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 Office action is in response to the amendment filed January 1, 2026. Claim 11 is amended. Claims 1-10 and 13 are canceled. Claims 16-17 are newly added. Claims 11-12 and 14-17 are pending and addressed below.
Response to Arguments
Applicant’s amendments to claim 11 have overcome the each and every claim objection previously set forth in the Non-Final Office Action mailed July 10, 2025.
Applicant's arguments filed January 12, 2026 have been fully considered but they are not persuasive. In response to applicant's argument that the teaching reference of Saliman (US 20110190815) does not teach first ends of the suture and suture grabber extending though an opening in the distal end and second ends that extend through and out of the proximal end, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). One having skill in the art would recognize the teachings of Saliman of using a retractable suture grabber to pull a suture around tissue and through the anchor body to attach the anchor to tissue would not require a change of the path of the suture extending through the proximal and distal ends of the anchor of Heaven (US 20110112550). Further, using a suture and suture grabber with the anchor of Heaven would require the suture and suture grabber to extend through the proximal and distal ends of the anchor. For clarity, below is an exemplary embodiment of how Examiner interprets Heaven would work in view of the teachings of Saliman.
PNG
media_image1.png
445
700
media_image1.png
Greyscale
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 11-12 and 14-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heaven et. al. (U.S. Pub. No. 2011/0112550) hereinafter, “Heaven,” in view of Saliman (U.S. Pub. No. 2011/0190815), in and further view of Glazer et. al. (U.S. Pub. No. 2008/0183220) hereinafter, “Glazer.”
Regarding claim 1, Heaven teaches a method of securing soft tissue to a bone anchor comprising:
inserting the bone anchor (100b; Fig. 1G) into a patient, wherein the bone anchor (100b) comprises:
an expandable anchor body (200; Fig. 1G) comprising:
a plurality of first tines (220; Fig. 1G) defined by a first expansion slot (see the space between first tines (220)) extending from a distal end (215; Fig. 1G) of the anchor body (200) toward a proximal end (218; Fig. 1G) of the anchor body (200), each of the first tines (220) being configured to extend outward to a greater extent at its distal portion than at its proximal portion (see Fig. 1H showing the distal portion of first tines (220) expanded); and
an expander (300b; Fig. 1G) comprising:
at least one expansion portion (310; Fig. 3D); and
a first opening (305a; Fig. 3F) in a distal end (317; Fig. 3F) of the expander (300b);
wherein the expander (300b) is displaceable between a first position (see Fig. 1G) relative to the anchor body (200) and a second position (see Fig. 1H) relative to the anchor body (200), wherein the expansion portion (310) is configured to expand the first tines (220) of the anchor body (200) when the expander (300b) is in the second position (Fig. 1H); and
a second opening (305b; Fig. 3F) in the distal end of the expander (300b) having a first end of a suture (390; Fig. 3F) extending therethrough, and a second end of the suture (390) extending through and out of a proximal end of the expandable anchor body (218, see Fig. 1G).
However, Heaven does not explicitly teach the anchor body with a plurality of second tines as claimed.
Glazer teaches a suture anchor (100; Fig. 1) comprising a plurality of first tines (110; Fig. 1) and second tines (112; Fig. 1) defined by a second expansion slot (114a; Fig. 2) extending from the proximal end of the anchor body (100) toward the distal end of the anchor body (100), each of the second tines (112) being configured to extend outward to a greater extent at its proximal portion than at its distal portion (see Fig. 9 showing arrows demonstrating the expansion of the second tines (112)); and
an expander (126; Fig. 6) with an expansion portion (screw threads; see Fig. 6) wherein the expansion portion (screw threads) is configured to expand the second tines (112) of the anchor body (100) when the expander (126) is in the second position (see Fig. 9 showing the expander in a second position expanding the first and second tines).
Glazer is considered to be analogous to the claimed invention because it is in the same field of suture anchors. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the anchor body of Heaven to incorporate the teachings of Glazer by providing a second plurality of tines with a second expansion slot on the opposite side of the anchor body with respect to the first tines and first expansion slots with an expander capable of expanding both tines when moved from a first position to a second position. Doing so would increase the anchoring strength of the bone anchor in defective bone tissue or compromised bores, as recognized by Glazer (pp. [0008]).
Further, Heaven does not explicitly disclose a retractable suture grabber extending through the first opening. Heaven does teach the suture maybe pulled through the first opening of the expander to form a loop without explaining how the suture is grabbed and pulled (pp. [0097]).
Saliman teaches a suture anchor (202; Fig. 2A) with a first (208; Fig. 2A) and a second (210; Fig. 2A) opening with a suture (103; Fig. 1A) extending from one hole and a retractable suture grabber (105 & 107; Fig. 1A) extending through the other hole (pp. [0049]).
Saliman is considered to be analogous to the claimed invention because it is in the same field of suture anchors. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Heaven to incorporate the teachings of Saliman by providing a suture puller through the first opening of the expander in Heaven to pull the suture through the expander and form a loop. Doing so would secure a tendon or ligament to the suture anchor without the need to tie a knot in the suture, which would lead to less rubbing against tissue, as recognized by Saliman (pp. [0006]).
Further, one having skill in the art would understand that to incorporate the suture puller of Saliman into Heaven the second end of the suture grabber extend through and out of the proximal end of the expandable anchor body in order to pull the suture through the anchor body as seen in (Fig. 1G).
Finally, Heaven does not explicitly disclose extending one end of the suture around a tendon.
Saliman further teaches extending one end of a suture (103; Fig. 1) around tissue to engage with the suture grabber (see Fig. 14A).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the attachment method of Heaven to incorporate the teachings of Saliman by passing the suture around tissue in order to grasp and pull a suture around that same tissue with a suture grabber. Doing so would be obvious to try as a practitioner is limited to a finite number of predictable solutions for attaching a bone anchor to tissue using a suture and suture grabber with a reasonable expectation of success: either extending a suture around tissue and engaging it with a suture grabber, or extending a suture grabber around tissue and engaging it with a suture.
Regarding claim 12, modified Heaven further teaches when seen along a direction perpendicular to an axial direction of the anchor body (200), an axial position of a proximal end portion of the first expansion slot (the space between first tines) matches an axial position of a distal end portion of the second expansion slot (see e.g., annotated Fig. 2 of Glazer below showing the orientation of the first and second expansion slots of modified Heaven).
PNG
media_image2.png
467
586
media_image2.png
Greyscale
Regarding claim 14, Heaven further teaches the suture (390; Fig. 3F) extends through the expander (300b) and out of a proximal end (307; Fig. 3F) of the expander (300b).
Regarding claim 15, Heaven further teaches the first opening (350a) is offset from an axis of the expander (300b; see annotated Fig. 3F below).
PNG
media_image3.png
573
719
media_image3.png
Greyscale
Regarding claim 16, Saliman further teaches the first end of the retractable suture grabber (105; Fig. 1A) comprises a closed wire loop (see Fig. 1A).
Regarding claim 17, modified Heaven further teaches the first end of the retractable suture grabber (e.g., 107 in Fig. 1A of Sailman) is configured to retract proximally with respect to the expandable anchor body (200, Fig. 1G of Heaven) upon a pulling force on the second end of the retractable suture grabber (e.g., 105 in Fig. 1A of Sailman)(it is noted, one having skill in the art would recognize the suture grabber taught by Sailman would be pulled proximally through the anchor body of Heaven in order to pull the suture through the expander to form a loop as seen in Fig. 1G).
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.
Claim 11 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 12 of U.S. Patent No. 10,149,751 in view of Glazer, in view of Heaven, and further in view of Schmieding,.
Regarding claim 11, claim 12 of ‘751 claims a bone anchor comprising an expandable anchor body and an expander with a first and second opening, a suture, and a retractable suture grabber and method of implant comprising passing the suture around a tendon (recited as “soft tissue”) as claimed but does not claim the anchor body comprising a plurality of first and second tines defined by a first and second expansion slot, wherein the anchor body expanding comprises the first and second tines expanding.
Glazer teaches a suture anchor (100; Fig. 1) comprising a plurality of first tines (110; Fig. 1) defined by a first expansion slot (114b; Fig. 2) and second tines (112; Fig. 1) defined by a second expansion slot (114a; Fig. 2) extending from the proximal end of the anchor body (100) toward the distal end of the anchor body (100), each of the first tines (110) being configured to extend outward to a greater extent at its distal portion than at its proximal portion (see Fig. 9 showing arrows demonstrating the expansion of the first tines (11)), and the second tines (112) being configured to extend outward to a greater extent at its proximal portion than at its distal portion (see Fig. 9 showing arrows demonstrating the expansion of the second tines (112)); and
an expander (126; Fig. 6) with an expansion portion (screw threads; see Fig. 6) wherein the expansion portion (screw threads) is configured to expand the first and second tines (110 & 112) of the anchor body (100) when the expander (126) is in the second position (see Fig. 9 showing the expander in a second position expanding the first and second tines).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the anchor body of ‘751 to incorporate the teachings of Glazer by providing a second plurality of tines with a second expansion slot on the opposite side of the anchor body with respect to the first tines and first expansion slots with an expander capable of expanding both tines when moved from a first position to a second position. Doing so would increase the anchoring strength of the bone anchor in defective bone tissue or compromised bores, as recognized by Glazer (pp. [0008]).
Additionally, claims 1 and 12 of ‘751 do not claim a second end of the retractable suture grabber extending through the proximal end of the expandable anchor body. ‘751 does claim retracting the suture grabber through the first opening in the distal end of the expander, thereby pulling the first limb of the suture through the first opening. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the suture grabber extending through the proximal end of the expandable anchor body as there has to be a second end for the suture grabber to retract and the suture grabber would have to be pulled through the proximal end of the anchor body in order to secure the suture to the anchor body.
Further, claim 12 of ‘751 do not claim extending the first end of the retractable suture grabber around a tendon.
Schmieding teaches passing a retractable suture grabber (50; Fig. 1) around a tendon to engage with a suture (60; Fig. 2, see Figs. 1-4, pp. [0019], see also, Figs. 7-8).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the attachment method of ‘751 to incorporate the teachings of Schmieding by passing the suture grabber around tissue. Doing so would be obvious to try as a practitioner is limited to a finite number of predictable solutions for attaching a bone anchor to tissue using a suture and suture grabber with a reasonable expectation of success: either extending a suture around tissue and engaging it with a suture grabber, or extending a suture grabber around tissue and engaging it with a suture.
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 DANIEL A. ICET whose telephone number is (571)272-0488. The examiner can normally be reached M-F: 8:00-5:00 CT.
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 at 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DANIEL ICET/Examiner, Art Unit 3771
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771