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
Applicant’s election without traverse of claims 1-9 (Group I) in the reply filed on 7/14/2026 is acknowledged.
Claims 10-18 (Groups II and III) withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inner post for placement and release of a suture lock (Group II; Claims 10-13) and a method of cinching and terminating a suture (Group III; Claims 14-18), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/14/2026.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/5/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 7 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 7 recites the limitation "the breakaway portion of the inner post". There is insufficient antecedent basis for this limitation in the claim as no “breakaway portion” is defined within the limitations of claim 3, from which claim 7 depends. For the purposes of examination, claim 7 is interpreted to depend from claim 5 which introduces the “breakaway portion” as part of the claimed invention, thereby providing proper antecedent basis for the limitation(s).
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) 1-4 and 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Deuel (US 2021/0128139 A1) in view of Lombardo (US 2017/0042530 A1).
Regarding claim 1, Deuel discloses:
A suture locking cinch system (see Fig. 1), the system comprising:
an outer shaft (shaft 14; see Fig. 1), the outer shaft configured to provide a flexible (see Para. [0049] and [0070]; shaft 14 is flexible) hollow tube (see Para. [0048]; shaft 14 defines lumen 16 therein);
a pull rod (inner shaft 64; see Fig. 1), configured to be run through the outer shaft (see Fig. 1; see also Para. [0047]);
a suture lock tip assembly (portion of the exterior surface of cinch sleeve 40 located at and proximal to opening 49; distally facing surface 38 of connection sleeve 30; portion of the interior surface of cinch sleeve 40 located distally of opening 49; and exterior surface of cinch member 70 extending within cinch sleeve 40; see Figs. 2-4; see also Para. [0051]-[0057] and [0063]), the suture lock tip assembly configured to be frangibly removable to a distal end of the outer shaft (see Fig. 6; see also Para. [0068]; all components distal to coupler 20 are removable from shaft 14); and
a threader assembly (suture 5 and cinch member 70; see Fig. 2), the threader assembly configured to be removably coupled to the outer shaft (see Para. [0060] and [0068]; suture 5 and cinch member 70 may be removably loaded and connected to shaft 14).
However, Deuel does not disclose a handle assembly and thus does not expressly disclose:
a handle assembly, the handle assembly comprising:
a handle front; and
a handle back;
a proximal end of the outer shaft removably connected to the handle front;
wherein the pull rod is removably attached to the handle back and configured to be run through a channel in the handle front.
In the same field of endeavor, namely suture locking cinch systems, Lombardo discloses:
A suture locking cinch system (see Figs. 1-2), the system comprising:
a handle assembly (handle 204; see Fig. 1), the handle assembly comprising:
a handle front (distal end of handle 204; see Fig. 1); and
a handle back (proximal end of handle 204; see Fig. 1);
an outer shaft (shaft 62; see Fig. 1), the outer shaft configured to provide a hollow tube (see Para. [0055]), a proximal end of the outer shaft removably connected to the handle front (see Fig. 1; see also Para. [0055]-[0059]; shaft 62 is mater with handle 204 via key 280 and spindle 282 which may be decoupled therefrom);
a pull rod (actuator shaft 40; see Fig. 5; see also Para. [0055] and [0069]), the pull rod removably attached to the handle back (see Fig. 10; see also Para. [0055]-[0059]) and configured to be run through a channel in the handle front and through the outer shaft (see Fig. 10; see also Para. [0055] and [0057]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the device of Deuel to comprise a handle assembly comprising a handle front and handle back, as taught and suggested by Lombardo to, in this case, provide a control apparatus for a user to manipulate, hold and handle the suture locking cinch system of Deuel. In the combination, the shaft 14 and inner shaft 64 of Deuel would be removably coupled to and passing through a least a portion of the newly included handle (i.e., via the disclosed removably mating connection mechanism disclosed by Lombardo in Para(s). [0055]-[0059]) to provide a connection therebetween, allowing a user’s manipulation of the handle to cause respective actuation of the shaft assemblies. The shaft 14 and inner shaft 64 of Deuel are also noted to be attached to all components of the newly incorporated handle assembly (i.e., from the handle back to the handle front), at least indirectly, due the components being coupled to one-another.
Regarding claim 2, the combination of Deuel and Lombardo disclose all of the limitations of the invention of claim 1.
However, Deuel does not expressly disclose wherein the threader assembly comprises: a suture threader line, the suture threader line having a closed loop on a distal end the suture threader line; and a threader tab, a proximal end of the suture threader line configured to be removably attached to a distal end of the threader tab.
Lombardo further discloses:
a threader assembly comprising:
a suture threader line (loop 300; see Fig. 2) having a closed loop on a distal end of the suture threader line (see Fig. 2; see also Para. [0068]); and
a threader tab (trigger lever 302; see Fig. 2), a proximal end of the suture threader line configured to be removably attached to a distal end of the threader tab (see Para. [0068]).
Wherein the threader assembly configured to have a suture passes through loop 300 to draw the suture through an eyelet of an anchor device (see Para. [0068]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the device of Deuel to comprise a suture threader having a loop at the distal end thereof and accompanying threader tab trigger as taught and suggested by Lombardo to, in this case, capture and manipulate the free ends of a suture thread to be positioned through either the eyelet of an anchor or through a desired portion of tissue (i.e., as a guiding structure) (see Lombardo Para. [0068]).
Regarding claim 3, the combination of Deuel and Lombardo discloses the invention of claim 1, Deuel further discloses wherein the suture lock tip assembly comprises: an inner cutter assembly (portion of the exterior surface of cinch sleeve 40 located at and proximal to opening 49; see Figs. 2-3); an outer cutter assembly (distally facing surface 38 of connection sleeve 30; see Fig. 1; see also Para. [0063]); and a suture lock assembly (portion of the interior surface of cinch sleeve 40 located distally of opening 49; see Figs. 2-3; and exterior surface of cinch member 70 extending within cinch sleeve 40; see Figs. 2-3; see also Para. [0053]), wherein: the outer cutter assembly is fixed into a distal end the outer shaft (see Fig. 2; see also Para. [0056]-[0057]; connection sleeve 30 fixed to distal end of shaft 14 while coupled thereto); the inner cutter assembly is mounted in the outer cutter assembly (see Figs. 2-4; see also Para. [0051]; proximal portion of cinch sleeve 40 disposed within connection sleeve 30 during use); and the suture lock assembly is mounted in the inner cutter assembly (see Figs. 2-4; see also Para. [0053]-[0054]).
Regarding claim 4, the combination of Deuel and Lombardo discloses the invention of claim 3, Deuel further discloses wherein the suture lock assembly comprises: a suture lock outer (portion of the interior surface of cinch sleeve 40 located distally of opening 49; see Figs. 2-3); and an inner post (exterior surface of cinch member 70 extending within cinch sleeve 40; see Figs. 2-3), wherein: the inner post is positioned in the suture lock outer (see Figs. 2-3; see also Para. [0052]-[0053]); and the pull rod is coupled to a proximal end of the inner post (see Fig. 3; see also Para. [0054]).
Regarding claim 8, the combination of Deuel and Lombardo disclose all of the limitations of the invention of claim 1, Deuel, as modified by Lombardo, further disclose wherein: the handle front and handle back are molded with a boss feature that snaps together (molded boss features 350 snap together with recesses 346 and 347 during handle assembly; see Lombardo Para. [0065]; see also Figs. 10 and 15-16); and the boss feature is configured to movably join the handle front to the handle back and to provide a pivot hinge about which the handle front and handle back rotate (see Lombardo Para. [0065]).
Regarding claim 9, the combination of Deuel and Lombardo disclose the invention of claim 1, Deuel, as modified by Lombardo, further discloses wherein the handle assembly further comprises: a dowel pin (pins 350; see Fig. 10), the dowel pin configured to movably join the handle front to the handle back and to provide a pivot hinge about which the handle front and handle back rotate (see Para. [0065]; pins 350 mate with recesses 346 and 347 to join the handle components together to create a pivot hinge).
Allowable Subject Matter
Claims 5-6 is/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 5, the combination of Deuel and Lombardo disclose all of the limitations of the invention of claim 4.
However, none of either Deuel or Lombardo expressly disclose or suggest wherein the inner post comprises: ribs, the ribs are configured to provide an interference fit against the suture lock outer; a breakaway portion; a shearing under cut; and a shear point, wherein the inner post is configured to breakaway at the shear point when a shear force is applied by the pull rod.
While shear points and breakaway portions are well-known in the art, it would not have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the device of Deuel to include a plurality of ribs along the exterior surface of cinch member 70 extending within cinch sleeve 40 (i.e., the inner post) to provide an interference fit against the portion of the interior surface of cinch sleeve 40 located distally of opening 49 (i.e., suture lock outer) since such a modification would impede the operation function of the device. Deuel provides express disclosure of wherein the cinch member is configured to be slidable relative to the cinch sleeve such that the cinch member may selectively provide a cinching/locking force to a suture thread by binding it between the inner surface of the cinch sleeve and outer surface of the cinch member (see Para. [0053]-[0055]). Creating an interference fit between the cinching sleeve and cinching member would impede the ability for the two components to slide relative to one another and thus infringe upon their ability to cinch and lock a suture thread at a desired location. Therefore, one of ordinary skill in the art would not have modified the device of Deuel to have arrived at the claimed configured since such a modification would result in a substantial negative impact to the functionality of the device.
Claim 6 is additionally viewed to be allowable due to its dependency from and further modification of claim 5.
Claim 7 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Regarding claim 7 (see 112(b) rejection above), the combination of Deuel and Lombardo disclose all of the limitations of the invention of claim 3, Deuel further discloses wherein the inner cutter assembly comprises: an inner cutter (opening 49; see Fig. 2; see also Para. [0063).
However, none of either Deuel or Lombardo expressly disclose wherein the inner cutter comprises at least one tab on an inner surface of inner cutter; and the at least one tab is configured to engage the breakaway portion of the inner post.
It would not have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the device of Deuel to include a tab along the inner surface of the opening 49 configured to engage with a breakaway portion of the exterior surface of cinch member 70 extending within cinch sleeve 40 (i.e., the inner post) since such a modification would impede the operation function of the device. Deuel provides express disclosure of wherein the cinch member is configured to be slidable relative to the cinch sleeve such that the cinch member may selectively provide a cinching/locking force to a suture thread by binding it between the inner surface of the cinch sleeve and outer surface of the cinch member (see Para. [0053]-[0055]). Creating an interference fit between the cinching sleeve and cinching member (i.e., via the introduction of an engagement tab) would impede the ability for the two components to slide relative to one another and thus infringe upon their ability to cinch and lock a suture thread at a desired location. Therefore, one of ordinary skill in the art would not have modified the device of Deuel to have arrived at the claimed configured since such a modification would result in a substantial negative impact to the functionality of the device.
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 2005/0080425 A1 to Bhatnagar, US 11890033 B1 to McBride, US 2021/0298739 A1 to Binmoeller, US 2012/0158023 A1 to Mitelberg, US 2002/0107530 A1 to Sauer, US 2021/0137513 A1 to Rogers, US 2025/0000499 A1 to Yorita, US 2007/0005081 A1 to Findlay, US 2021/0007732 A1 to Fortson, US 2021/0128141 A1 to Deuel, US 2019/0357899 A1 to Gilbert, US 2021/0128139 A1 to Deuel, US 2020/0187988 A1 to Farmer, US 2025/0152168 A1 to Zeiner and US 2022/0022925 A1 to Stoll all disclose suture cinching systems comprising at least an outer tube, a pusher tube and suture lock assembly pertinent to the claimed limitations recited in claim 1.
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.
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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
/SHAUN L DAVID/Primary Examiner, Art Unit 3771
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