Ethicon, Inc.

Patent Trials and Appeals BoardOct 26, 2020

2020001737 (P.T.A.B. Oct. 26, 2020)

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. 14/177,894 02/11/2014 Anthony Miksza ETH5764USNP 1467 73119 7590 10/26/2020 Doherty IP Law Group LLC 37 Belvidere Avenue Washington, NJ 07882 EXAMINER BACHMAN, LINDSEY MICHELE ART UNIT PAPER NUMBER 3771 MAIL DATE DELIVERY MODE 10/26/2020 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 ANTHONY MIKSZA, ROBERT NERING, MARK D. KENYON, OMAR J. VAKHARIA, and DENNIS D. JAMIOLKOWSKI Appeal 2020-001737 Application 14/177,894 Technology Center 3700 Before JILL D. HILL, LEE L. STEPINA, and ARTHUR M. PESLAK, Administrative Patent Judges. STEPINA, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims 1–27. See Final Act. 1. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real party in interest as Ethicon, Inc. Appeal Br. 2. Appeal 2020-001737 Application 14/177,894 2 CLAIMED SUBJECT MATTER Appellant’s invention relates to systems, devices and methods that use surgical fasteners for securing implants to tissue. Spec. ¶ 2. Claims 1 and 20–22 are independent. Claim 1, reproduced below with emphasis added, is illustrative of the claimed subject matter: 1. An applicator system for surgical fasteners comprising: a surgical fastener insertion tool having a body with a proximal end, a distal end, a longitudinal axis extending between the proximal and distal ends of said body, a top side extending from the proximal end to the distal end of said body, a bottom side extending from the proximal end to the distal end of said body, and first and second lateral sides that extend from the proximal end to the distal end of said body and between the top and bottom sides of said body, said surgical fastener insertion tool including an insertion fork connected to the distal end of said body that extends laterally relative to the longitudinal axis of said body, said insertion fork having a proximal end connected to the distal end of said body, a distal end, and a curved shaft that extends from the proximal end of said insertion fork to the distal end of said insertion fork, wherein said curved shaft of said insertion fork has a top surface that is concave and that faces in the same direction as the top side of said body and a bottom surface that is convex and that faces in the same direction as the bottom side of said body; at least one cartridge containing a plurality of surgical fasteners, wherein said surgical fasteners are removed one at a time from said cartridge by engaging one of said surgical fasteners with said insertion fork and removing said engaged surgical fastener from said cartridge. Appeal Br. 23 (Claims Appendix). REFERENCES The prior art relied upon by the Examiner is: Name Reference Date Appeal 2020-001737 Application 14/177,894 3 Peiffer US 4,936,447 June 26, 1990 Esposito US 6,044,971 Apr. 4, 2000 Evans US 8,092,366 B2 Jan. 10, 2012 Doyle (“Doyle ’604”) US 2002/0111604 A1 Aug. 15, 2002 Nering US 2010/0292715 A1 Nov. 18, 2010 Euteneuer US 2012/0211543 A1 Aug. 23, 2012 Privitera US 2012/0323256 A1 Dec. 20, 2012 Doyle (“Doyle ’ 690”) US 2013/0184690 A1 July 18, 2013 REJECTIONS I. Claims 1, 2, 10–12, 17, 22, and 252 are rejected under 35 U.S.C. § 103(a) as unpatentable over Euteneuer, Evans, and Peiffer. II. Claims 3–9 are rejected under 35 U.S.C. § 103(a) as unpatentable over Euteneuer, Evans, Peiffer, Doyle ’604 and Doyle ’690. III. Claims 13–16 are rejected under 35 U.S.C. § 103(a) as unpatentable over Euteneuer, Evans, Peiffer, and Nering. IV. Claims 1, 18, 19, 21, and 26 are rejected under 35 U.S.C. § 103(a) as unpatentable over Euteneuer, Evans, and Esposito. V. Claims 20 and 27 are rejected under 35 U.S.C. § 103(a) as unpatentable over Euteneuer, Evans, Peiffer, and Privitera. VI. Claims 23 and 24 are rejected under 35 U.S.C. § 103(a) as unpatentable over Euteneuer, Evans, Peiffer, Doyle ’604, and Doyle ’690. 2 The Examiner’s omission of claim 2 from the heading of Rejection I appears to be a typographical error in that claim 2 is discussed in the body of the rejection. See Final Act. 4–5. Appeal 2020-001737 Application 14/177,894 4 OPINION Rejections I, IV and V Each of independent claims 1 and 20–22 includes the limitations, “said surgical fastener insertion tool including an insertion fork connected to the distal end of said body that extends laterally relative to the longitudinal axis of said body,” and requires that the insertion fork has “a curved shaft.” Appeal Br. 23, 27–29 (Claims App.). Appellant argues for the patentability of the claims subject to the first, fourth, and fifth grounds of rejection, i.e., claims 1, 2, 10–12, 17–22, and 25–27, as a group, based on the above note limitations of the independent claims. Appeal Br. 13–21. We select claim 1 as representative of the group, and claims 2, 10–12, 17–21, and 25–27 stand or fall with claim 1. 37 C.F.R. § 41.37(c)(1)(iv). Appellant makes arguments based on the above-noted limitations for independent claim 22, but because Appellant provides an additional argument for claim 22, we address the additional argument under a separate heading below. In each rejection, the Examiner relies on the combined teachings of Euteneuer and Evans for the above-noted limitations. See Final Act. 4–5. For Rejection I, the Examiner also relies on Peiffer to reject independent claims 1 and 22, but for limitations unrelated to the laterally extending insertion fork. See Final Act. 5, 7–8. For Rejection IV, the Examiner also relies on Esposito to reject independent claims 1 and 21, but for limitations unrelated to the laterally extending insertion fork. See Final Act. 12 and 14. For Rejection V, the Examiner also relies on Peiffer and Privitera to reject independent claim 20, but for limitations unrelated to the laterally extending insertion fork. See Final Act. 15–16. Appeal 2020-001737 Application 14/177,894 5 Turning to the teachings of Euteneuer and Evans, the Examiner finds that Euteneuer discloses a surgical fastener insertion tool having a body and including an insertion fork connected to the distal end of the body. Id. at 4. The Examiner finds that the insertion fork of Euteneuer does not extend laterally relative to the longitudinal axis of said body and is not curved, but the Examiner finds that Evans discloses an insertion tool having an insertion part that extends laterally relative to the longitudinal axis of the insertion tool body and is curved. Id. at 4–5. According to the Examiner, Evans teaches adjusting the shape of the insertion tool depending on which part of the body the insertion tool is used. Id. at 5. The Examiner concludes that it would have been obvious to modify Euteneuer’s insertion fork to be curved and extend laterally relative to the body “in order to access a particular part of the body.” Id. Appellant summarizes Euteneuer and Evans and then sets forth several reasons why the Examiner has allegedly failed to establish a prima facie case of obviousness. Appeal Br. 13–17. First, Appellant argues that Euteneuer’s insertion fork tines 134A, 134B must align with pilot holes 162A, 162B that are pre-formed in tissue T. Appeal Br. 17. According to Appellant, an insertion fork having a “curved shaft,” would not align with pilot holes that are axially extending, and would not advance properly into the pilot holes. Id. Second, Appellant argues that modifying Euteneuer so that tines 134A, 134 B extend laterally would prevent proper operation of staple push rod 130. Id. Specifically, Appellant asserts that because Euteneuer teaches that staple push rod 130 moves distally along axis D, Euteneuer would not Appeal 2020-001737 Application 14/177,894 6 function properly if the two insertion tines 134A, 134B are curved and extended laterally from the body. Id. at 19. Third, Appellant argues that because Euteneuer’s tines extend along the longitudinal axis of staple push rod 130 for axially movement, “if Euteneuer’s tines were curved as suggested by the Examiner, the tines would be unable to advance the legs of the staple into the axially-extending pilot holes that are pre-formed in the tissue T.” Id. at 20 (citing Euteneuer, Fig. 12C). Moreover, according to Appellant, Euteneuer’s longitudinally extending tool teaches away from a combination with an axially extending tool. Id. The Examiner responds that the modification does not merely turn Euteneuer’s existing insertion tool laterally. Ans. 5. Rather, one of ordinary skill would understand that, based on the teachings of Evans, the modification would be to “the entire tool shaft of [Euteneuer], including both the outer shaft 146 and the inner insertion tool body 132, to both have the same curvature such that after modification, both shafts continue to be coaxial with one another, as in [Euteneuer].” Id. Thus, according to the Examiner, Euteneuer’s modified device would continue to function as intended. Ans. 6. The Examiner finds that Euteneuer does not teach away from the proposed combination because Euteneuer does not require that the push rod and tines must extend in a particular direction, only that they both extend in the same direction. Ans. 7. According to the Examiner, by modifying Euteneuer’s entire tool shaft to extend laterally and be curved, Euteneuer continues to function in the manner intended, and has the added benefit of a curved shaft for easier surgeon access to a body part. Id. Appeal 2020-001737 Application 14/177,894 7 In reply, Appellant disagrees that Euteneuer’s modified device would continue to function as intended. Reply Br. 2. Appellant contends that Euteneuer teaches a distally directed force F that is continuously applied during staple insertion. Id. at 2–3 (citing Euteneuer, ¶¶ 77, 79–80; Figs. 12A–12C). According to Appellant, it would not be obvious to one skilled in the art to extend Euteneuer’s shaft 146 laterally because an operator would not be able to generate the force F that is necessary to form the pilot holes in the tissue and to maintain the force F on the tissue as the legs of the staple 100 are advanced into the pre-formed pilot holes 162A, 162B. If Euteneuer’s shaft 146 were extended laterally, an operator of Euteneuer’s device would have to twist or rotate the handle to generate a lateral force. This would clearly change the principle of operation of Euteneuer. Id. at 3. We disagree with Appellant’s arguments because Appellant provides no technical explanation or argument sufficient to establish that one of ordinary skill in the art would consider that the modified Euteneuer would not be able to generate sufficient force F. Rather, Appellant merely speculates that the force applied in the proposed device would be insufficient to form the required holes in the patient’s tissue. Reply Br. 3. The curved and laterally extending device in the Figure 11 embodiment of Evans, upon which the examiner relies, generates sufficient force to urge the introducer and anchor (staple) into tissue, and maintains the force until the anchor is released from the introducer using a button. See Evans, 8:1–12, 8:57–62; see also Final Act. 4–5. Appellant’s attorney argument, without more, does not apprise us of any reason as to why a similarly sufficient force would not be achieved by the modified version of Euteneuer proposed by the Examiner. Appeal 2020-001737 Application 14/177,894 8 We also disagree with Appellant’s arguments (see Appeal Br. 17–20) relating to inoperability, change in the principle of operation, and teaching away. As the Examiner explains, the modification entails making the entire shaft of Euteneuer curved and laterally extending, which would align the staple with the pilot holes and would allow proper operation of staple push rod 130, as evidenced by Evans. Evans, 8:60–62 (“an introducer needle 111 with a halo-shaped needle shaft 110, a handle 112 and a button 113 for releasing the anchor 1 from the distal end of the needle.”). The modified version of Euteneuer would still function to introduce staples into tissue and would perform this function using the same principle of operation, namely, by using a tool to push a fastener into tissue. The fact that the pushing action required results from a “bent” device does not change the principle of operation. Appellant’s speculation that the modified device would require the operator “to twist or rotate the handle to generate sufficient force” and that “this would clearly change the principle of operation of Euteneuer” (Reply Br. 3) is unavailing because (i) Appellant does not provide evidence or technical argument establishing that such twisting and rotation would actually be necessary, and (ii) even if required, such twisting and rotation would not change the principle of operation of Euteneuer’s device (pushing a fastener into tissue). As to Appellant’s argument that Euteneuer teaches away from the proposed combination, we agree with the Examiner that Euteneuer does not require that the push rod and tines extend only in the longitudinal direction, and it is sufficient that they merely extend in the same direction. Ans. 7. Appellant does not identify any portion of Euteneuer that teaches away from the claimed arrangement, e.g., by criticizing, disparaging, or discouraging Appeal 2020-001737 Application 14/177,894 9 pursuit of the claimed arrangement. See In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004). Rather, Appellant’s contention on this point appears to be based on the unpersuasive contention, discussed above, that only a longitudinal force is sufficient for implanting a staple. Appeal Br. 20. We have considered all of Appellant’s arguments in support of the patentability of claim 1, but find the Examiner has the better position. For these reasons, we sustain the rejection of claim 1. Claims 2, 10–12, 17–21, and 25–27 fall with claim 1. Claim 22 Appellant includes an additional argument in support of claim 22. See Appeal Br. 21. Appellant alleges the Examiner erred in making a factual finding regarding Evans. In its entirety, Appellant’s argument is that “[i]n Evans, the shaft 110 (FIG. 11) is not connected to the distal end face of the handle 112, and it is not ‘connected to the first lateral side’ of the handle as required by the limitations found in independent claim 22.” Id. Claim 22, recites, in part, “said insertion fork having a proximal end connected to the first lateral side of said body at the distal end of said body.” Appeal Br. 29 (Claims App.). The Examiner finds that Evans’s insertion tool “has a body (110, 112) with a longitudinal axis and an insertion part (unlabeled, called ‘halo-shaped needle’ in specification) that extends laterally from the distal end of the body relative to the longitudinal axis of the insertion tool body and is curved.” Final Act. 5 (citing Evans, Fig. 11); see also Evans 6:63–67. Given that the Examiner finds that elements 110 and 112 of Evans, together, meet the claimed body, and given that Evans’s insertion fork (halo- shaped needle) has a proximal end connected to the first lateral side of body Appeal 2020-001737 Application 14/177,894 10 110 at a distal end of body 110, Appellant’s argument regarding only the connection at the end face of handle 112 does not address the findings of fact made by the Examiner. In other words, Appellant’s argument does not address the rejection as presented, and, therefore, does not identify Examiner error. Accordingly, we sustain the rejection of claim 22. Rejections II, III, and VI Claims 3–9, 13–16, 23, and 24 depend from one of claims 1 and 22. Appellant does not make arguments for the patentability of claim 3–9, 13– 16, 23, and 24 aside from those discussed above regarding claims 1 and 22. See Appeal Br. 21. Accordingly, for the same reasons, we sustain Rejections II, III, and VI. CONCLUSION The Examiner’s rejections are affirmed. Appeal 2020-001737 Application 14/177,894 11 DECISION SUMMARY Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1, 2, 10–12, 17, 22, 25 103 Euteneuer, Evans, Peiffer 1, 2, 10–12, 17, 22, 25 3–9 103 Euteneuer, Evans, Peiffer, Doyle ’604, Doyle ’690 3–9 13–16 103 Euteneuer, Evans, Peiffer, Nering 13–16 1, 18, 19, 21, 26 103 Euteneuer, Evans, Esposito 1, 18, 19, 21, 26 20, 27 103 Euteneuer, Evans, Peiffer, Privitera 20, 27 23, 24 103 Euteneuer, Evans, Peiffer, Doyle ’604, Doyle ’690 23, 24 Overall outcome: 1–27 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). See 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED