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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08/17/2026 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-11, 16-20 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 Status
Claims 1-11, 16-20 and 20 are examined below.
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.
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) 1-11, 16-20 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Horrell (US 2012/0172936 A1) in view of Da Silva (US 2020/0178953 A1) and Dreyfuss (US 2007/0060922 A1)
Regarding claim 1, Horrell teaches an apparatus for approximation of two bones (10, repair device, fig. 2), comprising:
a first anchor (12, first anchor, fig. 2) comprising:
a first proximal end (34, proximal end, fig. 3A);
a first distal end (32, tip, fig. 3A) configured for insertion into a first hole (see annotated fig. 10, below) in a first bone (2, tibia, fig. 2); and
a first distal tip (32, tip, fig. 3A);
a locking assembly (14, second anchor, fig. 2) comprising:
a second proximal end (80, head, fig. 6B); and
a second distal end (82, body, fig. 6B) configured for insertion into a second hole (see annotated fig. 10, below) in a second bone (4, fibula, fig. 2); and
a flexible segment (16, tether, fig. 2)
wherein the locking assembly is configured such that there is a second distance between the second distal end of the locking assembly and a second side of the second bone (see annotated fig. 2, below),
wherein the first anchor and the flexible segment are configured to be simultaneously delivered into the two bones such that when the first anchor is inserted into the first bone (¶ [0131], fig. 13), the plurality of third proximal ends of the flexible segment extend proximally from a first side of the second bone (fig. 13), and
wherein the locking assembly is configured to be inserted into the second bone after the simultaneous delivery of the first anchor and the flexible segment into the two bones (¶ [0132]).
PNG
media_image1.png
322
313
media_image1.png
Greyscale
PNG
media_image2.png
416
410
media_image2.png
Greyscale
Horrell fails to teach a locking assembly releasable engages the flexible segment and a non-threaded flexible segment. However, Da Silva teaches a device for stabilized fixation of bone that includes
a locking assembly (20, plug assembly, fig. 4A) comprising:
a second proximal end (see annotated fig. 4B, below); and
a second distal end (see annotated fig. 4B, below) configured for insertion into a second hole (42, hole, fig. 3) in a second bone (40, fibula, fig. 3); and
a non-threaded flexible segment (24, suture, fig. 2A) extending from approximate the first distal tip of the first anchor to the locking assembly (fig. 2A) and configured to adjust a first distance between the first and second bones (¶ [0006], The phrase “a non-threaded flexible segment . . . configured to adjust a first distance between the first and second bones” is a functional recitation (see MPEP 2114.II). The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. In this case, the suture is considered to be capable of adjusting a first distance between the first and second bones.);
wherein the locking assembly is configured to accept a plurality of third proximal ends of the flexible segment (fig. 2A, suture tails) and further to releasably engage the flexible segment to fix the first distance between the first and second bones (¶ [0014]),
wherein the locking assembly is configured to releasably engage the flexible segment (¶ [0014]).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the apparatus of Horrell to include a locking assembly releasable engages the flexible segment and an non-threaded flexible segment as taught by Da Silva in order to provide rigid and consistent fixation with a knotless closure during the healing phase (¶ [0005-0006], Da Silva). For clarity, the plug assembly of Da Silva is replacing the second anchor of Horrell as the locking assembly and the suture of Da Silva is replacing the tether of Horrell as the non-threaded flexible segment.
PNG
media_image3.png
202
354
media_image3.png
Greyscale
Horrell in view of Da Silva does not explicitly teach a non-threaded flexible segment (24, suture, fig. 2B, Da Silva) extends from the distal tip of a screw like first anchor (12, first anchor, fig. 2, Horrell). However, Dreyfuss teaches a suture anchor that includes a flexible segment (30, flexible strand, fig. 1) extending from the distal tip of a screw like anchor (4, anchor body, fig. 1).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the apparatus of Horrell and Da Silva to include a flexible segment extending from the distal tip of a screw like anchor as taught by Dreyfuss in order to increase the pullout strength of the suture even in soft bone, provide increased suture fixation and eliminate the anchor "pull back" (abstract, Dreyfuss).
Regarding claim 2, Horrell as modified by Da Silva and Dreyfuss discloses the invention substantially as claimed and as discussed above with respect to claim 1, and additionally teaches the first anchor passes through the second hole (¶ [0006], fig. 11, Horrell) and is threaded within the first bone in the first hole from the first distal end to the first proximal end (¶ [0127], Horrell).
Regarding claim 3, Horrell as modified by Da Silva and Dreyfuss discloses the invention substantially as claimed and as discussed above with respect to claim 2, and additionally teaches the flexible segment extends beyond the second distal end of the locking assembly (fig. 2B, Da Silva).
Regarding claim 4, Horrell as modified by Da Silva and Dreyfuss discloses the invention substantially as claimed and as discussed above with respect to claim 2, and additionally teaches the first hole is disposed on a first side of the first bone (see annotated fig. 2, below, Horrell), and wherein the first anchor is configured such that there is a third distance between the first distal end of the first anchor and a second side of the first bone (see annotated fig. 2, below, Horrell).
PNG
media_image4.png
425
559
media_image4.png
Greyscale
Regarding claim 5, Horrell as modified by Da Silva and Dreyfuss discloses the invention substantially as claimed and as discussed above with respect to claim 1, and additionally teaches the locking assembly is configured to be coupled to a bone plate (¶ [0117], Horrell), and wherein the bone plate is configured to be coupled to the first side of the second bone (¶ [0117], Horrell).
Regarding claim 6, Horrell as modified by Da Silva and Dreyfuss discloses the invention substantially as claimed and as discussed above with respect to claim 1, and additionally teaches the locking assembly further comprises one or more openings for receiving the flexible segment (36, slots, fig. 4A, ¶ [0062], Da Silva) and is configured to anchor the flexible segment to hold the locking assembly to the first side of the second bone (fig. 3, Da Silva).
Regarding claim 7, Horrell as modified by Da Silva and Dreyfuss discloses the invention substantially as claimed and as discussed above with respect to claim 1, and additionally teaches the locking assembly further comprises:
a body (30, plug, fig. 4A, Da Silva) comprising the second proximal end, the second distal end, and an internal cavity (54, hole, fig. 6B, Da Silva); and
a locking insert (34, screw, fig. 4A, Da Silva) moveable from a first position to a second position within the internal cavity (¶ [0062], Da Silva);
wherein the locking assembly is configured to receive the flexible segment through one or more openings (36, slots, fig. 4A, ¶ [0062], Da Silva); and
wherein the locking insert is configured to transition from the first position to the second position to lock the flexible segment at a length (¶ [0022-0023], Da Silva).
Regarding claim 8, Horrell as modified by Da Silva and Dreyfuss discloses the invention substantially as claimed and as discussed above with respect to claim 1, and additionally teaches the locking assembly further comprises:
a locking insert (34, screw, fig. 4A, Da Silva); and
a button (30, plug, fig. 4A, Da Silva) comprising:
a first opening (54, hole, fig. 4A, Da Silva) configured to accept a third distal end of the locking insert (35a, threads, fig. 4A, ¶ [0064] , Da Silva); and
one or more second openings (36,slots, fig. 4A, Da Silva) configured to accept the plurality of third proximal ends of the flexible segment (¶ [0062] , Da Silva).
Regarding claim 9, Horrell as modified by Da Silva and Dreyfuss discloses the invention substantially as claimed and as discussed above with respect to claim 8, and additionally teaches the locking assembly is further configured to lock the flexible segment at a length when the plurality of third proximal ends of the flexible segment are pulled in a proximal direction through the one or more second openings (¶ [0066], Da Silva). The phrase “the locking assembly is further configured to lock the flexible segment at a length when the plurality of third proximal ends of the flexible segment are pulled in a proximal direction through the one or more second openings” is a functional recitation (see MPEP 2114.II). The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. In this case, the plug assembly of Da Silva is considered to be capable of locking the flexible segment at a length when the plurality of third proximal ends of the flexible segment are pulled in a proximal direction through the one or more second openings.
Regarding claim 10, Horrell as modified by Da Silva and Dreyfuss discloses the invention substantially as claimed and as discussed above with respect to claim 8, and additionally teaches the locking insert comprises:
a cap (32, cap, fig. 4A, Da Silva) configured to be placed on a fourth proximal end of the button (37, flange, fig. 4A, Da Silva); and
a screw (34, screw, fig. 4A, Da Silva) configured to be screwed through the cap and the button and into the second bone (fig. 4A, Da Silva); and
the locking assembly is further configured to lock the flexible segment at a length when the plurality of third proximal ends of the flexible segment are pulled in at least one of an approximately proximal direction and an approximately perpendicular direction through the one or more second openings and between the fourth proximal end of the button and a distal end of the cap (¶ [0066], Da Silva). The phrase “the locking assembly is further configured to lock the flexible segment at a length when the plurality of third proximal ends of the flexible segment are pulled in at least one of an approximately proximal direction and an approximately perpendicular direction through the one or more second openings and between the fourth proximal end of the button and a distal end of the cap” is a functional recitation (see MPEP 2114.II). The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. In this case, the plug assembly of Da Silva is considered to be capable of locking the flexible segment at a length when the plurality of third proximal ends of the flexible segment are pulled in at least one of an approximately proximal direction and an approximately perpendicular direction through the one or more second openings and between the fourth proximal end of the button and a distal end of the cap.
Regarding claim 11, Horrell teaches an apparatus for approximation of two bones (10, repair device, fig. 2), comprising:
a first anchor (12, first anchor, fig. 2) comprising:
a first proximal end (34, proximal end, fig. 3A);
a first distal end (32, tip, fig. 3A) configured for insertion into a first hole (see annotated fig. 10, below) in a first bone (2, tibia, fig. 2);
wherein the first anchor passes through a second hole in a second bone (¶ [0006], see annotated fig. 10, below) and is inserted within the first bone in the first hole from the first distal end to the first proximal end (¶ [0127]); and
a first distal tip (32, tip, fig. 3A);
a locking assembly (14, second anchor, fig. 2) comprising:
a second proximal end (80, head, fig. 6B); and
a second distal end (82, body, fig. 6B) configured for insertion into the second hole (see annotated fig. 10, below) in a second bone (4, fibula, fig. 2); and
a flexible segment (16, tether, fig. 2)
wherein the locking assembly is configured such that there is a second distance between the second distal end of the locking assembly and a second side of the second bone (see annotated fig. 2, below), and
wherein the first anchor and the flexible segment are configured to be simultaneously delivered into the two bones such that when the first anchor is inserted into the first bone (¶ [0131], fig. 13), the plurality of third proximal ends of the flexible segment extend proximally from a first side of the second bone (fig. 13), and
wherein the locking assembly is configured to be inserted into the second bone after the simultaneous delivery of the first anchor and the flexible segment into the two bones (¶ [0132]).
PNG
media_image1.png
322
313
media_image1.png
Greyscale
PNG
media_image2.png
416
410
media_image2.png
Greyscale
Horrell fails to teach a locking assembly releasable engages the flexible segment and a non-threaded flexible segment. However, Da Silva teaches a device for stabilized fixation of bone that includes
a locking assembly (20, plug assembly, fig. 4A) comprising:
a second proximal end (see annotated fig. 4B, below); and
a second distal end (see annotated fig. 4B, below) configured for insertion into a second hole (42, hole, fig. 3) in a second bone (40, fibula, fig. 3); and
a non-threaded flexible segment (24, suture, fig. 2A) extending from approximate the first distal tip of the first anchor to the locking assembly (fig. 2A) and configured to adjust a first distance between the first and second bones (¶ [0006], The phrase “a non-threaded flexible segment . . . configured to adjust a first distance between the first and second bones” is a functional recitation (see MPEP 2114.II). The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. In this case, the suture is considered to be capable of adjusting a first distance between the first and second bones.);
wherein the locking assembly is configured to accept a plurality of third proximal ends of the flexible segment (fig. 2A, suture tails) and further to releasably engage the flexible segment to fix the first distance between the first and second bones (¶ [0014]),
wherein the locking assembly is configured to releasably engage the flexible segment (¶ [0014]).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the apparatus of Horrell to include a locking assembly releasable engages the flexible segment and an non-threaded flexible segment as taught by Da Silva in order to provide rigid and consistent fixation with a knotless closure during the healing phase (¶ [0005-0006], Da Silva). For clarity, the plug assembly of Da Silva is replacing the second anchor of Horrell as the locking assembly and the suture of Da Silva is replacing the tether of Horrell as the non-threaded flexible segment.
PNG
media_image3.png
202
354
media_image3.png
Greyscale
Horrell in view of Da Silva does not explicitly teach a non-threaded flexible segment (24, suture, fig. 2B, Da Silva) extends from the distal tip of a screw like first anchor (12, first anchor, fig. 2, Horrell). However, Dreyfuss teaches a suture anchor that includes a flexible segment (30, flexible strand, fig. 1) extending from the distal tip of a screw like anchor (4, anchor body, fig. 1). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the apparatus of Horrell and Da Silva to include a flexible segment extending from the distal tip of a screw like anchor as taught by Dreyfuss in order to increase the pullout strength of the suture even in soft bone, provide increased suture fixation and eliminate the anchor "pull back" (abstract, Dreyfuss).
Regarding claim 16, Horrell as modified by Da Silva and Dreyfuss discloses the invention substantially as claimed and as discussed above with respect to claim 11, and additionally teaches the locking assembly further comprises:
a body (30, plug, fig. 4A, Da Silva) comprising the second proximal end, the second distal end, and an internal cavity (54, hole, fig. 6B, Da Silva); and
a locking insert (34, screw, fig. 4A, Da Silva) moveable from a first position to a second position within the internal cavity (¶ [0062], Da Silva);
wherein the locking assembly is configured to receive the flexible segment through one or more openings (36, slots, fig. 4A, ¶ [0062], Da Silva); and
wherein the locking insert is configured to transition from the first position to the second position to lock the flexible segment at a length (¶ [0022-0023], Da Silva).
Regarding claim 17, Horrell as modified by Da Silva and Dreyfuss discloses the invention substantially as claimed and as discussed above with respect to claim 11, and additionally teaches the locking assembly further comprises:
a locking insert (34, screw, fig. 4A, Da Silva); and
a button (30, plug, fig. 4A, Da Silva) comprising:
a first opening (54, hole, fig. 4A, Da Silva) configured to accept a third distal end of the locking insert (35a, threads, fig. 4A, ¶ [0064], Da Silva); and
one or more second openings (36,slots, fig. 4A, Da Silva) configured to accept the plurality of third proximal ends of the flexible segment (¶ [0062] , Da Silva).
Regarding claim 18, Horrell as modified by Da Silva and Dreyfuss discloses the invention substantially as claimed and as discussed above with respect to claim 17, and additionally teaches the locking assembly is further configured to lock the flexible segment at a length when the plurality of third proximal ends of the flexible segment are pulled in a proximal direction through the one or more second openings (¶ [0066], Da Silva). The phrase “the locking assembly is further configured to lock the flexible segment at a length when the plurality of third proximal ends of the flexible segment are pulled in a proximal direction through the one or more second openings” is a functional recitation (see MPEP 2114.II). The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. In this case, the plug assembly of Da Silva is considered to be capable of locking the flexible segment at a length when the plurality of third proximal ends of the flexible segment are pulled in a proximal direction through the one or more second openings.
Regarding claim 19, Horrell as modified by Da Silva and Dreyfuss discloses the invention substantially as claimed and as discussed above with respect to claim 17, and additionally teaches the locking insert comprises:
a cap (32, cap, fig. 4A) configured to be placed on a fourth proximal end of the button (37, flange, fig. 4A); and
a fastener (34, screw, fig. 4A) configured to be inserted through the cap and the button and into the second bone (fig. 4B).
Regarding claim 20, Horrell as modified by Da Silva and Dreyfuss discloses the invention substantially as claimed and as discussed above with respect to claim 19, and additionally teaches the locking assembly is further configured to lock the flexible segment at a length when the plurality of third proximal ends of the flexible segment are pulled in at least one of an approximately proximal direction and an approximately perpendicular direction through the one or more second openings and between the fourth proximal end of the button and a distal end of the cap (¶ [0066], Da Silva). The phrase “the locking assembly is further configured to lock the flexible segment at a length when the plurality of third proximal ends of the flexible segment are pulled in at least one of an approximately proximal direction and an approximately perpendicular direction through the one or more second openings and between the fourth proximal end of the button and a distal end of the cap” is a functional recitation (see MPEP 2114.II). The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. In this case, the plug assembly of Da Silva is considered to be capable of locking the flexible segment at a length when the plurality of third proximal ends of the flexible segment are pulled in at least one of an approximately proximal direction and an approximately perpendicular direction through the one or more second openings and between the fourth proximal end of the button and a distal end of the cap.
Regarding claim 27, Horrell as modified by Da Silva and Dreyfuss discloses the invention substantially as claimed and as discussed above with respect to claim 1, and additionally teaches the flexible segment is configured to adjust the first distance between the first and second bones when force is applied on the plurality of third proximal ends of the flexible segment in a proximal direction. The phrase “the flexible segment is configured to adjust the first distance between the first and second bones when force is applied on the plurality of third proximal ends of the flexible segment in a proximal direction” is a functional recitation (see MPEP 2114.II). The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. In this case, the tether of Horrell-936 interacting with the locking assembly of Da Silva is considered to be capable of adjusting the first distance between the first and second bones when force is applied on the plurality of third proximal ends of the flexible segment in a proximal direction.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TERESA M DUDDEN whose telephone number is (571)272-0435. The examiner can normally be reached Monday - Tuesday and Thursday - Friday 7:30 am - 6:00 pm EST.
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, JERRAH C EDWARDS can be reached at 408-918-7557. 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.
/T.M.D./Examiner, Art Unit 3774
/YASHITA SHARMA/Primary Patent Examiner, Art Unit 3774
