DETAILED ACTION
Applicant’s amendment and remarks filed September 4, 2026 are acknowledged and entered. Claims 8, 10 and 15 are under examination with regard elected species of record. Any prior objection or rejection that is not repeated or addressed below is either moot or withdrawn in view of Applicant’s amendment.
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 DNA virus (elected species), specifically a Herpesviridae virus (claim 15), that is attenuated and replication-defective due to treatment with a compound selected from centanamycin, or a salt or solvate thereof. The composition elicits an immune response to the pathogenic particles in a subject. The compound is represented by Formula III (claim 10, elected species), which is the formula for centanamycin:
PNG
media_image1.png
164
228
media_image1.png
Greyscale
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 8, 10 and 15 remain 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.
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]) (claim 8). 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.
Applicant’s arguments filed September 4, 2026 have been carefully considered but fail to persuade. Applicant points out that Amanna discloses that the inactivation process can damage the antigenic epitopes of an immunogen and thus result in reduced immunogenicity, e.g., formaldehyde (see paragraph [0003]). Applicant argues that this teaching would lead one of ordinary skill in the art to understand that not every alkylating agent is going to be useful as an inactivating agent for immunogenic compositions. Thus, Applicant reasons that since Amanna does not specifically name centanamycin, one would doubt its suitability.
In response, Amanna does not state that the only useful agents are those that are named. Rather, Amanna provides a broad disclosure of alkylating agents, “such as”, etc. (see paragraph [0002]). Similar language is found in paragraph [0018], [0026], [0028] and [0079], for example. Therefore, Amanna does not limit their disclosure to named agents only.
Applicant argues that Good does not disclose attenuation of DNA viruses with centanamycin. Rather, Good discloses attenuation of malaria-causing, eukaryotic parasite Plasmodium chabaudi.
In response to Applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In this instance, the rejection does not rely solely on one reference. As outlined above, 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]). Therefore, the claims remain rejected for reasons of record.
Conclusion
No claim is allowed.
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