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 .
Response to Arguments
Regarding claims 10-16 21-23, Applicant’s arguments have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 1, 2, 4-6, 8, 9 and 23 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.
The new limitations: “comprising a body having a proximal end and a distal end” make the claim indefinite. As disclosed in the specification, the “one-way tissue engagement feature” has been identifies as element (204). Element (204) comprises a plurality of teeth (220) and nowhere in the specification discloses that those teeth are described as a body having a proximal end and a distal end. The specification mentions that element (202) is the body and the body has a proximal end (212) and a distal end (210), see Figs. 2A and 5C. Therefore, if the one-way tissue engagement feature (204) is inside the lumen of body (202), then the one-way tissue engagement feature cannot comprise of the body and proximal and distal ends. Finally, the body (202) can comprise the one-way tissue engagement feature but not the other way around. Correction is required.
Suggested language: “comprising: --- a body having a proximal end and a distal end, the body circumscribing the one-way tissue engagement feature, the body having an opening that receives a length of a … ---.
Regarding claim 23, the word: “unbroken” makes the claim indefinite. It seems like the Applicant’s representative is trying to overcome the previous rejection by adding ambiguous language that is not disclosed in the original disclosure. The Vaughan reference shows a whole implant that is NOT broken. The reference shows an implant having a plurality of holes (60) to allow the growth of tissue but that does not mean that the implant is broken. Correction is required.
Claim Rejections - 35 USC § 103
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 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.
Claims 10-16 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Vaughan US Patent 9,474,592B1 in view of Kam et al US Patent Pub. 2023/0032150A1.
Regarding claims 10-12, Vaughan discloses a fastener (10) for anchoring a tether (18) within a body of a patient, the fastener comprising: a one-way tissue engagement feature(48) having an opening (42, see Figs. 3-6) that receives a length of a tether and permits the length of the tether to pass through the opening in a first direction and restricts movement of the tether in a second direction opposite the first direction; and an engagement feature/stop (62) configured to maintain contact between the fastener and a bone of the patient in response to tension applied to the tether in the second direction to keep the fastener in place relative to the bone. Vaughan discloses an oblong shape (see Fig. 18), however, does not disclose a polygonal cross-sectional shape.
Kam et al discloses an anchoring system (100) having a body (102) and a fixation system (106). The body (102) is substantially cylindrical or rectangular. The body can be rectangular for the purpose of avoiding accidental rotation of the anchor relative to the patient’s bone.
It would have been obvious to one ordinary skill in the art to modify the cylindrical shape of the anchoring system with a rectangular shape in order to avoid accidental rotation of the anchoring system relative to the patient’s bone.
Regarding claim 13, see element 62 as the lip that circumscribes the body and contact a surface of bone around the bone tunnel (see Fig. 7).
Regarding claim 14, see Fig. 5 having a cylindrical body at an angle with respect to the stop (62) for the purpose of being used as a replacement of an ACL implant.
Regarding claim 15, see Fig1. Inherently the cylindrical body is capable of having a slightly smaller configuration with respect to the bone tunnel for the purpose of fitting the bone tunnel.
Regarding claim 16, see Fig. 13 disclosing the base (50) and the tapered edged tip (52). See col. 8, lines 1-9 disclosing the movement/deflection of the teeth increasing the diameter passage of the lumen when the ligament is passing through the lumen.
Regarding claim 23, see Figs. 1-17 discloses an implant having holes (60), however, that does not mean that the device is broken. The device is made of a whole piece; therefore, it is not broken.
Claims 21 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Vaughan US Patent 9,474,592B1 in view of Kam et al US Patent Pub. 2023/0032150A1 as applied to claim 10 above, and further in view of WO 2021/050712A1.
Vaughan in view of Kam et al disclose the invention substantially as claimed. However, Vaughan et al in view of Kam et al does not disclose a set of teeth comprising a flat tip and wherein the flat tips are parallel to each other.
WO 2021/050712A1 discloses an implant having a plurality of anchors (pillars 146) having a flat tip and parallel to each other for the purpose of holding a ligament in place and avoid tearing of the artificial ligament.
It would have been obvious to one having ordinary skill in the art to modify the set of teeth of the Vaughan reference by adding flat tips in order to hold in place the artificial ligament and avoid tearing of the artificial ligament.
Allowable Subject Matter
Claims 18-20 are allowed.
Claims 1, 2, 4-6, 8, 9 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.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALVIN J STEWART whose telephone number is (571)272-4760. The examiner can normally be reached Monday-Friday 8:30AM-6PM EST.
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/ALVIN J STEWART/Primary Examiner, Art Unit 3799 1/28/26