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 with traverse of group (I), claims 11 - 17 in the reply filed on 01/13/2026 is acknowledged. The traversal is on the ground(s) that no search burden will be required. This is not found persuasive because Examiner asserts that although there may be some overlap in searching fields, there are different subclasses to be searched for device and methods (analogous/out-of-art subclasses vs. method only subclasses), which Examiner believes constitutes a search burden. The requirement is still deemed proper and is therefore made FINAL.
Claims 1 – 10 and 18 – 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 01/13/2026.
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.
Claim(s) 11 – 13 and 16 – 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bertagnoli et al. (US Pub. 2007/0233129 A1).
Claim 11, Bertagnoli discloses a clamp system for the preparation of a distal radius bone graft [abstract, Figs. 1 – 12], comprising:
a clamp [at least a portion of 64] configured to contact the graft and secure the graft within the clamp [capable of contacting and securing bony structure i.e. 12, ¶47 and Figs.9-10]; and
a base [at least a portion of 62, Fig.2] connected to the clamp, the base comprising a graft-engaging block [at least a body portion of 62 defines a block capable of engaging bony structure, i.e. Figs. 9 – 10];
wherein the graft-engaging block comprises a graft-engaging surface configured to engage a first surface of the graft and secure the graft within the clamp [at least a surface portion of 62 facing towards the bony structure, Fig.2],
wherein the clamp is configured to continuously contact and secure the graft while at least a portion of the graft opposite the first surface is removed from the graft [at least a portion of 64 capable of continuously securing a bony structure, i.e. Fig. 12. Note, the structure disclosed by Bertagnoli is substantially identical to that claimed, and therefore inherently capable of performing the claimed functions if one desire to do so].
Bertagnoli discloses the limitations of claim 11, as above, and further, Bertagnoli discloses:
Claim 12, wherein the clamp comprises a first securement feature and a second securement feature configured to contact and secure the graft [wherein at least a portion of 64 defines two members 66, Fig.3], wherein in a first configuration, the first securement feature is configured to contact a scaphoid facet of the graft and the second securement feature is configured to contact a lunate facet of the graft, and wherein in a second configuration, the first securement feature is configured to contact the lunate facet of the graft and the second securement feature is configured to contact the scaphoid facet of the graft [Note, the structure disclosed by Bertagnoli is substantially identical to that claimed, and therefore inherently capable of performing the claimed functions if one desire to do so, Figs. 9 – 12].
Claim 13, wherein the clamp further comprises: a first end connected to the first securement feature; a second end connected to the second securement feature [wherein at least a portion of 64 defines two members 68, Fig.3]; and a fulcrum housing [wherein at least a portion by 70, Fig.3] connecting the first end and first securement feature to the second end and second securement feature [Fig.3], wherein the first end and the second end are configured such that when the first end and the second end are moved toward one another, the first securement feature and the second securement feature are moved toward one another, and vice versa [Figs.3 – 4].
Claim 16, wherein the base further comprises a drilling guide [at least a portion of 20] comprising a plurality of guide channels [36 and/or internal channels by 26, Fig.1], the drilling guide being configured to drill a plurality of channels through the graft when a drill bit is passed through the plurality of guide channels and forcibly pressed against the graft [Fig.12].
Claim 17, wherein the clamp comprises a first securement feature and a second securement feature configured to continuously contact and secure the graft, without contacting a portion opposite the first surface of the graft such that at least part of the portion opposite the first surface of the graft may be removed without physical interference from the first securement feature and the second securement feature [wherein at least a portion of 64 defines two members 66, Fig.3].
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) 14 – 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bertagnoli et al. (US Pub. 2007/0233129 A1) in view of Frey et al. (Us Pub. 2020/0138519 A1).
Claims 14 – 15, Bertagnoli discloses the limitations of claim 11, as above, except for explicitly disclosing wherein the graft engaging surface comprises a shape configured to match a 3D shape of a first surface of the graft; or comprises a plurality of modular inserts configured to match the average curvatures and dimensions of the one or more graft surfaces.
Frey teaches an analogous system [abstract, Figs.1 – 47] comprising a block [i.e. at least a portion of 1102] having bone engaging surface [at least a surface portion of 1102 facing the bone], and wherein the graft engaging surface comprises a shape configured to match a 3D shape of a first surface of the graft; or comprises a plurality of modular inserts configured to match the average curvatures and dimensions of the one or more graft surfaces [1114, ¶274 - ¶277, Figs. 43].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current application to combine the teachings of Bertagnoli and Frey, and construct the surface of the block of Bertagnoli having a plurality of patient specific inserts in view of Frey. One would have been motivated to do so in order to decrease the possibility of improper placement of the block relative to the bone [Frey, ¶275].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL S. HANNA whose telephone number is (571)270-3248. The examiner can normally be reached 8-5 M-F.
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/SAMUEL S HANNA/Primary Examiner, Art Unit 3775