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 amendments
In the amendments dated 11/6/25, claim 29 is indicated as (original) but it should have been indicated as (new).
Election/Restrictions
Applicant’s election without traverse of Claims 9-17 in the reply filed on 11/6/25 is acknowledged.
Claim Objections
Claims 9, 24, 27 are objected to because of the following informalities:
In claims 9, 24, and 27, semicolons are used in some cases where a different or no punctuation mark should be used. See Claim 9, 24, and 27: “with both soft anchors deployed;” should use a comma or colon, and “passing the first repair suture through the second soft anchor by;” should have a colon or no punctuation.
Claim 27 recites “extending though second soft anchor.” This has a typographical error and is missing an article and should be “extending through the second soft anchor.”
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 10, 21, 22, and 28 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 10 and 28 recite “sheet-like.” It is unclear exactly how this limits the structure because of the word “like.” This should be replaced with a clear and definite structure such as “sheet.”
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.
Claim(s) 9, 15, 23-24, 27, 29-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lund [US 2018/0221010 A1] in view of Rodriguez et al. [US 2015/0173739 A1, hereinafter “Rodriguez”].
Re. claim 9, Lund discloses a method of forming a knotless suture staple [Figs. 8-9], comprising:
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deploying a first soft [Par. 0095] anchor [first anchor 10] in a first bone portion [of 90, Fig. 8], the first soft anchor comprising a first repair suture [first repair suture 20] extending therethrough, and wherein the first soft anchor also includes a first deploying suture [40] threaded through the first soft anchor and also through the second repair suture defining a second knotless suture-locking-passage region [Fig. 8], wherein deploying includes applying tension to the second deploying suture [Par. 0048];
deploying a second soft [Par. 0095] anchor [10] in a second bone portion [of 90], spaced away from the first bone portion [Fig. 8], the second soft anchor comprising a second repair suture [20] extending therethrough, , and wherein the second soft anchor also includes a second deploying suture [40] threaded through the second soft anchor and also through the second repair suture defining a second knotless suture-locking-passage region, wherein deploying includes applying tension to the second deploying suture [Par. 0048];
with both soft anchors deployed;
passing the first repair suture through the second soft anchor [Fig. 9] by;
coupling the first repair [20] suture to a second deploying suture [40]; and
withdrawing the second deploying suture to remove the second deploying suture from the second soft anchor and replace it with the first repair suture, including drawing the first repair suture through the second knotless suture-locking-passage region to form a first leg of the knotless suture staple [Fig. 9; Par. 0048];
and passing the second repair suture through the first soft anchor [Fig. 9], by;
coupling the second repair suture extending from the second soft anchor to the first deploying suture [Fig. 9; Par. 0048]; and
withdrawing the first deploying suture to remove it from the first soft anchor and replace it with the second repair suture including drawing the second repair suture through the first knotless suture-locking-passage region to form a second leg of the knotless suture staple [Fig. 9]; and
tensioning the first and second repair suture to knotless lock the first and second legs of the knotless suture staple [“two flexible ends for additional pulling/tensioning of the final repair,” Par. 0048].
Lund differs from the claimed invention in that Lund fails to disclose the repair sutures including a cannulation, the respective deploying sutures threaded through the soft anchors and also through the cannulation of the repair suture defining a knotless suture-locking-passage region, the knotless suture-locking-passage region interwoven repeatedly through and along the respective soft anchor.
However, Rodriguez discloses a method of forming a knotless suture [Par. 0007, Figs. 7-14], comprising:
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deploying a first soft anchor [Annotated Fig. 8 above] in a first bone portion [112], the first soft anchor comprising a first repair suture [with ends 82 and 84] extending therethrough, the first repair suture including a cannulation [“lumen,” Par. 0076], and wherein the first soft anchor also includes a first deploying suture [with end 90] threaded through the first soft anchor and also through the cannulation defining a first knotless suture- locking-passage region [86], the first knotless suture-locking-passage region interwoven repeatedly through and along the first soft anchor [Fig. 8; Par. 0076], wherein deploying includes applying tension to the first deploying suture [“The snare 90 may now be pulled distally,” Par. 0077, Fig. 10];
coupling the first repair suture to a second deploying suture [94]; and
and passing a second repair suture end through the first soft anchor [Figs. 9-12], by;
coupling a second repair suture end extending from the soft anchor to the first deploying suture [Fig. 10, coupling 90 to 82]; and
withdrawing the first deploying suture to remove it from the first soft anchor and replace it with the second repair suture end including drawing the second repair suture through the first knotless suture-locking-passage region to form a second leg of the knotless suture staple [Figs. 10-11]; and
tensioning the first and second repair suture to knotless lock the first and second legs of the knotless suture staple [Fig. 14].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of Lund by configuring the first and second repair sutures to be cannulated, and the first and second deploying sutures (of Lund) to be threaded through the respective first or second soft anchor and also through the cannulation defining a first (second) knotless suture- locking-passage region, the first (second) knotless suture-locking-passage region interwoven repeatedly through and along the first (second) soft anchor, as taught by Rodriguez, because this cannulation and repeated weaving because this configuration allows for an anchor’s size and shape to be manipulated by the application of tension to generate a bone-lock configuration [Rodriguez Pars. 0040, 0072-0073; Figs. 13-14].
Re. claim 24, Lund discloses a method of forming a knotless suture staple [Figs. 8-9], comprising:
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deploying a first soft [Par. 0095] anchor [first anchor 10] in a first bone portion [of 90, Fig. 8], the first soft anchor comprising a first repair suture [first repair suture 20] extending therethrough, and wherein the first soft anchor also includes a first deploying suture [40] threaded through the first soft anchor and also through the second repair suture defining a second knotless suture-locking-passage region [Fig. 8], wherein deploying includes applying tension to the second deploying suture [Par. 0048];
deploying a second soft [Par. 0095] anchor [10] in a second bone portion [of 90], spaced away from the first bone portion [Fig. 8], the second soft anchor comprising a second repair suture [20] extending therethrough, , and wherein the second soft anchor also includes a second deploying suture [40] threaded through the second soft anchor and also through the second repair suture defining a second knotless suture-locking-passage region, wherein deploying includes applying tension to the second deploying suture [Par. 0048];
with both soft anchors deployed;
passing the first repair suture through the second soft anchor [Fig. 9] by;
coupling the first repair [20] suture to a second deploying suture [40]; and
withdrawing the second deploying suture to remove the second deploying suture from the second soft anchor and replace it with the first repair suture, including drawing the first repair suture through the second knotless suture-locking-passage region to form a first leg of the knotless suture staple [Fig. 9; Par. 0048];
and passing the second repair suture through the first soft anchor [Fig. 9], by;
coupling the second repair suture extending from the second soft anchor to the first deploying suture [Fig. 9; Par. 0048]; and
withdrawing the first deploying suture to remove it from the first soft anchor and replace it with the second repair suture including drawing the second repair suture through the first knotless suture-locking-passage region to form a second leg of the knotless suture staple [Fig. 9]; and
tensioning the first and second repair suture to knotless lock the first and second legs of the knotless suture staple [“two flexible ends for additional pulling/tensioning of the final repair,” Par. 0048].
Lund differs from the claimed invention in that Lund fails to disclose the repair sutures including a cannulation, the respective deploying sutures threaded through the soft anchors and also through the cannulation of the repair suture defining a knotless suture-locking-passage region, the knotless suture-locking-passage region interwoven repeatedly through and along the respective soft anchor. Lund fails to disclose deploying the first soft anchor on an external surface of a first bone portion and deploying a second soft anchor on a second bone portion.
However, Rodriguez discloses a method of forming a knotless suture [Par. 0007, Figs. 7-14], comprising:
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deploying a first soft anchor [Annotated Fig. 8 above] in a first bone portion [112], the first soft anchor comprising a first repair suture [with ends 82 and 84] extending therethrough, the first repair suture including a cannulation [“lumen,” Par. 0076], and wherein the first soft anchor also includes a first deploying suture [with end 90] threaded through the first soft anchor and also through the cannulation defining a first knotless suture- locking-passage region [86], the first knotless suture-locking-passage region interwoven repeatedly through and along the first soft anchor [Fig. 8; Par. 0076], wherein deploying includes applying tension to the first deploying suture [“The snare 90 may now be pulled distally,” Par. 0077, Fig. 10];
coupling the first repair suture to a second deploying suture [94]; and
and passing a second repair suture end through the first soft anchor [Figs. 9-12], by;
coupling a second repair suture end extending from the soft anchor to the first deploying suture [Fig. 10, coupling 90 to 82]; and
withdrawing the first deploying suture to remove it from the first soft anchor and replace it with the second repair suture end including drawing the second repair suture through the first knotless suture-locking-passage region to form a second leg of the knotless suture staple [Figs. 10-11]; and
tensioning the first and second repair suture to knotless lock the first and second legs of the knotless suture staple [Fig. 14].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of Lund by configuring the first and second repair sutures to be cannulated, and the first and second deploying sutures (of Lund) to be threaded through the respective first or second soft anchor and also through the cannulation defining a first (second) knotless suture- locking-passage region, the first (second) knotless suture-locking-passage region interwoven repeatedly through and along the first (second) soft anchor, as taught by Rodriguez, because this cannulation and repeated weaving because this configuration allows for an anchor’s size and shape to be manipulated by the application of tension to generate a bone-lock configuration [Rodriguez Pars. 0040, 0072-0073; Figs. 13-14].
Regarding the anchors being deployed on an external surface, Rodriguez teaches deploying the first soft anchor on an external surface of a first bone portion and deploying a second soft anchor on a second bone portion [Fig. 13-15]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of the modified Lund by applying it to a repair method in which the anchors are deployed on the surface of a bone portion because this allows the method to be used in a known method of tissue repair in which, for example, an ACL is reconstructed [Rodriguez Par. 0002].
Re. claim 27, Lund discloses a method of forming a knotless suture staple [Figs. 8-9], comprising:
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deploying a first soft [Par. 0095] anchor [first anchor 10] in a first bone portion [of 90, Fig. 8], the first soft anchor comprising a first repair suture [first repair suture 20] fixedly [via 28] coupled to the first soft anchor and extending through the first soft anchor with a first repair suture end extending from a proximal end of the first soft anchor [Fig. 8],
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and wherein the first soft anchor also includes a first deploying suture [40] threaded through the first soft anchor and also through the second repair suture defining a second knotless suture-locking-passage region [Fig. 8], wherein deploying includes applying tension to the second deploying suture [Par. 0048];
deploying a second soft [Par. 0095] anchor [10] in a second bone portion [of 90], spaced away from the first bone portion [Fig. 8], the second soft anchor comprising a second repair suture [20] fixedly [via 28] coupled to the second soft anchor and extending through the second soft anchor with a proximal end extending from a proximal end of the second soft anchor [Fig. 8], and wherein the second soft anchor also includes a second deploying suture [40] threaded through the second soft anchor and also through the second repair suture defining a second knotless suture-locking-passage region, wherein deploying includes applying tension to the second deploying suture [Par. 0048];
with both soft anchors deployed;
passing the first repair suture through the second soft anchor [Fig. 9] by;
coupling the first repair [20] suture to a second deploying suture [40]; and
withdrawing the second deploying suture to remove the second deploying suture from the second soft anchor and replace it with the first repair suture end, including drawing the first repair suture end through the second knotless suture-locking-passage region to form a first leg of the knotless suture staple [Fig. 9; Par. 0048];
and passing the second repair suture end through the first soft anchor [Fig. 9], by;
coupling the second repair suture end extending from the second soft anchor to the first deploying suture [Fig. 9; Par. 0048]; and
withdrawing the first deploying suture to remove it from the first soft anchor and replace it with the second repair suture end including drawing the second repair suture end through the first knotless suture-locking-passage region to form a second leg of the knotless suture staple [Fig. 9]; and
tensioning the first and second repair suture to knotless lock the first and second legs of the knotless suture staple [“two flexible ends for additional pulling/tensioning of the final repair,” Par. 0048].
Lund differs from the claimed invention in that Lund fails to disclose the repair sutures including a cannulation, the respective deploying sutures threaded through the soft anchors and also through the cannulation of the repair suture defining a knotless suture-locking-passage region, the knotless suture-locking-passage region interwoven repeatedly through and along the respective soft anchor.
However, Rodriguez discloses a method of forming a knotless suture [Par. 0007, Figs. 7-14], comprising:
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deploying a first soft anchor [Annotated Fig. 8 above] in a first bone portion [112], the first soft anchor comprising a first repair suture [with ends 82 and 84] extending therethrough, the first repair suture including a cannulation [“lumen,” Par. 0076], and wherein the first soft anchor also includes a first deploying suture [with end 90] threaded through the first soft anchor and also through the cannulation defining a first knotless suture- locking-passage region [86], the first knotless suture-locking-passage region interwoven repeatedly through and along the first soft anchor [Fig. 8; Par. 0076], wherein deploying includes applying tension to the first deploying suture [“The snare 90 may now be pulled distally,” Par. 0077, Fig. 10];
coupling the first repair suture to a second deploying suture [94]; and
and passing a second repair suture end through the first soft anchor [Figs. 9-12], by;
coupling a second repair suture end extending from the soft anchor to the first deploying suture [Fig. 10, coupling 90 to 82]; and
withdrawing the first deploying suture to remove it from the first soft anchor and replace it with the second repair suture end including drawing the second repair suture through the first knotless suture-locking-passage region to form a second leg of the knotless suture staple [Figs. 10-11]; and
tensioning the first and second repair suture to knotless lock the first and second legs of the knotless suture staple [Fig. 14].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of Lund by configuring the first and second repair sutures to be cannulated, and the first and second deploying sutures (of Lund) to be threaded through the respective first or second soft anchor and also through the cannulation defining a first (second) knotless suture- locking-passage region, the first (second) knotless suture-locking-passage region interwoven repeatedly through and along the first (second) soft anchor, as taught by Rodriguez, because this cannulation and repeated weaving because this configuration allows for an anchor’s size and shape to be manipulated by the application of tension to generate a bone-lock configuration [Rodriguez Pars. 0040, 0072-0073; Figs. 13-14].
Re. claims 15 and 29, the modified Lund teaches 15. (Original) The method of claim 9 wherein the first repair suture includes a tape portion [tape 20, Par. 0050] and wherein passing the first repair suture through the second soft anchor places the tape portion in engagement with a tissue to be repaired [as set forth above].
Re. claims 23 and 30, the modified Lund teaches applying tension to both the first repair suture and first deploying suture, but is silent regarding the order of tension applied. However, performing the method such that deploying the first soft anchor includes applying tension to both the first repair suture and first deploying suture, simultaneously would have been obvious to one of ordinary skill in the art before the effective filing date of the invention because it amounts to a change in sequence of performing the steps which does not achieve unexpected results and is thus prima facie obvious. See MPEP 2144.04.IV.C.
Claim(s) 10, 21-22,28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lund in view of Rodriguez, as applied to claim 9 or 27, and further in view of Van Kampen [US 2016/0361155 A1].
Re. claims 10 and 28, as best understood, Lund discloses tensioning a first and second repair suture to knotless lock the knotless suture staple, and the first and second bone portions as set forth above, but fails to teach a bio-inductive sheet- like implant. However, Van Kampen teaches a method of tendon repair comprising obtaining a bio-inductive sheet- like implant [50, Fig. 6; Par. 0101] and wherein stapling the bio-inductive sheet-like implant to the first and second portions [Par. 0117]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of Lund by adding the step of obtaining a bionductive sheet and attaching it as taught by Van Kampen because this allows for improved healing and reattachment of the implant [Van Kampen Par. 0004].
Re. claim 21 and 22, the modified Lund teaches the method set forth above, with Van Kampen teaching the bio-inductive sheet. Modifying the method of Lund-Van Kampen to include passing the first repair suture through the bio-inductive sheet-like implant and along an outer surface of the bio-inductive sheet-like implant would have been obvious to one of ordinary skill in the art before the effective filing date of the invention because this is required in order to allow the sheet-like implant to be used in the method of Lund. Regarding the order of operations, Passing the first/second repair suture through the sheet first, before coupling the first/second repair suture to the second/first deploying suture respectively would have been obvious in order to allow the suture to act as a staple for the sheet.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lund in view of Rodriguez, as applied to claim 9, and further in view of Foerster [US 6585730 B1]
Re. claim 11, in Fig. 15(a), Lund teaches the first and second bone are portions of a humerus bone [Par. 0079], but fails to describe the repair of the supraspinatus tendon. However, Foerster teaches, in a method of forming a knotless suture anchoring device, repairing the supraspinatus tendon [Col. 14 lines 11-18]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of the modified Lund by configuring the bone to be the humerus and the method to repair a suprasinatus tendon because this allows the above method to be used in a common rotator cuff repair procedure [Foerster Col. 14 lines 15-18], amounting to a simple substitution of one known element/step (the bone and tissue worked upon) for another with predictable results.
Claim(s) 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lund in view of Rodriguez, as applied to claim 9, and further in view of Jastifer et al. [US 20180243078 A1, hereinafter “Jastifer”].
Re. claim 12, the modified Lund teaches the repair method above but fails to teach the bone portions are portions of a calcaneus for repair of an Achilles tendon. However, Jastifer teaches a repair method
Re. claim 13, the modified Lund teaches the repair method above but fails to teach the first and second bone portions are portions of the femur adjacent a Gluteus Medius.
Jastifer teaches the first and second bone portions are portions of the femur. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of the modified Lund by configuring the bone to be a femur because this allows the above method to be used in a common repair procedure [Jastifer Par. 0104] amounting to a simple substitution of one known element/step (the bone and tissue worked upon) for another with predictable results. Regarding the bone being adjacent a Gluteus Medius, given the above teachings, one of ordinary skill would reasonably be apprised of the benefits of applying the above method to a femur adjacent the gluteus medius given the location of the desired repair.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lund in view of Rodriguez, as applied to claim 9, and further in view of Dooney et al. [US 20190021719 A1, hereinafter “Dooney”].
Re. claim 14, the modified Lund teaches the method above including passing the first repair suture through the second soft anchor passes the first repair suture first along an exterior surface over to the second soft anchor, and wherein tensioning the first and second repair suture to knotless lock the knotless suture staple, tensions the suture staple at a target tension [see claim 9 above] but fails to teach the first bone portion is a distal end of a fibula and the second bone portion is aDooney teaches a repair method using anchors wherein the first bone portion is a distal end of a fibula and the second bone portion is a
Claim(s) 25-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lund in view of Rodriguez, as applied to claim 24, and further in view of Cotton et al. [US 20180344892 A1, hereinafter “Cotton”].
Re. claim 25, the modified Lund teaches operating on an ACL [see claim 24 above], but fails to disclose details of the procedure. However, Cotton teaches, in a method of ACL repair, anchors are placed in first and second bone are portions are located opposing sides of an ACL insertion location [Fig. 1]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of the modified Lund by applying it to a repair method in which the anchors are deployed on opposing sides of an ACL insertion location because this allows the method to be used in a known method of tissue repair in which, for example, an ACL is reconstructed.
Re. claim 26, Cotton further teaches coupling the first and second repair sutures to an ACL [Fig. 1, Par. 0019]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of the modified Lund by coupling the first and second repair sutures to an ACL because this allows the method to be used in a known method of tissue repair in which, for example, an ACL is reconstructed.
Allowable Subject Matter
Claim 16 is objected to as being dependent upon 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. Lund and Rodriguez as combined above fail to teach or suggest the first and second knotless suture-locking-passage regions are interwoven through a single side of the respective tubular body lumens and absent an opposing side. Rodriguez teaches weaving through opposite sides, and for the purpose of changing the shape of the anchor as depicted (see citations above). There would have been no motivation to weave through only one side because this would prevent the desired shape change.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIN MCGRATH whose telephone number is (571)270-0674. The examiner can normally be reached M-F 9 am to 5 pm ET.
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/ERIN MCGRATH/Primary Examiner, Art Unit 3771