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 .
Response to Arguments
Applicant's arguments filed 04/21/2026 have been fully considered but they are not persuasive.
Applicant argues: Bertagnoli does not disclose the limitations directed to the configuration of the graft engaging surface.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant argues: Frey fails to remedy the deficiency, because Frey teaches models that include patient specific surfaces to mate with patient’s anatomy. However, Frey is silent about graft engaging block having a graft engaging surface.
Response: the office is of the position that the structure disclosed by Frey exhibits substantially identical structure to that claimed, and therefore inherently capable of performing the claimed functions if one desire to do so, wherein a block intended to engage anatomical structure is capable of engaging graft, where a graft can be taken therefrom. Accordingly, a PHOSITA considering the entirety of Frey and giving the claims their BRI, should understand that a block intended to engage anatomical structure is substantially equivalent to a block intended to engage a graft.
In view of the receding explanation, the rejection is deemed proper and hereby maintained.
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).
Claims 11 and 15, 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 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] 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 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
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 SAMUEL S. HANNA whose telephone number is (571)270-3248. The examiner can normally be reached 8-5 M-F.
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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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/SAMUEL S HANNA/Primary Examiner, Art Unit 3775
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