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
1. Claims 1, 2 are amended. Claims 4-7 are withdrawn. New claims 8-10 are added. It is noted applicant elected species SEQ ID NO: 125 and injectable preparation in the reply filed 10/23/2024. It is also noted support for the amino acid sequence recited in SEQ ID NO: 125 appears to be found in provisional application 62/845414 (5/9/2019), while SEQ ID NO: 125 labeled as such has support in 16/537447 (8/9/2019).
Claims 1-3, 8-10 are under consideration.
Claim Objections
2. (previous objection, withdrawn) Claim 1 was objected to because of the following informalities.
Applicant contends: the claim is amended.
In view of applicant’s amendments, the objection is withdrawn.
Claim Rejections - 35 USC § 112
3. (previous rejection, withdrawn) Claims 1-3 were rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and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.
Applicant contends: the claim is amended.
In view of applicant’s amendments, the rejection is withdrawn.
4. (previous rejection, withdrawn) Claims 1-3 were rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
Applicant contends: the claim is amended.
In view of applicant’s amendments, the rejection is withdrawn.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
5. (new, necessitated by amendment) Claims 2, 8 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
See claims 2, 8 as submitted 6/24/2025.
Claims 2, 8 recite “a subsequence, portion, homologue, variant or derivative thereof’. Thus, the claim is drawn to a genus of subsequence, portion, homologue, variant or derivative products.
The following quotation from section 2163 of the Manual of Patent Examination Procedure is a brief discussion of what is required in a specification to satisfy the 35 U.S.C. 112 written description requirement for a generic claim covering several distinct inventions:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice..., reduction to drawings..., or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus... See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.'A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
Thus, when a claim covers a genus of inventions, the specification must provide written description support for the entire scope of the genus. Support for a genus is generally found where the applicant has provided a number of examples sufficient so that one in the art would recognize from the specification the scope of what is being claimed.
In the present case, the specification recites: SEQ ID NOs: including SEQ ID NO: 125 (elected species); as well as subsequence, portion, homologue, variant or derivative of each thereof [0014], generally.
However, given the breadth of the terms "subsequence, portion, homologue, variant or derivative,” the application does not teach a representative set of such subsequences, portions, homologues, variants or derivatives. Further, there is no apparent common structure to the different subsequences, portions, homologues, variants or derivatives. There is therefore a high level of uncertainty as to which subsequences, portions, homologues, variants or derivatives fall within the scope of the indicated genus.
In view of the fact that the examples provided do not demonstrate possession of subsequences, portions, homologues, variants or derivatives, and that the application has identified no basic or conserved structures correlating with subsequences, portions, homologues, variants or derivatives, there is insufficient written description support for the indicated genus.
Nor does the application provide a specific structure of the subsequences, portions, homologues, variants or derivatives within the genus that correlates with the required function. Because there is no identification of basic or conserved structures common to each subsequence, portion, homologue, variant or derivative, nor sufficient representative examples by which such a structure may be determined, the application also fails to provide sufficient written description support for the identified genus of subsequences, portions, homologues, variants or derivatives through identification of a structure and function.
For the reasons above, the application has not provided sufficient written description support for the use of the genus of subsequences, portions, homologues, variants or derivatives identified in claims 2, 8. The application therefore fails to provide adequate support for methods of using this genus of subsequences, portions, homologues, variants or derivatives.
Claim Rejections - 35 USC § 101
6. (previous rejection, withdrawn) Claims 1, 3 were rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
Applicant contends: claim 1 is amended; the isolated peptides are not found in nature and are markedly different than any naturally occurring product; the inventors discovered that administration of the isolated peptides as clamed produce anti-ZIKV cross reactive immunity; the peptides are not only markedly different but also produce unique effect.
In view of applicant’s amendments and election of species SEQ ID NO: 125, the rejection is withdrawn.
Claim Rejections - 35 USC § 102
7. (previous rejection, withdrawn) Claim 1 was rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Blight et al. (WO2016181147A1)(cited in applicant’s IDS submitted 9/15/2023).
Applicant contends: Blight et al. does not disclose peptide as claimed.
In view of applicant’s amendments, the rejection is withdrawn.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
8. (previous rejection, maintained as to claims 1, 3; new necessitated by amendment as to claims 9, 10) Claims 1, 3, 9, 10 are rejected under 102(a)(1)/102(a)(2) as being anticipated by Shresta et al. (US2016130305)(previously cited; cited in applicant’s IDS submitted 9/15/2023).
See claims 1, 3, 9, 10 as submitted 6/24/2025.
Applicant contends: Shresta et al. does not disclose peptide as claimed; Shresta et al. discloses the entire sequence but not discrete isolated peptide.
Applicant’s arguments are considered but found unpersuasive.
See the rejection as recited in the previous Office Action.
It is noted Shresta et al. teaches: Dengue virus (DV) peptides, including T cell epitopes, structural and non-structural (NS) polypeptide sequences, subsequences and modifications thereof, nucleotide sequences encoding such peptides, and compositions including such peptides and encoding nucleotide sequences, and cells expressing such peptides, are provided. Such DV peptides, nucleotide sequences and compositions, can be used to elicit, stimulate, induce, promote, increase, enhance or activate an anti-DV CD8.sup.+ T cell response or an anti-DV CD4.sup.+ T cell response. Such peptides, nucleotide sequences and compositions can also be used for and in methods of vaccination/immunization of a subject against Dengue virus (DV) (e.g., to provide protection against DV infection and/or pathology), and for treatment of a subject in need thereof, for example, treatment of the subject for a Dengue virus (DV) infection or pathology (abstract).
As to amended claim 1, and claims 9, 10, it is noted Shresta et al. teaches: SEQ ID NO: 1213, a 15 amino acid sequence with 96.6% identity with instant SEQ ID NO: 125 (See Result 2 of STIC Sequence Search Result 20241118_161301_us-18-368-949-125.szlim20.rag in Supplemental Content Tab, also teaching wherein the sequence represents a DENV3 NS5 epitope peptide used in treating DV infections)(as recited in claims 1, 9, 10).
The rejection is maintained and extended for reasons of record.
Claim Rejections - 35 USC § 103
9. (previous rejection, withdrawn) Claim 2 was rejected under 35 U.S.C. 103 as being unpatentable over Blight et al. (cited above) as applied to claim 1 above.
Applicant contends: Blight et al. does not teach or suggest peptide as claimed;
the claimed compositions are capable of inducing increased immune protection.
In view of the withdrawal of the rejection over Blight et al. above on which the instant rejection depends, the instant rejection is also withdrawn.
10. (previous rejection, withdrawn) Claim 3 was rejected under 35 U.S.C. 103 as being unpatentable over Blight et al. as applied to claim 1 above, and further in view of Stinchcomb et al. (US20100303860; previously recited)
Applicant contends: Stinchcomb et al. fails to teach or suggest peptide as claimed and fails to remedy the deficiencies.
In view of the withdrawal of the rejection over Blight et al. above on which the instant rejection depends, the instant rejection is also withdrawn.
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, 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.
11. (previous rejection, maintained as to claim 2; new necessitated by amendment as to claim 8) Claims 2, 8 are rejected under 35 U.S.C. 103 as being unpatentable over Shresta et al. (cited above) as applied to claims 1, 3, 9, 10 above.
See claims 2, 8 as submitted 6/24/2025.
Applicant contends: Shresta et al. does not teach or suggest peptide as claimed;
the claimed compositions are capable of inducing increased immune protection.
Applicant’s arguments are considered but found unpersuasive.
See the rejection as recited in the previous Office Action and above.
As to amended claims 2, 8, the claims recite “further comprising one peptide … comprising an amino acid sequence which as at least 95% identical to … SEQ ID NO: 125, or a subsequence…”.
It is noted Shresta et al. also teaches: combination compositions [120]; wherein dengue virus (DV) peptides, subsequences, portions and modifications thereof can be administered as a combination composition [0121]; including amounts in single or multiple doses, alone or in combination with one or more other compounds [0125].
Thus, such a combination as claimed (peptide as recited in claim 1), as well as “further” peptides in claims 2, 8 is considered an obvious embodiment in view of the teachings or suggestions of Shresta et al. One of ordinary skill in the art would have motivated and had a reasonable expectation of success in arriving at the claimed composition in view of the teachings or suggestions of Shresta et al. There would have been a reasonable expectation of success given the underlying materials and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
12. (new, necessitated by amendment) Claims 2, 8 are rejected under 35 U.S.C. 103 as being unpatentable over Shresta et al. as applied to claims 1, 3, 9, 10 above, and further in view of Roth et al. (WO2019092142)(cited in applicant’s IDS submitted 9/15/2023).
See claims 2, 8 as submitted 6/24/2025.
See the teachings of Shresta et al. above.
Roth et al. also teaches: chimeric peptide for preventing Zika and Dengue virus (abstract); treatment (p. 23); T-cell epitope SEQ ID NO: 64, 15 amino acid fragment that has 100% identity with instant SEQ ID NO: 125 (See Result 1 of STIC Sequence Search Result 20241118_161301_us-18-368-949-125.szlim20.rag in Supplemental Content Tab)(as recited in claims 2, 8).
One of ordinary skill in the art would have been motivated to combine peptide as taught by Roth et al. with the peptide as taught by Shresta et al. Shresta et al. teaches peptide for treating Dengue infection, and Roth et al. also teaches peptide for treating Dengue infection (See MPEP 2144.06: Art Recognized Equivalence for the Same Purpose: I. COMBINING EQUIVALENTS KNOWN FOR THE SAME PURPOSE: "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980)).
One of ordinary skill in the art would have had a reasonable expectation of success for combining peptide as taught by Roth et al. with the peptide as taught by Shresta et al. There would have been a reasonable expectation of success given the underlying materials and methods (peptides for treating dengue infection as taught by Shresta et al. and Roth et al.) are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Conclusion
13. With respect to SEQ ID NO: 125 and 35 U.S.C. 101, it is noted that Shresta et al. (cited above) teaches: wherein candidate epitopes were identified using a consensus approach; where 15-mers were predicted for binding to H-2 I-A [0172]. Further, Roth et al. (cited above) teaches wherein: inventors established map of distribution of ZIKV T-cell epitopes by quantifying ex vivo IFNy responses against peptides covering the whole ZIKV proteomic sequence by ELISPOT assay (p. 3).
14. No claims are allowed.
15. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to M FRANCO G SALVOZA whose telephone number is (571)272-4468. The examiner can normally be reached M-F 8:00 to 5:00.
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/M FRANCO G SALVOZA/Primary Examiner, Art Unit 1671