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 Group 1, Claims 1-16 in the reply filed on November 10, 2025 is acknowledged.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 11 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 10 requires that the first and second resection features extend thorough the body and that they are parallel to each other. Claim 11 then claims that the first and second resection features extend through the body at an angle so that the bone graft is wedge shaped. Claim 11 depends form claim 10 and offers a contradicting limitation to claim 10. It would be impossible to have something defined as parallel to also form an angle such that a wedge shape is created, since a wedge indicates a triangular shape.
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) 1-7, 9-10, 12-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee et al. (U.S. Patent No. 9668746).
Lee et al. discloses an apparatus for harvesting bone for a surgical procedure comprising: a body (10); a bone attachment feature (24, Paragraph 32); a first resection feature (40B) configured to guide a first osteotomy of a donor bone (Figure 4A); a second resection feature (40C) configured to guide a second osteotomy of the donor bone (Figure 4A), the second resection feature being offset from the first resection feature (Figure 4A) by a dimension set according to a harvesting guide model to provide a predefined bone graft dimension (Paragraph 35, “In use, the template assembly 10 may be used to resect a portion of bone from the bone of the donor which is slightly larger than the corresponding resected opening in the bone of the patient.”). It can be construed form the resected opening is the harvesting guide model and the dimension is predefined by the opening size.
Regarding claim 2, the predefined bone graft dimension is one of a set of predefined dimensions determined for an opening in a planned surgical procedure (it is considered that all surgeries require planning).
Regarding claim 3, the body comprises a bone engagement surface (14) configured to engage a surface of the donor bone.
Regarding claim 4, the bone engagement surface comprises a contour (Figure 1B) 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 31, “The donor template may accordingly define a contact surface for placement along or upon the underlying bone as a well as a curved template portion to facilitate conformance against the bone surface.”). The statement is overly broad and does not provide any inherent structure to the claim. Furthermore, such statements verge on defining how the product is made, and such statements are given little patentably weight in an apparatus claim so long as the claimed structure is shown.
Regarding 5. the bone engagement surface is configured to engage at least two cortical surfaces of the donor bone. Due to the size of the device, it is considered capable of engaging two cortical surfaces.
Regarding claim 6, the apparatus further comprise a landmark registration feature configured to engage a landmark of the donor bone (the curve of the surface 14 can be considered a landmark registration feature).
Regarding claim 7, the apparatus further comprising a guard pin guide (26) configured to receive a guard pin into the donor bone such that the guard pin prevents cutting donor bone beyond a boundary.
Regarding claim 9, the apparatus further comprising an alternative resection feature (42C) that is offset from the first resection feature by a second dimension, the second dimension different from the dimension (Figure 2D).
Regarding claim 10, the first resection feature and the second resection feature 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 1A, 1B).
Regarding claim 12, the donor bone is a calcaneus of a patient of a Lapidus surgical procedure. This claim only further limits the functional language of claim 1, and it is considered that the device of Lee et al. can be used on the calcaneus of a patient.
Regarding claim 13, Lee et al. discloses a system for harvesting bone for a surgical procedure comprising: a harvesting guide (Figure 1A) comprising: a body (10); a bone attachment feature (24); a first resection feature (40B), the first resection feature configured to guide a first osteotomy of a donor bone (Figure 4A); and a second resection feature (40C), the second resection feature configured to guide a second osteotomy of the donor bone (Figure 4A), the first resection feature extending through the body parallel to the second resection feature (Figure 4A), the first resection feature separated from the second resection feature by a distance defined based on a patient-specific bone graft insertion site (paragraph 31, “The donor template may accordingly define a contact surface for placement along or upon the underlying bone as a well as a curved template portion to facilitate conformance against the bone surface.”); and a guard (Figure 3A, the walls of the cutting slots are considered the guard) configured to prevent cutting the donor bone beyond a boundary.
Regarding claim 14, the harvesting guide comprises: a third resection feature (40A) that extends from a bone-facing side to a non-bone-facing side of the body; wherein the third resection feature guides a third osteotomy that connects the first osteotomy and the second osteotomy.
Regarding claim 15, the third resection feature comprises an edge (Figure 3A).
Claim(s) 1, 10, 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cerundolo et al. (U.S. Publication No. 2019/0262010).
Cerundolo et al. discloses an apparatus for harvesting bone for a surgical procedure comprising: a body (200); a bone attachment feature (202); a first resection feature (210) configured to guide a first osteotomy of a donor bone; a second resection feature (210) configured to guide a second osteotomy of the donor bone (Figure 2A), the second resection feature being offset from the first resection feature (Figure 2A) by a dimension set according to a harvesting guide model to provide a predefined bone graft dimension (paragraph 62).
Regarding claim 10, the first resection feature and the second resection feature 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 2B).
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 2C).
Claim(s) 1, 7, 8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kuyler et al. (U.S. Patent No. D1079011).
Kuyler et al. discloses an apparatus for harvesting bone (See below) for a surgical procedure comprising: a body; a bone attachment feature; a first resection feature configured to guide a first osteotomy of a donor bone; a second resection feature configured to guide a second osteotomy of the donor bone, the second resection feature being offset from the first resection feature by a dimension set according to a harvesting guide model to provide a predefined bone graft dimension (the dimension between the first and second resection features are in essence predefined, since someone had to determine the size of the device in the first place. Furthermore, the harvesting guide model is considered part of a functional limitation of the dimension and does not differentiate from the prior art device).
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Regarding claim 7, the apparatus further comprising a guard pin guide (see above) configured to receive a guard pin into the donor bone such that the guard pin prevents cutting donor bone beyond a boundary.
Regarding claim 8, the guard pin guide is positioned at an end of at least one of the first resection feature and the second resection feature (See figure provided above).
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) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (U.S. Patent No. 9668746) in view of Steiner et al. (U.S. Patent No. 7780668).
Lee discloses the claimed invention except for the system further comprising a jig configured to guide shaping of a bone graft resected from the donor bone using the harvesting guide. Steiner et al. teaches a jig (20) for shaping an allograft (210). The allograft is first removed from a larger piece of material and then shaped with the jig (20). The jig allows a surgeon to easily create correctly dimensioned grafts (column 4, lines 53-55). It would have been obvious to one skilled in the art to construct the system of Lee et al. with a jig in view of Steiner et al. in order to easily create a dimensionally correct graft.
Conclusion
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/ANDREW YANG/ Primary Examiner, Art Unit 3775