Ex Parte Bianchi et al

Patent Trial and Appeal BoardSep 17, 2012

11313280 (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. 11/313,280 12/19/2005 John R. Bianchi 15765US04 2774 52727 7590 09/18/2012 REGENERATION TECHNOLOGIES, INC. c/o MCANDREWS, HELD & MALLOY 500 WEST MADISON STREET 34TH FLOOR CHICAGO, IL 60661 EXAMINER IWAMAYE, ANDREW MICHAEL ART UNIT PAPER NUMBER 3774 MAIL DATE DELIVERY MODE 09/18/2012 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 JOHN R. BIANCHI, ZHUKAUSKAS A. ARUNAS, TODD E. GOEDE, LAUREN M. BROWN, GUY B. GROVER, WESLEY I. LEWIS, and JOE KUTSAVAGE ____________________ Appeal 2010-005322 Application 11/313,280 Technology Center 3700 ____________________ Before: STEVEN D.A. MCCARTHY, KEN B. BARRETT, and CHARLES N. GREENHUT, Administrative Patent Judges. GREENHUT, Administrative Patent Judge. DECISION ON APPEAL Appeal 2010-005322 Application 11/313,280 2 STATEMENT OF CASE Appellants appeal under 35 U.S.C. § 134 from a rejection of claims 1- 4, 7, and 9-36. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. The claims are directed to an adjustable and fixed assembled bone- tendon-bone graft. Claim 1, reproduced below, is illustrative of the claimed subject matter: 1 An implant comprising: a first bone component at a first end of said implant, a second bone component at a second end of said implant; and a segment of soft tissue having a first end, a midsection and a second end; wherein said first bone component comprises a bone block assembly for securing soft tissue comprising a first intermediate bone block and a second intermediate bone block, said first intermediate bone block and said second intermediate bone block sandwiching said soft tissue therebetween; and wherein the first end and the second end of said soft tissue contact said first bone component, and the midsection of said soft tissue contacts said second bone component; and wherein said first intermediate bone block comprises a tissue engaging surface that contacts one side of said soft tissue and said second intermediate bone block comprises a tissue engaging surface that contacts an opposing side of said soft tissue; and wherein the tissue engaging surface of said first intermediate bone block comprises at least one compression surface and at least one cavity, said at least one compression surface for compressing said soft tissue against the opposing face, and said at least one cavity for receiving overflow soft tissue from said at least one compression surface; and wherein said at least one cavity comprises at least one channel having an undercut cross sectional profile. Appeal 2010-005322 Application 11/313,280 3 REFERENCES The prior art relied upon by the Examiner in rejecting the claims on appeal is: Moertel Talboy Allcock US 4,034,444 US 4,611,592 US 5,902,015 Jul. 12, 1977 Sep. 16, 1986 May 11, 1999 Buskirk Steiner ‘810 Steiner ‘811 Hermann Dinger Kalfas US 2002/0072806 A1 US 2003/0171810 A1 US 2003/0171811 A1 US 2005/0059987 A1 US 2005/0159812 A1 US 2005/0228378 A1 Jun. 13, 2002 Sep. 11, 2003 Sep. 11, 2003 Mar. 17, 2005 Jul. 21, 2005 Oct. 13, 2005 REJECTIONS Claims 1-4, 7, 9, 10, 12-15, 18, 19, 22-27, 29, and 32-36 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Buskirk, Steiner ‘810, and one of Hermann, Kalfas, Talboy or Moertel. Ans. 4. Claim 11 is rejected under 35 U.S.C. § 103(a) as being unpatentable over the combination of references applied to claim 7 supra, and further in view of Allcock. Ans. 17. Claims 16, 17, 20, and 21 are rejected under 35 U.S.C. § 103(a) as being unpatentable over the combination of references applied to claim 14 supra, and further in view of Dinger. Ans. 18. Claims 28, 30, and 31 are rejected under 35 U.S.C. § 103(a) as being unpatentable over the combination of references applied to claim 23 supra, and further in view of Steiner ‘811. Ans. 20. OPINION The Examiner determined that Buskirk discloses the basic implant of each of the independent claims involved in this appeal, 1, 32, 33, and 34. Appeal 2010-005322 Application 11/313,280 4 Ans. 4-5. The Examiner also determined that it would have been obvious to modify Buskirk to include a loop-type arrangement as described in Steiner ‘810. Ans. 5-6. Neither of these points is in dispute. The Examiner recognized that Buskirk “fails to teach the at least one cavity to comprise at least one channel having an undercut cross sectional profile” as required by each of the claims involved in this appeal. Ans. 6 (bold face in original). The Examiner initially seems to rely on Hermann, Kalfas, Talboy and Moertel as teaching channels. Ans. 6-8. However, the Examiner also appears to recognize that, to discourage slippage at the bone-soft tissue interface, Buskirk suggests using grooves (Buskirk p. 7, para. [0082]) which may reasonably be interpreted as a “channel[s].” Ans. 22. In any case, it is clear that Buskirk fails to teach or suggest providing those grooves with an undercut cross sectional profile. Hermann, Kalfas, Talboy, and Moertel are each cited by the Examiner, as alternatives, to account for this deficiency. Of the four references cited by the Examiner, Hermann comes the closest to providing the requisite evidentiary support for a conclusion of obviousness. However, Hermann still falls short. Like Appellants, we agree that the embodiment of Hermann depicted in figures 2A-C, as cited by the Examiner (Ans. 6), does not teach “channel[s].” The Specification makes a distinction between structures having “teeth or ridges” and channels. Spec. 10, paras. [23], [24]. Thus, to the extent the Examiner takes the position, we cannot agree that a person of ordinary skill in the art would understand Hermann’s discrete traction elements 200 to form “channel[s]” as read in light of the Specification because they are more like the distinguished teeth. Appeal 2010-005322 Application 11/313,280 5 Further, to the extent the Examiner takes the position that the shape of the traction elements in the embodiment depicted in Figures 2A-C of Hermann would have led one of ordinary skill in the art to modify Buskirk’s grooves to have an undercut cross section (Ans. 22), we also cannot agree. While Hermann states that this configuration improves traction on body tissues while minimizing trauma (p. 1, para. [0012]), the specific purpose of the shape of the head portion is not expressly stated. Hermann does not discuss exactly how these structures interact with tissue. Thus, it is not clear how such a shape would be incorporated into Buskirk’s grooves to provide some benefit. Furthermore, the term undercut as used to describe a cavity is expressly defined in the Specification: “the cavities open up to be wider than their surface opening.” Spec., para. [26]. When viewed from the side in Figure 2A the head portion 202 of each traction element does define an open space thereunder. But the elements that appear adjoining in Figure 2A are actually staggered. See Figs. 2B, 2C. In the embodiment depicted in Figures 2A-C of Hermann there does not appear to actually be cavities opening up to be wider than their surface opening. Thus, even if the general shape of the open space were somehow incorporated into Buskirk’s groves, it does not appear that such a modification would yield the claimed subject matter. Accordingly the rejections based upon the Examiner’s proposed combination of Buskirk, Steiner, and Hermann cannot be sustained. We also agree with Appellants that the rejections based in part on either Kalfas, Talboy, or Moertel also cannot be sustained. App. Br. 14-16, 20-21. What we agree is lacking in each of the Examiner’s proposed combinations is a reasonable expectation that Buskirk’s device would successfully benefit from the combination proposed by the Examiner. Appeal 2010-005322 Application 11/313,280 6 The portion of Kalfas the Examiner purports teaches an undercut profile, bore 222, is for receiving a rod 220 in a rigid spinal implant system. Ans. 7 (citing Kalfas Fig. 3). For Talboy, it is the area between projections 42 in a clamp for holding an electrical or suction line during a surgical procedure. Ans. 7 (citing Talboy Fig. 3b). For Moertel, it is the openings accommodating a flexible elongate member 50 in leg portion 32 of head portion 30 of the coupling elements 22, 24 of a zipper-type arrangement (fig. 1). While the Examiner has established that undercutting is a technique used in various devices, we find no evidence of record or reasoning articulated by the Examiner to demonstrate that one of ordinary skill in the art would have reasonably expected some predictable benefit to result from applying the teachings of Kalfas, Talboy, or Moertel regarding undercutting to Buskirk’s tissue-engaging grooves. The undercuts of Kalfas, Talboy, and Moertel do not involve contacting tissue or a material demonstrated by the Examiner to be recognized as similar. Thus, the Examiner has not established that one of ordinary skill in the art would have recognized Kalfas, Talboy and Moertel’s teachings related to undercutting as pertinent to such an application. “[I]t is not enough to simply show that the references disclose the claim limitations; in addition, ‘it can be important to identify a reason that would have prompted a person of ordinary skill in the art to combine the elements as the new invention does.’” Transocean Offshore Deepwater Drill., Inc. v. Maersk Contractors USA, Inc., 617 F.3d 1296, 1303 (Fed. Cir. 2010) (Citing KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398, 401 (2007)). The remaining references, as applied by the Examiner, do not account for the aforementioned deficiencies. Appeal 2010-005322 Application 11/313,280 7 DECISION The Examiner’s rejections are reversed. REVERSED hh