DETAILED ACTION
This action is in response to Applicant’s amendment filed on 7 May 2026.
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) 1-6, 9-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Perler et al. (U.S. Publication No. 2022/0338934).
Perler et al. disclose a patient specific apparatus (1700), although not specifically stated for harvesting bone, the device would be capable of harvesting bone. The apparatus comprising: a body (1402); a bone attachment feature (1406); a first resection feature (1434) configured to guide a first osteotomy of a donor bone of a patient receiving the surgical procedure; a second resection feature (1406) configured to guide a second osteotomy of the donor bone, the second resection feature positioned relative to the first resection feature by a predetermined distance defined by the body (as seen in figure 17A, there is a distance separating the two slots. The distance is considered predetermined since the device is patient specific). The structure disclosed is able to, “correspond to a dimension that satisfies a patient-specific bone graft dimension”, since such dimension is arbitrary and the cuts made by the device would produce bone pieces that could be the necessary size required by a specific patient.
Regarding claim 2, the language only further modifies the functional language and does not provide additional elements to the structure of the apparatus.
Regarding claim 6 comprising a landmark registration feature (2102) configured to engage a landmark of the donor bone.
Regarding claim 9, an alternate embodiment shows an alternative resection feature (1438) that is offset from the first resection feature by a second dimension, the second dimension different from the patient specific dimension (Figure 15B).
Regarding claim 10, the first resection feature (can be 1436 of figure 15B) and the second resection feature (can be 1438 of figure 15B) each extend through the body from a bone-facing side of the body to a non-bone-facing side of the body and wherein the first resection feature and the second resection feature extend through the body parallel to each other (Figure 15B).
Regarding claim 11, the first resection feature and the second resection feature extend through the body at an angle such that the first osteotomy and the second osteotomy form a wedge-shaped bone graft (Figure 17B).
Regarding claim 12, the donor bone is a calcaneus of a patient of a Lapidus surgical procedure. The limitation is considered only further limiting functional language. Since claim 1 provides nothing “specific” about the patient specific apparatus, it is considered that the device of Perler et al. could be used on the Calcaneus of a patient.
In the alternative, Perler et al discloses claims 1, 3-5 in the following manner.
Perler et al. disclose a patient specific apparatus (1043) (Paragraph 102), although not specifically stated for harvesting bone, the device would be capable of harvesting bone. The apparatus comprising: a body (Figure 10); a bone attachment feature (1046); a first resection feature (1049) configured to guide a first osteotomy of a donor bone of a patient receiving the surgical procedure; a second resection feature (The flat edge of end 1045 in figure 10 can be considered a resection feature) configured to guide a second osteotomy of the donor bone, the second resection feature positioned relative to the first resection feature by a predetermined distance defined by the body (as seen in figure 10 there is a distance separating the two surfaces. The distance is considered predetermined since the device is patient specific). The structure disclosed is able to, “correspond to a dimension that satisfies a patient-specific bone graft dimension”, since such dimension is arbitrary and the cuts made by the device would produce bone pieces that could be the necessary size required by a specific patient.
Regarding claim 3, the body comprises a patient-specific bone engagement surface configured to engage a surface of the donor bone, and the donor bone is the calcaneus of the patient receiving the surgical procedure (paragraph 102).
Regarding claim 4, the patient specific bone engagement surface comprises a patient specific contour at least partially determined based on a bone model of the donor bone, the bone model defined based on medical imaging of the donor bone (paragraph 13).
Regarding claim the patient specific bone engagement surface is configured to engage at least two cortical surfaces of the donor bone (paragraph 102)
Regarding claim 13, the limitations mirror that of claim 1 with the addition of stating the bone to be a calcaneus bone in the functional language and also that the patient specific bone graft is defined in a preoperative plan for the patient. The predetermined distance, although further limited by a preoperative plan, is still an arbitrary element that the device of Perler is able to satisfy. Thus claim 13 is anticapted by Perler.
Regarding claim 14, it can be considered that the outer edges of the device 1043 are all resection features since they are flat and would be capable of guiding a blade pressed against it. Therefore, there are three resection features that from a first osteotomy, a second osteotomy, and a third osteotomy that connects the first and third, (i.e three sides of the device).
Regarding claim 15, the third resection features comprises an edge (since it is an edge of the apparatus).
Allowable Subject Matter
Claims 7-8, 16 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 alone or in combination fails to disclose the elements of the patient specific bone harvesting guide and further including a guard pin guide or a shaping jig.
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 ANDREW YANG whose telephone number is (571)272-3472. The examiner can normally be reached 9:00 - 9:00 M-F.
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/ANDREW YANG/Primary Examiner, Art Unit 3775
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