DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of Group II, species of virus, Herpesviridae, and Formula III, reading on claims 8, 10 and 13-15, in the reply filed on February 4, 2026 is acknowledged. Claims 1-4, 6, 9, 17, 19, 20, 22-25, 27 and 28 are withdrawn from consideration being directed to non-elected subject matter.
Claims Summary
Claim 8 is directed to an immunogenic composition comprising a pharmaceutically acceptable carrier or diluent and an effective amount of isolated or purified particles from a virus (elected species, also recited in claim 13) that is attenuated and replication-defective due to treatment with a compound selected from centanamycin, or a salt, solvate, analog or derivative thereof. The composition elicits a protective immune response to the pathogenic particles in a subject. The compound is represented by Formula III (claim 10), which is the formula for centanamycin:
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The virus is a DNA virus (claim 14), specifically a Herpesviridae virus (claim 15).
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.
Claims 8 and 13-15 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 8 is directed to an embodiment wherein the virus is treated with an analog or derivative of centanamycin. The specification does not provide a definition for either of these terms, “analog” or “derivative” such that the metes and bounds of the structures can be determined. Claims 13-15 are included in this rejection because they depend from claim 8.
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 8, 10 and 13-15 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 an immunogenic composition of an attenuated, replication-defective DNA virus that elicits an immune response, does not reasonably provide enablement for the same composition wherein the immune response is protective, nor for any virus of the Herpesviridae. 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 an immunogenic composition comprising an attenuated, replication-defective virus that induces protective immunity in the recipient such that upon subsequent challenge with the wild-type (pathogenic) virus, the recipient is protected from disease caused by an infection. The claims encompass any virus (claims 8, 10 and 13), any DNA virus (claim 14), and any virus of Herpesviridae (claim 15), which includes, for example, HSV-1, HSV-2, CMV, EBV and VZV as it pertains to humans. The nature of the invention is attenuated virus particles that have been attenuated by treatment with centanamycin, which alkylates DNA irreversibly, resulting in inhibition of DNA replication (see paragraph [0110] of the published application, US 2023/0390386 A1).
The specification demonstrates in working examples that centanamycin inhibits growth of HCMV, HSV-2 and VZV (see Figures 1-3 and 5). Also shown is centanamycin-attenuated murine CMV administered to mice with alum adjuvant protected mice against subsequent challenge (see paragraph [0186] of the published application, US 2023/0390386 A1). The specification states that centanamycin is effective against DNA viruses (see paragraph [0188]). Applicant’s own work states that the method of attenuation is not applicable to RNA viruses, and that further work is required to determine whether the method is suitable for certain populations of individuals susceptible to CMV infection, as well as other DNA viruses in a medical context (see abstract and page 9, left column, first paragraph of Jaijyan et al., Cell Reports Methods, 2, 100287, September 19, 2022, 15 pages). Jeffrey Cohen reports that while there are vaccines for VZV, vaccines for other viruses from Herpesviridae, such as HSV, CMV and EBV remain at large. Challenges to developing vaccines for HSV, CMV and EBV include the inability of an individual’s natural immunity to prevent reactivation (see abstract and page 2 of Cohen, J. Clin. Invest., 2024, 134(9):e179483, 6 pages).
In view of the breadth of the claims, the nature of the invention, the limited guidance and working examples in the specification, and the state of the art which speaks to unpredictability, it would require undue experimentation to make or use the claimed invention. Amendment of the claims to require that the virus is a DNA virus, and removal of the embodiment of protective immunity, would overcome this rejection.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 8 and 13-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Amanna et al. (US 2019/0201520A1, “Amanna”, cited in the IDS 4/27/2023). The claims are summarized above and correlated with the teachings of the prior art in bold font below. Please note that this rejection addresses the embodiment of the claims wherein an analog of centanamycin is used to attenuate viruses. Since the structure of the analog is not clearly set forth (see indefiniteness rejection above), the rejection is based on prior art that uses what is reasonably an analog of centanamycin, lacking any further distinction between the analog recited in the claims and the agents described in Amanna. Further, please note that the claims are rejected on the basis of their enabled embodiments, i.e., immunogenic compositions that induce an immune response.
Amanna discloses immunogenic compositions comprising attenuated DNA viruses that are rendered attenuated and replication-defective by treatment with alkylating agents comprising ethyleneimine monomer (EI) or binary ethyleneimine (BEI) that alkylate nucleic acids at N3 (see paragraphs [0003], [0210] and [0218]) (claims 8, 13 and 14). The instant specification discloses that centanamycin alkylates DNA at N3 (see paragraph [0010] of the published application, US 2023/0390386 A1). Since EI and BEI alkylate at N3, they are reasonably considered analogs of centanamycin. The immunogenic compositions further comprise a pharmaceutically acceptable carrier or diluent (see paragraphs [0248] and [0250]) (claim 8). Viruses that can be treated with alkylating agents include viruses from Herpesviridae (see paragraphs [0178]-[0179]) (claim 15). Therefore, the claims are anticipated by the prior art.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 8, 10 and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Amanna et al. (US 2019/0201520A1, “Amanna”, cited in the IDS 4/27/2023) in view of Good et al (US 2014/0186402 A1, “Good”, cited in the IDS 4/27/2023). The claims are summarized above and correlated with the teachings of the prior art in bold font below. Please note that this rejection addresses the embodiment of the claims wherein centanamycin is used to attenuate viruses. Further, please note that the claims are rejected on the basis of their enabled embodiments, i.e., immunogenic compositions that induce an immune response.
Amanna discloses immunogenic compositions comprising attenuated DNA viruses that are rendered attenuated and replication-defective by treatment with alkylating agents, for example, ethyleneimine monomer (EI) or binary ethyleneimine (BEI) that alkylate nucleic acids at N3 (see paragraphs [0003], [0210] and [0218]) (claims 8, 13 and 14). The immunogenic compositions further comprise a pharmaceutically acceptable carrier or diluent (see paragraphs [0248] and [0250]) (claim 8). Viruses that can be treated with alkylating agents include viruses from Herpesviridae (see paragraphs [0178]-[0179]) (claim 15).
Amanna does not disclose attenuation with centanamycin. However, it would have been obvious to have done so with a reasonable expectation of success. Centanamycin alkylates DNA at N3 (see Good, paragraph [0044]), in the same manner as the alkylating agents used by Amanna, EI and BEI. One would have been motivated to use any alkylating agent, such as centanamycin, since Amanna is not limited to EI and BEI, rather, they represent a broader class of alkylating agents (see paragraph [0002]) (claims 8 and 10). Therefore, the claims would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Conclusion
No claim is allowed.
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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
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