13949639 (P.T.A.B. Sep. 18, 2018)

Ex Parte Kilburn-Peterson et al

Patent Trial and Appeal BoardSep 18, 2018

13949639 (P.T.A.B. Sep. 18, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 13/949,639 07/24/2013 27777 7590 09/20/2018 JOSEPH F. SHIRTZ JOHNSON & JOHNSON ONE JOHNSON & JOHNSON PLAZA NEW BRUNSWICK, NJ 08933-7003 UNITED ST A TES OF AMERICA FIRST NAMED INVENTOR Christopher Kilburn-Peterson UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www .uspto.gov ATTORNEY DOCKET NO. CONFIRMATION NO. MIT5119USDIV1 6403 EXAMINER LYNCH, ROBERT A ART UNIT PAPER NUMBER 3731 NOTIFICATION DATE DELIVERY MODE 09/20/2018 ELECTRONIC Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): jnjuspatent@corus.jnj.com lhowd@its.jnj.com pairjnj@firsttofile.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte CHRISTOPHER KILBURN-PETERSON, JOSEE. LIZARDI, and KRISTIAN DIMATTEO Appeal2017-008603 Application 13/949,639 Technology Center 3700 Before DEMETRA J. MILLS, RICHARD M. LEBOVITZ, and TIMOTHY G. MAJORS, Administrative Patent Judges. MILLS, Administrative Patent Judge. DECISION ON APPEAL This is an appeal 1 under 35 U.S.C. Â§ 134. The Examiner has finally rejected claims 16-20, 24, 25, and 29--32 under 35 U.S.C. Â§ 103(a) for obviousness. We have jurisdiction under 35 U.S.C. Â§ 6(b). We affirm. 1 The Appeal Brief identifies DePuy Mitek, LLC as the real party in interest. Br. 2. Appeal2017-008603 Application 13/949,639 STATEMENT OF THE CASE The following claims are representative. 16. A suture anchor kit comprising: a suture anchor adapted for implantation into a humeral head for attaching a rotator cuff to the humeral head having at least one suture limb extending therefrom, the suture anchor comprising a distal end for entering bone, an opposite proximal end and a side between the distal end and proximal end; a suture anchor passing tool holding the suture anchor side prior to the suture anchor being implanted into the humeral head. 20. A suture anchor kit comprising: a positional guide adapted to pass through a rotator cuff tendon; a suture anchor adapted for implantation into a humeral head for attaching a rotator cuff to the humeral head, having at least one suture limb extending therefrom; a driver adapted to drive the suture anchor into the humeral head; and means for positioning the suture anchor at a target site by passing the suture anchor laterally underneath a rotator cuff tendon to intercept the positional guide which is passed through the rotator cuff tendon. 25. A suture anchor kit according to claim 24 wherein the suture anchor comprises a first lateral portion and a second lateral portion, the first lateral portion and second lateral portion engageable with each other laterally at a target site beneath a rotator cuff tendon with the positional guide within the central bore. 29. A suture anchor kit according to claim 16 wherein the suture anchor comprises a recess at its proximal end at least a portion of which comprises a tool receiving cross-sectional shape; and wherein the kit further comprises an awl having a sharp distal tip and a cross-section proximal of the tip shaped to 2 Appeal2017-008603 Application 13/949,639 mate with the tool receiving cross-sectional shape on the suture anchor. 31. A suture anchor kit according to claim 29 wherein the anchor further comprises internal threads within the recess and wherein the suture anchor kit further comprises a proximal anchor having a threaded distal section mating with the internal threads of the suture anchor. Cited References Fitts Wyman Goble Fanton Grounds of Rejection us 6,096,060 US 2002/0010468 Al US 2004/0006349 Al US 2008/0275469 A 1 A.ug. 1, 2000 Jan. 24, 2002 Jan. 8, 2004 Nov. 6, 2008 1. Claims 16-20, 24, and 32 are rejected under pre-AIA 35 U.S.C. Â§ 103(a) as being unpatentable over Goble in view of Wyman. 2. Claim 25 is rejected under pre-AIA 35 U.S.C. Â§ 103(a) as being unpatentable over Goble in view of Wyman and Fanton. 3. Claims 29 and 30 are rejected under pre-AIA 35 U.S.C. Â§ 103(a) as being unpatentable over Goble in view of Wyman and Fitts. 4. Claim 31 is rejected under pre-AIA 35 U.S.C. Â§ 103(a) as being unpatentable over Goble in view of Wyman, Fitts and Fanton. FINDINGS OF FACT The Examiner's findings of fact are set forth in the Final Office Action at pages 2-11. The following facts are highlighted. 1. Goble discloses a surgical apparatus guide assembly device, and Figure 1 is reproduced below. 3 Appeal2017-008603 Application 13/949,639 5 _____ ,,.-~ Ft t.. I Figure 1 of Goble, reproduced above, shows interference screw 100, transverse pin 200, and a transverse pin guide assembly 300. Goble ,r 36. 2. Figure 9 of Goble is reproduced below. Flt;.. , Figure 9, reproduced above, shows transverse guide assembly 300, boom member 305, and guide member 315 not in use. Goble ,r 43. 3. Figures 22A and 22B of Fanton are reproduced below. 4 Appeal2017-008603 Application 13/949,639 Â·. FiG. 22f.3 Figures 22A and 22B, reproduced above, show bone anchor member 442 and plug portion 450. The central bore of the anchor member is element 444. Plug portion 450 has a main body 451 having proximal and distal regions. Bone anchor member 442 is inserted into a hole of the bone before plug portion 450 is inserted into bore 444. Fanton ,r,r 311-16. 4. Fitts, Figure 4 is reproduced below. Fitts, Figure 4, reproduced above, shows an awl/driver 100 with a support shaft 104 and tip 110 to facilitate penetration of tissue. Fitts col. 5, 11. 30-50. The driver 100 with anchor 10 attached (see, Fig. 1) is then introduced into the body through one of the arthroscopic portals (not shown) and the tip 110 is used to pierce the tissue so the surgeon can manipulate it into position over the pilot hole 122. Cols. 5 and 6. 5 Appeal2017-008603 Application 13/949,639 PRINCIPLES OF LAW In making our determination, we apply the preponderance of the evidence standard. See, e.g., Ethicon, Inc. v. Quigg, 849 F.2d 1422, 1427 (Fed. Cir. 1988) (explaining the general evidentiary standard for proceedings before the Office). During ex parte prosecution, claims are to be given their broadest reasonable interpretation consistent with the description of the invention in the specification. In re Zietz, 893 F.2d 319, 321 (Fed. Cir. 1989). If a prior art structure is capable of performing the intended use as recited in the preamble, then it meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997). While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. Id. at 1477-78. Obviousness Rejection I-Goble and Wyman Claim 16 The Examiner finds that Goble teaches each element claimed except Goble fails to expressly disclose a suture limb extending from the suture anchor. However, Wyman teaches ( see Figs. 1- 6) an interferences screw anchor (2, Fig. 6) having a suture limb ( 42) extending therefrom in order to beneficially assist and facilitate pulling the interference screw into a joint or bone tunnel while further retaining the screw in proper position for engagement with the bone tunnel ([0010]; [0014]; [0029]). Final Act. 7. 6 Appeal2017-008603 Application 13/949,639 The Examiner concludes that it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device of Goble to have a suture limb extending from the suture anchor in order to beneficially assist and facilitate pulling the interference screw into a joint or bone tunnel while further retaining the screw in proper position for engagement with the bone tunnel, as taught by Wyman. Final Act. 7. Appellants contend that The Examiner has failed to establish a credible reason why one of skill in the art at the time of Appellants' invention would have been motivated to combine the teachings of Goble et al. with Wyman et al. and further, even if this alleged combination had been made if would fail to reach the presently claimed invention. Br. 4. More particularly, Appellant[ s] allege[] that there is no credible motivation to combine Goble and Wyman and that it would be "difficult if not impossible" (Appeal Brief, p. 4) to provide the bone screw of Goble at the top of the bone tunnel as provided by the method steps of Wyman. Ans. 4. The Examiner responds, explaining that Wyman expressly teaches (see Figs. 1-6) the incorporation of a suture (42) coupled to the anchor (2, Fig. 6) in order to beneficially assist and facilitate pulling the interference screw into a joint or bone tunnel while further retaining the screw in proper position for engagement with the bone tunnel ([0010]; [0014]; [0029]). Additionally, it is unclear why Appellant[ s '] argument requires the screw of Goble to be inverted/reversed with screw entry from the top of the bone tunnel (i.e. seeming to modifying Wyman in view of Goble instead of as presently rejected). Goble discloses screw entry from the bottom of the bone tunnel and the beneficial suture 7 Appeal2017-008603 Application 13/949,639 attachment taught in Wyman can be incorporated to further improve and facilitate such a deployment system. Ans. 2-3. Appellants further argue that claim 16 further defines both a suture limb extending from the anchor and a passing tool holding the anchor side. The Examiner analogizes the stay suture of Wyman et al. and the cross pin of Goble et al. to the present suture and passing tool respectively. However, even if the alleged combination were made these two parts would not appear together. The stay suture is employed temporarily to pull the Wyman et al. anchor into the hole and is then later removed and if the alleged combination were made it would surely be removed prior to placing the pin so that the pin would not make the removal of the stay suture difficult or impossible. Br. 5. ANALYSIS We agree with the Examiner's fact-finding, statement of the rejection, and responses to Appellants' arguments as set forth in the Answer. We find that the Examiner has provided evidence to support a prima facie case of obviousness. We provide the following additional comments to the Examiner's arguments set forth in the Final Office Action and Examiner's Answer. Claim Interpretation We begin with claim interpretation. "[T]he name of the game is the claim." In re Hiniker Co., 150 F.3d 1362, 1367 (Fed. Cir. 1998) quoting, Giles Sutherland Rich, Extent of Protection and Interpretation of Claims- American Perspectives, 21 Int'l Rev. Indus. Prop. & Copyright L. 497,499 8 Appeal2017-008603 Application 13/949,639 (1990) ("The U.S. is strictly an examination country and the main purpose of the examination, to which every application is subjected, is to try to make sure that what each claim defines is patentable. To coin a phrase, the name of the game is the claim"). Therefore, we carefully first addressfocus on claim interpretation in this case. Claim 16 is directed to a suture anchor kit having two items: a) a suture anchor and b) a suture anchor-passing tool (which is capable of holding the suture anchor side prior to the suture anchor being implanted into the humeral head). The Specification defines a "suture anchor passing tool" as a "tool ... adapted to grasp the suture anchor side." Spec. 3. Since the term "grasp" means "[to] hold firmly" 2, we interpret the term "suture anchor passing tool" consistent with the meaning presented in the Specification, as any device, which is capable of holding the suture anchor firmly by its side. The Specification provides two embodiments of a passing tool that include a passing stick (90; Fig. 10) or a grasper (122; Fig. 15B). As a broadest reasonable interpretation, the term "passing tool," therefore, includes any tool that is capable of holding a suture anchor by its side prior to implantation. Claim 16 recites "a suture anchor passing tool holding the suture anchor side prior to the suture anchor being implanted into the humeral head." What Appellants do not claim is a passing or grasping tool for positioning the suture anchor prior to implantation; or a tool to facilitate 2 ENGLISH OXFORD LIVING DICTIONARY (https:// en.oxforddictionaries.com/ definition/ grasp) (last visited Sept. 14, 2018). 9 Appeal2017-008603 Application 13/949,639 delivery and positioning of the suture anchor to/at the insertion location prior to implantation. Discussion As to claim 16, Appellants argue that the Examiner analogizes the cross pin of Goble to the passing tool, as claimed. Br. 4--5. Appellants argue that if the alleged combination were made, the stay suture of Wyman and the pin of Goble would not appear together. "The Wyman stay suture is employed temporarily to pull the Wyman anchor into the hole and is then later removed and if the alleged combination were made it would surely be removed prior to placing the pin so that the pin would not make the removal of the stay suture difficult or impossible." Br. 5. We are not persuaded by Appellants' arguments. The Examiner finds that The claims at issue are kit claims wherein the prior art kit need only be capable of performing the intended use or functional language as presently claimed. Still further, it is the Examiner's position that the disclosed use of the system of Goble is irrelevant to the kit claims as long as the system/kit of Goble in view of Wyman is capable of being used in the intended or functional manner as claimed. Ans. 4. For example, if one of ordinary skill in the art were to take the guide assembly device of Goble, Figure 1, with pin 200 and the transverse interference screw or suture anchor of Wyman attached (before it is implanted in the body); the device would be capable of "holding" the suture anchor by its side before implantation. Therefore, given the breadth of the current claim, it reads on the guide assembly device of Goble with a suture anchor attached, before it is inserted into the patient. 10 Appeal2017-008603 Application 13/949,639 In other words, the guide assembly of Goble with the pin and transverse interference screw or suture anchor of Wyman attached, is capable of holding the suture anchor side prior to the suture anchor being implanted into the humeral head, as claimed. Fig. 1, FF 1. As a general matter, functional limitations directed to intended uses of a claimed product do not serve to structurally distinguish the product from prior art products that are capable of performing the claimed function. Schreiber, 128 F.3d at 1478-79 (holding that a prior art apparatus meeting all claimed structural limitations was anticipatory because it was capable of performing the claimed function). As to Appellants' argument concerning the motivation to combine Goble with Wyman, the Examiner reasons that one of ordinary skill in the art would have modified "the device of Goble to have a suture limb extending from the suture anchor in order to beneficially assist and facilitate pulling the interference screw into a joint or bone tunnel while further retaining the screw in proper position for engagement with the bone tunnel, as taught by Wyman." Final Act. 7. The motivation to combine references does not have to be identical to the applicants' motivation to establish obviousness. In re Kemps, 97 F.3d 1427, 1430 (Fed. Cir. 1996). Appellants have not persuasively rebutted the Examiner's indicated motivation to combine the cited references. Appellants are reminded that claim 16 is directed to a suture anchor kit with two items (a suture anchor and a suture anchor passing tool), not the use of the kit. Even if the suture anchor is adapted for a specific use, Appellants have not shown why one of ordinary skill in the art would not have included the guide assembly (passing tool) of Goble with a suture 11 Appeal2017-008603 Application 13/949,639 anchor, in a kit together for the reasons indicated by the Examiner, in view of the Examiner's reasoning to combine the two items. The obviousness rejection is affirmed. Obviousness Rejection 2 - Goble, Wyman, and Fanton With respect to claim 25,[3J the Examiner finds that Goble in view of Wyman discloses an anchor fixation system ... , but fails to teach the anchor comprising first and second lateral portions engageable with each other laterally at a target site beneath a rotator cuff tendon with the positional guide within the central lumen. However, Fanton teaches (see Figs. 3A-3E) an anchor system comprising first (22a, Fig. 3A) and second (22b, Fig. 3A) lateral portions engageable with each other laterally (as shown in Fig. 3B) at a target site beneath a rotator cuff tendon with the positional guide within the central lumen (portions 22a,22b are fully capable of such a use if one so desires) in order to provide for an efficient manner of suture- to-anchor attachment that eliminates the need for threading suture ends through anchor passages thereby increasing the speed and use of both the anchor and the anchoring surgical procedure ([0188]-[0195]). Ans. 7-8. Appellants contend that the Examiner is engaging in hindsight reconstruction of Appellants' invention, and has not indicated a reason to combine a two part anchor with the disclosures of Goble and Wyman. Br. 6. Appellants further argue that, [t]he Examiner asserts that Fanton et al. teach parts combinable beneath a rotator cuff tendon and admits that Fanton et al. fail to teach the positional guide. How a surgeon would thread the suture through the convoluted passages and assemble the anchor while positioned in a very tight space 3 This argument is also applicable to claim 20, which also recites a positional guide. 12 Id. Appeal2017-008603 Application 13/949,639 under a rotator cuff tendon all while working through an access cannula boggles the imagination. We are not persuaded. According to the present Specification, in a preferred embodiment, the positional guide is a needle. Spec. 1. No further definition of the claimed positional guide, or structural or functional arrangement of the positional guide, has been provided in the Specification. Therefore, the Examiner has given the claim language "positional guide" its broadest reasonable interpretation. 4 The Examiner relies on element 400 of Goble (the drill bit) as the positional guide adapted to (here, capable of) pass through a rotator cuff tendon ( drill bit 400 is fully capable of such a function if one so desires). Ans. 6. Appellants provide no argument with respect to whether or not the drill bit of Goble is capable of functioning as a positional guide passing through a rotator cuff tendon. Again, the issue here is one of claim breadth. Appellants' further argue that the suture anchor of Wyman has no convoluted passages, and there is a desire in Wyman to be able to easily remove the suture anchor. Br. 6. Thus, Appellants contend that one of ordinary would not use a suture anchor with two components because this would add an additional step and would not increase speed of use. Id. We are not persuaded. Fanton discloses an alternative, two-part suture anchor with a locking assembly to inhibit undesirable movement of the sutured tissue. Fanton ins. This provides motivation to substitute the suture anchor 4 Note, Appellants do not claim a positional guide that is a needle having a bore for threading. 13 Appeal2017-008603 Application 13/949,639 of Fanton for that of Wyman, to achieve a more securely anchored suture anchor. The preponderance of the evidence favors the Examiner's position and the rejection 2 is affirmed. Obviousness Rejection 3 - Goble, Wyman, and Fitts The Examiner finds that the combination of Goble in view of Wyman fails to teach the anchor comprising a recess at its proximal end at last a portion of which comprises a tool receiving a cross-sectional shape and further comprising an awl with a sharp tip and a cross-section proximal of the tip shaped to mate with the tool receiving cross-sectional shape on the anchor. Ans. 8-9. To make up for this deficiency, the Examiner finds that Fitts teaches (see Figs. 1-8) an anchor system comprising an anchor (10) comprising a recess (24) at its proximal end at last a portion of which comprises a tool receiving cross-sectional shape ( col. 4, lines 48-62; col. 5, lines 34-36; bore 24 cross-sectional shape taught as being triangular or any other functional non-circular shape) and further comprising an awl (100) with a sharp tip (110) ... shaped to mate with the tool receiving cross-sectional shape ( defining bore 24) on the anchor (1 O)[,] in order to facilitate and combine the steps of piercing of tissue and driving of a threaded anchor wherein a sharp distal tip pierces tissue and identifies the spot desired for fixation while the proximal tool receiving cross-sectional shape retains and drives the threaded anchor without the added need for a guide wire and with minimal trauma to the surgical site ( col. 2, line 65-col. 3, line 1 O; col. 2, lines 29-44; col. 4, lines 48-62; col. 5, lines 30-50). Ans. 8-9. 14 Appeal2017-008603 Application 13/949,639 Appellants contend that the Examiner has engaged in hindsight reconstruction of Appellants' invention. Br. 6. Appellants contend that [t]here is no need to pierce and push tissue with the knee repairs of Goble et al. and Wyman et al. and the skilled artisan would not seek to mix in this unrelated shoulder art. Goble et al. and Wyman et al. place a graft into a predrilled hole that has additional room for the interference screw. The awl is unnecessary with the predrilled hole and would not work in such a situation to create the hole. Id. at 6-7. Appellants argue that all the previously argued deficiencies of claim 16 also apply to this claim. Id. at 7. We are not persuaded, and find that the Examiner has provided motivation found in the cited prior art to combine the awl of Fitts with the disclosures of Goble and Wyman. For example, the Examiner argues thatFitts expressly teaches an awl shaped to mate with a tool receiving cross- sectional shape ( defining bore 24) on the anchor in order to facilitate and combine the steps of piercing of tissue and driving of a threaded anchor, wherein a sharp distal tip pierces tissue and identifies the spot desired for fixation while the proximal tool receiving cross-sectional shape retains and drives the threaded anchor without the added need for a guide wire and with minimal trauma to the surgical site. Ans. 6-7. The Examiner reasons that the benefits of the awl may be realized when the combined system/kit is used in other procedures, as one so desires, and the benefit of the screw mated with a sharp tipped awl beneficially assists and facilitates the delivery of the screw to a pre-formed hole by means of inserting the sharp awl tip eliminating the need for a guide wire "as is done in the disclosed steps of Goble (see Fig. 11; a distal guiding awl tip 15 Appeal2017-008603 Application 13/949,639 would further facilitate and improve locating and inserting screw within the bone tunnel)." Ans. 6-7. Appellants have provided no evidence that instruments, such as an awl, used in orthopedic knee repair are inappropriate for modification and/or use in shoulder repairs. The obviousness rejection 3 is affirmed for the reasons of record. Arguments not made are waived. Obviousness Rejection 4- Goble, Wyman, Fitts, and Fanton Claim 31 is rejected in view of Goble, Wyman, Fitts, and Fanton. The Examiner finds that Fanton expressly teaches (see Figs. 18A-18B) the incorporation of an anchor (343) having internal threads (371) within the recess and the kit further comprising a proximal anchor (360) having a threaded distal section (3 61) mating with the internal threads (3 71) of the suture anchor (343) in order to provide a threaded retention mechanism for holding the suture in a locked state that furthers allows for the added option of suture re-adjustment as needed ([0288]- [0291 ]). Ans. 7. The Examiner further finds that, this arrangement of "Fanton beneficially assists and facilitates selective suture tension adjustment ([0288]- [0291]) which includes selective suture removal (e.g. when either completely "loosened" or cut) and is therefore directly in line with the teachings of Wyman." Ans. 7-8. Figure 22A of Fanton shows a bone anchor member 442 and a plug portion 450. The plug portion is inserted or mated into the bore 444 of the bone anchor member 442. Fanton ,r,r 311-316. Appellants provide no 16 Appeal2017-008603 Application 13/949,639 argument with respect to whether the anchor and plug of Fanton is capable of functioning as a modified anchor with internal threads within the recess, as claimed. Appellants further rely on their arguments with respect to claim 16, as applied to claim 31. App. Br. 7. Appellants' arguments with respect to claim 16 above were unpersuasive and remain unpersuasive here. Thus, we affirm the rejection of claim 31. CONCLUSION OF LAW The cited references support the Examiner's obviousness rejections, which are affirmed for the reasons of record. All pending, rejected claims fall. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. Â§ 1.136(a). See 37 C.F.R. Â§ 41.50(Â±). AFFIRMED 17