Ex Parte 6936051 et alDownload PDFPatent Trial and Appeal BoardOct 24, 201395000449 (P.T.A.B. Oct. 24, 2013) Copy Citation UNITED STATES PATENT AND TRADEMARKOFFICE 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. 95/000,449 03/12/2009 6936051 101.0056-14REX 9875 22882 7590 10/24/2013 MARTIN & FERRARO, LLP 1557 LAKE O'PINES STREET, NE HARTVILLE, OH 44632 EXAMINER CLARK, JEANNE MARIE ART UNIT PAPER NUMBER 3993 MAIL DATE DELIVERY MODE 10/24/2013 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 ____________ NuVASIVE, INC., Requester and Appellant v. ZIMMER SPINE, INC., Patent Owner and Respondent ____________ Appeal 2012-003391 Reexamination Control 95/000,449 Patent 6,936,051 B2 Technology Center 3900 ____________ Before RICHARD E. SCHAFER, SALLY G. LANE, and RICHARD M. LEBOVITZ, Administrative Patent Judges. LEBOVITZ, Administrative Patent Judge. DECISION ON REQUEST FOR REHEARING This is a Request for Rehearing by Patent Owner under § 41.77(b)(2) (“Req. Reh’g”) of the PTAB Decision of February 26, 2013 (“February 2013 Decision”). Claim 1 and dependent claims 9, 12, and 13 are pending. In the February 2013 Decision, three new grounds of rejection were set forth over independent claim 1, and it was left to the Examiner to determine whether Appeal 2012-003391 Reexamination Control 95/000,449 Patent 6,936,051 B2 2 the new grounds were applicable to dependent claims 9, 12, and 13 (February 2013 Decision 2 and 8). The three new grounds of rejection are as follows: A. Claim 1 under 35 U.S.C. § 103(a) based on U.S. Patent No. 5,364,399 to Lowery et al. (“Lowery”) in view of U.S. Patent No. 3,842,825 to Wagner (“Wagner”); B. Claim 1 under 35 U.S.C. § 103(a) based on U.S. Patent No. 5,888,223 to Bray (“Bray”) in view of U.S. Patent No. 5,397,363 to Gelbard (“Gelbard”); and C. Claim 1 under 35 U.S.C. § 103(a) based solely on Bray. In view of the comments in this Request for Rehearing, and the new evidence attached to it, we withdraw the rejections. CLAIM 1 Claim 1 is representative and reads as follows: 1. A plate system adapted for application to the anterior human cervical spine and for contacting at least a portion of the anterior aspects of at least two vertebral bodies, said plate system comprising: a plate having a longitudinal axis and a length sufficient to span a disc space and overlap portions of at least two adjacent cervical vertebral bodies, said plate having a lower surface for placement against the vertebral bodies and an upper surface opposite said lower surface, said lower surface being concave along a substantial portion of the longitudinal axis of said plate; at least two bone screw receiving holes extending through said plate from said upper surface through said lower surface, each of said bone screw receiving holes having a Appeal 2012-003391 Reexamination Control 95/000,449 Patent 6,936,051 B2 3 central longitudinal axis and being adapted to receive a bone screw to attach for engaging said plate to the cervical spine; and a lock adapted to overlie at least a portion of said at least two bone screw receiving holes, said lock having an elongated segment having a width, a length longer than said width, and a surface adapted to bear against said plate, said lock being adapted to engage said plate and being adapted to retain at least two bone screws to said plate when said length of said elongated segment is generally transverse to the longitudinal axis of said plate. A. REJECTION OVER LOWERY AND WAGNER Claim 1 stands rejected under 35 U.S.C. § 103(a) as obvious in view of Lowery and Wagner. Claim 1 is directed to a “plate system adapted for application to the anterior human cervical spine and for contacting at least a portion of the anterior aspects of at least two cervical vertebral bodies.” The system comprises a “plate” which has sufficient length to span two adjacent vertebral bodies, at least two bone receiving screws extending through the plate for attaching the plate to the cervical spine and “a lock adapted to overlie at least a portion of said at least two bone screw receiving holes.” The lock has “an elongated segment having a width, a length longer than said width.” The lock is “adapted to retain at least two bone screws to said plate when said length of said elongated segment is generally transverse to the longitudinal axis of said plate.” Lowery Lowery is said by Requester to describe a plate system comprising a plate, bone receiving screws, and a lock adapted to overlie the screw holes Appeal 2012-003391 Reexamination Control 95/000,449 Patent 6,936,051 B2 4 for the bone receiving screws (Requester § 41.77(c) Comments 13). The following disclosures, listed as findings of fact (“FF”) from Lowery, are pertinent: [FF1] Figure 1 of Lowery, reproduced below, shows a cervical plating system attached to a cervical spine: [FF2] Figure 1 shows elongated fixation plate 20 instrumented to cervical vertebra between C3 and C5 vertebrae. The fixation plate 20 is engaged to the vertebrae by bone engaging screws 20 (Lowery, col. 5, ll. 1- 13). [FF3] “Screw fixation means 40 is provided to firmly and rigidly fix certain of the bone engaging screws to the plate.” (Lowery, col. 5, ll. 13- 15.) [FF4] Figure 5, reproduced below, is an end cross-sectional view of fixation plate 20: Appeal 2012-003391 Reexamination Control 95/000,449 Patent 6,936,051 B2 5 [FF5] Figure 5 shows the bone engaging screw 30 passing through screw bores 27 of fixation plate 20, enlarged head 32 of screw 30, spherical recess 28 (screw bore recess) of the screw bores 27 in the plate 20, screw fixation means 40 comprising locking screw 45, fixation bore 41 having recessed bore 42 into which screw fixation means 40 inserts (Lowery, col. 6, l. 15 to col. 7, l. 13). The bone engaging screws 30 are shown just prior to being completely fixed within the fixation plate 20 (id. at col. 6, 39-41). [FF6] One important component of the preferred embodiment of the invention is screw fixation means [40] for clamping the head of the bone screws to the plate. Pursuant to this invention, the screw fixation means [40] engaging the plate [20] at its upper surface to clamp the bone screw heads [32] within recesses [28] in the plate. Preferably, the bone screws and the screw fixation means are configured to reside within recesses in the plate [28 and 42] so that these components are flush with or below the upper surface of the plate. This aspect realizes an advantage over prior systems which include components projecting above the fixation plate [20], leading to irritation and trauma of the surrounding tissue. (Lowery, col. 2, l. 61 to col. 3, l. 5.) Appeal 2012-003391 Reexamination Control 95/000,449 Patent 6,936,051 B2 6 [FF7] Lowery teaches that the screw head is flush with the upper surface of the bone fixation plate 20: The truncated spherical aspect of the head allows substantially the entire screw head 32 to rest entirely within the screw bore recess 28. In this manner, a portion of the screw head 32 is substantially flush with the upper surface 22 of the plate, while the remainder of the screw resides below the upper surface within the recess 28. (Lowery, col. 6, ll. 33-39.) [FF8] As with other cervical implant systems, the present invention contemplates some means for fixing the bone engaging screws 30 to the fixation plate 20 to prevent the screws from working loose over time. (Lowery, col. 6, ll. 53-56.) [FF9] The screw fixation means 40 includes a threaded fixation bore 41 formed in the plate 20 between the two screw bores 27 at each end of the plate (Lowery, col. 6, ll. 58-61). The fixation bore 41 includes a recessed bore 42 which defined from the upper surface 22 of the plate, as shown in the cross-sectional view of Figure 4 reproduced below (id. at col. 6, ll. 62- 64). [FF10] Figure 4 shows the recessed bore 42 for the screw fixation means. Appeal 2012-003391 Reexamination Control 95/000,449 Patent 6,936,051 B2 7 [FF11] The fixation means 40 has a locking screw 45 (as shown in Figure 5) (Lowery, col. 7, ll. 1-4) The locking screw 45 includes a flat head 47 which is thin enough to reside entirely within the recessed bore portion 42 in the plate so that the locking screw is not exposed above the upper surface 22 of the plate. (Lowery, col. 7, ll. 4-8.) Wagner Requester acknowledges that Lowery does not describe a lock having “an elongated segment having a width, a length longer than said width” as recited in claim 1 (Requester § 41.77(c) Comments 13). However, Requester contends that this “feature . . . was well known in the prior art cervical plate[s].” (Id.) As evidence, Requester cites Wagner which Requester stated “discloses that it was known to employ an elongate-shaped plate at an end portion of a bone plate system so as to cover and retain a plurality of bone screws.” (Id.) Requester reproduced Figure 4 of Wagner: [FF12] Appeal 2012-003391 Reexamination Control 95/000,449 Patent 6,936,051 B2 8 [FF13] Figure 4, reproduced above, shows a “hip fixation device.” (Wagner, col. 2, ll. 10-11.) [FF14] Figure 4 shows handle portion 3 and bowl portion 4 (Wagner, col. 2, ll. 38-40), hip screws 10 having square heads 14 (id. at col. 2, ll. 56- 62), and curved ovular plate 16 which fits over bowl portion 4 which, when washers 25 and nuts 26 are threaded on to bolts 18, produces compression “on the heads 14 of screws 10 thereby keeping them in place and preventing them from backing out of the femur.” (Id. at col. 2, l. 63 to col. 3, l. 13.) Reason to combine Requester stated: One of ordinary skill in the art would have been prompted to modify Lowery’s lock 45 so as to provide an elongate-shaped cover plate over the end portion of the Lowery’s bone plate (as taught by Wagner) to thereby cover the Lowery’s bone screw heads and exert a “positive compression ... on the heads” that prevents the bone screws from backing out. (Requester § 41.77(c) Comments 13.) Requester states that Wagner teaches that other means can be utilized to attach a cover plate to the underlying bone plate, and “Lowery discloses that the bone plate includes a recess configured to receive the perimeter of the lock.” (Requester § 41.77(c) Comments 14.) To support this argument, written testimony was provided by Dr. Gary L. Lowery (Lowry Declaration executed May 10, 2011 (“Lowery Decl.”). Dr. Lowery is an orthopedic surgeon who, at the time the declaration was executed, was Executive Vice President for Strategic Development at Paradigm Spine LLC (Lowery Decl. ¶ 1). Dr. Lowery stated that he has “actively engaged in the design of Appeal 2012-003391 Reexamination Control 95/000,449 Patent 6,936,051 B2 9 medical devices and methods related to orthopedics, and specifically have designed anterior cervical spine plating systems.” (Id.) Dr. Lowery testified that his employer is not affiliated with the Requester (id. at 2.) Dr. Lowery also testified that he did not received compensation for his declaration (id.) Dr. Lowery testified: [A] person of ordinary skill in the art prior to the alleged invention of the ‘051 patent would have known that the cover plate in the resulting combination can be secured to the plate in a manner that reduces the profile of the anterior cervical plate system (e.g., selecting particular fasteners and providing recesses). (Lowery Decl. ¶ 17) Patent Owner’s Arguments Patent Owner identifies the disclosure in Lowery describing that the bone engaging screws 30 and screw fixation means 40 are designed to reside within recesses in the plate to avoid irritation and trauma to the surrounding tissues (FF6, FF9, and FF11; Req. Reh’g 14-15). Patent Owner contends that If Lowery was provided with the cover plate 16 of Wagner, Patent Owner submits that use of the cover plate 16 would necessarily contravene the inventive concepts of Lowery. Unlike the head 47 of the locking screw 45, the cover plate 16 would cover the entirety of the heads 32 of the bone engaging screws 30, and could not be received in the recessed bore 42. Thus, the cover plate 16 would cover the upper surface 22 of the plate 20, and by its very nature, project above the plate 20 contrary to the teachings of Lowery. (Req. Reh’g 15.) Appeal 2012-003391 Reexamination Control 95/000,449 Patent 6,936,051 B2 10 In addition, Patent Owner argues that bolts 18, washers 25, and nuts 26 would all protrude above the cover plate and extend into the flesh of the patient to “create all the worst design features that Lowery teaches to avoid.” (Req. Reh’g 16.) Thus, Patent Owner contends, providing the plate of Wagner on Lowery would render Lowery “unsuitable for its intended purpose” (id.). Because the teachings are so divergent, Patent Owner contends the one of ordinary skill in the art would not look to combine Lowery and Wagner (id. at 17). Discussion We agree with Patent Owner that Lowery’s bone fixation device with a flush bone engaging screw and screw fixation means screwed into recessed bores in the bone fixation plate (FF5-FF7 and FF9-FF11) is a substantially different configuration than the bulky plate described by Wagner, which comprises washers and nuts (FF12 & FF14) that would project above the bone plate, a configuration disparaged by Lowery (FF6). Specifically, Lowery teaches that Preferably, the bone screws and the screw fixation means are configured to reside within recesses in the plate so that these components are flush with or below the upper surface of the plate. This aspect realizes an advantage over prior systems which include components projecting above the fixation plate, leading to irritation and trauma of the surrounding tissue. (FF6.) Thus, Wagner’s device has the structure which Lowery specifically teaches is disadvantageous, providing a disincentive to have incorporated Wagner’s cover plate and accompanying bolts and washers into Lowery’s Appeal 2012-003391 Reexamination Control 95/000,449 Patent 6,936,051 B2 11 bone fixation system. “Under the proper legal standard, a reference will teach away when it suggests that the developments flowing from its disclosures are unlikely to produce the objective of applicant’s invention. ” Syntex (USA) LLC v. Apotex, Inc., 407 F.3d 1371, 1380 (Fed. Cir. 2005) (citations omitted). In this case, one of ordinary skill in the art would have been discouraged from applying Wagner to Lowery’s bone fixation device, because it would result in projections into the tissue, contrary to Lowery’s objective to have a flush, recessed fixation means. However, even were it true, as testified by Dr. Lowery, that the skilled artisan “would have known that the cover plate in the resulting combination can be secured to the plate in a manner that reduces the profile of the anterior cervical plate system” (Lowery Decl. ¶ 17), the claimed invention would still not have been obvious to one of ordinary skill in the art. Claim 1 recites that lock is “adapted to retain at least two bone screws to said plate when said length of said elongated segment is generally transverse to the longitudinal axis of said plate.” While Wagner’s elongated plate retains the bone screws when transverse to the longitudinal axis of the plate, it not “adapted to retain the bone screws” in this position, but could be utilized in either the transverse or longitudinal position. For the foregoing reasons, we reverse rejection A based on Lowery and Wagner. REJECTIONS BASED ON BRAY Appeal 2012-003391 Reexamination Control 95/000,449 Patent 6,936,051 B2 12 Under 37 C.F.R. § 1.131, a reference cited under 35 U.S.C. § 103(a) may be antedated. According to 37 C.F.R. § 1.131 (a), when any claim of a patent under reexamination is rejected, “the owner of the patent under reexamination ... may submit an appropriate oath or declaration to establish invention of the subject matter of the rejected claim prior to the effective date of the reference or activity on which the rejection is based.” Therefore, a declaration under 37 C.F.R. § 1.131 can be used to overcome a rejection under 35 U.S.C. § 103(a) based on prior art considered applicable under 35 U.S.C. § 102(e). Under § 1.131(b), “[t]he showing of facts shall be such, in character and weight, as to establish reduction to practice prior to the effective date of the reference, or conception of the invention prior to the effective date of the reference coupled with due diligence from prior to said date to a subsequent reduction to practice or to the filing of the application.” Bray is a continuation of the Bray parent non-provisional application (U.S. Serial No. 08/764,089) filed December 6, 1996. Both Bray and the Bray parent application claim priority to the '365 Bray provisional application (U.S. Provisional Serial No. 60/008,365) filed December 8, 1995. Patent Owner seeks to antedate Bray by establishing practice of the claimed invention prior to December 8, 1995. Declarations under § 1.131 to establish such reduction to practice accompanied the Request for Rehearing. A petition was granted by the Board to have the declarations entered and considered (Decision on Petitions dated May 17, 2013). In the Declaration under 37 C.F.R. § 1.131 by the sole inventor of the ’051 patent, Gary K. Michelson, Dr. Michelson testified that the multilock anterior cervical plate system was reduced to practice prior to December 8, Appeal 2012-003391 Reexamination Control 95/000,449 Patent 6,936,051 B2 13 1995 (Michelson Decl. §§ 4-6). Dr. Michelson provided drawings that he testified were created and dated prior to December 8, 1995, which depict all the features of claim 1 (id. at p. 2-3 (Exhibit 1)). Dr. Michelson also provided photographs which he testified are of a “sample of my multilock anterior cervical plate design” . . . made for me, confidentially, by Neil A. Haworth prior to December 8, 1995.” (Id. at 4.) Dr. Michelson describes how the photographs show the limitations of the claim. Page 4 of the photographs clearly depicts in the lower left corner a photograph of: a lock adapted to overlie at least a portion of said at least two bone screw receiving holes, said lock having an elongated segment having a width, a length longer than said width, and a surface adapted to bear against said plate, said lock being adapted to engage said plate and being adapted to retain at least two bone screws to said plate when said length of said elongated segment is generally transverse to the longitudinal axis of said plate. The lock is shown mounted in the plate with the bone screw receiving holes as claimed. The plate is shown on pages 1-3 to have a “lower surface being concave along a substantial portion of the longitudinal axis of said plate,” as claimed, and the other claimed features. (Michelson Decl. ¶ 4.) Declarations were also provide by two declarants, Bradley Coates and Neil A. Haworth, who testified to have been shown by Dr. Michelson, prior to December 6, 1995, the multilock anterior cervical spine system depicted in the photographs of Exhibit 1. Mr. Bradley Coates, employed by Sofamor Danek (Appendix C), testified: Appeal 2012-003391 Reexamination Control 95/000,449 Patent 6,936,051 B2 14 4. Prior to December 6, 1995, Dr. Michelson came to Sofamor Danek in Memphis and disclosed to me a multilock anterior plate for use on a human anterior cervical spine that he had previously designed. 5. At that meeting, prior to December 6, 1995, Dr. Michelson showed me the multilock anterior cervical plate displayed in the photographs, attached as Exhibit 1, under the confidentially provisions of a Non-Disclosure Agreement signed by Dr. Michelson and John Pafford for Sofamor Danek, attached as Exhibit 2. Mr. Neil A. Haworth testified in his declaration that he was hired by Dr. Michelson prior to December 6, 1995 to make him samples of his multilock anterior cervical lock (Haworth Decl. 3). Mr. Haworth testified that he made the multilock cervical plate system shown in the photographs of Exhibit 2 prior to December 6, 1995 and that such plate system had all the features recited in the claim (id. at 5- 7). Based on the evidence provided, we conclude that sufficient evidence has been provided establishing that the inventor actually reduced to practice the subject matter of claim 1, antedating Bray. Because Bray is antedated and not prior art to the claims, we reverse Rejections B. and C. based on Bray. REHEARING GRANTED Appeal 2012-003391 Reexamination Control 95/000,449 Patent 6,936,051 B2 15 PATENT OWNER: MARTIN & FERRARO, LLP 1557 LAKE O’PINES STREET, NE HARTVILLE, OH 44632 THIRD PARTY REQUESTER: FISH AND RICHARDSON, P.C. P.O. 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