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
The amendment filed January 9, 2026 has been entered. Claims 1-20 are currently pending.
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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Duran (US 5,947,982, hereinafter “Duran”) in view of Heneveld (US 2019/0167257, hereinafter “Heneveld”).
Regarding claim 1, Duran discloses the invention substantially as claimed including a method for surgical tissue repair, the method comprising:
providing a surgical device comprising: an elongate member (18);
a first jaw member (16) extending from a distal end of the elongate member; and
a second jaw member (14) extending from the distal end of the elongate member, the second jaw member comprising: a curved portion extending from the distal end of the elongate member and curved away from the first jaw member; a straight portion extending from a distal end of the curved portion (see annotated Fig 4 below); and
positioning a suture (32) through the second jaw member such that the suture engages a tissue penetrator (30);
positioning the first jaw member and the second jaw member around a tissue (Fig 6B); moving the first jaw member toward the second jaw member to engage the tissue (Figs 6B-6C); and deploying the tissue penetrator from the second jaw member through the tissue and through the first jaw member (Figs 6C-D) (col 3, ln 18-23; col 5, ln 14-25).
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[AltContent: arrow][AltContent: arrow][AltContent: arrow][AltContent: ][AltContent: textbox (Elongate member)][AltContent: textbox (Second jaw)][AltContent: textbox (Straight portion)][AltContent: textbox (Curved portion)][AltContent: ]
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However, Duran fails to disclose the claimed trigger, wherein moving the first jaw member toward the second jaw member to engage the tissue is performed by at least partially actuating the trigger and subsequently, the tissue penetrator from the second jaw member through the tissue and through the first jaw member is performed by further actuating the trigger. Heneveld discloses a similar method for surgical tissue repair comprising moving first (30) and second (40) jaws toward each other to engage tissue and subsequently deploying a tissue penetrator (70) from the second jaw (40) and through tissue and the first jaw to approximate, ligate, fixate, and/or close biological tissue (Figs 1A-C; abstract, para [0097-0100]). Heneveld teaches actuation is achieved through a trigger (50), wherein the trigger is at least partially actuated to move the first jaw member toward the second jaw member to engage the tissue (Figs 1A to 1B; rotating approximately 5 to 10 degrees; para [0099]) and, subsequently, after at least partially actuating the trigger, deploying the tissue penetrator (70) by further actuating the trigger (Figs 1B to 1C; rotating additional 30 to 40 degrees; para [0099]). 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 Duran to include the trigger and activation mechanism taught by Heneveld and include the steps of partially actuating the trigger to move the first jaw toward the second jaw when engaging tissue and subsequently further actuating the trigger to deploy the tissue penetrator to more controllably actuate the jaws and penetrating mechanism in a simple manner. Furthermore, the substitution of one known element for another (type of actuation mechanism) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention since the substitution of the actuation mechanism with a single trigger controlling both the movement of the jaws and the penetrating mechanism shown in Heneveld would have yielded predictable results.
Regarding claims 2 and 12, further comprising retracting the tissue penetrator (30) in the second jaw member (repeating suturing process – col 3, ln 24-26).
Regarding claims 3 and 13, further comprising moving the first jaw member away from the second jaw member (Fig 6D; col 5, ln 20-21).
Regarding claims 4 and 14, wherein deploying the tissue penetrator (30) comprises abutting, with the tissue penetrator, a shoulder of the second jaw member (shoulder of opening 42; col 3, ln 52-col 4, ln 8).
Regarding claims 5 and 15, wherein moving the first jaw member toward the second jaw member comprises actuating a trigger (24) to move the first jaw member toward the second jaw member (Fig 1; col 3, ln 1-17).
Regarding claims 6 and 16, wherein deploying the tissue penetrator from the second jaw member comprises actuating a trigger (24) to deploy the tissue penetrator from the second jaw member (Fig 1; col 3, ln 1-13- – actuation of trigger moves jaws together, which in turn deploys the issue penetrator).
Regarding claims 7 and 17, wherein positioning the suture (32) comprises positioning the suture in a notch in the tissue penetrator (30) (Figs 2, 3) such that the tissue penetrator is configured to move a suture loop through the first jaw member (col 3, ln 43-48 – attached together).
Regarding claims 8 and 18, wherein deploying the tissue penetrator (30) comprises capturing the suture in a suture retainer, the suture retainer configured to retain a suture loop (col 4, ln 9-28).
Regarding claims 9 and 19, wherein the suture loop is configured to be released from the suture retainer by pulling on an end of the suture loop (fully capable of being released if enough force is applied; repeating suturing process – col 3, ln 24-35).
Regarding claims 10 and 20, wherein the notch of the tissue penetrator is proximal to a distal end of the tissue penetrator (Figs 2, 3; col 3, ln 43-48).
Regarding claim 11, Duran discloses the invention substantially as claimed including a method for surgical tissue repair, the method comprising:
positioning a suture loop (at least a portion of suture 32 that at least slightly curves or arcs) of a suture (32) at least partially around (in the vicinity of) a surgical device, the surgical device comprising: an elongate member (18);
a first jaw member (16) extending from a distal end of the elongate member; and
a second jaw member (14) extending from the distal end of the elongate member, the second jaw member comprising: a curved portion extending from the distal end of the elongate member and curved away from the first jaw member; a straight portion extending from a distal end of the curved portion (see annotated Fig 4 above); and
positioning the first jaw member and the second jaw member around a tissue (Fig 6B); moving the first jaw member toward the second jaw member to engage the tissue (Figs 6B-6C); and deploying a tissue penetrator (30) from the second jaw member through the tissue and through the first jaw member such that the tissue penetrator captures the suture loop and pulls the suture at least partially through the tissue (Figs 6C-D) (col 3, ln 18-23; col 5, ln 14-25).
However, Duran fails to disclose the claimed trigger, wherein moving the first jaw member toward the second jaw member to engage the tissue is performed by at least partially actuating the trigger and subsequently, the tissue penetrator from the second jaw member through the tissue and through the first jaw member is performed by further actuating the trigger. Heneveld discloses a similar method for surgical tissue repair comprising moving first (30) and second (40) jaws toward each other to engage tissue and subsequently deploying a tissue penetrator (70) from the second jaw (40) and through tissue and the first jaw to approximate, ligate, fixate, and/or close biological tissue (Figs 1A-C; abstract, para [0097-0100]). Heneveld teaches actuation is achieved through a trigger (50), wherein the trigger is at least partially actuated to move the first jaw member toward the second jaw member to engage the tissue (Figs 1A to 1B; rotating approximately 5 to 10 degrees; para [0099]) and, subsequently, after at least partially actuating the trigger, deploying the tissue penetrator (70) by further actuating the trigger (Figs 1B to 1C; rotating additional 30 to 40 degrees; para [0099]). 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 Duran to include the trigger and activation mechanism taught by Heneveld and include the steps of partially actuating the trigger to move the first jaw toward the second jaw when engaging tissue and subsequently further actuating the trigger to deploy the tissue penetrator to more controllably actuate the jaws and penetrating mechanism in a simple manner. Furthermore, the substitution of one known element for another (type of actuation mechanism) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention since the substitution of the actuation mechanism with a single trigger controlling both the movement of the jaws and the penetrating mechanism shown in Heneveld would have yielded predictable results.
Response to Arguments
Applicant’s arguments, see amendment, filed January 9, 2026, with respect to the rejection(s) of claim(s) 1-20 under Duran (US 5,947,982) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Heneveld (US 2019/0167257).
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 MARIE RODJOM whose telephone number is (571)272-3201. The examiner can normally be reached Monday - Thursday 8-5.
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/KATHERINE M RODJOM/Primary Examiner, Art Unit 3771
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