Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Acknowledgement is hereby made of receipt and entry of the communication filed on Jun. 10, 2026. Claims 1, 10-23 and 29-31 are pending. Claims 1 and 10-22 are withdrawn. Claims 23 and 29-31 are currently examined.
The current rejection is shifted to the non-elected species of mRNA encoding an interferon based on the amendment filed on Dec. 1, 2025.
Effective Filing Date
The instant application is a 371 of PCT/US2021/054622, filed on Oct. 12, 2021, and is a CIP of 17/068,087 filed on Oct. 12, 2020 (now US Patent 11813329), which is in turn a CIP of 15/442,281 filed on Feb. 24, 2017 (now US Patent 10799574), which is in turn a CIP of 14/921,648 filed on Oct. 23, 2015 (now US PAT 10238729). However, none of the prior applications provide sufficient written description support for the instant claims which specify a second active ingredient which is an immune-based therapeutic selected from N-acetyl cysteine or mRNA encoding a cytokine. Accordingly, the effective filing date of the instant application is considered as Oct. 12, 2021, the PCT filing date.
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.
(Previous Rejection – Withdrawn) Claim 29 was rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and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.
This rejection is withdrawn in view of the amendment filed on Jun. 10, 2026.
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.
(Previous Rejection – Maintained) Claims 23 and 29-31 are rejected under 35 U.S.C. 103 as being unpatentable over Shi et al. (Clin Pharmacol Ther. 2007 Feb; 81(2): 259-64) in view of Arico et al. (JOURNAL OF INTERFERON & CYTOKINE RESEARCH, 2012, 32(6): 235-247), and further in view of Hotz et al. (Sci. Transl. Med. 13, eabc7804 (2021), 8 September 2021).
Applicant argues that Shi primarily describes preventative effects using HPV vaccine and does not address the use of HPV vaccine as an actual treatment for developed cancers, and that the adjuvants taught in Shi are chemical in nature and are not cytokines or anti-tumor agents known to have per se anti-cancer activity. Applicant argues that there is no teaching or suggestion in Shi that would motivate a person of ordinary skill in the art to produce an anti-cancer pharmaceutical composition as claimed, comprising an HPV L1 protein component and a second active for anti-cancer therapeutic use.
Applicant argues that Office Action then cites Arico as describing the use of interferon-a (IFN-a) as an adjuvant in vaccines, i.e., still preventive compositions. And that neither Shi nor Arico, separately or together, teach or suggest a therapeutic composition, namely an anti-cancer therapeutic composition for treating cancer, and that a person of ordinary skill would not be motivated to look to either of the Shi or Arico references when seeking to discover an anti-cancer therapeutic composition as claimed. Applicant argues that, even if properly combined, Arico fails to cure the defect of Shi of failing to provide a teaching or suggestion of the claimed anti-cancer composition.
Applicant argues that although describing administration of mRNA encoding cytokines, Hotz requires mRNA encoding a mixture of four different cytokines (IL-12sc, IFN-a, GM-CSF, and IL-15), that Hotz does not describe selection of a single cytokine for use, and does not mention that any one - just one - of the cytokines may be used in a composition also comprising HPV vaccine, and that Hotz provides no teaching or suggestion connecting the disclosures of Shi or Arico, or that would lead a person of ordinary skill in the art to combine all three references and predictably arrive at the claimed anti-cancer composition.
Applicant’s arguments are not persuasive. It is noted that the claims are directed to a pharmaceutical composition, i.e., a product. Merely adding to the name of the composition the modifying phrase “anti-cancer therapeutic” does not change the structure and property of the composition.
Shi teaches an HPV vaccine composition comprising highly purified L1 (major capsid) proteins from HPV type 6, 11, 16 and 18, and a pharmaceutically-acceptable carrier. Teachings of Arico indicate that interferon-a has potential adjuvant activities and is promising in modulating cancer vaccinations. Teachings of Hotz indicate that interferon-a can be delivered to a subject in need thereof via administration of an encoding mRNA. Even though the HPV vaccines in Shi are generally considered preventive vaccines, they are administered against HPV-associated cancers. Therefore, one of skill in the art would have been motivated to introduce immune modulatory effect of interferon-a disclosed in Arico and Hotz into the HPV vaccines disclosed in Shi.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 extension fee 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NIANXIANG (NICK) ZOU whose telephone number is (571)272-2850. The examiner can normally be reached on Monday - Friday, 8:30 am - 5:00 pm, EST. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MICHAEL ALLEN, on (571) 270-3497, can be reached. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. 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.
/NIANXIANG ZOU/Primary Examiner, Art Unit 1671
Prosecution Insights