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
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 8/13/25 has been entered.
Claims 1, 4, 6-10, 12, 14, 17, 21, 22, 26, 50 and 51 are pending. Claims 4, 12, 17, 26, and 51 have been withdrawn. Claim 6 has been amended.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied and constitute the complete set presently being applied to the instant application.
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Claims 4, 12, 17, 26, and 51 are withdrawn as not being directed to the elected species.
Claims 1, 6-10, 14, 21, 22 and 50 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.
Drawings
The replacement drawings were received on 8/13/25. These drawings are accepted.
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 and 50 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 Claim 22, 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).
Response to Arguments
Applicant's arguments filed 8/13/25 have been fully considered but they are not persuasive.
Applicant argues, beginning on page 8, that Petrovsky does not disclose inulin is an NFkB inhibitor, and teaches instead that it is a particle capable of downregulating pro-inflammatory gene expression, including innate immune responses pathways and the IL1 cytokine pathway. Applicant further argues that Petrovsky does not actually provide any examples of NFkB inhibitors or data on the use of NFkB inhibitors.
This is not found persuasive. Regardless of the mechanism of action of inulin, Petrovsky explicitly teaches that the composition comprises an NFkB inhibitor and an adjuvant, which may be CpG (e.g. paragraphs 0041, 0047, 0048, 0075; Claim 8). 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). The fact that Petrovsky exemplifies, or even prefers, inulin, does not teach away from the broader disclosure of NFkB inhibitors. Petrovsky additionally allows for the combination of inulin and inhibitors of NFκB activation, by reciting “and” (e.g. paragraph 0041 and 0064). Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). “A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use.” In re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994). “the prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed….” In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004) (MPEP 2145 D).
The Examiner notes that obviousness requires a reasonable expectation of success and not absolute predictability. Evidence showing there was no reasonable expectation of success may support a conclusion of nonobviousness. In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976). Note MPEP 2143.02 II. The above rejection provides a reasonable expectation that the NFkB inhibitor of Hawiger (SN50) would be suitable as one of the recited NFkB inhibitors of Petrovsky, and Applicant has provided no evidence to the contrary. Prior art is presumed to be operable (see MPEP 716.07).
Accordingly, the rejection is maintained.
Conclusion
No claim is allowed.
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