Ex Parte Livesey et al

Patent Trial and Appeal BoardSep 17, 2012

10273780 (P.T.A.B. Sep. 17, 2012)

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. 10/273,780 10/18/2002 Stephen A. Livesey STR.0307US 2913 84398 7590 09/17/2012 Finnegan/KCI 901 New York Avenue, NW Washington, DC 20001 EXAMINER POPA, ILEANA ART UNIT PAPER NUMBER 1633 MAIL DATE DELIVERY MODE 09/17/2012 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 STEPHEN A. LIVESEY, DAVID J. MCQUILLAN, HERBERT DANIEL BENIKER, LAWRENCE E. BOERBOOM, and WARREN O. HAGGARD ____________ Appeal 2011-009953 Application 10/273,780 Technology Center 1600 ____________ Before TONI R. SCHEINER, DONALD E. ADAMS, and LORA M. GREEN, Administrative Patent Judges. ADAMS, Administrative Patent Judge. DECISION ON APPEAL This appeal under 35 U.S.C. § 134 involves claims 1, 8-10, 14, and 36-44 (App. Br. 6). We have jurisdiction under 35 U.S.C. § 6(b). STATEMENT OF THE CASE The claims are directed to a method of treatment. Claims 1 and 14 are representative and are reproduced in the Claims Appendix of Appellants’ Brief. Appeal 2011-009953 Application 10/273,780 2 Claims 1, 8-10, 14, and 39-44 stand rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Bilbo,1 Fowler,2 and Suckow.3 Claims 1, 8-10, 14, and 36-44 stand rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Bilbo, Fowler, Suckow, Bonadio,4 and Seandel.5 Claims 1, 8-10, 14, and 36-44 stand provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1, 2, 4, 5, 17, 18, 22, and 25-28 of copending Application No. 12/883,515. We affirm the obviousness rejections under 35 U.S.C. § 103(a). Appellants do not contest the provisional obviousness-type double patenting rejection (see App. Br. 11). Therefore, the provisional rejection is summarily affirmed and will not be further addressed. See MANUAL OF PATENT EXAMINING PROCEDURE § 1205.02 (“If a ground of rejection stated by the examiner is not addressed in the appellant's brief, that ground of rejection will be summarily sustained by the Board.”). 1 Bilbo, US 2002/0103542 A1, published August 1, 2002. 2 Edward B. Fowler, et al., Ridge Preservation Utilizing an Acellular Dermal Allograft and Demineralized Freeze-Dried Bone Allograft: Part II. Immediate Endosseous Implant Placement, 71(8) J. PERIODONTOL 1360- 1364 (2000). 3 M.A. Suckow, DVM, Enhanced Bone Regeneration Using Porcine Small Intestinal Submucosa, 12 J. INVESTIGATIVE SURGERY 277-287 (1999). 4 Bonadio, et al., US 5,942,496, issued August 24, 1999. 5 M. Seandel, et al., Growth factor-induced angiogenesis in vivo requires specific cleavage of fibrillar type I collagen, 97(8) BLOOD 2323-32 (2001) (PubMed Abst. only). Appeal 2011-009953 Application 10/273,780 3 Obviousness: ISSUE Does the preponderance of evidence on this record support a conclusion of obviousness? FACTUAL FINDINGS (FF) FF 1. Bilbo suggests a method for the repair of damaged organ or tissue, including bone and periosteum, in a mammalian patient (Ans. 6-7; Bilbo 8: ¶ [0056] and Abstract). FF 2. Bilbo’s method comprises “placing non-particulate acellular collagen matrices derived from donor collagen-based tissues or organs [e.g., the acellular layer of porcine intestinal collagen (i.e., small intestinal submucosa or SIS) or … human dermis-derived AlloDerm] in or on the recipient organs or tissues,” wherein “the recipient tissue could be periosteum . . . or bone” (Ans. 6-7). FF 3. Bilbo suggests that the donor may be a human or porcine donor source, wherein porcine “is the preferred source” (see generally Ans. 6-7; Bilbo 2: ¶ [0013]). FF 4. Bilbo suggests “that the acellular matrices could comprise a growth factor … are capable … [of] promot[ing] cell adhesion … and proliferation … and that, upon implantation, these matrices are repopulated via the ingrowth of host cells” (Ans. 7; Bilbo 1: ¶ [0003], 3: ¶ [0017], 8: ¶ [0052], and 8-9: ¶ [0059]). FF 5. Examiner finds that Bilbo fails to suggest the treatment of “defects in a long bone having a periosteal defect” (Ans. 7). Appeal 2011-009953 Application 10/273,780 4 FF 6. Suckow suggests the repair of “critical gaps in long bones having periosteal defects by implanting non-particulate SIS into the gap” (id.; see also Suckow 285: col. 2, ll. 17-22 (“In summary, porcine small intestinal submucosa facilitates rapid filling of a long-bone defect in rats. The presence of cellular marrow in SIS-treated rats suggests that SIS may facilitate recruitment and seeding of newly formed bone with cellular elements typical of mature bone”)). FF 7. Suckow suggests that defects “filled with … SIS demonstrated partial filling of the defect as early as 3 weeks after implantation” and that “[f]illing was significantly greater at 6 weeks … and at 12 and 24 weeks … than a 3 weeks” (Suckow 279: col. 2, ll. 10-12 and 284: col. 1, ll. 6-9). FF 8. Appellants’ Specification discloses that particulates “generally hav[e] a particle size of about 1 micron to about 900 microns, about 30 microns to about 750 microns, or about 150 to about 300 microns” (Spec. 12: 11-13). In this regard, Appellants’ Specification distinguishes between “pieces” and “particulates” (see Spec. 7: 1-3 (“a matrix derived from a heart valve can be provided as a whole valve, as small sheets or strips, as pieces cut into any of a variety of shapes and/or sizes, or in a particulate form” (emphasis added)). FF 9. Examiner finds that Fowler suggests “that AlloDerm is suitable to be used in humans for bone regeneration” (Ans. 8). FF 10. Examiner finds that the combination of Bilbo, Suckow, and Fowler does “not specifically teach … [the use of] AlloDerm to repair periosteum associated with [a] critical gap defect,” but nonetheless, finds that “Bilbo teaches that practically any non-particulate acellular collagen matrix is suitable to repair periosteum” (id.). Appeal 2011-009953 Application 10/273,780 5 FF 11. Zhao6 suggests that “[a]ll the prepared implants were wrapped snug around the ends of the bone defect” (Zhao 59: col. 2, ll. 36-37). FF 12. Zhao suggests that at “4 weeks after the implantation operation … [t]he segmental bond defect treated with SIS is empty under X-ray detection” (Zhao 62: col. 2, Fig. 6 legend). ANALYSIS The combination of Bilbo, Fowler, and Suckow: Appellants provide separate arguments for the following groups of claims: (I) claims 1, 8-10, 39-40, and 42-44 and (II) claims 14 and 41. Claims 1 and 14 are representative. 37 C.F.R. § 41.37(c)(1)(vii). Based on the combination of Bilbo, Fowler, and Suckow Examiner concludes that, at the time Appellants’ invention was made, it would have been prima facie obvious to (i) “apply Bilbo’s SIS to a long bone having a critical gap and a periosteal defect to achieve the predictable result of treating the bone,” (b) “replace the porcine SIS with AlloDerm when treating bone defects in humans,” and (c) “implant AlloDerm on the periosteal defect associated with the critical gap defect in the human long bone … to achieve the predictable result of repairing the damaged human periosteum” (Ans. 7-8). 6 Lin Zhao, et al., The study of the feasibility of segmental bone defect repair with tissue- engineered bone membrane: a qualitative observation, 3 STRAT TRAUM LIMB RECON 57-64 (2008). Appeal 2011-009953 Application 10/273,780 6 Claim 1: Appellants contend that while “Bilbo discusses a variety of different acellular tissue matrices and a long list of possible treatment sites … Bilbo provides no guidance as to what type of tissue matrices would be successful in treating such defects in bone” (App. Br. 13; Reply Br. 4). We are not persuaded (see Ans. 10 (“By reading Bilbo, one of [ordinary] skill in the art would have concluded that the acellular collagen matrices are equivalent in their repairing capabilities and would [have] found it obvious to select any of them for repairing a defect in any target tissue/organ of interest,” including bone and periosteum); see also FF 1-2). Appellants provide no persuasive evidence or reasoning to support a conclusion that Bilbo’s suggestion to use SIS or AlloDerm to treat bone is not a suggestion that SIS or AlloDerm are functionally equivalent materials for the treatment of bone (see Reply Br. 4; Cf. Ans. 10). Since Bilbo suggests the treatment of periosteum, we are not persuaded by Appellants’ contentions regarding periosteum (App. Br. 14-16; Cf. FF 1-2). Claim 1 does not require “wrapping a[] defect” (see Claim 1). Therefore, we are not persuaded by Appellants’ contention that “Suckow never describes wrapping any defect” (App. Br. 14). Bilbo suggests source tissue that can be used to treat bone or periosteum (FF 1-3). Accordingly, we are not persuaded by Appellants’ contention to the contrary (App. Br. 17; see also Ans. 11). For the same reason we are not persuaded by Appellants’ contention that Bilbo “never provides any example or discussion of … treating bone using dermis or any other tissue” (id.; Reply Br. 7; Cf. Ans. 11). In re Mills, 470 F.2d 649, 651 Appeal 2011-009953 Application 10/273,780 7 (CCPA 1972) (“All the disclosures in a reference must be evaluated … a reference is not limited to the disclosure of specific working examples.”). Claim 14: Appellants contend that the treatment of gap defects is unpredictable in this art and “was only achieved by pre-seeding the … [matrix] with cells (as done by Zhao) or completely filling the defects with particulate material (as done by Suckow)” (Reply Br. 5; see also App. Br. 18). We are not persuaded. Examiner relies on Suckow to establish that non-particulate materials are useful in treating gap defects in bone (FF 6). According to Appellants’ Specification particulate materials have a size range of “about 1 micron to about 900 microns” (FF 8; see also App. Br. 20). In addition, Appellants’ Specification distinguishes between pieces of tissue and particulates (id.). Accordingly, we are not persuaded by Appellants’ contention that Suckow’s “‘[m]inced 1mm x 1mm tissue are particulates” (App. Br. 20; see also id. at 22; Reply Br. 5-6; see also Ans. 15).7 In sum, notwithstanding Appellants’ contention to the contrary, Suckow suggests the use of non-particulate material. Given Appellants’ recognition that Suckow suggests the treatment of gap defects in bone, we are not persuaded by Appellants’ contentions regarding Zhao (see e.g., Reply Br. 5; id. at 7 (“successful treatment of long bone gap defects using small intestine submucosa … was only achieved [in Suckow] by completely filling the defects with minced particles” (emphasis added))). In addition, Appellants’ inference regarding Zhao is based on 7 For clarity, one micron is 0.001 millimeter (mm). Appeal 2011-009953 Application 10/273,780 8 Zhao’s figure 6, which is an x-ray taken 4 weeks after the repair operation (FF 12; Cf. App. Br. 17-18). Suckow, which Appellants recognize as a successful treatment of bone, suggested only partial repair after 3 weeks, with “significantly greater [filling] at 6 weeks … and at 12 and 24 weeks … than at 3 weeks” (FF 7; Ans. 13-14). Accordingly, the inference Appellants’ draw from Zhao is based on a time frame that precedes the time period that those of ordinary skill in this art would have recognized as the time period where significant bone repair occurs (FF 12; Cf. FF 7). Therefore, we are not persuaded by Appellants’ contention that Zhao suggests some level of unpredictability in the art (App. Br. 15). Claim 14 does not require wrapping or the treatment of long bones (see Claim 14; see also Ans. 13). Accordingly, we are not persuaded by Appellants’ contention that Suckow fails to suggest “wrapping a bone” (App. Br. 19; Cf. FF 6 (Suckow suggests the repair of “critical gaps in long bones having periosteal defects by implanting non-particulate SIS into the gap”) (emphasis added)). In addition, this further undermines Appellants’ reliance on Zhao, wherein all the implants in Zhao were wrapped around the ends of the bone defect (FF 11; Ans. 13 (“the teachings of Zhao et al., drawn only to wrapping the bone gap … are not material to the instant rejection”)). In this regard, we recognize Examiner’s “note that there is no teaching in Zhao et al. indicating that filling the bone defect in the absence of pre- seeded cells would not be successful” (Ans. 13). Since Suckow is not relied upon in isolation, we are not persuaded by Appellants’ contention that “one skilled in the art would not understand, based on Suckow, that dermal matrices could be predictably used to treat periosteal defects given the unpredictability in the art” (App. Br. 20). Bilbo Appeal 2011-009953 Application 10/273,780 9 suggests the use of dermal or SIS matrices (see FF 2). Appellants acknowledge Suckow’s successful use of SIS to treat bone defects (see e.g., Reply Br. 7). Appellants fail to provide persuasive reasoning or evidence to establish that a person of ordinary skill in this art would not have reasonably considered the use of a dermal matrix, as suggested by Bilbo, to fill critical gaps, as suggested by Suckow, would have yielded the predictable result of successfully treating the bone defect (see generally Ans. 11-12). See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (“The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.”). We are not persuaded by Appellants’ contention that Suckow obtained “limited success” and suggested that “[a]dditional studies will be needed to further. . . . evaluate the potential applications of SIS as a bone graft substitute” (App. Br. 20 (alteration original); see also App. Br. 22-23). Notwithstanding Appellants’ contention to the contrary, Suckow expressly states “[i]n summary, porcine small intestinal submucosa facilitates rapid filling of a long-bone defect in rats. The presence of cellular marrow in SIS- treated rates suggests that SIS may facilitate recruitment and seeding of newly formed bone with cellular elements typical of mature bone” (FF 6). Bilbo suggests the use of SIS or AlloDerm to treat bone defects including periosteal defects (FF 1-5). Fowler suggests that AlloDerm is suitable for use in humans (FF 9). Suckow suggests treatment of a critical gap defect of bone with SIS (FF 6). Taken together, we find no error in Examiner’s reasoning that while the combination of Bilbo, Suckow, and Fowler does “not specifically teach … [the use of] AlloDerm to repair periosteum associated with [a] critical gap defect”, “Bilbo teaches that Appeal 2011-009953 Application 10/273,780 10 practically any non-particulate acellular collagen matrix[, such as SIS or AlloDerm] is suitable to repair periosteum” (FF 10). Because Fowler is not relied upon in isolation, we are not persuaded by Appellants’ contention that “Fowler cannot suggest that Allo[D]erm could be used for successful treatment of periosteal gap defects or any defect in long bones because Fowler does not treat any of those types of defects” (App. Br. 21 (emphasis added); Reply Br. 8; Cf. Ans. 19-20). For the same reasons we are not persuaded by Appellants’ contention that Fowler used AlloDerm as a “barrier membrane” (id. at 22). The combination of Bilbo, Fowler, Suckow, Bonadio, and Seandel: Appellants contend that Bonadio and Seandel fail to make up for the deficiencies in the combination of Bilbo, Fowler, and Suckow (App. Br. 23). Having found no deficiency in the combination of Bilbo, Fowler, and Suckow, we are not persuaded by Appellants’ contention (see Ans. 20). CONCLUSION OF LAW The preponderance of evidence on this record supports a conclusion of obviousness. The rejection of claims 1 and 14 under 35 U.S.C. § 103(a) as unpatentable over the combination of Bilbo, Fowler, and Suckow is affirmed. Claims 8-10, 39-40, and 42-44 fall with claim 1. Claim 41 falls with claim 14. 37 C.F.R. § 41.37(c)(1)(vii). The rejection of claim 1 under 35 U.S.C. § 103(a) as unpatentable over the combination of Bilbo, Fowler, Suckow, Bonadio, and Seandel is Appeal 2011-009953 Application 10/273,780 11 affirmed. Because they are not separately argued claims 8-10, 14, and 36-44 fall with claim 1. 37 C.F.R. § 41.37(c)(1)(vii). 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