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 .
Response to Amendment
The amendment filed 29 April 2026 in which claims 1, 12, and 33 were amended, claims 34-36 were added, and claims 16-18 were cancelled has been entered.
Claims 1-15 and 32-36 are under examination on the merits.
Specification
(Previous objection, withdrawn). Applicant’s amendments to the Specification submitted on 29 April 2026 have overcome the objection previously set forth in the Non-Final Office Action mailed 06 February 2026.
Claim Objections
(Previous objection, withdrawn as to claims 1 and 12). Applicant’s amendments to claims 1 and 12 submitted on 29 April 2026 have overcome the objections previously set forth in the Non-Final Office Action mailed 06 February 2026.
Claim Rejections - 35 USC § 112 - Enablement
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
(Previous rejection, withdrawn as to claims 16-18 due to cancelation of the claims). Claims 16-18 were rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claims contained subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. The applicant canceled claims 16-18 on the response filed 29 April 2026.
(New rejection, necessitated by addition of claim 34). Claim 34 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the Specification, while being enabling for treating an infectious disease or cancer, does not reasonably provide enablement for preventing an infectious disease or cancer. The Specification does not enable any person skilled in the area to which it is most nearly connected, to use the invention commensurate in scope with these claims.
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue.” These factors include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
In re Wands, 858 F.2d 732, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
The breadth of claim 34 broadly encompasses a method of preventing or treating4 an infectious disease or cancer by inducing an immune response in a patient by administering the vaccine delivery system of claim 1. With regard to prevention of an infectious disease or cancer, it is noted that the term “preventing” was interpreted in an absolute sense to mean to always keep something from happening to arising i.e. preventing infection from occurring not just preventing cell to cell transfer.
The embodiment of preventing an infectious disease is not enabled because not all infections by an infectious disease are prevented by vaccine delivery system being claimed. The embodiment of preventing cancer is not enabled because only recurrent cancers with the same tumor antigens would be prevented by the vaccine delivery system claimed. The level of skill in the art is high and would include, e.g. PhD level scientists.
The Specification provides an example of the vaccine delivery system inducing an immune response in mice (Mouse Serum ELISA) and that cGAMP is used in anti-cancer immunotherapy (¶0152) but does not provide any working examples or reasonable direction in preventing all infections caused by an infectious disease or preventing cancer.
Amanna, et al. (Curr Top Microbiol Immunol. 2020;428:1-30., hereinafter “Amanna”) provides a review of the state of the art in vaccine efficacy. Vaccines are not 100% effective in preventing infection (§2.1, 3.1, 3.2). Anand, et al. (Pharm Res. 2008 Sep;25(9):2097-116., hereinafter “Anand”) provides a review of the state in the art in preventing cancer. Cancer risks may be mitigated by lifestyle changes but some cancer is genetic and cannot be prevented (Abstract). Amanna and Anand demonstrate that the ability of a vaccine to prevent some infections or some cancer is not reasonably predictive of the ability of the vaccine to prevent all infectious diseases or all cancers.
In view of the breadth of the claims, the limited teachings of the specification and the examples regarding preventing an infectious disease and cancer, the state of the art, and the low predictability with regard to the ability of a vaccine to prevent an infectious disease or cancer, it would require undue experimentation to practice the claimed methods. Amendment to the claims to only require treatment of an infectious disease or cancer would overcome the rejection.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
(Previous rejection, withdrawn as to claims 1-4, 7-9, 12-15, and 32-33). Claims 1-4, 7-9, 12-15, and 32-33 were rejected under 35 U.S.C. 103 as being prima facie obvious over Satchi-Fainaro and Zhao. This rejection is withdrawn due to Applicant’s amendment to claim 1 submitted on 29 April 2026.
(Previous rejection, withdrawn as to claims 5-6). Claims 5-6 were rejected under 35 U.S.C. 103 as being prima facie obvious over Satchi-Fainaro, Zhao, and Du. This rejection is withdrawn due to Applicant’s amendment to claim 1 submitted on 29 April 2026.
(Previous rejection, withdrawn as to claims 10-11). Claims 10-11 were rejected under 35 U.S.C. 103 as being prima facie obvious over Satchi-Fainaro, Zhao, and Oleszycka. This rejection is withdrawn due to Applicant’s amendment to claim 1 submitted on 29 April 2026.
(Previous rejection, withdrawn as to claims 16-18). Claims 16-18 were rejected under 35 U.S.C. 103 as being prima facie obvious over Satchi-Fainaro, Zhao, Shibuya, and Dekker. This rejection is withdrawn due to Applicant’s cancelation of claims 16-18 submitted on 29 April 2026.
(New rejection, necessitated by amendment to claim 1 and addition of claims 34-36).
Claims 1-4, 7-9, 12-15, and 32-36 are rejected under 35 U.S.C. 103 as being unpatentable over Roth, et al. (ACS Cent Sci. 2020 Oct 28;6(10):1800-1812., NPL-IDS, filed, 12/11/2023, hereinafter “Roth”) and further in view of Satchi-Fainaro (Prior Art of Record).
Regarding claims 1-2, Roth teaches a vaccine delivery system which comprises a hydrogel comprising a polymer non-covalently cross-linked with nanoparticles (Figure 1) an antigen (OVA) and adjuvant (Poly I:C) encapsulated in the hydrogel (pg. 1803, column 1), and that the antigen and adjuvant is separate from the nanoparticles (Figure 1A) . Roth does not teach that the adjuvant is a dinucleotide adjuvant. However, Satchi-Fainaro teaches a polymeric nanoparticle vaccine that contains an adjuvant which is a TLR ligand, including Poly I:C, MPLA, flagellin, Resiquimod, and CpG (a dinucleotide adjuvant) (pg. 4, lines 22-30).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to have substituted the Poly I:C adjuvant taught by Roth for the CpG adjuvant taught by Satchi-Fainaro. See KSR rationale (B): Simple substitution of one known element for another to obtain predictable results (MPEP 2141(III). One of ordinary skill would have had reasonably expectation of success of substituting the Poly I:C adjuvant for the CpG adjuvant because both were known TLR ligand adjuvants.
Regarding claims 3-4, Satchi-Fainaro teaches that the adjuvant can be cGAMP, a cyclic dinucleotide (Claims 1-3, pg. 4 line 32).
Regarding claim 7, Roth teaches that the polymer is HPMC-C12 (pg. 1802, column 2).
Regarding claims 8-9, Roth teaches that the nanoparticles are polymeric and comprise PEG-PLA (pg. 1082, column 2).
Regarding claim 12, Satchi-Fainaro teaches at least one toll-like receptor ligand adjuvant, and further teaches that both CpG and Resiquimod are TLR ligand adjuvants (claims 1-3 and pg. 4 line 29).
Regarding claim 13, Roth teaches a method of inducing an immune response against the vaccine antigen by administering the vaccine to a subject (Figure 3).
Regarding claims 14-15, Roth teaches that the vaccine delivery system induces an increased production of IgG and IgG1 antibodies compared to controls (Figure 3).
Regarding claim 32, Satchi-Fainaro teaches TLR ligand adjuvants, which are TLR agonists (pg. 4, lines 22-30).
Regarding claim 33, Roth teaches that the hydrogel is shear-thinning (pg. 1803, column 1).
Regarding claim 34, Roth teaches that inducing the immune response treats an infectious disease (pg. 1807, column 1).
Regarding claim 35, Roth teaches administering the vaccine by injection into a subject (Figure 1).
Regarding claim 36, Roth teaches that the vaccine delivery system release the antigen and adjuvant in the subject for at least 2 weeks (Figure 2j and pg. 1803, column 2).
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art before the effective filing date, especially in absence of evidence to the contrary.
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Roth and Satchi-Fainaro as applied to claims 1-4, 7-9, 12-15, and 32-33 above, and further in view of Du (Prior Art of Record).
As discussed above the vaccine delivery system of claim 1 was rendered prima facia obvious over Roth and Satchi-Fainaro.
Regarding claims 5 and 6, Satchi-Fainaro teaches that the nanoparticle antigen can be a viral antigen, more specifically a SARS viral antigen (pg. 20, line 16). Roth and Satchi-Fainaro do not teach that the viral antigen comprises an RBD for a virus. However, Du teaches that the RBD of SARS is a good vaccine target as it is the part of the SARS S protein that binds to the ACE2 receptors, therefore creating binding/neutralizing antibodies against the RBD would prevent viral entry (pg. 230).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Roth and Satchi-Fainaro to include the viral antigens taught by Du because Du teaches that the RBD of SARS is a good vaccine target as antibodies against the viral antigen would advantageously prevent cell entry (pg. 230). One of skill in the art would have had reasonable expectation of success at combining Roth, Satchi-Fainaro, and Du because they all teach vaccines.
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art before the effective filing date, especially in the absence of evidence to the contrary.
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Roth and Satchi-Fainaro as applied to claims 1-4, 7-9, 12-15, and 32-36 above, and further in view of Oleszycka (Prior Art of Record).
As discussed above the vaccine delivery system of claim 1 was rendered prima facie obvious over Roth and Satchi-Fainaro.
Regarding claims 10 and 11, Satchi-Fainaro teaches a vaccine nanoparticle with multiple adjuvants (Claims 1-3 and 30). Roth and Satchi-Fainaro do not teach that one of the adjuvants is aluminum hydroxide (alum). However, Oleszycka teaches that alum is the most common adjuvant in non-living vaccines (Abstract). Alum has been successfully used in humans and promotes antibody-mediated protective immunity, though it is a poor inducer of cellular immune response, making it an ideal candidate for part of a multi-adjuvant vaccine (Abstract).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Roth and Satchi-Fainaro of a nanocomposite gel vaccine delivery system with viral antigens and multiple adjuvants with the teachings of Oleszycka of the adjuvant alum. Oleszycka provides motivation by teaching that alum has been previously used in licensed human vaccines and promotes antibody mediated-protective immunity (Abstract). One of skill in the art would have had reasonable expectation of success at combining Roth, Satchi-Fainaro, and Oleszycka because they all teach vaccines.
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art before the effective filing date, especially in the absence of evidence to the contrary.
Arguments
Applicant contends on page 10 of the Remarks submitted on 29 April 2026 that the amendments made to claim 1 renders the claims patentable over Satchi-Fainaro and Zhao.
In response: Applicant’s arguments with respect to claims 1-15 and 32-33 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. New rejections to claims 1-15 and 32-33 have been made above as necessitated by the amendments to the claims that required the newly presented limitation that the antigen and adjuvant be separate from the nanoparticles.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
(Previous rejection, maintained as to claims 1-2, 7-9, 13, and 32-33). Claims 1-2, 7-9, 13, and 32-33 were rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,5, 19, and 23-25 of U.S. Patent No. 12,433,959 in view of Shibuya.
(Previous rejection, withdrawn as to claims 1-2 and 7-9). Claims 1-2 and 7-9 were provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,7, 8, 14, 15, and 17 of copending Application No. 17/925,443. This rejection is withdrawn because the claims of the copending application require the adjuvant to be present on the surface of the nanoparticles, while the instant application requires the nanoparticles and the adjuvant to be separate.
(Previous rejection, withdrawn as to claim 13). Claim 13 was provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7 and 20 of copending Application No. 17/925,443 in view of Zhao. This rejection is withdrawn because the claims of the copending application require the adjuvant to be present on the surface of the nanoparticles, while the instant application requires the nanoparticles and the adjuvant to be separate.
(Previous rejection, maintained as to claims 1-2, 7-9, 13, and 32-33). Claims 1-2, 7-9, 13, and 32-33 were provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4,11, 14, 17, and 19 of copending Application No. 19/317,911 in view of Shibuya.
Arguments
Applicant contends on page 11 of the Remarks submitted on 29 April 2026 that the claims are patentably distinct and elected not to file a terminal disclaimer.
In response: Since Applicant did not file a terminal disclaimer with the Response, the double patenting rejections of record are maintained for the reasons set forth above.
Conclusion
NO CLAIMS ARE 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.
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/CASSANDRA SENN GRIZER/ Examiner, Art Unit 1672
/THOMAS J. VISONE/ Supervisory Patent Examiner, Art Unit 1672
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