Ex Parte KaplanDownload PDFPatent Trial and Appeal BoardSep 6, 201311778951 (P.T.A.B. Sep. 6, 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. 11/778,951 07/17/2007 Lee D. Kaplan 068992-0106 1353 23524 7590 09/09/2013 FOLEY & LARDNER LLP 3000 K STREET N.W. SUITE 600 WASHINGTON, DC 20007-5109 EXAMINER EREZO, DARWIN P ART UNIT PAPER NUMBER 3773 MAIL DATE DELIVERY MODE 09/09/2013 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 LEE D. KAPLAN1 __________ Appeal 2011-013206 Application 11/778,951 Technology Center 3700 __________ Before ERIC GRIMES, ERICA A. FRANKLIN, and ANNETTE R. REIMERS, Administrative Patent Judges. GRIMES, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to a suture anchor, which have been rejected for obviousness. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 Appellant identifies the Real Party in Interest as Dr. Lee Kaplan (Appeal Br. 2). App App capa and r repro (Id. a bone anch eal 2011-0 lication 11 The Spe ble [of] all e-tensiona duced bel Figure 3 anchor 3 inner su the plug having t into the 310, the between t 6, ¶ 29.) The Spe via a scre or 310 ma 13206 /778,951 ST cification owing the ble” (Spec ow: B shows 10 compr rface 312, 320. . . . hreads 32 anchor 31 plug 320 the plug 3 cification w mechan y also hav ATEMEN describes “ tensioning . 6, ¶ 28). is[ing] a w that may The plug 5 such th 0 and the p secures t 20 and the states that ism on the e a means 2 T OF TH [s]uture a of a tissu The Spec all having or may no 320 comp at when a lug 320 i he suture inner sur “[a]nchor outer surf for driving E CASE nchors 300 e with a su ification’s an outer t have thr rises an suture(s) s inserted (s) 330 vi face 312 o 310 may b ace 311 o the screw . . . [that] ture to be Figure 3B surface 31 eads to se outer wall 330 is dr into the an a a frictio f the wall e secured f the wall. mechani are adjustable is 1, an cure 321 aped chor n fit 311. in any . . . The sm into Appeal 2011-013206 Application 11/778,951 3 bone. For example, the anchor 310 may have a hex-head, slot, Phillips-type head, or other shaped head that may be mated to a driver.” (Id. at 6, ¶ 30.) Claims 1-6 and 21-24 are on appeal. Claim 1 is the only independent claim and reads as follows: 1. A surgical instrument comprising: an anchor comprising: a wall comprising: an outer surface; an inner surface; a first end; and a second end; wherein the first end is shaped to be mated to a driver that is configured to secure the anchor within a bone; and a plug comprising a first end, a second end, and an outer wall; wherein: the anchor and the plug form a knotless suture anchor configured to: anchor an unknotted suture; provide for tensioning and re-tensioning of the suture after securing of the anchor within a bone wherein the re-tensioning comprises loosening the plug and adjusting the length of the suture; and the anchor is tapered from the first end of the anchor to the second end of the anchor, wherein the first end of the anchor has a larger diameter than the second end of the anchor. Issue The Examiner has rejected all of the claims on appeal under 35 U.S.C. § 103(a) as obvious based on Foerster,2 Goble,3 and Burkhart4 (Answer 4). 2 Foerster et al., US 2004/0098050 A1, published May 20, 2004. Appeal 2011-013206 Application 11/778,951 4 The Examiner finds that Foerster discloses a suture anchor having an anchor and plug meeting most of the limitations of claim 1 (id.), and which is “fully capable of providing tensioning and re-tensioning of the suture since the device features mating threads between the anchor and the plug” (id. at 4-5). The Examiner acknowledges that Foerster does not teach that the end of its anchor is shaped to be mated to a driver or that the anchor has a tapered profile (id. at 4). However, the Examiner finds that Goble teaches a similar instrument in which the end is mated to a driver (id. at 5) and that Burkhart teaches “an anchor designed to penetrate bone and having a tapered configuration” (id.). The Examiner concludes that it would have been obvious to incorporate these features into Foerster’s suture anchor to allow a surgeon to use an elongated driver to deliver the anchor and to make the anchor easier to insert into the bone (id. at 5-6). Appellant contends that none of the cited references describes a suture anchor that allows re-tensioning of a suture after the device is deployed in a bone (Appeal Br. 10-16). Appellant also contends that the references do not provide any reason to combine their teachings (id. at 17) or provide a reasonable expectation of successfully producing a re-tensionable suture anchor (id. at 18-20). The issue presented is: Does the evidence of record support the Examiner’s conclusion that the cited references would have made obvious a device meeting the limitations of claim 1? 3 Goble et al., US 5,702,397, issued Dec. 30, 1997. 4 Burkhart, US 6,267,766 B1, issued July 31, 2001. App App Find surg (id. a achie the s the k appr wher sutur 2, ¶ the s eal 2011-0 lication 11 ings of Fa 1. Foers ically (Foe t 1, ¶ 6), b ve, impos houlder. S not has be 2. Foers oaches for ein … the e to the bo 14). 3. Foers oft tissue t 4. Foers 13206 /778,951 ct ter states t rster 1, ¶ 3 ut “[sutur sible to ad uture tens en fixed.” ter states t repairing re is no re ne anchor ter disclos o adjacent ter’s Figur hat a torn ) and that e] knots tie just, and a ion is also (Id. at 1, hat “[w]ha the rotator quirement , and wher es devices bone stru e 27 is rep 5 rotator cuf arthroscop d arthrosc re located impossibl ¶ 7.) t is neede cuff or fix for the sur ein suture for “anch cture” (id. roduced b f tendon i ic techniq opically a in less tha e to measu d, therefor ing other geon to tie tension ca oring sutu at 2, ¶ 15) elow: s typically ues are le re difficul n optimal re and adj e, are new soft tissue a knot to n be adjus re[s] whic . repaired ss invasive t to areas of ust once s to bone, attach the ted” (id. a h attach[ ] t Appeal 2011-013206 Application 11/778,951 6 Figure 27 shows a cross-sectional view of one embodiment of Foerster’s device “comprising a binding tapered threaded anchor” (id. at 4, ¶ 54). 5. Foerster states that the embodiment shown in Figure 27 includ[es] bone anchor wings 230 for axially anchoring the body 228 within [a bone] cavity, as discussed in connection with prior embodiments. Suture lengths 34a, 34b extend distally through a center portion of the body 228, and continue about a suture return member or pin (not shown), extending proximally out of the body 228. . . . The interior wall 232 of the body 228 includes threads 234, and is tapered. . . . A tapered plug 236, having external threads 238 which complement the threads 234, and are adapted for engagement therewith, is adapted for disposition within the body 228, as shown in the figure. After the suture has been appropriately tensioned, as discussed in connection with prior embodiments, the plug 236 is threaded into the body 228, in order to create a zig-zag shaped binding lock on the suture 34. (Id. at 8, ¶ 88.) 6. Foerster states that its Figures 1A through 1F illustrate the use of its “suture anchor system 20[ ] for repairing a rotator cuff tendon injury” (id. at 4, ¶ 57). 7. Foerster states that a trocar is used to form a conduit through the soft tissue of the shoulder (id. at 4, ¶ 58) and “the surgeon passes a length of suture through the soft tissue of the rotator cuff tendon 22 so that a loop 32 of suture material is embedded therein” (id. at 4, ¶ 59). 8. The two free ends of the suture are then “withdrawn from the patient and coupled to the suture anchor system 20” (id.), a cavity is formed in the humerus bone (id. at 4, ¶ 60), and the “surgeon then positions a suture Appeal 2011-013206 Application 11/778,951 7 anchor 46 within the cavity 40 and secures it therein to prevent removal from the cavity” (id.). 9. Foerster states that the “suture anchor 46 performs two functions: anchoring itself within the body cavity and anchoring the sutures therein” (id. at 4, ¶ 61). 10. Foerster states that the suture anchor can anchor itself in the cavity using expandable anchoring members (id.), or “an anchoring structure that expands into contact with the cancellous matter 44 or a body resembling a screw may also be used” (id. at 4, ¶ 62). 11. Foerster states that [d]esirably, the particular manner of anchoring the suture with respect to the suture anchor 46 permits easy adjustment of the length of suture between the suture anchor 46 and the loop 32 formed in the soft tissue prior to anchoring the suture. This adjustment allows the surgeon to establish the proper tension in the length of suture for effective repair of the soft tissue. (Id. at 5, ¶ 63.) 12. Foerster states that its Figure 1D “shows the anchoring member 48 after having been radially expanded,” with the anchor 46 thereby “prevented from being removed from the cavity 40” (id. at 4, ¶ 61). 13. Foerster states that its Figure 1D “also illustrates the two free ends 34a, 34b of the length of suture having been pulled taught [sic] prior to securing within the suture anchor 46” (id. at 5, ¶ 63). 14. Foerster states that its Figure 1E shows “the fully deployed suture anchor 46 after the free ends 34a, 34b have been placed in tension and locked within the suture anchor” (id. at 5, ¶ 64). Appeal 2011-013206 Application 11/778,951 8 15. Goble discloses “a bone anchor and system for its use for endosteal mounting and setting tension and length on a ligament” (Goble 2:6-7). 16. Goble discloses that “[e]ach bone anchor includes a center longitudinal cavity formed therethrough, with a distal end that is sided to receive a turning tool” (id. at 2:65-67). 17. Burkhart discloses a suture anchor (Burkhart 1:55). 18. Burkhart’s Figure 1 is reproduced below: Figure 1 shows suture anchor 10 having threads 16 (id. at 2:37-39) as well as “tool 30 . . . [which] is used to engage walls 12C of the head 12” (id. at 2:61-63). Principles of Law “If a person of ordinary skill can implement a predictable variation [of a known work], § 103 likely bars its patentability.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007). “A patent applicant is free to recite features of an apparatus either structurally or functionally. See In re Swinehart, 58 C.C.P.A 1027, 439 F.2d Appeal 2011-013206 Application 11/778,951 9 210, 212, 169 USPQ 226, 228 (CCPA 1971) (‘There is nothing intrinsically wrong with [defining something by what it does rather than what it is] in drafting patent claims.’). Yet choosing to define an element functionally, i.e., by what it does, carries with it a risk.” In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997). “‘Functional’ terminology may render a claim quite broad. By its own literal terms a claim employing such language covers any and all embodiments which perform the recited function.” In re Swinehart, 439 F.2d 210, 213 (CCPA 1971). Analysis We agree with the Examiner that the device of claim 1 on appeal would have been obvious based on the cited references. As the Examiner found, Foerster discloses a similar device meeting most of the limitations of claim 1, Goble discloses a device having a first end shaped to be mated to a driver, and Burkhart discloses a device having a tapered configuration with a narrower tip (Answer 4-5). We agree with the Examiner that it would have been obvious to modify Foerster’s anchor body 228 to have a tapered configuration and a first (larger) end shaped to be mated to a driver in order to allow easier insertion of the anchor using an elongated driver (see Answer 5-6). This conclusion is strengthened by Foerster’s express suggestion that the suture anchor can be anchored in a bone cavity either using expandable anchor members, as shown in Foerster’s Fig. 27 (FF 4) or by “a body resembling a screw” (FF 10); i.e., tapered, threaded, and capable of being turned with a driver. Appeal 2011-013206 Application 11/778,951 10 Appellant argues, however, that Foerster’s suture anchor “is actually incapable, of re-tensioning after the device is deployed within a bone” (Appeal Br. 10). Appellant reasons that Foerster states that its suture anchor “‘permits easy adjustment of the length of suture . . . prior to anchoring the suture’” (id., citing Foerster ¶ 53) and that Foerster’s Figures 1D and 1E show that the free ends of the suture are “pulled taught and are placed in tension and locked in the suture anchor as it is deployed within the bone” (id., citing Foerster ¶¶ 63-64). Appellant urges that “the express teachings of Foerster illustrate and describe that the suture is locked within the suture anchor and the anchor is then deployed” (id.). We disagree with this reasoning. Foerster describes its Figure 1D as showing its device in a state where its anchor body has been anchored in a body cavity (FF 12) and the free ends of the suture have been pulled taut prior to anchoring the suture in the suture anchor (FF 13). Foerster states that Figure 1E shows the suture anchor after the ends of the suture have been placed in tension and locked in the suture anchor (FF 14). Thus, Foerster describes a device in which the ends of the suture are tensioned (pulled taut) and then locked in place. Some of the embodiments of Foerster’s device are intended to lock the suture in place in a way that it cannot afterward be loosened. For example, the embodiment shown in Foerster’s Figures 2 and 3 includes a plug made of a compliant material that is compressed by a cap, also compressing channels through which the suture passes, “thereby clamping or locking the suture in place” (Foerster 5, ¶ 68). Similarly, the embodiment shown in Foerster’s Figures 4 and 5 includes a monofilament fiber that Appeal 2011-013206 Application 11/778,951 11 “becomes tightly wrapped about the suture . . . , thus locking the suture 34 in place lengthwise” (id. at 5, ¶ 70). Thus, some of Foerster’s embodiments include structures that are intended to prevent loosening of the suture after it has been locked in place. The embodiment of Figure 27, however, includes a plug having threads that engage threads in the anchor body, so that “the plug 236 is threaded into the body 228, in order to create a zig-zag shaped binding lock on the suture 34” (FF 5). Foerster does not describe any special structure of the threads of its Figure 27 embodiment that would prevent the threaded plug from being removed from the anchor body by simply being turned in the opposite direction. We therefore agree with the Examiner that, by virtue of its structure, Foerster’s Figure 27 embodiment allows re-tensioning of the sutures by loosening the plug and adjusting the length of the suture, followed by re-tightening of the plug to lock the adjusted suture in place. Appellant also argues that Goble’s anchor is not re-tensionable (Appeal Br. 11-15) and that Burkhart’s device is “a unitary suture anchor” (id. at 15) rather than a suture anchor having a body and plug (id. at 16). These arguments are not persuasive because we agree with the Examiner that Foerster teaches a re-tensionable suture anchor, and that it would have been obvious to give Foerster’s suture anchor a tapered shape in view of Burkhart’s teaching of a tapered suture anchor and Foerster’s suggestion to shape its anchor body like a screw (FF 10). Appellant also argues that the cited references do not provide a reasonable expectation of success in making a re-tensionable suture anchor (Appeal Br. 18-20), which is not persuasive because we agree with the Appeal 2011-013206 Application 11/778,951 12 Examiner that Foerster’s Figure 27 embodiment has a structure that makes it capable of carrying out the claimed function of re-tensioning. Finally, Appellant argues that there is no reason provided to modify Foerster’s plug to be mated with a driver because “[t]here is no driver device shown or described by Foerster, and FIG. 27 of Foerster fails to show any structure with which to mate a driver to the plug. Thus, hand insertion of the plug into the anchor is as much a likely conclusion based upon the teachings of Foerster.” (Reply Br. 5.) Appellant argues that “[w]hile the device of Goble requires a driver for operation, there is no such requirement in Foerster” (id. at 6). This argument is also unpersuasive. First, Foerster states that accessing the humerus and rotator cuff tendon requires the surgeon to “make[] an incision or stab wound through the outer dermal layers of sufficient size to permit passage of the trocar 30 through the skin and the deltoid muscle, into proximity with the humeral head 24” (Foerster 4, ¶ 58). The steps of the surgery are performed via this conduit to the humeral head (id. at 4, ¶ 59). Appellant has cited no evidence to support the assertion that a suture anchor could be inserted by hand through the incision or conduit described by Foerster. Appellant’s argument that “hand insertion of the plug into the anchor” is likely based on Foerster’s teachings (Reply Br. 5) does not address the relevant limitation, because claim 1 requires that the anchor, not the plug, has an end shaped to be mated with a driver. We note that Foerster expressly suggests using an anchor body “resembling a screw” (FF 10) in its suture anchor. This suggestion provides additional reason to modify Appeal 2011-013206 Application 11/778,951 13 Foerster’s anchor body to allow it to be mated to a driver, as required by claim 1. Conclusion of Law The evidence of record supports the Examiner’s conclusion that the cited references would have made obvious a device meeting the limitations of claim 1. Claims 2-6 and 21-24 have not been argued separately and therefore fall with claim 1. 37 C.F.R. § 41.37(c)(1)(vii). SUMMARY We affirm the rejection of the claims on appeal as obvious based on Foerster, Goble, and Burkhart. 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 dm Copy with citationCopy as parenthetical citation