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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 6/30/25 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 9 is objected to because of the following informalities: in line 1, “damage” should read --damaged--. Appropriate correction is required.
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 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dreyfuss et al. (US 2013/0023928 A1).
Regarding claim 1, Dreyfuss discloses (Figures 8 and 9) a knotless surgical construct (40) for tissue repair, comprising: at least one flexible strand comprising a free end (end 44), a loop end (at 42) opposite the free end, and a repair length therebetween, the repair length being configured to form a continuous and adjustable repair loop (45) when the free end extends through the loop end (Figure 9), the repair loop capable of encircling a tear in tissue; and a self-locking device (41) being located adjacent to the loop end of the flexible strand, the self-locking device capable of fixing the repair loop once the repair loop is tensioned around the tear without the use of any knots or fixation devices (paragraph 0034).
Regarding claim 2, Dreyfuss discloses (Figure 9) the free end (44) of the flexible strand extends through the self-locking device (41; paragraph 0034).
Regarding claim 3, Dreyfuss discloses (Figure 9) the self-locking device is a finger-trap suture (paragraph 0034).
Claims 1-3, 5-12, 18, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hirotsuka et al. (US 2016/0302789 A1) (“Hirotsuka”).
Regarding claim 1, Hirotsuka discloses (Figures 6A-6J) a knotless surgical construct for tissue repair, comprising: at least one flexible strand (600) comprising a free end (see Figure 6A annotated below), a loop end (see Figure 6A annotated below) opposite the free end, and a repair length therebetween, the repair length being configured to form a continuous and adjustable repair loop when the free end extends through the loop end (Figure 6D), the repair loop capable of encircling a tear in tissue; and a self-locking device (601) being located adjacent to the loop end of the flexible strand, the self-locking device capable of fixing the repair loop once the repair loop is tensioned around the tear (Figure 6I) without the use of any knots or fixation devices (paragraphs 0117, 0144-0150).
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Regarding claim 2, Hirotsuka discloses (Figure 6D) the free end of the flexible strand (600) extends through the self-locking device (601; paragraph 0148).
Regarding claim 3, Hirotsuka discloses that the self-locking device (601) is a finger-trap suture (paragraphs 0143-0149).
Regarding claim 5, Hirotsuka discloses (Figure 6B) a separate shuttling device (603) coupled to the free end of the flexible strand (paragraphs 0144, 0147, 0148).
Regarding claim 6, Hirotsuka discloses (Figure 6A, 6B) that the shuttling device (603) is a shuttle suture (paragraphs 0144, 0147, 0148).
Regarding claim 7, Hirotsuka discloses (Figures 6A-6J) a method of knotless tissue repair, comprising the steps of: passing, in a first direction, a free end (see Figure 6A annotated above) of at least one flexible strand of a surgical construct (600) through or around damaged tissue (paragraph 0148); threading the free end through a loop end of the flexible strand that is opposite the free end (Figures 6C and 6D), thereby forming a continuous and adjustable repair loop with a repair length of the flexible strand that is between the free end and the loop end, such that the repair loop encircles a tear in the tissue (Figures 6D and 6E); pulling on the free end to tension the repair loop around the tear in the damaged tissue (Figures 6F-6I); and after the step of pulling on the free end to tension the repair loop, fixing the repair loop without knotting or anchoring the flexible strand to secure the repair (paragraphs 0143-0152).
Regarding claim 8, Hirotsuka discloses (Figure 6A) that the free end of the flexible strand and the loop end of the flexible strand extend from inferior and superior surfaces, respectively, of the tissue (see Figure 6A annotated below).
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Regarding claim 9, Hirotsuka discloses that the tissue that is damage is a meniscus (paragraph 0152) and the superior and inferior surfaces are femoral and tibial surfaces (paragraphs 0166-0167), respectively.
Regarding claim 10, Hirotsuka discloses that the flexible strand (600) self-locks (at 601) when fixing the repair loop (paragraphs 0143-0149).
Regarding claim 11, Hirotsuka discloses (Figure 6A) that the flexible strand (600) self-locks using a finger-trap suture (601) that is adjacent the loop end of the flexible strand (paragraphs 0143-0149).
Regarding claim 12, Hirotsuka discloses (Figures 6D-6I) that the free end of the flexible strand extends through the finger-trap suture (601; paragraph 0148).
Regarding claim 18, Hirotsuka discloses (Figure 6A) that the step of passing the free end of the flexible strand through or around tissue that is damaged includes passing at least a portion of the repair length of the flexible strand through a thickness of the tissue that is damaged near the tear (paragraph 0148).
Regarding claim 19, Hirotsuka discloses (Figure 6I) that the tissue is a meniscus and the repair loop extends through the thickness of the meniscus (paragraphs 0148, 0152).
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 16, 17, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Hirotsuka et al. (US 2016/0302789 A1) (“Hirotsuka”).
Regarding claims 16 and 17, Hirotsuka discloses the method substantially as claimed. Hirotsuka discloses that the tissue is a meniscus (paragraph 0152). However, Hirotsuka fails to disclose the step of passing the free end of the flexible strand through or around tissue that is damaged includes wrapping the repair length of the flexible strand around an outside of the tissue to form the repair loop, wherein the repair loop encircles the outside of the meniscus.
In paragraph 0025, Hirotsuka further discloses that any of the disclosed suture constucts may be used to suture tissue, and in particular secure a loop of suture through and/or around tissue. Further, Hirotsuka discloses that any of the disclosed methods may also be used to form a loop of suture around a torn meniscus (paragraph 0027).
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 method disclosed in Figures 6A-6J of Hirotsuka to wrap the repair length of the flexible strand around an outside of the tissue to form the repair loop, wherein the repair loop encircles the outside of the meniscus, as Hirotsuka discloses that any of the methods disclosed may be used to form a loop of suture around a torn meniscus (paragraph 0027). Further, this modification would create a fully-circumferential, vertical stitch to provide uniform compression along the entire height of the meniscus and maintain coaptation of the tear at both the inferior and superior meniscal surfaces (paragraph 0164).
Regarding claim 20, Hirotsuka discloses the invention substantially as claimed. However, it is not clear from Figures 6A-6J that at least another portion of the repair length of the flexible strand extends through the thickness of the tissue at a location different than the at least a portion of the repair length.
In paragraph 0025, Hirotsuka discloses that any of the suture constructs disclosed may be used to suture tissue, and in particular to secure a loop of suture through and/or around tissue (paragraph 0025). The methods depicted in Figures 3A-3G, 4A-4G, and 5A-5J all disclose that another portion of the repair length of the flexible strand extends through the thickness of the tissue at a location different than the at least a portion of the repair length.
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 method disclosed in Figures 6A-6J of Hirotsuka such that at least another portion of the repair length of the flexible strand extends through the thickness of the tissue at a location different than the at least a portion of the repair length, as taught in the alternate methods presented in Figures 3A-3G, 4A-4G, and 5A-5J of Hirotsuka. This modification forms a cinch loop around that tear that is tightened to squeeze the tear together and approximate the tissue (Hirotsuka, Figure 5J; paragraph 0232).
Allowable Subject Matter
Claims 4 and 13-15 are 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.
Claim 4 recites that the repair length doubles on itself to define a cinch loop that extends through the loop end such that the repair loop comprises at least two flexible strand lengths. These limitations, in combination with the limitations of claim 1, are not disclosed or suggested by the prior art of record. Hirotsuka fails to disclose or suggest that the repair length doubles on itself to define a cinch loop that extends through the loop end such that the repair loop comprises at least two flexible strand lengths.
Claim 13 recites the step of passing the free end, in a second direction, through or around the tissue, the second direction being the reverse of the first direction, so that the repair loop doubles to comprise at least two flexible strand repair lengths. These limitations, in combination with the limitations of claim 7, are not disclosed or suggested in the prior art of record. Hirotsuka fails to disclose or suggest the step of passing the free end, in a second direction, through or around the tissue, the second direction being the reverse of the first direction, so that the repair loop doubles to comprise at least two flexible strand repair lengths.
Claims 14 and 15 are dependent on claim 13, thus would also be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Schwartz et al. (US 2003/0078617 A1; Figures 1-53) discloses various constructs and methods for repairing meniscus tears.
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/C.D.K/Examiner, Art Unit 3771
/DIANE D YABUT/Primary Examiner, Art Unit 3771
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