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 Invention I and Species B in the reply filed on June 29th, 2026 is acknowledged.
Claims 13 (Species C) and 22 (Invention II) are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention and/or Species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on June 29th, 2026.
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.
Claims 1-11 and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Perler (U.S. Publication 2022/0211387).
Perler discloses a device (for example see Figures 3A-3D) comprising:
(claim 1) a body (300)
(claim 1) a patient-specific bone engagement member on a bone-facing side of the body
(claim 1) the patient-specific bone engagement member configured to engage a first bone and a second bone to correct a bone condition of the second bone relative to the first bone
(claim 2) wherein the patent-specific bone engagement member is configured to fully engage with bone the first bone and the second bone when both bones are in a predetermined position
(claim 3) wherein the patient-specific bone engagement member is configured to partially engage with one of the first bone and the second bone when one of the first bone and the second bone is in a predetermined position
(claim 4) wherein the patient-specific bone engagement member comprises a bone engagement surface configured to engage with a cortical surface of at least one of the first bone and the second bone
(claim 4) the bone engagement surface having a contour at least partially determined based on a bone model of a patient’s foot (paragraph 9)
(claim 9) wherein the bone engagement surface comprises a three-dimensional surface having an aspect that is patient-specific (for example see Figure 3D)
(claim 5) wherein the bone engagement surface comprises a first bone engagement surface (342) configured to engage with a first bone and a second bone engagement surface (344) configured to engage with the second bone
(claim 6) wherein the first bone engagement surface is configured to engage with the first bone and the second bone engagement surface is configured to engage with the second bone what at least one of the first bone and the second bone is repositioned from an original position to a predetermined position (the surfaces are fully capable of performing these functions if one so desired)
(claim 7) wherein the first bone engagement surface is configured to engage with the first bone and the second bone engagement surface is configured to engage with the second bone when the first bone maintains an original position and the second bone is repositioned from an original position to a predetermined position (the surfaces are fully capable of performing these functions if one so desired)
(claim 8) wherein the second bone engagement surface is configured to provide palpable feedback to a user when the second bone moves to a predetermined position (the surface is capable of providing palpable feedback, i.e. solid connection to the bone surface)
(claim 10) wherein the patient-specific bone engagement member comprises an opening (the examiner is interpreting the divots formed in the surface as an opening) in the body
(claim 10) the opening configured to accept at least a portion of one of the first bone and the second bone and at least partially determined based on a bone model
(claim 14) wherein the first bone is a cuneiform and the second bone is a metatarsal
(claim 1) a reference feature guide configured with the body to guide formation of a reference feature for at least one of the first bone and the second bone
(claim 11) wherein the reference feature guide comprises at least one opening (340) in the body that extends from a bone-facing side to a side opposite the bone-facing side
(claim 12) a landmark registration feature (320) that extends from a bone-facing side of the body
(claim 12) the landmark registration feature configured to engage with a landmark (such as the joint space between the bones) of a patient
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 12 is rejected under 35 U.S.C. 103 as being unpatentable over Perler (U.S. Publication 2022/0211387) in view of Kuyler (U.S. Publication 2022/0370082).
Perler discloses the invention was claimed, see above, except for the device further comprising a handle. Kuyler teaches a device comprising a body (30) having an engagement surface configured to engage a first bone and a second bone (for example see Figure 4B), wherein the device further comprises a handle (44) extending away from the body in order to provide a gripping location for the instrument during use (see paragraph 48). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the device of Perler further comprising a handle in view of Kuyler in order to provide a gripping location for the instrument during use.
Allowable Subject Matter
Claims 15-21 are allowed.
The following is an examiner’s statement of reasons for allowance:
Regarding claim 15:
Perler (U.S. Publication 2022/0211387) discloses a device comprising:
(claim 15) a positioner (300) that provides a reference feature for an osteotomy procedure corresponding to a model reference of a model comprising:
(claim 15) a positioner body (310) including
(claim 15) a bone-facing side and a non-bone facing side (see Figures 3A-3D)
(claim 15) a first bone engagement surface (342) of the bone-facing side
(claim 15) the first bone engagement surface shaped to engage a first bone
(claim 15) the surface shape is based at least in part on a model of the first bone
(claim 15) a second bone engagement surface (344) of the bone-facing side
(claim 15) the second bone engagement surface shaped to engage a second bone
(claim 15) wherein the surface shape is based at least in part on a model of the second bone
(claim 15) a first reference feature guide (elements 340 in 310) formed in the positioner body and configured to guide formation of a first reference feature for the first bone
(claim 15) a second reference feature guide (elements 340 in 330) formed in the positioner and configured to guide formation of a second reference feature for the second bone
Perler fails to disclose the device wherein the positioned includes a handle and the device includes a resection guide coupled to the reference feature. Kuyler teaches a device comprising a body (30) having an engagement surface configured to engage a first bone and a second bone (for example see Figure 4B), wherein the device further comprises a handle (44) extending away from the body in order to provide a gripping location for the instrument during use (see paragraph 48). The examiner was unable to find a reference or a combination of references that disclose the limitations of claim 15 as presented.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 for cited references the examiner felt were relevant to the application.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nicholas Woodall whose telephone number is (571) 272-5204. The examiner can normally be reached on Monday-Friday 8am to 5:30pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Kevin Truong, at (571. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NICHOLAS W WOODALL/Primary Examiner, Art Unit 3775
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