (App. Br. 2; Reply Br. 2; Ans. 3). We have jurisdiction under 35 U.S.C. § 6(b). STATEMENT OF THE CASE The claims are directed to a medical device. Claims 1 and 24 are representative and are reproduced in the Claims Appendix of Appellants’ Brief. Appeal 2011-011358 Application 12/056,689 2 Claims 1-5, 11, 13, 14, and 16-24 stand rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of DeWitt 1 and Pacetti. 2 Claims 6-8 and 25 stand rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of DeWitt, Pacetti, and Middleton. 3 Claims 9, 10, and 12 stand rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of DeWitt, Pacetti, and Kunz. 4 We affirm. The combination of DeWitt and Pacetti: ISSUE Does the preponderance of evidence on this record support a conclusion of obviousness? FACTUAL FINDINGS (FF) FF 1. DeWitt suggests a biodegradable coating system for medical devices, such as a metal stent, that comprises multiple layers, such as different first and second biodegradable polymer layers, which form “a bioactive agent releasing coating” (Ans. 5; DeWitt 2: ¶ [0013], 20: ¶ [0203], and 27: ¶ [0267]). FF 2. DeWitt suggests that a “bioactive agent can be present in the first polymer, the second polymer, or both” (id. at 5-6; DeWitt 20: ¶ [0203]). 1 DeWitt et al., US 2006/0147491 A1, published July 6, 2006. 2 Pacetti et al., US 2006/0246108 A1, published November 2, 2006. 3 John C. Middleton and Arthur J. Tipton, Synthetic biodegradable polymers as orthopedic devices, 21 BIOMATERIALS 2335-2346 (2000). 4 Kunz et al., US 6,663,881 B2, issued December 16, 2003. Appeal 2011-011358 Application 12/056,689 3 FF 3. DeWitt suggests that the bioactive agent “release kinetics profile … can be adjusted by [the] polymeric composition and relative position of individual polymer layers within the coating” (DeWitt 22: ¶ [0221]; Ans. 6). FF 4. DeWitt suggests that “[i]n some embodiments, the second biodegradable polymer has a slower bioactive agent release rate than the first biodegradable polymer” (DeWitt 2: ¶ [0014] (emphasis added); see generally App. Br. 6; see also Ans. 7 (DeWitt exemplifies a device that differs from Appellants’ “claimed invention … by the orientation of the layers on the device”)). FF 5. DeWitt suggests that “the order of application of the coated layers can be modified such that the first biodegradable polymer is utilized in an outermost coated layer, while the second biodegradable polymer is utilized in a coated layer at the device surface” (DeWitt 2: ¶ [0019] (emphasis added); Ans. 16). FF 6. DeWitt suggests that “the principle [sic] mode of degradation for many of the biodegradable polymers (particular the lactide, glycolide, and copolymers) is hydrolysis,” which “proceeds first by diffusion of water into the material followed by random hydrolysis, fragmentation of the material, and finally a more extensive hydrolysis…. The hydrolysis can be affected by the size (i.e. polymer molecular weight), hydrophilicity and crystallinity of the polymer” (Ans. 9-10 (emphasis added); DeWitt 21: ¶ [0208]). FF 7. DeWitt suggests the coating layers may comprise, inter alia, “poly(L-lactide), MW=100,000-150,000” and “poly(DL-lactide-co- glycolide), MW=50,000-75,000” (Ans. 9; DeWitt 30: ¶ [0304]). FF 8. Examiner finds that “[w]hile DeWitt … suggests lower crystallinity polymers to provide elasticity to accommodate device expansion, DeWitt Appeal 2011-011358 Application 12/056,689 4 does not expressly teach amorphous biodegradable polymers; however, amorphous biodegradable polymers were well known in the art at the time the invention was made” as suggested by Pacetti (Ans. 8). FF 9. Pacetti suggests that “the release of polymer crystallites at a late time point once the amorphous polymer phase has degraded is associated with increased late term inflammatory reactions” and therefore “suggests the use of entirely amorphous polymers …[to] improve coatings b[y] reducing the risk of this late term inflammatory reaction” (Ans. 8; Pacetti). ANALYSIS Based on the combination of DeWitt and Pacetti Examiner concludes that, at the time Appellants’ invention was made, it would have been prima facie obvious [T]o combine the prior art elements of DeWitt and Pacetti according to known methods to yield the predictable result of providing a medical device as instantly claimed because DeWitt provides a showing that a stent with a metallic substrate and biodegradable coatings substantially the same as instantly claimed were known and Pacetti expressly suggests the use of amorphous polymeric coatings would improve known devices by reducing the risk of late term inflammatory reactions after medical device implantation. Further, Pacetti teaches amorphous polymeric coatings for medical devices to implement this teaching. (Ans. 9.) Appeal 2011-011358 Application 12/056,689 5 Appellants provide separate arguments for the following groups of claims: (I) Claims 1-5, 11, 13, 14, and 16-23; (II) Claim 24. Claims 1 and 24 are representative. 5 Claim 1: We are not persuaded by Appellants’ contention that DeWitt teaches away from the claimed invention because “claims 1 and 23 of DeWitt … state that the second biodegradable polymer is selected to have a slower bioactive agent release rate relative to the first biodegradable polymer” (App. Br. 5 and 7-8; see also id. at 6 (“DeWitt teaches multi-layer coatings wherein the second (upper) layer has a slower release rate than the first (lower) layer”); Cf. FF 4 and 5). Appellants’ contentions discount DeWitt’s suggestion that “[i]n some embodiments the second biodegradable polymer has a slower bioactive agent release rate than the first” and that “the order of application of the coated layers can be modified such that the first biodegradable polymer is utilized in an outermost coated layer” (FF 4 and 5; Cf. App. Br. 7-8). 5 We recognize, but have not considered, the contentions Appellants present in their Reply Brief relating to claims not separately argued in their Principal Brief on Appeal (see e.g., Reply Br. 10 (“Claims 5 and 20” (emphasis removed)); id. at 11 (“Claims 7, 8, and 25” (emphasis removed)); and id. at 11-12; Cf. App. Br. 4-10). Appellants fail to explain why these contentions were not presented earlier. See Ex parte Borden, 93 USPQ2d 1473, 1474 (BPAI 2010) (informative) (absent a showing of good cause, the Board is not required to address “arguments that could have been made in the principal brief on appeal … but were not”). Appeal 2011-011358 Application 12/056,689 6 We are not persuaded by Appellants’ contention that the second layer suggested in DeWitt’s “Table 2 … does not contain any therapeutic agent” (App. Br. 5; Cf. FF 2). For the foregoing reasons, we are not persuaded by Appellants’ contention that Examiner’s rejection is based on hindsight reconstruction (id. at 5-6). We are not persuaded by Appellants’ unsupported intimation that a person of ordinary skill in this art would not have combined DeWitt with Pacetti, because “there are other good reasons to employ a polymer with some degree of crystallinity as described in DeWitt” (App. Br. 7; Cf. FF 9). Claim 24: Appellants’ claim 24 requires, inter alia, a first polymer that has a number average molecular weight that is at least two times that of the second polymer (see Claim 24). Appellants contend that the combination of DeWitt and Pacetti fails to teach this limitation of Appellants’ claim 24. We are not persuaded. DeWitt suggests the coating layers may comprise, inter alia, “poly(L- lactide), MW=100,000-150,000” and “poly(DL-lactide-co-glycolide), MW=50,000-75,000” (FF 7). Therefore, notwithstanding Appellants’ contention to the contrary, DeWitt suggests the use of polymers that have a number average molecular weight that differ by at least two times within a single device (id.; Cf. App. Br. 9). As discussed above, DeWitt suggests that the placement of particular polymer layers is determined based on the desired bioactive agent release kinetics profile (FF 3-6). Therefore, DeWitt suggests to a person of ordinary skill in this art a first polymer having a Appeal 2011-011358 Application 12/056,689 7 number average molecular weight that is at least two times that of the second (outer) polymer as is required by Appellants’ claim 24 (see Ans. 9-10). CONCLUSION OF LAW The preponderance of evidence on this record supports a conclusion of obviousness. The rejection of claims 1 and 24 under 35 U.S.C. § 103(a) as unpatentable over the combination of DeWitt and Pacetti is affirmed. Claims 2-5, 11, 13, 14, and 16-23 are not separately argued and fall with claim 1. The combination of DeWitt, Pacetti, and Middleton: ISSUE Does the preponderance of evidence on this record support a conclusion of obviousness? ANALYSIS The claims were not separately argued and therefore stand or fall together. Claim 6 is representative. For the reasons set forth above, we find no deficiency in the combination of DeWitt and Pacetti. Therefore, we are not persuaded by Appellants’ contention that Middleton, “cited for its teachings regarding poly(d,l-lactic acid), and poly(d,l-lactide-co-glycolide) with differing monomer contents,” fails to make up for the deficiency in the combination of DeWitt and Pacetti (App. Br. 9). CONCLUSION OF LAW The preponderance of evidence on this record supports a conclusion of obviousness. The rejection of claim 6 under 35 U.S.C. § 103(a) as unpatentable over the combination of DeWitt, Pacetti, and Middleton is Appeal 2011-011358 Application 12/056,689 8 affirmed. Claims 7, 8, and 25 are not separately argued and fall with claim 6. The combination of DeWitt, Pacetti, and Kunz: ISSUE Does the preponderance of evidence on this record support a conclusion of obviousness? ANALYSIS The claims were not separately argued and therefore stand or fall together. Claim 9 is representative. For the reasons set forth above, we find no deficiency in the combination of DeWitt and Pacetti. Therefore, we are not persuaded by Appellants’ contention that Kunz, “cited for its teachings regarding how the rate of degradation of a biodegradable matrix may be modified,” fails to make up for the deficiency in the combination of DeWitt and Pacetti (App. Br. 9). CONCLUSION OF LAW The preponderance of evidence on this record supports a conclusion of obviousness. The rejection of claim 9 under 35 U.S.C. § 103(a) as unpatentable over the combination of DeWitt, Pacetti, and Kunz is affirmed. Claims 10 and 11 are not separately argued and fall together with claim 9. Appeal 2011-011358 Application 12/056,689 9 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 cdc