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
Claims 15-20 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/05/2026.
Response to Amendment
As of the reply filed 5/05/2026, claims 1-14 and 47-52 are pending. Claims 15-46 are cancelled. Claims 47-52 are new.
Drawings
The drawings are objected to because throughout the figures, the lines, numbers and letters are not uniformly thick and well defined; and numbers and reference characters are not plain and legible for all figures (see Figs. 1-2, 4, 5, 6A-E, 10, 11A-B, 12A-D, 13A-G, 14A-J, 15A-G, 16A-C, 17M-O, 17AA, 18A-P, 19A-F, 21A-L, and 22). This applies to shading. Solid black shading areas are not permitted, except when used to represent bar graphs or color. The use of shading in the drawings fail to aid in understanding of the invention and it reduces legibility. Spaced lines for shading are preferred. These lines must be thin, as few in number as practicable, and they must contrast with the rest of the drawings. All drawings must be made by a process which will give them satisfactory reproduction characteristics. Every line, number, and letter must be durable, clean, black (except for color drawings), sufficiently dense and dark, and uniformly thick and well-defined. See 37 CFR 1.84 (m) and (I).
Furthermore, the use of photographs, as such in Figs. 1, 4, 6A-E, 10, 11A-B, 12A-D, 13A-G, 14A-J, 15A-G, 16A-C, 17M-O, 17AA, 19A-C, 19F, 21A-L, and 22, are not ordinarily permitted in utility applications unless they are the only practicable medium for illustrating the claimed invention (see 37 CFR 1.84 (b) and MPEP 608.02 V. 2).
The drawings are further objected to because:
Fig. 9 includes two “100” reference numerals. It is believed that the “100” with an arrow should instead be “10” to reference the tissue anchor assembly, similar to Fig. 8 (see annotated Fig. 9 below)
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Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 48-49 are objected to because of the following informalities:
Claim 48, lines 1-2: the limitation “wherein the first end comprises beveled edge” is missing an article and should be amended to recite “wherein the first end comprises a beveled edge” instead.
Claim 49, lines 1-2: the limitation “wherein the first end comprises beveled edge” is missing an article and should be amended to recite “wherein the first end comprises a beveled edge” instead.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1-4, 8, 10, 12, 14, and 47-52 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hoffman (US PGPub 2022/0031300 A1).
With respect to claim 1, Hoffman discloses a tissue anchor assembly (see Figs. 8A-B) comprising:
a tissue anchor (212 in Fig. 8B, see also isolated views in Figs. 9A-C) comprising an elongated member, wherein the elongated member comprises a first end and a second end (PP [0141]: “the suture implant 200 preferably includes the tissue anchor 212 having a proximal end 214 and a distal end 216”, first end is 216 on the left, second end is 214 on the right), wherein the elongated member comprises a lumen (236 in Fig. 9B) extending from the first end to the second end (PP [0145]: “The tissue anchor 212 desirably has an elongated channel 236 that extends along the length L.sub.2 of the tissue anchor and between the proximal and distal ends 214, 216 of the tissue anchor”), wherein the elongated member comprises an opening (238A) between the first end and the second end (238A is between first end 216 and second end 214); and
a suture (see suture in Figs. 8A-B and isolated view in Fig. 9C), wherein the suture enters the lumen (236) at the first end (216) of the elongated member, forms a suture loop (224) through the opening (238A in Fig. 9B, see unmarked opening in Fig. 9C, the suture extends out through 238A to form the suture loop 224) of the elongated member, and exits the lumen (236) at the second end (214) of the elongated member (PP [0141]: “The suture implant 200 desirably includes a large suture loop 224 having a first end with a fixed knot 226 that is located adjacent the distal end 216 of the tissue anchor 212 and a second end including a sliding suture 230 that extends from a proximal opening at the proximal end 214 of the tissue anchor 212”).
Regarding claim 2, Hoffman further discloses wherein the suture is a continuous suture (see suture in Fig. 9C, PP [0141]: “The suture implant 200 desirably includes a large suture loop 224 having a first end with a fixed knot 226 that is located adjacent the distal end 216 of the tissue anchor 212 and a second end including a sliding suture 230 that extends from a proximal opening at the proximal end 214 of the tissue anchor 212”, the suture enters and exits anchor 212 as a continuous strand).
Regarding claim 3, Hoffman further discloses wherein the suture comprises a suture tail (portion of suture to the left of knot 226 in Fig. 9C, see annotated Fig. 9C below, PP [0159]: “the excess amount of suture material including the sliding suture 230 may be trimmed away and/or cut using a cutting tool 258”) extending from the first end (216) of the elongated member (body of 212).
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Regarding claim 4, Hoffman further discloses wherein the suture tail (portion of suture to the left of knot 226 in Fig. 9C, see annotated Fig. 9C above, PP [0159]: “the excess amount of suture material including the sliding suture 230 may be trimmed away and/or cut using a cutting tool 258”) is configured to act as the release suture to remove the tissue anchor (PP [0141]: “The large suture loop 224 also desirably includes a slip knot 228 that is adjacent an underside of the tissue anchor 212”, PP [0143]: “as the sliding suture 230 is pulled away from the proximal end 214 of the tissue anchor 212, the slip knot 228 moves toward the closed end 232 of the large suture loop 224 for reducing the size of the large suture loop”, slip knots have a release end which is configured to release the knot upon actuation, and a standing end which is configured to tighten the knot upon actuation, since 230 is acknowledged as the standing end for tightening the suture loop, the suture tail as shown above in the annotated Fig. 9C is the release end configured to release the knot upon actuation).
Regarding claim 8, Hoffman further discloses wherein the suture comprises a knot (228 in Fig. 9C) near the second end (214 in Fig. 9A, right end in Fig. 9C) of the elongated member (body of 212, “near” is a relative descriptor, under a broadest reasonable interpretation knot 228 is relatively near second end 214).
Regarding claim 10, Hoffman further discloses wherein the suture comprises a knot (226 in Fig. 9C) near the first end (216 in Fig. 9A, left end in Fig. 9C) of the elongated member (body of 212).
Regarding claim 12, Hoffman further discloses wherein the suture comprises a knot (228 in Fig. 9C) along the suture loop (224).
Regarding claim 14, Hoffman further discloses wherein the knot (228 in Fig. 9C) is spaced from the opening (238A in Fig. 9A) of the elongated member (body of 212, see Figs. 9A and C, 224 is spaced apart from 238A, PP [0141]: “The large suture loop 224 also desirably includes a slip knot 228 that is adjacent an underside of the tissue anchor 212”, see also Fig. 8B with knot 228 apart from the body of 212 including unmarked aperture 238A).
Regarding claim 47, Hoffman further discloses wherein the elongated member (body of 212 in Figs. 9A-C) comprises a cylindrical shape (212 is tubular with a hollow aperture extending therethrough and is therefore cylindrical).
Regarding claim 48, Hoffman further discloses wherein the second end (214 in Fig. 9A) comprises [a] beveled edge (PP [0144]: “the proximal and distal ends 214, 216 of the tissue anchor 212 may be tapered”, 214 has a bevel around a longitudinal axis extending through lumen 236).
Regarding claim 49, further discloses wherein the second end (216 in Fig. 9A) comprises [a] beveled edge (PP [0144]: “the proximal and distal ends 214, 216 of the tissue anchor 212 may be tapered”, 216 has a bevel around a longitudinal axis extending through lumen 236).
Regarding claim 50, Hoffman further discloses wherein the opening (238A in Fig. 9A) is perpendicular to the lumen (236 in Fig. 9B, PP [0145]: “tissue anchor 212 preferably includes a pair of laterally extending channels 238A, 238B that extend along respective second axes A.sub.4 that are substantially perpendicular to the longitudinal axis A.sub.3 of the tissue anchor 212”).
Regarding claim 51, Hoffman further discloses wherein the suture is nonabsorbable (PP [0118]: “the single suture strand 118, and the suture loop 124 including the fixed knot 126, the slip knot 128, and the sliding suture 130 may be made of conventional, biocompatible, absorbable materials, non-absorbable materials, and combinations of absorbable and non-absorbable materials. Preferred non-absorbable materials include polypropylene, a polymer blend of polyvinylidene fluoride and polyvinylidene fluoride-co-hexafluoropropylene, polyethylene, polyvinylidene fluoride (PVDF), polyesters, polyethylene terephthalate, glycol-modified polyethylene terephthalate, polytetrafluoroethylene, fluoropolymers, nylons etc. and the like, or copolymers of combinations thereof”, emphasis added, see Fig. 1 for comparable suture to the embodiment shown in Figs. 8A-B and 9C).
Regarding claim 52, further discloses wherein the opening (238A in Fig. 9A) is at a midpoint between the first end (216) and the second end (214, Merriam-Webster defines “midpoint” to mean “a point at or near the center or middle”, the broadest reasonable interpretation of “midpoint” given this definition and the lack of a special definition for this term in the present application encompasses Fig. 9A of Hoffman, which shows opening 238A near the center of the anchor 212).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Hoffman (US PGPub 2022/0031300 A1), as applied to claim 1 above, and further in view of Wales et al. (US PGPub 2013/0211451 A1).
Regarding claim 5, Hoffman discloses wherein the tissue anchor assembly includes a catch pledget (234 in Fig. 8B), but fails to explicitly disclose a bone anchor.
In the related field of tissue anchor assemblies for tissue approximation (abstract), which is related to the present disclosure as it relates to implanting a tissue anchor and suture assembly into a patient for securing tissue, Wales et al. teaches a tissue anchor assembly (see Fig. 9) comprising a tissue anchor (218, PP [0047]: “the tissue anchor assembly 218 includes a tissue anchor 220 and a suture element 222, which as shown is in the form of a loop through which the suture material forming the suture loop 210 is passed, thus allowing the tissue anchor assembly 218 to slide along the suture loop 210 as it is tightened”), a suture (222) forming a loop (210) and a bone anchor (10).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Hoffman device according to the teachings of Wales et al. to include the bone anchor as claimed in lieu of the pledget of Hoffman. One of ordinary skill in the art would have been motivated to perform this modification because doing so constitutes the combination of prior art elements according to known methods to yield predictable results. Modifying the Hoffman assembly to replace the pledget with a bone anchor as taught by Wales et al. would not have altered the main operating principle of the Hoffman assembly, which aims to approximate tissue, but would have simply enabled the assembly to be used to approximate soft tissue (via the tissue anchor 212 in Fig. 8B) relative to a target bone via the bone anchor of the Wales et al. reference in an adjustable suture loop assembly (Hoffman PP [0143]: “as the sliding suture 230 is pulled away from the proximal end 214 of the tissue anchor 212, the slip knot 228 moves toward the closed end 232 of the large suture loop 224 for reducing the size of the large suture loop”, Wales et al. PP [0047]: “a single bone anchor assembly 10 is slidably coupled to the suture loop 210 by the suture element 15 which is connected to the bone anchor assembly 10”). Additionally, the bone anchor of Wales et al. would perform the same function when combined with the Hoffman assembly as it does separately by ensuring tension in the suture loop (which the pledget of Hoffman is also configured to do, see PP [0040]). Lastly, Hoffman already contemplates that “a component that is similar to the tissue anchor 212 may also be used as the catch pledget 234 of the suture implant (FIG. 8A) with the slip knot loop 229 passing through the elongated channel 236” (PP [0147]), indicating that using another anchor in the place of the pledget would not have altered the main operating principle of the Hoffman assembly.
Regarding claim 6, Hoffman as modified by Wales et al. further discloses wherein the suture loop (224 in Fig. 8B of Hoffman, see also 210 in Fig. 9 of Wales et al.) is configured to be secured to the bone anchor (10 in Fig. 9 of Wales et al., the combination as proposed would place the bone anchor 10 of Wales et al. in the place of pledget 234 of Hoffman such that the bone anchor is secured to the suture loop).
Regarding claim 7, Hoffman as modified by Wales et al. further discloses wherein the bone anchor (10 in Fig. 9 of Wales et al., see also isolated view of bone anchor 10 in Fig. 1) is configured to be implanted on a mandible of a patient (PP [0035]: “the fingers 45 each have a free end 50 opposite the first portion 40 and terminate in a tip 52 and include edges 54 that are configured to engage bone at the implantation site for securing the bone anchor assembly 10 thereto”, PP [0034]: “The bone anchor assembly 10 and suture element 15 are, in the various embodiments, particularly suited for orthopedic repair procedures such as, for example, crossover toe, hallux valgus, hammertoe, carpometacarpal arthroplasty, Bankart repair, intervertebral disc repair procedures, or other general orthopedic procedures”, the bone anchor 10 is configured for general orthopedic procedures and includes fingers 45 to facilitate engagement to a bone site such as a mandible of a patient, MPEP 2112.01 states that “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established”, in the present case the bone anchor reads on the structural limitations at hand and can be considered configured for use on a mandible, see In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977)).
Claims 9, 11, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Hoffman (US PGPub 2022/0031300 A1), as applied to claim 1 above, and further in view of Allen et al. (US PGPub 2016/0038267 A1).
Regarding claims 9 and 13, Hoffman fails to disclose wherein the knot is an overhand knot, since knot 228 is “a slip knot” (PP [0139]).
In the same field of implant and suture assemblies (abstract), Allen et al. teaches an assembly (10 in Fig. 4) comprising a suture anchor (12) and a suture (30, PP [0041]: “the extension members 30 (e.g., 30a, 30b) can be constructed of a suture”), wherein the suture (30) comprises an overhand knot (A, PP [0053]: “A first overhand knot A is tied on the top side 14a of the anchor 14, e.g., approximately 4 inches from the first end 36a of the suture loop 30b”) near a first end of the suture anchor (12).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Hoffman device according to the teachings of Allen et al. such that the knot is an overhand knot. One of ordinary skill in the art would have been motivated to perform this modification since doing so constitutes applying a known technique (the use of an overhand knot in securing sutures to anchor assemblies as taught by Allen et al.) to the known device of Hoffman ready for improvement to yield predictable results. Modifying the Hoffman knot to specifically be an overhand knot would not alter the main operating principle of the Hoffman device, as Hoffman does not include any statements of criticality regarding any preferred knot construction variety, but would simply secure the suture as disclosed with an overhand knot configured to “provide efficient tensioning and locking adjustment of the implant” (PP [0017]), similarly to the slip knot of Hoffman.
Regarding claim 11, Hoffman is silent on wherein the knot is an overhand knot.
In the same field of implant and suture assemblies (abstract), Allen et al. teaches an assembly (10 in Fig. 4) comprising a suture anchor (12) and a suture (30, PP [0041]: “the extension members 30 (e.g., 30a, 30b) can be constructed of a suture”), wherein the suture (30) comprises an overhand knot (A, PP [0053]: “A first overhand knot A is tied on the top side 14a of the anchor 14, e.g., approximately 4 inches from the first end 36a of the suture loop 30b”) near a first end of the suture anchor (12).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Hoffman device according to the teachings of Allen et al. such that the knot is an overhand knot. One of ordinary skill in the art would have been motivated to perform this modification since doing so constitutes applying a known technique (the use of an overhand knot in securing sutures to anchor assemblies as taught by Allen et al.) to the known device of Hoffman ready for improvement to yield predictable results. Modifying the Hoffman knot to specifically be an overhand knot would not alter the main operating principle of the Hoffman device, as Hoffman does not include any statements of criticality regarding any preferred knot construction variety, but would simply secure the suture as disclosed with an overhand knot.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Surti (US PGPub 2010/0145385 A1) teaches a tissue anchor (20 in Fig. 1) comprising a cylindrical body (24), a central aperture (38) through which a strand (30) extends to form a loop (32). The ends of the strand (30) are secured to proximal and distal ends of the anchor cylindrical body (24) via welds (PP [0019]: “The ends of strand 30 are secured within the lumen 36 of the cannula by welds 44”). Fig. 3 shows an alternative embodiment in which the ends of the strand (130) extend beyond the proximal and distal ends (126 and 128) of the anchor body (124). Both embodiments include the respective loops (32 and 132) interfacing with a suture (22), but neither embodiment includes knots formed in the strand.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Bridget E. Rabaglia whose telephone number is (571)272-2908. The examiner can normally be reached Monday - Thursday, 7am - 5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571) 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIDGET E. RABAGLIA/Examiner, Art Unit 3771
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