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 .
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 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.
Response to Amendment
The Response filed September 24, 2025 has been entered. Claims 1-12 and 15-20 are pending in the application. The rejections of claims under 35 U.S.C. 112(d) are withdrawn in light of Applicant’s amendments to the claims. Response to applicant's arguments can be found at the end of this Office action.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-6, 8, 10-12, and 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Harari (U.S. Patent Application Publication No. 20210128136) in view of Schluzas et al. (U.S. Patent No. 6146406; hereinafter “Schluzas”)
Regarding claim 1, Harari discloses a tissue anchor (830; Figs. 10A-11D; paras. [0062]-[0070]) used in repairing a wound after an endoscopic resection procedure (anchoring element (830) is capable of use in repairing a wound as claimed because no structure in the anchoring element would prevent it from performing such a function), the tissue anchor comprising:
an elongated main body (hollow cylindrical element; para. [0065]) defining a channel therethrough (Figs. 10C and 11C), the main body defining a longitudinal axis and having a proximal end portion and a distal end portion (annotated Fig. 10A below),
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wherein the distal end portion terminates in a continuous distal-most edge that encircles the channel (annotated Fig. 10A above) and lies in a plane transverse to the longitudinal axis (annotated Fig. 10C below),
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the distal-most edge including a first portion (annotated Fig. 10B below) having a concave shape (portion of the edge defining cut out (920) has a concave shape; annotated Fig. 10C above) and an opposite second portion (annotated Fig. 10B) having a concave shape (portion of the edge defining cut out (920); annotated Fig. 10C above),
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the distal edge forming first and second teeth that project axially beyond adjacent portions of the distal-most edge (annotated Fig. 10C above; the teeth extend axially beyond portions of the distal-most edge forming cut outs (920)); and
at least two tines (904) coupled to the main body, wherein the at least two tines are configured to move relative to the main body between a stowed configuration (Figs. 11A-11D), and a deployed configuration (Figs. 10A-10D), in which the at least two tines flare outwardly relative to the main body.
The device of Harari discloses the invention substantially as claimed, except for the distal-most edge being sharp and the first and second portions converging to form first and second teeth.
Schluzas, a reference in the tissue anchor field of endeavor, teaches providing an anchor (10) with a distal-most edge that is sharp and includes first and second portions (30, 32) converging along the distal-most edge to form respective first and second distal teeth (34, 36) that project axially beyond adjacent portions of the distal-most edge such that the distal end portion is configured to puncture tissue during distal insertion of the main body into the tissue (Figs. 2A-2B) to facilitate inserting the anchor into tissue (col. 3, ll. 12-14).
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It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to configure the distal-most edge to be sharp and have the first and second portions converging along the distal-most edge to form respective first and second distal teeth that project axially beyond adjacent portions of the distal-most edge such that the distal end portion is configured to puncture tissue during distal insertion of the main body into the tissue, in view of Schluzas, in order to facilitate passing the distal portion of the anchor through tissue.
Regarding claim 2, Harari discloses wherein the at least two tines are linear in the stowed configuration (Fig. 11A).
Regarding claim 3, Harari discloses wherein the at least two tines are arcuate in the deployed configuration (Fig. 10A).
Regarding claim 4, Harari disclose wherein the at least two tines are fabricated from a shape memory material (nitinol; para. [0065]) configured to transition the at least two tines from the stowed configuration to the deployed configuration when the at least two tines reach a preset, threshold temperature (nitinol is well-known to have the material characteristic of being configured to transition between shapes at a preset threshold temperature).
Regarding claim 5, Harari discloses wherein the at least two tines have an outer surface that is circumferentially-aligned with or positioned radially inward from an outer surface of the main body when the at least two tines are in the stowed configuration (Fig. 11A).
Regarding claim 6, Harari discloses wherein each of the at least two tines has a first end attached to the distal end portion of the main body, and a free second end (Fig. 10A).
Regarding claim 8, Harari disclose wherein the at least two tines are positioned on the main body in opposition to one another (Fig. 10C).
Regarding claim 10, Harari discloses wherein the main body defines at least two elongated cutouts therein (Fig. 10C), the at least two tines being positioned within the respective at least two elongated cutouts when the at least two tines are in the stowed configuration (Figs. 11A-11D).
Regarding claim 11, Harari discloses wherein the main body has a tubular shape, and the channel is cylindrical (para. [0065]).
Regarding claim 12, Harari discloses wherein the channel is opened at each of the proximal and distal end portions of the main body (Fig. 10C).
Regarding claim 15, Harari discloses wherein when the at least two tines are in the deployed configuration, the at least two tines have a convex, proximal-facing surface and a concave, distal-facing surface (annotated Fig. 10C below).
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Regarding claim 16, Harari discloses wherein the at least two tines and the main body are monolithically formed with one another (Fig. 10A; para. [0065]).
Regarding claim 17, Harari discloses a tissue anchor (830; Figs. 10A-11D; paras. [0062]-[0070]) used in repairing a wound after an endoscopic resection procedure (anchoring element (830) is capable of use in repairing a wound as claimed because no structure in the anchoring element would prevent it from performing such a function), the tissue anchor comprising:
an elongated main body (hollow cylindrical element; para. [0065]) including a proximal end portion (annotated Fig. 10A below) and a distal end portion (annotated Fig. 10A below), the main body defining a longitudinal axis and a channel that extends from the proximal end portion to the distal end portion (Figs. 10C and 11C);
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wherein the distal end portion terminates in a continuous distal-most edge that encircles the channel (annotated Fig. 10A above) and lies in a plane transverse to the longitudinal axis (annotated Fig. 10C below),
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the distal-most edge including a first portion (annotated Fig. 10B below) having a concave shape (portion of the edge defining cut out (920) has a concave shape; annotated Fig. 10C above) and an opposite second portion (annotated Fig. 10B) having a concave shape (portion of the edge defining cut out (920); annotated Fig. 10C above),
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the distal edge forming first and second teeth that project axially beyond adjacent portions of the distal-most edge (annotated Fig. 10C above; the teeth extend axially beyond portions of the distal-most edge forming cut outs (920)); and
at least two tines (904) having a first end coupled to the main body, and a free second end (Fig. 10A), wherein the at least two tines are configured to transition between a stowed configuration (Figs. 11A-11D), and a deployed configuration (Figs. 10A-10D, the free second end of the at least two tines are positioned a greater radial distance from an outer surface of the main body when the at least two tines are in the deployed configuration than when the at least two tines are in the stowed configuration (Figs. 10C-10D).
The device of Harari discloses the invention substantially as claimed, except for the distal-most edge being sharp and the first and second portions converging to form first and second teeth.
Schluzas, a reference in the tissue anchor field of endeavor, teaches providing an anchor (10) with a distal-most edge that is sharp and includes first and second portions (30, 32) converging along the distal-most edge to form respective first and second distal teeth (34, 36) that project axially beyond adjacent portions of the distal-most edge such that the distal end portion of the main bod is configured to puncture tissue during distal insertion of the main body into the tissue (Figs. 2A-2B) to facilitate inserting the anchor into tissue (col. 3, ll. 12-14).
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It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to configure the distal-most edge to be sharp and have the first and second portions converging along the distal-most edge to form respective first and second distal teeth that project axially beyond adjacent portions of the distal-most edge such that the distal end portion is configured to puncture tissue during distal insertion of the main body into the tissue, in view of Schluzas, in order to facilitate passing the distal portion of the anchor through tissue.
Regarding claim 18, Harari discloses wherein the at least two tines are linear in the stowed configuration (Fig. 11A), and arcuate in the deployed configuration (Fig. 10A).
Regarding claim 19, Harari discloses wherein the at least two tines are fabricated from a shape memory material (nitinol; para. [0065]) configured to transition the at least two tines from the stowed configuration to the deployed configuration when the at least two tines reach a preset, threshold temperature (nitinol is well-known to have the material characteristic of being configured to transition between shapes at a preset threshold temperature).
Regarding claim 20, Harari discloses wherein the main body defines at least two elongated cutouts therein (Fig. 10C), the at least two tines being positioned within the respective at least two elongated cutouts when the at least two tines are in the stowed configuration (Figs. 11A-11D).
Claims 7 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Harari in view of Schluzas, as applied to claims 1 and 6 above, and further in view of Martins et al. (U.S. Patent No. 5356413; hereinafter “Martins”).
Regarding claim 7, the modified device discloses the invention substantially as claimed, except for the free second end being perpendicular to a longitudinal axis.
Martins, a reference in the tissue anchor field of endeavor, teaches configuring a free end (46) of tines (44) to be perpendicular to a longitudinal axis (15) defined by a main body (14) when the tines are in a deployed configuration (Figs. 3-4; col. 7, ln. 51 – col. 8, ln. 43) to maintain the tissue anchor in place during use (Figs. 6-7; col. 10, ll. 10-59).
It would have been obvious to a person having ordinary skill in the art at the time the invention was made to configure the tines such that the free second end is perpendicular to a longitudinal axis defined by the main body when the at least two tines are in the deployed configuration, in view of Martins, in order to securely hold the tissue anchor in place within a patient.
Regarding claim 9, the modified device discloses the invention substantially as claimed, except for the at least two tines including four tines.
Martins teaches providing four tines (44) positioned circumferentially spaced from one another about a main body (14; Fig. 4) to maintain the tissue anchor in place during use (Figs. 6-7; col. 10, ll. 10-59).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to configure the tissue anchor such that the at least two tines include four tines positioned circumferentially spaced from one another about the main body, in view of Martins, in order to provide more even pressure to tissue around the tissue anchor to securely hold the tissue anchor in place within a patient.
Response to Arguments
Applicant's arguments filed September 24, 2025 have been fully considered but they are not persuasive.
On pages 8-10 of the Response, Applicant argues that Harari does not disclose the distal-most edge geometry recited in independent claim 1. These arguments are not persuasive.
On page 8 of the Response, Applicant argues that cut out (920) of Harari is not a portion of “a continuous distal-most edge lying in a transverse plane” (Response pg. 8. This argument is not persuasive.
Claim 1 recites inter alia “the distal end portion terminates in a continuous distal-most edge that encircles the channel and lies in a plane transverse to the longitudinal axis.”
As can be seen in annotated Fig. 10A Harari below, the distal end portion of anchor (830) has a distal-most edge that is continuous and encircles the channel of the anchor. The distal-most edge includes edges forming cut out (920).
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Also, as can be seen in annotated Fig. 10C of Harari below, the forward facing surface (922) forms part of the distal-most edge and lies in a plane transverse to the longitudinal axis of anchor (830).
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Thus, the distal end portion of anchor (830) in Harari “terminates in a continuous distal-most edge that encircles the channel and lies in a plane transverse to the longitudinal axis,” as recited in claim 1.
Applicant’s arguments with respect to the newly recited feature of “the distal-most edge being sharp and including a first portion having a concave shape and an opposite second portion having a concave shape, the first and second portions converging along the distal-most edge to form respective first and second distal teeth that project axially beyond adjacent portions of the distal-most edge such that the distal end portion is configured to puncture tissue during distal insertion of the main body into the tissue,” as recited in claim 1 (Response pp. 9-10) has been considered but are moot because the new ground of rejection over Harari and Schluzas does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Specifically, Schluzas is relied upon for teaching a sharp distal-most edge with first and second concave shapes converging to form first and second distal teeth configured to puncture tissue.
For the reasons above, Examiner maintains that claim 1 is not allowable over the applied prior art.
As Applicant asserts that independent claim 17 has been amended to include similar recitations as those amended into claim 1 (Response p. 10) and does not present additional arguments as to the merits of claim 17, Examiner maintains that claim 17 is not allowable over the applied prior art for the same reasons as claim 1.
Conclusion
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 Jonathan A Hollm whose telephone number is (703)756-1514. The examiner can normally be reached Mon - Fri 8:30-5:30.
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/J.A.H/Jonathan HollmExaminer, Art Unit 3771
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771