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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/6/2025 has been entered.
Response to Amendment
In response to the amendment filed on 1/6/2025, claim 3 is cancelled, and claims 1, 2, 4-12 are pending.
The amendments obviate the previous 35 U.S.C. 112 rejections. Those rejections are hereby withdrawn.
Response to Arguments
Applicant’s arguments, see pages 5-7, filed 1/6/2025, with respect to the 35 U.S.C. 102 rejection under Dreyfuss have been fully considered and are persuasive. The rejection under Dreyfuss of claims 1, 2, 4, 6, 7 and 9-12 has been withdrawn.
Applicant's arguments filed 1/6/2025 with respect to the 35 U.S.C. 102 rejection under Armington et al have been fully considered but they are not persuasive. Applicant argues Armington et al fails to disclose “wherein a portion of the second portion of suture material extends through the first loop at a position proximally beyond and outside of the splice and of the anchor.” Applicant provides on page 7 of the remarks an annotated figure of Armington et al, pointing in the upward direction for “proximally” in Fig. 3A. However, as detailed in the rejection below, the Examiner has interpreted “proximally” as extending in the downward opposite direction from what Applicant has illustrated in the remarks. As seen in Fig. 8 of Applicant’s figures (and indicated by Applicant as support for the claimed language), “proximally” appears to be in the direction away from the anchor and the splice. Therefore, the Examiner has similarly interpreted “proximally” in Armington et al as in the direction away from both the anchor and the splice and is thus interpreted as the downward direction. With such an interpretation, it can be seen that a portion (as annotated below in claim 1) of the second portion of the suture material does in fact extend through the first loop (suture material beginning from portion 358 which exits oval opening 320 and loops back and returns to oval opening 320 at portion 354) at a position proximally (downward) beyond and outside of the splice (segment between apertures 368 and 364) and of the anchor (302) because "beyond" in its broadest, reasonable interpretation only requires "at or to the further side of" as defined by the Oxford Language dictionary. As seen in the annotated figure below, the annotated portion extending through the first loop is at a position outside of the splice and the anchor. The portion extends through the first loop also at a position beyond the splice and of the anchor because the location is to the further side of the splice and the anchor. Therefore, Armington et al appears to meet the limitations of claim 1 as amended.
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.
Claim(s) 1, 2, 4-9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Armington et al (WO 2017/210659).
Armington et al discloses the following limitations:
Claim 1. A knotless instability anchor (300) (Fig. 3A; no knot exists in the construct of Fig. 3A) comprising:
an anchor (302) having a first side (right side as seen in Fig. 3A) and a second side (left side as seen in Fig. 3A) with a suture material (340) passing therethrough from the first side to the second side ([0033]-[0035]),
wherein the suture material has a first portion of suture material extending from the first side of the anchor (material of suture emerging downward from right side of oval opening 320 beginning around portion 358 and through that end of the suture) and a second portion of suture material extending from the second side of the anchor (material of suture emerging downward from the left side of oval opening 320 beginning around portion 362 and through that end of the suture);
a splice (segment between apertures 368 and 364 and indicated by the annotated box in the figure below) formed in the second portion of suture material ([0037]-[0039]); and
a first loop (suture material beginning from portion 358 which exits oval opening 320 and loops back and returns to oval opening 320 at portion 354; this looping back of the suture material forms a loop as seen in Fig. 3A) formed by the first portion of suture material;
wherein a portion (see annotated figure below) of the second portion of suture material extends through the first loop at a position proximally beyond (interpreted as in the downward direction of Fig. 3A) and outside of the splice and of the anchor ([0037], [0038] the suture follows a path from portion 370, then into and through the cited first loop at portion 372, and out and beyond the at portion 374. The annotated portion of the second portion of suture material can be seen below the horizontal dashed line, indicating it is proximally beyond (below) and outside of the splice and of the anchor. An annotated figure is provided below:
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Claim 2. The anchor of claim 1, further comprising a second loop (suture portion containing 370, 372 and 374 as annotated in the figure from claim 1) formed by the second portion of suture material ([0038]).
Claim 4. The anchor of claim 2, further comprising a first limb (394) formed by the second portion of suture material ([0039]).
Claims 5 and 8. The anchor of claim 1, wherein the first loop (annotated in the figure from claim 1) is adjustable; wherein a perimeter of the first loop is configured to be decreased from a first size to a second size smaller than the first size (as seen in Fig. 3A and discussed in [0035]-[0040], suture 340 is disposed in oval aperture 320 in a way that allows the suture to be capable of being moved relative thereto, which results in the first loop being adjustable. Specifically, in [0040], pulling on portions of the suture such as tail 394 allows for portions 370 and 364 to be adjusted and moved in the direction of arrow 398; therefore, indicating the oval aperture is of a size capable of allowing suture material 340 to move therethrough. Therefore, in light of such disclosure, if a user pulls upward on portion 350, the annotated first loop in the figure from claim 1 is capable of being adjusted from a first size to a second smaller size).
Claim 6. The anchor of claim 1, wherein the second portion includes an adjustable loop (loop defined by portions 370, 372 and 374)
Claim 7. The anchor of claim 1, wherein the suture material passes through the anchor at more than one passing location (Fig. 3A; multiple locations seen at suture portions 358, 354, 362, 348, 380).
Claim 9. The anchor of claim 6, wherein a perimeter of the adjustable loop (loop defined by portions 370, 372 and 374) is configured to be decreased from a first size to a second size smaller than the first size ([0040]).
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.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Armington et al in view of Norton et al (US 2015/0173754).
Claim 10. Armington et al discloses the invention substantially as claimed above, but fails to disclose the anchor is selected from the group consisting of an all-suture anchor. Instead, Armington et al discloses the anchor as a cleat (302), a hard anchor as known in the art ([0033]).
However, in the same field of endeavor, Norton et al teaches a knotless instability anchor, wherein the anchor may be any suitable anchor including soft all-suture anchors or hard anchors ([0027]; wherein US 8562647 is incorporated by reference and describes anchor 150 as being formed of suture material in col. 5, ll. 17-43). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to substitute the hard cleat anchor of Armington et al with an all-suture anchor as taught by Norton et al since such an anchor provides a soft, flexible configuration which allows the anchor to change shape and size to achieve a larger shape in the implanted configuration to lock the anchor (US 8562647 incorporated by reference in Norton et al: col. 6, ll. 41-63)
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Armington et al in view of Dreyfuss et al (US 2014/0052179).
Claim 11. Armington et al discloses the invention substantially as claimed above, but fails to disclose a passing limb releasably connected to the first portion.
However, in the same field of endeavor, Dreyfuss er al teaches a knotless instability anchor (200) ([0039]; Fig. 14-15), comprising: an anchor (10) having a first side (right side as seen in Figs. 14-15) and a second side (left side as seen in Figs. 14-15) with a suture material (11) passing therethrough from the first side to the second side ([0039)), wherein the suture material has a first portion of suture material extending from the first side of the anchor (portion of suture material extending out of the right opening in anchor 10 in Figs. 14-15) and a second portion of suture material extending from the second side of the anchor (portion of suture material extending out of the left opening in anchor 10 in Figs. 14-15) ([0039)); a splice (53) formed in the second portion of suture material ([0040]); and a first loop (15a) formed by the first portion of suture material; wherein a portion (11a) of the second portion of suture material extends through and beyond the first loop (15a), and the second portion of the suture material that extends through and beyond the first loop is positioned outside of the splice and outside of the anchor ([0040]; Figs. 14 illustrates how free end 11a of the second portion is guided into loop 15a and extends through loop 15a. Fig. 15 illustrates how free end 11a is positioned through and beyond loop 15a), wherein a passing limb (70) is releasably connected to the first portion (Fig. 14; [0039]-[0040]; connected at eyelet 15a). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Armington et al with a passing limb releasably connected to the first portion to allow the passing limb to function as a suture passer to form the anchor construct ([0039], [0040]). In other words, Armington et al describes how the suture material is routed and looped to form the overall construct. A passing limb (suture passer) as taught by Dreyfuss et al would advantageously allow the surgeon to more easily pass through and pull the suture ends to form the loops of the overall construct.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Armington et al in view of Monllor et al (US 2016/0296223).
Claim 12. Armington et al discloses the invention substantially as claimed above, but fails to disclose a driver with the knotless instability anchor loaded thereon.
However, Monllor et al teaches a knotless instability anchor loaded on a driver ([0136], [0155]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Armington et al with the knotless instability anchor loaded on a driver as taught by Monllor et al to provide a tool for manipulating and delivering the knotless instability anchor at the treatment site.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE SHI whose telephone number is (571)270-5620. The examiner can normally be reached Mon-Fri, 8-4 EST.
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/KATHERINE M SHI/Primary Examiner, Art Unit 3771
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