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 .
Application Status
Claims 1-2, 4, 6-7, 10-13, 15-21, 23, 27, and 30 are pending and examined on the merits herein.
Grounds of Rejection Withdrawn
Previous objection to the drawings is withdrawn in view of amendment.
Previous objection to claim 1 is withdrawn in view of amendment.
Previous rejection of claims 1-2, 4, 7, 10-13, 16, 20-21, 23, and 30 under 35 U.S.C. 102 are withdrawn in view of claim amendments.
Previous rejection of claims 15, 17-19, 30 under 35 U.S.C. 103 are withdrawn in view of claim amendments.
Information Disclosure Statement
Two of the information disclosure statements filed 04/29/2026 fail to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed; there is no copy FOR Ref 2: EP2308473 included or NPL Ref 20: Rollin Martinet et al. It has been placed in the application file, but the information referred to therein has not been considered.
Claim Rejections - 35 USC § 103
New Rejection Necessitated by Amendment
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-2, 4, 6, 10-13, 15-17, and 20-21 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Anderson (US 2014/00663388 A1; PTO-892).
Regarding claims 1 and 6-7, Anderson teaches cationic biodegradable nanoparticles comprising a CaMKII inhibitor and a mitochondrial location sequence (MLS) peptide (claim 1), wherein the CaMKII inhibitor is a peptide (claim 10), wherein the nanoparticles comprise a biodegradable polymer (claim 2), wherein the nanoparticles have an average diameter between about 25 nm and 500 nm (claim 8). Anderson further teaches a goal to prepare peptide-loaded PLGA/PAMAM nanoparticles that range in size from 80 nm to 500 nm (para 0064).
Regarding the size of the nanoparticles there is substantial overlap in the claimed ranges and as the size of the nanoparticles is a variable that is optimizable by one of ordinary skill in the art it would be obvious that a size within both ranges could be produced (e.g. 150-200nM as seen in instant Fig 2D).
Regarding claims 2, 4, 10-11, Anderson teaches wherein the nanoparticles comprise polyamidoamine (PAMAM) dendrimers (claim 3), wherein the nanoparticles comprise polylactic-co-glycolic acid (PLGA) (claim 4), wherein the nanoparticles comprise a mixture of PAMAM and PLGA (claim 5).
Regarding claim 12, Anderson teaches the PG number denotes the generation of the PAMAM dendrimer used to prepare the particle in Fig 4b and particles prepared with higher generation dendrimers illustrated greater buffering capacity (para 0017) and further that PAMAM dendrimers suitable for preparing the presently disclosed nanoparticles may include 3rd-, 4th-, 5th-, or preferably at least 6th-generation dendrimers (para 0035).
Regarding claim 13, Anderson teaches the pharmaceutical preparations utilized in the methods disclosed herein may be manufactured by means that include, but are not limited to, mixing, granulating, dissolving, or lyophilizing processes (para 0049).
Regarding claim 15, Anderson teaches a pharmaceutical composition comprising the nanoparticles of claim 1 (claim 15).
Regarding claims 16-17, 20, and 23, Anderson teaches a method of treating or preventing a disease or disorder associated with mitochondrial CaMKII activity in a patient in need thereof, the method comprising administering the pharmaceutical composition of claim 16 to the patient (claim 17), wherein the disease or disorder is selected from a group selected from cancer, metabolic diseases, and neurodegenerative diseases (claim 19). Anderson further teaches “patient” may be used interchangeably with the term “subject” or “individual” and may include an “animal” and in particular a “mammal.” Mammalian subjects may include humans
Regarding claim 21, Anderson teaches that the presently disclosed cationic biodegradable nanoparticles may be formulated as a pharmaceutical composition and administered to a patient having, suspected of having, or at risk for acquiring hyperplasia or cancer including melanoma or breast cancer (para 0052).
Claims 18-19, 27, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Anderson (US 2014/0066388 A1; PTO-892) as applied to claims 1-2, 4, 6, 10-13, 15-17, and 20-21 above, and further in view of and Bolhassani (Mol Cancer 10, 3 (2011); PTO-892), Melief (J Clin Invest. 2015 Sep;125(9):3401-12; PTO-892) and Bratzler (US 2011/0293723 A1; cited in OA 11/28/2025).
The teachings of Anderson regarding claims 1-2, 4, 6, 10-13, 15-17, and 20-21 are detailed above.
Anderson does not teach wherein the immunogen is encoded in a vector; wherein the vector is a viral vector; or wherein the viral vector is an adenovirus, lentivirus, retrovirus, herpesvirus or AAV; or wherein the immunogen or vector is administered at a site that is different than the administration site for the nanoparticles.
Regarding claims 18-19, Bolhassani teaches that cancer vaccines are the promising tools in the hands of the clinical oncologist and that optimally designed cancer vaccines should combine the best tumor antigens with the most effective immunotherapy agents and/or delivery strategies to achieve positive clinical results (abstract). Bolhassani further teaches that nanoparticles (NPs) such as dendrimers, polymeric NPs, metallic NPs, magnetic NPs and quantum dots have emerged as effective vaccine adjuvants for infectious diseases and cancer therapy (abstract). Bolhassani further teaches that adenovirus has been evolved specifically to deliver DNA into cells and are the most common gene delivery tools used in gene therapy with the major advantage that live vectors produce the antigen in its native conformation (section 1, para 1). Bolhassani further teaches that recombinant adenoviruses (Ads) have enormous potential for gene therapy because they are extremely efficient at delivering DNA to target cells, can infect both dividing and quiescent cells, have a large capacity for incorporation of cDNA expression cassettes, and have a low potential for oncogenesis because they do not insert their genome into the host DNA (section 1, para 4). Bolhassani further teaches PLGA microspheres typically range in size from 1 to 10 μm in diameter, a size that is readily phagocytosed by dendritic cells and other antigen-presenting cells (APCs) and further that PLGA NPs have been shown to effectively enhance immune responses (section 2.3, para 2 and 4). Bolhassani further teaches that PLGA NPs elicit both CD8+ and CD4+ T cell responses by releasing antigen intracellularly (section 2.3, para 2).
Regarding claim 18, Melief teaches that the clinical benefit of therapeutic cancer vaccines has been established and mostly noted as prolonged survival (abstract). Melief further teaches that effective cancer vaccines deliver concentrated antigen to both HLA class I and II molecules of DCs, promoting both CD4 and CD8 T cell responses but suboptimal vaccine design and an immunosuppressive cancer microenvironment are the root causes of the lack of cancer eradication (abstract).
Regarding claim 30, Melief teaches that drugs or physical treatments
can mitigate the immunosuppressive cancer microenvironment and include chemotherapeutics, radiation, indoleamine 2,3-dioxygenase (IDO) inhibitors, inhibitors of T cell checkpoints, agonists of selected TNF receptor family members, and inhibitors of undesirable cytokines (abstract; Fig 3).
Regarding claim 27, Bratzler teaches a dosage form comprising: (1) a first population of synthetic nanocarriers that have one or more first antigens coupled to them, (2) one or more second antigens that are not coupled to the synthetic nanocarriers, and (3) a pharmaceutically acceptable excipient (claim 1), a method comprising: administering the dosage form of claim 1 to a subject (claim 55), wherein the subject has or is at risk of having cancer (claim 57). Bratzler further teaches that in embodiments antigens are not coadministered with the synthetic nanocarriers (para 0041) and further that the antigen and nanocarrier can be administered separately at a different time-point and/or at a different body location and/or by a different immunization route (para 0116). Bratzler further teaches that to the purpose of adding a second antigen is to provide broader immune protection against different strains of a given pathogen (para 0002) which can be broadened to be applied to cancer (para 0031) through targeting of cancer antigens (para 0065). Bratzler further teaches that the compositions and methods described herein can be used to induce, enhance, suppress, modulate, direct, or redirect an immune response to cancer (para 0131).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application that to use an adenovirus vector to deliver a cancer vaccine as taught by Bolhassani, with an additional therapeutic as taught by Melief, as separate dosages at separate sites of administration as taught by Bratzler in the method to enhance immune response in cancer treatment with CamKII-PAMAM-PLGA targeted for cancer treatment as taught by Anderson. The ordinary artisan would have been motivated to do so because Melief teaches that the clinical benefit of therapeutic cancer vaccines has been established and mostly noted as prolonged survival and that effective cancer vaccines deliver concentrated antigen to both HLA class I and II molecules of DCs, promoting both CD4 and CD8 T cell responses. Melief further teaches that drugs or physical treatments can mitigate the immunosuppressive cancer microenvironment including chemotherapeutics and/or inhibitors of T cell checkpoints. Bolhassani teaches that dendrimers and polymeric NPs are effective vaccine adjuvants for infectious diseases and cancer therapy. Bolhassani further teaches that recombinant adenoviruses (Ads) have enormous potential for gene therapy because they are extremely efficient at delivering DNA to target cells, can infect both dividing and quiescent cells, have a large capacity for incorporation of cDNA expression cassettes, and have a low potential for oncogenesis because they do not insert their genome into the host DNA. Bratzler teaches that the administration of a second antigen at a separate administration site provides broader immune protection against multiple cancer antigens. The ordinary artisan has a reasonable expectation of success to use an adenovirus vector to deliver a cancer vaccine in combination with chemotherapy or a checkpoint inhibitor in the method of enhancing an immune response to cancer with PAMAM-PLGA nanoparticles in order to increase the efficiency of transduction, and enhance the immune response induced by the cancer vaccine and provide broader immune protection against multiple cancer antigens.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-2, 4, 6-7, 10-13, 15-21, 23, 27, and 30 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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 AMBER K FAUST whose telephone number is (703)756-1661. The examiner can normally be reached Monday - Thursday 9:00am-6:00pm EST.
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/AMBER K FAUST/Examiner, Art Unit 1643
/GARY B NICKOL/Primary Examiner, Art Unit 1643
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