DETAILED ACTION
This Office Action is responsive to the Amendment filed 11 February 2026.
Claims 1-20 are now pending. The Examiner acknowledges the amendments to claims
1-11 and 14-20.
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 .
Claim Objections
Claim 7 is objected to because of the following informalities: at lines 2 and 4, “anchor” should apparently read --anchors--. 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.
Claims 1-10 and 12-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Huxel (U.S. Patent No. 5,972,022). Regarding claims 1 and 3, Huxel discloses a tissue traction system for applying traction to tissue within a patient’s body (Figs. 1-4 and col. 3, lines 10-13 – col. 4, lines 11-39), comprising: a stretchable tether 40 having a first end and a second end (Figs. 2-3 and col. 3, lines 10-20);
a first tissue anchor 20 coupled with the first end of the stretchable tether 40 (Figs. 2 and 3; col. 3, lines 35-52); and a second tissue anchor 20 coupled with the second end of the stretchable tether 40 (Fig. 3 and col. 4, lines 53-58); wherein: at least one of the first and anchors 20 is configured to engage target tissue within the patient’s body as well as one of the ends of the stretchable tether 40 (Fig. 3 and col. 3, lines 10-53); and the other of the at least one of the first and second tissue anchors 20 is configured to releasably engage the other end of the stretchable tether 40 (via opening 27 in end 21 of the member 20 - Fig. 1, 3 and 8; col. 3, lines 36-52 and col. 4, lines 45-58), and is configured to anchor the other end of the stretchable tether 40 to anchoring tissue within the patient’s body spaced apart from the target tissue (via the hook/piercing point of member 20 – col. 3, lines 35-48) to exert traction on the target tissue, stretching the stretchable tether 40 along a vector extending between the target tissue and the anchoring tissue to lift the target tissue away from tissue surrounding the target tissue (capable thereof as the fasteners are subjected to a pulling/tensile force applied by the stretchable tether – col. 3, lines 54-57 and col. 4, lines 32-44).
Regarding claim 2, the at least one of the first and second tissue anchors 20 has a first end (at proximal end 21) engaging the one of the ends of the tether 40 (via opening 27) (Figs. 1, 3 and col. 3, lines 36-50) and a second end (at distal end 26) configured to engage tissue (see Figs. 1, 3 and col. 53, lines 36-50).
Regarding claim 4, the other of the at least one of the first and second tissue anchors 20 is configured to engage tissue via a third tissue anchor configured to engage tissue (“If desired, more than one hook may be mounted together to form member 20 as seen in Fig. 2” – col. 3, lines 44-45).
Regarding claim 5, the other of the at least one of the first and second tissue anchors 20 engages the tether 40 via an eyelet 27 (Figs. 1 and 3; and col. 3, lines 36-52).
Regarding claim 6, at least one of the first and second tissue anchors 20 has jaws for engaging tissue (as seen in Fig. 6; col. 3, lines 45-52 and col. 4, lines 39-44).
Regarding claim 7, the jaws extend from a first end of the at least one of the first and second tissue anchor 20 and the tether 40 is coupled to the first end of the at least one of the first and second tissue anchor 20 (as seen in Fig. 6, the tether 40 is coupled to the first end of the anchor 20, and the jaws extend from that first end).
Regarding claim 8, the first tissue anchor 20 comprises a first anchor coupled to the first end of the tether 40 (Figs. 2-3 and col. 3, lines 36-52), the first anchor having a fastener configured to engage tissue (“piercing point 28 has a locking barb 29 to fix or lock the engagement member 20 in tissue – col. 3, lines 36-43); and the second tissue anchor 20 comprises a second anchor coupled to the second end of the tether 40 (Figs. 2-3 and col. 3, lines 36-52), the second anchor having a fastener configured to engage tissue (“piercing point 28 has a locking barb 29 to fix or lock the engagement member 20 in tissue – col. 3, lines 36-43).
Regarding claim 9, the at least one of the first and second tissue anchors 20 is a tissue clip having jaws (the double-hook member 20 in Fig. 2 is interpreted as a tissue clip having jaws – col. 4, lines 40-44).
Regarding claim 10, Huxel discloses a tissue traction system for applying traction to tissue within a patient’s body (Figs. 1-4 and col. 3, lines 10-13 – col. 4, lines 11-39), comprising: a stretchable tether 40 having a first end and a second end (Figs. 2-3 and col. 3, lines 10-20); a first tissue anchor 20 coupled to the first end of the tether 40 (Figs. 2 and 3; col. 3, lines 35-52; and col. 4, lines 32-58) and configured to engage target tissue within the patient’s body (col. 3, lines 10-53); and an engagement element 20 comprising a loop 21 (Fig. 2) configured to be releasably engaged by a second tissue anchor (loop 21 is capable of releasably engaging another loop, or anything that can “catch” on the loop 21), the loop 21 positioned at the second end of the tether 40 (Figs. 2-3 and col. 4, lines 53-58) for anchoring the second end of the stretchable tether 40 with respect to anchoring tissue within the patient’s body spaced apart from the target tissue (col. 3, lines 9-52 and col. 4, lines 33-39) to exert traction on the target tissue within the patient’s body, stretching the stretchable tether 40 along a vector extending between the target tissue and the anchoring tissue to lift the target tissue away from tissue surrounding the target tissue (capable thereof as the fasteners are subjected to a pulling/tensile force applied by the stretchable tether – col. 3, lines 54-57 and col. 4, lines 32-44).
Regarding claims 12 and 13, the stretchable tether 40 comprises a rubber band (col. 3, lines 9-24 and 54-67 – col. 4, lines 1-3) including a loop in addition to the loop of the engagement element (as shown in Figs. 2-3).
Regarding claims 14-15, Huxel discloses a tissue traction system (Figs. 1-4 and col. 3, lines 10-13 – col. 4, lines 11-39), comprising: a stretchable, elongated tether 40 having a first end and a second end (Figs. 2-3 and col. 3, lines 10-20); a first tissue anchor 20 configured to couple the first end of the tether 40 to a patient’s tissue at a first location (Figs. 2 and 3; col. 3, lines 35-52); and a second tissue anchor 20 configured to be separable from the tether 40 (see at least Figs. 1-3 where the hooks/“anchors” can be separated from the tether as described at col. 3, lines 45-53 and col. 4, lines 45-58), the second tissue anchor 20 configured to couple the second end of the tether to the patient’s tissue at a second location (via the hook/piercing point of anchor 20 – col. 3, lines 35-48) to exert a biasing force on the tether and the patient’s tissue at the first or second location (capable thereof as the fasteners are subjected to a pulling/tensile force applied by the stretchable tether – col. 3, lines 54-57 and col. 4, lines 32-44).
Regarding claim 16, the second tissue anchor 20 comprises a loop, eyelet or hook (col. 3, lines 36-53 and Figs. 1-3).
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 10-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12, 13, 15 and 16 of U.S. Patent No. 10,973,506. Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and those of the patent disclose a tissue traction system, comprising: a stretchable tether having a first end and a second end; a first tissue anchor coupled to the first end of the tether and configured to engage target tissue; and an engagement element comprising a loop configured to be releasably engaged by a second tissue anchor, the loop positioned at the second end of the stretchable tether for anchoring the second end of the tether with respect to anchoring tissue. With respect to claim 10, the most recent amendments of specifying that the anchors are tissue anchors does not change the interpretation of the claim as the claim recites that the first…anchor is configured to engage tissue, and the “second tissue anchor” is not required by the claim language.
Allowable Subject Matter
Claims 17-20 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 17, while the prior art teaches a tissue traction system, comprising: a stretchable tether having a first end and a second end; a first tissue anchor configured to couple the first end of the stretchable tether to a patient's tissue at a first location; and a second tissue anchor configured to be separable from the stretchable tether, and configured to couple the second end of the stretchable tether to the patient's tissue at a second location to exert a biasing force on the stretchable tether and the patient's tissue at the first or second location, the prior art of record does not teach or fairly suggest a tissue traction system as claimed by Applicant, further comprising a third anchor deployed separately from the stretchable tether.
Regarding claims 18-20, while the prior art teaches a tissue traction system, comprising: a stretchable tether having a first end and a second end; a first tissue anchor configured to couple the first end of the stretchable tether to a patient's tissue at a first location; and a second tissue anchor configured to be separable from the stretchable tether, and configured to couple the second end of the stretchable tether to the patient's tissue at a second location to exert a biasing force on the stretchable tether and the patient's tissue at the first or second location, the prior art of record does not teach or fairly suggest a tissue traction system as claimed by Applicant, further comprising a third tissue anchor comprising a stretchable element, the third tissue anchor spaced apart from the second tissue anchor.
Response to Arguments
Applicant’s arguments filed 11 February 2026 with respect to the rejection of claims 1-9 and 14-20 under 35 U.S.C. 112(b) have been fully considered and are persuasive in light of the amendments.
Applicant’s arguments filed 11 February 2026 with respect to the rejection of claim 15 under 35 U.S.C. 112(d) have been fully considered and are persuasive in light of the amendments.
Applicant’s arguments filed 11 February 2026 with respect to the rejection of claims 1-10 and 12-16 under 35 U.S.C. 102(a)(1) citing Huxel (‘022) have been fully considered and are not persuasive. Regarding claims 1 and 10, Applicant contends that claim 1 has been amended to more particularly point out that the tissue anchor is “configured to releasably engage” an end of a stretchable tether, and such releasable engagement requires that the structure be designed to permit intentional, non-destructive release and re-engagement to enable positioning during the traction procedure. In response to such, although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Applicant further states that the cinch knot/loop created by Huxel creates a permanent, tightening coupling designed to secure tissue for wound repair, not to permit intentional release and repositioning. While Figs. 8-9 and col. 4, lines 45-54 discuss the creation of a cinch knot, this type of knot is reversible, affording the cinch knot of Huxel the ability to be releasably engageable to another component. Although Applicant relies upon the notion of permitting “intentional….release….to enable positioning during the traction procedure…” and “adjust traction vectors during a procedure,” it is noted that none of these limitations are found in the currently presented claims. Further, the claims do not discuss any repositioning of any recited elements, or adjustment of traction vectors during a traction procedure. Applicant further sates that the claimed tissue traction system is directed to adjustable tissue traction during surgical procedures and Huxel is directed to tissue repair and proximation and thus the limitation of “configured to releasably engage’ enables repositioning functionality essential to traction application by absent from Huxel’s fixed repair structure. Again, the claims do not require any repositioning functionality, and as noted in the rejection above, Huxel is capable of such as Huxel specifically teaches the application of a tensile force (col. 3, lines 54-57) and “sufficient tissue holding capability to effectively be maintained in tissue when subjected to a pullout force or tensile force applied by the elastomeric member” (col. 4, lines 32-44). Specifically with respect to claim 10, Applicant contends that the loop of Huxel does not permit intentional release and re-engagement for traction adjustment, however as previously noted, such traction adjustment is not recited in the claims. Specifically with respect to claim 14, Applicant contends that the second tissue anchor of Huxel is not configured to be separable from the stretchable tether as this limitation requires the structure to permit intentional separation and re-coupling to enable adjustment of traction vectors. Again, as previously noted, such re-coupling and adjustment of traction vectors is not recited in the claims. In view of the foregoing, the rejection of claims 1-10 and 12-16 under 35 U.S.C. 102(a)(1) citing Huxel (‘022) has been maintained.
Applicant’s arguments filed 11 February 2026 with respect to the rejection of claims 10-13 on the ground of nonstatutory double patenting have been maintained for the reasons noted above under “Double Patenting.”
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: U.S. Patent No. 9,101,357.
THIS ACTION IS MADE FINAL. 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 CHRISTINE HOPKINS MATTHEWS whose telephone number is (571)272-9058. The examiner can normally be reached Monday - Friday, 7:30 am - 4:00 pm.
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/CHRISTINE H MATTHEWS/Primary Examiner, Art Unit 3791