Ex Parte 6623486 et alDownload PDFPatent Trials and Appeals BoardAug 19, 201395000468 - (D) (P.T.A.B. Aug. 19, 2013) Copy Citation 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. 90/009,378 01/08/2009 6623486 SYNT-0703 5757 53443 7590 08/19/2013 WOODCOCK WASHBURN LLP CIRA CENTRE, 12TH FLOOR 2929 ARCH STREET PHILADELPHIA, PA 19104-2891 EXAMINER REIP, DAVID OWEN ART UNIT PAPER NUMBER 3993 MAIL DATE DELIVERY MODE 08/19/2013 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 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. 95/000,468 05/08/2009 6623486 SYNT-0712 2083 53443 7590 08/19/2013 WOODCOCK WASHBURN LLP CIRA CENTRE, 12TH FLOOR 2929 ARCH STREET PHILADELPHIA, PA 19104-2891 EXAMINER REIP, DAVID OWEN ART UNIT PAPER NUMBER 3993 MAIL DATE DELIVERY MODE 08/19/2013 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 ____________________ SMITH & NEPHEW, INC. Requester, Cross-Appellant, Respondent v. SYNTHES (U.S.A.) Patent Owner, Appellant, Respondent ____________________ Appeal 2013-002114 Reexamination Control 95/000,468 and 90/009,378 1 Patent US 6,623,486 B1 2 Technology Center 3900 ____________________ Before RICHARD M. LEBOVITZ, JEFFREY B. ROBERTSON and DANIEL S. SONG, Administrative Patent Judges. SONG, Administrative Patent Judge. DECISION ON APPEAL 1 These reexamination proceedings were merged by Decision, Sua Sponte, to Merge Reexamination Proceedings, mailed July, 10, 2009. The citations in this decision are to the record of inter partes Reexamination Control 95/000,468 unless otherwise indicated. 2 Issued September 23, 2003 to Weaver et al. (hereinafter "'486 patent"). Appeal 2013-002114 Reexamination Control 95/000,468 and 90/009,378 Patent US 6,623,486 B1 2 Claims 1-18 are subject to reexamination (RAN 3 1). The Patent Owner appeals from the Examiner's Final Rejection of claims 1-13, 16 and 17 under 35 U.S.C. §§ 134, 306 and 315 (2002), the appeal of claims 14, 15 and 18 having been withdrawn (ABPO 1). The Requester also cross-appeals under 35 U.S.C. §§ 134 and 315, the Examiner's non-adoption of certain proposed rejections for claims 10-13 (CABR 2). We have jurisdiction of the appeal under 35 U.S.C. §§ 134, 306 and 315. An oral hearing with the Patent Owner's representative and the Respondent's representative was held before the Patent Trial and Appeal Board on April 3, 2013, a transcript of which has been entered into the electronic record. The '486 patent is presently involved in the following infringement litigation proceedings, both of which have been stayed pending the conclusion of the present reexamination proceeding (ABPO 1): 3 The following abbreviations for certain documents in the record are used herein the documents as follows: 1. Right of Appeal Notice = RAN 2. Appeal Brief of Patent Owner = ABPO 3. Rebuttal Brief of Patent Owner in response to Examiner's Answer = Reb. Br. PO 4. Cross-Appeal Brief of Requester = CABR 5. Respondent Brief of Requester in response to Appeal Brief of Patent Owner = Res. Br. R We also note that because the Examiner's Answer merely incorporates the RAN by reference, we cite to the RAN herein. Appeal 2013-002114 Reexamination Control 95/000,468 and 90/009,378 Patent US 6,623,486 B1 3 1. Synthes (U.S.A.) v. Smith & Nephew, Inc., Civil Action No. 03- 0084 (E.D. Pa); and 2. Synthes (U.S.A.) v. G.M. Dos Reiss JR Ind. Com De Equip Medico, Civil Action No. 3:07 cv 309 (S.D. Cal.). In the present reexamination proceeding, 93 grounds of rejections were proposed by the Requester. The Examiner adopted 86 of these proposed grounds (Grounds 1, 2, 6, 8, 9, 11-85, 4 87-92; RAN 14-15). The Patent Owner appeals 77 of the adopted grounds that reject one or more of claims 1-13, 16 and 17 which are rejected under Grounds 1, 2, 8, 9, 11-17, 19-32, 34-37, 39-41, 43-45, 47-51, 53-61, 64-85 and 87-92 5 (ABPO 1). Of the proposed grounds of rejection not adopted by the Examiner, Grounds 12, 6 86 and 93 are cross-appealed by the Requester (CABR 2). In addition to the various briefs submitted in support of its appeal and in response to the cross-appeal, the Patent Owner also relies on Declarations of Drs. Turen and Parsons, and Mr. Haag, together with Exhibits referred to therein. Similarly, in addition to the various briefs submitted in support of its cross-appeal and in response to the Patent Owner's appeal, the Requester also relies on the Declarations of Mr. Donoghue and Dr. Marsh. We AFFIRM the Examiner's rejections with respect to the Patent Owner's appeal, and do not reach the Requester's cross-appeal. 4 Ground 12 adopted only with respect to claim 11 (RAN 23-24). 5 The appeal of claim(s) 14, 15 and 18 that were rejected under Grounds 6, 18, 33, 38, 42, 46, 52, 62 and 63 was withdrawn by the Patent Owner (ABPO 1). 6 Ground 12 cross-appealed only with respect to claim 12. Appeal 2013-002114 Reexamination Control 95/000,468 and 90/009,378 Patent US 6,623,486 B1 4 BACKGROUND The subject '486 patent issued from a continuation application of an application that issued as U.S. Patent No. 7,128,744 7 which was the subject of the Board's 8 decision in an inter partes reexamination appeal 9 involving the same parties. Smith & Nephew, Inc. v. Synthes, 2012 WL 169750 (BPAI) (hereinafter "Board Decision" or "Board Dec."). The Board Decision was appealed to the Court of Appeals for the Federal Circuit which recently rendered a decision reversing the Board. Smith & Nephew, Inc. v. Rae and Synthes, 2013 WL 3388454 (Fed. Cir. 2013). Because some of the issues raised in the present appeal were addressed or overlap with those in Smith & Nephew v. Rae and Synthes, we discuss the Board Decision and the Court's reversal prior to addressing the present appeal. Board Decision In the appeals involving the parent U.S. Patent No. 7,128,744 (hereinafter "'744 patent"), two of the main issues were: 1. Whether the Examiner erred in concluding that it would have been obvious to one of ordinary skill in the art to modify a condylar buttress plate having a head portion that includes unthreaded bone anchor holes as described in K982222, Koval or Synthes Catalog so as to only provide holes having a threaded portion in the head portion of the buttress plate. 7 Issued to Weaver et al. on Oct. 31, 2006. 8 Formerly Board of Patent Appeals and Interferences. 9 Appeal No. 2011-010701. Appeal 2013-002114 Reexamination Control 95/000,468 and 90/009,378 Patent US 6,623,486 B1 5 2. Whether the Examiner erred in concluding that it would have been obvious to one of ordinary skill in the art to modify a condylar buttress plate as described in K982222, Koval or Synthes Catalog to provide holes in the shaft portion of the buttress plate having a threaded portion as well as non-threaded holes. ('744 Board Dec. *3). As to "Issue 2," the Board affirmed the Examiner's rejections concluding that it would have been obvious to one of ordinary skill to modify a condylar buttress plate as described in K982222, Koval or Synthes Catalog to provide holes in the shaft portion of the buttress plate having a threaded portion as well as non-threaded holes ('744 Board Dec. *10). However, as to "Issue 1," the Board reversed various rejections of claims requiring the bone plates to have a head with only threaded holes which are conically tapered, concluding that the articulated rationale 10 for 10 The Examiner adopted the rejection proposed by the Requester, the following articulated rationale being representative: [I]t would be obvious to one of ordinary skill in the art to modify K982222 to include a head portion that includes only threaded, conically tapered holes since such a configuration is nothing more than one of numerous configurations one of ordinary skill would find obvious for the intended use given the known advantages of using threaded holes in the head portion of a plate. Haas, for example, discloses a bone plate that has a head portion that includes all threaded holes. … The plate holes of Haas are all threaded and conically tapered …. It would be obvious to modify K982222 with Haas based on the advantages of locked screws as discussed in Haas (e.g., "the angularly stabile, screw/plate connection which is achieved by means of the outer thread of the screw head and an internal threading of Appeal 2013-002114 Reexamination Control 95/000,468 and 90/009,378 Patent US 6,623,486 B1 6 modifying condylar buttress plates so as to provide a head with only threaded holes lacked adequate rational underpinnings and was likely based on impermissible hindsight because provision of non-threaded holes in the head allowed for generation of compression which is an important function of such plates (id. at *7). The Board also stated that the evidence was "insufficient to establish that the tapered holes disclosed in Haas are usable to impart compression," or to establish that such holes "were one of the known hole configurations that were suitable for use with both non-locking and locking screws." (Id. at *7-*8). The Requester appealed the Board Decision to the Federal Circuit. CAFC Decision: Smith & Nephew, Inc. v. Rae and Synthes Upon appeal by the Requester, the Court reversed the Board Decision and held that "the examiner correctly ruled that disputed claims would have been obvious." 2013 WL 3388454 *8. In its decision, the Court rejected the Board's analysis and stated the following: 1. If a physician regarded it as preferable to have stabilization rather than compression in the head portion of a bone plate, an obvious solution would have been to use more threaded holes and locking screws in that part of the plate. (Id. at *4). 2. [A] person of ordinary skill would not have had to use a screw with a 'rounded-bottom head' that would stick the plate hole, thus prohibiting a varying direction the [sic] screw" (p. 341)). (Board Dec. at *6, quoting Request for Inter Partes Reexamination, Exhibit E, 4). Appeal 2013-002114 Reexamination Control 95/000,468 and 90/009,378 Patent US 6,623,486 B1 7 out from the plate. Instead, a conically shaped screw could sit in the Haas holes without any risk of protrusion. The '744 specification states, as a general proposition, that 'any surgical screw that has a non-threaded head ... of an appropriate size and geometry for select plate holes of the bone plate can be used' in the claimed bone plate. '744 patent, col. 4, ll. 20–22. The patent thus suggests the choice of any appropriate screw design rather than limiting the choice to a screw that would sit too high in a conical hole. (Id. at *5). 3. [T]he Board's reliance on the fact that the partially threaded holes in the ′686 patent are only partly conical (and partly cylindrical) does not undermine the '744 patent's admission that partially threaded holes, regardless of their shape, could provide compression. Neither the Board nor Synthes has argued that there is anything about the Haas fully conical shape that would suggest that a standard, non-locking screw could not have been used in such a hole to achieve compression. (Id. at *5). 4. The patent confirms what common sense suggests: a person of skill could adjust a plate hole's geometry—whether conical, cylindrical, or otherwise—to fit any standard screw without sacrificing compression. (Id. at *5). 5. The ′744 specification's description of the '686 patent therefore discloses that the prior art used non-locking screws in threaded holes. Because that prior art reference demonstrated that non-locking screws could achieve compression in either type of hole, the motivation to combine the Haas holes with the condylar plates was clear: The use of threads in all of the holes would offer the advantage of added flexibility for the surgeon, who could choose to use locking or non-locking screws in any of the holes in the head portion of the plate. (Id. at *6). 6. The Board discounted [DRP and LRP] references on the ground that the examiner had not relied on them as a basis Appeal 2013-002114 Reexamination Control 95/000,468 and 90/009,378 Patent US 6,623,486 B1 8 for his rejections. The examiner, however, incorporated Smith & Nephew's arguments by reference, including its discussion of those two references. The references were clearly probative as to whether it was known at the time of the invention that non- locking screws could be used in threaded holes. (Id. at *6). Thus, the court made clear in its decision that modifying condylar buttress plates of K982222 and Koval that have a head portion with both threaded and non-threaded holes so as to provide only threaded holes as shown in Haas would have been obvious to one of ordinary skill in the art. THE CLAIMED INVENTION Claims 1-13, 16 and 17 on appeal are directed to a bone plating system which is used to repair a bone fracture, and a method for bone fracture fixation. Independent claims 1, 10, 16 and 17 read as follows (ABPO, Claims App'x., paragraph formatting and emphasis added): 1. A bone plating system for fixation of bone comprising: a bone plate having: an upper surface; a bone-contacting surface; at least one first hole passing through the upper and bone-contacting surfaces and having a thread; and at least one second hole passing through the upper and bone-contacting surfaces; a first screw having a shaft with a thread for engaging bone and a head with a thread configured and dimensioned to mate with the thread of the first hole; and a second screw having a shaft with a thread for engaging bone and a head, wherein the first and second screws remain seated in their respective holes for substantially as long as the bone plate is implanted, Appeal 2013-002114 Reexamination Control 95/000,468 and 90/009,378 Patent US 6,623,486 B1 9 wherein the bone plate includes a plurality of first and second holes, and a corresponding plurality of first and second screws are provided, and wherein the bone plate includes a head portion configured and dimensioned to conform to a metaphysis of a bone and a shaft portion configured and dimensioned to conform to a diaphysis of a bone and the head portion has only first plate holes. 10. A method for fracture fixation of bone comprising the steps of: reducing the fracture to bring bone fragments in close apposition; compressing a bone plate against the bone with at least one first fastener to hold the fracture reduction; and securing at least one second fastener at a fixed angular relationship to the bone plate, wherein the at least one first fastener is inserted before the at least one second fastener and the at least one first fastener and the at least one second fastener remain in bone for substantially as long as the bone plate is implanted. 16. A bone plating system for fixation of bone comprising: a bone plate having: an upper surface; a bone-contacting surface; at least one first hole passing through the upper and bone-contacting surfaces and having a thread; and at least one second hole passing through the upper and bone-contacting surfaces; a first screw having a shaft with a thread for engaging bone and a head with a thread configured and dimensioned to mate with the thread of the first hole; and a second screw having a shaft with a thread for engaging bone and a head, wherein the first and second screws remain seated in their respective holes for substantially as long as the bone plate is implanted, Appeal 2013-002114 Reexamination Control 95/000,468 and 90/009,378 Patent US 6,623,486 B1 10 wherein the bone plate includes a plurality of first and second holes, and a corresponding plurality of first and second screws are provided, and wherein the bone plate includes a head portion configured and dimensioned to conform to a metaphysis of a bone and a shaft portion configured and dimensioned to conform to a diaphysis of a bone and wherein the head portion has a curved surface, includes an anterior fork substantially parallel to an anterior side of the shaft portion, and includes a posterior fork extending out from a posterior side of the shaft portion. 17. A bone plating system for fixation of bone comprising: bone plate having: an upper surface; a bone-contacting surface; at least one first hole passing through the upper and bone-contacting surfaces and having a thread; and at least one second hole passing through the upper and bone-contacting surfaces; a first screw having a shaft with a thread for engaging bone and a head with a thread configured and dimensioned to mate with the thread of the first hole; and a second screw having a shaft with a thread for engaging bone and a head, wherein the first and second screws remain seated in their respective holes for substantially as long as the bone plate is implanted, wherein the bone plate includes a plurality of first and second holes, and a corresponding plurality of first and second screws are provided, and wherein the bone plate includes a head portion configured and dimensioned to conform to a metaphysis of a bone and a shaft portion configured and dimensioned to conform to a diaphysis of a bone and wherein the shaft portion has both first and second plate holes. Appeal 2013-002114 Reexamination Control 95/000,468 and 90/009,378 Patent US 6,623,486 B1 11 APPEAL OF THE PATENT OWNER The Rejections In view of the large number of rejections, we do not reproduce the rejections herein but point to the proposed rejections as set forth in the Right of Appeal Notice (RAN 5-14). However, the rejections can be generally categorized as follows: 1. Rejections principally based on K982222 11 (Grounds 28-32, 34- 37, 39-41, 43-45, 47). 2. Rejections principally based on Zimmer 12 (Grounds 65-80). 3. Rejections principally based on Koval 13 (Grounds 89-92). 4. Rejections principally based on Mückter 14 (Grounds 21-27). 5. Rejections principally based on Distal Radius Plate 15 (Grounds 81-85, 87, 88). 6. Rejections principally based on Schuhli Guide 16 (Grounds 1, 2, 8, 48-51, 53-61, 64). 11 Summary of Safety and Effectiveness Information, No. K982222, August 26, 1988. 12 Periarticular Plating System (Advertisement), 12 J. of Ortho. Trauma 5, June/July 1998. 13 Koval, K., et al., Distal Femoral Fixation: A Biomechanical Comparison of the Standard Condylar Buttress Plate, a Locked Buttress Plate, and the 95-Degree Blade Plate, 11 J. of Orthopaedic Trauma 7, pp. 521-524, October, 1997. 14 Patent WO 99/25266 issued to Mückter 15 Synthes, The Titanium Distal Radius Plate Technique Guide (hereinafter "DRP") 1997. 16 Synthes, Schuhli Technique Guide, 1995 (hereinafter "Schuhli Guide"). Appeal 2013-002114 Reexamination Control 95/000,468 and 90/009,378 Patent US 6,623,486 B1 12 7. Rejections principally based on Kassab 17 (Grounds 13-17, 19, 20). 8. Rejection principally based on Haag 18 (Ground 9). 9. Rejections principally based on Locking Reconstruction Plate 19 (Grounds 11, 12). Issues The dispositive issues on appeal are as follows: 1. Whether the Examiner erred in concluding that it would have been obvious to one of ordinary skill in the art to modify a condylar buttress plate having a head portion that includes unthreaded bone anchor holes as described in K982222 or Koval so as to only provide holes having a thread in the head portion. 2. Whether the Examiner erred in concluding that providing a bone plate with an anterior fork substantially parallel to an anterior side of the shaft portion would have been an obvious variation, and that such a fork is disclosed in the plate of the Synthes Catalog. 3. Whether the Examiner erred in concluding that it would have been obvious to one of ordinary skill in the art to modify a condylar buttress 17 Kassab, S.S., et al., Patients Treated for Nonunion with Plate and Screw Fixation and Adjunctive Locking Nuts, 347 Clinic. Ortho. And Related Research, pp. 86-92, Feb. 1998. 18 Patent US 5,976,141 issued to Haag. 19 Synthes Maxillofacial, The Locking Reconstruction Plate Technique Guide (hereinafter "LRP") 1997. Appeal 2013-002114 Reexamination Control 95/000,468 and 90/009,378 Patent US 6,623,486 B1 13 plate as described in K982222 or Koval to provide threaded holes in the shaft portion of the buttress plate as well as non-threaded holes. 4. Whether the Examiner erred in finding that the method of claim 10 is disclosed in Kassab. 5. Whether the Examiner erred in concluding that the method of claim 10 would have been obvious to one of ordinary skill in the art based on Schuhli Guide in view of Klaue '823. Analysis Apparatus Claims 1-9, 16 and 17 As to the apparatus claims 1-9, 16 and 17, sixty-eight different grounds of rejections have been adopted by the Examiner and are appealed by the Patent Owner. While we have considered all of these appealed grounds of rejections and arguments of the parties submitted, we limit our decision to certain rejections based on K982222 and Koval as they formed the basis for the rejections in the appeal of the parent '744 patent. Prior art references K982222 and Koval each disclose a condylar buttress plate that includes a head portion with threaded holes, but also includes two holes that are not threaded (K98222 Description; Koval Abstract, Discussion, Fig. 1). Claims 1-9 Grounds 30-32 reject apparatus claims 1-9 based on K982222 in view of Haas, as well as various tertiary prior art references for certain claims, by modifying the K982222 plate so as to provide only threaded holes on the head portion thereof (RAN 7-8, 14). Grounds 89-92 similarly reject Appeal 2013-002114 Reexamination Control 95/000,468 and 90/009,378 Patent US 6,623,486 B1 14 apparatus claims 1-9 based on the combination of Koval and Haas, as well as various tertiary prior art references for certain claims (RAN 13-14). The secondary reference Haas discloses a "Less Invasive Stabilization System" plate in which all of the holes are conical and threaded to receive screws with threaded heads (Haas, pp. 340-341, Diags. 3 and 4). As to independent claim 1, the dispute centers on the limitation that "the head portion has only first plate holes" which are recited to be threaded ("at least one first hole passing through the upper and bone-contacting surfaces and having a thread"). The Examiner rejected this claim based on the combination of K982222 and Haas, adopting the proposed rejection set forth by the Requester which stated: To the extent that K982222 does not disclose a head portion having only first plate holes, it would be obvious to one of ordinary skill in the art modify K982222 to include a head portion that includes only first holes since such a configuration is nothing more than one of numerous configurations one of ordinary skill would find obvious for the intended use given the known advantages of using threaded, first plate holes in the head portion of a plate. Haas, for example, discloses a bone plate that has a head portion that includes all threaded holes. … The plate holes of Haas are all threaded, therefore, the head has only first plate holes. Based on the disclosure of Haas, it would have been obvious to one of ordinary skill in the art to modify K982222 to include all threaded holes in the head portion, as taught by Haas, to achieve the advantages of using a locking screw arrangement (e.g., based on the disclosure of Haas regarding the advantages of using a locking screw arrangement so that there is "no longer any compression pressures on the periosteum and circulation remains unimpeded." (Summary). (Request for Inter Partes Reexamination, Exhibit U, pp. 3-4; see also pp. 75-76). Appeal 2013-002114 Reexamination Control 95/000,468 and 90/009,378 Patent US 6,623,486 B1 15 The rationale for the rejections based on the combination of Koval and Haas is substantively similar (see Request for Ex Partes Reexamination pp. 48; Exhibit C, pp. 12). Thus, the issue raised with respect to these grounds and the articulated rationale substantively mirrors that of the related appeals of the parent '744 patent noted above (see supra, fn. 10). The Patent Owner's submitted arguments and evidence in support of patentability of independent claim 1, and claims 2-9 that ultimately depend therefrom, are substantively the same as those presented and addressed by the Court in Smith & Nephew v. Rae and Synthes, 2013 WL 3388454. In particular, the Patent Owner argues that there is no motivation to modify the plates in K982222 or Koval to have a head portion with only threaded bone anchor holes because the unthreaded holes function to allow for fracture reduction and compression, and their removal would render the plates inoperable for their intended purpose (ABPO 25-39). These arguments and evidence relied upon by the Patent Owner, as well as the analysis by the Board in agreement thereto, were found to be unpersuasive and erroneous by the Federal Circuit court. Smith & Nephew v. Rae and Synthes, 2013 WL 3388454, **4-6 (see excerpts of the Court's decision reproduced supra). The court held that it would have been obvious to modify condylar buttress plates of K982222 or Koval to provide a head having only threaded holes disclosed in Haas (id.). This case differs from Smith & Nephew v. Rae and Synthes because in this appeal before the Board, Synthes has relied upon secondary considerations of commercial success to establish the non-obviousness of the claimed subject matter. In the latter case, the court did not address the Appeal 2013-002114 Reexamination Control 95/000,468 and 90/009,378 Patent US 6,623,486 B1 16 evidence of commercial success in its decision because unlike in the appeal to the Board, Synthes did not rely on such evidence for patentability (Smith & Nephew v. Rae and Synthes, 2013 WL 3388454, *7, fn. 7 ("Synthes has not relied on any objective indicia of non-obviousness, such as commercial success, to buttress its case.")). Therefore, we consider the obviousness of the claims at issue in view of the proffered evidence of nonobviousness. For the reasons discussed infra under the heading "Commercial Success," we agree with the Examiner that the evidence does not adequately demonstrate non-obviousness of the claimed invention because the evidence is inadequate to establish nexus between the claimed invention and the commercial success. Correspondingly, the Examiner's rejections of independent claim 1 and dependent claims 2-9 in Grounds 30-32 (K982222 and Haas) and in Grounds 89-92 (Koval and Haas), are affirmed. Claim 16 Independent claim 16 is drawn to a bone plating system for fixation of bone. The claim comprises a bone plate and recites, inter alia, that the bone plate has the following features: wherein the head portion has a curved surface, includes an anterior fork substantially parallel to an anterior side of the shaft portion, and includes a posterior fork extending out from a posterior side of the shaft portion. Appeal 2013-002114 Reexamination Control 95/000,468 and 90/009,378 Patent US 6,623,486 B1 17 In addition, unlike independent claim 1, claim 16 does not recite that the head portion has only threaded holes. Claim 16 stands rejected under, inter alia, the following grounds: Ground 30 based on K982222 in view of Haas; Ground 47 based on K982222 in view of Synthes Catalog; and Ground 89 based on Koval in view of Haas. As to Grounds 30 and 89, the position of the Examiner as articulated by the Requester is that one of ordinary skill would appreciate such a fork structure would be an obvious variation to conform to the condyle structure of the femur (RAN 7, 13; see, e.g., Request for Inter Partes Reexamination, Exhibit U; see also ABPO 45). The Patent Owner argues that "this feature of claim 16 is not simply 'an obvious variation' useful to conform the plate to the condyle structure." (ABPO 46). The Patent Owner disagrees with the Examiner's assertion and states, "[t]he parallel anterior fork does nothing for conforming the plate to the curved condyle surface" and such conforming of the plate "has nothing whatsoever to do with the parallel relationship between the anterior fork of the head portion and the anterior side of the plate shaft." (Id., emphasis in original). According to the Patent Owner, while the specification of the '486 patent "fails to disclose a function for this parallel anterior-fork limitation," this feature "assist[s] in aligning the femur shaft because the plate is used as a fracture reduction aid" (Reb. Br. PO 32), such benefit apparently not being recognized in the art. We are not persuaded. Firstly, the Patent Owner does not direct our attention to evidence, such as testimony of an expert, as to how an anterior Appeal 2013-002114 Reexamination Control 95/000,468 and 90/009,378 Patent US 6,623,486 B1 18 feature that is "substantially parallel to an anterior side" functions to assist the alignment of the femur shaft. In re Schulze, 346 F.2d 600, 602 (CCPA 1965) (Mere argument is no substitute for such evidence). It is not apparent to us, nor has the Patent Owner adequately explained, how a "substantially parallel" anterior fork would further "assist" a surgeon in aligning the femur shaft considering the head portion of the plate must conform to the condyle surface of the bone thereby determining the position of the shaft portion to which the femur shaft must be secured. To the extent that the anterior side assists the alignment of the femur shaft by facilitating proper positioning of the head portion on the condyle structure, this is consistent with the Requester and the Examiner's position that shaping the head of the plate to properly conform to the condyle structure would be an obvious variation and design choice. As to Ground 47 which is based on the combination of K982222 and Synthes Catalog, the Patent Owner asserts that the Examiner's finding that Synthes Catalog discloses "an anterior fork substantially parallel to an anterior side of the shaft portion" is erroneous (ABPO 46). The Patent Owner's Appeal Brief includes an annotated Figure 7 of the '486 patent (id. at 46) and the photograph of a condyle buttress plate in Synthes Catalog which is purported to show that the anterior fork of Synthes Catalog is at an angle to the anterior side instead of being parallel (id. 46-47). However, we initially note that claim 16 does not recite "parallel" but instead, recites "substantially parallel." Furthermore, the Patent Owner's annotation of Figure 7 submitted in its Appeal Brief is contrary to the specification of the '486 patent. Fork 68 annotated and relied upon by the Appeal 2013-002114 Reexamination Control 95/000,468 and 90/009,378 Patent US 6,623,486 B1 19 Patent Owner as corresponding to the recited anterior fork is actually identified in the specification of the '486 patent as the "posterior fork 68" while fork 64 is identified in the specification as the "anterior fork 64." (See col. 6, ll. 18-22; Fig. 7). In particular, the specification states "[h]ead portion 60 includes an anterior fork 64 substantially parallel to an anterior side 66 of shaft portion 62." (Id.). Thus, the anterior fork of the plate in the Synthes Catalog is "substantially parallel" to the anterior side to the extent that the anterior fork 64 of the '486 patent is described to be substantially parallel. Finally, for the reasons discussed infra under the heading "Commercial Success," the evidence of commercial success submitted by the Patent Owner does not establish sufficient nexus between the evidence and the claimed invention so as to persuasively demonstrate non- obviousness of the claimed invention. Therefore, we agree with the Examiner and the Requester that the recited limitation is an obvious variation and design choice, and further agree that Synthes Catalog discloses the limitation at issue. Hence, we affirm the Examiner's rejection of claim 16 under Ground 30 (K982222 and Haas), Ground 47 (K982222 and Synthes Catalog) and Ground 89 (Koval and Haas). Claim 17 Claim 17 cites, inter alia, a bone plate "wherein the shaft portion has both first and second plate holes," that is, a shaft portion having both threaded and unthreaded holes. Unlike independent claim 1, claim 17 does not recite that the head portion has only threaded holes. This claim stands Appeal 2013-002114 Reexamination Control 95/000,468 and 90/009,378 Patent US 6,623,486 B1 20 rejected, inter alia, under Ground 30 based on K982222 in view of Haas, and under Ground 89 based on Koval in view of Haas. This issue substantively mirrors that of "Issue 2" in the related appeal at the Board with respect to the parent '744 patent reproduced supra (Board Dec. **9-11). In this regard, the Patent Owner's submitted arguments that "none [of the prior art] ever suggested modifying the shaft portion DCU holes," and that such replacement would result in loss of the functions provided by the DCU holes (ABPO 47-48) have been already addressed in the Board Decision with respect to the appeal regarding the parent '744 patent. Specifically, in discussing modification of the shaft portion of the condylar buttress plates of K982222 and Koval to also provide threaded holes of Hass (together with the existing unthreaded holes), we concluded that: In our view, it would have been obvious to one of ordinary skill in the art that the benefit of angular stabilization offered by providing threaded holes in the head portion of the bone plate would be similarly applicable to the shaft portion of the bone plate for reasons and benefit of being angular stabile as articulated in Haas (See Haas, 340-341; see also Decl. of Marsh, ¶¶ 77, 79-80, 83). Further, we observe that the proposed modification is not to only provide threaded holes in the shaft of the prior art condylar buttress plates. Rather, the suggested modification is to provide both non-threaded and threaded holes in the shaft. Hence, the compression between the condylar buttress plate and the bone can be attained using the non-threaded holes. … Therefore, based on the evidence before us, it would have been obvious to one of ordinary skill in the art that by providing both unthreaded as well as at least partially threaded holes in the shaft portion of the prior art Appeal 2013-002114 Reexamination Control 95/000,468 and 90/009,378 Patent US 6,623,486 B1 21 condylar buttress plates, the angular stabile connection of the screw/plate connection as taught in Haas can be attained. (Board Dec. *10). Finally, for the reasons discussed infra under the heading "Commercial Success," the evidence of commercial success submitted by the Patent Owner does not establish sufficient nexus between the evidence and the claimed invention so as to persuasively demonstrate non- obviousness of the claimed invention. Hence, in view of the above, we affirm the Examiner's rejection of claim 17 under Ground 30 (K982222 and Haas) and Ground 89 (Koval and Haas). Remaining Grounds Each of the apparatus claims 1-9, 16 and 17 have been rejected under at least two separate grounds. Hence, the other grounds of rejections of one or more of these claims based on other primary references are redundant and we decline to reach them. Method Claims 10-13 Grounds 1, 2, 8, 9, 11, 12, 13, 81 and 88 reject one or more of the method claims 10-13 (RAN 5, 6 and 13). Of claims 10-13, only claim 10 is an independent claim. As a preliminary matter, the Patent Owner argues that claim 10 should be interpreted to require two fasteners which are "two different types" as described by their function (ABPO 69-70) and that the specification of the '486 patent discloses a non-locking screw and a locking screw for their Appeal 2013-002114 Reexamination Control 95/000,468 and 90/009,378 Patent US 6,623,486 B1 22 respective functions (ABPO 70). However, whereas the claims recite "first fastener to hold the fracture reduction" and "second fastener" secured "at a fixed angular relationship to the bone plate," we do not agree that such recitations necessitates two different types of "screws" and in particular, a "non-locking screw" and a "locking screw" as asserted by the Patent Owner. Whereas the specification of the '486 patent discloses such locking and non- locking screws, claim 10 is clearly broader than the disclosed embodiment. Not only is the locking/non-locking screws not recited, claim 10 further utilizes a term "fastener" that encompasses not only screws, but encompasses a broader genus of devices of which screws are merely one species. Patent Owner argues that in specific embodiments described in the patent a non-locking screw and locking screw serve as the first and second fasteners (ABPO 70), but Patent Owner did not establish that one of ordinary skill the art, upon reading the patent, would have recognized that such fasteners would necessarily have had such non-locking and locking structures. We note that a particular embodiment appearing in the written description must not be read into the claim if the claim language is broader than the embodiment. See Superguide Corp. v. DirecTV Enterprises, Inc., 358 F.3d 870, 875 (Fed. Cir. 2004) ("Though understanding the claim language may be aided by the explanations contained in the written description, it is important not to import into a claim limitations that are not a part of the claim. For example, a particular embodiment appearing in the written description may not be read into a claim when the claim language is broader than the embodiment."). Appeal 2013-002114 Reexamination Control 95/000,468 and 90/009,378 Patent US 6,623,486 B1 23 Ground 2 Under Ground 2, claims 10-12 stand rejected as anticipated by Kassab. The Patent Owner asserts that Kassab does not inherently disclose the order of the method steps recited in the claim and in fact, a person of ordinary skill in the art would understand that the screw for the threaded nut was the first screw inserted in Kassab (ABPO 73, citing Decl. of Turen dated March 22, 2010, ¶ 79). The Patent Owner also argues that Kassab also fails to disclose "two different types of fasteners." (ABPO 73). The Examiner finds that Kassab discloses the recited order because it discloses "after tensioning, use of a schuhli at a distal screw." (RAN 17, citing Kassab, p. 91, description for Fig. 3B). According to the Examiner, "it is clear that the osteotomy is reduced and then 'tensioned' by the 'first' fastener, i.e. the fastener shown bridging the osteotomy, and then a 'second' fastener is inserted through the plate and a [s]chuhli on the proximal side of the osteotomy." (RAN 17). We agree with the Examiner. Kassab discloses that "after tensioning, use of a schuhli at distal screw Number 4 on the proximal side of the osteotomy." (P. 91, Fig. 3A-D and caption therewith). "[T]ensioning" refers to securing the plate against the bone as shown in the illustration of Figure 3B and the radiograph of Figure 3D (id.). Further, contrary to the Patent Owner's assertion, Kassab explicitly states that schuhli is used "after tensioning" thereby disclosing the sequence of its use (id.). Whereas the schuhli nut may have to be positioned together with the bone plate, Kassab states that it is not used (i.e., the screw inserted there through) until after tensioning. The schuhli nut functions to secure the Appeal 2013-002114 Reexamination Control 95/000,468 and 90/009,378 Patent US 6,623,486 B1 24 second fastener in a fixed angular relationship to the bone plate as recited by claim 10. The Patent Owner's argument that Kassab also fails to disclose "two different types of fasteners" is unpersuasive because such language is not present in the claim. In re Self, 671 F.2d 1344, 1348 (CCPA 1982) (features not appearing in the claims cannot be relied upon for patentability). To the extent that the Patent Owner relies on the recited "first fastener" and a "second fastener" to be interpreted to mean a "non-locking screw" and a "locking screw," we disagree with such an interpretation for the reasons discussed supra. The claim does not require "two different types of fasteners" (much less a "non-locking screw" and a "locking screw") but rather, merely recites a "first fastener" that is used for compression, and a "second fastener at a fixed angular relationship to the bone plate." Kassab discloses this limitation. Secondary consideration evidence is not pertinent to anticipation rejections, and thus, immaterial to the anticipation rejection of claims 10-12. Thus, in view of the above, the Examiner's rejection of claims 10-12 as being anticipated by Kassab is affirmed. Ground 8 Method claims 10-13 also stand rejected as obvious over Schuhli Guide in view of Klaue '823. The Patent Owner argues that the combination of Schuhli Guide and Klaue '823 does not result in the claimed method because it is the locking nut, instead of the plate, that is compressed against the bone ("compressing a bone plate against the bone with at least one first Appeal 2013-002114 Reexamination Control 95/000,468 and 90/009,378 Patent US 6,623,486 B1 25 fastener to hold the fracture reduction") (ABPO 75). The Patent Owner further argues that only one type of screw is used in the cited prior art, but the claim requires a first and second fastener (ABPO 75). The Examiner's position is that it would have been obvious to make the nut in Schuhli Guide integral to the plate, specifically relying on Figure 8B of Klaue '823 which discloses providing a schuhli-type threaded protrusion integral to the lower surface of a bone plate (RAN 20; Request for Inter Partes Reexamination, Exhibit L). We agree with the Examiner that the claimed invention would have been obvious to one of ordinary skill in view of the combined teachings of Schuhli Guide and Klaue '823. Klaue '823 clearly demonstrates the obviousness of providing a plate with a threaded locking feature integrally thereon (see Klaue '823, Fig. 9; col. 5, ll. 18-40). Furthermore, Schuhli Guide discloses the recited order of inserting the first fastener through a hole without a schuhli so as to stabilize the schuhlis (i.e., to compress the plate and schuhli combination against the bone) before inserting the second fastener through the schuhli (see Schuhli Guide, p. 7, steps 4 and 5; see also Request for Inter Partes Reexamination, Exhibit L). As to evidence of commercial success, the evidence does not demonstrate an adequate nexus between the method of claims 10-13 and the sales of the LCP kits as discussed infra under the heading "Commercial Success." Hence, in view of the above, we affirm the Examiner's rejection of claims 10-13 as being obvious over Schuhli Guide in view of Klaue '823. Appeal 2013-002114 Reexamination Control 95/000,468 and 90/009,378 Patent US 6,623,486 B1 26 Ground 13 Claim 13 which depends from independent claim 10 stands rejected as being obvious over Kassab. The Patent Owner relies on dependency of claim 13 on claim 10 for patentability and refers to its arguments submitted with respect to the anticipation rejection of claim 10 in Ground 2 (ABPO 79- 80). Again, the evidence of commercial success does not demonstrate an adequate nexus as discussed infra. Thus, because claim 10 remains rejected over Kassab in Ground 2 for the reasons discussed supra, the Examiner's rejection of claim 13 is also affirmed. Remaining Grounds Each of the method claims 10-13 have been rejected under two separate grounds. Hence, the other rejections of one or more of these claims under Grounds 1, 8, 9, 11, 12 20 (for claim 11), 81 and 88 based on other primary references are redundant and we decline to reach them. Commercial Success The Appellant alleges that it has sufficiently established non- obviousness through evidence of commercial success and copying as set forth in the Declaration of René Haag (App. Br. 80-84). The Examiner states that the Declaration of Haag and the proffered evidence of commercial 20 As noted, this ground of rejection was maintained by the Examiner with respect to claim 11, but withdrawn with respect to claim 12 (RAN 6, 22-24). The withdrawal of this ground of rejection as to claim 12 has been cross- appealed by the Requester. Appeal 2013-002114 Reexamination Control 95/000,468 and 90/009,378 Patent US 6,623,486 B1 27 success and copying have been considered but finds them unpersuasive (RAN 36). The Examiner incorporates by reference, the position of the Requester as set forth in pages 87-99 of the Requester's comments filed June 25, 2010 (id.). The Requester argues, inter alia, that the Patent Owner has "failed to show that success of the Relevant Products was due [to] the critical claimed features," that the products include unclaimed features, and that the Patent Owner has not accounted for numerous unrelated economic and market factors such as brand loyalty, purchasing contracts and market share/power (Resp. Br. R 32-33). As previously noted, we first observe that secondary consideration evidence is not pertinent to anticipation rejections, and thus, is immaterial to the anticipation rejection of claims 10-12 under Ground 2. The evidence does appear to show commercial success of the kits in which the bone plates referred to as Locking Compression Plate (shown in Decl. of Haag, Exhibits A-C; hereinafter "LCP bone plates") are sold together with corresponding locking and non-locking screws and various other components (Decl. of Haag ¶¶ 19-25, Exhibits G-I). However, in having considered the evidence, we agree with the Examiner that the evidence does not adequately demonstrate non-obviousness of the claimed invention. As to all of the rejected claims, the various LCP bone plates upon which the asserted commercial success is based include figure-eight shaped "Combi holes" (Decl. of Haag, Exhibit A, 3; Exhibit B, 3; Exhibit C, 3) which are not disclosed in the Specification of the '486 patent. The "Combi holes" are clearly identified in the evidence as being a "feature" that Appeal 2013-002114 Reexamination Control 95/000,468 and 90/009,378 Patent US 6,623,486 B1 28 "combine[s] a dynamic compression unit (DCU) hole with a locking screw hole. The Combi hole provides the flexibility of axial compression and locking capability throughout the length of the plate shaft." (Decl. of Haag, Exhibit A, 2; Exhibit B, 2; Exhibit C, 2). As raised by the Requester and the Examiner, the unique features and benefits of the "Combi holes" may have contributed to commercial success, especially considering their asserted advantageous function. Such features are not recited in any of the rejected claims, nor disclosed in the specification of the '486 patent, and thus, can diminish the nexus between the evidence of commercial success and the claimed invention. However, while recognizing that this issue has been raised in the appeal (Reb. Br. PO 32-33), the Patent Owner fails to proffer rebuttal evidence, arguments or explanation to address the possible impact of "Combi holes" in its Rebuttal Brief. Furthermore, with respect to independent claim 1 which specifically recites that the head portion has only first plate holes that have a thread, we note that the commercial implementations of the LCP bone plates have holes for "K-wire" and sutures that appear to be unthreaded (Decl. of Haag, Exhibit A, 3; Exhibit B, 3; Exhibit C, 3). We also agree with the Requester and the Examiner that the Patent Owner has not adequately addressed other factors that may have had significant bearing on the commercial success of the kits, and in particular, group purchasing contracts. While the Patent Owner and Mr. Haag assert that "Synthes did not implement any shift or change in its normal marketing practices in the plate and screw market" (ABPO 83; Decl. of Haag, ¶ 26), they fail to adequately explain the impact of "group purchasing Appeal 2013-002114 Reexamination Control 95/000,468 and 90/009,378 Patent US 6,623,486 B1 29 organizations" used in the industry on the commercial success information provided (see Decl. of Donoghue ¶ 15). As to the method claims 10-13, we are not provided with persuasive analysis as to how the evidence proffered supports the conclusion that the recited method would not have been obvious. In this regard, the evidence does not demonstrate an adequate nexus between the method recited in claims 10-13 and the sales of the LCP kits. Thus, because the evidence is insufficient to establish adequate nexus between the claims and the commercial success, we agree with the Examiner that the Patent Owner has failed to establish non-obviousness with respect to the invention recited in the rejected claims. Finally, whereas copying by competitors has been asserted by the Patent Owner (ABPO 84; Decl. of Haag ¶ 25), we are not directed to persuasive evidence demonstrating copying by others. Conclusions for Patent Owner's Appeal 1. The Examiner did not err in concluding that it would have been obvious to one of ordinary skill in the art to modify a condylar buttress plate having a head portion that includes unthreaded bone anchor holes as described in K982222 or Koval so as to only provide holes having a thread in the head portion. 2. The Examiner did not err in concluding that providing a bone plate with an anterior fork substantially parallel to an anterior side of the shaft portion would have been an obvious variation, and that such a fork is disclosed in the plate of the Synthes Catalog. Appeal 2013-002114 Reexamination Control 95/000,468 and 90/009,378 Patent US 6,623,486 B1 30 3. The Examiner did not err in concluding that it would have been obvious to one of ordinary skill in the art to modify a condylar buttress plate as described in K982222 or Koval to provide threaded holes in the shaft portion of the buttress plate as well as non-threaded holes. 4. The Examiner did not err in finding that the method of claim 10 is disclosed in Kassab. 5. The Examiner did not err in concluding that the method of claim 10 would have been obvious to one of ordinary skill in the art based on Schuhli Guide in view of Klaue '823. Appeal 2013-002114 Reexamination Control 95/000,468 and 90/009,378 Patent US 6,623,486 B1 31 CROSS-APPEAL OF THE REQUESTER The Non-adopted Rejections The Requester cross-appeals the following proposed rejections that were not adopted or not maintained by the Examiner: Ground 12: Claim 12 under 35 U.S.C. § 103(a) as being obvious over the combination of Locking Reconstruction Plate (hereinafter "LRP") in view of Sutter and Surer. Ground 86: Claim 12 under 35 U.S.C. § 103(a) as being obvious over Distal Radius Plate (hereinafter "DRP") in view of Koval. Ground 93: Claims 10-13 under 35 U.S.C. § 103(a) as being obvious over Koval in view of DRP. (CABR 2) The primary reference LRP of Ground 12 pertains to a modular fixation system for the jaw (see, generally, LRP). The primary reference DRP of Ground 86 pertains to a plate for modular fixation system for the forearm (see, generally, DRP). Claim 12 specifically recites application of the method "wherein the fracture is adjacent at least one of the following group: a distal tibia, a proximal tibia, a distal femur, or proximal femur." However, both the LRP and DRP devices are for bones that do not bear the weight of the body such as the tibia or the femur. During the Oral Hearing, in response to a question asking whether loading must be considered when the claim specifies the bone to which the method is applied, the Requester conceded that the LRP and DRP references do not address "some unique issues with respect to the femur and fixing those fractures." (See Oral Hearing Transcript, pp. 46, l. 3-47, l. 16). As Appeal 2013-002114 Reexamination Control 95/000,468 and 90/009,378 Patent US 6,623,486 B1 32 such, the Requester argued that the strongest rejection not adopted by the Examiner is Ground 93 which is based on the combination of Koval and DRP since Koval is directed to fixing fractures in the distal femur (id.). Nonetheless, the Requester also concedes that Koval does not expressly disclose the order of insertion of the first and second fasteners as recited by claim 10, and that the teachings of DRP is required to address this deficiency (see Oral Hearing Transcript, pg. 47, ll. 1-4). In refusing to adopt the proposed rejection of claims 10-13 in Ground 93, the Examiner's position is that a person of ordinary skill, without the benefit of hindsight based on the '486 patent, would not start with the cadaver study disclosed in Koval, and then look to the teachings of the DRP Guide "to apply the Koval plate on a femoral fracture by following the steps of the DRP Guide." (RAN 29). However, as discussed supra, claims 10-13 stand rejected under Grounds 2 and Ground 13 (based on Kassab alone), and Ground 8 (based on Schuhli Guide in view of Klaue '823). These rejections that have been affirmed in the Patent Owner's appeal do not raise the above noted issues that are present in proposed Grounds 12, 86 and 93. Correspondingly, in our view, the cross-appealed rejections appear to be weaker than those already addressed supra and are largely moot in view of the affirmed rejections of these claims in the Patent Owner's appeal. As such, we decline to reach the arguments of the Requester. Appeal 2013-002114 Reexamination Control 95/000,468 and 90/009,378 Patent US 6,623,486 B1 33 ORDERS 1. The Examiner's rejections of one or more apparatus claims 1-9, 16 and 17 under Grounds 30-32, 47 and 89-92 are AFFRIMED. 2. We decline to reach the remaining grounds of rejection of the apparatus claims. 3. The Examiner's rejections of one or more method claims 10-13 under Grounds 2, 8 and 13 are AFFIRMED. 4. We decline to reach the remaining grounds of rejection of the method claims. 5. We decline to reach of the arguments of the Requester in the Cross-Appeal. Rejection of claims 1-13, 16 and 17 is: AFFIRMED Requests for extensions of time in this merged reexamination proceeding are governed by 37 C.F.R. §§ 1.550(c) and 1.956. ak Appeal 2013-002114 Reexamination Control 95/000,468 and 90/009,378 Patent US 6,623,486 B1 34 Woodcock Washburn, LLP Cira Centre, 12 th Floor 2929 Arch Street Philadelphia, PA 19104-2891 Third Party Requester: Hunton & Williams, LLP Intellectual Property Department 1900 K Street, NW Suite 1200 Washington, DC 20006-1109 Copy with citationCopy as parenthetical citation