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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 3/4/2025, 6/2/2025, 6/12/2025 and 8/13/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claim(s) 2-3 is/are objected to because of the following informalities:
Claim 2 recites, “including a lumen which configured” which is missing a linking term between “which” and “configured” (i.e., “is”).
Claim 3 recites “wherein the first jaw configured to be opened and closed” which is missing a linking term between “jaw” and “configured” (i.e., “is”).
Claim 3 additionally recites, “wherein the scope configured to image the needle” which is missing a linking term between “scope” and “configured” (i.e., “is”).
Claim 6 recites “wherein the suture device includes a channel configured to insert a treatment device” which conveys a meaning of wherein the channel itself is the mechanism for insertion of the treatment device into itself. Examiner suggests modification to more clearly convey wherein the channel is configured to receive the treatment device therein, rather than performing the act of insertion itself.
Claim 19 recites “wherein the suture device includes a channel configured to insert a treatment device” which conveys a meaning of wherein the channel itself is the mechanism for insertion of the treatment device into itself. Examiner suggests modification to more clearly convey wherein the channel is configured to receive the treatment device therein, rather than performing the act of insertion itself.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 6-7 and 15-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by West (US 2022/0061640 A1).
Regarding claim 1, West discloses:
A medical system (see Figs. 3) comprising:
a suture device (suturing device 20 see Fig. 3);
wherein the suture device includes:
an arm (tube 36, see Fig. 3);
a first jaw (connecting member 54, see Fig. 3) and a second jaw (needle capture device 40, see Figs. 3-4) that are attached to a distal end of the arm (see Fig. 3); and
a needle (needle 44, see Fig. 3-4) configured to attach a thread (suture 46, see Figs. 3-4), and wherein at least one of the first jaw and the second jaw configured to be opened and closed to deliver the needle therebetween (see Figs. 3-4 showing wherein connecting member 54 may be pivoted between an open and closed position; see also Para. [0195]).
Regarding claim 6, West discloses the invention of claim 1, West further discloses wherein the suture device includes a channel (lumen of tube 36, see Figs. 4-5) configured to insert a treatment device (helical tip 42 extends distally from the lumen of tube 36, see Fig. 4), and wherein the treatment device configured to protrude from a distal end of the channel to the distal end side (see Fig. 4 showing helical tip 42 extending distally beyond the tube 36).
Regarding claim 7, West discloses the invention of claim 1, West further discloses wherein the arm includes a bendable bending portion (see Para. [0005]-[0006] mentioning wherein the device is flexible to be navigated through the anatomical space).
Regarding claim 15, West discloses the invention of claim 6, West further discloses a thread attraction tool as the treatment device (cinch assembly 116, see Figs. 19 and 32-33), wherein the thread attraction tool includes a hooking portion with a hook shape or a helical coil shape at a distal end (hook 140, see Figs. 19-20).
Regarding claim 16, West discloses:
A suture device (suturing device 20 see Fig. 3) comprising:
an arm (tube 36, see Fig. 3);
a first jaw (connecting member 54, see Fig. 3) and a second jaw (needle capture device 40, see Figs. 3-4) that are attached to a distal end of the arm (see Fig. 3); and
a needle (needle 44, see Fig. 3-4) configured to attach a thread (suture 46, see Figs. 3-4);
wherein at least one of the first jaw and the second jaw configured to be opened and closed to deliver the needle therebetween (see Figs. 3-4 showing wherein connecting member 54 may be pivoted between an open and closed position; see also Para. [0195]).
Regarding claim 17, West discloses the invention of claim 16, West further discloses wherein the first jaw configured to be opened and closed (see Figs. 3-4 showing wherein connecting member 54 may be pivoted between an open and closed position; see also Para. [0195]) and includes a through hole going through in the opening and closing direction (see Examiner’s Diagram of Fig. 5 below showing wherein connecting member 54 comprises a through hole opening passing therethrough).
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Examiner’s Diagram of Fig. 5
Regarding claim 18, West discloses the invention of claim 17, West further discloses wherein the arm includes a cutout at a distal end of the arm (see Figs. 3-6 wherein tube 36 comprises a plurality of cutouts at the distal end thereof to allow additional surgical instruments (e.g., helical tip 42, see Fig. 4) to be pass therethrough) , and wherein the cutout communicates with the through hole and forms a part of the through hole (see Fig. 3 showing wherein the through hole formed between opposing arms of the connecting member 54 and the instrument cutouts within the tube 36 are in communication such that a deflectable/bendable instrument may distally protrude from the lumen of the tube 36 and pass through the through hole of the connecting member 54).
Regarding claim 19, West discloses the invention of claim 16, West further discloses wherein the suture device includes a channel (lumen of tube 36, see Figs. 4-5) configured to insert a treatment device (helical tip 42 extends distally from the lumen of tube 36, see Fig. 4), and wherein the treatment device configured to protrude from a distal end of the channel to the distal end side (see Fig. 4 showing helical tip 42 extending distally beyond the tube 36).
Regarding claim 20, West discloses the invention of claim 16, West further discloses wherein the arm includes a bendable bending portion (see Para. [0005]-[0006] mentioning wherein the device is flexible to be navigated through the anatomical space).
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) 2-5 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over West (US 2022/0061640 A1) in view of Phee (US 2015/0230697 A1).
Regarding claim 2, West discloses all of the limitations of the invention of claim 1.
However, while West discloses wherein an optional medical manipulator (i.e., guide tube 146, see Figs. 22-23) may be used to provide a conduit to a desired location while protecting the surrounding tissue from inadvertent damage (see Para. [0201]); wherein the optional medical manipulator includes a lumen to insert the suture device (see Figs. 22-23 and Para. [0201]), West does not provide an express disclosure of wherein the medical manipulator includes a lumen for a scope and an imaging unit.
In the same field of endeavor, namely guide tubes for surgical instruments, Phee teaches a medical manipulator (probe 100, see Figs. 1B and 3A) configured to act as a guide tube for additional endoscope devices and imaging devices (see Para. [0219]-[0220]); wherein the medical manipulator comprises a lumen to insert additional medical devices (tool channels 130, see Fig. 3A and Para. [0125] and [0238]) and an additional lumen for a scope (imaging scope 200, see Fig. 3A and Para. [0125]; imaging scope 200 inserted through an additional lumen 140 per Para. [0125]) having an imaging unit (camera module 222, see Fig. 3A and Para. [0145]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known medical manipulator guide tube for another (see KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, 82 USPQ2d 1385 (2007)) to have obtained the predictable result of substituting the guide tube 146 of West for the imaging probe 100 of Phee. Since West provides an express disclosure pertaining to the use of an optional guide tube for providing a conduit to a desired location while protecting the surrounding tissue from inadvertent damage (see West Para. [0201]), one of ordinary skill in the art would have expected the device(s) of West to function equally well with either the guide tube 146 disclosed by West or the alternative known imaging probe disclosed by Phee, since both members are configured to serve as a guide tube for guiding additional surgical instruments to a target site. Additionally, the imaging probe 100 of Phee further comprises a scope (imaging scope 200, see Phee Fig. 3A and Para. [0125]) having an imaging unit (camera module 222, see Fig. 3A and Para. [0145]) which would allow a user to capture images beyond the distal end of the imaging probe (see Para. [0139]).
Regarding claim 3, the combination of West and Phee discloses the invention of claim 2, West, as modified by Phee, further discloses wherein the first jaw configured to be opened and closed (see West Figs. 3-4 showing wherein connecting member 54 may be pivoted between an open and closed position; see also Para. [0195]) and includes a through hole going through in the opening and closing direction (see Examiner’s Diagram of West Fig. 5 below showing wherein connecting member 54 comprises a through hole opening passing therethrough), and wherein the scope configured to image the needle through the through hole (see Phee Para. [0132]-[0136] mentioning wherein the imaging scope 200, as a subcomponent of the imaging probe of Phee, is maneuverable at the distal end thereof so as to allow a user better visualize the target area; since the imaging scope 200 of Phee is maneuverable, a user may orient the imaging scope 200 such that the needle may be imaged through the through hole of the connecting member 54).
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Examiner’s Diagram of West Fig. 5
Regarding claim 4, the combination of West and Phee disclose the invention of claim 3, West, as modified by Phee, further discloses wherein the scope is bendable in a direction directed to the through hole in a state in which the scope has protruded from a distal end portion of the medical manipulator (see Phee Fig. 3A; see also Phee Para. [0132]-[0136] mentioning wherein the imaging scope 200 is axially slidable along the length of the imaging probe; imaging scope 200 is also laterally bendable relative to the central axis as shown in Figs. 3A and 4A-4B).
Regarding claim 5, the combination of West and Phee disclose the invention of claim 3, West further discloses wherein the arm includes a cutout at a distal end of the arm (see Figs. 3-6 wherein tube 36 comprises a plurality of cutouts at the distal end thereof to allow additional surgical instruments (e.g., helical tip 42, see Fig. 4) to be pass therethrough), and wherein the cutout communicates with the through hole and forms a part of the through hole (see Fig. 3 showing wherein the through hole formed between opposing arms of the connecting member 54 and the instrument cutouts within the tube 36 are in communication such that a deflectable/bendable instrument may distally protrude from the lumen of the tube 36 and pass through the through hole of the connecting member 54).
Regarding claim 8, the combination of West and Phee disclose the invention of claim 2, West, as modified by Phee, further discloses wherein the medical manipulator includes a bendable bending portion (see Phee Para. [0120] mentioning wherein the imaging probe of Phee is flexible).
Allowable Subject Matter
Claim(s) 9-14 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 claim 9, West discloses all of the limitations of the invention of claim 6.
However, West does not expressly disclose:
An anchor applier as the treatment device, wherein the anchor applier includes:
a body;
a first anchor and a second anchor that are detachably attached to the body;
a plug that is detachably attached to the first anchor and the second anchor; and
a blade, wherein a thread hole configured to insert a thread is formed in the first anchor and the second anchor, wherein the first anchor is fixed to a first fixed portion of the thread inserted into the thread hole when the plug is detached, wherein the second anchor is fixed to a second fixed portion of the thread inserted into the thread hole when the plug is detached, and wherein the blade configured to cut the thread between the first fixed portion and the second fixed portion.
While suture-clamping anchor appliers are well-known in the art, (see US 2005/0240203 A1 to Fuseri, US 2006/0047314 A1 to Green, US 2005/0165424 A1 to Gallagher, US 3541591 A to Hoegerman and US 5810853 A to Yoon), none of the prior art expressly discloses an anchor applier comprising a first anchor and second that are detachably attached to the anchor applier body; and a plug that is detachably attached to the first anchor and the second anchor; wherein the first anchor is fixed to a first fixed portion of the thread inserted into the thread hole when the plug is detached, wherein the second anchor is fixed to a second fixed portion of the thread inserted into the thread hole when the plug is detached, and wherein the blade configured to cut the thread between the first fixed portion and the second fixed portion.
The required configuration of a dual-anchor assembly having a blade configured to cut a suture thread passing through and gripped by the pair of anchors is not taught or rendered obvious by the available prior art of record.
Claims 10-14 are also objected to as being allowable due to their dependency from and further modification of claim 9.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's
disclosure. See the attached PTO-892 Notice of References Cited. Specifically, US 2017/0007345 A1 to Smith, US 2015/0230697 A1 to Smith, US 2017/0035413 A1 to Takahashi, US 2005/0251166 A1 to Vaughan, US 5944739 A to Zlock, US 2025/0090170 A1 to Kubo and US 2024/0260958 A1 to Woodward all disclose nested endoscope devices comprising a suture assembly and nested suture manipulator tool configured to aid in suturing procedures.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MITCHELL B HOAG whose telephone number is (571)272-0983. The examiner can normally be reached 7:30 - 5:00 M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 5712724695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.B.H./Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771
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