DETAILED ACTION
Election/Restrictions
Applicant’s election of species without traverse is acknowledged and entered. The elected species are: a polynucleotide encoding a first fusion protein, a coronavirus, a viral expression vector-based vaccine, an HLA signal sequence and HLA transmembrane domain, and a polypeptide of SEQ ID NO: 44. The election of SEQ ID NO: 44 is not commensurate in scope with the election of a first targeting domain. For the first targeting domain, Applicant has elected an HLA signal sequence and HLA transmembrane domain, however, SEQ ID NO: 44 comprises CD74 cytoplasmic domain and HLA transmembrane domain. The claims that read on the elected species are claims 1-4, 11 and 18-20.
Specification
The disclosure is objected to because of the following informalities:
Table 1 needs sequence identifiers for each cytoplasmic tail sequence.
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code on pages 91-92. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claims Summary
Claim 1 is directed to a vaccine encoding a first fusion protein comprising:
A first targeting domain: a lysosomal targeting domain (claim 3), an HLA signal sequence and HLA transmembrane domain (claim 4);
A coronavirus spike (S) protein or fragment thereof; the coronavirus is SARS-CoV or SARS-CoV-2 (claim 2)
The vaccine is a viral expression vector-based vaccine (claim 11). The vaccine further comprises an adjuvant (claim 18). Claim 19 is directed to a method of treating, protecting against, and/or preventing COVID-19 in a subject in need thereof, comprising administering the vaccine of claim 1. Claim 20 is directed to a method of generating an immune response against one or more strains of SARS-CoV-2, comprising administering the vaccine of claim 1.
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 1-4, 11 and 18-20 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 some embodiments does not reasonably provide enablement for all. Specifically, claims 1-4, 11 and 18 are not enabled for any coronavirus vaccine except SARS-CoV-2. (Although claim 2 recites SARS-CoV-2, it is an optional embodiment. Since it is not required, claim 2 is rejected.) Additionally, the enabled fragments of the spike protein of SARS-CoV-2 that function as a vaccine are those that are immunogenic. Claim 19 is not enabled for the treatment of COVID-19. Claims 19 and 20 are not enabled for protection, prevention or inducing an immune response against one or more strains of SARS-CoV-2 when the antigen is generically recited as a coronavirus spike protein or fragment thereof, as opposed to a spike protein/fragment of SARS-CoV-2. 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 vaccine against a coronavirus, specifically SARS-CoV-2 in some claims. A vaccine is understood to prevent disease. The coronavirus component of the fusion protein encodes a spike protein or a fragment thereof. The spike protein is not from any particular coronavirus. The fragment is of no particular length, thus encompassing any length. The claims also encompass a method of treating COVID-19, protecting against COVID-19, preventing COVID-19, and inducing an immune response against COVID-19 by administering a construct that encodes any coronavirus spike protein or fragment thereof. Coronaviruses include, for example, SARS-CoV-2, SARS-CoV, MERS, and common cold viruses such as OC43, 229E, NL63 and HKU1. Thus, the vaccine claims encompass prevention of the common cold, for example. The method claims encompass prevention of COVID-19 by administering a construct that encodes a MERS spike protein fragment, or a HKU1 spike protein or fragment thereof of any length.
The nature of the invention is the induction of an immune response against a coronavirus that results in protection against disease caused by that coronavirus. By administering a construct that encodes a fusion protein comprising a targeting domain and an antigen, an immune response is induced that will prevent disease upon subsequent challenge with the respective coronavirus.
The state of the art concerning vaccines for the common cold caused by coronaviruses is that there is no vaccine, see the CDC’s document, About Human Coronaviruses (available from www.cdc.gov/human-coronaviruses/about/index.html, February 6, 2026, accessed March 5, 2026, 2 pages). The state of the art concerning treatment for COVID-19 is the use of drugs, not vaccines (see CDC’s Types of COVID-19 Treatment, February 5, 2026, available from www.cdc.gov/covid/treatment/index.html, accessed March 5, 2026, 4 pages). The state of the art concerning MERS is that there is no vaccine, see the CDC’s document, About Middle East Respiratory Syndrome (MERS), available from www.cdc.gov/mers/about/index.html, December 4, 2024, accessed March 5, 2026, 3 pages).
The specification does not provide guidance or working examples of treatments for COVID-19, nor prevention of the common cold and MERS. The specification does not show how antigens from any coronavirus would serve to induce immunity against SARS-CoV-2. The specification provides examples of influenza M1 protein, and SARS-CoV-2 spike protein.
Given the breadth of the claims, the nature of the invention, the state of the art, the limited guidance and working examples, and the lack of predictability (surrounding the prevention of the common cold, MERS, treatment of COVID-19, the use of any coronavirus antigen to induce protective immunity against COVID-19, etc.), it would require undue experimentation to make and use the claimed invention.
Alternative language to consider for “vaccine” is “pharmaceutical composition”, when referencing a coronavirus generally (see instant specification, paragraph [0026] of the published application US 20230310585).
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.
Claims 1-4, 11 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Fikes et al. (US 2003/0220285 A1, “Fikes”) in view of Stewart-Jones et al. (US 2023/0108894 A1 with priority to provisional application 62/967,006, filed January 28, 2020) or in view of Le et al. (Nature Reviews Drug Discovery, May 2020, 19:305-306, “Le”, cited in the IDS filed 3/6/2023). The claims are summarized above and correlated with the teachings of the prior art in bold font below. Please note that the claims are rejected on the basis of their recited structure and enabled embodiments.
Fikes discloses expression vectors encoding epitopes (antigens) fused to a lysosomal targeting sequence from HLA-DM, which includes the signal sequence and the transmembrane domain (see paragraphs [0024], [0093] and [0180]) (claims 1, 3 and 4, aspects of fusion protein, lysosomal targeting domain, antigen, HLA signal sequence and HLA transmembrane domain). Expression vectors include viral vectors (see paragraph [0083]) (claim 11). Fikes discloses nucleic acid vaccines encoding the fusion proteins and administration to individuals to stimulate an immune response for prophylactic and therapeutic applications (see abstract, paragraph [0135]-[0147]) (claim 1, aspects of vaccine, method of protecting against and/or preventing COVID-19, and generating an immune response). Pharmaceutical carriers include liposomes (see paragraph [0141]) (claim 18, aspect of adjuvant).
Fikes’ generic fusion construct does not name coronavirus spike protein, nor SARS-CoV-2, specifically. However, it would have been obvious to have selected any antigen of interest, such as viral epitopes, as suggested by Fikes (see paragraph [0084]). One would have been motivated to use the spike protein of SARS-CoV-2 in view of its global significance, as seen in Stewart-Jones’s construct or the constructs disclosed in Le that use the S protein, with a reasonable expectation of success (see Stewart-Jones, paragraphs [0002] and [0006], or Le’s Table 1) (claims 1, 2, 19 and 20). Therefore, the claimed invention would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Conclusion
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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