DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Arguments
Applicant argues in the response filed 08/12/2026 that the claim amendments would overcome the claim objections and double patenting rejections. The previous claim objections and double patentable rejections have been withdrawn. However new objections and double patent rejections have been made below.
The applicant argues prior art reference Hashimoto does not teach the cap positioned over the distal end face of the endoscope. However it is to be noted that there are no further limitation with respect to the structure of the cap, positively how the cap is positioned over the distal end face of the endoscope, and/or how the needle holder arm is mounted with respect to the cap. Hashimoto does teach a structure that can read on a cap and can be positionable over a distal end, therefore a face of an endoscope. The cap/cover can help couple the needle holder arm to the endoscope. Therefore Hashimoto can teach the cap limitations. Further limitations are needed to overcome the prior art rejection of record.
Claim Objections
Claim 4 is objected to because of the following informalities: It would be known that the needle holder arm will have a distal end, but for clarity purposes and to avoid any antecedent issues, line 4 should be amended to read “a distal end of the needle holder arm” or an amendment of a similar scope. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: Line 5 states “an opening of the instrument channel”. Claim 13 is dependent off of claim 7 which already recites “an opening of the instrument channel” in line 8. It would seem both openings of claim 7 and 13 are the same opening. For clarity purposes and to avoid any antecedent issues, line 5 should be amended to read “the opening of the instrument channel” or an amendment of a similar scope. Appropriate correction is required.
Claim 19 is objected to because of the following informalities: Lines 4-5 states “an opening of the instrument channel”. Claim 19 is ultimately dependent off of claim 15 which already recites “an opening of the instrument channel” in line 9. It would seem both openings of claim 15 and 19 are the same opening. For clarity purposes and to avoid any antecedent issues, lined 4-5 should be amended to read “the opening of the instrument channel” or an amendment of a similar scope. Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 1-20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent Publication 2003/0181924 to Yamamoto in view of U.S. Patent Publication 2007/0162052 to Hashimoto.
As to claim 1, Yamamoto discloses a method for suturing tissue adjacent a distal end face of an endoscope defining at least one instrument channel (figure 90-93, the device as seen in figure 90-93 can be interpreted to be an endoscope with instrument channels, see Annotated Figure below), the method comprising moving a needle holder arm (216/218) holding a suture needle (213) having a needle tip (tip of 213) to pass the suture needle through tissue (“tissue” figure 90-94), and transferring the suture needle, after passing through the tissue, within a place intersecting the distal end face of the endoscope (figure 91-93) and to a needle capture device (212) along the distal end face of the endoscope (figure 92-93) but is silent about the holder arm is mounted with respect to a cap positionable over the distal end face of the endoscope
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Hashimoto discloses a simile device/system (suturing device) having a needle holder arm (3/8) mounted with respect to a cap (6) positionable over a distal end face of the endoscope (figure 1) for the purpose of helping to allow the rotation of the needle holder with respect to the device (paragraph 35). The distal end face is not further defined nor is how the needle holder is mounted. The cover 6 is attached to a distal end of the endoscope which will then be able to be positionable over the distal end face. The holder arm is mounted to the endoscope so will be mounted with respect to the cover/cap 6. The cap 6 seems to help allow the holder arm to be attached and moved with respect to the endoscope. A similar cover/cap can be used with Yamamoto which can help mount the holder arm to the endoscope. It would have been obvious to one of ordinary skill in the art at the time of the invention to use the cap of Hashimoto in the method of Yamamoto where the needle holder arm is mounted with respect to the cap in order for helping to allow the rotation of the needle holder with respect to the device.
As to claim 2, Yamamoto as modified by Hashimoto discloses the method above in the embodiment of figures 90-93 but is silent about grasping tissue with a tissue grasper distal to the distal end face of the endoscope, and moving the needle through the tissue grasped by the tissue grasper distal to the distal end of the endoscope. Yamamoto does disclose another embodiment comprising grasping tissue with a tissue grasper (152, figure 50) distal to the distal end face of the endoscope (12), and moving the needle through the tissue grasped by the tissue grasper distal to the distal end of the endoscope (figure 50) for the purpose of being able to control and better position the tissue to punctured (paragraph 188, 245). Yamamoto does disclose that the embodiments can be modified and/or other embodiments added (paragraph 459). Therefore the tissue grasper can be added to modify the embodiment of figure 90-93 to better grasp the tissue. It would have been obvious to one of ordinary skill in the art at the time of the invention to use the tissue grasping step with a tissue grasper of figure 50 in the embodiment of figure 90-93 to be able for the method to comprise extending the tissue grasper through the distal opening of the instrument channel of the endoscope to grasp tissue in order for being able to control and better position the tissue to punctured.
As to claim 3, with the method of Yamamoto and Hashimoto above, Yamamoto discloses the extending the tissue grasper through the distal opening of the of the at least one instrument channel of the endoscope to grasp tissue (figure 50).
As to claim 4, with the method of Yamamoto and Hashimoto above, Yamamoto discloses rotating the needle holder arm to move the suture needle between a first position (figure 90) in which the needle tip is not parallel to a longitudinal axis of the endoscope and a second position (figure 91) in which the distal end of the needle holder arm is closer to the distal end of the needle holder arm is closer to the distal end of the endoscope than with the first position (figure 90,91) and in which the needle tip is directed at an opening of the at least one instrument channel along the distal end of the face of the endoscope (figure 91).
As to claim 5, with the method of Yamamoto and Hashimoto above, Yamamoto discloses moving the needle holder arm along a plane extending through the at least one instrument channel to transfer the needle to the needle capture device, the needle capture device extending through the instrument channel (figure 90-93).
As to claim 6, with the method of Yamamoto and Hashimoto above, Yamamoto discloses aligning a distal end of the needle holder arm (the end of 216, where the needle 213 is located can be the distal end of the needle holder arm) with the at least one instrument channel of the endoscope (figure 91).
As to claim 7, Yamamoto discloses a treatment device for use with an endoscope having an instrument channel with a longitudinal axis and a distal end face (see annotated figure above) the treatment device comprising a needle (213) having a needle tip (tip of 213), a needle holder arm (216/218) configured to releasably hold the needle (figure 90-93), and a needle capture device (212) configured to releasably hold the needle and positionable within an opening of the instrument channel (figure 92, 93), wherein the needle holder arm is movable within a plane intersecting the distal end face of the endoscope to pass the needle through tissue of a patient and to transfer the needle from the needle holder arm to the needle capture device (figure 90-93) but is silent about the needle holder arm is mounted with respect to a cap positionable over the distal end face of the endoscope.
Hashimoto discloses a simile device (suturing device) having a needle holder arm (3/8) mounted with respect to a cap (6) positioned over a distal end face of the endoscope (figure 1) for the purpose of helping to allow the rotation of the needle holder with respect to the device (paragraph 35). The distal end face is not further defined nor is how the needle holder is mounted. The cover 6 is attached to a distal end of the endoscope which will then be able to be positionable over the distal end face. The holder arm is mounted to the endoscope so will be mounted with respect to the cover/cap 6. The cap 6 seems to help allow the holder arm to be attached and moved with respect to the endoscope. A similar cover/cap can be used with Yamamoto which can help mount the holder arm to the endoscope. It would have been obvious to one of ordinary skill in the art at the time of the invention to use the cap of Hashimoto in the method of Yamamoto where the needle holder arm is mounted with respect to the cap in order for helping to allow the rotation of the needle holder with respect to the device.
As to claim 8, with the device of Yamamoto and Hashimoto above, Yamamoto discloses the needle holder arm is rotatable in the plane which intersects the distal end face of the endoscope (figure 90-93).
As to claim 9, with the device of Yamamoto and Hashimoto above, Yamamoto discloses the plane in intersects the instrument channel of the endoscope (figure 90-93). The plane that the needle holder arm moves will intersect the instrument channel since the needle holder arm ends up coaxial with the channel.
As to claim 10, with the device of Yamamoto and Hashimoto above, Yamamoto discloses the needle holder arm is rotatable from a first position (figure 90) to a second position (figure 91), wherein in the second position the needle holder arm holds the needle so that the needle tip is coaxial with the instrument channel of the endoscope and directed at the distal end face of the endoscope (figure 91-93).
As to claim 11, with the device of Yamamoto and Hashimoto above, Yamamoto discloses the needle holder arm is curved through an angle of approximately ninety degrees (figure 90). The holder 216 extends in a curved manner from the member 218 at approximately 90 degrees as well as the holder 216 is curved and also seems to be approximately 90 degrees as seen best seen in figure 91.
As to claim 12, with the device of Yamamoto and Hashimoto above, Yamamoto discloses the needle holder arm is pivotably coupled with respect to the endoscope (via the links as seen in figure 90-93) at a position laterally away from the endoscope instrument channel (figure 90-93).
As to claim 13, with the device of Yamamoto and Hashimoto above, Yamamoto discloses needle holder arm is rotatable from a first position (figure 90) in which the needle hold arm hold the needle so that the needle tip is not parallel to a longitudinal axis of the endoscope, to a second position (figure 91) in which the needle holder arm holds the needle so that the needle tip is directed at an opening of the instrument channel along the distal end of the face of the endoscope (figure 91).
As to claim 14, with the device of Yamamoto and Hashimoto above, Yamamoto discloses the needle is configured to be releasably inserted into an end of the needle holder arm (figure 90-93).
As to claim 15, Yamamoto discloses a system comprising an endoscope or a guide member having a distal end face and defining an instrument channel therethrough (see annotated figure above), a needle (213) having a needle tip (tip of 213), a needle holder arm (216/218) being adapted to releasably hold the needle within a plane intersecting the distal end face of the endoscope to cause the needle puncture a tissue (figure 90-93), and a needle capture device (212) positioned within an opening of instrument channel (figure 92) and adapted to receive the needle from the needle holder and to releasably hold the needle upon release of the needle from the needle holder arm (figure 92, 93) but is silent about the needle holder arm mounted with respect to a cap positioning over the distal end face of the endoscope or guide member.
Hashimoto discloses a simile system (suturing device) having a needle holder arm (3/8) mounted with respect to a cap (6) positioned over a distal end face of the endoscope (figure 1) for the purpose of helping to allow the rotation of the needle holder with respect to the device (paragraph 35). The distal end face is not further defined nor is how the needle holder is mounted. The cover 6 is attached to a distal end of the endoscope which will then be able to be positionable over the distal end face. The holder arm is mounted to the endoscope so will be mounted with respect to the cover/cap 6. The cap 6 seems to help allow the holder arm to be attached and moved with respect to the endoscope. A similar cover/cap can be used with Yamamoto which can help mount the holder arm to the endoscope. It would have been obvious to one of ordinary skill in the art at the time of the invention to use the cap of Hashimoto in the method of Yamamoto where the needle holder arm is mounted with respect to the cap in order for helping to allow the rotation of the needle holder with respect to the device.
As to claim 16, with the system of Yamamoto and Hashimoto above, Yamamoto discloses the needle holder arm is movable in a first direction toward the distal end face of the endoscope or guide member to move the needle tip closer to the instrument channel (figure 90-93), and in a second direction opposite first direction (figure 93-94).
As to claim 17, with the system of Yamamoto and Hashimoto above, Yamamoto discloses the needle holder arm is curved through an angle of approximately ninety degrees (figure 90). The holder 216 extends in a curved manner from the member 218 at approximately 90 degrees as well as the holder 216 is curved and also seems to be approximately 90 degrees as seen best seen in figure 91.
As to claim 18, with the system of Yamamoto and Hashimoto above, Yamamoto discloses the needle holder arm is pivotably coupled with respect to the endoscope or guide member (via the links as seen in figure 90-93) at a position laterally away from the instrument channel (figure 90-93).
As to claim 19, with the system of Yamamoto and Hashimoto above, Yamamoto discloses needle is moved in the first direction from a first position (figure 90) in which the needle tip is angled relative to an axis of the instrument channel, to a second position (figure 91) in which the needle tip is directed at an opening of the instrument channel and coaxial with the instrument channel axis.
As to claim 20, with the system of Yamamoto and Hashimoto above, Yamamoto discloses the needle is configured to be releasably inserted into an end of the needle holder arm (figure 90-93).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 15- 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15-20 of copending Application No. 18/583,208 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because with respect to claim 15, the reference application is directed to a treatment device for use with an endoscope having an instrument channel with a longitudinal axis and a distal end face (claim 15) the treatment device comprising a needle (claim 15) having a needle tip (claim 15), a needle holder arm (claim 15) mounted with respect to a cap positionable over the distal end face of the endoscope or guide member, the needle holder arm being adapted to releasably hold the needle (claim 16), and a needle capture device (claim 16) configured to releasably hold the needle and positionable within an opening of the instrument channel (claim 16), wherein the needle holder arm is movable within a plane intersecting the distal end face of the endoscope to pass the needle through tissue of a patient and to transfer the needle from the needle holder arm to the needle capture device (claim 16).
As to the instant application’s claim 17-20, see reference application claims 15, 16.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Patent Publication 2002/0116010 to Chung (as cited reference E in the 892 filed 05/13/2026), U.S. Patent Publication 2002/0198542 to Yamamoto (as cited reference F in the 892 filed 05/13/2026), and U.S. Patent Publication 2004/0138682 to Onuki (as cited reference G in the 892 filed 05/13/2026) all disclose similar devices, systems, and method pertinent to the scope of the claims.
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 ALEXANDER J ORKIN whose telephone number is (571)270-7412. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/ALEXANDER J ORKIN/Primary Examiner, Art Unit 3771
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