Ex Parte Hartdegen et alDownload PDFPatent Trials and Appeals BoardAug 5, 201310940396 - (D) (P.T.A.B. Aug. 5, 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. 10/940,396 09/14/2004 Vernon R. Hartdegen E3383-00135 (702.192.01) 6375 8933 7590 08/06/2013 DUANE MORRIS LLP - Philadelphia IP DEPARTMENT 30 SOUTH 17TH STREET PHILADELPHIA, PA 19103-4196 EXAMINER SCHAPER, MICHAEL T ART UNIT PAPER NUMBER 3775 MAIL DATE DELIVERY MODE 08/06/2013 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 ____________ Ex parte VERNON R. HARTDEGEN, KEVIN WONG, and ROBERT M. FENCL ____________ Appeal 2011-010492 Application 10/940,396 Technology Center 3700 ____________ Before ERIC GRIMES, MELANIE L. McCOLLUM, and ULRIKE W. JENKS, Administrative Patent Judges. JENKS, Administrative Patent Judge DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to a method and device for moving two adjacent bone pieces together to reduce a fracture. The Examiner has rejected the claims for obviousness. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. Appeal 2011-010492 Application 10/940,396 2 STATEMENT OF THE CASE The Specification is directed to reducing fractures with a compression brace having two fastener retaining portions with a hole to receive a fastener as well as a pair of bridge members that are attached between the retaining portions. The fasteners that secure the compression brace to the bone have a lengthwise shaft sized to pass through the fastener hole and an upper portion that is sized to fit into the hole of the brace (Spec. 4). Claims 16-18 and 23-33 on appeal, and can be found in the Claims Appendix of the Appeal Brief (App. Br. 21-24). Claim 16 is illustrative of the claims on appeal, and reads as follows: 16. A surgical device for pressing and retaining adjacent bones against one another, such as to reduce a fracture, comprising: a compression brace, said compression brace having at least two fastener retaining portions, each said fastener retaining portion having a fastener hole therethrough for receiving a fastener, said fastener hole having an internal thread, a pair of bridge members positioned between and extending from surfaces of said fastener retaining portions, said bridge members spaced apart from one another to thereby form a compression opening between said fastener retaining portions, and at least two fasteners, each said fastener having a lengthwise shaft sized to pass through said fastener hole and a head portion sized and configured to retain said fastener in said fastener hole, an upper thread on said shaft adjacent said head of said fastener for engaging said internal thread in said fastener hole to thereby maintain said fastener in a substantially fixed relation to said fastener retaining portion, and a lower thread for engaging bone. Appeal 2011-010492 Application 10/940,396 3 The Examiner has rejected the claims as follows: I. claims 16, 17, 20, 21, 23-25, and 33, under 35 U.S.C. § 103(a) as unpatentable over Nicola1 and Harris;2 II. claim 18 under 35 U.S.C. § 103(a) as unpatentable over Nicola and Harris in further view Leung;3 III. claims 16 and 26-32, under 35 U.S.C. § 103(a) as unpatentable over Groiso4 and Harris. I. The Issue: Obviousness over Nicola and Harris The Examiner takes the position that: Nicola discloses the claimed invention except for the fastener hole having an internal thread; an upper thread on said shaft adjacent said head of said fastener for engaging said internal thread in said fastener hole to thereby maintain said fastener in a substantially fixed relation to said fastener retaining portion, i.e. a locking means. (Ans. 4-5.) The Examiner finds that Harris discloses a locking screw mechanism for orthopedic applications (id. at 5-6). The Examiner concludes that it would have been obvious for one of ordinary skill in the art “to have modified the device of Nicola with a bone plate system wherein the fastener hole has an internal thread . . . in view of Harris for locking the screw into the fastener for backout prevention and maintaining the fastener's angle with respect to the plate” (id. at 6). 1 Toufick Nicola, US 2,580,821, issued Jan. 1, 1952. 2 Peter M. Harris, US 2003/0153919 Al, published Aug. 14, 2003. 3 Takkwong Ross Leung et al., US 2005/0277937 Al, published Dec. 15, 2005. 4 Jorge A. Groiso, US 5,947,999, issued Sep. 7, 1999. App App the E prov and H Find repro Figu ll 43 (Nic sprin eal 2011-0 lication 10 The issu xaminer’s ided suffic arris? ings of Fa FF 1. N duced bel re 2 is a to -44; Ans. 4 [T]he p reversely for conn to be co portion opposite sections different line of th ola col. 2, FF 2. N g tension 10492 /940,396 e is: Does conclusio ient rebutt ct icola discl ow: p plan vie .) late inclu arranged ecting the nnected b 3 betwee edges of 4 portions distances e plate. ll. 8-18) icola discl on the bon the prepo n of obvio al evidenc osed a bon w of the sp des two i and have plate to th y the pla n which the plate of which than their osed the u e sections 4 nderance o usness an e to overc e fastenin ring impa dentical e screw ope e sections te. The and the e are norm intermedi ends from se of a bon (Nicola co f evidenc d if so hav ome the co g device a ctor bone nd portio nings 2 to of a broke plate also nd portio ally longi ate their e the long e plate to l. 1, ll. 34 e of record e Appellan mbination s shown in plate (Nico ns 1 that receive sc n bone tha has a ce ns at eac tudinal cu nds are sp itudinal c maintain c -35). support ts of Nicola Figure 2, la col. 1, are rews t are ntral h of rved aced enter onstant App App Figu first col. (Nic Figu recei eal 2011-0 lication 10 re 3, repro step in the 1, ll. 45-47 [B]roken sections One en correspo opposite squeezed into the fasten th [into the opposite from eac bone end ola col. 2, FF 3. H re 2, depic ving a scr 10492 /940,396 duced abo applicatio ; Ans. 4.) bone sec across or d portion nding bo spring se together correspon e plate to bone], t spring se h other, th s into tigh ll. 24-48.) arris discl ted below ew. ve, “is a p n of the pl tions A an in bridgin 1 of th ne section ctions 4 so as to e ding bon the bone. he spring ctions con e plate is t contact w osed an or ; here the a 5 lan view o ate to brok d B . . . the g relation e plate i by scre are presse longate . e section After the sections tract or sp shortened ith each o thopedic i ssembly c f the bone en bone s plate is l to the bro s then s ws 5. T d toward . . screws through t screws ha are releas ring outw so as to p ther. mplant ass ontains in plate show ections.” aid on the ken ends ecured to hereupon each oth 6 are scre he holes ve been d ed and as ardly or a ull the br embly, sh ternal thre ing the (Nicola bone . . . . the the er or wed 2 to riven the way oken own in ads for App App Figu bone Figu Figu ¶ 00 whic secti threa eal 2011-0 lication 10 re 2 is an e plate (Ha FF 4. Ha re 4, depic re 4 is a cr 15.) FF 5. H h is prefer ons 52, 54 d configur 10492 /940,396 nd view o rris 2: ¶¶ 0 rris disclo ted below oss section arris disclo ably a sing along the ations.” ( f an impla 012-0013 sed a screw : of the im sed that “ le continu longitudin Harris 2: ¶ 6 nt showin ). having t plant and [t]he screw ous thread al length o 0020; An g locking s wo section locking sc 20 . . . in 50 havin f the scre s. 5.) crews fitt s as show rew (Harri cludes a th g two regi w that hav ed into the n in s 2: read ons or e differing Appeal 2011-010492 Application 10/940,396 7 FF 6. Harris disclosed that the benefit of a locking screw is improved pull out strength: One problem that may be encountered with implants that are fastened to the bone using a screw is that there may be too much play between the screw and the implant, or that the screw may back out of the implant. . . . Locking mechanisms help to ensure that the screw does not back out of the plate. If a screw backs out of an implant depending on the placement there may be a risk that it may project beyond the top surface of the implant into a sensitive biological area. (Harris 1: ¶ 0004.) Principle of Law “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). As expressly recognized in KSR, any art recognized need or problem can provide a reason for combining claim elements. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). Analysis Appellants contend that “Nicola does not teach or suggest a surgical device including at least two fastener retaining portions each of which includes an internally threaded fastener hole or a pair of spaced apart bridge members positioned between and extending from surfaces of said fastener retaining portions.” (App. Br. 7.) We are not persuaded. Claim 16 requires “a pair of bridge members positioned between and extending from surfaces of said fastener retaining Appeal 2011-010492 Application 10/940,396 8 portions, said bridge members spaced apart from one another to thereby form a compression opening between said fastener retaining portions.” The Examiner interprets that the claim allows the bridge members to contain a spacer (Ans. 10). See In re Zletz, 893 F.2d 319, 322 (Fed. Cir. 1989) (“[D]uring patent prosecution when claims can be amended, ambiguities should be recognized, scope and breadth of language explored, and clarification imposed.”). The Examiner finds that Nicola’s bone fastening device provides “two bridge members, and are spaced apart by ref. no. 3.” (Ans. 10; see also FFs 1, 2.) We find the Examiner’s interpretation of the claim limitation reasonable. We agree with the Examiner that the claim, as presented, does not specify that the bridge member cannot be held apart by a spacer as shown in Nicola’s figures (FFs 1, 2). Appellants contend that there is no motivation to combine the references because: [I]t is not advantageous to thread the openings since it fixes the relative angle between the screw and the plate. Consequently, threading openings in bone plates limits the ability of a surgeon during surgery to account for different bone sizes, bone quality (an important factor in screw fixation), bone morphology, fracture size, and the number of bone fragments. (App. Br. 8.) We are not persuaded. We agree with the Examiner’s conclusion that it would have been obvious for one of ordinary skill in the art “to have modified the device of Nicola with a bone plate system wherein the fastener hole has an internal thread . . . in view of Harris for locking the screw into the fastener for backout prevention and maintaining the fastener's angle with respect to the plate.” (Ans. 6.) Appeal 2011-010492 Application 10/940,396 9 “[O]bviousness must be determined in light of all the facts, and there is no rule that a single reference that teaches away will mandate a finding of nonobviousness. Likewise, a given course of action often has simultaneous advantages and disadvantages, and this does not necessarily obviate motivation to combine. See [Winner Int'l Royalty Corp. v. Wang, 202 F.3d 1340,] 1349 n. 8 [(Fed.Cir.2000)] (“The fact that the motivating benefit comes at the expense of another benefit, however, should not nullify its use as a basis to modify the disclosure of one reference with the teachings of another. Instead, the benefits, both lost and gained, should be weighed against one another.”). Medichem, S.A. v. Rolabo, S.A., 437 F.3d 1157, 1165 (Fed. Cir. 2006). Nicola disclosed attaching the bone plate, an orthopedic implant, with screws (FF 2), while Harris also disclosed attaching orthopedic implants with screws, specifically, locking screws (FF 3). In addition, Harris expressly recognizes that a “locking mechanism helps ensure that the screw does not back out of the plate” (FF 6). Thus, Harris provides motivation to use locking screws in an orthopedic implant. We agree with the Examiner’s conclusion that based on Harris it would have been obvious to substitute locking screws for the regular screws used in Nicola’s bone plate system. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). Appellants contend that “Harris explicitly teaches that screw 20 includes a single continuous thread 50, i.e., not first (upper) and second (lower) threads as disclosed in claim 16.” (App. Br. 8.) We are not persuaded. The Examiner “notes that the claim language does not state that the threads need to be separate and distinct from each other.” (Ans. 10.) Even though Harris may use a single continuous screw thread the screw, nevertheless, has “two regions or sections 52, 54 along the longitudinal length of the screw that have differing thread configurations.” Appeal 2011-010492 Application 10/940,396 10 (FF 5.) “The first area 52 is a bone engaging area which has a buttress configuration known in the art as a cancellous thread.” (Harris 3: ¶ 0021.) “The second area of threads 54 forms a locking area that preferably extends over a length that generally corresponds to the length of the mating threads or female threads 14 within the through bore 13.” (Id. at ¶ 0022.) Harris thereby provides that the screw threads have two separate engagements. “[T]he thread runs out to an insertion tip 56 which further may include one or more flutes 58 so that the screw is self-tapping. In addition, the thread runs to the distil [sic] end having the head 18.” (Harris 2: ¶ 0020; Ans. 5; see also FF 4.) We conclude that the Examiner has met the burden of presenting a prima facie case based on the combination of Nicola and Harris. Because the Examiner presents a prima facie case of obviousness, we consider whether Appellants submit sufficient evidence or argument in rebuttal. In re Rijckaert, 9 F.3d 1531, 1532 (Fed. Cir. 1993). Evidence rebutting a prima face case of obviousness may include “[e]vidence of unexpected results.” Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1369 (Fed. Cir. 2007). “For objective [evidence of secondary considerations] to be accorded substantial weight, its proponent must establish a nexus between the evidence and the merits of the claimed invention.” Wyers v. Master Lock Co., 616 F.3d 1231, 1246 (Fed. Cir. 2010) (quoting In re GPAC Inc., 57 F.3d 1573, 1580 (Fed. Cir. 1995), emphasis and bracketed material added by the Wyers court). Appellants contend that their showing of (1) unexpected results (App. Br. 9-10), (2) commercial success (id. at 10-12), and (3) copying by others (id. at 12-16) are sufficient to overcome a conclusion of obviousness. Appeal 2011-010492 Application 10/940,396 11 Appellants argue that improved bending stiffness of their product is unexpected. Specifically, that the “CLAW® compression plate has a bending stiffness of about 15.8 N/mm, which is considerably higher than the bending stiffness of Applicant's own CHARLOTTETM compression staple (about 11.5 N/mm).” (App. Br. 9; see also McCombs-15 Declaration ¶4.) We are not persuaded that the McCombs-1 Declaration provides evidence of unexpected results sufficient to overcome the prima facie case even though it provides that Appellants’ commercial product with the locking screws has a higher bending stiffness than their commercial staple product (McCombs-1 Declaration ¶4). “One way for a patent applicant to rebut a prima facie case of obviousness is to make a showing of ‘unexpected results,’ i.e., to show that the claimed invention exhibits some superior property or advantage that a person of ordinary skill in the relevant art would have found surprising or unexpected.” In re Soni, 54 F.3d 746, 750 (Fed. Cir. 1995). The Examiner finds that “Appellant has failed to show that the assumedly unexpected results of the claimed invention has a significance equal to or greater than the expected properties of invention.” (Ans. 11.) Appellants acknowledge that “it was expected that the use of screws rather than fixed legs would provide greater pull out strength, and this proved to be the case. . . . However, higher bending strength and stiffness was not one of the expected advantages of the new design. . . . Applicant expected that the plates would have about the same bending strength and stiffness as unibody compression staples.” (App. Br. 9-10.) Here the expected properties as 5 McCombs Declaration, signed October 24, 2007 (McCombs-1), referencing Exhibits B-G. Appeal 2011-010492 Application 10/940,396 12 acknowledged by Appellants, and recognized by the prior art would be improving pull out strength (App. Br. 9-10; FF 6). What is missing from the Declaration is an analysis showing that the improved bending stiffness is the result of the features of the claimed invention (locking screws in combination with a compression brace having fastener retaining portions connected by bridge members) rather than, for example, the plate’s shape or dimensions, or the composition from which it is made. There has to be a nexus between the unexpected property and the claimed invention. See In re Kao, 639 F.3d 1057, 1068 (Fed. Cir. 2011) (“Where the offered secondary consideration actually results from something other than what is both claimed and novel in the claim, there is no nexus to the merits of the claimed invention.”). In addition, “when unexpected results are used as evidence of nonobviousness, the results must be shown to be unexpected compared with the closest prior art.” In re Baxter-Travenol Labs., 952 F.2d 388, 392, 21 USPQ2d 1281, 1285 (Fed. Cir. 1991). Appellants assert that the claimed invention showed unexpectedly higher bending strength in comparison to their own CHARLOTTETM compression staple, but the McCombs-1 Declaration does not provide a description of that product that would allow a determination of whether it is closer to the instantly claimed product than the product described by Nicola. Appellants therefore have not shown that their allegedly unexpected results were obtained in a comparison to the closest prior art. Appellants argue that the McCombs-1 and -2 Declarations show commercial success of the commercialized CLAW® plates (App. Br. 11; Appeal 2011-010492 Application 10/940,396 13 McCombs-1 and McCombs-26 Declarations). Specifically, Appellants contend that the “CLAW® plates continued to outsell Applicant's CHARLOTTE™ compression staples despite having an average sales price that is approximately three (3) times the sales price of the CHARLOTTE™ compression staples.” (Id.) We are not persuaded that either the McCombs-1 or -2 Declarations provides evidence of commercial success that outweighs the evidence supporting the Examiner’s rejection. The Declarations show an increasing sales trend for the CLAW® plates (McCombs-1, Exhibit C; McCombs-2, Exhibit A) in comparison to the CHARLOTTE™ compression staples. The Examiner finds that “Appellant has failed to show that the commercial success of the claimed invention is not a result in a shift in advertising, especially since the CHARLOTTETM staple is marketed to allegedly be less effective than the CHARLOTTETM CLAWTM plate, as seen in Exhibit B.” (Ans. 11.) What is missing from the Declarations is a nexus showing that the increasing sales are a result of the features of the claimed invention and not just due to the effort of advertisements. Commercial success is relevant in the obviousness context only if it is established that the sales were a direct result of the unique characteristics of the claimed invention, as opposed to other economic and commercial factors unrelated to the quality of the claimed subject matter. In re Huang, 100 F.3d 135, 140 (Fed. Cir. 1996), citing Cable Elec. Products, Inc. v. Genmark, Inc., 770 F.2d 1015, 1026- 1027 (Fed. Cir. 1985). In other words, a nexus is required between the sales and the merit of the claimed invention, and no such nexuses has been shown by Appellants. 6 McCombs Declaration, signed June 22, 2010 (McCombs-2). Appeal 2011-010492 Application 10/940,396 14 Appellants argue that the McCombs-1 Declaration shows copying of the CLAW® plates. (App. Br. 12-15.) Specifically, that “[b]etween about May 2005 - July 2007, there were no other devices like the CLAW® compression plate on the market” until July 12, 20077 when Integra received FDA approval for their Uni-CP™ plating system. (App. Br. 11-12.) Appellants point out that: [T]he UNI-CpTM plate includes a compression brace having at least two fastener retaining portions, each said fastener retaining portion having a fastener hole therethrough for receiving a fastener, said fastener hole having an internal thread [Surfix Locking Technology includes an internally threaded hole that engages the threads of threaded fastener], a pair of bridge members positioned between and extending from surfaces of said fastener retaining portions [see bridge members extending between fastener retaining portions]. (App. Br. 12-13, brackets in original.) We are also not persuaded by Appellants’ contention of copying by Integra/Newdeal. The Examiner finds that “Appellant has failed to provide other evidence of non-obviousness by copying, e.g. competitors copying the invention after failing to produce a suitable solution, or the presence of identical invention made (Appellant alleges ‘substantial [equivalence]’ has been made).” (Ans. 12.) We agree with the Examiner’s position in that the Appellants have not shown that the competitors have made an identical product. Here, as pointed out by Appellants the Integra/Newdeal product may be substantially similar to the claimed product (App. Br. 13), nevertheless, there are differences between the claimed product and the Integra/Newdeal product. The Integra/Newdeal product differs from the 7 McCombs-1, Exhibit F Appeal 2011-010492 Application 10/940,396 15 claimed product in that it uses a screw and locking washer system instead of a single locking screw “having . . . an upper thread on said shaft adjacent said head of said fastener for engaging said internal thread in said fastener hole . . . and a lower thread for engaging bone,” as claimed. Specifically,“‘[t]he rigidity of the ‘legs’ is obtained using the Newdeal Locking System including a screw and a washer.” (App. Br. 14; see also McComb-1, Exhibit D, E, and G.) The Integra sales brochure indicates that they are using the Surfix technology system in their plates; this system relies on a threaded lipped socket, a (bone) screw and a locking screw (washer) (McComb-1, Exhibit D, G). As Appellants concede, “the SURFIX® locking system used on the Integra UNI-CPTM compression plate splits the locking screw into two parts consisting of a screw and a lock screw” (Appeal Br. 14). Thus, the separate locking screw/washer system is one difference between the Integra/Newdeal product and the claimed product. What is missing from the McComb-1 Declaration is any evidence showing that the success of the Appellants’ product has a relation to the claimed features and that the competitors’ product uses these same feature to achieve their success. We conclude that the evidence cited by the Examiner supports a prima facie case of obviousness with respect to claim 16, and Appellants have not provided sufficient evidence of secondary considerations that outweighs the evidence supporting the prima facie case. As Appellants do not argue the claims separately, claims 17, 20, 21, 23-25, and 33 fall with claim 16. 37 C.F.R. § 41.37 (c)(1)(vii). Appeal 2011-010492 Application 10/940,396 16 II. The Issue: Obviousness over Nicola, Harris and Leung The Examiner recognizes that neither Nicola nor Harris provide a system where the “upper thread comprises double lead threads, said double- lead threads providing selective locking of said fastener in said fastener hole.” (Ans. 7.) The Examiner relies on Leung for this feature and concludes that it would have been obvious to “have modified the device of Nicola and Harris with a bone plate system wherein said upper thread of the fastener comprises double lead threads, said double-lead threads providing selective locking of said fastener in said fastener hole in view of Leung for the predictable reason of increased backout strength.” (Id.) The issue is: Does the preponderance of evidence of record support the Examiner’s conclusion of obviousness with the combination of Nicola, Harris and Leung? Findings of Fact FF 7. Leung disclosed that: Engagement of the threaded head 24 with the ridges 22 functions to orient the bone screw 20A relative to the plate member 12 and to fix the bone screw 20A relative to the plate member 12. Given the orientation of the circular ridges, the bone screw 20A is resultingly oriented with its longitudinal axis Al generally perpendicular to the plane defined by the plate member 12. In the embodiment illustrated [Fig. 3], the head 24 of the first bone screw 20A includes a double lead thread 26. (Leung 2: ¶ 0027; Ans. 7.) FF 8. Leung disclosed the use of double lead threads. App App Figu (Leu 22 al perp Anal refer toge of sp skill set fo on th not p “fail agre faste eal 2011-0 lication 10 re 3, depic ng 1: ¶ 00 low for an endicular o ysis Appellan ences all f ther form a aced apart ed in the a rth in clai Having f e combina ersuaded s to teach e with the ners of Ni 10492 /940,396 ted above 12) “[T]h gulation in rientation ts contend ail to discl compress bridge m rt would n m 16,” fro ound no d tion of Ni by Appella or suggest Examiner’ cola and H , is a cross e double le incremen .” (Leung that beca ose a pair ion openin embers [si ot have ha m which c eficiency cola and H nts’ conte a surgical s conclusi arris is ob 17 sectional ad thread ts of appr 3: ¶ 0037 use the “N of spaced g and ext c, fastener d any reas laim 18 d in the Exam arris as di ntion that device” as on the add vious beca view of th [on screw oximately ) icola, Har apart bridg end from t retaining on to creat epends. (A iner’s pr scussed ab the combi claimed ( ing double use “said e plating s head] and 5° to 10° ris, and Le e membe he surface portions?] e a surgic pp. Br. 1 ima facie c ove (I), w nation wit App. Br. 1 lead thre double lea ystem the ridges from the ung rs that s of a pair , one al device a 7.) ase based e are also h Leung 7). We ads to the d threads s Appeal 2011-010492 Application 10/940,396 18 providing selective locking of said fastener in said fastener hole in view of Leung for the predictable reason of increased backout strength.” (Ans. 7, 13.) We are also not persuaded by Appellants’ contention that “Leung highlights the advantages of providing a surgeon with flexibility in positioning bone screws in a patient by explicitly teaching that the spherical head of a screw is not to be threaded such that the bone screw can engage the bone at various angles with respect to the plate member.” (App. Br. 17.) “The prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed.” In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004). Leung provides that the “[e]ngagement of the threaded head 24 with the ridges 22 functions to orient the bone screw 20A relative to the plate member 12 and to fix the bone screw 20A relative to the plate member 12.” (FF 7.) Leung also discloses using multiple screws where some have the threaded head and other do not. Specifically, the “spherical shape of the head 28 cooperates with the ridges 22 to allow the second bone screw 20B to angulate relative to the plate member 12. . . .[and] can be engaged with the bone at a variable angle.” (Leung 2: ¶ 0029.) Leung recognizes that this use differs from that of screws with threaded heads that provide a fixed relationship. Even with this fixed relationship the double lead thread feature of Leung allows for some angulation of the fixed screw with the plate (FF 8.) We conclude that the evidence cited by the Examiner supports a prima facie case of obviousness with respect to claim 18, and as discussed above Appeal 2011-010492 Application 10/940,396 19 (I) Appellants have not provided sufficient evidence of secondary considerations that outweighs the evidence supporting the prima facie case. III. The Issue: Obviousness over Harris and Groiso The Examiner takes the position that: Groiso discloses a method of compressing and retaining first and second adjacent bones together . . . . . . except for said fastener hole having an internal thread; and said fastener having an upper thread on said shaft adjacent said head of said fastener for engaging said internal thread in said fastener hole to thereby maintain said fastener in a substantially fixed relation to said fastener retaining portion. (Ans. 7-9.) The Examiner looks to Harris for “a bone plate system wherein said fastener hole has an internal thread (14 on 13); and said fastener having an upper thread (see FIG. 2 [FF 3]) on said shaft adjacent said head of said fastener for engaging said internal thread in said fastener hole.” (Ans. 9.) The Examiner concludes that it would have been obvious to have “modified the method and device of Groiso with a bone plate system wherein said fastener hole has an internal thread. . .” in view of Harris “for backout prevention and maintaining the fastener’s angle with respect to the plate.” (Id.) The issue is: Does the preponderance of evidence of record support the Examiner’s conclusion of obviousness in the combination of Groiso in view of Harris? Findings of Fact FF 9. Groiso disclosed a bone plate having bridge members extending from the fastening surface. App App Figu exten (Gro Anal refer featu cont cont set fo does other threa long eal 2011-0 lication 10 re 29, dep ding wing These la 77 there securem used bot bone par 78 to be maintain gap 78 m iso col. 8, ysis Appellan ences and res of the end that “H inuous thre rth in clai We are n not state t .” (Ans. 1 d the scre itudinal len 10492 /940,396 icted abov s (Groiso terally ex in for the ent of the h for osteo ts are desi enlarged a spacin ay be dec ll. 14-21; ts contend that “Groi surgical d arris expl ad 50, and m 16.” (I ot persuad hat the thr 0.) Even w, neverth gth of the e, shows a col. 4, l. 2 tending w provision clip to th synthesis red to be b and also i g between reased in s Ans. 8.) that there so and Ha evice” as c icitly teach not a fast d. at 18.) ed. The E eads need though Ha eless, has screw tha 20 top plan v 5). ings [75] of a scr e bone. T of two bo rought tog n a situati the bone ize. is no mot rris fail to laimed (A es that sc ener havin xaminer “ to be sepa rris may u “two regio t have diff iew of a c each conta ew to pro his embo ne parts in ether by c on where parts in w ivation to teach or su pp. Br. 19 rew 20 inc g first and notes that rate and d se a single ns or secti ering thre lip having in an ape vide incre diment ca which the ausing the it is desir hich cas combine t ggest eac .) Appella ludes a sin second th the claim istinct from continuo ons 52, 54 ad configu laterally rture ased n be two gap ed to e the he h of the nts gle reads as language each us screw along the rations.” Appeal 2011-010492 Application 10/940,396 21 (FF 5.) “The first area 52 is a bone engaging area which has a buttress configuration known in the art as a cancellous thread.” (Harris 3: ¶ 0021.) “The second area of threads 54 forms a locking area that preferably extends over a length that generally corresponds to the length of the mating threads or female threads 14 within the through bore 13.” (Id. at ¶ 0022.) Appellants contend that the skilled artisan “would have understood that it is advantageous not to thread the fixation holes of a bone plate to provide a surgeon with flexibility in the angle at which screws are to be received through the fixation holes as inherently taught by Nicola, Leung, and Groiso.” (App. Br. 19.) Groiso disclosed attaching the bone plate, an orthopedic implant, with screws (FF 9), while Harris also disclosed attaching orthopedic implants with screws, specifically, locking screws (FF 3). In addition, Harris expressly recognizes that a “locking mechanism helps ensure that the screw does not back out of the plate” (FF 6). We agree with the Examiner’s conclusion that based on Harris it would have been obvious to substitute locking screws for the regular screws used in Groiso’s bone plate system. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). Appellants contend that the “Groiso reference does not teach or even suggest removing the staple legs and replacing the legs with screws or threading the apertures defined by the wings.” (Reply Br. 8.) We are not persuaded. Claim 16 does not exclude the addition of staple legs to the surgical device. Thus, it would not be necessary for the references to disclose or suggest removing the staple legs from Groiso’s device as asserted by Appellants. Appeal 2011-010492 Application 10/940,396 22 We conclude that the evidence cited by the Examiner supports a prima facie case of obviousness with respect to claim 16 in view of Groiso and Harris. As discussed above (I) Appellants have not provided evidence of secondary considerations that outweighs the evidence supporting the prima facie case. Appellants do not argue the claims separately, and claims 26-32 fall with claim 16. 37 C.F.R. § 41.37 (c)(1)(vii). SUMMARY We affirm the rejection of claims 16, 17, 20, 21, 23-25, and 33, under 35 U.S.C. § 103(a) as unpatentable over Nicola and Harris. We affirm the rejection of claim 18 under 35 U.S.C. § 103(a) as unpatentable over Nicola and Harris in further view Leung. We affirm the rejection of claims 16 and 26-32, under 35 U.S.C. § 103(a) as unpatentable over Groiso and Harris. TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED lp Copy with citationCopy as parenthetical citation