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 with traverse of Group II, claims 6- 20 in the reply filed 4/06/26 is acknowledged. The traversal is on the ground(s) that amended independent (method) claim 1 recites the same or similar structural features as independent (apparatus) claim 14. This is not found persuasive because the method claims 1- 5 are not commensurate with the elected apparatus claims 6- 20 and would require distinct searching. As noted in the Restriction Requirement, mailed 2/05/26, a complete search for methods for securing soft tissue to bone is distinct from a complete search for the apparatus claims. Since an apparatus claim must include searching for apparatus used to practice methods materially different than methods for securing soft tissue to bone, such as, for example, apparatus used to practice repair of the natural vertebral or spinal disc wall (A61F2/442), the search would be burdensome without the Restriction.
The requirement is still deemed proper and is therefore FINAL.
Response to Amendment
The Amendment filed 4/06/26 has been entered. Claims 1- 5 are withdrawn as being directed to a non-elected invention. Claims 7- 13 and 15- 20 are amended. Claims 6- 20 are being addressed by this Office Action.
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) 6- 7, 11- 12, 14- 16 and 18- 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McCartney (US Pub. No. 2014/0257382 A1). McCartney and Sugimoto are cited in the IDS filed 7/08/24.
Regarding claim 6, McCartney discloses a tissue repair assembly comprising:
an anchor body (30, 30’) (Figs. 1A- 8) (P. [0023] - - In a substitute embodiment of the filamentary sleeve 30, the filamentary sleeve 30 may be provided with an alternative configuration as illustrated in FIG. 1B … While any of these sleeves (including sleeves 30 and 30') could be used in the present invention, sleeve 30 is illustrated throughout the various disclosed embodiments for reasons of clarity and simplicity; it is noted even though sleeve 30 is illustrated throughout the reference, anchor body 30’ shown in Fig. 1B is used for this rejection);
a first suture (20) (Figs. 1A- 8) connected to the anchor body (30, 30’); and
wherein the anchor body (30, 30’) is configured to be deployed by tensioning the first suture (20) such that the anchor body (30, 30’) changes from a first configuration (Fig. 1B), in which the anchor body (30, 30’) is longitudinally elongate, to a second configuration (Fig. 4A), in which the anchor body (30) is longitudinally compressed (Ps. [0023], [0042] - - These pass-throughs 31 may also facilitate folding and compressing of the filamentary sleeve 30' by drawing together discrete portions of the filamentary sleeve that are disposed between the pass-throughs as the filamentary material disposed within and through the pass-throughs are tensioned; Once the filamentary sleeve 30 is inserted in the bore hole 81, either or both the loading member 20 and working suture 50 may be tensioned to deploy sleeve 30 and firmly seat the sleeve 30 within the bore hole 81); and
wherein the first suture (20) is configured to lock the tissue repair assembly in the second configuration (Fig. 4A), and secure a second suture (50) (Figs. 2- 8) relative to the anchor body (30, 30’) (Ps. [0045] - [0046] - - the tension on the working tails 51 may contract the half-hitch knot 52 and allow the user to maintain appropriate tension on the working suture 50 and the tissue 60 while the half-hitch 52 is slid into the filamentary sleeve 30, as seen in FIG. 7; As the knot 52 enters into the pathway 33, the knot 52 may become trapped by the fold 32 (or other material of sleeve 30), at which point further tension on the working tails 51 and loading tails 21 further contracts the half-hitch knot 52, until the working suture 50 and sleeve 30 are fixedly secured with one another and the engagement is so tight that it is no longer capable of sliding, thereby effectively securing the tissue 60).
Regarding claim 7, McCartney further discloses wherein the anchor body (30, 30’) includes a first end (34) (Figs. 1A, 3) and a second end (35) (Figs. 1A, 3) and an end (21) (Figs. 1A- 7) of the first suture (20) exits the first end (34) of the anchor body (30, 30’) (See Fig. 3) (P. [0032] - - loading loop 22 extends out of one side 35 of the filamentary sleeve 30 and the loading tails 21 extend from the other side 34).
Regarding claim 11, McCartney further discloses wherein in the second configuration (Fig. 4A), the anchor body (30,30’) is configured to expand laterally (Ps. [0023], [0046] - - As such, a pulling force, typically originating from the filamentary material passing through the filamentary sleeve 30', creates a deploying friction between the filamentary sleeve 30' and bore hole 81 (if present, as in FIGS. 4 and 5). This friction buckles the filamentary sleeve 30' material between the pass-throughs 30' causing them to expand outwardly against the bore hole 81, thereby significantly increasing the friction against the bone, which provides for a very strong anchor; as the half-hitch 52 contracts and tightens, the material forming the knot 52 may become localized at a point, which further expands the filamentary sleeve 30 against the bore hole 81).
Regarding claim 12, McCartney further discloses wherein at least a portion of the anchor body (30, 30’) includes a shaped element (31) (Fig. 1B) configured to enhance bone engagement (P. [0023] - - the filamentary sleeve 30' may be generally cylindrical with a plurality of pass-throughs 31 … These pass-throughs 31 may be symmetrically disposed along one side of the filamentary sleeve 30'. The symmetrical arrangement is such that when the filamentary sleeve 30' is folded in half at least one pass-through 31 will face an opposing pass-through 31. These pass-throughs 31 may also facilitate folding and compressing of the filamentary sleeve 30' by drawing together discrete portions of the filamentary sleeve that are disposed between the pass-throughs as the filamentary material disposed within and through the pass-throughs are tensioned).
Regarding claim 14, McCartney discloses a tissue repair assembly comprising:
an anchor body (30, 30’) (Figs. 1A- 8) (P. [0023] - - In a substitute embodiment of the filamentary sleeve 30, the filamentary sleeve 30 may be provided with an alternative configuration as illustrated in FIG. 1B … While any of these sleeves (including sleeves 30 and 30') could be used in the present invention, sleeve 30 is illustrated throughout the various disclosed embodiments for reasons of clarity and simplicity; it is noted even though sleeve 30 is illustrated throughout the reference, anchor body 30’ shown in Fig. 1B is used for this rejection);
a first suture (20) (Figs. 1A- 8) connected to the anchor body (30, 30’), the first suture (20) configured to be locked relative to the anchor body (30, 30’) when in a tensioned state (Fig. 8) (P. [0046] - - The working tails 51 and loading member 20 are trimmed close to the surface of the bone 80 resulting in a configuration as shown in FIG. 8 where the filamentary sleeve 30 is fixedly secured in the bore hole 81 and the half-hitch 52 fixedly secures the working suture 50, sleeve 30 and tissue 60 to one another and to the bore hole 81. Thus, as illustrated, a portion of the loading member 20 can remain within the filamentary sleeve 30); and
a second suture (50) (Figs. 2- 8) slidable relative to the anchor body (30, 30’) when the first suture (20) is in an un-tensioned state (Figs. 2, 3) (P. [0041] - - This tension passes the retriever loop 41 through the pathway 33 of the filamentary sleeve such that the working suture 50 is partially disposed within the filamentary sleeve 30 and the working tails extend from the pathway 33 and reside adjacent the loading loop 22, as shown in FIG. 3).
Regarding claim 15, McCartney further discloses wherein the second suture (50) is received within at least a portion of the anchor body (30, 30’) (P. [0041] - - This tension passes the retriever loop 41 through the pathway 33 of the filamentary sleeve such that the working suture 50 is partially disposed within the filamentary sleeve 30 and the working tails extend from the pathway 33 and reside adjacent the loading loop 22, as shown in FIG. 3).
Regarding claim 16, McCartney further discloses wherein the first suture (20) is received within at least a portion of the anchor body (30, 30’) (See Fig. 1B), and a first portion (21) (Figs. 1A- 7) of the first suture (20) exits the anchor body (30, 30’) through a first opening (34) (Figs. 1A, 3), and a second portion (22) (Figs. 1A- 5) of the first suture (20) exits the anchor body (30, 30’) through a second opening (35) (Figs. 1A, 3) (See Fig. 1A).
Regarding claim 18, McCartney further discloses wherein the first suture (20) is configured to be tensioned to deploy the anchor body (30, 30’) (Ps. [0045], [0046] - - Referring to FIGS. 6 and 7, with the half-hitch knot 52 tied through the loading loop 22, the loading tails 21 are tensioned as demonstrated by arrow 71. Contemporaneous with the tensioning of the loading tails 21, the working tails 51 are tensioned as demonstrated by arrow 72. The tension on the loading tails 21 pulls the half-hitch knot 52 resulting in the sliding of half-hitch 52 toward the bore hole 81 and filamentary sleeve 30 as illustrated by FIG. 6; As the knot 52 enters into the pathway 33, the knot 52 may become trapped by the fold 32 (or other material of sleeve 30), at which point further tension on the working tails 51 and loading tails 21 further contracts the half-hitch knot 52, until the working suture 50 and sleeve 30 are fixedly secured with one another and the engagement is so tight that it is no longer capable of sliding, thereby effectively securing the tissue 60).
Regarding claim 19, McCartney further discloses wherein the first suture (20) is configured to secure the second suture (50) relative to the first suture (20) and relative to the anchor body (30, 30’) (Ps. [0045] - [0046] - - Referring to FIGS. 6 and 7, with the half-hitch knot 52 tied through the loading loop 22, the loading tails 21 are tensioned as demonstrated by arrow 71. Contemporaneous with the tensioning of the loading tails 21, the working tails 51 are tensioned as demonstrated by arrow 72. The tension on the loading tails 21 pulls the half-hitch knot 52 resulting in the sliding of half-hitch 52 toward the bore hole 81 and filamentary sleeve 30 as illustrated by FIG. 6 … the tension on the working tails 51 may contract the half-hitch knot 52 and allow the user to maintain appropriate tension on the working suture 50 and the tissue 60 while the half-hitch 52 is slid into the filamentary sleeve 30, as seen in FIG. 7; As the knot 52 enters into the pathway 33, the knot 52 may become trapped by the fold 32 (or other material of sleeve 30), at which point further tension on the working tails 51 and loading tails 21 further contracts the half-hitch knot 52, until the working suture 50 and sleeve 30 are fixedly secured with one another and the engagement is so tight that it is no longer capable of sliding, thereby effectively securing the tissue 60).
Regarding claim 20, McCartney further discloses wherein the second suture (50) is connected to the anchor body (30, 30’) (See Figs. 6, 7) (P. [0046] - - As the knot 52 enters into the pathway 33, the knot 52 may become trapped by the fold 32 (or other material of sleeve 30), at which point further tension on the working tails 51 and loading tails 21 further contracts the half-hitch knot 52, until the working suture 50 and sleeve 30 are fixedly secured with one another and the engagement is so tight that it is no longer capable of sliding, thereby effectively securing the tissue 60).
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) 13 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over McCartney (US Pub. No. 2014/0257382 A1) in view of Sugimoto et al. (US Pub. No. 2007/0010857 A1).
Regarding claim 13 and 17, McCartney discloses the apparatus of claim 6 and claim 14 respectively, but McCartney does not disclose
(claim 13 and claim 17) wherein the anchor body extends between a first end and a second end, and the first end includes a first hardened element and the second end includes a second hardened element.
However, Sugimoto teaches a tissue repair assembly in the same field of endeavor (Abstract)
(claim 13 and claim 17) wherein the anchor body (74) (Figs. 6- 10B) extends between a first end (74a) (Figs. 6- 10B) and a second end (74b) (Figs. 6- 10B), and the first end (74a) includes a first hardened element and the second end (74b) includes a second hardened element (Ps. [0010], [0046] - - The anchor member itself may be designed in any of numerous manners, including designs that have a uniform width along the length thereof, and designs that have a varying width along the length. Other features may be incorporated such as edge portions that are slightly more rigid than a central area of the anchor member. Entire sections of the anchor member may be relatively rigid as compared to fold line portions thereof while still resulting in a generally flexible anchor member. As necessary, hinge portions, such as living hinges, may be designed into the anchor member to allow for folding or other shortening action of the anchor member; Strip 74 may have variable stiffness including, for example, a relatively rigid perimeter or relatively rigid edges 74e, 74f (FIG. 7) or intermittent relatively rigid sections 74c'' separated by flexible sections such as living hinges 74d'' (FIG. 7C) that may aid in folding and securing the elongate strip 74'' into a folded condition; it is noted a relatively rigid perimeter necessarily includes a first and second hardened element along the first end and second end).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the anchor body associated with McCartney such that the anchor body extends between a first end and a second end, and the first end includes a first hardened element and the second end includes a second hardened element according to the teachings Sugimoto because it would aid in folding and securing the anchor body into a folded condition (Sugimoto - - Ps. [0010], [0046]).
Allowable Subject Matter
Claims 8- 10 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.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 8, the prior art does not teach or suggest, alone or in combination with the remainder of the claim limitations, wherein the first suture includes a securing structure along a length of the first suture, the securing structure includes a pre-formed knot that is present prior to, during and after securement of the second suture.
The closest cited prior art reference McCartney (US Pub. No. 2014/0257382 A1) discloses a tissue repair assembly comprising: an anchor body (30, 30’) (Figs. 1A- 8); a first suture (20) (Figs. 1A- 8) connected to the anchor body (30, 30’), the first suture (20) configured to be locked relative to the anchor body (30, 30’) when in a tensioned state (Fig. 8) (P. [0046]); and a second suture (50) (Figs. 2- 8) slidable relative to the anchor body (30, 30’) when the first suture (20) is in an un-tensioned state (Fig. 2) (P. [0041]). McCartney further disclosing a knot (52) (Figs. 5- 8) formed during the securement as shown in Figs. 4A- 7), but McCartney does not teach or suggest, alone or in combination, wherein the first suture includes a securing structure along a length of the first suture, the securing structure includes a pre-formed knot that is present prior to, during and after securement of the second suture.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KANKINDI RWEGO whose telephone number is (303)297-4759. The examiner can normally be reached Tuesday and Wednesday: 9:00am- 5:30pm PST.
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/KANKINDI RWEGO/Primary Examiner, Art Unit 3771
Prosecution Insights