DETAILED ACTION
The following is a non-final office action is response to communications received on 05/24/2023. Claims 13-23 are currently pending and addressed below.
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
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 13-16 & 18-23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bindseil et al. (US 7,252,685). Please refer to the annotated figure below in consideration of the following rejection:
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Regarding Claim 13, Bindseil teaches a kit for filling bone material in a bone implant, the kit comprising:
a bone implant (12) comprising a mesh (Col 3: lines 6-9) having an inner surface (shown as the inside of member 16) and an outer surface (shown) opposing the inner surface, the inner surface configured to receive a bone material (14) when the inner surface of the mesh is in an open configuration (i.e., prior to suturing 26);
a plurality of projections (sutures 26; Col 5: lines 37-47) disposed on or in at least a portion of the inner surface of the mesh (as it passes through the inside of implant 12), the plurality of projections extending from at least the portion of the inner surface of the mesh and configured to engage a section of the inner surface (of opposing member 16) of the mesh or a section of the outer surface of the mesh (sutures shown in contact with exterior of member 16) or both sections of the inner and outer surfaces of the mesh in a closed configuration (Fig 2) so as to enclose the bone material (14); and
a tray (Col 4: lines 32-38 teaches a mold, press or other shaping device used to assemble implant 12) having a proximal end, a distal end (although not illustrated, any mold would inherently comprise a proximal and distal end), and a longitudinal recess disposed therebetween (any mold would inherently comprise a cavity with a longitudinal axis), the longitudinal recess configured to receive the mesh (16) in the open configuration to allow filling of the bone material (14) into the bone implant.
Regarding Claim 14, Bindseil teaches wherein the recess of the tray forms a slot (the mold cavity discussed supra) for receiving the mesh.
Regarding Claim 15, Bindseil teaches wherein the longitudinal recess is a channel, a trough, a slot, a groove or grooves, an indent or indents or a combination thereof (the mold cavity discussed supra).
Regarding Claim 16, Bindseil teaches wherein the longitudinal recess in centrally located in the tray (as the device 12 is symmetrical, the recess would be disposed centrally).
Regarding Claim 18, Bindseil teaches wherein (i) the bone material comprises fully demineralized bone fibers and surface demineralized bone chips; (ii) the bone material comprises calcium phosphate; or (iii) the bone material comprises autograft (Col 7: lines 55-58).
Regarding Claim 19, Bindseil teaches a method of implanting a bone implant at a surgical site, the method comprising:
providing a bone implant (12) comprising a mesh (Col 3: lines 6-9) having an inner surface (shown as the inside of member 16) and an outer surface (shown) opposing the inner surface, the inner surface configured to receive a bone material (14) when the inner surface of the mesh is in an open configuration (i.e., prior to suturing 26); a plurality of projections (sutures 26; Col 5: lines 37-47) disposed on or in at least a portion of the inner surface of the mesh (as it passes through the inside of implant 12), the plurality of projections extending from at least the portion of the inner surface (of opposing member 16) of the mesh and configured to engage a section of the inner surface of the mesh or a section of the outer surface of the mesh (sutures shown in contact with exterior of member 16) or both sections of the inner and outer surfaces of the mesh in a closed configuration (Fig 2) so as to enclose the bone material (14);
disposing the bone material in the inner surface of the mesh by orientating the mesh in the open configuration (i.e., prior to sewing closed via sutures 26);
enclosing the bone material (14) in the mesh by orientating the mesh in the closed configuration (Fig 2); and placing the bone implant at the surgical site thereby implanting the bone implant at the surgical site (Col 2: lines 37-40).
Regarding Claim 20, Bindseil teaches wherein (i) the plurality of projections are hooks; (ii) the inner surface (shown) comprises a plurality of recesses (holes where sutures 26 pass) configured to mate with the plurality of projections (26) of the inner surface; or (iii) the bone material is fully demineralized bone fibers and surface demineralized bone chips.
Regarding Claim 21, Bindseil teaches wherein (i) the mesh is foldable (Fig 2) in the closed configuration to enclose the bone material; (ii) the inner surface of the mesh comprises a fold line extending from a distal end to a proximal end of the inner surface, the fold line forming a compartment to receive the bone material; (iii) the mesh is configured to roll the section of the inner surface over the bone material to enclose the bone material; (iv) the plurality of projections are disposed on or in the entire inner surface of the mesh or (v) the section of the inner surface comprises a plurality of recesses (holes where sutures 26 pass) configured to mate with the plurality of projections (26) of the inner surface.
Regarding Claim 22, Bindseil teaches wherein the bone material (14) is partially enclosed by the mesh (except for opening 18).
Regarding Claim 23, Bindseil teaches wherein the inner surface (shown) of the mesh comprises a distal end (shown) and a proximal end (shown) and a compartment (interpreted as a cylindrical shape radially inward of the sutures 26) extending from the distal end to the proximal end, the compartment configured to receive the bone material, the compartment having none of the plurality of the projections (Fig 2).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bindseil et al. (US 7,252,85) in view of Bagga et al. (US 2011/0144764).
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Regarding Claim 17, as set forth supra, Bindseil discloses the invention substantially as claimed. However, Bindseil does not specifically disclose wherein the tray is made of a metal, thermoform, a polymer or a combination thereof.
Bagga teaches a surgical kit (200) in the same field of endeavor. Said kit comprising a tray (210) with a recess for holding and manipulating the bone graft material (10) during surgery [0083]. Said tray constructed of thermoplastic (i.e., a polymer) or other convenient material [0083].
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to construct the mold/holder, as taught by Bindseil, from the thermoplastic (or other material) to provide a strong and stable device for manipulating the graft during surgery. It has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN AINSLEY DUKERT whose telephone number is (571)270-3258. The examiner can normally be reached Mon-Fri 6am-4pm.
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/BRIAN A DUKERT/Primary Examiner, Art Unit 3774