Ex Parte Wiedrich et alDownload PDFPatent Trial and Appeal BoardSep 15, 201612389696 (P.T.A.B. Sep. 15, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 12/389,696 0212012009 Thomas Wiedrich 20792 7590 09/15/2016 MYERS BIGEL & SIBLEY, PA PO BOX 37428 RALEIGH, NC 27627 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. 9624-13 3711 EXAMINER JONES, DIANA S ART UNIT PAPER NUMBER 3775 MAILDATE DELIVERY MODE 09/15/2016 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) BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte THOMAS WIEDRICH, TIAN DA VIS, and THOMAS J. KOOB Appeal2014-009277 Application 12/389,696 Technology Center 3700 Before WILLIAM A. CAPP, LEE L. STEPINA, and SEAN P. O'HANLON, Administrative Patent Judges. CAPP, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Appellants seek our review under 35 U.S.C. § 134 of the final rejection of claims 1-10, 12-14, 22-25, 27, 28, and 34 under 35 U.S.C. § 102(a) as anticipated by Koob (US 2008/0200992 Al, pub. Aug. 21, 2008); claims 11, 29, and 31 as unpatentable under 35 U.S.C. § 103(a) over Koob and Conners (US 5,258,009, iss. Nov. 2, 1993); and claims 32 and 33 over Koob and Shapiro (US 4,414,967, iss. Nov. 15, 1983). We have jurisdiction under 35 U.S.C. § 6(b ). We AFFIRM. Appeal2014-009277 Application 12/389,696 THE INVENTION Appellants' invention relates to implantable medical constructs. Spec. i-f 2. Claim 1, reproduced below, is illustrative of the subject matter on appeal. 1. An implantable biostaple comprising collagen fibers having sufficient rigidity ex vivo and in vivo to define a biostaple body with a self-supported pre-formed shape with a crown and two opposing outwardly extending legs, wherein, in operative position, the legs extend outwardly from the crown over their entire length. OPINION Anticipation of Claims 1-10, 12-14, 22-25, 27-28, and 34 by Koob Claim 1 The Examiner finds that Koob discloses all of the elements of claim 1. Final Action 2. In particular, the Examiner finds that Koob discloses an implantable biostaple, comprising collagen fibers, that is capable of having sufficient rigidity ex vivo and in vivo to define a biostaple body with a self- supported pre-formed shape with a crown and two opposing outwardly extending legs. Id. Appellants traverse the Examiner's rejection by arguing that Koob's constructs are flexible, not rigid. Appeal Br. 4. Appellants also argue that Koob lacks a pre-formed shape with a crown and two opposing outwardly extending legs. Id. at 5. Appellants argue that Koob describes a flexible construct that may rolled, wrapped or folded for insertion in a substantially round bone tunnel. Id. In response, the Examiner states the Koob' s structure 20 is a solid structure and, therefore, capable of maintaining its shape. Ans. 9. The 2 Appeal2014-009277 Application 12/389,696 Examiner finds that Koob discloses that its structure has strength and stiffness similar to natural tendons and ligaments and, therefore, is sufficiently rigid to meet the claim limitations. Id. (citing Koob i-f 103). The Examiner directs our attention to an annotated version of Koob, Figure 4, to demonstrate that Koob's construct exhibits a crown and two outwardly extended legs. Id. (referring to Ans. 7 drawing). Appellants' arguments do not persuade us that the Examiner erred in finding that Koob is capable of having sufficient rigidity to define a self- supported, pre-formed shape as claimed. Appellants argue claim 1 as if the "self-supported pre-formed shape" limitation is a structural limitation. However, the claim merely recites a biostaple comprised of collagen fibers that has sufficient rigidity "to define" a biostaple body with a self-supported pre-formed shape. Claims App. In other words, as long as Koob's biostaple comprised of collagen fibers has sufficient rigidity that it is capable of assuming a self-supported, pre-formed shape with a crown and two outwardly extending legs, the claim is satisfied. See In re Swinehart, 439 F.2d 210, 212 (CCPA 1971). Swinehart maintains that a patent applicant is free to recite features of an apparatus either structurally or functionally. Id. ("[T]here is nothing intrinsically wrong with [defining something by what it does rather than what it is] in drafting patent claims."). Yet, choosing to define an element functionally, i.e., by what it does, carries with it a risk: where the Patent Office has reason to believe that a functional limitation asserted to be critical for establishing novelty in the claimed subject matter may, in fact, be an inherent characteristic of the prior art, it possesses the authority to require the applicant to prove that the subject matter shown to be in the prior art does not possess the characteristic relied on. 3 Appeal2014-009277 Application 12/389,696 T J -'- I') 1 ') lU. al L l.J. In the instant case, Koob discloses exemplary properties of collagen fibers of different sizes. Koob i-f 106. Performance parameters including stiffness are reported. Id.; see also Figs. 14A-C. 1 Koob teaches that lesser and greater numbers of fibers may be used depending on the desired tensile strength, rigidity, or other mechanical parameters of the construct at the target implant site. Id. i-f 77. The Examiner finds that Koob is capable of satisfying the functional limitation directed to a rigid, pre-formed shape. The Examiner supports this position with evidence that Koob has strength and stiffness similar to natural tendons and ligaments and reasons that this is sufficiently rigid to satisfy the claim. Ans. 9. The Examiner's reasoning is sufficient to shift the burden of persuasion to Appellants. See In re Spada, 911 F.2d 705, 708 (Fed. Cir. 1990) ("when the PTO shows sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not."). Appellants attempt to traverse the Examiner's findings of fact and accompanying technical reasoning with mere legal argument: Clearly, natural tendons and ligaments do not have a rigid structure such that they have a pre-formed shape with a crown and two opposing outwardly extending legs as claimed. Instead, natural tendons and ligaments have a flexible strength and stiffness that allows them to bend and stretch. 1 Koob also cites to and incorporates by reference the disclosures regarding collagen fibers in Thomas J. Koob, Biomimetic approaches to Tendon Repair, COMPARATIVE BIOCHEMISTRY AND PHYSIOLOGY PART A 133 (2002) 1171-1192; and U.S. Provisional Application Ser. No. 60/60/883,408, Filed Jan. 4, 2007 to Koob et al., entitled, Methods of Making High Strength NDGA Polymerized Collagen Fibers and Related Collagen-Prep Methods, Medical Devices and Constructs. Koob i-f 106 4 Appeal2014-009277 Application 12/389,696 Reply Br. 3. However, it is well settled that attorney argument cannot take the place of evidence in the record. Estee Lauder, Inc. v. L 'Orea!, S.A., 129 F.3d 588, 595 (Fed. Cir. 1997). Furthermore, as used in the Specification, "rigid" does not mean incapable of being bent. Rather, the Specification merely teaches that the biostaple construct of collagen fibers has sufficient rigidity to retain its shape. Spec. i-fi-1 8, 9, 30, 68. The biostaple 10 can be configured to be sufficiently rigid to retain its shape yet also flexible to approximate the stiffness and flexibility of a ligament. Spec. i168. In the instant case, Appellants present no evidence that tends to show that Koob' s construct is not capable of meeting the functional rigidity limitation of claim 1. In particular, while Appellants' Specification acknowledges that natural ligaments possess both flexibility and "stiffness" (Spec. i1 68), Appellants present no evidence that such stiffness is not sufficient to allow the biostaple construct to maintain a pre-formed shape ex vivo. The burden of persuasion on this issue having shifted to Appellants, we find that Appellants have failed to carry their burden. Appellants next argue that Koob provides no enabling description "as to how to form long thin flexible collagen fibers into a rigid, self-supported biostaple before implantation." Appeal Br. 8. Appellants argue that forming such a bio-staple "is difficult." Id. Appellants contend that Koob lacks a disclosure that would enable a person of ordinary skill in the art to form fibers into the claimed shape. Id. Appellants' non-enablement argument is not persuasive. The Examiner is entitled to a presumption that Koob enables claim 1: 5 Appeal2014-009277 Application 12/389,696 [A]n examiner, who has no access to experts or laboratories, is not in a position to test each piece of prior art for enablement in citing it, and requiring him to do so would be onerous, if not impossible. An examiner, therefore, is not required to anticipate every possible response to a rejection, including showing that a cited reference is enabling. Consistent with the statutory frame-work and our precedent, we therefore hold that, during patent prosecution, an examiner is entitled to reject claims as anticipated by a prior art publication or patent without conducting an inquiry into whether or not that prior art reference is enabling. As long as an examiner makes a proper prima facie case of anticipation by giving adequate notice under§ 132, the burden shifts to the applicant to submit rebuttal evidence of nonenablement. In re Antor Media Corp., 689 F.3d 1282, 1289 (Fed. Cir. 2012). Here, Appellants offer no persuasive evidence to rebut the presumption that Koob is an enabling reference. In view of the foregoing, we determine that the Examiner's findings of fact are supported by preponderance of the evidence and we sustain the rejection of claim 1. Claim 12 Claim 12 is an independent claim that is directed to a medical kit that includes a biostaple that is substantially similar to the biostaple of claim 1. Claims App. In traversing the rejection, Appellants essentially repeat the same arguments that we considered and found unpersuasive with respect to claim 1 and find equally unpersuasive here. We sustain the rejection of claim 12. Claims 5 and 24 Claims 5 and 24 depend from claim 1 and add limitations directed to the dimensions of a bone tunnel which the biostaple is configured to reside 6 Appeal2014-009277 Application 12/389,696 within. Claims App. The Examiner finds that Koob's construct is capable of residing in bone tunnels as claimed. Final Action 3, 4 (citing Koob, iTiT 7 4, 78, 82). In traversing the rejection, Appellants essentially repeat the same arguments that we considered and found unpersuasive with respect to claim 1 and find equally unpersuasive here. We sustain the rejection of claims 5 and 24. Claims 7, 22, and 34 Claims 7 and 22 depend from claim 1. Claims App. Claim 34 depends from claim 1. Id. These claims contain limitations directed to the number and/or length of collagen fibers in the biostaple. Id. Appellants argue these claims together. Appeal Br. 11. We select claim 22 as representative. See 37 C.F.R. § 41.37(c)(l)(iv) (2015). The Examiner finds that Koob discloses a construct that has between about 2--400 elongate collagen fibers with a leg length of about 5-10 mm. Final Action 4 (citing Koob iTiT 77, 82). In traversing the rejection, Appellants essentially repeat the same arguments that we considered and found unpersuasive with respect to claim 1 and find equally unpersuasive here. We sustain the rejection of claims 7, 22, and 34. Claims 25 and 27 Claim 25 depends from claim 1 and claim 27 depends from claim 12. Claims App. Each claim contains a limitation directed to a gelatin binder that holds the fibers together and fills voids to form a substantially constant leg diameter. Id. Appellants argue these claims together. Appeal Br. 11- 12. We select claim 25 as representative. 7 Appeal2014-009277 Application 12/389,696 The Examiner finds that Koob discloses a construct comprising a gelatin binder as claimed in claim 25. Final Action 4 (citing Koob i-f 68). Appellants acknowledge that Koob discloses that its fibers can be held together using a gelatinous coating. Appeal Br. 11. However, Appellants argue that Koob fails to disclose using a gelatin binder to fill voids and create a construct with a substantially constant leg diameter. Id. In response, the Examiner points out that Koob states, "The array of fibers can be held together in any suitable manner including by their natural affinity to stick together upon compression or extrusion, by using a sticky coating or adhesive, such as a gelatinous coating," Ans. 9 (quoting Koob i-f 68). The Examiner directs our attention to Figure 4B of Koob as exhibiting a substantially constant leg diameter. Id. In their reply, Appellants essentially reiterate the arguments from their Appeal Brief. Reply Br. 4. We have reviewed Figure 4B of Koob. "Description for the purposes of anticipation can be by drawings alone as well as by words." In re Mraz, 455 F.2d 1069, 1072 (CCPA 1972). In view of what is shown in Figure 4B of Koob, the Examiner's findings with respect to a substantially constant leg diameter are supported by a preponderance of the evidence. We sustain the rejection of claims 25 and 27. Claim 28 Claim 28 depends from claim 1 and adds the limitation: "wherein the crown is substantially horizontal with rounded opposing outer edge portions." Claims App. In traversing the rejection, Appellants essentially repeat the same arguments that we considered and found unpersuasive with 8 Appeal2014-009277 Application 12/389,696 respect to claim 1 and find equally unpersuasive here. \Ve sustain the rejection of claim 28. Claims 2--4, 6, 8-10, 13, 14, and 23 Appellants do not argue for the separate patentability of claims 2--4, 6, 8-10, 13, 14, and 23 apart from arguments presented with respect to claims 1 and 12 which we have previously considered and found unpersuasive. We sustain the rejection of claims 2--4, 6, 8-10, 13, 14, and 23. See 37 C.F.R. § 41.37(c)(l)(iv)(2015) (waiver where claims not argued separately). Claim 11 Unpatentability of Claims 11, 29, and 31 over Koob and Conners Claim 11 is an independent claim that is substantially similar in scope to claim 25 except that the legs of the biostaple have a beveled edge. Claims App. The Examiner relies on Conners as disclosing a staple with a crown, two legs, and beveled end points. Final Action 6. The Examiner concludes that it would have been obvious to a person of ordinary skill in the art at the time of the invention to modify the device of Koob with leg portions having beveled edges. Id. at 7. According to the Examiner, a person of ordinary skill in the art would have done this to cleanly pierce or penetrate tissue. Id. Appellants traverse the rejection by arguing many of the points that we considered and found unpersuasive with respect to claims 1 and 25 and that we find equally unpersuasive here. Appeal Br. 12-13. Appellants also argue that there is no reason to modify Koob with the teachings of Conners. Id. at 13. Appellants argue that Conners uses sharply chiseled end points to pierce body organs and tissue. Id. Appellants contrast the purpose of 9 Appeal2014-009277 Application 12/389,696 Conners with that of the instant invention that is formed to extend into bone tunnels. Id. In response, the Examiner states that Connors teaches beveled end points that are configured to improve insertion into tissue. Ans. 10. We are not persuaded that the Examiner erred in modifying Koob with Conners. Appellants' Specification teaches that: The legs 16, 17 can be aligned with the respective bone tunnel 110 and pushed in. The beveled end of the legs can help facilitate equal forces are exerted during insertion. Spec. i-f 54. We discern little difference between beveling an edge to pierce tissue and beveling an edge to facilitate insertion into a bone tunnel. "A reference may be read for all that it teaches, including uses beyond its primary purpose." In re Mouttet, 686 F.3d 1322, 1331 (Fed. Cir. 2012), citingKSRint'l Co. v. Teleflex Inc., 550U.S. 398, 418-21 (2007). Itis common sense that familiar items may have obvious uses beyond their primary purposes, and a person of ordinary skill often will be able to fit the teachings of multiple patents together like pieces of a puzzle. KSR, 550 U.S. at 420. A person of ordinary skill in the art would have readily seen that Connor's beveled edges facilitate insertion of Koob's construct into bone tunnels. We sustain the rejection of claim 11. Claims 29 and 31 Appellants do not argue for the separate patentability of claims 29 and 31 apart from arguments presented with respect to claim 11 which we have previously considered and found unpersuasive. We sustain the rejection of claim 29 and 31. 10 Appeal2014-009277 Application 12/389,696 Unpatentability of Claims 32 and 33 over Koob and Shapiro Claims 32 and 33 depend from claims 1 and 12 respectively and each add a limitation directed to the crown length that is less than the length of the legs. Claims App. The Examiner relies on Shapiro as disclosing biostaples for joining bone to bone and ligament to bone that have a crown length that is less than the leg length as claimed. Final Action 8. The Examiner concludes that it would have been obvious to a person of ordinary skill in the art at the time the invention was made to modify Koop with a biostaple having component lengths as taught by Shapiro. Id. According to the Examiner, a person of ordinary skill in the art would have done this because such a configuration is useful in joint preplacement surgery and ligamentous reconstruction. Id. (citing Shapiro, col. 4, 11. 11-13). Appellants argue that Shapiro describes a construct that is "distinctly different" than the collagen constructs of Koob. Appeal Br. 15. Appellants argue that Shapiro's staples are driven into a portion of a bone using a power tool. Id. Appellants contend, therefore, that a person of ordinary skill in the art would have had no reason to combine Koob and Shapiro. Id. Appellants' arguments are not persuasive. The Examiner merely relies on Shapiro as teaching respective lengths for the crown and leg portions. Final Action 8; Ans. 10. Shapiro discloses a method of joining bone to bone, tendon to bone, and ligament to bone using a power staple gun or a power rivet gun. Shapiro, Abstract. Shapiro discloses staples that have legs that are longer than the crown. Shapiro, Fig. 8. The instant application and Shapiro both disclose joining joints in the hand. Shapiro, Fig. 1; Appellants' Fig. 5. The mere fact that Shapiro's staples are used in connection with a different method of insertion does not negate its 11 Appeal2014-009277 Application 12/389,696 usefulness to a person of ordinary skill in the art in teaching the respective component lengths. Mouttet, supra. We sustain the rejection of claims 32 and 33. DECISION The decision of the Examiner to reject claims 1-14, 22-25, 27-29, and 31-34 affirmed. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(l )(iv). AFFIRMED 12 Copy with citationCopy as parenthetical citation