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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on Dec. 16, 2025 has been entered.
DETAILED ACTION
Acknowledgement is hereby made of receipt and entry of the communication filed on Dec. 16, 2025. Claims 1, 4, 9, 15, 16, 19-21 and 23-25 are pending and currently examined.
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 1, 4, 9, 15, 16, 19-21 and 23-25 are rejected under 35 U.S.C. 103 as being unpatentable over Bunnik et al. (PGPub US 20190202869 A1, published 7/4/2019, filed 3/19/2019; hereinafter referred to as “Bunnik”) in view of Weiner et al. (WO 2008014521 A2, published 1/31/2008; hereinafter referred to as “Weiner”), and further in view of Yan et al. (WO 2010085697 A1, published 7/29/2010, filed 1/22/2010; hereinafter referred to as “Yan”).
Relevance of Bunnik, Weiner and Yan is set forth in the withdrawn rejections in the previous Office action mailed on Apr. 24, 2024.
Briefly, Bunnik teaches nucleic acid molecules encoding HPV16 or HPV18 E6E7 fusion proteins and their use as therapeutic vaccines against Vulvar Intraepithelial Neoplasia (VIN) caused by HPV HPV16 and/or HPV18. However, Bunnik is silent on the sequences represented by SEQ ID NOs: 2 and 10 of the current claims, even though it teaches its own versions of HPV16 and HPV18 fusion proteins comprising E6 and E7 antigens (e.g., SEQ ID NOs: 1, 3, 5, 20 and 22) as well as nucleic acid sequences encoding them (e.g., SEQ ID NOs: 2, 4, 6, 21 and 23).
Weiner teaches an HPV16 E6E7 fusion protein, SEQ ID NO: 23 (encoded by nucleic sequence SEQ ID NO: 22), which is identical to SEQ ID NO: 2 of the instant claims (encoded by SEQ ID NO: 1 which is identical to SEQ ID NO: 22 of Weiner).
Yan teaches an HPV18 E6E7 fusion protein sequence, SEQ ID NO: 2 (and a nucleic acid sequence encoding it, SEQ ID NO: 1), that is identical to the instant SEQ ID NO: 10 (and a nucleic acid sequence encoding it, SEQ ID NO: 9).
It would have been prima facie obvious for one of ordinary skill in the art at the time of invention to substitute the HPV16 and HPV18 E6E7 fusion proteins of Bunnik with those of Weiner and Yan to arrive at the invention as claimed. One would have been motivated to do so to test the therapeutic effect of the fusion protein disclosed in Weiner and Yan in the studies of Bunnik. Additionally, such a combination, or a substitution of one element for another known in the field to have the same function, is evidence that the claimed invention may be found obvious. See e.g., KSR International v. Teleflex Inc., 82 U.S.P.Q.2d 1385, at 1395. Therefore, the instant invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Applicant’s Arguments
Applicant’s arguments filed on Dec. 16, 2025 have been fully considered and are addressed as follows.
To the 103 rejection, Applicant argues, referring to paragraphs in Bunnik (e.g., [0017], [0055], [0444], [0445], [0517], and [0520]), that Bunnik in no uncertain terms warns against the substitution of its HPV16 and HPV18 constructs. Applicant argues that in view of Bunnik's clear warning against substitution of its HPV16 and HV18 constructs with other constructs having even minor amino acid differences, one skilled in the art would have had no motivation to substitute the constructs of Bunnik with those of Weiner and Yan or any reasonable expectation of success in doing so; and that not only does Bunnik itself specifically distinguish the constructs of Yan 2009 and hence Weiner, but one skilled in the art would have understood the constructs of Weiner and Yan to be significantly structurally different from those of Bunnik and, as such, "cannot be considered mere alternatives that could be substituted for each other." Applicant disagrees with the Examiner’s standing that Applicant’s arguments amount to a teaching away from combining Bunnik with Weiner and Yan, arguing that the patent examiner does not produce a prima facie case, and that the Applicant is under no obligation to submit evidence or arguments to show nonobviousness.
Applicant’s arguments are not persuasive. Instead of relying on “teaching away”, Applicant appears to be trying to establish that the constructs of Bunnit and those of Weiner and Yan are not substitutable based on the “warnings” in Bunnit. The Examiner does not agree. A combination, or a substitution of one element for another known in the field to have the same function, is evidence that the claimed invention may be found obvious. See e.g., KSR International v. Teleflex Inc., 82 U.S.P.Q.2d 1385, at 1395. The E6-E7 fusion constructs of Bunnit, Weiner and Yan are known in the field to have the same function of inducing immune response to the respective antigens and potential therapeutic effect in treatment of HPV-related lesions. They are considered to be functionally substitutable.
Conclusion
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 8:30 a.m. - 5:30 p.m. ET. 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. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MICHAEL ALLEN, can be reached on (571)270-3497. The fax phone number for the organization where this application or proceeding is assigned is (571)273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at (866)217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call (800)786-9199 (IN USA OR CANADA) or (571) 272-1000.
/NIANXIANG ZOU/ Primary Examiner, Art Unit 1671