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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/10/2026 has been entered.
Response to Arguments
Applicant's arguments filed 03/10/2026 have been fully considered but they are not persuasive. Applicant argues on pages 5-7 that Mitelberg fails to teach “suturing elements both freely movable with respect to, within, and outside of the limiting region”. Applicant argues on page 6 that Mitelberg teaches plunger 106 includes a base 126 and a catch 128 which engage with latch 114 of the tubular member 104. Applicant argues that plunger 106 is not configured to travel outside of 104 and that modifying the element to do so would destroy the intended purpose of the device. However, it is the examiners position that plunger 106 is not relied upon to teach the suturing elements. The suturing elements are interpreted in the rejection previously set forth as 132 and 134. Applicant has not provided any arguments as to how these elements fail to demonstrate the recited claim limitation. See FIGs 6-10 where 132 and 134 are shown as moving within and outside of the limiting region. Therefore, it is the examiners position that arguments regarding the movement and positioning of plunger 106 are moot because this element does not define the claimed suturing element. It is the examiners position that the previous rejection and the rejection set forth below provide sufficient teaching that suturing elements 132 and 134 are both freely movable with respect to, within, and outside of the limiting region 104. Therefore, applicants’ argument is not persuasive.
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.
Claim(s) 1-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mitelberg et al. (US 2012/0158023).
Regarding claim 1, Mitelberg et al. discloses an endoscopic suturing device (100, FIG 2), comprising an elongated tubular element (102, 104, FIG 2, [0040]) which extends from a tensioning element (110, [0040]) associable with an elongated tensionable suturing element (108, [0049]), wherein the elongated tubular element comprises an inlet end provided with a receptacle (104) with a limiting region (Distal region of 104; See annotated FIG 7 attached), the tensioning element comprising a tension point (110b) and the elongated tensionable suturing element comprising a proximal end (End 166 shown in FIGs 6-10) and a distal end (End received within handle 110 and attached to movable slide 110b, FIG 2), wherein the proximal end comprises suturing elements (132, 134) both freely movable with respect to, within, and outside of the limiting region (FIG 6-7 show movement of 134 relative to the limiting region and FIG 9-10 show movement of 132 relative to the limiting region. Examiner notes that 132 is at some points releasable constrained to plunger 106, but is still freely movable relative to 104 which forms the limiting region. Further, the movement occurs within the limiting region, as portions of 132, 132 are radially surrounded by 104 while entering or exiting the lumen. The movement also occurs outside of the limiting region such as the state of FIG 10 where 134, 132 are both freely movable outside of the lumen), so that the distal end enters the receptacle (one end of 108 can be fed into the elongate tubular element by entering through 104 and extending to the slide attachment in 110) for fastening to the tension point (In order to be mechanically attached at 110b) and the suturing elements are delimited by the limiting region (See annotated FIG 7 below) and rigidly joined to each other (Such as in the state of FIG 7-9) when the tensioning element is activated ([0049]).
PNG
media_image1.png
198
511
media_image1.png
Greyscale
Regarding claim 2, Mitelberg et al. discloses the suturing elements collectively define a passage for at least one suture thread (174, FIGs 6-10 show the passageway for the suture between 134 and 132, [0046-0052]).
Regarding claim 3, Mitelberg et al. discloses the suturing elements comprise a first suturing element (134) rigidly fixed on the proximal end (FIG 6) and a second suturing element (132) with free movement around and longitudinally to the elongated tensionable suturing element (108 slides freely within 132 therefore the pieces are movable rotationally and longitudinally relative to one another).
Regarding claim 4, Mitelberg et al. discloses the rigid union between the suturing elements is configured by the detachment of a first suturing element (134, wherein detachment is interpreted as detachment of 134 from 166 as a result of the rigid union between 134 and 132 as shown in the stage of FIG 8), rigidly fixed on the proximal end (FIG 6) for mechanical interference fit to a second suturing element (132) with longitudinal movement limited by the limiting region when the tensioning element is activated ([0049], the distal rim of the limiting region abuts a lip on 132 and thereby provides a resistive force such that when 108 and 134 are retracted proximally, 134 is forced into a mechanical interference fit with 132).
Regarding claim 5, Mitelberg et al. discloses a rigid union between the suturing elements is configured by detachment of a first suturing element (134, wherein detachment is interpreted as detachment of 134 from 166 as a result of the rigid union between 134 and 132 as shown in the stage of FIG 8) comprising a lower portion (The portion received within 132) provided with a surrounding projection (barb 162, [0045]).
Regarding claim 6, Mitelberg et al. discloses the limiting region comprise a stopper (106, [0040, 0042-0044]) which extends transversely and toward the elongated tensionable suturing element (106 extends radially inward towards 108) so as to define a passage for movement of the elongated tensionable suturing element (106 has a lumen which allows for the slidable passage of 108, FIGs 3 and 6-8) together with the limitation of movement of the suturing elements ([0043-0044]).
Regarding claim 7, Mitelberg et al. discloses the receptacle (104) comprise an upper opening (112) longitudinal to the elongated tensionable suturing element (FIGs 6-8) so as to configure the movement of at least one suture thread (FIGs 6-8 show suture 174 received through the opening, [0046-0048]).
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) 8 is rejected under 35 U.S.C. 103 as being unpatentable over Mitelberg et al. (US 2012/0158023) in view of Montenegro et al. (US 2021/0235969).
Regarding claim 8, Mitelberg et al. discloses the invention substantially as claimed, as set forth above for claim 1. Mitelberg discloses the proximal handle 110 may include a stationary shaft 110a and movable slide or spool 110b conventionally used in association with many endoscopic instruments. Alternatively, the handle 110 may include a lever rotatable relative to a stationary member, or a movable trigger, or any other suitable handle assembly for longitudinally displacing the flexible shaft 108 relative to the first and second tubular members 102, 104 ([0040]).
Mitelberg is silent regarding the tensioning element comprising an upper opening longitudinal to the elongated tensionable suturing element for fastening the distal end to the tension point.
However, Montenegro et al teaches a tensioning element (102) for fastening to an end of an elongated tensionable suturing element (118, FIG 1, [0042]) wherein the tensioning element comprises a stationary shaft and a spool (112), and the tensioning element comprising an upper opening (See longitudinal opening in 102 along the handle shaft 110 which receives spool 112 and the end of pull wire 118) longitudinal to the elongated tensionable suturing element (FIG 1) for fastening the distal end to the tension point (The tension point is housed within the upper opening.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the stationary shaft 110a of Mitelberg to comprise an upper opening, as taught by Montenegro, for the purpose of creating a longitudinal slot to receive the spool and tension point of the tensionable suturing element, thereby achieving the predictable result of forming a sliding handle attachment commonly known in the art to impart a proximal retracting force on the tensionable suturing element via the spool.
Claim(s) 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Mitelberg et al. (US 2012/0158023) in view of Kim et al. (US 2015/0342600).
Regarding claims 9-10 8, Mitelberg et al. discloses the invention substantially as claimed, as set forth above for claim 1. Mitelberg discloses the proximal handle 110 may include a stationary shaft 110a and movable slide or spool 110b conventionally used in association with many endoscopic instruments. Alternatively, the handle 110 may include a lever rotatable relative to a stationary member, or a movable trigger, or any other suitable handle assembly for longitudinally displacing the flexible shaft 108 relative to the first and second tubular members 102, 104 ([0040]).
Mitelberg is silent regarding the tension point comprising a split body with a lower part comprising a slot for fastening with the distal end, the lower part rigidly fixed on the tensioning element and an upper part being operationally able to fit into the lower part.
However, Kim teaches a tensioning element (200, FIG 6-10) for fastening to an end of an elongated tensionable suturing element (String 211b, [0056-0059]) at a tension point (220) comprising a split body with a lower part (221) comprising a slot for fastening with the distal end ([0063] discloses 211b can be pressed to a rotation shaft of 221 and caught between 223 and 221 thus fixing the string between the two pieces), the lower part rigidly fixed on the tensioning element and an upper part (223) being operationally able to fit into the lower part (FIG 10, 223 is inserted into 221, [0063-0064]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the tension point of Mitelberg to comprise a split body with the lower part comprising a slot for fastening with the distal end, the lower part rigidly fixed on the tensioning element and the upper part being operationally able to fit into the lower part, as taught by Kim, for the purpose of creating rigid but adjustable attachment of the tensionable suturing element to the tensioning element such that the length can be adjusted if desired but remain mechanically connected during use to apply the desired retractive force.
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.
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, 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BROOKE LABRANCHE/Primary Examiner, Art Unit 3771
Prosecution Insights