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 .
Formal Matters
Claims 1, 3, and 4 are currently amended. Claims 1-19 are pending and under examination.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 15 April 2025 and 18 august 2025 have been considered by the examiner. Signed copies are attached.
Response to Arguments
Applicant’s arguments have been fully considered, but Applicant’s amendments to the claims require a modification of the rejection, necessitated by these amendments, as set forth below.
Objections/Rejections Modified – Necessitated by Amendment
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-19 are rejected under 35 U.S.C. 103 as being unpatentable over Viker et al., US 20140031835 (30 January 2014) in view of Shelton et al., US 20180064442 (8 March 2018) and further in view of Bailly et al., US 20030187465 (2 October 2003).
Regarding claim 1, Viker teaches a fastening device (100) comprising:
a shaft (FIG 1A, shaft 110);
a needle extending from the shaft (FIGs 1B, needle 115),
the needle comprising a slot extending along at least a portion of the needle (FIG 1B, aperture 120);
the device configured to receive at least one fastener (FIGs 2A-B) comprising a first bar (124) and a second bar (125) connected by a bar connector (126) (FIGs 1B-C, 2A-B),
the first bar (124) configured to be positioned within the needle and the second bar (125) configured to be positioned outside the needle (FIG 5C);
a push member (push rod 121) configured to push the fastener out of the needle (115) (¶47).
Viker does not expressly teach one or more control rods comprising a connector, the connector configured for connection to a surgical robot.
Viker does not teach wherein the fastener is manipulated to reorient the second bar relative to the first bar prior to exiting the needle. Shelton teaches surgical instruments comprising a handle, a shaft, and end effector, including components to deliver surgical fasteners (Abstract; claim 28) to a patient. Shelton teaches a control rods (FIG 1, firing rod 104) comprising a connector (FIG 1, articulation system 109) configured for connection (FIGs 1, 2, articulation link 70, engagement nubs 48) to a surgical robot (¶212).
Bailey teaches surgical fasteners, including “I” and “H”-type fasteners, comprising a first bar and a second bar connected by a bar connector (FIGs 11-16) a first bar positioned within the needle and a second bar positioned outside the needle within the shaft (FIGs 11-13); and a push member configured to push the fastener out of the needle (push rod 42), where at least one deflector (transverse finger 59) is positioned in proximity to a slot (¶30) extending along a portion of the needle (FIGs 11-16) wherein at least one deflector is configured relative to the slot such that the second bar is reoriented relative to the first bar by the at least one deflector as the fastener is pushed distally by the push member (FIGs 11-16).
Viker, Shelton, and Bailly teach in the same field of endeavor involving delivery of surgical fasteners. Viker, Shelton, and Bailly included each element claimed, although not necessarily in a single reference. Viker discloses the claimed base needle-based fastener delivery system (shaft, needle with longitudinal slot, inner and outer bar fastener arrangement, and push member). Viker does not disclose a deflector configured to reorient the second bar during advancement nor a connector for a robotic attachment. Robotic and minimally invasive surgeries increasingly require controlled fastener orientation. A person of ordinary skill in the art would reasonably consult the literature on deflector-based orientation. Engineers working on Viker-style devices would naturally consider mechanisms like Bailly’s to control fastener orientation. Bailly explains that by allowing the anchoring bar to be used to cause the catching bar to pivot and to orientate it roughly parallel to the reinforcement and then allowing the catch bar to be used to retain the anchoring bar and force it to pivot in the tissue, it adopts a position parallel to the textile reinforcement (¶26) allowing placement without excessive stressing having been exerted on the fastener and positing the fastener to enhance anchoring (¶27). Bailly specifically addresses reorientation of a fastener’s outer bar via a transverse deflector positions adjacent a needle slot (FIGs 11-16; ¶30). Because Viker includes a longitudinal needle slot and a push rod path that advances the same type of bar-style fastener, a person of ordinary skill in the art seeking to control fastener orientation in Viker’s architecture would reasonably consults Bailly’s deflector solution, which results in pivoting of the fastener within the tissue and enhancing anchoring. Bailly’s transverse finger can be incorporated alongside Viker’s slot (same general location and interaction with the advancing fastener) using known assembly methods without redesigning Viker’s core delivery path. Shelton discloses control/firing rods and articulation connectors intended to mate with surgical robots (FIG 1, ¶212). A person of ordinary skill in the art attempting to render Viker’s push rod robot-compatible would look for established connector/articulation designs to avoid creating a novel robot interface. Shelton’s connector and articulation links are modular and can be adapted to the push/firing rod path of Viker’s device to enable robotic actuation. Because the references address the same engineering problem (needle-based deployment of surgical fasteners) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding a deflector adjacent to the existing slot; attaching a robot-compatible connector to the existing push/firing rod), a person of ordinary skill in the art would have had a reasonable expectation of success in combining these teachings.
Regarding claim 2, Viker modified by Shelton and Bailly teaches the fastening device of claim 1, as set forth above, wherein the shaft is configured to rotate and/or articulate (Viker: rotating staging shaft 123).
Regarding claim 3, Viker modified by Shelton and Bailly teach the fastening device of claim 1, as set forth above, wherein at least one control rod (Shelton: FIG 1, firing rod 104) provides motion for moving a fastener from a conveyance zone through a transition zone (Shelton: claim 28).
Regarding claim 4, Viker modified by Shelton and Bailly teach the fastening device of claim 1, as set forth above, wherein at least one control rod (Shelton: FIG 1, firing rod 104) is configured to provide motion for moving a fastener from a transition zone through a manipulation zone and deploying the fastener (Shelton: claim 28).
Regarding claim 5, Viker modified by Shelton and Bailly teach the fastening device of claim 1, as set forth above, wherein the one or more control rod connectors (Shelton: FIG 1, articulation system 109) configured for connection are configured for connection (Shelton: articulation link 70, engagement nubs 48) to one or more control rods of the surgical robot (Shelton: ¶212).
Regarding claim 6, Viker modified by Shelton and Bailly teach the fastening device of claim 1, as set forth above, wherein the one or more control rod connectors (Shelton: FIG 1, articulation system 109) comprise a connection clamp or union configured to interact with a ball or end feature on the surgical robot (Shelton: ¶216 engagement nubs 48 for releasably engaging a distal end of an elongated shaft assembly 16).
Regarding claim 7, Viker modified by Shelton and Bailly teach the fastening device of claim 6, as set forth above, wherein the connection clamp or union (Shelton: articulation link 70 and engagement nubs 48) comprises a first position (BRI: lock or unlock position) in the device to receive the ball or end feature on the surgical robot (Shelton: ¶216 engagement nubs 48 for releasably engaging a distal end of an elongated shaft assembly 16).
Regarding claim 8, Viker modified by Shelton and Bailly teach the fastening device of claim 6, as set forth above, wherein the connection clamp or union (Shelton: articulation link 70 and engagement nubs 48) comprises a second position (BRI: lock or unlock position) in the device to secure the control rod connection to the surgical robot (Shelton: ¶216 engagement nubs 48 for releasably engaging a distal end of an elongated shaft assembly 16).
Regarding claim 9, Viker modified by Shelton and Bailly teach the fastening device of claim 1, as set forth above, wherein the connector on the fastening device comprises a collar (Shelton: rotatable collar 5580) that attaches to the surgical robot (Shelton: ¶240).
Regarding claim 10, Viker modified by Shelton and Bailly teach the fastening device of claim 1, wherein the connector on the fastening device (Shelton: 20) threads onto the surgical robot (Shelton: ¶292, firing rod 104 is in threaded engagement with the drive tube 102).
Regarding claim 11, Viker modified by Shelton and Bailly teach the fastening device of claim 1, configured to receive a fastener cartridge (Shelton: 26) comprising one or more fasteners (Shelton: claim 28).
Regarding claim 12, Viker modified by Shelton and Bailly teach the fastening device of claim 11, wherein the fastener cartridge (Shelton: 26) is replaceable (Shelton: claim 29).
Regarding claim 13, Viker modified by Shelton and Bailly teach the fastening device of claim 11, wherein the fastener cartridge (Shelton: 26) is configured for replacement while the device remains connected to the surgical robot (Shelton: claim 29; ¶430).
Regarding claim 14, Viker modified by Shelton and Bailly teach the fastening device of claim 11, wherein the fastener cartridge (Shelton: 26) comprises features to secure the cartridge to the device (Shelton: claim 28; ¶216).
Regarding claim 15, Viker modified by Shelton and Bailly teach the fastening device of claim 11, wherein the fastener cartridge (Shelton: 26) comprises spring loading features (torsion spring 5592) to secure the cartridge to the device (Shelton: ¶249, device loading unit (DLU), torsion spring 5592).
Regarding claim 16, Viker modified by Shelton and Bailly teach the fastening device of claim 11, wherein the fastener cartridge (Shelton: 26) comprises features that align the cartridge to a transition zone of the device (Shelton: ¶219, articulation mechanism 110).
Regarding claim 17, Viker modified by Shelton and Bailly teach the fastening device of claim 11, wherein the fastener cartridge (Shelton: 26) comprises features that align the cartridge to the control rods or push rods of the device (Shelton: ¶243, alignment indicia 5510, 5590).
Regarding claim 18, Viker modified by Shelton and Bailly teach the fastening device of claim 11, as set forth above, wherein the fastener cartridge (Shelton: 26) is flexible (Shelton: ¶281).
Regarding claim 19, Viker modified by Shelton and Bailly teach the fastening device of claim 1, as set forth above, the needle of the device is configured for replacement while the device remains connected to the surgical robot (Shelton: claim 29; ¶430).
Conclusion
No claim is allowed.
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 CHERIE M POLAND whose telephone number is (703)756-1341. The examiner can normally be reached M-W (9am-9pm CST) and R-F (9am-3pm CST).
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, Jackie Ho can be reached at 571-272-4696. 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.
/CHERIE M POLAND/Examiner, Art Unit 3771
/SHAUN L DAVID/Primary Examiner, Art Unit 3771