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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 5/19/2026 has been entered.
Claims 17 and 21-22 are amended.
Claims 11-13, 18-20, and 23-29 are canceled.
Claims 30-36 are newly added.
Claims 17, 21-22, and 30-36 are pending and considered herein.
Claim Status, Canceled Claims
In light of the cancelation of Claims 11-13, 18-20, and 23-29, all objections/rejections against these claims, are withdrawn.
Claim Objections
In light of the claim cancelations, the double patenting objection warnings against 17 and 21-22, are withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 17, 21, and 30-36 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims are generic for the amount of ethanol solvent, the amount of genipin, and amount of dry gelatin microparticles reacted for 14-18 hours, as in Claim 1. Claim 22 limits the genipin to 0.5% (wt/vol), 90% ethanol, and 50 mg/mL dry gelatin microparticles. Thus, the broad claims are not so restricted in amounts of genipin, ethanol, and/or dry gelatin microparticles. Claim 21, from which Claim 22 depends, makes clear that the amount of crosslinking between 10-60%. All of this is in the context of a medium with less than 10% serum components (Claim 1).
The specification teaches the degree of crosslinking of gelatin microparticles is expressed in terms of cross-linking time (e.g., paragraph 35) and provides support for 90% ethanol, 0.5% (w/v) genipin, and 50 mg/mL dry gelatin microparticles, in the context 14-18 hours reaction time. Paragraph 51 makes it clear crosslinking may be 10-60%, and paragraph 52 indicates similar amounts of components and 14-18 hour reaction time. Paragraphs 65-66 parallel paragraphs 51-52. And again, paragraphs 71-72 parallel paragraphs 51-52. A single example is provided at 16 hours of cross-linked particles (e.g., Example 2), which was found to increase proliferation by 1.6 times that of particles made for more or less reaction time (e.g., GMS_16 in Example 7). Thus, the purpose of these particles is to increase proliferation when less FBS is utilized than the normal 10%.
From this, the specification indicates an understanding that products of the reaction depend on the components and their amounts, and in terms of reaction time, and that specific levels of crosslinking with genipin in the microparticles increases proliferation at less than 10% serum components.
The Art, similarly, recognizes that the product can be defined in terms of components and their amounts, and reaction time (e.g., 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). Solario notes 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).
Thus, given the very large range of concentrations and amounts of the components of the reaction, and large range of reaction time, and disclosure of only 10-60% in the context of 14-18 hour reaction time, in the context of 90% Ethanol, 0.5% (w/v) genipin, and 50 mg/mL of dry gelatin microparticles, the Artisan would not have understood Applicant to have been in possession of distinct components and amounts, and times other than 14-18 hours, as such is required to obtain the specification’s purpose of these reactions: increasing proliferation when there is less than 10% serum components.
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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.
In light of the amendment, the rejections of Claim(s) 17 and 21 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, are withdrawn.
To wit, the specific conditions of microparticle manufacture are not taught and are not obvious, as it would require hindsight.
Claim 22 free of the art
It is noted that for the same reasoning as is given for the withdraw of the Art rejections above, Claim 22 is free of the Art of record.
However:
Claim 22 is 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.
Conclusion
No claim is allowed.
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
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