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 1-16) in the reply filed on 5/15/2026 is acknowledged.
Claims 17-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II, there being no allowable generic or linking claim. The requirement is still deemed proper and is therefore made FINAL.
Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be amended in compliance with 37 CFR 1.48(b) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. Any amendment of inventorship must be accompanied by a request under 37 CFR 1.48(b) and by the fee required under 37 CFR 1.17(i).
Response to Amendment
In response to the amendment filed on 5/15/2026, Claims 17-20 have been withdrawn, no new claims have been added, thus Claims 1-16 are pending.
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 1-16 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.
Claim 1 recites the limitation “the opening” in line 14, “the repair member” in line 14-15.There is insufficient antecedent basis for this limitation in the claim. Examiner best understands “the opening” to mean “the lumen”. Examiner best understands the limitation “the repair member” to mean “the repair suture”.
Claim 7 recites the limitation “the locking passage region” in line 3. There is insufficient antecedent basis for this limitation in the claim. Examiner best understands the limitation “the locking passage region” to mean “the knotless locking region”.
Claim 10 recites the limitation “the repair member” in line 13-14. There is insufficient antecedent basis for this limitation in the claim. Examiner best understands the limitation “the repair member” to mean “the repair suture”.
Claim 15 recites the limitation “the transfer suture” in line 2, “the locking passage region” in line 2. There is insufficient antecedent basis for this limitation in the claim. Examiner best understands the limitation “the transfer suture” to mean “the snare construct” recited similar to claim 7. Examiner best understands the limitation “the locking passage region” to mean “the knotless locking region”.
Claims 2-6, 8-9, 11-14, 16 are rejected on the basis of being dependent on rejected claims.
Claim Rejections - 35 USC § 102
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.
Claims 1, 3-6, 10, 12-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20140052179 Dreyfuss et al. (hereinafter Dreyfuss).
Regarding claim 1, Dreyfuss discloses a tissue repair system for repairing a break in a soft tissue (abstract, paragraph 5, 17) comprising:
a repair construct (Fig. 5-8, 14-15) comprising:
an anchor (100/200a) formed of soft flexible material (paragraph 24) and configured to directly engage a first external surface of the soft tissue (the anchor 100/200a is capable of being configured to directly engaging a first external surface of the soft tissue 95 as intended use);
a repair suture (51/11, Fig. 5-8, 14-15) having a first end fixedly coupled to the anchor and a second end extending from the anchor (as seen in Fig. 5-8, suture 51 is tied at a first end to anchor 100 at knot 52 and a second end extends from the anchor; as seen in Fig. 14-15, eyelet 15 is larger than the aperture from where the suture exits on the right side and pulling on the suture end 11a would cause the eyelet to get stuck and fix it to the anchor), wherein the repair suture defines a lumen (as seen in Fig. 5-8, 14-15, suture 51/11 passes through itself through a lumen in splice region 75/53);
a snare construct (70, Fig. 14) extending within and along a length of the repair suture lumen in a region of the repair suture directly adjacent the anchor (as seen in Fig. 14), defining a knotless locking region (splice region 75/53, paragraph 40), the snare construct having a first end extending from a first end of the knotless locking region and a second end extending from a second end of the knotless locking region (as seen in Fig. 14);
wherein the snare construct first end is configured to be first passed through a first side of the lumen and then couple to the repair suture second end, such that with tension on the snare construct second end draws the repair suture second end through the soft tissue in a first direction from a second external surface to the first external surface on the first side of the break, and then in an opposing direction from the first external surface through the knotless locking region and through the second external surface on a second side of the break, to form a repair loop (55a) in the repair suture extending through the soft tissue and around the break, and wherein tension on the repair suture second end is configured to actuate the knotless locking region and knotlessly lock the repair loop (paragraph 39-40, Fig. 14-15, as the claimed limitation is an intended use of the snare construct and repair suture, the suture 51/11 is capable of being passed through the soft tissue 95 when the snare construct 70 couples with a second end of the repair suture (paragraph 39, free end 11a of repair suture 11 passes through eyelet 71 of snare construct 70) and then tension is drawn to pull the repair suture through the soft tissue, and then pulled from the first side of the soft tissue to the second side of the soft tissue through the knotless locking region (splice region 75/53) to form a repair loop 55a and knotlessly lock the repair loop).
Regarding claim 3, Dreyfuss discloses the limitations of claim 1 and further discloses wherein the anchor forms a V-shape (as seen in Fig. 3, 7-8, anchor 100 is a V-shape) or a Z-shape and wherein tension on the repair suture is configured to flatten the V-shape or Z-shape (because the anchor 100/200a is made of soft flexible material, it is capable of flattening when tension on the repair suture (51, Fig. 5-8; 11, Fig. 14-15) is applied).
Regarding claim 4, Dreyfuss discloses the limitations of claim 1 and further discloses wherein the knotlessly locking region is configured to extend through an entire thickness of the soft tissue (as the claimed limitation is an intended use of the knotlessly locking region, the knotlessly locking region (splice region 75/53) is capable of extending through the entire thickness of the soft tissue 95).
Regarding claim 5, Dreyfuss discloses the limitations of claim 4 and further discloses wherein the knotlessly locking region is configured to extend through an entire thickness of the soft tissue and across the break (as the claimed limitation is an intended use of the knotlessly locking region, the knotlessly locking region (splice region 75/53) is capable of extending through the entire thickness of the soft tissue 95 and across the break of the soft tissue).
Regarding claim 6, Dreyfuss discloses the limitations of claim 1 and further discloses wherein the repair suture first end forms a loop through the anchor, terminating in a fixed knot (52, Fig. 5-8), to fixedly couple the repair suture to the anchor (paragraph 32).
Regarding claim 10, Dreyfuss discloses a tissue repair system for repairing a break in a soft tissue (abstract, paragraph 5, 17) comprising:
a repair construct (Fig. 5-8, 14-15) comprising:
an anchor (100/200a) formed of soft flexible material (paragraph 24) and configured to directly engage a first external surface of the soft tissue (the anchor 100/200a is capable of being configured to directly engaging a first external surface of the soft tissue 95 as intended use);
a repair suture (51/11, Fig. 5-8, 14-15) having a first end fixedly coupled to the anchor and a second end extending from the anchor (as seen in Fig. 5-8, suture 51 is tied at a first end to anchor 100 at knot 52 and a second end extends from the anchor; as seen in Fig. 14-15, eyelet 15 is larger than the aperture from where the suture exits on the right side and pulling on the suture end 11a would cause the eyelet to get stuck and fix it to the anchor), wherein the repair suture defines a lumen (as seen in Fig. 5-8, 14-15, suture 51/11 passes through itself through a lumen in splice region 75/53);
a snare construct (70, Fig. 14) extending within and along a length of the repair suture lumen in a region of the repair suture directly adjacent the anchor (as seen in Fig. 14), defining a knotless locking region (splice region 75/53, paragraph 40), the snare construct having a first end extending from a first end of the knotlessly locking region and a second end extending from a second end of the knotlessly locking region (as seen in Fig. 14);
wherein the snare construct first end is configured be passed from the first external surface of the tissue, through the tissue and through a second external surface of the tissue at a first location and then couple to the repair suture second end, such that tension on the snare construct second end draws the repair suture second end through the soft tissue in a first direction from the second external surface to the first external surface at the first location, and then from the first external surface through the knotlessly locking region to the second external surface at a second location of the soft tissue, to form a repair loop (55a) in the repair suture extending through the soft tissue, and wherein tension on the repair suture second end is configured to actuate the knotless locking region and knotlessly lock the repair loop (paragraph 39-40, Fig. 14-15, as the claimed limitation is an intended use of the snare construct and repair suture, the first end of the snare construct 70 is capable of being passed from the first external surface of the tissue, through the tissue and through a second external surface of the tissue at a first location and then couple to the repair suture second end, and the suture 51/11 is capable of being passed through the soft tissue 95 when the snare construct 70 couples with a second end of the repair suture (paragraph 39, free end 11a of repair suture 11 passes through eyelet 71 of snare construct 70) and then tension is drawn to pull the repair suture through the soft tissue, and then pulled from the first side of the soft tissue to the second side of the soft tissue through the knotless locking region (splice region 75/53) to form a repair loop 55a and knotlessly lock the repair loop).
Regarding claim 12, Dreyfuss discloses the limitations of claim 10 wherein the anchor forms a V-shape or a Z-shape (as seen in Fig. 3, 7-8, anchor 100 is a V-shape) and wherein tension on the repair suture in configured to flatten the V-shape or Z- shape against the first external surface (because the anchor 100/200a is made of soft flexible material, it is capable of flattening against the first external surface when tension on the repair suture (51, Fig. 5-8; 11, Fig. 14-15) is applied).
Regarding claim 13, Dreyfuss discloses the limitations of claim 10, and further discloses wherein the knotlessly locking region is configured to extend through an entire thickness of the soft tissue (as the claimed limitation is an intended use of the knotlessly locking region, the knotlessly locking region (splice region 75/53) is capable of extending through the entire thickness of the soft tissue 95).
Regarding claim 14, Dreyfuss discloses the limitations of claim 10, and further discloses wherein the repair suture first end forms a loop through the anchor, terminating in a fixed knot (52, Fig. 5-8), to fixedly couple the repair suture to the anchor (paragraph 32).
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.
Claims 1-2, 6, 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over US 20170049434 Dooney et al. (hereinafter Dooney) in view of Dreyfuss.
Regarding claim 1, Dooney discloses a tissue repair system for repairing a break in a soft tissue (abstract, paragraph 3-5) comprising:
a repair construct (100, Fig. 1-5) comprising:
an anchor (10) configured to directly engage a first external surface of the soft tissue (Fig. 3, 5, the anchor 10 is capable of directly engaging a first external surface of the soft tissue 50 as the suture 30 is tightened and brings the anchor in direct contact with the anchor);
a repair suture (30) having a first end fixedly coupled to the anchor and a second end extending from the anchor (paragraph 32, as seen in Fig. 1-5, a knot 31 fixes a first end of the suture to the anchor and a second end (33a, 33b) extends through and out of the anchor), wherein the repair suture defines a lumen (paragraph 34, as seen in Fig. 1-5, suture 30 passes through itself through a lumen in splice region 39);
a snare construct (40) extending within and along a length of the repair suture lumen in a region of the repair suture directly adjacent the anchor (as seen in Fig. 1-2, 4), defining a knotless locking region (splice region 39, paragraph 34-38), the snare construct having a first end extending from a first end of the knotless locking region and a second end extending from a second end of the knotless locking region (as seen in Fig. 1-2, 4);
wherein the snare construct first end is configured to be first passed through a first side of the lumen and then couple to the repair suture second end, such that with tension on the snare construct second end draws the repair suture second end through the soft tissue in a first direction from a second external surface to the first external surface on the first side of the break, and then in an opposing direction from the first external surface through the knotless locking region and through the second external surface on a second side of the break, to form a repair loop (88a/88b) in the repair suture extending through the soft tissue and around the break, and wherein tension on the repair suture second end is configured to actuate the knotless locking region and knotlessly lock the repair loop (paragraph 32-38).
Dooney is silent on the anchor formed of soft flexible material.
However, Dreyfuss teaches a tissue repair system for repairing a break in a soft tissue (abstract, paragraph 5, 17) that comprises an anchor (100/200a) formed of soft flexible material (paragraph 24).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Dooney with the teachings of Dreyfuss in order to provide a soft flexible anchor that easily conforms to irregular shapes of tissue surfaces for maximum surface contact.
Regarding claim 2, the combination of Dooney and Dreyfuss teaches the limitations of claim 1 and Dooney further discloses wherein the repair suture second end is configured to be passed through a second side of the break before coupling to the snare construct first end, such that the repair loop includes three passes through the soft tissue (paragraph 38, as seen in Fig. 4-5, the second end 33a, 33b, are passed through the tissue three times to create the repair loop 88a/88b).
Regarding claim 6, the combination of Dooney and Dreyfuss teaches the limitations of claim 1, and Dooney further discloses wherein the repair suture first end forms a loop through the anchor, terminating in a fixed knot (31, Fig. 1), to fixedly couple the repair suture to the anchor (paragraph 32).
Regarding claim 10, Dooney discloses a tissue repair system for repairing a break in a soft tissue (abstract, paragraph 3-5) comprising:
a repair construct (100, Fig. 1-5) comprising:
an anchor (10) configured to directly engage a first external surface of the soft tissue (Fig. 3, 5, the anchor 10 is capable of directly engaging a first external surface of the soft tissue 50 as the suture 30 is tightened and brings the anchor in direct contact with the anchor);
a repair suture (30) having a first end fixedly coupled to the anchor and a second end extending from the anchor (paragraph 32, as seen in Fig. 1-5, a knot 31 fixes a first end of the suture to the anchor and a second end (33a, 33b) extends through and out of the anchor), wherein the repair suture defines a lumen (paragraph 34, as seen in Fig. 1-5, suture 30 passes through itself through a lumen in splice region 39);
a snare construct (40) extending within and along a length of the repair suture lumen in a region of the repair suture directly adjacent the anchor (as seen in Fig. 1-2, 4), defining a knotless locking region (splice region 39, paragraph 34-38), the snare construct having a first end extending from a first end of the knotless locking region and a second end extending from a second end of the knotless locking region (as seen in Fig. 1-2, 4);
wherein the snare construct first end is configured be passed from the first external surface of the tissue, through the tissue and through a second external surface of the tissue at a first location and then couple to the repair suture second end, such that tension on the snare construct second end draws the repair suture second end through the soft tissue in a first direction from the second external surface to the first external surface at the first location, and then from the first external surface through the knotlessly locking region to the second external surface at a second location of the soft tissue, to form a repair loop (88a/88b) in the repair suture extending through the soft tissue, and wherein tension on the repair suture second end is configured to actuate the knotless locking region and knotlessly lock the repair loop (paragraph 32-38, as the claimed limitation is an intended use of the snare construct and repair suture, the first end of the snare construct 40 is capable of being passed from the first external surface of the tissue, through the tissue and through a second external surface of the tissue at a first location and then couple to the repair suture second end).
Dooney is silent on the anchor formed of soft flexible material.
However, Dreyfuss teaches a tissue repair system for repairing a break in a soft tissue (abstract, paragraph 5, 17) that comprises an anchor (100/200a) formed of soft flexible material (paragraph 24).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Dooney with the teachings of Dreyfuss in order to provide a soft flexible anchor that easily conforms to irregular shapes of tissue surfaces for maximum surface contact.
Regarding claim 11, the combination of Dooney and Dreyfuss teaches the limitations of claim 10, and Dooney further discloses wherein the repair suture second end is configured to be pass through the soft tissue at the second location before coupling to the snare construct first end, such that the repair loop includes three passes through the soft tissue (paragraph 38, as seen in Fig. 4-5, the second end 33a, 33b, are passed through the tissue three times to create the repair loop 88a/88b).
Claims 7, 15 are rejected under 35 U.S.C. 103 as being unpatentable over Dreyfuss in view of US 20050137624 Fallman.
Regarding claim 7, Dreyfuss discloses the limitations of claim 1.
Dreyfuss is silent on wherein the repair suture second end is spliced with the snare construct, at a location spaced away from the knotless locking region.
However, Fallman teaches a device for connecting ends of a suture for sealing an incision (abstract, paragraph 6-8) that comprises a suture (530, Fig. 3) that is spliced in itself at a knotless locking region (532) and having a second end that is also spliced in itself at another location (534) that is spaced away from the knotless locking region (as seen in Fig. 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Dreyfuss with the teachings of Fallman to have the repair suture second end spliced with the snare construct of Dreyfuss at a second location as taught by Fallman in order to pull the second end of the repair suture through the second location to provide additional locking strength as disclosed by Fallman (paragraph 17).
Regarding claim 15, Dreyfuss discloses the limitations of claim 10.
Dreyfuss is silent on wherein the repair suture second end is spliced with the snare construct, at a location spaced away from the knotless locking region.
However, Fallman teaches a device for connecting ends of a suture for sealing an incision (abstract, paragraph 6-8) that comprises a suture (530, Fig. 3) that is spliced in itself at a knotless locking region (532) and having a second end that is also spliced in itself at another location (534) that is spaced away from the knotless locking region (as seen in Fig. 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Dreyfuss with the teachings of Fallman to have the repair suture second end spliced with the snare construct of Dreyfuss at a second location as taught by Fallman in order to pull the second end of the repair suture through the second location to provide additional locking strength as disclosed by Fallman (paragraph 17).
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Dooney in view of Dreyfuss as applied to claim 2 above, and further in view of US 20120283750 Saliman et al. (hereinafter Saliman).
Regarding claim 8, the combination of Dooney and Dreyfuss teaches the limitations of claim 2.
The combination is silent on further comprising an insertion device configured to arthroscopically insert the repair construct around the break, the insertion device having a distal end with an axially slideable needle, and wherein the needle is configured to pass the snare construct first end through the soft tissue on a first side of the break and is also configured to pass the repair suture second end through the soft tissue on a second side of the break.
However, Saliman teaches a device for arthroscopically repairing a meniscus break (abstract, paragraph 12-13; meniscus tear or break in Fig. 6a, 37a, paragraph 204, 228) that comprises an insertion device (600, Fig. 40a) having a distal end with an axially slideable needle (tissue penetrator 603, Fig. 40b-f, paragraph 34, 255-257), and wherein the needle is configured to pass a snare construct first end (loop/suture puller, paragraph 34-35) through the soft tissue on a first side of the break and is also configured to pass a repair suture second end (607) through the soft tissue on a second side of the break (Fig. 40b-g, paragraph 239-240, 255-259).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modification of Dooney with Dreyfuss with the teachings of Saliman in order to provide a minimally invasive surgical device to suture and repair a tissue break.
Regarding claim 9, the combination of Dooney, Dreyfuss and Saliman teaches the limitations of claim 8, and Saliman teaches wherein the needle is configured to place the anchor onto the first external surface of the soft tissue while passing either the snare construct first end or the repair suture second end through the soft tissue. (suture may be tightened and/or knotted, anchored, or otherwise secured in position…In some variations, suture anchors, ties or stays may be used. In some variations, knotless anchors, ties or stays may be used, paragraph 218, 233; as the claimed limitation is an intended use of the needle, the needle (tissue penetrator 603) of Saliman is capable of placing the modified anchor of Dooney with Dreyfuss on the first external surface of the soft tissue while passing either the snare construct first end (loop/suture puller) or the repair suture second end (607) through the soft tissue (paragraph 239-240, 255-259)).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Dooney in view of Dreyfuss as applied to claim 11 above, and further in view of Saliman.
Regarding claim 16, the combination of Dooney and Dreyfuss teaches the limitations of claim 11.
The combination is silent on further comprising an insertion device having a distal end with an axially slideable needle, and wherein the needle is configured to pass the snare construct first end through the soft tissue and is also configured to pass the repair suture second end through the soft tissue.
However, Saliman teaches a device for repairing a meniscus break (abstract, paragraph 12-13; meniscus tear or break in Fig. 6a, 37a, paragraph 204, 228) that comprises an insertion device (600, Fig. 40a) having a distal end with an axially slideable needle (tissue penetrator 603, Fig. 40b-f, paragraph 34, 255-257), and wherein the needle is configured to pass a snare construct first end (loop/suture puller, paragraph 34-35) through the soft tissue and is also configured to pass a repair suture second end (607) through the soft tissue (Fig. 40b-g, paragraph 239-240, 255-259).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modification of Dooney with Dreyfuss with the teachings of Saliman in order to provide a minimally invasive surgical device to suture an repair a tissue break.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KHOA TAN LE whose telephone number is (703)756-1252. The examiner can normally be reached Monday - Friday 8am - 4:30pm.
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/KHOA TAN LE/Examiner, Art Unit 3771 /MOHAMED G GABR/Primary Examiner, Art Unit 3771
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