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 .
Claim Objections
The claims are objected to because the lines are crowded too closely together (see independent claims 1, 8, and 15), making reading difficult. Substitute claims with lines one and one-half or double spaced on good quality paper are required. See 37 CFR 1.52(b).
Claims 1, 8, and 15 are objected to because of the following informalities:
Claim 1, lines 4, 6, and 7 each reference “the bone” yet claim 1 does not introduce a bone as the object of functional language, therefore these recitations lack antecedent basis. It is recommended that a bone be introduced through functional language to provide antecedent basis, such as by amending line 4 to recite “the distal region configured to be located distally in a bone” instead.
Line 6 further states “the all-suture anchor in bone”, it is recommended that this line be amended to recite “the all-suture anchor in the bone” in conjunction with the recommended amendment to claim 1 described above.
Claim 8, lines 4, 6, 9, and 10 each reference “the bone” yet claim 8 does not introduce a bone as the object of functional language, therefore these recitations lack antecedent basis. It is recommended that a bone be introduced through functional language to provide antecedent basis, such as by amending line 4 to recite “the distal region configured to be located distally in a bone” instead.
Line 6 further states “the all-suture anchor in bone”, it is recommended that this line be amended to recite “the all-suture anchor in the bone” in conjunction with the recommended amendment to claim 8 described above.
Claim 8, lines 7 and 10 each end in “; and” before their respective paragraph breaks. It is recommended that the “and” in line 7 be removed since line 7 does not complete the second-to-last paragraph of the claim.
Claim 8, lines 12-15 recites “wherein the knot is configured such that tension on the expansion suture cinches the knot around a repair suture disposed through the plurality of loops, thereby locking the repair suture without tying a knot and also cinches around the two ends extending through the plurality of loops, thereby locking the all-suture anchor configuration” which is difficult to read. It is recommended that the appositive phrases beginning with “thereby…” be surrounded with commas to establish that they refer to the immediate preceding limitation. The Examiner recommends adding a comma after “without tying a knot” such that the limitation more easily reads “wherein the knot is configured such that tension on the expansion suture cinches the knot around a repair suture disposed through the plurality of loops, thereby locking the repair suture without tying a knot, and also cinches around the two ends extending through the plurality of loops, thereby locking the all-suture anchor configuration” instead.
Claim 15, line 3 recites “to a couple a repair tissue”, which appears to be missing a word. It is recommended that this line be amended to recite “to couple to a repair tissue” or “to couple with a repair tissue” instead.
Claim 15, lines 4-5, 7, 12, and 13 each reference “the bone” yet claim 15 does not introduce a bone as the object of functional language, therefore these recitations lack antecedent basis. It is recommended that a bone be introduced through functional language to provide antecedent basis, such as by amending lines 4-5 to recite “the distal region configured to be located distally in a bone” instead.
Line 7 further states “the all-suture anchor in bone”, it is recommended that this line be amended to recite “the all-suture anchor in the bone” in conjunction with the recommended amendment to claim 8 described above.
Claim 15, lines 12-13 recites “the anchor body”, which should be amended to recite “the all-suture anchor body” instead.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2-4, 9-11, and 16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 2, 9, and 16 recite “the plurality of loops wrapped around the shaft”, which is indefinite since it is unclear whether the plurality of loops is wrapped around the shaft during the cinching as functionally claimed in each independent claim or not. It is recommended that these claims be amended to more specifically recite “the plurality of loops wrapped around the shaft prior to the locking of the repair suture and the expansion suture”, or an equivalent thereof, to more specifically define when the plurality of loops is wrapped around the shaft.
Claims 3-4 and 10-11 depend from claims 2 and 9 and therefore inherit their deficiencies.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 7-8, 13, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gregoire et al. (WO 2018/085663 A1).
With respect to claim 1, Gregoire et al. discloses a tissue repair assembly (800 in Figs. 8A-D) for repairing tissue without the need to tie a knot, the tissue repair assembly comprising:
an all-suture anchor (204, abstract: “knotless all-suture anchors (204)”) with a proximal region and a distal region (upper proximal region of 204 and lower distal region of 204), the distal region configured to be located distally in the bone (824);
an expansion suture (220) threaded along the all-suture anchor (204, PP [0041]: “A length of tension suture 220 is shown woven through the implant 204 ”) such that with the all-suture anchor (204) in bone (824), two ends of the expansion suture (220, see two ends in Figs. 8A-B, PP [0041]: “with the free ends of the tension suture exiting the end of the soft anchoring implant and subsequently exiting the inserter tube 814 and the coaxial implant pusher 812”) are proximal of the all-suture anchor (204, 220 extends proximally such that the two ends are proximal to 204), wherein tension on the expansion suture (220) with the all-suture anchor (204) inserted in the bone (824) is configured to set the all-suture anchor (204) in an anchoring configuration (PP [0046]: “As the sutures 220 are tensioned, the implant 204 retracts upon itself with the end of the implant pusher 812 providing counter traction and assumes a shorted, expanded state with an increased effective diameter”);
wherein the expansion suture (220) forms a knot with a plurality of loops (PP [0032]: “multiple eyelets 218 may be configured into a loosely formed knot 228 formed by a portion of the tension suture 220”), at least one of the two ends extending through the plurality of loops (PP [0031]: “the tension suture 220 is wrapped or looped upon itself to form at least one eyelet 218 adjacent to the distal end 212 of the implant body 204”, 220 forms the loops 218, the ends of 220 extending through the loops 218 of knot 228) and wherein the knot (228 with loops 218) is configured to receive a repair suture (222, PP [0031]: “One or more repair sutures 222 (two, as shown) originating from soft tissue 224, are threaded or passed through the eyelet 218 or knot 228”); and
wherein the knot (228) is configured such that tension on at least one of the two ends (ends of 220) cinches the knot around both the repair suture (222) and the at least one of the two ends, thereby locking the repair suture (222) and all-suture anchor (204) in the anchoring configuration, without tying a knot (PP [0033]: “the tension suture 220 constricts around the repair sutures 222 to an extent that the eyelet 218 or knot 228 locks the repair sutures 222. Thus, the action of deploying the implant 204 both locks the implant body 204 into bone 208 and also secures the repair sutures 222 to the anchor body 204, effectively fixing the repair sutures 222 and thereby the soft tissue 224 to bone 208”).
Regarding claim 7, Gregoire et al. further discloses a snare extending through the plurality of loops, configured to draw the repair suture (222 in Figs. 8A-D) through the plurality of loops (218, PP [0043]: “a repair suture 222 may be coupled to soft tissue and then threaded through at least one of the eyelets 218. This may be achieved with a preassembled snare”).
With respect to claim 8, Gregoire et al. discloses a tissue repair assembly (800 in Figs. 8A-D) for repairing tissue without the need to tie a knot, the tissue repair assembly comprising:
an all-suture anchor (204, abstract: “knotless all-suture anchors (204)”) with a proximal region and a distal region (upper proximal region of 204 and lower distal region of 204), the distal region configured to be located distally in the bone (824);
an expansion suture (220) threaded along the all-suture anchor (204, PP [0041]: “A length of tension suture 220 is shown woven through the implant 204 ”) such that with the all-suture anchor (204) in bone (824), two ends of the expansion suture (220, see two ends in Figs. 8A-B, PP [0041]: “with the free ends of the tension suture exiting the end of the soft anchoring implant and subsequently exiting the inserter tube 814 and the coaxial implant pusher 812”) extend proximally from the all-suture anchor (204, 220 extends proximally such that the two ends are proximal to 204); and
wherein the all-suture anchor (204) and expansion suture (220) are configured such that tension on the expansion suture (220) with the all-suture anchor (204) inserted in the bone (824) changes a configuration of the all-suture anchor (204) to set within the bone (PP [0033]: “the tension suture 220 constricts around the repair sutures 222 to an extent that the eyelet 218 or knot 228 locks the repair sutures 222. Thus, the action of deploying the implant 204 both locks the implant body 204 into bone 208 and also secures the repair sutures 222 to the anchor body 204, effectively fixing the repair sutures 222 and thereby the soft tissue 224 to bone 208”, see Figs. 8C-D where 204 changes configurations); and
wherein the expansion suture (220) defines a knot (228) including a plurality of loops (PP [0032]: “multiple eyelets 218 may be configured into a loosely formed knot 228 formed by a portion of the tension suture 220”), the two ends extending through the plurality of loops (PP [0031]: “the tension suture 220 is wrapped or looped upon itself to form at least one eyelet 218 adjacent to the distal end 212 of the implant body 204”, 220 forms the loops 218, the ends of 220 extending through the loops 218 of knot 228) and wherein the knot (228) is configured such that tension on the expansion suture (220) cinches the knot (228) around a repair suture (222) disposed through the plurality of loops (PP [0031]: “One or more repair sutures 222 (two, as shown) originating from soft tissue 224, are threaded or passed through the eyelet 218 or knot 228”), thereby locking the repair suture (222) without tying a knot and also cinches around the two ends (ends of 220) extending through the plurality of loops (218 of knot 228), thereby locking the all-suture anchor (204) configuration (PP [0033]: “the tension suture 220 constricts around the repair sutures 222 to an extent that the eyelet 218 or knot 228 locks the repair sutures 222. Thus, the action of deploying the implant 204 both locks the implant body 204 into bone 208 and also secures the repair sutures 222 to the anchor body 204, effectively fixing the repair sutures 222 and thereby the soft tissue 224 to bone 208”).
Regarding claim 13, Gregoire et al. further discloses a snare extending through the plurality of loops, configured to draw the repair suture (222 in Figs. 8A-D) through the plurality of loops (218, PP [0043]: “a repair suture 222 may be coupled to soft tissue and then threaded through at least one of the eyelets 218. This may be achieved with a preassembled snare”).
With respect to claim 15, Gregoire et al. discloses a tissue repair assembly (800 in Figs. 8A-D) for repairing tissue without the need to tie a knot, the tissue repair assembly comprising:
a repair suture (222) configured to couple a repair tissue (224);
an all-suture anchor (204, abstract: “knotless all-suture anchors (204)”) that has a distal region (bottom end of 204) configured to be located distally in the bone (824);
an expansion suture (220) threaded along the all-suture anchor (204, PP [0041]: “A length of tension suture 220 is shown woven through the implant 204 ”) such that with the all-suture anchor (204) in bone (824), two ends of the expansion suture (220, see two ends in Figs. 8A-B, PP [0041]: “with the free ends of the tension suture exiting the end of the soft anchoring implant and subsequently exiting the inserter tube 814 and the coaxial implant pusher 812”) extend proximally from the all-suture anchor (204, 220 extends proximally such that the two ends are proximal to 204), and wherein one of the two ends of the expansion suture (220) is formed in a knot (228) in a plurality of loops, the other of the two ends extending through the plurality of loops (PP [0031]: “the tension suture 220 is wrapped or looped upon itself to form at least one eyelet 218 adjacent to the distal end 212 of the implant body 204”, 220 forms the loops 218, the ends of 220 form and extend through the loops 218 of knot 228); and
wherein the all-suture anchor (204) and expansion suture (220) are configured such that the tension on the expansion suture (220) with the all-suture anchor body (204) inserted in the bone (824) sets the [all-suture] anchor body (204) within the bone (824), cinches the knot (228) around the other one of the two ends (ends of 220) and an end of the repair suture (222) disposed through the plurality of loops (218), thereby locking the repair suture (222) and the expansion suture (220) two ends without tying a knot (PP [0033]: “the tension suture 220 constricts around the repair sutures 222 to an extent that the eyelet 218 or knot 228 locks the repair sutures 222. Thus, the action of deploying the implant 204 both locks the implant body 204 into bone 208 and also secures the repair sutures 222 to the anchor body 204, effectively fixing the repair sutures 222 and thereby the soft tissue 224 to bone 208”).
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.
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.
Claims 5, 14, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Gregoire et al. (WO 2018/085663 A1), as applied to claims 1, 8, and 15 above, and further in view of Swoyer et al. (US PGPub 2012/0232627 A1).
With respect to claims 5, 14, and 17, Gregoire et al. fails to disclose wherein the knot is a nail knot.
In the same field of suture anchor assemblies (abstract), Swoyer et al. teaches a deformable anchor sleeve and a pre-tied suture material for tensioning and deforming the sleeve (PP [0009]: “A suture material pre-tied in a self-locking compression knot extends around each compression member. The suture material includes distal ends adapted to receive a tension force that is transmitted as a radial compression force to deform the compression members and substantially engage the stop in a compressed configuration. The anchor sleeve compressively engages the therapy delivery element in the compressed configuration”). Swoyer et al. further teaches wherein “the self-locking compression knot is preferably a nail knot” (PP [0011]).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Gregoire et al. device according to the teachings of Swoyer et al. to include wherein the knot is a nail knot. One of ordinary skill in the art would have been motivated to perform this modification as it is a simple substitution of knot types that would have yielded predictable results, as the nail knot of Swoyer et al. is a locking knot meant to compress a target area after tensioning, similar to the functionality of the knot as disclosed by the Gregoire et al. reference. The modification as proposed would not have altered the main operating principle of the Gregoire et al. device, but would have simply used a similar locking knot instead, particularly since Gregoire et al. explicitly discloses that “The knot 228 can be any type of hitch, bend or locking knot known in the art” (PP [0031]), placing no criticality on the knot type.
Allowable Subject Matter
Claims 2-4, 9-11, and 16 would be allowable if amended to overcome the 112 rejections as outlined above and rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 6 and 12 are objected to for depending from a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims
The following is a statement of reasons for the indication of allowable subject matter:
The subject matter of claims 2-4, 6, 9-12, and 16 filed on 3/05/2025 could either not be found or was not suggested in the prior art of record.
With respect to claims 2, 9, and 16, the prior art does not disclose or render obvious at the effective filing date of the invention: the feature of wherein the plurality of loops are wrapped around the shaft, in combination with the other limitations of the independent claim.
The closest prior art is Gregoire et al. which discloses each of the limitations as described above. Gregoire et al. further discloses an insertion instrument (810 and 812 in Figs. 8A-D) including a shaft extending along a longitudinal axis of the insertion instrument (see shaft 810 extending along a longitudinal axis), configured to insert the all-suture anchor body (204) in the bone (824, see insertion in Figs. 8A-D with shaft 810 and push rod 812).
However, Gregoire et al. fails to disclose wherein the plurality of loops are wrapped around the shaft. Furthermore, the prior art of record does not suggest any motivation to modify the Gregoire et al. disclosure to arrive at these features since the knot (228 in Figs. 8A-D) and plurality of loops (218) of Gregoire et al. are located distally in the bone (824) and it would not be obvious to wrap the loops around the insertion instrument as doing so would alter the main operating principle of the Gregoire et al. assembly.
Claims 3-4 and 10-11 depend from claims 2 and 9 respectively and inherit the same reasons for allowability.
With respect to claims 6 and 12, the prior art does not disclose or render obvious at the effective filing date of the invention: the feature of wherein the plurality of loops is proximally spaced from the proximal region of the all-suture anchor.
The closest prior art is Gregoire et al. which discloses each of the limitations as described above.
However, Gregoire et al. fails to disclose wherein the plurality of loops is proximally spaced from the proximal region of the all-suture anchor. Furthermore, the prior art of record does not suggest any motivation to modify the Gregoire et al. disclosure to arrive at these features since the knot (228 in Figs. 8A-D) and plurality of loops (218) of Gregoire et al. are located distally in the bone (824) and modifying the assembly in the claimed manner would alter the main operating principle of the Gregoire et al. assembly.
Another close piece of prior art is Callison et al. (US PGPub 2015/0164497 A1), which discloses a suture assembly (see Figs. 16-20) including a soft anchor (340) comprising wrapping the loops of a nail knot (370) around a shaft (410) of an insertion instrument to deploy the nail knot (370) and cinch the assembly in place (see Figs. 16-20). Callison et al. further discloses a repair suture (390) and an expansion suture with free ends (371 and 372).
However, Callison et al. fails to disclose an expansion suture threaded along the anchor, since the repair suture (390) is the only suture which extends through the anchor (340).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Bridget E. Rabaglia whose telephone number is (571)272-2908. The examiner can normally be reached Monday - Thursday, 7am - 5pm.
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/BRIDGET E. RABAGLIA/Examiner, Art Unit 3771
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