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 .
Applicant’s amendment and response of 1/20/26, is entered.
Claims 11-13 are amended.
Claims 1-10 and 14-16 are canceled.
Claims 17-29 are newly added.
Claims 11-13 and 17-29 are pending and considered herein.
Claim Status, Canceled Claims
In light of the cancelation of Claims 1-10 and 14-16, all objections/rejections against these claims, are withdrawn.
Specification
In light of the amendment to the specification, the objection to the same, is withdrawn.
Claim Objections
Applicant is advised that should claims 11-12 and 23-25 be found allowable, claims 13 and 26-29, as well as 17-22, respectively, will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Each of the claimed methods contain the exact same steps, respectively. The sole distinction is the reasoning for the method, which does not alter the steps of the methods. Thus, despite a slight difference in wording, these claims have substantially the same scope.
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.
Due the amendment, requiring the microparticles to comprise IGF-1 or C-phyocyanin, and the media comprising serum components, the rejections of Claim(s) 11 and 13 under 35 U.S.C. 102(a)(1) as being anticipated by Solorio, et al. (2010) “Gelatin microspheres crosslinked with genipin for local delivery of growth factors”, Journal of Tissue Engineering and Regenerative Medicine, 4: 514-23 (Cited by Applicant), are withdrawn.
To wit, Solorio does not teach the incorporation of the specific growth factors.
Claim Rejections - 35 USC § 103
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 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, 17-21, 23-24, and 26-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Witt, et al. (2017) “Mesenchymal stem cells and myoblast differentiation under HGF and IGF-1 stimulation for 3D skeletal muscle tissue engineering”, BMC Cell Biology, 18:15 (16 pages); and Solorio, et al. (2010) “Gelatin microspheres crosslinked with genipin for local delivery of growth factors”, Journal of Tissue Engineering and Regenerative Medicine, 4: 514-23.
Witt teaches mono- and co-cultures of myoblasts and MSCs cultured in a media containing HGF and IGF-1, for 2-14 days (e.g., pp. 3-4, paragraph bridging pages). The media also contained bovine and/or fetal bovine serum (section “2.2. Cell cultures”).
However, Witt does not teach the use of genipin cross-liked gelatin microparticles.
On the other hand, the Artisan, interested in culturing cells, would be aware of Solorio, for its teaching of delivery of growth factors to cells, via gelatin microspheres (e.g., TITLE).
Solorio teaches the formation of gelatin microparticles for delivery of growth factors (ABSTRACT). Such is taught to be crosslinked by way of genipin (Id.) and they utilized 20, 50 and 80% saturation of crosslinks (Id.). It is noted that the degree of crosslinking can be controlled, allowing different rates of loading and unloading rates for the growth factors (e.g., pp. 515-16, paragraph bridging. The conclusion teaches that the control of crosslinking results in control of the release rate of the growth factors, and the microspheres can be delivered separately or as a part of a scaffold or defined microenvironment to control cell function.
Thus, at the time of invention, it would have been obvious to modify Witt with the genipin crosslinked gelatin microparticles of Solorio to deliver the HGF and/or IGF-1 of Witt. The Artisan would expect success, as the components are utilized for their art-recognized purposes.
Allowable Subject Matter
Claims 22, 25, and 29 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims (please also be aware of the objection warning above, as these claims are to the same substantial scope).
Conclusion
No claim is allowed.
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 ROBERT M KELLY whose telephone number is (571)272-0729. The examiner can normally be reached M-F: 8a-5p.
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ROBERT M. KELLY
Examiner
Art Unit 1638
/ROBERT M KELLY/Primary Examiner, Art Unit 1638