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
Applicant’s arguments, filed November 20, 2025, with respect to the rejection(s) of claim(s) 1-9, 12, and 13 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made. Please direct attention to rejection below, specifically reference Khatibi regarding the amended limitations of wherein the patient specific distance is determined in a preoperative plan.
Allowable Subject Matter
Claims 10 and 11 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.
The following is a statement of reasons for the indication of allowable subject matter: The prior art fails to teach or disclose wherein the proximal bone attachment feature comprises a first opening in the proximal bone attachment feature, the first opening configured to accept a fastener that engages the first bone, and a second opening in the proximal bone attachment feature, the second opening configured to accept a reduction guide that engages the first bone, the reduction guide configured to draw at least one of the first bone and the bone positioner toward each other when activated in one manner and extend at least one of the first bone and the bone positioner away from each other when activated in another manner.
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.
Claims 1-9, 12, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Pub. No. 2023/0077222 to Awtrey in view of U.S. Patent Pub. No. 2021/0113222 to Khatibi et al.
As to Claim 1, Awtrey discloses an apparatus (Figs. 1, 3B-5) for remediating a condition present in a patient's foot [0004]. The apparatus comprises a bone positioner (100) that comprises a bone attachment feature (110) configured to couple the bone positioner to at least one of a first bone and a second bone [0007, 0023, 0031], and a positioning member (AE) configured to position the second bone a patient-specific distance relative to the first bone for remediating a condition present in a patient's foot (specific positioning of AE described in [0023, 0034-0035]).
As to Claim 2, Awtrey discloses an apparatus further comprising a trajectory guide (130) configured to guide one or more fasteners into one or more bones at a patient- specific trajectory (desired position described in [0024], predetermined distance described in [0044]).
As to Claim 3, Awtrey discloses an apparatus further comprising a body (120) having a proximal end (towards 120C, Fig. 5) and a distal end (towards 120A, Fig. 5), the body connecting the positioning member (AE) and the trajectory guide (130), and wherein the positioning member (AE) is near the distal end of the body (Fig. 5, [0023]) and the trajectory guide (130) is near the proximal end of the body (Fig. 5, [0024]).
As to Claim 4, Awtrey discloses an apparatus further comprising a coupler (138) configured to join the bone positioner (100) and the trajectory guide (130, [0048]).
As to Claim 6, Awtrey discloses an apparatus wherein the trajectory guide (130) comprises a proximal opening (135) configured to receive a proximal sleeve (W1, [0029-0030, 0044]), a distal opening (134) configured to receive a distal sleeve [0026-0029], and wherein one of the proximal opening and the distal opening are configured to orient the proximal sleeve and the distal sleeve at a patient-specific angle relative to a long axis of the first bone (patient trajectory described in [0035]).
As to Claim 7, Awtrey discloses an apparatus wherein the positioning member (AE) further comprises a base that engages with the first bone (distal portion of AE, [0034-0035]), a leg (150) that extends from the base toward the second bone (Fig. 6B), and a foot connected to the leg, the foot configured to engage with the second bone [0023].
As to Claim 9, Awtrey discloses an apparatus wherein the bone attachment feature (110) comprises a proximal bone attachment feature (J, [0031]) configured to engage the first bone, and a distal bone (112) attachment feature configured to engage the second bone [0031, 0047].
As to Claim 12, Awtrey discloses an apparatus wherein the bone attachment feature is configured to couple the bone positioner (100) to both the first bone and the second bone [0031, 0047], the distal bone attachment feature comprising an opening (within 112), the opening configured to receive a fastener that engages the second bone [0023, 0031].
As to Claim 13, Awtrey discloses an apparatus wherein the positioning member (AE) comprises an offset adjustment member (J) coupled to the bone positioner and configured to change a position of the second bone relative to the first bone from an initial position to a second position for remediating a condition present in a patient's foot (adjustment via J described in [0031]).
As to Claims 1-9, 12, and 13, Awtrey discloses the claimed invention except for a wherein the patient-specific distance is determined in a preoperative plan, wherein the bone positioner is reusable in a subsequent surgical procedure and the trajectory guide is a single use patient-specific apparatus, wherein the patient-specific distance and the patient-specific trajectory are determined based on a bone model of one or more bones of a patient, the bone model generated based on medical imaging of the patient's foot and wherein the bone positioner is a patient-specific bone positioner and the trajectory guide is a patient-specific trajectory guide, wherein the bone positioner further comprises: a bone engagement surface configured to match a surface contour of at least one of the first bone and the second bone.
Khatibi discloses a surgical guide apparatus (10, Fig. 1, [0005]) wherein the patient-specific distance is determined in a preoperative plan ([0122] describes sizing of resection guide for the specific patient based on bone size, according to the preoperative surgical plan). A bone positioner is reusable in a subsequent surgical procedure and the trajectory guide is a single use patient-specific apparatus (reusable components described in [0007]). A patient-specific distance and a patient-specific trajectory are determined based on a bone model of one or more bones of a patient (patient specific guide described in [0056] modeling described in [0061]), the bone model generated based on medical imaging of the patient's foot and wherein the bone positioner (92) is a patient-specific bone positioner and the trajectory guide (90) is a patient-specific trajectory guide [0061, 0067, 0073]. The bone positioner (90) further comprises a bone engagement surface (91) configured to match a surface contour of at least one of the first bone and the second bone [0073] in order to allow the apparatus to be able to define features that are made to have positions, orientations, dimensions, and axes specific to the particular patient's anatomy including various anatomic or reverse alignment axes based on the computer-assisted pre-operative plan associated with the patient [0061, 0122].
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the apparatus of Awtrey with the resuable member and patient-specific modeling modifications of Khatibi in order to allow the apparatus to be able to define features that are made to have positions, orientations, dimensions, and axes specific to the particular patient's anatomy including various anatomic or reverse alignment axes based on the computer-assisted pre-operative plan associated with the patient.
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 CHRISTOPHER J BECCIA whose telephone number is (571)270-7391. The examiner can normally be reached Mon - Fri 8:30-5:00.
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/CHRISTOPHER J BECCIA/Primary Examiner, Art Unit 3775
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