Prosecution Insights
Last updated: May 29, 2026
Application No. 18/046,725

MULTIPLE-FIRING SUTURE FIXATION DEVICE AND METHODS FOR USING AND MANUFACTURING SAME

Final Rejection §103
Filed
Oct 14, 2022
Priority
Nov 18, 2013 — provisional 61/905,578 +5 more
Examiner
SCHWIKER, KATHERINE H
Art Unit
3771
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Edwards Lifesciences AG
OA Round
4 (Final)
67%
Grant Probability
Favorable
5-6
OA Rounds
0m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 67% — above average
67%
Career Allowance Rate
277 granted / 415 resolved
-3.3% vs TC avg
Strong +35% interview lift
Without
With
+35.1%
Interview Lift
resolved cases with interview
Typical timeline
3y 4m
Avg Prosecution
34 currently pending
Career history
457
Total Applications
across all art units

Statute-Specific Performance

§101
0.6%
-39.4% vs TC avg
§103
63.6%
+23.6% vs TC avg
§102
9.0%
-31.0% vs TC avg
§112
18.7%
-21.3% vs TC avg
Black line = Tech Center average estimate • Based on career data from 415 resolved cases

Office Action

§103
DETAILED ACTION Notice of Pre-AIA or AIA Status The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . Response to Amendment This office action is responsive to the amendment filed on 03/18/2026. As directed by the amendment: claim 19 has been amended and claim 20 has been cancelled. Thus, claims 1-19 are presently pending in this application. Response to Arguments Applicant's arguments filed 12/30/2025 have been fully considered but they are not persuasive. Applicant argues “As amended, claim 19 recites that the snare extension slide is operatively connected to the snare to extend the distal snare portion distally through the lateral opening from the interior of the shaft and through the lateral opening”. The Office respectfully disagrees. Claim 19 does recite the snare extension slide is operatively connected to the snare, however claim 19 does not require the snare extension slide to extend the distal snare portion distally through the lateral opening from the interior of the shaft and through the lateral opening. Instead, the claim simply recites “the lateral opening is sized to allow at least the distal snare portion of the snare to pass from the interior of the shaft and through the lateral opening”. Under broadest reasonable interpretation the lateral opening needs to be of a size that a snare distal end can pass through. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the snare extension slide is operatively connected to the snare to extend the distal snare portion distally through the lateral opening from the interior of the shaft and through the lateral opening) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Applicant further argues “Conklin does not teach or suggest introducing a snare or cord-lifting structure laterally through a side opening from the environment and then advancing that structure distally through a closed distal shaft portion separating the lateral opening from the distal end opening”. The Office agrees that Conklin does not teach introducing a snare or cord-lifting structure laterally through a side opening from the environment and then advancing that structure distally through a closed distal shaft portion separating the lateral opening from the distal end opening. However, as explained above, this limitation is not required by claim 19. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., introducing a snare or cord-lifting structure laterally through a side opening from the environment and then advancing that structure distally through a closed distal shaft portion separating the lateral opening from the distal end opening) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The claim simply recites “the lateral opening is sized to allow at least the distal snare portion of the snare to pass from the interior of the shaft and through the lateral opening”. Under broadest reasonable interpretation the lateral opening needs to be of a size that a snare distal end can pass through. Claim Rejections - 35 USC § 103 The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Conklin et al. (US 20130158600 A1) in view of Shikhman et al. (US 20120053599 A1), Lampropoulos et al. (US 20090234295 A1) and Nobles et al. (US 20070010829 A1). Regarding claim 19 Conklin discloses (fig. 27-29D) a multiple-firing clip device (see [0108]), comprising: a shaft 402 comprising an exterior surface (see fig. 28A), an interior configured to receive therein a plurality of suture fixation clips 350 (see fig. 28A), and a distal end opening shaped to eject at least one of the suture fixation clips therefrom (see fig. 28B); the shaft 402 defining a lateral opening 412 communicating between the interior and an environment outside the exterior surface and a distal shaft portion between the lateral opening and the distal end opening (see fig. 27, 28A, and [0108]). Conklin further discloses a pair of sutures 410 extending through the opening and hollow of the clip (see fig. 28A-28B). Conklin is silent regarding a shuttle longitudinally movable on the shaft and comprising: a shuttle body positioned on the shaft; a snare coupled to the shuttle body and having a distal snare portion; and a snare extension slide: movably disposed with respect to the shuttle body; and operatively connected to the snare to extend the distal snare portion distally, through the lateral opening from the environment into the interior of the shaft, through the distal shaft portion, and through the distal end opening. However Shikhman, in the same field of endeavor, teaches (fig. 30B-32B) a shuttle 674 longitudinally movable on a shaft 538 (see [0110] and [0113]) and comprising: a shuttle body 694 positioned on the shaft (see fig. 30B and [0110]); a snare 678 (see [0110]) coupled to the shuttle body 694 and having a distal snare portion (loop, see fig. 30B). Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Conklin to have a shuttle longitudinally movable on the shaft and comprising: a shuttle body positioned on the shaft; a snare coupled to the shuttle body and having a distal snare portion as taught by Shikhman, for the purpose of having a more efficient surgical procedure by eliminating tedious operation steps caused by having to thread we sutures through the clips see (Shikhman [0113]). Conklin as modified is silent regarding a snare extension slide: movably disposed with respect to the shuttle body; and operatively connected to the snare to extend the distal snare portion distally. However Lampropoulos, in the same field of endeavor, teaches (fig. 1) a shuttle 10 with a shuttle body 12 (see fig. 1); a snare 24 coupled to the shuttle body 12 and having a distal snare portion (see fig. 1 and [0028]); and a snare extension slide 22: movably disposed with respect to the shuttle body 12 (see [0031]); and operatively connected to the snare to extend the distal snare portion distally (see [0031]). Furthermore, To provide the device of Conklin as modified with a snare extension slide: movably disposed with respect to the shuttle body; and operatively connected to the snare to extend the distal snare portion distally would have been obvious to one of ordinary skill in the art, in view of the teachings of Lampropoulos, since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art at the time of the invention, i.e., one skilled in the art would have recognized that snare extension slide used in Lampropoulos would allow the device of Conklin as modified to move the snare relative to the shuttle. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). The language “a snare extension slide…operatively connected to the snare to extend the distal snare portion distally, through the lateral opening from the environment into the interior of the shaft, through the distal shaft portion, and through the distal end opening” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Conklin as modified meets the structural limitations of the claim, and a snare extension slide is capable of extending the distal snare portion distally, through the lateral opening from the environment into the interior of the shaft, through the distal shaft portion, and through the distal end opening. Conklin teaches a path through the lateral opening from the environment into the interior of the shaft, through the distal shaft portion, and through the distal end opening and is modified to have a snare on the shaft. Therefore the snare would be capable of being moved along that path. Conklin as modified is silent regarding the lateral opening is separated from the distal end opening by a closed distal shaft portion. However Nobles, in the same filed of endeavor, teaches (fig. 3 and 5-6) a lateral opening 120 that is separated from a distal end opening by a closed distal shaft portion (fig. 3, 5-6, and [0053]). Therefore, the substitution of one known opening type (the lateral opening is separated from the distal end opening by a closed distal shaft portion as taught in Nobles) for another (slot as taught in Conklin as modified) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention since Nobles teaches that a lateral opening that is separated from a distal end opening by a closed distal shaft portion is a suitable alternative to form a slot and the substitution of the lateral opening separated from the distal end opening by a closed distal shaft portion as taught in Nobles would have yielded predictable results, namely, an opening that allows a suture to pass through. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). Conklin as modified teaches the lateral opening (412 of Conklin) is sized to allow at least the distal snare portion of the snare to pass from the interior of the shaft and through the lateral opening. The language “the lateral opening is sized to allow at least the distal snare portion of the snare to pass from the interior of the shaft and through the lateral opening” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Conklin as modified meets the structural limitations of the claim, and the lateral opening is capable of the distal snare portion of the snare to pass from the interior of the shaft and through the lateral opening. Conklin discloses a lateral opening 412 and is modified to have a snare with a distal snare portion. The lateral opening 412 is open to the shaft thus the distal snare portion of the snare is capable of passing from the interior of the shaft and through the lateral opening. Allowable Subject Matter Claims 1-18 are allowed. See reasons for allowance in final rejection 09/23/2025. Conclusion Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a). A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE H SCHWIKER whose telephone number is (571)272-9503. The examiner can normally be reached Monday - Friday 7:30 am-4:00 pm. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771
Read full office action

Prosecution Timeline

Show 5 earlier events
Dec 08, 2025
Request for Continued Examination
Dec 21, 2025
Response after Non-Final Action
Dec 30, 2025
Non-Final Rejection mailed — §103
Mar 18, 2026
Response Filed
Apr 02, 2026
Final Rejection mailed — §103
May 07, 2026
Applicant Interview (Telephonic)
May 08, 2026
Examiner Interview Summary
May 13, 2026
Response after Non-Final Action

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

5-6
Expected OA Rounds
67%
Grant Probability
99%
With Interview (+35.1%)
3y 4m (~0m remaining)
Median Time to Grant
High
PTA Risk
Based on 415 resolved cases by this examiner. Grant probability derived from career allowance rate.

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