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 without traverse of Group II, Species 4, shown in Figs. 45-47 in the reply filed on 05/18/2026 is acknowledged. Claims 1 and 20-32 are pending.
Claim 1 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim.
Specification
The disclosure is objected to because of the following informalities:
The disclosure fails to describe how elected implant 550 is inserted into the patient in a compressed state as recited in claim 23.
Appropriate correction is required.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the compressed state of implant 550 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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 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.
Claim 23 is 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.
Claim 23 includes the recitation that the implant is inserted into the patient in a compressed state. It is unclear how this is mechanically possible as the specification merely recites that nail 550 is curved.
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.
Claim(s) 20-22 and 24-32, is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Marrero (US 2016/0135857 A1).
Concerning claim 20, Marrero discloses a surgical method comprising inserting a nail system into a patient (curved fusion nail 101 through the talus bone 105 and into the tibia bone 103); and releasing the nail system to provide compression on the patient’s joint (see par. 0022).
Concerning claim 21, wherein the nail system comprises an implant (see Fig. 5, element 101) and at least one fastener (see Fig. 5, elements 109, 110 and 111).
Concerning claim 22, wherein inserting the nail system into a patient comprises: inserting the implant into the patient; and inserting the at least one fastener through the implant in the patient. Marrero discloses inserting the curved fusion nail 101 through the talus bone 105 into the tibia bone 103, followed by inserting fasteners 109, 110, 111 through holes in the nail and into the bone (see Figs. 1, 5, 7).
Concerning claim 24, wherein the implant (see Fig. 3, element 101) is curved between a first end and a second end, Marrero discloses that the elongate body 130 of curved fusion nail 101 is curved between proximal end 113 and distal end 115.
Concerning claim 25, wherein the implant comprises at least one first through hole positioned near the first end of the implant; and a second through hole positioned near the second end of the implant. Marrero discloses holes for fasteners 110, 111 positioned near the proximal end 113 of curved fusion nail 101 (first end) and holes for fasteners 109 positioned near the distal end 115 (second end) (see Figs. 4-7 and the detailed description).
Concerning claim 26, wherein the at least one fastener comprises: at least one first fastener extending through the at least one first through hole of the implant; and a second fastener extending through the second through hole of the implant in a second direction. Marrero discloses proximal fasteners 110 and 111 extending through holes near the proximal end 113 of the nail and distal fasteners 109 extending through holes near the distal end 115 (see Figs. 5, 7 and the detailed description). The fasteners extend in different directions.
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Concerning claim 27, wherein inserting the at least one fastener through the implant and in the patient comprises: inserting the second fastener (110 or 111) through the second through hole in a first direction (see Fig. 3 above) after inserting the implant into the patient; and inserting the at least one first fastener (109) through the at least one first through hole in a second direction (see Fig. 3 above) of the implant into the patient.
Concerning claim 28, wherein the first direction is circumferentially rotated with respect to the second direction (see Fig. 2).
Concerning claim 29, wherein the first direction is offset from the second direction (see Figs. 2 and 3).
Concerning claim 30, wherein the second fastener is inserted across a joint of the patient (see Fig. 2 below).
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Concerning claim 31, wherein the at least one first fastener (see Fig. 3, element 111) is inserted across a joint of the patient. Marrero discloses that fastener 111 passes from the tibia 103, across the tibiotalar joint 107, and into the talus 105 (see Figs. 1, 3 and the detailed description — fastener inserted across the joint); the first direction is offset from the second direction as the proximal and distal fastener holes are oriented differently (see Figs. 5-7).
Concerning claim 32, wherein the at least one first fastener (109) is two first fasteners (see Figs. 2 and 3).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLEN HAMMOND whose telephone number is (571)270-3819. The examiner can normally be reached Monday-Friday 8 - 4 PM .
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo C. Robert, at 571 272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ELLEN C HAMMOND/Primary Examiner, Art Unit 3773
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