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 I, corresponding to claims 1-7, in the reply filed on 07/17/2026 is acknowledged. Claims 8-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/17/2026.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 5-6 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 5 recites “wherein the bone graft substitute is incubated ex vivo with the rAAV prior to implantation to the subject,” and claim 6 recites “wherein the bone graft substitute is incubated ex vivo with human bone marrow-derived stromal cells prior to implantation to the subject.” The claims are drawn to a bone graft substitute, and not a method of using the bone graft substitute. As such, the recitation of the incubation and implantation steps in claims 5-6 were interpreted herein as intended uses for the bone graft substitute—not additional structural limitations that further limit the claimed bone graft substitute.
While fully considered, these limitations were given no patentable weight, and claims 4-5 were interpreted herein to be encompassed by the bone graft substitute of claim 1. Moreover, any prior art reference(s) teaching the bone graft substitute of claim 1 was/were understood herein to be suitable for the intended uses recited by claims 5-6.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Shim et al. (WO 2019/183605, IDS-FOR, hereinafter “Shim”) in view of Awad et al. (Tiss. Eng., 13(8):1973-1985 (2007), hereinafter “Awad”) and Lee et al. (KR 101544175, hereinafter “Lee”).
Shim teaches bone grafts comprising a recombinant adeno-associated virus (rAAV) comprising an isolated nucleic acid comprising a nucleic acid sequence, e.g., an artificial miRNA with a human miR-33 backbone (amiRNA), encoding an inhibitory nucleic acid targeting sclerostin (SOST) or schnurri-3 (SHN3) (Abstract; page 2; page 5; page 6, lines 1-2; page 63; Example 6; claim 33). Shim further teaches that the rAAV comprises a capsid protein, e.g., an AAV9 capsid protein, comprising a heterologous bone-targeting peptide such as DSSDSSDSSDSSDSSDSS, which is identical to instant SEQ ID NO: 11 (page 3, lines 10-20; page 4, lines 1-18; SEQ ID NO: 16).
While, as discussed above, Shim teaches bone grafts comprising the rAAV, the reference does not teach a bone graft substitute with the rAAV and hydroxyapatite (HA) attached to the bone graft substitute, or that the bone graft substitute is an allogeneic bone graft. However, Awad teaches rAAVs expressing therapeutic nucleic acids can be coated, i.e., attached, onto bone allografts to enhance the clinical utility of the bone allografts (Abstract). Likewise, Lee teaches that HA can be functionalized onto the surface of bone allografts to improve adhesion and implantation (Abstract; page 2).
One of ordinary skill in the art would have been motivated to utilize rAAV and HA functionalization, as taught by Awad and Lee, respectively, for the bone graft taught by Shim in order to advantageously enhance the clinical properties of the graft with a reasonable expectation of success. One of ordinary skill in the art would have been further motivated to utilize allografts because Awad teaches that “allografts remain the standard choice for structural bone grafting because of the restricted size and availability of autologous bone grafts, problems with chronic pain at the donor site, and complications of the harvest procedures” (page 1974, first column).
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art at the time of filing especially in the absence of evidence to the contrary.
Conclusion
NO CLAIMS ARE ALLOWED
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Dupont et al., Cell Tissue Res., 347:575-588 (2012)
Graziani et al., Coatings, 10(522):1-17 (2020)
Nasu et al., J Orthop. Res 27:1162-1168 (2009)
Soballe et al., Acta Orthop. Scand., 74(3):239-247 (2003)
Wang et al., Biomater Transl., 2(1):19-29 (2021)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS J VISONE whose telephone number is (571)270-0684. The examiner can normally be reached Monday-Thursday, 8:30 AM to 6:30 PM.
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/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672
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