Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
2. Applicant’s response filed on 11/17/2025 is acknowledged.
3. Claims 1-26 and 28-29 are pending and under consideration for their full scope.
4. The following rejections are necessitated by the amendment filed on 11/17/2025.
5. The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
6. Claims 1-2, 20-26 and 28-29 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S Patent Application Publication 2003/235594 (PTO-892; Reference A) as evidenced by the attached sequence alignment.
U.S Patent Application Publication 2003/235594 teaches an isolated nucleic acid sequence encoding an antigen presentation enhancing hybrid polypeptide comprising the following elements: a) an N-terminal element consisting essentially of 4- 16 residues of the mammalian Ii-Key peptide LRMKLPKPPKPVSKMR and non-N- terminal deletion modifications thereof that retain antigen presentation enhancing activity; b) a chemical structure covalently linking the N- terminal element of step a) to the MHC Class II- presented epitope of element c), the chemical structure being a covalently joined group of atoms which when arranged in a linear fashion forms a flexible chain which extends up to the length of 20 amino acids likewise arranged in a linear fashion, the chemical structure being selected from the group consisting of: i) immunologically neutral chemical structures; ii) a MHC Class I epitope or a portion thereof; and/or iii) an antibody-recognized determinant or a portion thereof; and c) an antigenic epitope in the form of a polypeptide or peptidomimetic structure which binds to the antigenic peptide binding site of an MHC class II molecule; wherein the C- terminal element further comprises an MHC Class I- presented epitope, or a portion thereof, the amino acid residues comprising the MHC Class I-presented epitope or portion thereof being constituent residues of the MHC Class II-presented epitope; and wherein the C- terminal element further comprises an antibody- recognized determinant, or a portion thereof, the amino acid residues comprising the antibody-recognized determinant or a portion thereof being constituent residues of the MHC Class II-presented epitope.(In particular, claims, whole document)
The reference teaches the nucleic acids within a viral expression vector which also comprises nucleic acid encoding promoter and enhancer functions also may be included, for example, to provide for tissue-specific expression following in vivo administration. (In particular, paragraphs [0042]-[0055]).
The reference teaches that the nucleic acids in viral vectors can be used to treat allergic disease to peanuts. (In particular, paragraph [0078])
The reference teaches the Ii-Key/Ara h 1 hybrids comprising peanut epitopes from Ara h 1 (In particular, Example 1, Table 1) which comprise at least SEQ ID Nos 1, 8, 9 and 12 of Ar h1 1-5-6 (22 amino acids), Ara h1 1-5-4 (13 amino acids), Ara h 1 1-3-5 (16 amino acids) and Ara h1 1-2-4 (9 amino acids). (In particular, tables 1.2, 1.3, 1.4 and 1.5, paragraphs [0118]-[0125], whole document).
The recitations in claims 20-24 are inherent in the reference vectors. Products of identical chemical composition can not have mutually exclusive properties. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01.
From the combined teachings of the reference, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
7. No claim is allowed.
8. Claims 3-19 are objected to for dependence upon rejected base claims 1-2 but appear to be allowable if re-written in independent form.
9. 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 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.
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to NORA MAUREEN ROONEY whose telephone number is (571)272-9937. The examiner can normally be reached on M-F from 8:00am to 4:30pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner' s supervisor, Misook Yu, can be reached at telephone number (571) 272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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March 7, 2026
/Nora M Rooney/
Primary Examiner, Art Unit 1641
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