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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 Aug. 19, 2026 has been entered.
DETAILED ACTION
Acknowledgement is hereby made of receipt and entry of the communication filed on Aug. 19, 2026. Claims 1, 4, 9, 15, 16, 19-21 and 23-25 are pending and currently examined.
Claim Objections
Claim 1 is objected to because of the following informalities: claim 1 recites “human papillomavirus of subtype 18 (HPV16)” which should be “human papillomavirus of subtype 18 (HPV18)”. Appropriate correction is required.
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Relevance of Bunnik, Weiner and Yan is set forth in the withdrawn rejections in the previous Office actions.
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 Aug. 19, 2026 have been fully considered and are addressed as follows.
Applicant argues that the Office's rationale that one skilled in the art would have substituted the HPV 16 and HPV 18 E6E7 fusion proteins of Bunnik with those of Weiner and Yan "to test the therapeutic effect of the fusion protein disclosed in Weiner and Yan in the studies of Bunnik" presupposes that the outcome of the substitution was unknown - i.e., was unpredictable. Applicant argues that Bunnik firmly establishes that the result of the proposed substitution was unpredictable, and that Bunnik does not merely opine that other constructs are inferior; it reports experimental data showing that structurally similar E6E7 molecules behave differently in a biologic model, and it draws from those data the express conclusion of unpredictability in the field. Applicant argues that the record remains devoid of any basis for finding that a skilled artisan would have predicted the outcome of substituting the HPV16 and HPV18 E6E7 constructs of Weiner and Yan for those of Bunnik.
Applicant’s arguments are not persuasive.
There is no indication in the rejection that substitution of the HPV 16 and HPV 18 E6E7 fusion proteins of Bunnik with those of Weiner and Yan is unpredictable. The structural features of the E6E7 fusion proteins of the cited references are clearly disclosed and the properties of them are known and predictable. Bunnik teaches that E6/E7 fusion proteins with the transforming activities abolished are considered as an improvement over wt E6/E7 fusion protein. Weiner and Yan already teach HPV16 and HPV18 E6/E7 fusion proteins with the amino acid sequences identical to SEQ ID NOs: 2 and 10, and their application as vaccine antigens. One of skill in the art, when reading the teachings Bunnik would also realize that teachings of Weiner and Yan that wt E6/E7 fusion proteins may also be used in vaccine applications. Bunnik does not suggest “that the line of development flowing from the reference’s disclosure is unlikely to be productive of the result sought by the applicant”, i.e., combining nucleic acid molecules encoding the two fusion proteins disclosed in Weiner and Yan in one immunogenic composition. "A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use." In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994).
Since Bunnik, Weiner and Yan together teach that E6E7 fusion proteins of both the mutated form and the wild-type form can be used in vaccines against HPV-associated diseases, one of skill in the art would have reasonably predicted the results of the substitution/combination of fusion protein based upon in the current rejection. 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 MPEP 2144.06 and KSR International v. Teleflex Inc., 82 U.S.P.Q.2d 1385, at 1395.
In the current case, Weiner and Yan already teach HPV16 and HPV18 E6/E7 fusion proteins with the amino acid sequences identical to SEQ ID NOs: 2 and 10, and their application as vaccine antigens. One of skill in the art, when reading the teachings Bunnik would also realize that teachings of Weiner and Yan that wt E6/E7 fusion proteins may also be used in vaccine applications. Bunnik does not suggest “that the line of development flowing from the reference’s disclosure is unlikely to be productive of the result sought by the applicant”, i.e., combining nucleic acid molecules encoding the two fusion proteins disclosed in Weiner and Yan in one immunogenic composition. "A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use." In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994).
Conclusion
No claims are allowed.
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
