Detailed Office Action
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of the Claims
Acknowledgement is hereby made of receipt and entry of the communication filed 14 August, 2026. Claims 1-6, 10, 11, and 15-17 are pending in the instant application. Applicant’s election of Group II (claims 2 and 5-18) is noted. Because Applicants did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (M.P.E.P. § 818.03(a)).
35 U.S.C. § 119
Acknowledgment is hereby made of Applicants’ claim for foreign priority based on JP 2021-051107, filed 25 March, 2021, JP 2021-017633, filed 05 February, 2021, JP 2020-210564, filed 18 December, 2020, JP 2020-180524, filed 28 October, 2020, and JP 2020-173494, filed 14 October, 2020. Copies of the foreign priority documents submitted under 35 U.S.C. § 119(a)-(d), have been received and placed of record in the file.
37 C.F.R. § 1.98
The information disclosure statements filed 12 April, 2023,26 November, 2024, 26 March, 2025, 01 December, 2025, and 10 February, 2026, have been placed in the application file and the information referred to therein has been considered.
37 C.F.R. § 1.84
Acknowledgement is hereby made of receipt and entry of the drawings filed on 12 April, 2023, which are deemed to be acceptable.
35 U.S.C. § 112(a)
The following is a quotation 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.
Scope of Enablement
Claims 1-6, 10, 11, and 15-17 are rejected under 35 U.S.C. § 112(a), because the specification does not reasonably enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims. The claims are directed toward a temperature-sensitive (Ts) betacoronavirus comprising two mutations in NSP14, G248X and G416X. The specification provides a ts-SARS-CoV-2 virus with the following NSP mutations: G248V, G416S, and A504G. The first two mutations were sine qua non for the Ts phenotype. Thus, the claims are enabled for a Ts-SARS-CoV-2 virus comprising those specific mutations.
The legal considerations that govern enablement determinations pertaining to undue experimentation have been clearly set forth. Enzo Biochem, Inc., 52 U.S.P.Q.2d 1129 (C.A.F.C. 1999). In re Wands, 8 U.S.P.Q.2d 1400 (C.A.F.C. 1988). Ex parte Forman 230 U.S.P.Q. 546 (PTO Bd. Pat. App. Int., 1986). The courts concluded that several factual inquiries should be considered when making such assessments including the quantity of experimentation necessary, the amount of direction or guidance presented, the presence or absence of working examples, the nature of the invention, the state of the prior art, the relative skill of those in that art, the predictability or unpredictability of the art and the breadth of the claims. In re Rainer, 52 C.C.P.A. 1593, 347 F.2d 574, 146 U.S.P.Q. 218 (1965). The disclosure fails to provide adequate guidance pertaining to a number of these considerations as follows:
1) The claim breadth encompasses a large genus of betacoronaviruses (e.g., SARS-CoV, SARS-CoV-2, MERS-CoV, HCoV-OC43, HCoV-HKU1, BtCoV-HKU-4, BtCoV-HKU5, etc.) that are genotypically and phenotypically distinct.
2) The claim breadth is not limited to any particular mutation at amino acid positions 248 and 416.
3) The specification fails to demonstrate that the NSP14 protein is well-conserved amongst the different betacoronaviruses and that any given mutation in SARS-CoV-2 NSP14 would be applicable to other coronaviruses.
4) The specification fails to demonstrate that any mutation other than G248V or G416S will produce a Ts-phenotype.
5) The state-of-the-art teaches that single amino acid substitutions, even at the same location, can have unpredictable effects on the phenotypic properties of a virus carrying NSP14. For example, Case et al. (2016) demonstrated that single amino acid substitutions in NSP14 could produce viruses with delayed replication kinetics and decreased titers as compared to wildtype. Moreover, mutant genomes were translated less efficiently during viral infection (see Abstract, p. 7248). Another study by Ogando et al. (2020) demonstrated that single point mutations, including multiple mutations at the same position, in NSP14 produced a number of mutants that were replication-deficient. Only a single mutant was viable, and that one contained a highly conservative substitution.
Accordingly, when all the aforementioned factors are considered in toto, the skilled artisan would reasonably conclude that undue experimentation would be required to practice the claimed invention.
Correspondence
Any inquiry concerning this communication should be directed to Jeffrey S. Parkin, Ph.D., whose telephone number is (571) 272-0908. The Examiner can normally be reached Monday through Friday from 10:00 AM to 6:00 PM. A message may be left on the Examiner's voice mail service. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the Examiner are unsuccessful, the Examiner's supervisor, Michael Allen, Ph.D., can be reached at (571) 270-3497. Direct general status inquiries to the Technology Center 1600 receptionist at (571) 272-1600.
Information regarding the status of an application may be obtained from the Patent Center. Status information for published applications may be obtained from the Patent Center. Status information for unpublished applications is available through the Patent Center for authorized users only. Should you have questions about access to Patent Center, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Respectfully,
/JEFFREY S PARKIN/Primary Examiner, Art Unit 1671
30 September, 2026
Prosecution Insights