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 .
Election/Restrictions
Applicants’ response dated 06/03/2026 is acknowledged, including the elections of Invention I corresponding to claims 16-30. The amendments dated 06/03/2026 cancelled claims 31-35 corresponding to Invention II. Therefore, the only pending claims are drawn to a single invention and the requirement for restriction is hereby withdrawn.
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) 16 and 23-25 are rejected under 35 U.S.C. 103 as being unpatentable over Sharma et al. (US 2022/0378432) in view of Shikhman (US 2023/0389784).
Regarding claim 16 and 25, Sharma et al. discloses a clipping system (200, FIGs 11-14) for treating tissue ([0094-0102]), comprising: an end cap (208) including a proximal portion (226) coupled to a distal end of an insertion device/endoscope (wherein the endoscope is a component of the insertion device and 226 is mounted over 206 of the endoscope, FIG 11, [0094]) and a distal portion (234, [0095]) extending distally from the proximal portion (FIG 11); a clip (202) mounted over the distal portion of the end cap in the open configuration (Shown mounted over the endcap in FIGS 11-12 in the closed configuration and would also be positioned over the endcap in the open configuration, [0097]) so that first and second jaws (218, FIG 11-12) of the clip are separated from one another towards an open configuration, (“the insertion configuration, in which the jaws 218 are separated from one another to receive tissue therebetween”), the clip biased towards a closed configuration, in which the first and second jaws are moved toward one another (“an initial deployed configuration, in which the jaws 218 are moved toward one another to grip the tissue received therebetween”); a bifurcated tubing system (250, and channels 266, FIG 13, [0100-0102]) including a single proximal tubular structure (250, FIG 13, [0101]) and a pair of distal tubular structures (266), the single proximal tubular structure extends along a majority of a length of the endoscope from a proximal end connected to a user interface at a proximal end of an insertion device ([0101]) to a distal end (Distal end shown in FIG 13 at 256), each of which extends from a proximal end to a distal end (the length of the channel has a proximal end which converges “at a point at which proximal ends 256 of the extending members 210 meet and are connected to one another” and a distal end which extends towards the outer surface 236), the proximal end of each of the distal tubular structures connected to the distal end of the single proximal tubular structure via a bifurcation such that the pair of distal tubular structures are in communication with the single proximal tubular structure (See bifurcation in FIG 13, [0101]), the distal end of the each of the distal tubular structures connected to the end cap (because channels 266 are embedded within the wall 258 of the end cap); and a control assembly (210 and the control element not shown ,[0101]) including a pair of control wires (each of 210 and the respective control wire), each of which extends through the single proximal tubular structure ([0101] “the control element may extend through a coil 250 extending between a proximal end 226 of the adapter 208 and the actuating assembly”) and a corresponding one of the distal tubular structures (210 are also received through a corresponding channel 266, [0101]) so that the distal ends of the control wires extend distally past the distal ends of the distal tubular structures (FIG 14) to be releasably coupled to the clip ([0097]), the control wires configured to be longitudinally movable relative to the end cap to move the clip between an insertion configuration, in which the clip is mounted over the end cap in the open configuration ([0094-0095]), the closed configuration, in which the clip is moved distally off of the end cap to grip tissue therebetween ([0095] “he clip 202 may be moved from the insertion configuration to the initial deployed configuration by moving the clip 202 distally along and off the adapter 208 so that the jaws 218 are permitted to revert to spring closed under their bias to the initial deployed configuration, immediately distal of the adapter 208”), and a review configuration, in which the clip is physically separated from the end cap to enhance visual observation of the clip ([0095] “The system 100 may then be moved to the review configuration by moving the endoscopic shaft 224 proximally relative to the clip 202 as the extending members 210 play out so that the distal end 206 of the endoscopic shaft 224 is separated from the clip 202 via a distance selected so that the clip 202 is viewable via the endoscope 204 while the clip 202 remains coupled to the system 200 via the extending members 210”).
Sharma et al. is silent regarding a pair of overtubes received within the distal tubular structures to extend over a portion of the control wires received therein, the control wires and overtubes configured to interface with one another.
However, Shikhman teaches a tissue treatment device (300, FIGs 10-14) having a control wire (366, FIG 12-13, [0244-0245]) extending within and configured to interface with an overtube (368, [0244-0245]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to provide a pair of overtubes received within the distal tubular structures to extend over a portion of the control wires received therein, as taught by Shikhman, for the purpose of providing a structure such as a coil cable surrounding the control wire to provide a casing such that the untensioned state of the control wire is flexible making it easy to advance it through the torturous anatomy of a body lumen but when a tensioning forces is applied, the overtube compresses making it stiffer and improving pushability ([0245]).
Regarding claims 23-24, Sharma/Shikhman disclose the invention substantially as claimed, as set forth above for claim 16. Sharma further discloses wherein each of the control wires is releasably coupled to a corresponding one of the first and second jaws of the clip via an enlarged distal end (246, [0098]) received within a yoke of the corresponding one of the first and second jaws (Wherein the yoke is the opening in each jaw which the distal end of 210 passes through), the enlarged distal end connected to a remaining length thereof via a joint (connection between 246 and 248, [0099]) configured to separate the enlarged distal end from the remaining length when subject to a force exceeding a predetermined threshold value ([0099] “When a force exerted thereon exceeds a predetermined threshold force, the enlarged members 246 will separate, break away or otherwise disconnect from the distal ends 248, so that the extending members 210 and the endoscope 204 are fully separated from the clip 202 and may be removed from the body while leaving the clip 202 in place clipped over target tissue”), wherein each of the enlarged distal ends has a cross- sectional area that is larger than a cross-sectional area of an opening through which it enters the yoke of the corresponding jaw (FIG 12 shows the enlarged distal end – it is understood that the “enlarged ball” is enlarged relative to the yoke through which it passes to thereby form a connection, [0098]).
Allowable Subject Matter
Claims 17-22 and 26-30 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Regarding claims 17 and 26, the prior art of record fails to teach the proximal portion of the end cap includes a pair of longitudinally extending grooves aligned with the distal tubular structures, a spacer received within each of the grooves and held thereagainst via an O-ring.
Conclusion
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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