DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
INFORMATION DISCLOSURE STATEMENT
2. Information Disclosure Statement filed 2/20/2026 is acknowledged.
Claim Rejections - 35 USC § 112
3. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3 and 29 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
It is not clear if the biopolymer matrix has to include all of a-d or just one of these features since the end of the claim before c and d says “of”. It is believed that this should be or and that only one of a-d is required by the claim.
Claim 29 recites “virus-like particle” and the metes and bounds of the claim are unclear as to what constitutes such that it is like a virus.
Claim Rejections - 35 USC § 103
4. 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 1-3, 16-18, 20, 22-24, 29-30, 33, 35, 37-40, 43 and 46 are rejected under 35 U.S.C. 103 as being unpatentable over Scadden et al. (US 20250127929)-priority date 3/29/2022 in view of Gu et al. (US 20150359928).
Scadden et al. (US 20250127929) (hereinafter Scadden et al.) teach compositions for modulating the immune system that comprises administering a porous scaffold (para 0004-0005). The method results in transduction of about 1 % to 50 % (para 0009). The scaffolds include alginate (para 0013) and the pore diameter are between about 20 and 80 µm (para 0014 and 0151). The alginate polymers have an average molecular weight from 20 kDa to 500 kDa (para 0141). The composition includes cells (para 0246-0251). The active agent can be an amino acid, peptide, protein, vector (claim 7). The scaffold is placed into or adjacent target tissue (para 0082). The active agents can be administered such that it provides gene therapy and oncolytic virotherapies that utilize oncolytic viruses to preferentially kill tumor cells (para 0048). Therefore, it would be obvious to implant near a tumor. Claim 16 recites how the biopolymer matrix is generated and is regarded as a product by process claim. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe. Scadden et al. teach inclusion of viral vectors such as lentivirus (transduction agent) (paras 0064, 0067, 0076, 0226, claim 7). The composition can include siRNA (para 0067, 0076, 0252). The tissue includes bone tissue (para 0077). Exemplary macropore sizes include about 50 μm, about 100 μm, about 150 μm, about 200 μm, about 250 μm, about 300 μm, about 350 μm, about 400 μm, about 450 μm, about 500 μm, about 550 μm, and about 600 μm in diameter (para 0136, 0151). The composition can include cytokines such as IL-7 (paras 0018 and 0235). The composition can include T cell and B cells (para 0027). The composition can include active agents such as CRISPER/Cas 9 (immunomodulator).
Scadden et al. does not disclose stiffness ranging from 1 kPa to 1000 kPa or that the stiffness is from 25 % to 250 % of the stiffness of a target tissue.
Scadden teach a similar scaffold with the same alginate polymers and overlapping microporosity and thus the properties relied upon such as stiffness in compared to target tissue would necessary be present. Gu et al. (US 20150359928) teach in alginate hydrogels, stiffness of 1-10 Kpa led to primarily adipogenesis in MSCs, a stiffness of 11-30 kPa led to primary osteogenesis of MSCs (paras 0076, 0130, Table 1).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to optimize the level of stiffness. One would have been motivated to do so depending on the desired properties such as for the osteogenesis of MSCs.
CORRESPONDENCE
5. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Danah Al-awadi whose telephone number is (571) 270-7668. The examiner can normally be reached on 9:00 am - 6:00 pm; M-F (EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Robert A. Wax can be reached on (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANAH AL-AWADI/ Primary Examiner, Art Unit 1615
