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 .
Response to Amendment
The claims filed on May 12th, 2026, have been entered. Claims 1-15 and 20-21 remain pending in the Application. Claim 21 has been added by the Applicant.
Response to Arguments
Applicant’s arguments, see Remarks, filed May 12th, 2026, with respect to claims 1-8 and 21 have been fully considered and are persuasive. The 102(a)(1) and 103 rejections of claims 1-8 and 21 have been withdrawn.
The rejection of claims 9-15 and 20 under 102(a)(1) and 103 over Housman (Pub. No. 2019/0125332) has been withdrawn in light of Applicant’s amendment made May 12th, 2026; specifically, Housman does not teach the tubular connecting portion forming flush outer and inner surfaces.
Applicant’s arguments with respect to claim(s) 9-15 and 20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Objections
Claim 9 is objected to because of the following informalities: in lines 9-10 of claim 9, “a tubular connecting having” appears to be a typo from an amendment and should read “a tubular connecting portion having”. Appropriate correction is required.
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 13 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 13 recites the limitation "the shared inner diameter" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim. The amendment to claim 9 removed the introduction of the shared inner diameter, and the shared inner diameter was not introduced previously. For the purposes of examination, the claim shall be read as “a shared inner diameter.”
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 9-11 and 13-14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rogers et al. (Pub. No. 2021/0128137).
Regarding claim 9, Rogers et al. discloses suture anchor system (100; FIG. 1A-1B; [0026]) comprising: an anchor body (102) for anchoring within a target tissue, the anchor body comprising a proximal connecting portion (120); and an insertion instrument (132) for inserting the anchor body within the target tissue, the insertion instrument having an instrument connecting portion (138) at a distal end of an insertion instrument sleeve (body of 132); wherein the anchor body connecting portion and the insertion instrument connecting portion are configured to assemble to each other such that they interdigitate to define an axially coextensive length forming a tubular connecting portion (FIG. 1B: 120 and 132 come together and interdigitate to form a singular outer and inner surface) having an outer surface (FIG. 1B: outside of 120 and 132) and an inner-lumen surface (FIG. 1A: 108 and 132; [0026]), wherein the outer surface is collectively formed by a flush engagement between an outer surface of the anchor body connecting portion and an outer surface of the instrument connecting portion, thereby defining a shared, substantially uniform outer diameter for the tubular connecting portion (FIG. 1B: the flush engagement of 120 and 132 creates a single outer surface).
Regarding claim 10, Rogers et al. further discloses a plug (140) configured to move axially along a cannulation of the anchor body ([0027] 140 is configured to move axially within 122) and knotlessly lock a suture with the anchor body ([0024] the plug allows for the suture to be captured by pressing the suture within the anchor body eyelet), and wherein when the suture is knotlessly locked, the plug is disengaged from the insertion instrument (FIGs. 1A-1B: when 140 is as far distally as possible to be within 128, 140 is disengaged from the threads of 132).
Regarding claim 11, Rogers et al. further discloses the plug is configured to rotate while moving axially along the cannulation (FIGs. 1A-1B: when 140 moves distally within 128, 140 can rotate within 128) and wherein the tubular connecting portion is configured to inhibit the anchor body from rotating while rotating the plug (FIG. 1A: 132 allows 140 to rotate independently of 128).
Regarding claim 13, Rogers et al. further discloses the instrument connecting portion includes internal threads (139) configured to threadingly engage threads of the plug (142) and the anchor body proximal connecting portion is absent threads ([0027] 120 does not have threads), so that the shared inner diameter of the tubular connecting portion includes a segment that is threaded (139) and a segment that is absent threads (120).
Regarding claim 14, Rogers et al. further discloses the anchor body proximal connecting portion defines a first circumferential segment length of the tubular connecting portion (FIG. 1A: the length of 120 from proximal tip to 128) and the instrument connecting portion defines a second circumferential segment length of the tubular connecting portion (FIG. 1A: the length of 134) and wherein the first circumferential segment length is greater than the second circumferential segment length (FIG. 1A: since 134 fits into the space around 120 and 120 includes the portion going to 128, 120 is longer than 134).
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.
Claim(s) 12, 15, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rogers et al.
Regarding claim 12, Rogers et al. discloses the invention as disclosed in claim 9, as discussed above, and further discloses the anchor body proximal connecting portion defines an annular projection (FIG. 1A: the body of 120). Rogers et al. does not disclose the annular projection has two annular slots therethrough and the insertion instrument connecting portion includes two annular tabbed projections circumferentially spaced from each other, the two annular tabbed projections configured to be received by, one each, the two annular slots to define the tubular connecting portion.
Rogers et al. teaches a second embodiment (300; FIGs. 3A-4; [0032]), where the anchor body proximal portion defines four annular projections (320) defining four annular slots (FIG. 3A: spaces between 320) therethrough and the insertion instrument connecting portion includes four annular tabbed projections (334) circumferentially spaced from each other (FIG. 3A), the four annular tabbed projections configured to be received by, one each, the two annular slots to define the tubular connecting portion (FIG. 3A: 320 fit into 334), for the purpose of better securing the anchor relative to the insertion instrument.
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the first embodiment of Rogers to have multiple annular slots and multiple annular tabbed projections, as taught by the second embodiment of Rogers et al., for the purpose of better securing the anchor relative to the insertion instrument.
Regarding claim 15, Rogers et al. further discloses the anchor body comprises an eyelet (128) through the anchor body, having an entrance aperture (FIG. 1A: visible side of 128) and an exit aperture (FIG. 1A: the other side of 128) for receiving a suture therethrough ([0024] the suture goes through the eyelet 128), and wherein the exit and entrance apertures are circumferentially offset from the two annular slots of the anchor body connecting portion (FIG. 1A: 128 is circumferentially parallel to 120, which, in light of the modification above, places the two 128 as circumferentially offset to the slots which fit into the spaces between 120).
Regarding claim 20, Rogers et al. discloses a suture anchor system (100) comprising:
an anchor body (102) for anchoring within a target tissue, the anchor body having a first projection (120) that extends proximally from a proximal end of the anchor body (FIG. 1A), the first projection having an axial length (FIG. 1A) and an inner lumen (122), the inner lumen interrupted, to define a first annular gap (FIG. 1A: the space circumferentially around 102 that is not filled by 120), the first annular gap extending along an entire length of the axial length (FIG. 1A); and
an insertion instrument (132) for inserting the anchor body into the target tissue, the insertion instrument having a first tab (FIG. 1A: the circumferential body of 132 except for the space 134), and wherein the first tab extends distally from a distal end of the insertion instrument (FIG. 1A);
wherein the anchor body first annular gap is configured to receive the first tab to form a tubular connecting portion (FIG. 1B), the tubular connecting portion having an outer surface collectively formed by an outer diameter surface of the first projection and an outer diameter surface of the first tab (FIG. 1B: 132 and 102 form an outer surface), such that the outer diameter surface of the first tab is substantially flush with the outer diameter surface of the projection to define a shared, substantially uniform outer diameter (FIG. 1B: 102 is flush with 132 to form a single uniform outer diameter).
The first embodiment of Rogers et al. does not disclose the anchor body having a second projection, defining with the first projection a second annular gap, and the insertion instrument having a second tab circumferentially spaced from the first tab by an annular gap.
Rogers et al. teaches a second embodiment (300; FIGs. 3A-4; [0032]), where the anchor body proximal portion defines four annular projections (320) defining four annular slots (FIG. 3A: spaces between 320) therethrough and the insertion instrument connecting portion includes four annular tabbed projections (334) circumferentially spaced from each other (FIG. 3A), the four annular tabbed projections configured to be received by, one each, the two annular slots to define the tubular connecting portion (FIG. 3A: 320 fit into 334), for the purpose of better securing the anchor relative to the insertion instrument.
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the first embodiment of Rogers to have multiple annular slots and multiple annular tabbed projections, as taught by the second embodiment of Rogers et al., for the purpose of better securing the anchor relative to the insertion instrument. This modification would maintain the shared and substantially uniform outer diameter of the tubular connecting portion made of the outer diameter of the projections (120) and the outer diameter of the tabs (FIGs. 1A and 3A: the portions of the insertion instrument sleeve body which are between the openings 134).
Allowable Subject Matter
Claims 1-8 and 21 are allowed.
The following is an examiner’s statement of reasons for allowance:
Regarding claim 1, the prior art does not disclose, in combination with the remaining claim limitations, that the annular projection has an annular slot extending through an entire thickness of the radial thickness of the annular projection and where the external surface is collectively formed by the annular projection and the annular tab to define a shared outer diameter, and the inner lumen surface is collectively formed by the annular projection and the annular tab to define a shared inner diameter.
The closest prior art reference, Housman (Pub. No. 2019/0125332), does not disclose the external surface is collectively formed by the annular projection and the annular tab to define a shared outer diameter, and the inner lumen surface is collectively formed by the annular projection and the annular tab to define a shared inner diameter. The annular projection 612 with the annular slot 620 comes together with the annular tab 304, as shown in FIGs. 6-5 to 7-2, but they do not form a shared outer diameter and a shared inner diameter, and modifying Housman to change the relationship would frustrate the intended use of the invention due to the spring element 108 which is held in place by 304 and 612.
Another close prior art reference, Rogers et al. (Pub. No. 2021/0128137), does not disclose the annular projection has an annular slot extending through an entire thickness of the radial thickness of the annular projection. As shown in FIG. 3A, the tabs 320 on the external sides of the proximal end of anchor 302 form corresponding slots between them which can fit with the annular projection 334, but the slots do not extend entirely through the annular projection, as the surface 301 of the anchor 302 forms the lumen 322.
A third close prior art reference, Dacosta et al. (Pub. No. 2019/0336270), does not disclose the eyelet for the suture. As shown in FIG. 5, the suture is contained with 144, which does not extend through the anchor body nor does the cavity extend from the eyelet, as they are separated from each other. Modifying the anchor body to have an eyelet as claimed would frustrate the intended use of the device for being able to intercept the suture rather than thread through an eyelet.
Claims 2-8 and 21 are allowable for their dependence on claim 1.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
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 JAMES RYAN MCGINNITY whose telephone number is (571)272-0573. The examiner can normally be reached M-Th 8 am-5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JRM/Examiner, Art Unit 3771
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771
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