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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08/14/2026 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 11 and claims depending therefrom have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bosworth et al. (US Pub. 2016/0270933 A1).
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Claim 11, Bosworth discloses a clamp system for the preparation of a distal radius bone graft [abstract, Figs. 17 – 25 and Fig. 17 above], comprising:
a base [at least a portion of 170];
a clamp [at least a portion of 162] connected to and arranged on an upper side of the base [at least a portion of 162 connected to and arranged on a side of 170 facing towards 160, Fig.19], the clamp configured to contact and secure the graft within the clamp [at least a portion of 162 intended to contact bone by end 166, and exhibits substantially identical structure to the claimed clamp and therefore inherently capable of performing the claimed functions, i.e. engaging bone graft]; and
a graft-engaging block connected to and arranged on the upper side of the base [at least a portion of 158 connected to and arranged on a side of 170 facing towards 160, Figs.17 and 19];
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 portion of 158 intended to engage bone by an end towards the bone, and exhibits substantially identical structure to the claimed block and therefore inherently capable of performing the claimed functions, i.e. engaging bone graft and securing at least a portion of a graft within at least a portion of 162],
wherein the graft-engaging surface comprises a V-block shape or a shape including mating features based on average curvatures and dimensions of one or more graft surfaces determined from a database [Fig.17 above, V- block shape],
wherein the clamp is configured to continuously contact and secure the graft while at least a portion of the graft away from the first surface is removed from the graft [at least a portion of 162 intended to continuously contact and secure bone by end 166, and exhibits substantially identical structure to the claimed clamp and therefore inherently capable of performing the claimed functions, i.e. contacting and securing bone graft].
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) 11 – 13 and 15 – 17 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).
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Claims 11 and 15, Bertagnoli discloses a clamp system for the preparation of a distal radius bone graft [abstract, Figs. 1 – 12, Fig. 2 above], comprising:
a base [at least a portion of 20, Fig.2 above];
a clamp [at least a portion of at least one of clamps 64] connected to and arranged on an upper side of the base [a side of at least a portion of 20, defines an upper side of the base, to which a portion of clamp 64 is connected thereto via the body of 62 and arranged thereon, Fig.3], the clamp configured to contact and secure the graft within the clamp [capable of contacting and securing bony structure i.e. 12, ¶47 and Figs.9-10, exhibits substantially identical structure to the claimed clamp and therefore inherently capable of performing the claimed functions];
a graft engaging block connected to and arranged on the upper side of the base [at least a portion of 62, Fig.2, defines a block connected to and arranged on the upper side of the base, Fig.2 above and Fig.3];
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 defines a graft engaging surface capable of performing the claimed functions due to the substantially identical structure, Fig.2],
wherein the clamp is configured to continuously contact and secure the graft while at least a portion of the graft away from 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 does not disclose wherein the graft engaging surface comprises a shape including a mating features based on average curvatures and dimensions of a graft surface determined from a database; and 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 including mating features configured to match a 3D shape of a graft surface “ features based on average curvatures and dimensions of anatomical structure”; and 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 shape including mating features based on average curvatures and dimensions of graft surface “anatomical structure”, and 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].
The combination of Bertagnoli and Frey 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 defines a guide for guiding instrument / tool therethrough] comprising a plurality of guide channels [openings 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 away from 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 with substantially identical structure to that claimed, Fig.3].
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
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