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 03/05/2026 have been fully considered but they are not persuasive.
The Applicant argues using the locking assembly of Da Silva would render the apparatus of Horrell-936 inoperable for its intended purpose. That purpose being “to treat a syndesmosis injury by finely adjusting the position of the fibula bone through tightening down the second anchor 14 onto the tether 16” (pg. 10 of Applicant’s response). The examiner disagrees with this position. Horrell-936 is able to finely adjust the position of the fibula but that fine adjustment is a feature not the intended purpose. The intended purpose of Horrell-936 is to treat syndesmosis injuries without inhibiting the normal joint movement (¶ [0003], Horrell-936). The combination of Horrell-936 and Da Silva continues to accomplish the syndesmosis injury treatment without inhibiting normal joint movement.
Claim Status
Claims 1-11, 16-20 and 27 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-936 (US 2012/0172936 A1) in view of Horrell-302 (US 2016/0287302 A1) and Da Silva (US 2020/0178953 A1) .
Regarding claim 1, Horrell-936 discloses an apparatus (10 repair device, fig. 2) for approximation of two bones, 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, the embodiment in fig. 2 has a tether 16 with a flexible component 16A and a base component 16B however ¶ [0112] points to the tether being a single component tether) and configured to adjust a first distance between the first and second bones (¶ [0006]);
wherein the locking assembly is configured to accept a plurality of third proximal ends of the flexible segment. The phrase “configured to accept a plurality of third proximal ends of the flexible segment” is a function recitation that is not given full patentable weight. The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing the recited function in order to meet the claim requirements. In this case the locking assembly has a lumen, 84 that is capable of accepting a plurality of ends.
wherein the locking assembly is configured such that there is a second distance (see annotated, fig. 2, below) 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 (¶ [0131], fig. 13) such that when the first anchor is inserted into the first bone, 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]).
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Horrell-936 fails to teach the locking assembly releasably engages the flexible segment. However, Da Silva discloses a device for stabilized fixation of bone comprising a flexible segment (24) 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) that is configured to releasably engage the flexible segment to fix the first distance between the first and second bones (¶ [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-936 to include the locking assembly releasably engages the 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 suture of Da Silva is not replacing the flexible segment of Horrell-936. The plug assembly of Da Silva is replacing the second anchor of Horrell-936 as the locking assembly.
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Horrell-936 and Da Silva fail to teach the flexible segment extends from approximate the first distal tip of the first anchor to the locking assembly. However, Horrell-302 discloses a device for semi-rigid bone fixation with a flexible link (20) between two anchors (10, 18) that includes the flexible segment extending from the first distal tip of the first anchor to the locking assembly (fig. 3). 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-936 and Da Silva to include the flexible segment extends from approximate the first distal tip of the first anchor to the locking assembly as taught by Horrell-302 since it is combing prior art elements according to known methods to yield predictable result, which courts have recognized supports a conclusion of obviousness (see MPEP 2143). For clarity, the anchors and flexible link of Horrell-302 are not replacing the anchors and flexible segment of Horrell-936. Horrell-302 shows it is known in the art for the flexible segment to extend from approximate the first distal tip of the first anchor to the locking assembly.
Regarding claim 2, Horrell-936 further discloses the first anchor passes through the second hole (¶ [0006], fig. 11) and is threaded within the first bone in the first hole from the first distal end to the first proximal end (¶ [0127]).
Regarding claim 3, Horrell-936 fails to disclose the flexible segment extends beyond the second distal end of the locking assembly. However, Da Silva further discloses the flexible segment extends beyond the second distal end of the locking assembly (fig. 2B). 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-936 to include the flexible segment extends beyond the first proximal end of the first anchor 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).
Regarding claim 4, Horrell-936 further discloses the first hole is disposed on a first side of the first bone (see annotated fig. 2, below), 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).
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Regarding claim 5, Horrell-936 further discloses the locking assembly is configured to be coupled to a bone plate (¶ [0117]), and wherein the bone plate is configured to be coupled to the first side of the second bone (¶ [0117]).
Regarding claim 6, Horrell-936 fails to teach the locking assembly comprises openings for receiving the flexible segment. However, Da Silva further discloses the locking assembly further comprises one or more openings (36, slots, fig. 4A) for receiving the flexible segment (¶ [0062]) and is configured to anchor the flexible segment to hold the locking assembly to the first side of the second bone (fig. 3). 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-936 to include the locking assembly comprises openings for receiving the 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).
Regarding claim 7, Horrell-936 fails to teach the locking assembly further comprising a body, an internal cavity and a locking insert. However, Da Silva further discloses the locking assembly further comprises:
a body (30, plug, fig. 4A) comprising the second proximal end, the second distal end, and an internal cavity (54, hole, fig. 6B); and
a locking insert (34, screw, fig. 4A) moveable from a first position to a second position within the internal cavity (¶ [0062]);
wherein the locking assembly is configured to receive the flexible segment through one or more openings (36, slots, fig. 4A, ¶ [0062]); 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]).
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-936 to include the locking assembly further comprising a body, an internal cavity and a locking insert 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).
Regarding claim 8, Horrell-936 fails to teach the locking assembly comprises a locking insert and a button. However Da Silva further discloses the locking assembly further comprises: a locking insert (34, screw, fig. 4A); and a button (30, plug, fig. 4A) comprising: a first opening (54, hole, fig. 4A) configured to accept a third distal end of the locking insert (35a, threads, fig. 4A, ¶ [0064]); and one or more second openings (36,slots, fig. 4A) configured to accept the plurality of third proximal ends of the flexible segment (¶ [0062]). 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-936 to include the locking assembly comprises a locking insert and a button 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).
Regarding claim 9, Horrell-936 fails to teach the locking assembly is configured to lock the flexible segment at a length when the flexible segment ends are pulled in a proximal direction. However, Da Silva further discloses the locking assembly is 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]). 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. 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-936 to include the locking assembly is configured to lock the flexible segment at a length when the flexible segment ends are pulled in a proximal direction 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).
Regarding claim 10, Horrell-936 fails to teach the locking insert comprises a cap and a screw. However, Da Silva further discloses
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 screw (34, screw, fig. 4A) configured to be screwed through the cap and the button and into the second bone (fig. 4A); 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]). 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.
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-936 to include the locking insert comprises a cap and a screw 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).
Regarding claim 11, Horrell-936 discloses an apparatus (10 repair device, fig. 2) for approximation of two bones, 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 in a first bone (see annotated fig. 10, below);
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 in the second bone (fig. 2); and
a flexible segment (16, tether, fig. 2, the embodiment in fig. 2 has a tether 16 with a flexible component 16A and a base component 16B however ¶ [0112] points to the tether being a single component tether) and configured to adjust a first distance between the first and second bones (¶ [0006]);
wherein the locking assembly is configured to accept a plurality of third proximal ends of the flexible segment. The phrase “configured to accept a plurality of third proximal ends of the flexible segment” is a function recitation that is not given full patentable weight. The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing the recited function in order to meet the claim requirements. In this case the locking assembly has a lumen, 84 that is capable of accepting a plurality of ends.
wherein the locking assembly is configured such that there is a second distance (see annotated, fig. 2, below) 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 (¶ [0131], fig. 13) such that when the first anchor is inserted into the first bone, 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]).
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Horrell-936 fails to teach the locking assembly releasably engages the flexible segment. However, Da Silva discloses a device for stabilized fixation of bone comprising a flexible segment (24) 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) that is configured to releasably engage the flexible segment to fix the first distance between the first and second bones (¶ [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-936 to include the locking assembly releasably engages the 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 suture of Da Silva is not replacing the flexible segment of Horrell-936. The plug assembly of Da Silva is replacing the second anchor of Horrell-936 as the locking assembly.
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Horrell-936 and Da Silva fail to teach the flexible segment extends from approximate the first distal tip of the first anchor to the locking assembly. However, Horrell-302 discloses a device for semi-rigid bone fixation with a flexible link (20) between two anchors (10, 18) that includes the flexible segment extending from the first distal tip of the first anchor to the locking assembly (fig. 3). 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-936 and Da Silva to include the flexible segment extends from approximate the first distal tip of the first anchor to the locking assembly as taught by Horrell-302 since it is combing prior art elements according to known methods to yield predictable result, which courts have recognized supports a conclusion of obviousness (see MPEP 2143). For clarity, the anchors and flexible link of Horrell-302 are not replacing the anchors and flexible segment of Horrell-936. Horrell-302 shows it is known in the art for the flexible segment to extend from approximate the first distal tip of the first anchor to the locking assembly.
Regarding claim 16, Horrell-936 fails to teach the locking assembly further comprising a body, an internal cavity and a locking insert. However, Da Silva further discloses the locking assembly further comprises:
a body (30, plug, fig. 4A) comprising the second proximal end, the second distal end, and an internal cavity (54, hole, fig. 6B); and
a locking insert (34, screw, fig. 4A) moveable from a first position to a second position within the internal cavity (¶ [0062]);
wherein the locking assembly is configured to receive the flexible segment through one or more openings (36, slots, fig. 4A, ¶ [0062]); 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]).
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-936 to include the locking assembly further comprising a body, an internal cavity and a locking insert 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).
Regarding claim 17, Horrell-936 fails to teach the locking assembly comprises a locking insert, a button, a first opening, and one or more second openings. However, Da Silva further discloses the locking assembly further comprises:
a locking insert (34, screw, fig. 4A); and
a button (30, plug, fig. 4A) comprising:
a first opening (54, hole, fig. 4A) configured to accept a third distal end of the locking insert (35a, threads, fig. 4A, ¶ [0064]); and
one or more second openings (36,slots, fig. 4A) configured to accept the plurality of third proximal ends of the flexible segment (¶ [0062]).
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-936 to include the locking assembly further comprising a locking insert, a button, a first opening and one or more second openings 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).
Regarding claim 18, Horrell-936 fails to teach the locking assembly is configured to lock the flexible segment at a length when the flexible segment ends are pulled in a proximal direction. However, Da Silva further discloses the locking assembly is 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]). 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. 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-936 to include the locking assembly is configured to lock the flexible segment at a length when the flexible segment ends are pulled in a proximal direction 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).
Regarding claim 19, Horrell-936 fails to teach the locking insert comprises a cap and a fastener. However, Da Silva further discloses wherein:
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).
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-936 to include the locking insert comprises a cap and a fastener 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).
Regarding claim 20, Horrell-936 fails to teach the locking assembly is configured to lock the flexible segment at a length when the ends are pulled in a proximal and/or perpendicular direction. However, Da Silva further discloses 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]). 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. 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-936 to include the locking assembly is configured to lock the flexible segment at a length when the ends are pulled in a proximal and/or perpendicular direction 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).
Regarding claim 27, the combination of Horrell-936 in view of Da Silva 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
THIS ACTION IS MADE FINAL. 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 TERESA M DUDDEN whose telephone number is (571)272-0435. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, THOMAS BARRETT can be reached at (571) 272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/T.M.D./Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
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