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 .
Election/Restrictions
Amended Claims 1-7, 10, and 12-14 are under examination on the merits.
Response to Arguments
Applicant’s arguments, see pp. 1-5, filed 12/16/2025, with respect to the previous rejections under 35 U.S.C. §103 have been fully considered and are persuasive. The rejections under 35 U.S.C. §103 have been withdrawn.
New rejections of Claims 10 and 12-13 under 35 U.S.C. §112(a) and claim 12 under 35 U.S.C. §112(b) are raised below.
Objections
Specification
This application contains sequence disclosures that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR 1.821 through 1.825 for the reason(s) set forth below or on the attached Notice To Comply With Requirements For Patent Applications Containing Nucleotide Sequence And/Or Amino Acid Sequence Disclosures. The specification is objected to because pages 16 and 19 possess nucleic acid sequences without the appropriate SEQ ID NO:.
Applicants must comply with sequence rules in order to be considered a complete response to this Office Action.
Rejections Removed
The following rejections are hereby withdrawn due to Applicant’s amendment filed 12/16/2025:
35 U.S.C. §103: Claims 1 & 3-7 as being unpatentable over Palese, et al. (SK 29072000 A3, published 9/11/2001), in view of Schlender, et al. (J Virol. 2000 Sep;74(18):8234-42. PMID: 10954520); Claim 10 as being unpatentable over Palese and Schlender (supra), in further view of Crawford, et al. (WO2006116082A1, published 11/2/2006); Claims 12-14 as being unpatentable over Palese, Schlender, and Crawford (supra), in further view of Drew, et al. (PGPub US 20130129685 A1, published 5/23/2013, filed 2/11/2013); Claim 2 as being unpatentable over Palese and Schlender (supra), in further view of Alkheraif (Virology. 2017 Jul;507:123-134. doi: 10.1016/j.virol.2017.04.015. Epub 2017 Apr 19. PMID: 28432927).
New Objections
Claim Objections
Claim 14 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
New Rejections
Claim Rejections - 35 USC § 112
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.
Claims 10 and 12-13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a vaccine composition against BRSV comprising a BRSV infected MDBK cell and a pharmaceutically acceptable carrier, does not reasonably provide enablement for a vaccine composition against a generic virus, comprising a virus infected MDBK cell and a pharmaceutically acceptable carrier. Although vaccines are needed for a large number of viral pathogens, it is not clear that all of the viruses would be capable of infecting MDBK cells. Similarly, an MDBK cell infected with a particular virus is unlikely to be an effective vaccine against other, unrelated generic viruses. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make or use the invention commensurate in scope with these claims.
Nature of the invention/Breadth of the claims. The claimed invention encompasses a vaccine composition comprising a recombinant MDBK cell, characterized in that the cell is genetically engineered by which the interferon regulatory factors (IRF) IRF3 and/or IRF7 encoding genes are functionally inactivated by knockout of said IRF3 and/or IRF7 genes, which is infected with a virus, and a pharmaceutically acceptable carrier (claim 10). The pharmaceutically acceptable carrier comprises a natural deep-eutectic solvent (NADES) having a water activity of less than about 0.8 (claim 12). The virus may be a live virus or live attenuated virus (claim 13). In addition, pages 9 and 10 of the specification provide a list of viruses considered to be part of the claimed invention, influenza A virus is an example.
State of the art/Predictability of the art. Vaccination against viral disease has been widely performed for many years, and vaccines have been developed for a large number of viral pathogens in humans and animals. However, there is no evidence of a “universal vaccine” where vaccination with one virus results in immunity against all other viruses. In fact, vaccines against some viruses, such as influenza, are recommended every season (Key Facts About Seasonal Flu Vaccine. CDC.gov. 5-page printout. Accessed at website https://www.cdc.gov/flu/vaccines/keyfacts.html on 12/21/2025. Published 9/3/2025; p. 1). One of the reasons that influenza viruses are recommended yearly is that because influenza viruses are constantly changing, the composition of flu vaccines is reviewed annually, and vaccines are updated to protect against the viruses that will be most common during the upcoming flu season (p. 3).
Working examples/Guidance in the specification. The disclosure states that non-limiting examples of viruses that can be grown on MDBK cells include bovine parainfluenza virus 3, influenza A virus, porcine influenza virus (PIV), swine influenza virus (SIV), avian influenza virus, infectious bronchitis rhinotracheitisvirus (IBR), bovine herpesvirus 1 (BHV1), bovine viral diarrhea virus (BVDV), bovine coronavirus (BCV), bovine respiratory syncytial virus (BRSV), mumps virus, measles virus, Bunyaviridae members, and Schmallenberg virus (p. 9). Additionally, the specification demonstrates that BRSV titers are increased in IRF3, IRF7, and IRF3/IRF7 knockout MDBK cell lines (Examples 3-4).
Notably, the specification does not provide an example of a generic vaccine composition comprising a virus infected MDBK cell and a pharmaceutically acceptable carrier.
Amount of experimentation necessary. There would be undue experimentation for one of ordinary skill in the art to use the claimed invention when considering the breadth of the claims, nature of the invention, and prior art. Notably, there is no universal vaccine, where one virus protects against disease caused by all other viruses. As emphasized by the CDC’s recommendation for yearly influenza vaccines, vaccination against one strain of influenza does not necessarily provide protection against other strains of influenza, much less other, unrelated viruses. The specification does not provide any working examples of a vaccine composition comprising a virus infected MDBK cell and a pharmaceutically acceptable carrier.
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.
Claim 12 is 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 12 recites “having a water activity of less than about 0.8”. The term “less than about” renders the claim indefinite because it is unclear what is the maximum water activity encompassed by the claim.
Allowable Subject Matter
Claims 1-7 are allowable.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEFFREY MARK SIFFORD whose telephone number is (571)272-7289. The examiner can normally be reached 8:30 a.m. - 5:30 p.m. ET with alternating Fridays off.
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/JEFFREY MARK SIFFORD/Examiner, Art Unit 1671
/BENJAMIN P BLUMEL/Primary Examiner, Art Unit 1671