Ex Parte Bergin et alDownload PDFPatent Trial and Appeal BoardMay 26, 201612920695 (P.T.A.B. May. 26, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 12/920,695 10/28/2010 13387 7590 05/31/2016 SMITH & NEPHEW, INC. ATTN: Chief Patent Counsel 7135 Goodlett Farms Parkway Cordova, TN 38016 FIRST NAMED INVENTOR Alisha W. Bergin 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. 105826-0212-301 7473 EXAMINER HOBAN, MELISSA A ART UNIT PAPER NUMBER 3738 NOTIFICATION DATE DELIVERY MODE 05/31/2016 ELECTRONIC 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. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address( es): USPatentMail@ropesgray.com USPatentMail2@ropesgray.com Sabrina.Chambers@smith-nephew.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte ALISHA W. BERGIN, RICHARD D. LAMBERT, and DAVID C. KELMAN Appeal2014-002958 Application 12/920,695 Technology Center 3700 Before LINDA E. HORNER, MARK A. GEIER, and PAUL J. KORNICZKY, Administrative Patent Judges. HORNER, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Alisha W. Bergin et al. (Appellants) 1 seek our review under 35 U.S.C. § 134 of the Examiner's decision rejecting claims 7-10 and 12-172 under 35 U.S.C. § 103(a) as unpatentable over Meyer (US 4,549,319, issued October 29, 1985) and Bassik (US 2005/0203634 Al, published September 15, 2005). We have jurisdiction under 35 U.S.C. § 6(b ). 1 Appellants identify Smith & Nephew, Inc. as the real party in interest. Br. 2. 2 Claims 1-6, 11, 18, and 19 have been canceled and claims 20-23 have been withdrawn from consideration. Br. 5. Appeal2014-002958 Application 12/920,695 We AFFIRM. CLAIMED SUBJECT MATTER Appellants' claimed subject matter relates to a system "for implanting a modular revision hip prosthetic." Spec. para. 2. Claims 7 and 14 are independent claims. Claim 7 is illustrative of the subject matter on appeal and is reproduced below. 7. A revision hip implant comprising: (a) a monolithic stern having a long axis, a body portion, a distal intrarnedullary canal portion, and a proximal intrarnedullary canal portion located between the body portion and the distal intrarnedullary canal portion, wherein: (i) the body portion comprises a neck interface surface and a distal surface extending generally radially out frorn the long axis of the stern; and (ii) the proximal intrarnedullary canal portion comprises a distally extending taper surface; (b) a sleeve configured to be received over the distal intrarnedullary canal portion of the stern and further having: an inner surface configured to rnate with the distally extending taper surface of the proximal intrarnedullary canal portion; and a conical portion and a cylindrical portion, the conical portion being oriented proximal to the body portion of the stern and the cylindrical portion extending distally away frorn the conical portion; and ( c) a neck comprising a neck taper portion configured to be received in the neck interface surface of the body portion of the stern at an angle to the long axis. Br. 11 (Claims App.). 2 Appeal2014-002958 Application 12/920,695 ISSUE Appellants argue all of the claims on appeal as a group. Br. 5. We select independent claim 7 as the representative claim, and the remaining claims 8-10 and 12-17 stand or fall with claim 7. 37 C.F.R. § 41.37(c)(l)(iv). The Examiner found that Meyer discloses a femoral prosthesis 40 having a conical taper 42 which fits within a tapered bore 35 of a thin- walled, conical sleeve 34. 3 Final Act. 3; id. at 5 (finding that Meyer's sleeve 34 has a proximal conical portion). The Examiner found that "Meyer does not explicitly teach a cylindrical portion extending distally away from the conical [portion of the] sleeve." Id. at 6. The Examiner determined that it would have been obvious to one having ordinary skill in the art to modify Meyer's sleeve to add a cylindrical portion extending distally from the conical portion "to properly fit the individual anatomical requirements of a particular patient." Id. (finding that Meyer teaches using alternative constructions to accommodate the endless variety of human bones and finding that Appellants' Specification does not support any criticality to the claimed shape); see also id. at 2. 3 The Examiner proposes to modify Meyer with the teaching of Bassik to make Meyer's system as a modular prosthetic kit having a neck taper portion configured to be received in the neck interface surface of the body portion of the stem. Final Act. 7-8. Appellants do not contest the Examiner's findings as to Bassik or the proposed modification of Meyer with the teaching of Bassik. 3 Appeal2014-002958 Application 12/920,695 Appellants argue that the Examiner erred in using the general statement in Meyer that bones vary between patients to support a contention that any change to the sleeve in Meyer to better fit varied bones would have been obvious. Br. 7. Appellants further argue that Meyer teaches the conical shape of its sleeve provides for a taper locking interaction between the sleeve and stem, and that Meyer does not discuss making any modifications to the shape of the conical sleeve or address making such a change while still maintaining the taper locking mechanism. Id. Appellants contend that the shape of the claimed sleeve "provides an improved fit for some bones compared to an implant without a sleeve or an implant with a purely conical sleeve" and that the claimed sleeve "provides more flexibility for a surgeon and allows the surgeon to better fit some bone variations that cannot be fit well using an implant that allows a surgeon only to choose different sizes of conical sleeves." Id. at 8. The issue before us on appeal is whether the Examiner articulated adequate reasoning based on rational underpinnings to explain why one having ordinary skill in the art at the time of Appellants' invention would have been led to modify the conical sleeve of Meyer to include a cylindrical portion extending distally away from the conical portion of the sleeve. ANALYSIS Meyer discloses that one skilled in the art of joint prostheses uses the following three generally accepted principles for "successful fixation of joint prostheses by direct bone contact and support of the prosthesis": 4 Appeal2014-002958 Application 12/920,695 One, the prosthesis must be in contact with sound bone .... Two, the prosthesis must be a good fit in the prepared bony cavity. And three, there must not be motion between the prosthesis and the bone. Meyer, col. 2, 11. 52-63. Meyer discloses that these requirements "are closely interrelated and very much dependent on favorable geometric relationship between the prosthesis and the bone." Id., 11. 64-67. Meyer identifies the problem in the art as being "one of providing a prosthesis of the correct shape and size to contact the patient's bone at the optimum interface surface for satisfactory transfer of force from the prosthesis to the bone." Id., col. 3, 11. 3-7. Meyer also acknowledges that "[b]ecause humans vary so remarkably in physical size and shape, we begin to see that each prosthesis should be custom sized and shaped to suit the bone into which it is to be implanted." Id., 11. 15-18. Meyer identifies that one object of the invention is to: provide means for fastening intimately the load bearing component of an artificial joint prosthesis with high initial fastening strength without the use of [polymethyl methacrylate] cement in that part of the bone nearest the joint motion surface, while also permitting the critical structural load bearing component to have generous physical dimensions and contours which either add to, or do not diminish, the fatigue endurance strength of the prosthesis. Id., 11. 60-68. To achieve this object, Meyer teaches use of a collar, which abuts the excised proximal end of the femur, to transfer the force of compression from the prosthesis to the bone. Id., col. 5, 11. 6-8. Meyer discloses one embodiment in which a thin-wall truncated conical sleeve includes an 5 Appeal2014-002958 Application 12/920,695 integral collar and longitudinal fins, and the shaft of the stem is smooth and tapered and locks within the sleeve through the principle of mechanical tapers. Id., col. 6, 11. 31-33, 39--42; see also id., col. 11, 11. 49-58, Figs. 6- 11. Meyer discloses: This embodiment offers the advantages of permitting a variety of size selections for the sleeve component and for the stem component separately. Thus a smaller number of total components is needed to achieve a given number of total size combinations for the final assembly. The two component embodiment may be more economical to manufacture, and will conveniently allow selection of size and implantation of the sleeve before the stem is implanted. Id., col. 6, 11. 42-51; see also id., col. 11, 11. 59-62. Meyer discloses that to implant this prosthesis, the surgeon excises the head and neck of the femur and then reams the femoral canal to a depth and diameter to accept the stem and to accommodate the wall thickness of the sleeve. Id., col. 12, 11. 8-15. Meyer includes a series of sleeves, preferably four, of increasing sizes of envelope for each given tapered bore size, so that the surgeon can securely fix the sleeve in the proximal femur. Id., col. 12, 1. 58 - col. 13, 1. 3. Based on these disclosures, Meyer teaches that the design incentive of ensuring that the prosthesis is a good fit in the prepared bone cavity so as to avoid any motion between the prosthesis and the bone was present in the art, and Meyer recognizes that a prosthesis that is custom sized and shaped to fit the bone into which it is to be implanted is preferable due to the variation among humans in physical size and shape. We agree with the Examiner (Final Act. 2, 6) that this design incentive would have led one having 6 Appeal2014-002958 Application 12/920,695 ordinary skill in the art, through routine experimentation, to change the shape of the conical sleeve of Meyer, and that the claimed sleeve having a conical portion and a cylindrical portion extending distally from the conical portion is a predictable variation of Meyer's conical sleeve. "When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability." KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007). "[T]he analysis need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418. In light of the background knowledge of one having ordinary skill in the art, as evidenced by Meyer, the difference in shape between ivieyer' s conical sleeve and the claimed sleeve is not a patentable distinction. Although Meyer's solution is to use a collar that is conical in shape along its entire length, we are not persuaded by Appellants that Meyer would have discouraged one having ordinary skill in the art, in an effort to achieve the best fit for the bone cavity, from adding a cylindrical portion to the sleeve extending distally away from the conical portion. The addition of such a cylindrical portion would not detract from the taper locking function of Meyer's sleeve, because the Examiner's proposed modification does not propose to eliminate the conical portion of the sleeve, through which the taper locking occurs. 7 Appeal2014-002958 Application 12/920,695 Further, as noted by the Examiner (Final Act. 2), Appellants' Specification describes that the sleeve can be either entirely conical, or entirely cylindrical, or have both a conical portion and a cylindrical portion and that "[t]he shape and characteristics of the sleeve are chosen based upon the bone of the patient." Spec. paras. 27-28. Appellants do not show by persuasive argument or evidence that the claimed sleeve having both a conical portion and a cylindrical portion achieved unpredictable results over the prior art conical sleeve. Rather, Appellants acknowledge that the shape of the sleeve is dictated by the bone of the patient and that the claimed sleeve is preferable over a conical sleeve only for "some bones" and "some bone variations." Appeal Br. 8. For these reasons, we do not find Appellants' arguments persuasive of error in the rejection of claim 7 under 35 U.S.C. § 103(a) as unpatentable over ivieyer and Bassik. As such, we sustain the Examiner's rejection of claim 7, and claims 8-10 and 12-17 fall with claim 7. DECISION The decision of the Examiner to reject claims 7-10 and 12-17 is 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). See 37 C.F.R. § 1.136(a)(l )(iv). AFFIRMED 8 Copy with citationCopy as parenthetical citation