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
This action is entered in response to Applicant's amendment and reply of 1/22/26. Claims 22-41 are pending. Claims 22 and 31 are amended. Claims 38-41 are withdrawn.
Response to Arguments
The amendments to claim 22 and 31 do not overcome the previous double patenting rejection. Therefore, the rejection has been maintained below.
Applicant’s arguments, filed 1/22/26 with respect to the rejections of claims 22-30 as being anticipated by Vijay (US2013/0267998) under 35 U.S.C. 102(a)(1) and 31-37 as being unpatentable over Vijay under 35 U.S.C. 103 have been fully considered and the amendment overcomes the previous rejection. However, a new grounds of rejection has been made in view of Vijay (US2013/0267998) as set forth in the rejection below.
Claim Objections
Claims 22 and 31 are objected to because of the following informalities:
Claim 22 has been improperly amended in the response. Claim 22 recites “a plurality of barbs extending continuously around the perimeter of the elongate member and extending outwardly from the elongate member, the barbs configured to engage an interior wall of the drilled bone hole to secure the suture anchor”. Should be changed to: “a plurality of barbs extending continuously around the perimeter of the elongate member and extending outwardly from the elongate member, the barbs configured to engage an interior wall of the drilled bone hole to secure the suture anchor
Claim 31 has been improperly amended in the response. Claim 31 recites “plurality of barbs for engaging the suture with the drilled bone hole and wherein the plurality of barbs extending continuously around the perimeter of the elongate member and extending outwardly from the elongate member; “. Should be changed to ““plurality of barbs for engaging the suture with the drilled bone hole and wherein the plurality of barbs extending continuously around the perimeter of the elongate member and extending outwardly from the elongate member;.
Appropriate correction is required.
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 22-28, 31-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-6, 10, 13, and 14 of U.S. Patent No. 11350924 in view of Vijay (US2013/0267998).
Claim 1 of the patent recites everything of claim 22 of the application except for the first opening extending helically along a length of the elongate member, the second opening extending helically along the length of the elongate member. Vijay teaches a suture anchor 10 that receives a suture ([0067]). Where the suture anchor comprises a stop surface 48 that forms an opening ([0078]). Where the opening is interpreted as extending helically under broadest reasonably interpretation by forming a curved portion that is a part of a helix (see Fig. 3A). It would have been obvious to one having ordinary skill in the art to have modified the first and second openings in the claims of the ‘924 patent to extend helically as taught by Vijay in order to compress the suture for suture locking and retention ([0078]).
Claim 13 of the patent recites everything of claim 31 of the application except for the first opening extending helically along a length of the elongate member, the second opening extending helically along the length of the elongate member. Vijay teaches a suture anchor 10 that receives a suture ([0067]). Where the suture anchor comprises a stop surface 48 that forms an opening ([0078]). Where the opening is interpreted as extending helically under broadest reasonably interpretation by forming a curved portion that is a part of a helix (see Fig. 3A). It would have been obvious to one having ordinary skill in the art to have modified the first and second openings in the claims of the ‘924 patent to extend helically as taught by Vijay in order to compress the suture for suture locking and retention ([0078]).
17832420 claims
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11350924 claims
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17832420 claims
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11350924 claims
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Claim Rejections - 35 USC § 103
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.
Claims 22-37 are rejected under 35 U.S.C. 103 as being unpatentable over Vijay (US2013/0267998).
Regarding claim 22, Vijay discloses a suture anchor (10), comprising:
an elongate member (body of 16, see Fig. 1B) for implantation into a drilled bone hole (inserted into bone, where the portion of bone may be drilled, [0110]);
a distal eyelet (50) for receiving a suture (suture as described in [0067]);
a first opening (opening at the end of the slot 76, see annotated Fig. 5C) along a first channel (slots 76 of bone locking structure 14, see Fig. 5A, [0092]; the first opening is along the slot 76 by the slot 76 extending to the first opening) extending helically on the elongate member (the first channel is interpreted as extending helically on the elongate member by extending along the outside of the locking structure 14, see annotated Fig. 5C; the term helically is given its broadest reasonable interpretation as having any shape from the form of a helix, the curved portion of the first channel along the length of the locking structure as shown in annotated Fig. 5C below is interpreted as part of a helix);
a second opening (opening at the opposite side of the first opening as shown in annotated Fig. 5C) disposed adjacent to a distal end and aligned with a second channel (slots 76 of bone locking structure 14, see Fig. 5A, [0092]; slot 76 is aligned with the second opening by extending to the second opening) extending helically along the length of the elongate member (the second channel is interpreted as extending helically along a length of the elongate member by extending along the outside of the locking structure 14, see annotated Fig. 5C; the term helically is given its broadest reasonable interpretation as having any shape from the form of a helix, the curved portion of the second channel along the length of the locking structure as shown in annotated Fig. 5C below is interpreted as part of a helix);
a barb (barb defined by the top portion of structure 14 that extends circumferentially and does not have the slot 76 cut into it, see circumferential barb as shown in annotated Fig. 5A) extending continuously around the perimeter of the elongate member and extending outwardly from the elongate member (see Fig. 5A), the barbs configured to engage an interior wall of the drilled bone hole to secure the suture anchor ([0093]);
wherein a proximal end of the elongate member (proximal end of 16 on opposite side eyelet 50) engages the plurality of barbs with the drilled bone hole (proximal end 16 is expanded out by sleeve 12, [0068], therefore pushes the barbs 80 outward) and wherein a proximal aspect (end of wing 72, see Fig. 5A) allows for rotation of the elongate member within the drilled bone hole (the wing 72 is capable of allowing for rotating of the elongate member when grabbed and rotated by a tool).
Vijay does not explicitly disclose a plurality of barbs extending continuously around the perimeter of the elongate member and extending outwardly from the elongate member. Instead, Vijay discloses a single barb that extends continuously around the perimeter of the elongate member (see Fig. 5A). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the elongate member have a plurality of barbs, for the purpose engaging with more area of the bone, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
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Regarding claim 23, Vijay makes obvious the suture anchor of claim 22, wherein the distal eyelet comprises a first opening (50 corresponding with the largest slot 76 of 14) and a second opening (50 corresponding with the slot opposite the largest slot 76 of 14) on opposite sides of the elongate member (see Fig. 1A).
Regarding claim 24, Vijay makes obvious the suture anchor of claim 23, wherein the first channel (side slot 76 of 14, see Fig. 5C) and a second channel (slot opposite the side slot 76 of 14, see Fig. 5A and 5C) extending along opposite sides of the elongate member (see Fig. 5A and 5D).
Regarding claim 25, Vijay makes obvious the suture anchor of claim 24, wherein the first opening (50 corresponding with the largest slot 76 of 14) is oriented with respect to the first channel to enable applying tension to the suture after the suture anchor has been inserted into the bone hole ([0068], [0075]; tension applied to the suture at least by the components 12 and 14).
Regarding claim 26, Vijay makes obvious the suture anchor of claim 24, wherein the second opening (50 corresponding with the slot opposite the largest slot 76 of 14) is configured to enable placing the suture into a final position with respect to the plurality of barbs after implantation of the suture anchor into the bone hole ([0075]).
Regarding claim 27, Vijay makes obvious the suture anchor of claim 22, wherein the first and second channels include a beveled surface (the cut to form the slots 72 are interpreted as beveled, see Fig. 5A).
Regarding claim 28, Vijay makes obvious the suture anchor of claim 27, wherein the distal eyelet and the plurality of barbs cooperate to compress the portions of the suture between the plurality of barbs and the bone hole after rotation of the elongate member (the anchor is capable of being rotated before expansion of the wings by the sleeve 12 being pushed into the wing component 14, [0087]).
Regarding claim 29, Vijay makes obvious the suture anchor of claim 28, wherein the plurality of barbs are configured to engage with an inner wall of the bone hole upon turning of the suture anchor through a predetermined angle (the anchor is capable of being rotated counter-clockwise some angle interpreted as the predetermined angle before expansion of the wing component 14, [0087]).
Regarding claim 30, Vijay makes obvious the suture anchor of claim 29, wherein the predetermined angle comprises an angle of substantially 90 degrees clockwise with respect to the proximal end (the rotation would be capable of an angle of substantially 90 degrees before expansion of the wing component 14, [0087]).
Regarding claim 31, Vijay discloses a suture anchor (10), comprising:
an elongate member (16) for implantation into a drilled bone hole (see Fig. 9; [0006]; otherwise end section 45 will create a bone hole);
a distal eyelet (50) for receiving a suture (sutures, [0064]);
a first opening (opening at the end of the slot 76, see annotated Fig. 5C from the rejection of claim 22) along a first channel (slots 76 of bone locking structure 14, see Fig. 5A, [0092]; the opening is along the slots 76 by the slot 76 extending to the first opening) extending helically on the elongate member (the first channel is interpreted as extending helically on the elongate member by extending along the outside of the locking structure 14, see annotated Fig. 5C; the term helically is given its broadest reasonable interpretation as having any shape from the form of a helix, the curved portion of the first channel along the length of the locking structure as shown in annotated Fig. 5C in the rejection above is interpreted as part of a helix);
a second opening (opening at the opposite side of the first opening as shown in annotated Fig. 5C from the rejection of claim 22) disposed adjacent to a distal end and aligned with a second channel (slots 76 of bone locking structure 14, see Fig. 5A, [0092]; slot 76 is aligned with the second opening by extending to the second opening) extending helically along the length of the elongate member (the second channel is interpreted as extending helically along a length of the elongate member by extending along the outside of the locking structure 14, see annotated Fig. 5C; the term helically is given its broadest reasonable interpretation as having any shape from the form of a helix, the curved portion of the second channel along the length of the locking structure as shown in annotated Fig. 5C in the rejection above is interpreted as part of a helix);
a barb (barb defined by the top portion of structure 14 that extends circumferentially and does not have the slot 76 cut into it, see circumferential barb as shown in annotated Fig. 5A from the rejection of claim 22) for engaging the suture with the drilled bone hole ([0093]) and wherein the barb extends continuously around the perimeter of the elongate member and extending outwardly from the elongate member (see Fig. 5A);
a proximal end of the elongate member (proximal end of 16 on opposite side eyelet 50) for engaging the plurality of barbs with the drilled bone hole (proximal end 16 is expanded out by sleeve 12, [0068], therefore pushes the barbs 80 outward).
a beveled surface (the cut to form the slots 72 are interpreted as beveled, see Fig. 5A) extending along edges of the first and second channels to facilitate gradual compression of the suture during rotation of the suture anchor (the edges formed by the slots 72 would be capable of gradual compression during insertion of the sleeve 12 into the wing component 14, [0087]).
Vijay does not explicitly disclose a plurality of barbs extending continuously around the perimeter of the elongate member and extending outwardly from the elongate member. Instead, Vijay discloses a single barb that extends continuously around the perimeter of the elongate member (see Fig. 5A). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the elongate member have a plurality of barbs, for the purpose engaging with more area of the bone, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Vijay according to another embodiment teaches a bone anchor with suture channels and barbs, wherein (see [0099] and Figure 7) a depth line (112) is disposed on the elongate member (132) to indicate a proximal end of the first channel and the second channel (gaps 76) (see [0099]-[0104] and Figure 7) the depth line (112) indicates a depth within the bone hole (hole in 100) to which the elongate member (132) may be inserted that allows for final tensioning of the suture (20, 22, 28, or 29; initial tightening to bring the tendon toward the anchor see [0099], final tensioning with the tri-lock-see [0104]), the depth line (112) on the elongate member (132 or 16) to indicate a proximal end of the first channel (largest slot 76 of 14) and the second channel (slot opposite the largest slot 76 of 14), such that the depth line indicates a depth within the bone hole to which the elongate member may be inserted that allows for final tensioning of the suture (20, 22, 28, or 29; final tensioning is the tri-lock method of [0104]).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date to modify Vijay’s bone anchor with a depth line, as further taught by Vijay, in order to identify the proper bone anchor insertion depth (to avoid over and under inserting).
Regarding claim 32, Vijay makes obvious the suture anchor of claim 31, Vijay further teaches wherein the depth line is configured to indicate a proximal end of the first and second channels (indicator 112 indicates a proximal end of one or more channels by the indicating a depth within the bone hole to which the elongate member may be inserted, the indicator indicates the wings 164 have been inserted at the correct depth, [0099]; the wings defines the channels)
Regarding claim 33, Vijay makes obvious the suture anchor of claim 32, Vijay teaches wherein the depth line indicates a depth to which the elongate member may be inserted into the drilled bone hole that allows for final tensioning of the suture (20, 22, 28, or 29; final tensioning is the tri-lock method of [0104]).
Regarding claim 34, Vijay makes obvious the suture anchor of claim 31, Vijay further teaches wherein the one or more channels extend from the distal eyelet to the depth line (see Fig. 7, [0099]).
Regarding claim 35, Vijay makes obvious the suture anchor of claim 34, Vijay teaches wherein the plurality of barbs comprise one or more circular barbs disposed proximal of the one or more channels (circular barbs are described in [0094] and extend to the proximal end of the channels, see Fig. 1A).
Regarding claim 36, Vijay makes obvious the suture anchor of claim 35, wherein the one or more circular barbs extend continuously around a circumference of the elongate member (see Fig. 1A, [0094]).
Regarding claim 37, Vijay makes obvious the suture anchor of claim 36, Vijay teaches wherein the one or more circular barbs are configured to fixate the suture between the suture anchor and an interior wall of the drilled bone hole (see Fig. 1A, [0094]).
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 MIKAIL A MANNAN whose telephone number is (571)270-1879. The examiner can normally be reached M-F 10-6.
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/M.A.M/Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
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