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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-19 drawn to a surgical construct in the reply filed on 12/29/2025 is acknowledged.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3, 8-14, 16-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dooney Jr. et al. U.S. Publication 2021/0386418 A1.
Regarding Claim 1, Dooney Jr. et al. discloses a surgical construct 200 consisting of a fixed length of flexible coupler 206b connected to a first soft anchor 100 and to a second soft anchor 100’ (paragraph [0018], [0020], [0034]).
Regarding Claim 2, Dooney Jr. et al. discloses wherein the fixed length of flexible coupler 206b forms a staple across tissue to be fixated with the first soft anchor 100 and the second soft anchor 100’ (abstract and paragraph [0034]).
Regarding Claim 3, Dooney Jr. et al. wherein the surgical construct 200 is self-tensioning (paragraphs [0007-0008], [0019], [0021], [0029]).
Regarding Claim 8, Dooney Jr. et al. wherein each of the first soft anchor and the second soft anchor is an all-suture anchor (paragraph [0020]), and the flexible coupler is round suture (paragraph [0027]).
Regarding Claim 9, Dooney Jr. et al. discloses a surgical construct 200 comprising: a first soft anchor 100 with a first flexible sheath having a first open end and a second open end (as seen in Figure 9); a second soft anchor 100’ with a second flexible sheath having a first open end and a second open end (as seen in Figure 9); and a flexible coupler 206b connecting the first soft anchor 100 to the second soft anchor 100’, wherein the flexible coupler has a fixed length and wherein the flexible coupler forms at least one closed, flexible, continuous loop by being passed at least once through the first flexible sheath of the first soft anchor and at least once through the second flexible sheath of the second soft anchor (as seen in Figure 9).
Regarding Claim 10, Dooney Jr. et al. discloses wherein the first flexible sheath is a first suture tube (as seen in Figure 9, paragraph [0020]), the second flexible sheath is a second suture tube (as seen in Figure 9, paragraph [0020]), and the flexible coupler is round suture (paragraphs [0027], [0033]).
Regarding Claim 11, Dooney Jr. et al. discloses wherein the first soft anchor 100 and the second soft anchor 100’ resides into bone (paragraph [0032], [0034]) and wherein a portion of the flexible coupler 206b forms a bridge over tissue 90 to be secured to the bone (paragraphs [0018], [0033-0034]).
Regarding Claim 12, Dooney Jr. et al. discloses wherein the tissue is soft tissue (paragraphs [0018], [0033-0034]).
Regarding Claim 13, Dooney Jr. et al. discloses wherein the tissue is tendon, ligament or graft (paragraph [0018]).
Regarding Claim 14, Dooney Jr. et al. discloses wherein the flexible coupler is formed of (paragraphs [0004-0005], [0019-0020], [0027]).
Regarding Claim 16, Dooney Jr. et al. discloses a surgical repair 200 as seen in Figure 9 comprising: a first soft anchor 100 secured into a first tissue (e.g. bone hole) at a first location and a second soft anchor 100’ secured into the first tissue at a second location; and a suture bridge attached to the first soft anchor 100 and to the second soft anchor 100’ and extending above a second tissue 90.
Regarding Claim 17, Dooney Jr. et al. discloses wherein the first tissue is bone (paragraph [0032], [0034]) and the second tissue 90 is soft tissue to be attached to bone (paragraphs [0018], [0033-0034]).
Regarding Claim 18, Dooney Jr. et al. discloses wherein the suture bridge 206b has a fixed length and forms a locking staple with the first and second soft anchors 100, 100’ (as seen in Figure 9).
Regarding Claim 19, Dooney Jr. et al. discloses wherein at least one of the first and second soft anchors 100, 100’ secured into the first tissue 92, 94 (bone, see paragraph [0034]) has a doughnut-like shape (as seen in Figure 9).
Claim(s) 1, 5-7 and 9-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kaiser et al. U.S. Publication 2014/0046368 A1.
Regarding Claim 1, Kaiser et al. discloses a surgical construct 300A as seen in Figure 15 consisting of a fixed length of flexible coupler 304’ connected to a first soft anchor 150 and to a second soft anchor 150 (paragraph [0055]).
Regarding Claim 5, Kaiser et al. discloses wherein the fixed length of flexible coupler 304’ passes at least once through a first tubular sheath of the first soft anchor 150 and at least once through a second tubular sheath of the second soft anchor 150 to form a closed, continuous, flexible loop with a fixed perimeter (as seen in Figure 15 and paragraph [0055]).
Regarding Claim 6, Kaiser et al. discloses wherein the fixed length of flexible coupler 304’ enters the first tubular sheath at a first location (as seen in Figure 15), extends within the first tubular sheath and exits the first tubular sheath at a second location, wherein the second location is different from the first location (as seen in Figure 15, the first soft anchor 150 comprises a tubular sheath, wherein the suture 304’ enters at a first location and exits at a second location).
Regarding Claim 7, Kaiser et al. discloses wherein the fixed length of flexible coupler 304’ enters the second tubular sheath at a first location (as seen in Figure 15), extends within the second tubular sheath and exits the second tubular sheath at a second location, wherein the second location is different from the first location (as seen in Figure 15, the second soft anchor 150 comprises a tubular sheath, wherein the suture 304’ enters at a first location and exits at a second location).
Regarding Claim 9, Kaiser et al. discloses a surgical construct 300A comprising: a first soft anchor 150 with a first flexible sheath having a first open end and a second open end (as seen in Figure 15); a second soft anchor 150 with a second flexible sheath having a first open end and a second open end (as seen in Figure 15); and a flexible coupler 304’ connecting the first soft anchor 150 to the second soft anchor 150, wherein the flexible coupler 304’ has a fixed length and wherein the flexible coupler 304’ forms at least one closed, flexible, continuous loop by being passed at least once through the first flexible sheath of the first soft anchor 150 and at least once through the second flexible sheath of the second soft anchor 150 (as seen in Figure 15 and paragraph [0055]).
Regarding Claim 10, Kaiser et al. discloses wherein the first flexible sheath is a first suture tube (as seen in Figure 15, paragraph [0012], [0041]), the second flexible sheath is a second suture tube (as seen in Figure 15, paragraph [0012]), [0041], and the flexible coupler is round suture (paragraphs [0053-0055]).
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) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dooney Jr. et al. U.S. Publication 2021/0386418 A1.
Regarding Claim 4, Dooney Jr. et al. discloses wherein the fixed length of flexible coupler 206b is secured to the first soft anchor 100 and to the second soft anchor 100’ (as seen in Figure 9). However, in the embodiment used in the rejection above, Figure 9 of Dooney Jr. et al. does not expressly disclose the coupler is secured to the first and second soft anchor by a knot. Dooney Jr. teaches in Figures 4a-4b a flexible coupler 200a secured to a first soft tissue anchor 100 by a knot for the purpose of coupling the coupler to the tissue (paragraph [0025]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the construct of Figure 9 to further include a coupler that is secured to the soft tissue anchor via a knot as taught in Figures 4a-4b for the purpose of coupling the coupler to the tissue.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaiser et al. U.S. Publication 2014/0046368 A1 in view of Pilgeram U.S. Publication 2014/0249577 A1.
Regarding Claim 15, Kaiser discloses the flexible coupler 304’ is a suture (paragraph [0052-0055]). However, Kaiser et al. does not expressly disclose wherein the flexible coupler consists essentially of elastic material. Pilgeram teaches a construct in Figure 10B in the same field of endeavor comprising a flexible coupler 150 connecting a first soft anchor 20 to a second soft anchor 20’, wherein the flexible coupler 150 forms a closed, continuous loop (as seen in Figure 10B and paragraphs [0069-0070]), the flexible coupler is a filament (paragraph [0046] and [0069-0070]) defined as a suture or other thread-like material that is formed from PEEK, forming an elastic and flexible material (paragraph [0032]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Kaiser’s flexible coupler to be a suture formed from PEEK as taught by Pilgeram for the purpose of forming a filament that is elastic and flexible.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEEMA MATHEW whose telephone number is (571) 270-1452. The examiner can normally be reached on Monday-Friday 9 am – 5 pm.
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/SEEMA MATHEW/
Primary Examiner, Art Unit 3774
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