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 .
DETAILED ACTION
The Applicant’s reply filed on 3/26/26 is acknowledged. Claims 1, 4, 6-10, 12, 14, 17, 21, 22, 26 and 50-52 are pending. Claims 4, 12, 17, 26, and 51 have been withdrawn. Claim 52 is new.
Election/Restrictions
Applicant’s election without traverse of the species of
- SN50 as the NFkB inhibitor,
- Cpg as the species of adjuvant,
- antigenic fragments of HIV as the additional agent, and
- administration of the inhibitor and adjuvant in the same composition;
in the reply filed on 7/8/24 is acknowledged.
Claims 1, 6-10, 14, 21, 22, 50 and 52 are under consideration to the extent that the method comprises SN50 as the NFkB inhibitor, Cpg as the species of adjuvant, antigenic fragments of HIV as the additional agent, and administration of the inhibitor and adjuvant in the same composition.
Rejections Maintained and New Grounds of Rejections
Information Disclosure Statement
Acknowledgement is made of Applicant’s information disclosure statements (IDS) submitted on 1/14/26 and 3/26/26. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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, 6-10, 14, 21, 22, 50 and 52 are rejected under 35 U.S.C. 103 as being unpatentable over Petrovsky (US 2014/0314739; cited in IDS) in view of Hawiger et al. (US 2004/0235746; cited in IDS).
Petrovsky teaches a vaccine composition comprising inulin particles for use in the reduction or inhibition of inflammation, and/or for treating or preventing inflammatory disease, in a subject (e.g. abstract). Petrovsky teaches that the composition comprises an NFkB inhibitor and an adjuvant, which may be CpG (e.g. paragraphs 0047, 0048, 0075; Claim 8). Petrovsky teaches that the components are administered together (e.g. paragraph 0223).
Petrovsky does not teach that the NFkB inhibitor is SN50. This is made up for by the teachings of Hawiger et al.
Hawiger et al. teach the delivery of biologically active molecules, such as peptides, into the interior of cells by administering to the cells a complex comprising the molecule linked to an importation competent signal peptide (e.g. abstract). Hawiger et al. teach that the peptide is the NF-kB inhibitor SN50 (e.g. paragraphs 0027; Examples).
Regarding Claims 1, 6-8, and 21, it would have been obvious to one of ordinary skill in the art at the time of filing to select the SN50 of Hawiger et al. as the NFkB inhibitor of the compositions of Petrovsky. It would have been obvious to one of ordinary skill in the art to combine the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results. One of ordinary skill in the art would have predicted success as both Petrovsky and Hawiger are directed to vaccines comprising NFkB inhibitors. Simple substitution of one known element for another to obtain predictable results is obvious.
Regarding Claims 9, 10, 14, and 50, Petrovsky further teach the inclusion of HIV antigens (e.g. paragraph 0210).
Regarding Claims 22 and 52, Petrovsky teaches that the composition may be administered to an adult human subject in a range of 1 to 100 mg per dose, such as a 20 mg per dose, which is within the claimed range of “at least 12 mg” (e.g. paragraph 0167). This is also understood as a “dose to increase the immune response of the patient to an antigen provided in a vaccine”, as evidenced by Applicant’s claim 22 and paragraph 0026.
Response to Arguments and Declaration
Applicant's arguments filed 3/26/26 have been fully considered but they are not persuasive.
Applicant argues, beginning on page 6, that simple substitution of SN50 for the inulin of Petrovsky would not yield predictable results. The declaration of Dr. Aaron Esser-Kahn further argues that one would have no basis for selecting which, if any, NFkB inhibitors from the class would be effective in a vaccination method after reading Petrovsky, and further that there is a lack of predictability in the art. Therefore, a skilled artisan could not reasonably predict whether an NFkB inhibitor or activator should be used to activate an immune response when vaccinating a subject. Id. And even if a skilled artisan did chose to use an NFkB inhibitor, said artisan would have no reasonable expectation that any specific NFkB inhibitor would be useful as different NFkB inhibitors behave differently.
This is not found persuasive. Petrovsky disclose “(a) an anti-inflammatory component, such as inulin particles and/or one or more other anti-inflammatory inhibitors of IL-1 and/or one or more other anti-inflammatory inhibitors of NFκB activation” (emphasis added) (e.g. paragraph 0041). Hawiger et al. teach the delivery of biologically active molecules, such as peptides, into the interior of cells by administering to the cells a complex comprising the molecule linked to an importation competent signal peptide, by standard means known in the art for administering vaccines (e.g. abstract, paragraph 0054). Hawiger et al. teach that the peptide is the NF-kB inhibitor SN50 (e.g. paragraphs 0027; Examples). One of ordinary skill in the art would have predicted success in selecting SN50 not only because it is a NFkB inhibitor as suggested by Petrovsky, but because of Hawinger’s showing of the anti-inflammatory effects of SN50.
In addition, regarding the efficacy of other NFkB inhibitors as described in the Declaration, it is noted that the claims do not require any specific effect, efficacy, or outcome from administering the claimed composition. Claim 1 only requires a step of “administering an NFkB inhibitor and an adjuvant to the subject”.
Similarly, regarding the unpredictability of the art, Applicant has not demonstrated an effect for all of the compounds within the scope of claim 1, specifically those of Formula (I). It is unclear if all of the compounds within the scope of Claim 1 would be effective in the claimed method. Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980).
Accordingly, the rejection is maintained.
Conclusion
No claim is allowed.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLE PLOURDE BABSON whose telephone number is (571)272-3055. The examiner can normally be reached M-Th 8-4:30; F 8-12:30.
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/NICOLE P BABSON/ Primary Examiner, Art Unit 1619
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