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 .
Applicant’s reply and amendments to the claims have overcome the rejection under 35 USC § 102.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on January 7, 2026 has been considered by the examiner.
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.
Claim 1, 4, 8, 11-13, 22-24, and 26-32 are rejected under 35 U.S.C. 103 as being unpatentable over Bunnik et al. (USPgPub 2017/0051019), instant SEQ ID NO: 5 alignment with Geneseq db access no AO648663 Weiner et al 2008 WO2008014521; instant SEQ ID NO: 6 alignment with Geneseq db access no AOG48664 Weiner et al 2008 WO2008014521; instant SEQ ID NO 21 with Geneseq db access no AYF71829 on Sept 2010 by Weiner et al. in WO2010085697; instant SEQ ID NO 22 with Geneseq db access no AYF71833 on Sept 2010 by Weiner et al. in WO2010085697; instant SEQ ID NO: 17 alignment with Geneseq db access no AOG48659 Weiner et al 2008 WO2008014521; instant SEQ ID NO: 19 alignment with Geneseq db access no AOG48659 Weiner et al 2008 WO2008014521; instant SEQ ID NO: 2 alignment with Geneseq db access no AO648660 Weiner et al 2008 WO2008014521; and instant SEQ ID NO: 1 alignment with Geneseq db access no AO648659 Weiner et al 2008 WO2008014521, as evidenced by Davis et al. (Clinics in Colon and Rectal Surgery. 2018 Nov; 31 (06): 368-378).
All references of record.
Bunnik et al. teach a method of treating a subject with persistent HPV-infection and (histologically confirmed) anal intraepithelial neoplasia (AIN) by administering a vaccine comprising a nucleic acid encoding HPV16 and HPV18 E6/E7 fusion proteins encoded by SEQ ID NOs: 1 and 20, respectively, see paragraphs [0029, 0061, 0064, 0082, 0083, and 0438] and claims 1, 7, 13, and 23. While Bunnik et al. do not specifically mention, “anal high-grade squamous intraepithelial lesion (HSIL)”, the second and third paragraphs under “Taxonomy” of Davis et al. teach “anal intraepithelial neoplasia (AIN)” classification has been abandoned in favor of “high-grade intraepithelial lesion [HSIL]”, reflecting persistent precancerous lesions. Therefore, the AIN treated by Bunnik et al. is equivalent to the requisite anal high-grade squamous intraepithelial lesion (HSIL), as recited in instant claims 1 and 23.
The nucleic acids encoding HPV16 and HPV18 E6/E7 fusion proteins of Bunnik et al. are biosimilar to VGX-3100, as recited in instant claim 28. Paragraphs [0021, 0022] of Bunnik et al. state that the nucleic acid expressing the HPV16 and HPV18 E6/E7 fusions is a plasmid, as recited in instant claim 22. Paragraph [0087] of Bunnik et al. teach the composition comprising an adjuvant, recited in claim 24. Paragraph [0013] describes electroporation-enhanced immunization with E6/E7 fusions, as required in instant claim 26. Paragraphs [0089 and 0090] of Bunnik et al. discuss intramuscular administration, recited in instant claim 27. Claim 22 and paragraph [0094] teach administering a first and a second dose more than once, i.e., four doses, recited in instant claim 29, and that the administrations occur between two weeks and four months after the prime dose, which is within the range of the second dose at about four weeks after the first dose and the third dose about twelve weeks after the first dose, as recited in instant claims 30 and 31.
Regarding instant claim 32, claim 22 and paragraph [0094] of Bunnik et al. discuss administering a first and a second dose more than once, i.e., four doses, and that the administrations occur between two weeks and four months after the prime dose, and that booster administrations are provided to the same subject between one week and one year, i.e., twelve months after the first dose. Therefore, the temporal ranges for booster doses in the teachings of Bunnik et al. overlap with the instant booster intervals of claim 32. Absent evidence of criticality, the timing of each administration with respect to the claimed composition are adjustable. Therefore, it would have been prima facie obvious for a person having ordinary skill in the art prior to the effective filing date to routinely optimize the timing of booster administrations. MPEP 2144.05 states, “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine optimization.”
Bunnik et al. do not teach SEQ ID NOs: 5, 6, 21, and 22, as required in instant claim 1; SEQ ID NOs: 17 and 19, as required by instant claim 4; or SEQ ID NOs: 2 and 1, recited in instant claims 8-10 and 11-13, respectively.
Sequence alignments of Geneseq db access no AOG48663, AOG48664, AYF71829, and AYF71833; share 100% sequence identity with instant SEQ ID NOs: 5, 6, 21, and 22, respectively. Geneseq db access no AO648659 shares 100% identity with instant SEQ ID NOs: 1, 17, and 19.
It would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to have used the sequences of Weiner et al. as the HPV16 E6 and E7 of Bunnik et al. because Weiner et al. teach that the immunogens elicit stronger and broader immune responses compared to corresponding optimized antigens, see the description in the sequence alignments provided. One of ordinary skill in the art prior to the instant effective filing date would have had a reasonable expectation of success to have used the sequences of Weiner et al. as the HPV16 E6 and E7 of Bunnik et al. because Weiner et al. teach that Geneseq accession numbers AO648660, AO648659, AYF71829, and AYF71833 are HPV 16 and 18 E6 and E7 consensus coding sequences, respectively, AO648659 is an HPV vaccine coding sequence and Bunnik et al. teach a method of treating a subject with persistent HPV-infection and (histologically confirmed) anal intraepithelial neoplasia (AIN) by administering a vaccine comprising a nucleic acid encoding HPV16 E6/E7 fusion proteins, see paragraphs [0029, 0061, 0064, 0082, 0083, and 0438] and claims 1, 7, 13, and 23.
Claims 14, 15, 18-21, 25, and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Bunnik et al., as evidenced by Davis et al., and the sequence alignments of Weiner et al. supra, as applied to claims 1, 4, 8, 11-13, 22-24, and 26-32 above, and further in view of instant SEQ ID NO 23 with Geneseq db access no AYF71828 on Sept 2010 by Weiner et al. in WO2010085697; instant SEQ ID NO 24 with Geneseq db access bo AYF71828 on Sept 2010 by Weiner et al. in WO2010085697; instant SEQ ID NO: 10 alignment with Geneseq db access no AYF71829 Weiner et al WO2010085697; instant SEQ ID NO: 9 alignment with Geneseq db access no AYF71832 Weiner et al WO2010085697; and instant SEQ ID NO 11 with Geneseq db access bo AYF71830 on Sept 2010 by Weiner et al. in WO2010085697. All references of record.
See the teachings of Bunnik et al., as evidenced by Davis et al., and further in view of the sequence alignments of Weiner et al. above. Geneseq db access no AO648660 of Weiner et al. ‘521 shares 100% sequence identity with instant SEQ ID NO: 2, as required in instant claim 25.
Neither Bunnik et al. nor Weiner et al. teach SEQ ID NOs: 23 and 24, recited in instant claim 14, SEQ ID NO: 10, recited in claims 15, 18 and 25; or SEQ ID NO: 9, recited in claims 19-21.
Geneseq db access no: AYF71828 of Weiner et al. shares 100% identity with instant SEQ ID NOs: 23 and 24. Sequence alignments of Geneseq db access nos: AYF71829 and AYF71832 of Weiner et al share 100% sequence identity with instant SEQ ID NOs: 9 and 10, respectively.
It would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to have used the sequences of Weiner et al. as the HPV18 E6 and E7 of Bunnik et al. because Weiner et al. teach that the immunogens provide improved immune responses for prophylactic and therapeutic immunizations against HPV, see the description in the sequence alignments provided. One of ordinary skill in the art prior to the instant effective filing date would have had a reasonable expectation of success to have used the sequences of Weiner et al. as the HPV18 E6 and E7 of Bunnik et al. because Weiner et al. teach that Geneseq accession numbers AYF71829, AYF71828, and AYF71832 are HPV18 E6 and E7 consensus sequences and Bunnik et al. teach a method of treating a subject with persistent HPV-infection and (histologically confirmed) anal intraepithelial neoplasia (AIN) by administering a vaccine comprising a nucleic acid encoding HPV16 E6/E7 and HPV E6/E7 fusion proteins, see paragraphs [0029, 0061, 0064, 0082, 0083, and 0438] and claims 1, 7, 13, and 23.
Regarding instant claims 18 and 35, requiring the leader sequence of SEQ ID NO: 11, Bunnik et al. teach using a nucleic acid encoding a leader sequence in paragraphs [0017, 0038, 0060, and 0453]. Bunnik et al. do not teach or suggest SEQ ID NO: 11.
Geneseq db access no AYF71830 by Weiner et al. shares 100% identity with instant SEQ ID NO: 11, see the alignment provided.
It would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to have used the IgE leader sequence of Geneseq db access no AYF71830 as the leader sequence of Bunnik et al. with a reasonable expectation of success because the leader sequence of Geneseq db access no AYF71830 is useful in immunizing an individual against HPV in a vaccine, see the description provided in the alignment.
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Bunnik et al., as evidenced by Davis et al., and the sequence alignments of Weiner et al. supra as applied to claims 1, 4, 8, 11-15, 18-32, and 35 above, and further in view of instant SEQ ID NO: 7 alignment with Geneseq db access no AZL93388 by Weiner et al WO2011097640. All references of record.
See the teachings of Bunnik et al., as evidenced by Davis et al., above. Bunnik et al. teach using a nucleic acid encoding a leader sequence in paragraphs [0017, 0038, 0060, and 0453] Bunnik et al. do not teach or suggest SEQ ID NO: 7.
Geneseq db access no AZL93388 by Weiner et al. shares 100% identity with instant SEQ ID NO: 7, see the alignment provided.
It would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to have used the IgE leader sequence of Geneseq db access no AZL93388 as the leader sequence of Bunnik et al. with a reasonable expectation of success because the leader sequence of Geneseq db access no AZL93388 is useful in immunizing an individual against a pathogen in a vaccine, see the description provided in the alignment.
Response to Arguments
In response to the rejection of record, applicant refers in to paragraphs [0015, 0053, 0055, 0442, 0043, 0515, 0518] in Bunnik, warning against substitutions of its HPV16 and HPV 18 E6 E7 fusion protein 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 ‘521 or any reasonable expectation of success in doing so. Bunnik itself specifically distinguishes the constructs of Weiner ‘521 and Yan (2009), 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's arguments and a review of the teachings of Bunnik have been fully considered, but are found unpersuasive. Bunnik’s discussions of the invention lacking alternative substitutions does not constitute "teaching away" from the sequences of Weiner et al. Paragraph [0071] and Examples 3-5 and 9-12 of Bunnik emphasize inducing HPV16- and HPV-18-specific cellular immune responses for therapeutic efficacy. Similarly, Weiner et al. teach that the HPV E6/E7immunogens elicit stronger and broader cellular immune responses compared to corresponding optimized antigens, see the description in the sequence alignments provided. The E6/E7 fusion constructs of Bunnik and Weiner are known in the field to have the same function of inducing cellular immune responses to the respective antigens and potential therapeutic effect in treatment of HPV-related lesions. They are considered to be functionally substitutable.
Even assuming arguendo that the HPV16- and HPV-18 E6/E7 fusion proteins of Bunnik cannot be substituted with an alternative, Bunnik specifically teaches combining the HPV16- and HPV-18 E6/E7 fusion protein constructs with additional therapeutic vaccines against both HPV16 and HPV18 in the following paragraphs:
[0015] Provided is molecules that can be used in therapeutic vaccines against either HPV16 or HPV18. Such molecules can also be combined in therapeutic vaccines against both HPV16 and HPV18.
[0061] It can be used for subjects that are infected with HPV16 or HPV18, respectively. It may in certain embodiments also suitably be combined with vaccines against other HPV types. In certain embodiments, this combination is with a vaccine against HPV of a high risk type as identified above, e.g. a vaccine against HPV16 with a vaccine against HPV18. In other embodiments, the vaccine of the invention is combined with a vaccine against one or more of HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -68, -73, or -82. Such combinations could for instance be used if the exact type of HPV infection is not yet certain, or if an immune response with a prophylactic effect is desired against more than one HPV type. Also combinations of the vaccines of the invention with vaccines against HPV types that cause genital warts, such as HPV6 and/or HPV11, are envisaged. Sequences of these HPV types and the proteins encoded thereby (e.g. E6, E7, E2) are available to the skilled person in public databases…
[0449] The HPV16 E6E7SH fusion protein sequence can be combined with sequences of other HPV16 early proteins to target individuals with persistent infection and to broaden the immune repertoire in an immunized individual.
[0500] The HPV18 E6E7SH fusion protein sequence can be combined with sequences of other HPV18 early proteins to target individuals with persistent infection and to broaden the immune repertoire in an immunized individual.
In addition, the vaccine, method of inducing an immune response, and the method for treating a subject for persistent HPV infection, vulvar intraepithelial neoplasia (VIN), cervical intraepithelial neoplasia (CIN), vaginal intraepithelial neoplasia (VaIN), anal intraepithelial neoplasia (AIN), cervical cancer (such as cervical squamous cell carcinoma (SCC), oropharyngeal cancer, penile cancer, vaginal cancer and/or anal cancer, of Bunnik in claims 14-23 is accomplished by administering compositions comprising recited materials.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to have administered the HPV16- and HPV18- E6/E7 fusion proteins of Weiner in combination with the HPV16- and HPV18- E6/E7 fusion proteins of Bunnik to combine therapeutic efficacy against HPV16 and HPV18. MPEP § 2144.06 recites the conclusions of In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA), “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose...[T]he idea of combining them flows logically from their having been individually taught in the prior art.”
One of ordinary skill in the art prior to the instant effective filing date would have had a reasonable expectation of success for combining the HPV16- and HPV18- E6/E7 fusion proteins of Weiner in combination with the HPV16- and HPV18- E6/E7 fusion proteins of Bunnik because Bunnik explicitly teach combining the HPV16- and HPV-18 E6/E7 fusion protein constructs with additional therapeutic vaccines against both HPV16 and HPV18 in paragraphs [0015, 0061, 0449, and 0500] and the HPV16- and HPV18- E6/E7 fusion proteins of Bunnik and Weiner elicit stronger and broader cellular immune responses for therapeutic efficacy, see paragraph [0071] and Examples 3-5 and 9-12 of Bunnik and the description in the sequence alignments provided by Weiner et al.
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.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 4, 8, 11-15, and 18-32 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 9, 15, 16, 19-21, and 23-25 of copending Application No. 17,221,032 (reference application), SEQ ID NO: 5 alignment with Geneseq db access no AO648663 Weiner et al 2008 WO2008014521; instant SEQ ID NO: 6 alignment with Geneseq db access no AOG48664 Weiner et al 2008 WO2008014521; instant SEQ ID NO: 17 alignment with Geneseq db access no AOG48659 Weiner et al 2008 WO2008014521; instant SEQ ID NO: 19 alignment with Geneseq db access no AOG48659 Weiner et al 2008 WO2008014521, SEQ ID NO 21 with Geneseq db access bo AYF71829 on Sept 2010 by Weiner et al. in WO2010085697; instant SEQ ID NO 22 with Geneseq db access bo AYF71833 on Sept 2010 by Weiner et al. in WO2010085697; instant SEQ ID NO 23 with Geneseq db access bo AYF71828 on Sept 2010 by Weiner et al. in WO2010085697; instant SEQ ID NO 24 with Geneseq db access bo AYF71828 on Sept 2010 by Weiner et al. in WO2010085697 as evidenced by Davis et al. (Clinics in Colon and Rectal Surgery. 2018 Nov; 31 (06): 368-378). All references of record.
Although the claims at issue are not identical, they are not patentably distinct from each other because each method involves treating an individual by administering a composition comprising nucleotide sequences encoding HPV16 E6/E7 and HPV 18 E6/E7 antigen. SEQ ID NOs: 2 and 10 in claim 1 of ‘032, used in the method are identical to instant SEQ ID NOs: 10 and 2 of instant claims 8, 15, and 25. SEQ ID NOs: 1 and 9 in claims 9 and 16 of ‘032, used in the method are identical to instant SEQ ID NOs: 1 and 9 of instant claims 11-13 and 19-21.
While the preambles of the applications differ in that the instant application is drawn to treating anal high-grade squamous intraepithelial lesion and ‘032 is drawn to treating or preventing vulvar high-grade squamous intraepithelial lesion, the second and third paragraphs under “Taxonomy” of Davis et al. teach “anal intraepithelial neoplasia (AIN)” classification has been abandoned in favor of “high-grade intraepithelial lesion [HSIL]”, reflecting persistent precancerous lesions. Under “Anal Intraepithelial Neoplasia”, Davis et al. teach:
AIN is analogous to and is associated with both cervical and vulvar intraepithelial neoplasia
The preamble of the copending application does not alter the patient group that would be receiving the nucleic acid sequences in the method claimed in ‘032. Therefore, claims 1 and 4 of ‘032 anticipate instant claims 1 and 28.
Each application also has embodiments with the methods comprising electroporation, adjuvants, wherein the composition is a pharmaceutical composition, and the nucleic acid molecule comprising the nucleotide sequence comprising a plasmid. Further, each application discloses leader sequences for the nucleotide sequence encoding the HPV 18 E6- E7 fusion antigen. Claim 15 of ‘032 anticipates the leader sequence required in instant claim 18. Claims 19-21 of ‘032 anticipate the limitations recited in instant claims 22-24, respectively, and claim 23 of ‘032 anticipates instant claims 26 and 27 since electroporation administration occurs intramuscularly. Claims 24 and 25 of ‘032 anticipate the temporal range of administrations recited in instant claims 29-31.
Regarding instant claim 32, the claims of ‘032 do not mention that a fourth dose is administered about 40 weeks after the first dose, as recited. However, claim 25 of ‘032 recites that a fifth dose is administered at week 52, which reasonably encompasses “about 40 weeks”. Absent evidence of criticality, the timing of each administration with respect to the claimed composition are adjustable. Therefore, it would have been prima facie obvious for a person having ordinary skill in the art prior to the effective filing date to routinely optimize the timing of booster administrations. MPEP 2144.05 states, “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine optimization.”
The claims of ‘032 do not recite SEQ ID NOs: 5, 6, or 17 and 19 as required in claims 1 and 4.
Sequence alignments of Geneseq db access no AOG48663 and AOG48664 of Weiner et al share 100% sequence identity with instant SEQ ID NOs: 5 and 6, respectively, and AO648659 shares 100% identity with instant SEQ ID NOs: 17 and 19.
It would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to have used the sequences of Weiner et al. as the HPV16 E6 and E7 of ‘032 because Weiner et al. teach that the immunogens elicit stronger and broader immune responses compared to corresponding optimized antigens, see the description in the sequence alignments provided. One of ordinary skill in the art prior to the instant effective filing date would have had a reasonable expectation of success to have used the sequences of Weiner et al. as the HPV16 E6 and E7 of ‘032 because Weiner et al. teach that Geneseq accession numbers AOG48663 and AOG48664 are HPV16 E6 and E7 consensus sequences and AO648659 is an HPV vaccine coding sequence and ‘032 requires HPV16 and E6 and E7 in claim 1.
The claims of ‘032 do not recite SEQ ID NOs: 21 and 22, as recited in claim 6 or SEQ ID NOs: 23 and 24, recited in instant claim 14.
Sequence alignments of Geneseq db access nos: AYF71829 and AYF71833 of Weiner et al share 100% sequence identity with instant SEQ ID NOs: 21 and 22, respectively. Geneseq db access no: AYF71828 of Weiner et al. shares 100% identity with instant SEQ ID NOs: 23 and 24.
It would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to have used the sequences of Weiner et al. as the HPV18 E6 and E7 of ‘032 because Weiner et al. teach that the immunogens provide improved immune responses for prophylactic and therapeutic immunizations against HPV, see the description in the sequence alignments provided. One of ordinary skill in the art prior to the instant effective filing date would have had a reasonable expectation of success to have used the sequences of Weiner et al. as the HPV18 E6 and E7 of ‘032 because Weiner et al. teach that Geneseq accession numbers AYF71829, AYF71833, and AYF71828 are HPV18 E6 and E7 consensus sequences and ‘032 requires HPV18 and E6 and E7 in claim 1.
Claim 34 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 9, 15, 16, 19-21, and 23-25 of copending Application No. 17,221,032 (reference application) in view of instant SEQ ID NO: 7 alignment with Geneseq db access no AZL93388 by Weiner et al WO2011097640. All references of record.
Claim 15 of ‘032 requires a leader sequence, but does not recite SEQ ID NO: 7, as required.
Geneseq db access no AZL93388 by Weiner et al. shares 100% identity with instant SEQ ID NO: 7, see the alignment provided.
It would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to have used the IgE leader sequence of Geneseq db access no AZL93388 as the leader sequence of ‘032 with a reasonable expectation of success because the leader sequence of Geneseq db access no AZL93388 is useful in immunizing an individual against a pathogen in a vaccine, see the description provided in the alignment.
Claim 35 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 9, 15, 16, 19-21, and 23-25 of copending Application No. 17,221,032 (reference application) in view of Geneseq db access no AYF71830 by Weiner et al. shares 100% identity with instant SEQ ID NO: 11. All references of record.
Claim 15 of ‘032 requires a leader sequence, but does not recite SEQ ID NO: 11, as required.
Geneseq db access no AYF71830 by Weiner et al. shares 100% identity with instant SEQ ID NO: 11, see the alignment provided.
It would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to have used the IgE leader sequence of Geneseq db access no AYF71830 as the leader sequence of ‘032 with a reasonable expectation of success because the leader sequence of Geneseq db access no AYF71830 is useful in immunizing an individual against HPV in a vaccine, see the description provided in the alignment.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
In response to the rejection of record, applicant asserts that Davis does not suggest that LSIL and HSIL classification replaces the distinction between cervical and anal intraepithelial lesions. Applicant points out that anal or anal/perianal region is a distinct anatomical region from the vulvar region. A subject having an anal or anal/perianal intraepithelial lesion would not necessarily have a vulvar intraepithelial lesion, and vice versa.
Applicant’s arguments have been fully considered, but are found unpersuasive. Davis specifically teaches (Under “Taxonomy”):
The Lower Anogenital Squamous Terminology (LAST) project… unified terminology across all lower anogenital sites. For intraepithelial lesions, a two-tiered terminology-low or high (low-grade intraepithelial lesion [LSIL] and high-grade intraepithelial lesion [HSIL]) —reflects the biology of transient, productive HPV infections and persistent precancerous lesions.
Therefore, high-grade intraepithelial lesion, HSIL characterizing both pathologies in ‘032 and the instant claims pertains to the shared “biology of transient, productive HPV infections and persistent precancerous lesions”. Davis concludes, “The previously employed cervical intraepithelial neoplasia (CIN) or anal intraepithelial neoplasia (AIN) 1, 2, and 3 is abandoned in favor of this simpler classification.” Clearly, the current classification described by Davis pertains to histological pathology. The HSIL treated in the instant claims and the claims of ‘032 are identically characterized as high grade squamous intraepithelial lesions.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 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