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 Arguments
Applicant’s arguments, filed 07/10/2026, with respect to the rejection of claim 13 under Vijay have been considered but are moot as the arguments are directed to Applicant’s amendments, and the previous rejection of the claims has been withdrawn in light of said amendments. Specifically, the rejection was withdrawn because Vijay does not teach wherein the connector hole is threaded. It is noted that a new rejection has been made over Vijay in view of Dipoto. The teachings of Dipoto are relied upon for teaching the newly added limitations as discussed above.
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) 25-27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vijay et al. (US 20130267998) [hereinafter Vijay].
Regarding claim 25, Vijay discloses an asymmetrical anchor (Figs. 5B-C, para. 0085) having a distal end, a proximal end and a first plane extending from the distal end to the proximal end (see annotated Fig. 5B of Vijay below), the asymmetrical anchor comprising:
a connector hole (aperture 75) (para. 0090: “The bone anchor structure is also shown having a base and distal aperture 75”) formed on a proximal face of the distal end (see Figs. 5C-D) that is fully circumscribed on a first side of the first plane (see annotated Fig. 5D below), a central axis of the connector hole (aperture 75) extending along a central longitudinal axis of the asymmetrical anchor (see Figs. 5A and 5D);
a proximal anchor body portion (interpreted as portion comprising wings 72) extending proximally from the distal end (Figs. 5A-B, para. 0085), the proximal anchor body portion 72 having a concave surface and an opposed convex bone engaging surface (see annotated Figs. 5A and 5D below), wherein a volume of the proximal anchor body portion (portion with wings 72) is only enclosed on the first side of the first plane by the concave surface such that the connector hole (aperture 75) is accessible from a second side of the first plane (Fig. 5D, see annotated Fig. 5B below); and
one or more teeth (barbs 80) provided on the convex bone engaging surface configured to resist proximal movement of the asymmetrical anchor when the asymmetrical anchor has been inserted in a hole with a diameter equal to or less than a maximum diameter of the asymmetrical anchor (Figs. 5B, 7-8, para. 0093, 0101).
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Annotated Fig. 5B of Vijay
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Annotated Fig. 5A of Vijay
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Annotated Fig. 5D of Vijay
Regarding claim 26, Vijay discloses wherein the connector hole is configured to receive a distal end of a shaft of an inserter therein to couple the asymmetrical anchor to the inserter (see note below).
Note: “wherein the connector hole is configured to receive a distal end of a shaft of an inserter therein to couple the asymmetrical anchor to the inserter” is interpreted as functional language and intended use of the connector hole. Therefore, “a distal end of a shaft of an inserter” is not positively claimed and is interpreted as a functional component that the claimed connector hole is capable of receiving. Since Vijay discloses the structural component i.e. the connector hole to perform the functional limitation, the reference thereby discloses the functional limitation of the connector hole being capable of receiving the distal end of the shaft of the inserter. The examiner notes that a recitation of the intended use of the claimed invention and/or functionality of the claimed invention the must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 27, Vijay discloses wherein a size of the connector hole 75 remains substantially unchanged throughout receipt of the distal end of the shaft of the inserter (para. 0091 of Vijay: “The distal end opening 75 remains constant”).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 28 is rejected under 35 U.S.C. 103 as being unpatentable over Vijay et al. (US 20130267998) [hereinafter Vijay], as applied to claim 25 above, and further in view of DiPoto et al. (US 5957953) [hereinafter DiPoto].
Regarding claim 28, Vijay further discloses that the connector hole (aperture 75) cooperates with a plug component 16 such that the connector hole 75 is “held fixed and against stop surface 48 of the plug component 16 so that further axial movement of the wings is prohibited as the sleeve is urged into cavity 73” in para. 0090. However, Vijay is silent regarding that the connector hole is threaded.
DiPoto in the same field of endeavor of expandable suture anchors teaches that it is known in the art for a connector hole (interpreted as hole defined by bore 16) of an anchor body 20 to comprise threads 18 to mate with threads 28 of an inner member 14 (Fig. 1, col. 4 lines 62-65: “Inner member 14 (FIGS. 1 and 1C) includes a threaded distal section 28 with a blunt distal tip 28a which passes through bore 16 and engages threads 18 in outer member body 20”) for the purpose of fixing the anchor body to the inner member (col. 6 lines 41-43: “the threaded engagement with outer member 12, help retain inner member 14 in its inserted position and avoid inner member 14 "backing out" of outer member 12”).
In light of this teaching, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the connector hole and the plug component in Vijay to include the threads, as taught by Dipoto in order to not only secure the anchor body to plug component together, but to allow better control of expansion of the anchor body (col. 1 line 67 and col. 2 lines 1-4: “The threaded engagement between the inner and outer members allows the amount of expansion to be continuously adjusted according to the amount by which the inner member is rotated into the outer member”).
Claim(s) 13 and 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over Vijay et al. (US 20130267998) [hereinafter Vijay] in view of DiPoto et al. (US 5957953) [hereinafter DiPoto].
Regarding claim 13, Vijay discloses an asymmetrical anchor (Figs. 5B-C, para. 0085) having a distal end, a proximal end and a first plane extending from the distal end to the proximal end (see annotated Fig. 5B of Vijay below), the asymmetrical anchor comprising:
a connector hole (aperture 75) (para. 0090: “The bone anchor structure is also shown having a base and distal aperture 75”) formed on a proximal face of the distal end (see Figs. 5C-D) and provided entirely on a first side of the first plane (see annotated Fig. 5D below), a central axis of the connector hole (aperture 75) extending along a central longitudinal axis of the asymmetrical anchor (see Figs. 5A and 5D);
a proximal anchor body portion (interpreted as portion comprising wings 72) extending proximally from the distal end (Figs. 5A-B, para. 0085), the proximal anchor body portion 72 having a concave surface and an opposed convex bone engaging surface (see annotated Figs. 5A and 5D below), wherein a volume of the proximal anchor body portion (portion with wings 72) is only enclosed on the first side of the first plane by the concave surface such that the connector hole (aperture 75) is accessible from a second side of the first plane (Fig. 5D, see annotated Fig. 5B below); and
one or more teeth (barbs 80) provided on the convex bone engaging surface configured to resist proximal movement of the asymmetrical anchor when the asymmetrical anchor has been inserted in a hole with a diameter equal to or less than a maximum diameter of the asymmetrical anchor (Figs. 5B, 7-8, para. 0093, 0101).
Vijay further discloses that the connector hole (aperture 75) cooperates with a plug component 16 such that the connector hole 75 is “held fixed and against stop surface 48 of the plug component 16 so that further axial movement of the wings is prohibited as the sleeve is urged into cavity 73” in para. 0090. However, Vijay fails is silent regarding that the connector hole is threaded.
DiPoto in the same field of endeavor of expandable suture anchors teaches that it is known in the art for a connector hole (interpreted as hole defined by bore 16) of an anchor body 20 to comprise threads 18 to mate with threads 28 of an inner member 14 (Fig. 1, col. 4 lines 62-65: “Inner member 14 (FIGS. 1 and 1C) includes a threaded distal section 28 with a blunt distal tip 28a which passes through bore 16 and engages threads 18 in outer member body 20”) for the purpose of fixing the anchor body to the inner member (col. 6 lines 41-43: “the threaded engagement with outer member 12, help retain inner member 14 in its inserted position and avoid inner member 14 "backing out" of outer member 12”).
In light of this teaching, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the connector hole and the plug component in Vijay to include the threads, as taught by Dipoto in order to not only secure the anchor body to plug component together, but to allow better control of expansion of the anchor body (col. 1 line 67 and col. 2 lines 1-4: “The threaded engagement between the inner and outer members allows the amount of expansion to be continuously adjusted according to the amount by which the inner member is rotated into the outer member”).
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Annotated Fig. 5B of Vijay
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Annotated Fig. 5A of Vijay
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Annotated Fig. 5D of Vijay
Regarding claim 22, as discussed above, the combination of Vijay and DiPoto makes obvious the device of claim 13. Additionally, Vijay discloses wherein the central axis of the connector hole (aperture 75) extends along the central longitudinal axis of the asymmetrical anchor in a second plane that extends from the proximal end to the distal end and is orthogonal to the first plane (see annotated Fig. 5D [1] of Vijay below).
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Annotated Fig. 5D of Vijay
Regarding claim 23, as discussed above, the combination of Vijay and DiPoto makes obvious the device of claim 13. Additionally, Vijay discloses wherein the connector hole is configured to receive a distal end of a shaft of an inserter therein to couple the asymmetrical anchor to the inserter (see note below).
Note: “wherein the connector hole is configured to receive a distal end of a shaft of an inserter therein to couple the asymmetrical anchor to the inserter” is interpreted as functional language and intended use of the connector hole. Therefore, “a distal end of a shaft of an inserter” is not positively claimed and is interpreted as a functional component that the claimed connector hole is capable of receiving. Since modified Vijay discloses the structural component i.e. the connector hole to perform the functional limitation, the reference thereby discloses the functional limitation of the connector hole being capable of receiving the distal end of the shaft of the inserter. The examiner notes that a recitation of the intended use of the claimed invention and/or functionality of the claimed invention the must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 24, as discussed above, the combination of Vijay and DiPoto makes obvious the device of claim 13. Additionally, Vijay discloses wherein a size of the connector hole 75 remains substantially unchanged throughout receipt of the distal end of the shaft of the inserter (para. 0091 of Vijay: “The distal end opening 75 remains constant”).
Allowable Subject Matter
Claims 1, 5, and 7-12 are allowed.
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 LAUREN DUBOSE whose telephone number is (571)272-8792. The examiner can normally be reached Monday-Friday 7:30am-5:30 pm.
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 on 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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/LAUREN DUBOSE/Examiner, Art Unit 3771
/Andrew Restaino/Primary Examiner, Art Unit 3771
