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 . This action is in response to the Response to Election/Restriction received on December 17,2025. Claims 1-28 are currently pending.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-18 and 21-28) in the reply filed on December 17, 2025 is acknowledged.
Claims 19 and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on December 17, 2025.
Applicant’s election with traverse of Species I (Figures 8-10F and 12A-12C) in the reply filed on December 17,2025 is acknowledged. Applicant requests rejoinder of Species I and J because applicant alleged that the different species do not have mutually exclusive characteristics. This is not found persuasive, because applicant states that figures 11A-11F illustrate views of a talus resection guide 872 of an osteotomy system, according to an alternative embodiment. It should be noted that the talus resection guide 872 of figures 11A-F is a talus resection guide 872 that is similar or the same as the talus resection guide 824 described above, with the main difference being the talus resection guide 872 may be for a right ankle of a patient. Alternatively, or in addition, the talus resection guide 872 may be for a left ankle of a patient but the resection features 826 may be different from talus resection guide 824 due to user instructions 604 for a particular surgical procedure [paragraph 00316]. The key mutually exclusive characteristic difference is that Species I and J can be used for different surgical procedures. Therefore, the office asserts that the identified species I and J have mutually exclusive procedural uses as identified in applicant’s specification.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-10, 13, 14, and 18 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Carroll et al. (US Publication 2010/0217338), hereinafter “Carroll”.
Regarding claim 1, Carroll discloses an apparatus for an ankle fusion procedure to remediate a bone condition present in a patient's foot (Figures 21-23), comprising: a resection guide (120, Figure 21) comprising: a body (i.e., unitary body described in paragraph, 125 Figure 22) having an anterior side (side close to 135), a posterior side (side facing bone 134), a medial side (side close to 130), a lateral side (side close to 131), a superior side (side close to 133), and an inferior side (side close to 136); a first resection feature (129, Figure 23) capable of guiding a cutting tool to form a first osteotomy in a first bone (123, Figure 21), the first osteotomy defined based at least partially on user directions and at least partially on a bone model of at least a portion of the first bone, the bone model based on medical imaging of a patient's foot [paragraphs 0062, 0071 and 0068]; and a first bone attachment feature (134, Figure 24) capable of securing the resection guide to the first bone (i.e. bone engaging feature 134 including 130,131, and 133, releasably “interlock” with the topography of the exposed surface of the lower tibia 123, Figure 24 [paragraph 0070]).
Regarding claim 2, Carroll discloses further comprising: a bone engagement feature (130, Figure 26) capable of engaging with at least a portion of the first bone at a position that substantially matches a model position of a model of the resection guide engaging the bone model (i.e. bone engaging feature 134 including 130,131, and 133, releasably “interlock” with the topography of the exposed surface of the lower tibia 123, Figure 24 [paragraph 0070]).
Regarding claim 3, Carroll discloses wherein the bone engagement feature comprises: a bone engagement surface (131, Figure 26) capable of at least partially match a contour of a surface of the first bone when the resection guide is positioned for use(i.e. bone engaging feature 134 including 130,131, and 133, releasably “interlock” with the topography of the exposed surface of the lower tibia 123, Figure 24 [paragraph 0070]); and a body section (150, Figure 26) extending from the body to support the bone engagement surface.
Regarding claim 4, Carroll discloses wherein the bone engagement feature comprises a bone probe (133, Figure 26) capable of at least partially engaging with a landmark associated with the first bone.
Regarding claim 5, Carroll discloses wherein the bone engagement feature is capable of at being least partially on the user directions (i.e. according to a plan and mapped onto a computer model the model fits onto the bone, [paragraph 0053]) and at least partially on the bone model [paragraphs 0053 and 0071].
Regarding claim 6, Carroll discloses further comprising a plurality of bone engagement features (130, 131, or 133), at least one of the plurality of bone engagement features capable of being based on the user directions(i.e. according to a plan and mapped onto a computer model the model fits onto the bone, [paragraph 0053]).
Regarding claim 7, Carroll discloses further comprising: a second resection feature (150, Figure 23) coupled to the body and capable of guiding the cutting tool to form a second osteotomy in a second bone (124, Figure 21), the second osteotomy shaped to form a resection interface with the first osteotomy [paragraph 0064]; a second bone attachment feature (122, Figure 30) capable of securing the resection guide to the second bone; and wherein the second bone is part of a joint that includes the first bone (i.e. ankle joint).
Regarding claim 8, Carroll discloses a system for an ankle fusion procedure to remediate a bone condition present in a patient's foot (Figures 21-23), comprising: a tibial resection guide (120, Figure 21) comprising: a body (i.e., unitary body described in paragraph, 125 Figure 22) having an anterior side (side close to 135), a posterior side (side facing bone 134), a medial side (side close to 130), a lateral side (side close to 131), a superior side (side close to 133), and an inferior side (side close to 136); a tibia resection feature (129, Figure 23) capable of guiding a cutting tool to form a first osteotomy in a tibia (123, Figure 21), the tibia resection feature extending through the tibial resection guide from the anterior side to the posterior side at a position at least partially determined based on a bone model of at least a portion of the patient's foot [paragraphs 0062, 0071 and 0068], the bone model based on medical imaging of the patient's foot [paragraph 0062]; a tibial bone attachment feature (134, Figure 24) capable of securing the tibial resection guide to the tibia (i.e. bone engaging feature 134 including 130,131, and 133, releasably “interlock” with the topography of the exposed surface of the lower tibia 123, Figure 24 [paragraph 0070]); a talus resection guide (122, Figure 29) comprising: a body (i.e. an unitary body described in paragraph 0066) having an anterior side (side close to 188), a posterior side (side close to 183), a medial side (side close to 184), a lateral side (side close to 186), a superior side (side close to 189), and an inferior side (side close to 137);
a talus resection feature (179, Figure 30) capable of guiding the cutting tool to form a second osteotomy in a talus (124, Figure 21), the talus resection feature (179, Figure 30) extending through the talus resection guide from the anterior side to the posterior side at a position at least partially determined based on the bone model, the second osteotomy capable of cooperating with the first osteotomy to form a resection interface between the tibia and the talus [paragraphs 0068-0071 and Figure 27]; and a talus bone attachment feature (200, Figure 30) capable of securing the talus resection guide the talus.
Regarding claim 9, Carroll discloses wherein the resection interface consists of a resected distal end of the tibia and a resected proximal end of the talus (see Figure 27).
Regarding claim 10, Carroll discloses wherein the resection interface comprises a polygonal cross-section (see Figure 27) taken along an anterior-posterior axis that extends from the anterior side to the posterior side of the body.
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Regarding claim 13, Carroll discloses wherein: the tibial resection guide (120, Figure 21) comprises a tibial bone engagement feature (130, Figure 26)comprising a bone engagement surface capable of registering to a surface of the tibia (i.e. bone engaging feature 134 including 130,131, and 133, releasably “interlock” with the topography of the exposed surface of the lower tibia 123, Figure 24 [paragraph 0070]); and the talus resection guide comprises a talus bone engagement feature (one of 181, 184,186, and 183, Figure 29) comprising a bone engagement surface configured to register to a surface of the talus.
Regarding claim 14, Carroll discloses wherein at least one of the tibial bone engagement feature and the talus bone engagement feature comprise a body section (150, Figure 26 and 200, Figure 31, respectively) that is coupled to and supports the bone engagement surface and wherein the body section is configured based at least partially on user directions [paragraphs 0070-0072].
Regarding claim 18, Carroll discloses wherein one of the tibial resection guide and the talus resection guide comprise a fastener guide (180, Figure 31, capable of guiding a fixation system that fixes the tibia to the talus).
Allowable Subject Matter
Claims 11,12, and 15-17 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.
Claims 21-28 are allowed. The closest prior art reference, Carroll fails to disclose a resection guide having a first resection feature capable of guiding a cutting tool to form a curved osteotomy in a sagittal plane of an ankle of a patient, the curved osteotomy at least partially determined based on a bone model of at least a portion of a patient's ankle, the bone model based on medical imaging of the patient's ankle. A second resection feature configured to guide a cutting tool to form an angled curved osteotomy, the angled curved osteotomy having a curve in a sagittal plane of an ankle of a patient that extends at a first angle in a frontal plane of the ankle that is not perpendicular to a mechanical axis of a tibia of the patient, the angled curved osteotomy at least partially determined based on a bone model of at least a portion of the patient's ankle, the bone model based on medical imaging of the patient's ankle.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DIANA S JONES whose telephone number is (571)270-5963. The examiner can normally be reached Monday to Friday (8am to 4pm EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached at 571-272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Diana Jones/Examiner, Art Unit 3775
/KEVIN T TRUONG/Supervisory Patent Examiner, Art Unit 3775
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