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 .
Claim Objections
Claim 14 is objected to because of the following informalities: lines 1- 2- “A method of tissue repair with the surgical construct of claim 1, the method comprising: pulling, with the tail, the loop in a first direction into a bone tunnel” should be amended to - - A method of tissue repair with the surgical construct of claim 1, the method comprising: pulling, with the tail, the loop in a first direction into [[a]] the bone tunnel - - since it is clear that applicant is referring to the bone tunnel introduced in claim 1, amending the claim would provide proper antecedent basis. Appropriate correction is required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Application claims 1- 2, 4, 8, 10- 13 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3- 4, 6, 8, 10- 11 and 13 of U.S. Patent No. 11,712,233. Although the claims at issue are not identical, they are not patentably distinct from each other because
Regarding application claim 1, claim 1 of U.S. Patent No. 11,712,233 anticipates application claim 1. The only different language is “a loop configured to be anchored in a bone tunnel.” However, claim 1 of U.S. Patent No. 11,712,233 claims “the device being configured for anchoring the soft fixation device in a bone tunnel,” and as such, claim 1 of U.S. Patent No. 11,712,233 anticipates application claim 1.
Regarding application claim 2, claim 4 of U.S. Patent No. 11,712,233 anticipates application claim 2.
Regarding application claim 4, claim 6 of U.S. Patent No. 11,712,233 anticipates application claim 4.
Regarding application claim 8, claim 8 of U.S. Patent No. 11,712,233 anticipates application claim 8. The only different language is “a length of the at least one shuttle extends through the tail portion of the soft fixation device.” However since claim 1 claims “the tail portion extending from the loop,” claim 8 of U.S. Patent No. 11,712,233 anticipates application claim 8.
Regarding application claim 10, claim 3 of U.S. Patent No. 11,712,233 anticipates application claim 10.
Regarding application claim 11, claim 10 of U.S. Patent No. 11,712,233 anticipates application claim 11.
Regarding application claim 12, claim 11 of U.S. Patent No. 11,712,233 anticipates application claim 12.
Regarding application claim 13, claim 13 of U.S. Patent No. 11,712,233 anticipates application claim 13.
Regarding application claim 15, claim 4 of U.S. Patent No. 11,712,233 anticipates application claim 15. However, claim 1 of U.S. Patent No. 11,712,233 claims “the device being configured for anchoring the soft fixation device in a bone tunnel,” and as such, claim 1 of U.S. Patent No. 11,712,233 anticipates application claim 1.
Application claim 14 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,133,645 in view of Michalik et al. (US Pub. No. 2019/0231338 A1) and (US Pub. No. 2009/0234387 A1).
Regarding application 14, claim 1 of U.S. Patent No. 12,133,645 anticipates application claim 14, but claim 1 of U.S. Patent No. 12,133,645 does not claim
(application claim 14) the surgical construct of application claim 1.
However, 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 method of claim 1 of U.S. Patent No. 12,133,645 to include the apparatus used in the method, since it has been held to be within the general skill of a worker in the art to select a known apparatus on the basis of its suitability for the intended use as a matter of obvious choice. In re Leshin, 125 USPQ 416.
Accordingly, Michalik teaches a soft anchor in the same field of endeavor (Abstract, P. [0002]) comprising
(application claim 14) a surgical construct for tissue repair, the surgical construct comprising:
a loop (16) (Figs. 1- 4, 7- 8) configured to be anchored in a bone tunnel (P. [0038] - - FIG. 5 illustrates installation of the soft anchor 10 in a hole 46 in a bone 48; it is noted that even though Michalik discloses a bone hole 46, the loop is capable of being anchored in a bone tunnel);
a tail (T) (See Annotated Fig. 1) extending from the loop (16) and configured to pull the loop (16) into the bone tunnel (P. [0032] - - The sheath 12 bifurcates to define a bifurcation at a first location 18 into two segments 19 and 21 and the two segments 19 and 21 reconnect at a second location 20 to define the loop 16 as shown in Fig. 1; it is noted that the tail (T) extends from location 18 away from the loop (16) and this extension is capable of pulling the loop (16) into the bone tunnel); and
a repair strand (56) (Figs. 3- 6) having a section received in the loop (16) (See Fig. 3 showing repair strand (56) extending through and being received in the hollow of loop (16)) (P. [0036] - -The soft anchor 10 is attached to soft tissue 54 with a flexible strand 56 where the flexible strand preferably extends through the loop 16 of anchor 10), wherein the repair strand (56) extends from the loop (16) in a direction away from the tail (T) (See Fig. 3).
Michalik further disclosing the repair strand (56) is threaded through the soft tissue 54 and through the loop (16) of the sheath 12 of the soft anchor 10 to secure the soft tissue 54 to the soft anchor 10 (P. [0038]), but Michalik does not explicitly disclose
(claim 1) a free end as claimed.
However, Miller teaches a suture anchor in the same field of endeavor (Abstract)
(application claim 14) wherein the repair strand (13) (Figs. 1- 2, 6- 10, 13, 15- 16) has a free end configured to engage a tissue (92) (Figs. 13- 14) (P. [0048] - - The two free ends of each of the working sutures 13 now extend around and through a portion of the soft tissue 92, and the surgeon forms sliding knots 95 in the working sutures 13. The knots 95 are moved down the working suture 13 to cinch the soft tissue 92 against the bone 90 at the location of anchor 11 (FIG. 14)).
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 repair strand associated with Michalik to include a free end that engages a tissue according to the teachings of Miller because having a free end extending around and through a portion of soft tissue enables a surgeon to cinch the engaged tissue against the bone (Miller - - P. [0048]).
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 and 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Denham et al. (US Pub. No. 2012/0046693 A1).
Regarding claim 1, Denham discloses a surgical construct for tissue repair, the surgical construct comprising:
a loop (508) (Fig.16) configured to be anchored in a bone tunnel;
a tail (542) (Fig. 16) extending from the loop (508) and configured to pull the loop (508) into the bone tunnel; and
a repair strand (14, 22) (Fig. 16) having a section received in the loop (508), wherein the repair strand (14, 22) extends from the loop (508) in a direction away from the tail (542) and has a free end configured to engage a tissue (P. [0074] - - The second end 520 of construct 500 along with an end 552 of distal bicep tendon 150 can be passed through a portion 554 of construct 500 extending between the first end 512 and an exit side 558 of distal bicep tendon 150 opposite an entrance side 562 as shown in Fig. 21; it is noted that since the repair strand 522, 526 are pulled through tissue 150, the similar repair strand (14, 22) is capable of engaging tissue).
It is noted that the language, " a tail extending from the loop and configured to pull the loop into the bone tunnel," merely recites an intended use of the apparatus. The claim, however, is an apparatus claim, and is to be limited by structural limitations. " A tail extending from the loop and configured to pull the loop into the bone tunnel," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The Office submits that the device of Denham meets the structural limitations of the claim, and is capable of being pulled into the bone tunnel via the tail (542) extending from the loop (508).
Regarding claim 7, Denham further discloses wherein the loop (508) is discontinuous or open (See Fig. 16).
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) 1- 6, 10 and 15- 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Michalik et al. (US Pub. No. 2019/0231338 A1) in view of Miller et al. (US Pub. No. 2009/0234387 A1). Michalik is cited in the IDS filed 10/03/24.
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Regarding claim 1, Michalik discloses a surgical construct for tissue repair, the surgical construct comprising:
a loop (16) (Figs. 1- 4, 7- 8) configured to be anchored in a bone tunnel (P. [0038] - - FIG. 5 illustrates installation of the soft anchor 10 in a hole 46 in a bone 48; it is noted that even though Michalik discloses a bone hole 46, the loop is capable of being anchored in a bone tunnel);
a tail (T) (See Annotated Fig. 1) extending from the loop (16) and configured to pull the loop (16) into the bone tunnel (P. [0032] - - The sheath 12 bifurcates to define a bifurcation at a first location 18 into two segments 19 and 21 and the two segments 19 and 21 reconnect at a second location 20 to define the loop 16 as shown in Fig. 1; it is noted that the tail (T) extends from location 18 away from the loop (16) and this extension is capable of pulling the loop (16) into the bone tunnel); and
a repair strand (56) (Figs. 3- 6) having a section received in the loop (16) (See Fig. 3 showing repair strand (56) extending through and being received in the hollow of loop (16)) (P. [0036] - -The soft anchor 10 is attached to soft tissue 54 with a flexible strand 56 where the flexible strand preferably extends through the loop 16 of anchor 10), wherein the repair strand (56) extends from the loop (16) in a direction away from the tail (T) (See Fig. 3).
Michalik further disclosing the repair strand (56) is threaded through the soft tissue 54 and through the loop (16) of the sheath 12 of the soft anchor 10 to secure the soft tissue 54 to the soft anchor 10 (P. [0038]), but Michalik does not explicitly disclose
(claim 1) a free end as claimed.
However, Miller teaches a suture anchor in the same field of endeavor (Abstract)
(claim 1) wherein the repair strand (13) (Figs. 1- 2, 6- 10, 13, 15- 16) has a free end configured to engage a tissue (92) (Figs. 13- 14) (P. [0048] - - The two free ends of each of the working sutures 13 now extend around and through a portion of the soft tissue 92, and the surgeon forms sliding knots 95 in the working sutures 13. The knots 95 are moved down the working suture 13 to cinch the soft tissue 92 against the bone 90 at the location of anchor 11 (FIG. 14)).
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 repair strand associated with Michalik to include a free end that engages a tissue according to the teachings of Miller because having a free end extending around and through a portion of soft tissue enables a surgeon to cinch the engaged tissue against the bone (Miller - - P. [0048]).
Regarding claim 2, Michalik in view of Miller discloses the apparatus of claim 1, Michalik further disclosing further comprising an activation member (24) (Figs. 1- 8) configured to bunch the loop (16) in the bone tunnel (See Fig. 4) (P. [0037] - - when the portions 26 and 28 of the flexible strand 24 are pulled proximally in a direction A away from loop 16, the loop segment 30 of the flexible strand 24 pulls the sheath in the direction A, thereby bunching the sheath 12 at the end distal end 42 of the instrument 40, thereby creating a sheath bundle 51).
Regarding claim 3, Michalik in view of Miller discloses the apparatus of claim 2, Michalik further disclosing wherein the activation member (24) extends through the loop (16) (See Fig. 1) (P. [0033] - - the flexible strand 24 extends through the loop 16 of the sheath 12).
Regarding claim 4, Michalik in view of Miller discloses the apparatus of claim 2, Michalik further disclosing wherein the activation member (24) extends through the tail (T) (See Fig. 1) (P. [0033] - - The first portion 26 of the flexible strand 24 extends through the lumen 14 of the sheath 12 … and the second portion 28 of the flexible strand 24 extends through the lumen 14 of the sheath 12 with the first portion 26 such that both portions 26 and 28 are in the same lumen of the sheath 12).
Regarding claim 5, Michalik in view of Miller discloses the apparatus of claim 2, Michalik further disclosing wherein the activation member forms a loop (P. [0033] - - the flexible strand 24 extends through the loop 16 of the sheath 12 to form the loop segment 30).
Regarding claim 6, Michalik in view of Miller discloses the apparatus of claim 1, Michalik further disclosing wherein the loop (16) is continuous and closed (See Fig. 1).
Regarding claim 10, Michalik in view of Miller discloses the apparatus of claim 1, Michalik further disclosing wherein the loop (16) and the tail (T) are formed of a continuous piece (See Annotated Fig. 1).
Regarding claim 15, Michalik discloses a surgical construct for tissue repair, the surgical construct comprising:
a loop (16) (Figs. 1- 4, 7- 8) configured to be anchored in a bone tunnel (P. [0038] - - FIG. 5 illustrates installation of the soft anchor 10 in a hole 46 in a bone 48; it is noted that even though Michalik discloses a bone hole 46, the loop is capable of being anchored in a bone tunnel);
a tail (T) (See Annotated Fig. 1) extending from the loop (16) and configured to pull the loop (16) into the bone tunnel (P. [0032] - - The sheath 12 bifurcates to define a bifurcation at a first location 18 into two segments 19 and 21 and the two segments 19 and 21 reconnect at a second location 20 to define the loop 16 as shown in Fig. 1; it is noted that the tail (T) extends from location 18 away from the loop (16) and this extension is capable of pulling the loop (16) into the bone tunnel);
a repair strand (56) (Figs. 3- 6) having a section received in the loop (16) ) (See Fig. 3 showing repair strand (56) extending through and being received in the hollow of loop (16)) (P. [0036] - -The soft anchor 10 is attached to soft tissue 54 with a flexible strand 56 where the flexible strand preferably extends through the loop 16 of anchor 10), wherein the repair strand (56) extends from the loop (16) in a direction away from the tail (T) (See Annotated Fig. 1); and
an activation member (24) (Figs. 1- 8) configured to bunch the loop (16) to anchor the loop (16) in the bone tunnel (See Fig. 4) (P. [0037] - - when the portions 26 and 28 of the flexible strand 24 are pulled proximally in a direction A away from loop 16, the loop segment 30 of the flexible strand 24 pulls the sheath in the direction A, thereby bunching the sheath 12 at the end distal end 42 of the instrument 40, thereby creating a sheath bundle 51).
Michalik further disclosing the repair strand (56) is threaded through the soft tissue 54 and through the loop (16) of the sheath 12 of the soft anchor 10 to secure the soft tissue 54 to the soft anchor 10 (P. [0038]), but Michalik does not explicitly disclose
(claim 15) a free end as claimed.
However, Miller teaches a suture anchor in the same field of endeavor (Abstract)
(claim 15) wherein the repair strand (13) (Figs. 1- 2, 6- 10, 13, 15- 16) has a free end configured to engage a tissue (92) (Figs. 13- 14) (P. [0048] - - The two free ends of each of the working sutures 13 now extend around and through a portion of the soft tissue 92, and the surgeon forms sliding knots 95 in the working sutures 13. The knots 95 are moved down the working suture 13 to cinch the soft tissue 92 against the bone 90 at the location of anchor 11 (FIG. 14)).
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 repair strand associated with Michalik to include a free end that engages a tissue according to the teachings of Miller because having a free end extending around and through a portion of soft tissue enables a surgeon to cinch the engaged tissue against the bone (Miller - - P. [0048]).
Regarding claim 16, Michalik in view of Miller discloses the apparatus of claim 15, Michalik further disclosing wherein the activation member (24) extends through the loop (16) (See Fig. 1) (P. [0033] - - the flexible strand 24 extends through the loop 16 of the sheath 12).
Regarding claim 17, Michalik in view of Miller discloses the apparatus of claim 15, Michalik further disclosing wherein the activation member forms a loop (P. [0033] - - the flexible strand 24 extends through the loop 16 of the sheath 12 to form the loop segment 30).
Regarding claim 18, Michalik in view of Miller discloses the apparatus of claim 15, Michalik further disclosing wherein the loop (16) is continuous and closed (See Fig. 1).
Claim(s) 8- 9 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Michalik et al. (US Pub. No. 2019/0231338 A1) in view of Miller et al. (US Pub. No. 2009/0234387 A1) as applied to claim 1 and claim 15 above, and in further in view of Rodriguez et al. (US Pub. No. 2015/0173739 A1). Rodriguez is cited in the IDS filed 10/03/24.
Regarding claims 8 and 20, Michalik discloses the apparatus of claim 1 and claim 15 respectively, but Michalik does not disclose
(claim 8 and claim 20) further comprising a shuttle extending from the loop.
(claim 9) wherein the shuttle has a fixed loop configured to receive the free end of the repair strand.
However, Rodriguez teaches a knotless all suture tissue repair in the same field of endeavor (Title, Abstract) including a soft braided anchoring tubular implant (70) (Figs. 7- 17) (P. [0070]) and suture ends (82, 84) (Figs. 7- 17) are passed so as to be interwoven through the soft braided anchoring implant (70) (Ps. [0073], [0077]) and then is passed though tissue (102) (Figs. 10- 17) (P. [0077]), Rodriguez teaching
(claim 8 and claim 20) further comprising a shuttle (90, 94) (Figs. 8- 11) extending from the tubular implant (70) (P. [0016] - - an anchor assembly for securing tissue to a bone or tissue to tissue of an animal or human comprises an anchoring implant for inserting into the bone or tissue, a first suture extending through the anchoring implant, a first suture-locking cradle; and a first snare extending through the first suture-locking cradle. The first snare draws a first end of the first suture through the suture-locking cradle to form a first suture loop through the tissue, wherein applying tension to the first suture loop actuates the first suture locking cradle to bind the first suture therein, thereby prohibiting the first suture loop from expanding);
(claim 9) wherein the shuttle (90, 94) has a fixed loop configured to receive the free end of the repair strand (82) (Figs. 7- 17) (Ps. [0076], [0077] - - FIG. 8 shows a first snare 90 extending (or drawn) through the lumen of the suture locking region 86 of suture that is interwoven within the implant wall; FIG. 10 shows a suture strand end 82 passed through the tissue 102 and in the first snare 90. The snare 90 may now be pulled distally, drawing the suture end 82 through the first half of the anchor, creating the suture friction lock 86).
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 device of Michalik in view of Miller to include a shuttle extending from the loop wherein the shuttle has a fixed loop configured to receive the free end of the repair strand according to the teachings of Rodriguez because the snare would facilitate drawing the free end of the suture repair through the tissue and would allow a surgeon to draw the free end of the repair filament in, out and back into the braided loop material to form a suture lock, thereby preventing the tissue engagement from loosening (Rodriguez - - P. [0016], [0073], [0077]).
Allowable Subject Matter
Claim 19 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.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 19, the prior art does not teach or suggest, alone or in combination with the remainder of the claim limitations, wherein the loop is discontinuous or open.
The closest cited prior art reference, Michalik et al. (US Pub. No. 2019/0231338 A1) teaches a loop configured to be anchored in a bone tunnel, a tail extending from the loop and a repair strand that extends in a direction away from the tail. Michalik further teaches a repair strand that is received within the opening of a continuous loop (See Fig. 3). As such, modifying Michalik such that said loop is discontinuous or open would not be obvious to a person of ordinary skill in the art without improper hindsight reasoning. Thus, Michalik does not teach or suggest, alone or in combination wherein the loop is discontinuous or open.
Cited prior art reference Denham et al. (US Pub. No. 2012/0046693 A1) teaches a discontinuous or open loop, but Denham does not teach or suggest, alone or in combination, an activation member configured to bunch the loop to anchor the loop in the bone tunnel required by claim 15 from which claim 19 depends.
Conclusion
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/KANKINDI RWEGO/Primary Examiner, Art Unit 3771