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 amendments filed on 06/05/2026 have been entered. Claims 19-27 remain pending in the application. The amendments overcome the rejection under 35 USC 112(b) set forth in the previous office action dated 03/05/2026.
Response to Arguments
Applicant’s arguments, see pages 4-5, filed 06/05/2026, with respect to the rejection(s) of claim(s) 19 under 35 USC 102(a)(1) 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 Therefore, the rejection has been withdrawn.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 Litherland/Thomas.
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.
Claim(s) 19-23 and 25-27 are rejected under 35 U.S.C. 103 as being unpatentable over Litherland (US 2013/0245653) in view of Thomas et al. (US 2020/0046359).
Regarding claim 19-20, Litherland discloses a surgical ligation clip (210, FIG 13-17, [0074-0075]) comprising: (a) a first arm (220, 224) extending from a first proximal end (towards 260) to a first distal end (towards 228);(b) a second arm (222, 226) extending from a second proximal end (end towards 260) to a second distal end (end towards 230), wherein the second arm is movable relative to the first arm to clamp tissue between the first and second arms (FIGs 14A-14C, [0075] wherein tissue 208 is shown being clamped); (c) a column (216, 218, FIG 17) extending between the first and second arms (FIG 14C and 17), wherein the column includes upper and lower column portions (216 and 218 respectively) pivotable relative to each other (FIG 14A-14C shows pivoting of 216 and 218 relative to one another) about a deformable intermediate hinge element (wherein a hinge is created at the interface of 252/254) at or near a midpoint of the column (located near a midpoint, due to the uneven length of 216/218); and (d) an arcuate proximal hinge (260) extending between the first and second arms proximally of the column (FIGs 13-17), wherein the arcuate proximal hinge spans through an included angle of at least 180 degrees (260 is a living hinge, [0075], wherein at least some segment of the proximal end of the device can be interpreted as the arcuate proximal hinge and as shown by angle alpha, FIG 13, [0075] can span more than 180 degrees).
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Litherland is silent regarding the first arm includes a distal hook at the first distal end and the second arm includes a distal hook at the second distal end, wherein the distal hook at the first distal end includes a pair of sidewalls configured to laterally flank the second distal end of the second arm when the surgical ligation clip is in a fully closed state to inhibit lateral misalignment of the first and second arms.
However, Thomas et al. teaches in the same field of endeavor a surgical ligation clip (10, FIG 3-5, [0037]) having a first arm (14) from a first proximal end (24, [0038]) to a first distal end (26), wherein the first arm includes a distal hook (The shape of 42 and 40 is shown to form a hook, FIG 3, and also acts as a hook by engaging with locking element 30, [0040]) at the first distal end (FIG 3) and a second arm (12) extending from a second proximal end (18) to a second distal end (20), wherein the second arm includes a distal hook (30) at the second distal end (FIG 3), wherein the distal hook at the first distal end includes a pair of sidewalls (Inner walls formed by 42, FIG 1) configured to laterally flank the second distal end of the second arm when the surgical ligation clip is in a fully closed state (FIG 4 shows in the closed stated that the pair of sidewalls of 42 are positioned outside of the distal end 30) to inhibit lateral misalignment of the first and second arms (This engagement ensures the alignment of the arms).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the distal ends of the first and second arms of Litherland to each comprise a distal hook wherein the distal hook at the first distal end includes a pair of sidewalls configured to laterally flank the second distal end of the second arm when the surgical ligation clip is in a fully closed state to inhibit lateral misalignment of the first and second arms, as taught by Thomas, for the purpose of configuring the arms with a feature such that as the first and second jaws close towards one another around a target tissue, their alignment relative to one another is ensured.
Regarding claim 21, Litherland/Thomas disclose the invention substantially as claimed, as set forth above for claim 19. Litherland further discloses the upper column portion is connected to the first arm through an upper hinge element (240, [0075], FIG 13-14C) and the lower column portion is connected to the second arm through a lower hinge element ([0075] discloses the clip can have the hinge members disclosed in other embodiments, such as that of FIG 12 which comprises a hinge 141 on the lower jaw, [0072]).
Regarding claim 22, Litherland/Thomas disclose the invention substantially as claimed, as set forth above for claim 21. Litherland further discloses the lower hinge element has a thickness greater than a thickness of the upper hinge element (See FIGs 15-17 wherein the upper hinge shows a slight removal of material, particularly evident because the upper column is configured to flex more than the lower column).
Regarding claim 23, Litherland/Thomas disclose the invention substantially as claimed, as set forth above for claim 19. Litherland further discloses the lower column portion has a length less than a length of the upper column portion (See relative lengths in FIG 14A-14C).
Regarding claim 25, Litherland/Thomas disclose the invention substantially as claimed, as set forth above for claim 19. Litherland further discloses the arcuate proximal hinge extends from a proximal surface of the second arm at or near the second proximal end to an upper surface of the first arm at or near the first proximal end (The hinge formed at 260 connects to the first proximal end and the second proximal end, at what could be considered a proximal surface of the arm or an upper surface of the arm depending on the orientation of the device).
Regarding claim 26, Litherland/Thomas disclose the invention substantially as claimed, as set forth above for claim 19. Litherland further discloses first and second arms each include laterally-outwardly extending protrusions configured to be gripped by corresponding jaws of a robotic applicator (See laterally extending protrusions 287 in FIG 13 and 15, which are disclosed as being used for attaching to a clip applier, [0075]. Therefore, they are at least configured to be gripped by a robotic applicator).
Regarding claim 27, Litherland/Thomas disclose the invention substantially as claimed, as set forth above for claim 20. The device as modified by Thomas further discloses the pair of sidewalls are positioned to cover half or less than half of an open width of the distal hook (FIG 1 best shown the side walls. They are interpreted as being sufficiently narrow such that when combined, their width makes up approximately half of the total width of the distal hook).
Claim(s) 24 is rejected under 35 U.S.C. 103 as being unpatentable over Litherland (US 2013/0245653) in view of Thomas et al. (US 2020/0046359), further in view of Foshee (US 2020/0360021).
Regarding claim 24, Litherland/Thomas disclose the invention substantially as claimed, as set forth above for claim 19.
Litherland is silent regarding a cam leg extending from the second proximal end, wherein the cam leg includes a receptacle configured to receive the first proximal end when the surgical ligation clip is in a fully closed state to inhibit the surgical ligation clip from transitioning away from the fully closed state.
However, Foshee teaches in the same field of endeavor a surgical ligation clip (100, FIG 1) having a first arm (104), a second arm (102), an arcuate proximal hinge (106) and a cam leg (156, [0026-0027]) extending from the second proximal end (FIG 2), wherein the cam leg includes a receptacle (Indented region defined by tooth 160, FIG 2, [0027]) configured to receive the first proximal end (which engages with 162 of at the proximal end of the first arm, FIG 4, [0027]) when the surgical ligation clip is in a fully closed state (FIG 4) to inhibit the surgical ligation clip from transitioning away from the fully closed state ([0027]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of Litherland/Thomas to comprise a cam leg extending from the second proximal end, and a respective channel and undercut in the first proximal end, wherein the cam leg includes a receptacle configured to receive the first proximal end when the surgical ligation clip is in a fully closed state to inhibit the surgical ligation clip from transitioning away from the fully closed state, as taught by Foshee, for the purpose of providing a second latching mechanism in addition to the first latching mechanism (distal hooks taught by Litherland/Thomas) thereby reinforcing the first latching mechanism such that “the second locking mechanism may prevent the surgical clip from opening when the first locking mechanism wears and/or breaks, such as when uneven absorption and/or degradation of the surgical clip causes the first locking mechanism to disengage” ([0027]).
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 BROOKE N LABRANCHE whose telephone number is (571)272-9775. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 5712727134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BROOKE LABRANCHE/Primary Examiner, Art Unit 3771
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