DETAILED ACTION
The Non-Final Office Action mailed on 07/28/2026 is hereby VACATED, and the statutory period for reply to that action is rendered moot. An oversight occurred wherein the Preliminary Amendment timely filed on May 30, 2025, in response to the Notice to File Missing Parts, was not entered/processed appropriately prior to examination. As a result, the previous Office Action incorrectly examined the claims filed on December 18, 2024, which had been canceled by the applicant. Following an interview/communication with the applicant’s representative (Danielle Davis on behalf of Attorney of Record Meredith Struby) on September 30, 2026, the record has been corrected. The Preliminary Amendment filed on May 30, 2025, has now been entered and is the operative claim set for this application. Accordingly, this new Non-Final Office Action is being issued to provide a complete examination on the merits of the operative claims (Claims 35-54).
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 Amendment
Acknowledgment is made to Applicant’s amendments filed on 05/30/2025 which are entered. A complete action on the merits of pending claims 35-54 appears below.
Specification
The disclosure is objected to because of the following informalities:
Paragraph [0009] on page 4 of the specification should be amended to the following: A protective cover can be provided for the flexible connector at a portion of the flexible connector comprising at least one selected from the group consisting of the intra-connector sliding loop engagement portion and the connector-device sliding loop engagement portion. The protective cover reduces friction and chafing.
Paragraph [0011] on page 5 of the specification should be amended to the following (delete comma before period): The implantable device can be a graft. The implantable medical device can be a second cleat comprising first and second holes. The connector- device engagement portion of the flexible connector can be threaded through one of the holes in a first direction and through the other of the holes in a second direction forming a sliding connector-device engagement. The implantable medical device can include a plate comprising first and second holes. The connector-device engagement portion of the flexible connector can be threaded through one of the holes in a first direction and through the other of the holes in a second direction forming a sliding connector-device engagement.
Paragraph [0076] on page 23 of the specification should be amended to the following: A recess or groove 243 is disposed between the proximate ends of aperture 234 and aperture 236. Groove 243 is generally concave, as viewed from the perspective of Fig. 2, and in certain embodiments, has edges that are chamfered or curved. As will be understood upon review of the further description below, apertures 234, 236, and groove 243 are sized to accommodate suture material for an adjustable cleat and suture combination.
Paragraph [0120] on page 37 of the specification should be amended to the following: As shown in Figs. 28-29, the tail 622 can be passed over the upward facing bend 639 to form a downward facing bend 642 that rests on the upward facing bend 639 with an ascending portion 648 and a descending portion 652. An upward facing bend 650 is thereby formed. The descending portion 652 is turned upward at a bend 658 to form an ascending portion 654. A portion 662 of the ascending portion 654 is captured longitudinally within a portion 661 of the portion 646 and enters at an aperture 666 and exits at an aperture 670.
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.
Claims 35-54 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8, 11, 12, 19, 21-26, and 28 of U.S. Patent No. 10,722,344 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons.
Independent claims 35 and 48 of the present application are directed to a method of repairing an anterior cruciate ligament employing an adjustable fixation device comprising a member (cleat) having first and second substantially ovular bores (one tapered) with a bridge/recess therebetween, a flexible connector threaded through the bores to form first and second upward-facing bends that slidably engage one another (intra-connector sliding loop engagement), axial and transverse engagements of the tensioning end relative to the loops and bridge, a tissue graft engaged by the flexible connector, positioning of the member through a bone channel, and tensioning to secure the graft. Claim 48 further requires capturing the first end of the flexible connector in a first aperture in a side wall thereof.
Claim 19 of U.S. Patent No. 10,722,344 B2 (supported by the device of claims 1 and 11) recites a method for the adjustable fixation of an implantable medical device that employs the same essential structure and functional relationships: a cleat with first and second openings and a connector seat, a flexible connector forming first and second cleat loops with an intra-connector sliding loop engagement portion (first loop slidably traversing the second), a connector-device sliding loop engagement portion, and a tensioning end having both axial and transverse sliding connector-connector engagement portions that transversely engage the loops and extend between the loops and the connector seat. The patent expressly contemplates application of the method to anterior cruciate ligament repair (claim 28) and identifies the implantable device as a graft (claim 12). The additional conventional ACL surgical steps recited in present claims 35 and 48 (forming a channel, passing and securing the member, drawing the graft into the channel, and securing with an anchor) do not patentably distinguish the claims.
Dependent claims 36-41 and 49-52 further limit the flexible connector by requiring one or more apertures in a side wall thereof and the corresponding capturing or exiting of an end of the flexible connector through those apertures. These limitations correspond directly to the axial sliding connector-connector engagement portion already recited in claims 1, 3, 4, 19, and 21-22 of the ’344 patent (portion of the tensioning end positioned in an axial channel formed by axial threading through a portion of a cleat loop).
Dependent claims 42-44 and 53 further require first and second circular apertures in the body and the placement (and optional tensioning) of guide sutures therethrough. These limitations are expressly recited in claims 8 and 26 of the ’344 patent (lateral guide holes for receiving guiding sutures).
Dependent claims 45-47 and 54 further limit the tissue graft as substantially tubular, optionally having a suture extending through its longitudinal axis, and the anchor as a suture anchor. These features are conventional in ACL graft fixation and are fully consistent with the graft of claim 12 and the ACL application of claim 28 of the ’344 patent; they do not introduce patentably distinct subject matter.
Accordingly, claims 35–54 are obvious variants of the claims of U.S. Patent No. 10,722,344 B2 and are not patentably distinct therefrom.
Claim Objections
Claims 37, 39, and 49-51 are objected to because of the following informalities:
Claim 37 states in the 2nd-3rd lines of the claim, “a first end of a flexible connector” which should be “the first end of the flexible connector” given that both limitations were introduced in independent claim 35 which claim 37 depends upon in the dependency hierarchy, and using an article such as “a” rather than “the” creates confusion as to whether Applicant is referring to the previously claimed limitations or introducing new ones.
Claim 39 states in the 4th (last) line of the claim, “a second upward facing bend in the flexible connector” which should be “the second upward facing bend in the flexible connector” given that the limitation is introduced in independent claim 35 which claim 39 depends upon in the dependency hierarchy, and using an article such as “a” rather than “the” creates confusion as to whether Applicant is referring to the previously claimed limitations or introducing new ones.
Claims 49 and 51 state in the 2nd (last) line of the claims, respectively, “a side wall thereof” which should be “the side wall thereof” given that the limitation is introduced in independent claim 48 which claims 48 and 51 depend upon in the dependency hierarchy, and using an article such as “a” rather than “the” creates confusion as to whether Applicant is referring to the previously claimed limitations or introducing new ones.
Claim 50 states in the 4th (last) line of the claim, “a second upward facing bend in the flexible connector” which should be “the second upward facing bend in the flexible connector” given that the limitation is introduced in independent claim 48 which claim 50 depends upon in the dependency hierarchy, and using an article such as “a” rather than “the” creates confusion as to whether Applicant is referring to the previously claimed limitations or introducing new ones.
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 35-54 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 35, 37, 45, and 48 each recite “first substantially ovular bore” and “second substantially ovular bore.” The term “substantially” is a relative term of degree that renders the claims indefinite. The specification does not provide a clear standard for measuring the degree of “substantially,” nor does it define the metes and bounds of what constitutes a “substantially ovular” shape versus a shape that is not substantially ovular. While paragraph [0050] defines “flat oval” and “tapered flat oval,” those definitions do not expressly define or quantify the term “substantially” as used in the claims, and the claims themselves do not incorporate the defined terms “flat oval” or “tapered flat oval.” As a result, a person of ordinary skill in the art would not be able to determine the scope of the claims with reasonable certainty. See MPEP 2173.05(b). For purposes of examination, the term “substantially ovular bore” is interpreted as encompassing any bore having a generally elongated, rounded cross-sectional shape approximating an oval geometry (including the flat-oval and tapered-flat-oval shapes illustrated in the drawings), subject to ordinary manufacturing tolerances.
Claims 36-47 are rejected by virtue of their dependency on claim 35. Claims 46-47 are rejected by virtue of their dependency on claim 45. Claims 49-54 are rejected by virtue of their dependency on claim 48.
Appropriate correction is required.
Allowable Subject Matter
Claims 35-54 are allowed. As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
The following is a statement of reasons for the indication of allowable subject matter: The prior art of record, alone or in combination, fails to teach or render obvious a method to repair an anterior cruciate ligament comprising the steps of: providing a member comprising a body, an inner surface, an outer surface, a first substantially ovular bore extending between the inner and outer surfaces, a second substantially ovular bore extending between the inner and outer surfaces, the second substantially ovular bore being tapered, and a recess within the body extending between the first and second substantially ovular bores, the body comprising a bridge portion extending between the first and second substantially ovular bores; passing a first end of a flexible connector through the first substantially ovular bore, over the bridge portion, and through the second substantially ovular bore; passing a second end of the flexible connector through the first substantially ovular bore, over the bridge portion, and through the second substantially ovular bore to thereby form a first upward facing bend in the flexible connector; passing the second end of the flexible connector over the first upward facing bend in the flexible connector to thereby form a second upward facing bend in the flexible connector; passing a tissue graft over the second upward facing bend in the flexible connector; forming a channel in at least one of a tibia bone and a femur bone; passing the member through the channel; securing the member to the tibia bone or the femur bone; tensioning the second end of the flexible connector so as to draw the second upward facing bend and the tissue graft into the channel; and securing the tissue graft in the channel with an anchor, as recited in independent claim 35.
Independent claim 48 further requires the step of capturing the first end of the flexible connector in a first aperture located in a side wall of the flexible connector after the first end has been passed through the first and second substantially ovular bores.
The closest prior art is Miller (U.S. PGPUB No. 2012/0109194 A1). Miller discloses a suspensory graft fixation device comprising an elongated anchor member having a pair of suture-receiving apertures and a central bridge portion, with a single strand of filamentous material wound repeatedly through the apertures and about the bridge to form a plurality of individual suture loops that collectively provide an adjustable graft-supporting loop (see, e.g., paragraphs [0020]-[0022] and Figures 1-5). The device is used for ACL repair by advancing the anchor through bone tunnels and tensioning the free ends to shorten the loop and draw the graft into the tunnel.
Miller, however, does not teach the claimed member having a first substantially ovular bore and a second tapered substantially ovular bore with a recess and bridge portion therebetween, nor the specific sequence of (i) passing a first end of the flexible connector through the first bore, over the bridge, and through the second bore, (ii) passing a second end of the flexible connector through the first bore, over the bridge, and through the second bore to form a first upward facing bend, and (iii) thereafter passing the second end over the first upward facing bend to form a second upward facing bend over which the tissue graft is passed, as required by claims 35 and 48. Miller also does not teach capturing the first end in a side-wall aperture of the flexible connector as required by claim 48.
The remaining prior art of record (Justin (U.S. PGPUB No. 2012/0065731 A1); Albertorio (U.S. PGPUB No. 2010/0256677 A1); Zajac (U.S. PGPUB No. 2012/0123474 A1); and Chavan (U.S. PGPUB No. 2018/0249998 A1)) likewise fails to teach or suggest the combination of the recited member geometry and the precise sequence of forming the first and second upward facing bends by the claimed passings of the flexible connector ends, with the tissue graft disposed over the second upward facing bend, followed by the recited channel-formation, member-passage, tensioning, and anchoring steps.
Conclusion
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/O.N./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771
