DETAILED ACTION
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 allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). 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, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on February 4, 2026 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 2/4/2026 has been considered by the examiner.
Claim Objections
Claim 1 is objected to because of the following informalities: identification of SEQ ID NO: 2 should be recited prior to “a nucleotide sequence that encodes SEQ ID NO: 2” for consistency with the remainder of the claim, which identifies SEQ ID NO: 6 as p35 in lines 13-14 and identifies SEQ ID NO: 8 as p40 in lines 21-22. Appropriate correction is required.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 4-12, and 17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
Claim 1 encompasses:
a fragment of a nucleotide sequence that encodes SEQ ID NO:2; and
a nucleotide sequence that is at least 95% homologous to a fragment of a nucleotide sequence that encodes SEQ ID NO:2;
a fragment of a nucleotide sequence that encodes SEQ ID NO:6: and
a nucleotide sequence that is at least 95% homologous to a fragment of a nucleotide sequence that encodes SEQ ID NO:6
a fragment of a nucleotide sequence that encodes SEQ ID NO:8: and
a nucleotide sequence that is at least 95% homologous to a fragment of a nucleotide sequence that encodes SEQ ID NO:8.
A fragment is defined in paragraph [0034] of the instant published disclosure (USPgPub 2023/0000969) that comprises 60% or more homology of the length of the particular full length antigen, excluding any heterologous signal peptide added. SEQ ID NO: 2 is 280 amino acids. 60% of the full length is 168 residues. SEQ ID NO: 6 is 219 amino acids. 60% of the full length is approximately 131 residues. SEQ ID NO: 8 is 328 amino acids. 60% of the full length is approximately 197 residues. Each of the fragments encompass up to 40% of unrelated sequences. Each of these sequences also encompass at least 95% homology to each of the fragments comprising up to 40% of unrelated sequences, which is an even greater percentage of divergence from the original sequences.
The applicable standard for the written description requirement can be found in MPEP 2163; University of California v. Eli Lilly, 43 USPQ2d 1398 at 1407; PTO Written Description Guidelines; Enzo Biochem Inc. v. Gen-Probe Inc., 63 USPQ2d 1609; Vas- Cath Inc. v. Mahurkar, 19 USPQ2d 1111; and University of Rochester v. G.D. Searle & Co., 69 USPQ2d 1886 (CAFC 2004). To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. In this case, the only factor present in the specification are sequences SEQ ID NOs: 2, 6, and 8. There is no disclosure of sufficient characteristics of the claimed genus of sequence variations of up to 40-45% to allow persons of ordinary skill in the art to recognize that applicants were in possession of the claimed genus of SEQ ID NOs: 2, 6, and 8 by any sequence that is at least 40% to 45% homologous thereto.
Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus. A definition by function alone is not sufficient because it is only an indication of what a thing does, rather than what it is. Eli Lily, 119 F.3 at 1568, 43 USPQ2d at 1406.
The court clearly states in Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, that “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.” (See page 1117.) The specification does not clearly allow persons of ordinary skill in the art to recognize that the inventors invented what is claimed. As discussed above, the skilled artisan cannot envision the distinguishing, identifying characteristics of the encompassed genus of sequences having up to 40% to 45% difference in homology to full length SEQ ID NOs: 2, 6, and 8. Given that the specification has only described SEQ ID NOs: 2, 6, and 8, the full breadth of the claims does not meet the written description provision of 35 U.S.C. 112, first paragraph.
Claims 1, 4-12, and 17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of treating or preventing recurrent respiratory papillomatosis in an individual by administering a nucleotide sequence comprising SEQ ID NO: 2 (HPV6 E6/E7 fusion protein) and SEQ ID NOs: 6 and 8, corresponding to p30 and p45 IL-12 subunits, respectively, does not reasonably provide enablement for a method of treating or preventing recurrent respiratory papillomatosis in an individual by administering a nucleotide sequence comprising SEQ ID NO: 2 (HPV6 E6/E7 fusion protein) and one or more of SEQ ID NO: 6 or 8, corresponding to p30 and p45 IL-12 subunits. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The instant claims are drawn to a method of treating or preventing recurrent respiratory papillomatosis in an individual by administering a nucleotide sequence comprising SEQ ID NO: 2 (HPV6 E6/E7 fusion protein) and one or more of SEQ ID NO: 6 or 8, corresponding to p30 and p45 IL-12 subunits. However, the working examples only show administration of a plasmid, “INO-3106” encoding HPV6 E6 and E7 proteins in combination with plasmid, “INO-9012”, encoding synthetic human IL-12 (p35 and p40 subunits) in “Study Design”, beginning in paragraph [0139] of the instant published disclosure, USPgPub 2023/0000969 and “Safety and Tolerability of INO-3106 and INO-9012 with EP”, beginning in paragraph [0154]. There is no disclosure, guidance, or working example provided demonstrating efficacy in a method of treating or preventing recurrent respiratory papillomatosis in an individual by administering HPV6 E6 and E7 proteins in combination with p35 or p40, or one or more copies of each, as required in the instant claims. The art does not teach expressing p35 or p40 or one or more of each, or either in combination with a vaccine. The skilled artisan would not predict success for a method of treating or preventing recurrent respiratory papillomatosis in an individual by administering a nucleotide sequence comprising SEQ ID NO: 2 (HPV6 E6/E7 fusion protein) and one or more of p30 or p45 IL-12 subunits, as asserted by the claims. There is no nexus bridging the gap between what is claimed and the data provided in the working examples. For these reasons, it is determined that an undue quantity of experimentation would be required of the skilled artisan to use the invention in the scope claimed.
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 1, 4-12, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Weiner et al. (WO 2013/055326, of record, hereinafter, “Weiner ‘326”), Weiner et al. (WO 2013/090296, cited in the IDS, hereinafter, “Weiner ‘296”), Chattergoon et al. (Vaccine. 2004; 22: 1744-1750, cited in the IDS), and Wolf et al. (Journal of Immunology. 1991; 146 (9): 3074-3081, abstract only).
Weiner ‘326 teach a method of administering a composition comprising a nucleic acid molecule encoding an HPV6 E6-E7 fusion antigen, see page 7, lines 9-33; page 10, lines 15-18; page 11, lines 7-10, 20, and 21; page 23, lines 22-26; page 26, lines 10-12, line 22 to page 27, line 2 and lines 22-24; Figures 3B and 5; and claims, 1, 12, and 20, to treat and prevent HPV infections leading to cancer and/or carcinomas of the lung, tonsil, and larynx and otolaryngologic diseases, see page 3, lines 9-11; page 10, line 32 to page 11, line 1. On page 1, lines 24-26, Weiner et al. list recurrent respiratory papillomatosis as an otolaryngologic disease.
The instant preamble states that the method is “for treating or preventing recurrent respiratory papillomatosis”. The preamble phrase does not affect the structure or steps of the claimed invention. The method of Weiner et al. require the same method steps of administering the same composition, i.e., a nucleic acid encoding an HPV6 E6-E7 fusion protein, to treat and prevent HPV infections leading to cancer and/or carcinomas of the lung, tonsil, and larynx and otolaryngologic diseases. Therefore, the method of Weiner et al. anticipates a nucleic acid encoding an HPV6 E6-E7 fusion protein which is capable treating and preventing recurrent respiratory papillomatosis by administration of instant claim 1.
Genseq database acc no BAN43912 (SEQ ID NO: 1) of Weiner et al. (cited previously) shares 100% identity with instant SEQ ID NO: 2, see the alignment provided, as required in instant claims 1, 4, and 5. On page 8, lines 9-11 and 22-23, Weiner et al. anticipate SEQ ID NO: 1 without a leader sequence at the 5’ end, required by instant claim 6.
Genseq database acc no BAN43912 (SEQ ID NO: 2) of Weiner et al. (cited previously) shares 100% identity with instant SEQ ID NO: 1, see the alignment provided, recited in instant claims 7-9.
Page 18, lines 4-7 and 12 of Weiner ‘326 teach that the nucleic acids are co-administered with an adjuvant, as required by instant claim 12. Page 18, line 29 to page 19, line 3 of Weiner ‘326 teaches the pharmaceutical composition of instant claim 11.
On page 13, lines 20-23 and 26, Weiner ‘326 teach additionally administering nucleic acids that encode IL-12, recited in instant claim 1. Genseq database acc no BAP83898 of Weiner ‘326 shares 100% identity with instant SEQ ID NO: 6, see the alignment provided (cited previously), and Genseq database acc no BAP83900 of Weiner ‘326 (cited previously) shares 100% identity with instant SEQ ID NO: 8, recited in instant claim 1.
On page 16, line 9 to page 17, line 20 and page 22, lines 14-22, Weiner ‘326 teach administration of plasmids encoding HPV-6, E6-E7 fusion proteins by electroporation, as required by instant claims 10 and 17.
Weiner ‘326 does not teach a nucleic acid encoding p35 and p40 subunits of IL-12, as required by instant claim 1.
Weiner ‘296 does, see claim 1.
One of ordinary skill in the art prior to the instant effective filing date would have been motivated to have expressed a nucleic acid encoding p35 and p40 subunits of IL-12, as taught by Weiner ‘296 in the method of Weiner ‘326 because Weiner ‘296 teaches these subunits are an impressive immune enhancing cytokine, particularly when engineered as a DNA vaccine, see the paragraph bridging pages 2-3. In addition, Chattergoon et al. teach co-immunization of pIL-12 and plasmid encoded antigens sustain a greater memory response than those immunized with the plasmid antigen alone and results in improved outcome after challenge. One of ordinary skill in the art prior to the instant effective filing date would have had a reasonable expectation of success to have expressed a nucleic acid encoding p35 and p40 subunits of IL-12, as taught by Weiner ‘296 in the method of Weiner ‘326 because Weiner ‘296 because Weiner ‘296 combines the nucleic acid encoding p35 and p40 subunits with HPV, see the paragraph bridging pages 27-28 and claims 1, 2, 17, 40, 47, and 66. In addition, Wolf et al. attributes that p35 and p40 subunits with enhancement of cytotoxicity by natural killer cells and induction of IFN-gamma and concludes that this cytokine may be useful in cancer therapy (1991).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHANON A FOLEY whose telephone number is (571)272-0898. The examiner can normally be reached M-F, generally 5:30 AM-5 PM, flexible.
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/Shanon A. Foley/ Primary Examiner, Art Unit 1671