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 Apr. 28, 2026. 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Relevance of Bunnik, Weiner and Yan is set forth in the withdrawn rejections in the previous Office action mailed on Apr. 24, 2024.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 Apr. 28, 2026 have been fully considered and are addressed as follows.
To the 103 rejection, Applicant argues that Bunnik disclosed polypeptide “comprise essentially all possible T-cell epitopes of HPV16 or HPV18 oncoproteins E6 and E7, but nevertheless have a strongly reduced (as compared to wt E6 and E7), up to non-detectable, transforming activities, by comprising fragments of the E6 and E7 proteins that have been re-ordered, while at the same time containing a minimized number of undesired strong neo-epitopes" (Bunnik at [0017]). Applicant argues that, in short, Bunnik describes its constructs as "a significant improvement over constructs described by others" and as having "a significantly improved immunologic profile since chances of an altered immune response as compared to native E6 and E7 have been minimized in the molecules of the disclosure, as compared to approaches described by others" (Bunnik at [0057]). Applicant argues that one skilled in the art armed with Bunnik thus would not have sought to substitute the sequences of Weiner or Yan for those of Bunnik because doing so would have run the risk of re-introducing the very disadvantages of prior vaccine design approaches that Bunnik set out to avoid: removal of important T-cell epitopes from and/or introducing new undesired T-cell epitopes into the proteins, leading to an undesired immune response. Applicant argues that Bunnik in no uncertain terms teaches that its HPV16 and HPV18 constructs cannot be substituted with those of the prior art, including Yan 2009, stating that "[t]he observed differences between seemingly highly similar molecules in a biologic model system demonstrate that such molecules cannot be considered mere alternatives that could be substituted for each other.”
Applicant’s arguments are not persuasive. Even though, as Applicant has argued, Bunnik may teach that E6/E7 fusion proteins with the transforming activities abolished are considered as an improvement over wt E6/E7 fusion protein, this teaching cannot be considered as teaching away. A reference may be said to “teach away” when a skilled artisan, “upon reading the reference, would be discouraged from following the path set out in the reference, or would be led in a direction divergent from the path that was taken by the applicant”. In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994). “[I]n general, a reference will teach away if it suggests that the line of development flowing from the reference’s disclosure is unlikely to be productive of the result sought by the applicant.” Gurley, 27 F.3d at 553.
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
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 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
Prosecution Insights