DETAILED ACTION
This action is in response to Applicant’s amendment filed on December 12, 2025.
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 .
Claim Rejections - 35 USC § 102
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) 1-5, 9-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Carter et al. (U.S. Patent No. 5935128).
Carter et al. discloses an apparatus for remediating a condition present in a patient, the apparatus comprising: a body (30); a bone engagement surface on a bone-facing side of the body (Figure 3), the bone engagement surface configured to engage a surface of a patient (Figure 3); a bone attachment feature (36) configured to couple the body to a long bone of the patient; and a resection feature (40) having a trajectory guide (the structure that slow 40 is formed through is a trajectory guide) that guides resection of the long bone to separate a malleolus from the long bone. It is noted that the structure is disclosed and thus the functional limitations are considered capable of being performed by the device of Carter et al.
Regarding claim 2, wherein the surface of the patient is a surface of the long bone and the bone engagement surface is shaped to match a contour of the surface of the long bone and defined at least in part based on medical imaging of a portion of the long bone. As seen in figure 2 and 3, the bone engaging surface is curved and matches a curvature of the bone.
Regarding claim 3, the bone engagement surface is defined at least in part based on a bone model of a portion of the long bone. The bone engagement surface is curved, thus it can be construed that the surface is defined by a bone model, i.e mental model.
Regarding claim 4, the surface of the patient is a surface of skin covering the long bone of the patient; and the resection feature is configured to guide resection of the skin by a cutting tool to expose the long bone. It is noted that claim 4 is functional and the device Carte et al. is capable of performing the claimed function.
Regarding claim 5, the resection feature (40) comprises an opening that extends from the bone-facing side to a side opposite the bone-facing side (Figure 2, 3).
Regarding claim 9, the bone attachment feature (36) comprises one or more holes that extend through the body from one side of the body to the bone-facing side of the body (Figure 2).
Regarding claim 10, the one or more holes extend through the body at a first trajectory that substantially matches a second trajectory of an opening of the resection feature. It can be construed that the middle hole of the three holes 36 (Figure 2) has the same trajectory as the trajectory of the resection opening
Regarding claim 11, the one or more holes have a circular cross section and a first diameter substantially the same as a second diameter of one or more anchor pins configured for deployment through the one or more holes to secure the body to the long bone. As seen in Figure 2, the holes 36 are countersunk and it can be seen that the narrow part of the hole has substantially the same diameter as the threaded portion of anchor pin 38.
Regarding claim 12, the apparatus further comprising a stop configured to control a maximum depth of a cutting tool inserted into the resection feature. The front edge of the block surrounding the slot 40 can be considered a stop.
Regarding claim 13, the apparatus further comprising a fixation guide (50) having one or more openings (56) that indicate a path for fasteners into the long bone.
Regarding claim 14, Carter et al discloses an osteotomy system for remediating a condition present in a patient, comprising: a resection guide (30) comprising: one or more bone attachment features (36) configured to couple the resection guide to a bone (Figure 2, 3); and a resection feature (40) having a trajectory guide (the structure that slow 40 is formed through is a trajectory guide) that guides resection of the bone to dissect the bone into a proximal fragment and distal fragment; and a fixation guide (50) comprising one or more openings (56) that indicate a path for fasteners through the distal fragment and into the proximal fragment of the bone.
Regarding claim 15, wherein the one or more bone attachment features align with the resection feature (It can be construed that the middle hole of the three holes 36 (Figure 2) has the same trajectory as the trajectory of the resection opening) and one or more of the resection guide and the fixation guide comprises a bone engagement surface (Figure 2).
Regarding claim 16, The osteotomy system of claim 14, wherein the fixation guide comprises one or more sleeves (56, Figure 4C) each configured to accept a fastener ( a fastener could be inserted if one desired)
Regarding claim 17, the osteotomy system further comprising a body (65) having a coupler (thread of thumbscrew) configured to couple the resection guide to the fixation guide and position the fixation guide relative to the resection guide.
Regarding claim 18, the one or more openings of the fixation guide are aligned vertically with respect to a longitudinal axis of the bone (Figure 6).
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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.
Claim(s) 6-8 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carter et al in view of Perler et al. (U.S. Patent No. 11931106).
Carter et al. discloses the claimed invention except for the various features that are patient specific, i.e. the trajectory guide and resection opening feature). Perler et al. teaches a patient specific cut guide since such provides unique benefits of providing a precise correction, optimal cut, and reduce the likelihood of improper correction (Column 9, lines 24-37). It would have been obvious to one skilled in the art to construct the device of Carter et al. with patient specific features in view of Perler et al. to provide optimal cuts and correction to reduce the chance of improper correction.
Response to Arguments
The amendments are not extensive enough to overcome Carter and Perler. It was discussed to include more details regarding the patient specific aspect of the device; however, the amendments do not add any new elements regarding the patient specific attributes.
Allowable Subject Matter
Claim 20 is allowed.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/ANDREW YANG/Primary Examiner, Art Unit 3775