DETAILED ACTION
Applicant’s amendment, remarks and affidavit filed February 13, 2026 are acknowledged and entered. Any prior objection or rejection that is not repeated or addressed below is withdrawn or moot in view of Applicant’s amendment. Claims 1, 7, 8, 11, 16-18, 20-23, 25 and new claims 26 and 27 are under examination.
Claims Summary
Claim 1 is directed to a method for preventing SARS-CoV-2 infection by inducing a protective immune response comprising administering a composition comprising:
A SARS-CoV-2 gene encoding a spike protein, the gene comprising SEQ ID NO: 1, and
A SARS-CoV-2 gene encoding the ORF3a protein, the gene comprising SEQ ID NO: 2
A bicistronic expression vector comprises the genes (claims 7 and 18). The composition is administered in two doses (claim 8). Claim 11 is directed to a bicistronic expression vector cassette. The bicistronic expression cassette further comprises one or more components, such as a CMV promoter, among other components listed in claim 16. The cassette is further described in claim 17. The composition is a vaccine composition or an immunogenic composition (claim 25). Administration is via intramuscular, intravenous, etc. routes (claim 20), electroporation (claims 21-22), or liposome-mediated delivery (claim 23). New claim 26 is directed of inducing an immune response against SARS-CoV-2 by administering the bicistronic expression vector cassette, as plasmid DNA (claim 27).
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 1, 7, 8, 18-23 and 25 remain 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 method of inducing an immune response against SARS-CoV-2, does not reasonably provide enablement for a method of preventing a SARS-CoV-2 infection. 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.
The breadth of the claims encompasses a method of preventing a SARS-CoV-2 infection in any subject by administering a composition that is comprised of a spike gene and an ORF3a gene, which are in some instances included in a bicistronic expression vector or cassette. Also claimed is a vaccine composition comprising the same.
The nature of the invention is the induction of a protective immune response that will prevent disease upon subsequent exposure to SARS-CoV-2.
The specification and working examples show that the claimed compositions are immunogenic with regard to plasmid DNA constructs. Specifically, Examples 1-2 describe the construction of a plasmid comprising sequences optimized for human expression of spike and, ORF3a or nucleocapsid. Examples 3 and 7 demonstrate that the plasmids induce immune responses in mice. In the specification, no challenge experiments were performed to demonstrate protective efficacy.
Suryawanshi et al. (Vaccine, available online September 10, 2023, 41, 6174-6193) review the various types of SARS-CoV-2 vaccines and candidates, including mRNA, DNA, and protein-based constructs, noting that DNA constructs have low immunogenicity in humans (see Table 2 of Suryawanshi). Chavda et al. (Expert Rev Vaccines, 2021, 20(12):1549-1560) discloses the need for DNA constructs to be protected from degradation and an increased ability to transfect cells in vivo, noting electroporation and encapsulation in liposomes, among other methods (see pages 5-6, bridging paragraph, and Table 2).
In view of the breadth of the claims (prevention of SARS-CoV-2 infection in any subject), the nature of the invention (two genes capable of eliciting protective immunity), the state of the art (low immunogenicity of DNA in humans), the limited guidance in the specification, the limited working examples, and low level of predictability (with regard to immunogenicity in the absence of particular forms/methods of administration or adjuvants), it would require undue experimentation to practice the invention as claimed.
Applicant’s arguments and the declaration of Dr. Moonsup Jeong filed under 37 CFR 1.132 on February 13, 2026, have been carefully considered but fail to persuade. Applicant argues that the specification demonstrates that the plasmid DNA vaccine induces antigen-specific antibody responses, robust T-cell immune responses, neutralizing antibody activity and inhibition of ACE2-spike interaction. Applicant argues that these features are well-established mechanisms of prophylaxis. The declaration of Dr. Jeong details an experiment in which mice were administered the claimed construct (genes for spike and NS3a) and subsequently challenged with SARS-CoV-2. The composition induced robust neutralizing antibody titers, viral RNA reduction in lung tissue, reduction in lung pathology, a survival relative control animals.
In response to Applicant’s remarks concerning the specification and the experiment outlined by Dr. Jeong showing a challenge experiment in mice, while the immunological results are promising in mice, they are not predictive of prevention of infection in humans. The obstacle of sufficient immunogenicity in humans that rises to the level of protective immunity is not addressed by the instant specification nor the declaration of Dr. Jeong. Suryawanshi et al. discloses that DNA constructs have low immunogenicity in humans (see Table 2 of Suryawanshi), and Chavda et al. discloses the need for DNA constructs to be protected from degradation and an increased ability to transfect cells in vivo, noting electroporation and encapsulation in liposomes, among other methods (see pages 5-6, bridging paragraph, and Table 2). Therefore, the rejection is maintained for reasons of record.
This rejection can be overcome by limiting the claims to methods of inducing an immune response (claims 1, 7, 8 and 18-23) and an immunogenic composition (claim 25).
Conclusion
Claims 11, 16, 17, 26 and 27 are allowable.
SEQ ID NO: 1-4, representing optimized sequences, are free of the prior art of record.
THIS ACTION IS MADE FINAL. 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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Stacy B. Chen whose telephone number is 571-272-0896. The examiner can normally be reached on M-F (7:00-4:30). If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Visone, can be reached on 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
/STACY B CHEN/Primary Examiner, Art Unit 1672
Prosecution Insights