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 claimed filed on September 26th, 2025, have been added. Claims 1 and 3-4 remain pending in the Application. Claim 2 has been canceled by the Applicant. The claim amendments overcome the previous claim objections and 112(b) rejections.
Response to Arguments
Applicant's arguments filed September 26th, 2025, have been fully considered but they are not persuasive.
Applicant argues that Ryan et al. (U.S. Patent No. 11,083,465) fails to disclose the limitation “the pair of arm portions are closed in such a manner that the second claw portion covers the first claw portion from the outside” because in FIG. 3, when the spike 128 of 110 is received between the spikes 128 of 112, and 110 and 112 are brought into the closed position, the second claw portion cannot reach the first claw portion, and therefore cannot cover the first claw portion from the outside. Examiner respectfully disagrees. The claim language of “cover” does not require physical contact between the two claw portions; rather, the second claw portion only needs to extend around a portion of the first claw portion. When 128 of 110 is received with the 128 of 112,as disclosed in C5:L61-65, the claw portion of 110 will extend distally past and around the claw portion of 112 based on how in FIGs. 3-4, the 128 of 110 is located prior to the curve of the distal end of 110 while the 128 of 112 is located after the curve of the distal end of 112, and 110 will thereby “cover” 112.
Applicant further argues that Ryan et al. fails to disclose the limitation “a first claw portion of the opening/closing portion, which is the claw portion of one arm portion of the pair of arm portions, is bent from a base end by a predetermined radius of curvature, a second claw portion of the opening/closing portion, which is the claw portion of the other arm portion, is bent from a base end portion by a radius of curvature longer than the first claw portion and larger than the predetermined radius of curvature” because the claw portions of FIG. 3 seem to have three-dimensional bowl-shaped forms that do not clearly show the radius of curvature bent from a base end. Examiner respectfully disagrees. As pointed out in the argument above, the claw portion of 110 extends distally past and at least partially around the claw portion of 112 based on their interlocking spikes 128 being placed at different points of their distal claw curves. For the claw portion of 110 to extend distally past and at least partially around the claw portion of 112, the claw portion of 110 must have a longer curve and therefore a larger radius of curvature than the claw portion of 112.
Applicant finally argues that Ryan et al. fails to disclose the limitation “an operation portion” because the opening/closing portion of Ryan et al. is indicated as 110 and 112, which Applicant states are a clip themselves, and that the short tubular portion at the proximal end of 110 and 112 referred to as capsule 116 is considered the tubular sheath, but is not in the proper position for the operation portion to be the actuator in the handle portion. Examiner respectfully disagrees. The only claim language to the clip is functional language (such as “the opening/closing portion has a pair of claw portions…that can pull a clip”), and so as long as the opening/closing portion is capable of conducting the functional language, the claim limitations are satisfied. If a clip were placed between the pair of claw portions 110 and 112, then 110 and 112 could conduct the claimed functions as outlined in the Non-Final Rejection dated May 27th, 2025. With that limitation satisfied, the operation portion only needs to be at a proximal end of the sheath, which C4:L60-62 discloses the actuator is proximal to 116, and allow an operation wire 108 to slide with respect to 116 while inserted through 116, which the handle actuator does by advancing or retracting 108 to open and close 110 and 112.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1 and 4 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Ryan et al. (U.S. Patent No. 11,083,465).
Regarding claim 1, Ryan et al. discloses an endoscopic treatment tool (100; FIG. 1), comprising:
a tubular sheath (116);
an operation portion (C4:L60-62: an actuator on a handle) provided at a proximal end of the sheath (C4:L60-62: the actuator is at the proximal end of 116) and allows an operation wire (108) inserted through the sheath to slide with respect to the sheath (C5:L22-26: 108 can slide relative to 116 to advance or retract 110 and 112); and
an opening/closing portion (110 and 112) constituted by an elastic body (C5:L1-5: 110 and 112 are biased to an open position, which makes them elastic because they will spring back to the original open position if pressed into a closed position) having a pair of arm portions (110 and 112) attached at a distal end of the operation wire (C4:L62-64: the distal end of 108 is attached to 110 and 112) and arranged so as to open each other in a substantially V shape as the pair of arm portions goes to a distal tip of the pair of arm portions (FIG. 1: 110 and 112 are arranged in a V-shape from proximal end to distal tips),
the opening/closing portion protrudes from the distal end of the sheath to open the pair of arm portions by an elasticity of the pair of arm portions by sliding the sheath towards a proximal side with respect to the operation wire (FIG. 1 and C5:L22-26: 110 and 112 extend from 116 and assume the open position when 116 is moved with respect to 108),
the opening/closing portion is buried in the distal end of the sheath to close the pair of arm portions by sliding the sheath distally with respect to the operation wire (C5:L27-30: 110 and 112 move to a closed position when 116 is moved distally with respect to 108), wherein
the opening/closing portion has a pair of claw portions (Annotated FIG. 3 below) at the tip of each of the pair of arm portions that are bent in a closing direction (Annotated FIG. 3) and that can pull a clip connected to a loop member into the sheath by holding a part of the clip during a movement to bury the opening/closing portion in the sheath (Annotated FIG. 3: 110 and 112 are capable of pulling a clip by holding a part of the clip when placed in the closed position),
a gap (Annotated FIG. 3 and C5:L61-65: when 110 and 112 are brought into the closed position, the spikes 128 are brought together and the spike 128 of 110 is received between the spikes 128 of 112; in this position, since the spikes 128 of 112 are extend beyond the distal tip of 112 while the spike 128 of 110 is located more proximally to the distal tip of 110, the first claw portion is kept very slightly apart from the second claw portion, forming a gap) at a closest portion between the pair of claw portions when the pair of arm portions are buried in the sheath and closed, wherein the gap has a specified value that prevents the loop member from passing through when a part of the loop member is clipped between the pair of claw portions (C5:L61-65: the interaction of spikes 128 of 110 and 112 prevents the loop member from passing through when part of the loop member is secured between 110 and 112),
a first claw portion (Annotated FIG. 3 above: distal end of 112) of the opening/closing portion, which is the claw portion of one arm portion of the pair of arm portions, is bent from a base end by a predetermined radius of curvature (Annotated FIG. 3: the curved distal end of 112 has a first radius of curvature),
a second claw portion (Annotated FIG. 3: distal end of 110) of the opening/closing portion, which is the claw portion of the other arm portion, is bent from a base end portion by a radius of curvature longer than the first claw portion and larger than the predetermined radius of curvature (Annotated FIG. 3: the distal end of 110 has a second radius of curvature greater than the first radius of curvature of the distal end of 112),
the pair of arm portions are closed in such a manner that the second claw portion covers the first claw portion from the outside while in a state of being buried in the sheath (Annotated FIG. 3: when 110 and 112 assume the closed position, the distal end of 112 will be covered by the distal end of 110), and
the closest portion is formed between the protruding end portion of the first claw portion and the region between the protruding end portion of the second claw portion and the base end portion (Annotated FIG. 3: the closed portion is formed between the distal end of 110 and the distal end of 112).
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Regarding claim 4, Ryan et al. further discloses the opening/closing portion is a connection hook (FIG, 1: 110 and 112 are connection hooks) that releasably connects a medical clip indwelled while clipping body tissue (FIG. 3: 110 and 112 are capable of pulling the clip by holding a part of the clip while moving towards the closed position).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ryan et al. in view of Matsuo et al. (Pub. No. 2023/0346409).
Regarding claim 3, Ryan et al. discloses the invention as claimed in claim 1, as discussed above. Ryan et al. is silent regarding the dimensions of the treatment tool, including that the specified value of the gap is 0.15 mm or less.
Matsuo et al. teaches in the same field of endeavor of endoscopic treatment tools for use in endoscopic submucosal dissection ([0091]), and discloses an endoscopic treatment tool (20; FIG. 2A; [0098]) comprising an opening/closing portion comprising a pair of arm portions (21, 22), where the diameter of the body of the tool is 2.2 mm ([0100]) for the purpose of being the correct size to operate in ESD ([0100]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have made the diameter of the treatment tool of Ryan et al. as 2.2 mm, as taught by Matsuo et al., for the purpose of operating in ESD. With the diameter of the treatment tool of Ryan et al. being 2.2 mm, the specified value of the gap formed when the pair of claw portions are brought together will be significantly smaller, as the length of the spikes 128 in FIGs. 1-3 are less than half the diameter of 116 (FIGs. 1-2), and the gap would be less than a tenth of the length of the spikes (FIG. 3), which would make the gap less than 0.11 mm.
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 JAMES RYAN MCGINNITY whose telephone number is (571)272-0573. The examiner can normally be reached M-Th 8 am-5:30 pm.
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/JRM/Examiner, Art Unit 3771
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771