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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 8/8/2025 has been entered.
Election/Restrictions
Amended claims 4-10 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: The originally presented claims were drawn to a method of defining a personalized vaccine against HIV/AIDS. Claim 4 (and dependent claims 5-10) has been amend to recite “A method for administering the personalized vaccine against HIV/AIDS”, which is a new independent method claim that is different from the originally filed method claims. Method claims 1-3 and 11-19 and method claims 4-10 differ in the method objectives, method steps, in the reagents used, and have different final outcomes. Additionally, the search burden is at least doubled and deemed unduly burdensome.
Since applicant has received an action on the merits for the originally presented invention (A method of defining a personalized vaccine against HIV/AIDS), this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 4-10 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
Status of the Claims
Claims 4-10 have been withdraw as being directed to a non-elected invention. Claims 1-3 and 11-19 are under examination at this time.
Withdrawn Rejections
The rejection of claims 4-10 and 12-19 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, has been withdrawn in view of applicant’s amendments to the claims.
Specification
The disclosure is objected to because of the following informalities: Page 11 contains amino acid sequences without the appropriate sequence identifier (e.g., SEQ ID NO: X). Appropriate correction is required.
The use of trademarks has been noted in this application. A trademark should be capitalized wherever it appears and be accompanied by the generic terminology.
Although the use of trademarks is permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner, which might adversely affect their validity as trademarks.
Claim Objections
Claim 1 is objected to because of the following informalities: For clarity and consistency, claim 1 should be amended as follows:
Part c) “translating the sequences of a) into amino acid sequences of circulating . . . . “.
Part d) “aligning the amino acid sequences of c) and creating a consensus sequence . . . .”
Part f) “where only epitopes showing a binding affinity having an IEDB score of >100 and mapping to positions on the gag protein documented to interact with the HLA Class I haplotypes of the individual are selected”
Part g) “synthesizing the epitopes selected in step f)”
rewritten for clarity, particularly steps f), g) and h), should be rewritten for clarity. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 1-3 and 11-19 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.
Claim 1, step f), recites “selection of epitopes including a plurality of peptides”. It is not clear how one selects “a plurality of peptides” where the previous step only relates to epitopes.
For claim 2, it is not clear if the 2-7 peptides are the epitopes of claim 1, step f), the “plurality of peptides” of claim 1, step f), or a different set of peptides. Further, the order recited does not indicate which gag sequences are preferred and the meaning of the ordered gag sequences. Lastly, claim 2 is not clear. For example, it is not clear how the combination of two to seven peptides are used “based on the following order based on position within the gag sequence: Gag256-377 > Gag147-169 ≥ Gag225-251”.
The term “highest ranking” in claim 11 is a relative term which renders the claim indefinite. The term “highest ranking” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprized of the scope of the invention.
Claim 12 recites the limitation "The method for administering the personalized vaccine" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation "The method for administering the personalized vaccine" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Accordingly, one of ordinary skill in the art will not know the metes and bounds of the claim.
Conclusion
No claim is allowed.
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/NICOLE KINSEY WHITE/Primary Examiner, Art Unit 1672