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
Election Restrictions
1. Applicant’s election without traverse of Group I and species (ebola virus) in the reply filed on 9/1/2026 is acknowledged.
Claims 44-47, 63, 71, 72, 94, 115 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9/1/2026.
Claims 37, 48-50, 56-58, 62, 91, 108-117 are under consideration.
Information Disclosure Statement
2. The information disclosure statements (IDS) were submitted on 7/3/2024; 9/1/2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
3. The disclosure is objected to because of the following informalities:
The use of trademarked terms has been noted in this application in [0029, 0196], among possibly others. The terms should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are 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 commercial marks.
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.
4. Claims 110-112, 117 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.
See claims 110-112, 117 as submitted 9/1/2026.
As to claims 110-112, it is not clear if “nucleocapsid protein” refers to the C-terminal fragment of the nucleocapsid protein (as recited in claim 108) or not.
As to claim 117, the claim recites “the composition of claim 17”. Claim 17 is canceled, so it is not clear what claim the claim depends on. In view of the indefiniteness, claim 117 is interpreted to depend on claim 116.
Claim Rejections - 35 USC § 103
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.
5. Claims 37, 57, 58, 91 are rejected under 35 U.S.C. 103 as being unpatentable over Ciaramella et al. (WO2018170347)(cited in applicant’s IDS submitted 7/3/2024) in view of
Mauro et al. (WO2010098861A1)(See PTO-892: Notice of References Cited).
See claims 37, 57, 58, 91 as submitted 9/1/2026.
Ciaramella et al. teaches: RNA comprising ORF encoding antigens (p. 2); including embodiments wherein RNA comprises mRNA (p. 6)(as recited in claim 37); including fusion proteins (p. 20)(as recited in claim 37); transfection into mammalian host cells (p. 24); 5 UTR and 3’ UTR (p. 86); signal peptide (p. 86)(as recited in claim 37); including wherein antigenic peptide is nucleocapsid (p. 67); wherein nucleocapsid is LASV (p. 67); as well as betacoronavirus nucleocapsid protein (p. 73); wherein antigen or antigens may include two or more proteins (p. 20)(as recited in claim 37); excipient (p. 52)(as recited in claim 37). It is also noted Ciaramella et al. teaches wherein “in some embodiments” formulation includes lipid nanoparticle (p. 68); but also wherein formulations can include polymers and proteins (p. 53)(as recited in claim 37). Ciaramella et al. also teaches: ebolavirus (p. 80)(as recited in claim 48); linkers such as GGGS (p. 22)(as recited in claim 57); intradermal injection (p. 70)(as recited in claim 91).
In view of such teachings or suggestions, the embodiment as recited in claim 37 is considered an obvious embodiment in view of Ciaramella et al. In view of the foregoing, all the claimed limitations are found in one reference and are taught to be optional variations to a ‘base’ product they exemplify. As such, the claimed embodiment is within the scope of Ciaramella et al., and thus Ciaramella et al. renders the composition prima facie obvious. The rationale to support this conclusion of obviousness is that Ciaramella et al. provides a teaching, suggestion, and motivation to substitute different variables disclosed within the reference. Furthermore, there is no evidence on the record that indicates that the claimed supplement exhibits any unexpected results compared to the prior art.
Ciaramella et al. does not teach: mammalian signal peptide (as recited in claims 37, 58).
Mauro et al. teaches: expression constructs ([0079]; CD5 signal peptide [0079].
One of ordinary skill in the art would have been motivated to use peptide as taught by Mauro et al. with the composition as taught by Ciaramella et al. Ciaramella et al. teaches mRNA vaccines including for transfection and signal peptide, and Mauro et al. teaches such a signal peptide (See MPEP 2144.06: Substituting equivalents known for the same purpose).
One of ordinary skill in the art would have had a reasonable expectation of success for using peptide as taught by Mauro et al. with the composition as taught by Ciaramella et al. There would have been a reasonable expectation of success given the underlying materials (signal peptide as taught by Mauro et al. and Ciaramella et al.) 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.
6. Claim 62 is rejected under 35 U.S.C. 103 as being unpatentable over Ciaramella et al. in view of Mauro et al. as applied to claims 37, 57, 58, 91 above, and further in view of Rauch et al. (WO2018115527)(cited in applicant’s IDS submitted 7/3/2024).
See the recitations to claim 62 as submitted 6/20/2023.
See the teachings of Ciaramella et al. above.
Ciaramella et al. does not teach: chitosan.
Rauch et al. teaches: mRNA vaccines (abstract); for coronavirus infections (abstract); transfection agents including chitosan (p. 79).
One of ordinary skill in the art would have been motivated to use agent as taught by Rauch et al. with the composition as taught by Ciaramella et al. Ciaramella et al. teaches mRNA vaccines including for transfection, and Rauch et al., which also teaches mRNA vaccines and transfection, teaches the benefits of agents known and used with such mRNA vaccines (See MPEP 2144.06: Substituting equivalents known for the same purpose).
One of ordinary skill in the art would have had a reasonable expectation of success for using agent as taught by Rauch et al. with the composition as taught by Ciaramella et al. There would have been a reasonable expectation of success given the underlying materials (mRNA vaccines as taught by Rauch et al. and Ciaramella et al.) 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.
7. Claims 48, 49, 56 are rejected under 35 U.S.C. 103 as being unpatentable over Ciaramella et al. in view of Mauro et al. as applied to claims 37, 57, 58, 91 above, and further in view of Wang et al. (US 20030138459 A1)(See PTO-892: Notice of References Cited) and Xu et al. (US 20210100892 A1)(See PTO-892: Notice of References Cited).
See the recitations to claims 48, 49, 56 as submitted 6/20/2023.
See the teachings of Ciaramella et al. in view of Mauro et al. above. To reiterate, Ciaramella et al. teaches: including fusion proteins (p. 20); including wherein antigenic peptide is nucleocapsid (p. 67); wherein antigen or antigens may include two or more proteins (p. 20).
Ciaramella et al. in view of Mauro et al. does not teach: wherein the first and second viruses are both members of the ebolavirus genus; wherein the nucleotide sequence further encodes a third nucleocapsid protein of a third virus and a fourth nucleocapsid protein of a fourth virus, and the first, second, third and fourth viruses are Zaire ebolavirus, Sudan ebolavirus, Bundibugyo ebolavirus, and Taï Forest ebolavirus; wherein the nucleotide sequence of (ii)
further encodes at least one further nucleocapsid protein of at least one further virus, and
wherein the at least one further virus is different from the first and second viruses.
Wang et al. teaches: use of viral antigens (abstract); including wherein vaccination with nucleocapsid protein protects from challenge with Ebola [0009]; Ebola nucleocapsid protein (claim 32 of Wang et al.). Xu et al. teaches: wherein EBOVs includes species Bundibugyo; Zaire; Sudan; Tai Forest [0128](as recited in claim 49).
One of ordinary skill in the art would have been motivated to use nucleocapsid antigen of Ebola as well as the claimed species of Ebola et al. by Wang et al. and Xu et al. with construct as taught by Ciaramella et al. in view of Mauro et al. Ciaramella et al. in view of Mauro et al. teaches use of two or more antigens as well as nucleocapsid antigens and Ebolavirus, and Wang et al. and Xu et al. teach such antigens as well as such Ebolaviruses (See MPEP 2144.06: Substituting equivalents known for the same purpose).
One of ordinary skill in the art would have had a reasonable expectation of success for using nucleocapsid antigen of Ebola as well as the claimed species of Ebola et al. by Wang et al. and Xu et al. with construct as taught by Ciaramella et al. in view of Mauro et al. There would have been a reasonable expectation of success given the underlying materials (Ebola nucleocapsid antigens as taught by Xu et al. and Wang et al. and Ciaramella et al. in view of Mauro et al.) 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.
Conclusion
8. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
A. Kawaoka et al. (US-20030215794-A1)(See PTO-892: Notice of References Cited) teaches NP#2, which comprises sequence with 100% identity with instant SEQ ID NO: 18 (See Result 2 of STIC Sequence Search Result 20260914_003014_us-18-569-589-18.rag in Supplemental Content Tab).
B. Blaney et al. (WO2012106490A1)(See PTO-892: Notice of References Cited) teaches: SEQ ID NO: 31, which comprises sequence with 100% identity with instant SEQ ID NO: 20 (See Result 2 of STIC Sequence Search Result 20260914_002817_us-18-569-589-20.rag in Supplemental Content Tab); as well as SEQ ID NO: 19, which comprises sequence with 100% identity with instant SEQ ID NO: 21 (See Result 2 of STIC Sequence Search Result 20260914_002817_us-18-569-589-21.rag in Supplemental Content Tab).
C. Aceti et al. (“Fragment screening targeting Ebola virus nucleoprotein C-terminal domain identifies lead candidates,” Antiviral Res 180: 104822. Doi:10.1016/j.antiviral.2020.104822. (2020))(See PTO-892: Notice of References Cited) teaches: targeting Ebola virus nucleoprotein C-terminal domain lead candidates (title).
D. Dzubanska et al. (“The structure of the C-terminal domain of the Zaire ebolavirus nucleoprotein,” Acta Cryst. D70, 2420-2429 (2014))(See PTO-892: Notice of References Cited) teaches: N and C terminal domains of NP of Zaire EBOV abstract).
9. SEQ ID NO: 19 is free of the prior art of record.
10. Claim 50 is objected to for depending on a rejected claim.
11. Claims 108, 109, 113, 114, 116 are allowed.
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 1672
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