DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examine dunder the first inventor to file provisions of the AIA .
Information Disclosure Statements
Information Disclosure Statement (IDS) filed on 12/03/2025 has been considered by the Examiner. A signed copy of the IDS is included with the present Office Action.
Claims Status
Claims 1-4, 8-11, 13-15, 17-20, 24-25 are under current examination.
Applicants' arguments/amendments filed on 11/18/2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants remarks with regards to the 112(a) and 112(b) rejections are considered moot in view of the claim amendments and withdrawal of all prior rejections. Applicants remarks with regards to the prior 102 rejections are withdrawn in view of the new rejections presented below necessitated by the claim amendments. The following rejections are newly applied in view of the claim amendments.
New rejections nictitated by amendments
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1,3-4, and 13-14 and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang et al. (WO2014144885-see IDS filed 12/03/2025).
Claim 1 requires a vaccine for inducing an immune response in a subject against one or more cancer antigens comprising a nucleic acid molecule encoding a consensus TERT antigen, wherein the nucleic acid molecule encoding the consensus TERT antigen encodes a sequence selected from: an amino acid sequence is 90% identical or more to a sequence that includes SEQ ID NO: 48.
Weiner et al. teach cancer vaccines comprising one or more nucleic acid or amino acid sequences of cancer antigens, see paragraph [0006]-[0007] and [0057] and [00284]-[00296 and [00412]-[00415]. Weiner discloses the amino acid sequence of hTERT protein is SEQ ID: NO 24 which the vaccine comprises cancer antigens hTERT, see claim 1 and [00292], [00299] and claims 1 and 23. The vaccine can comprise melanoma associated antigen MAGE 1, see paragraph [0310] or the viral antigen from Hepatitis C, see paragraphs [0006], [0070], [0354] and claims 1-2 and 24. The vaccine can comprise adjuvants including IL-12, IL-15, or IL-28, see paragraph [0409] and claims 1, 11, and 12. SEQ ID: NO: 24 is 95.9% identical to SEQ ID:NO 48 (see attached seq search for SEQ ID NO: 48 and SEQ Query Match presented below). Accordingly, Wang’s teachings anticipates the instant claims.
ALIGNMENT:
Query Match 95.9%; Score 5699; Length 1158;
Best Local Similarity 95.8%;
Matches 1084; Conservative 15; Mismatches 32; Indels 0; Gaps 0;
Qy 1 PRAPRCRAVRSLLRSRYREVLPLATFVRRLGPQGRRLVQRGDPAAFRALVAQCLVCVPWD 60
||||||||||||||| |||||||||||||||||| |||||||||||||||||||||||||
Db 19 PRAPRCRAVRSLLRSHYREVLPLATFVRRLGPQGWRLVQRGDPAAFRALVAQCLVCVPWD 78
Qy 61 ARPPPAAPSFRQVSCLKELVARVVQRLCERGARNVLAFGFALLDGARGGPPEAFTTSVRS 120
|||||||||||||||||||||||:||||||||:|||||||||||||||||||||||||||
Db 79 ARPPPAAPSFRQVSCLKELVARVLQRLCERGAKNVLAFGFALLDGARGGPPEAFTTSVRS 138
Qy 121 YLPNTVTDTLRGSGAWGLLLRRVGDDVLVHLLARCALYVLVAPSCAYQVCGPPLYDLGAA 180
|||||||| ||||||||||||||||||||||||||||:||||||||||||||||| ||||
Db 139 YLPNTVTDALRGSGAWGLLLRRVGDDVLVHLLARCALFVLVAPSCAYQVCGPPLYQLGAA 198
Qy 181 TQARPPPHASGTRRGLGTEQAWNHSVREAGVPLGLPAPGARRRRGSAGRSLPLAKRPRRG 240
||||||||||| || || |:||||||||||||||||||||||| ||| ||||| ||||||
Db 199 TQARPPPHASGPRRRLGCERAWNHSVREAGVPLGLPAPGARRRGGSASRSLPLPKRPRRG 258
Qy 241 AAPEPERTPVGQGSWAHPGRTRGPSDRGFCVVSPARPAEEATSLEGALSGTRHSHPSVGR 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 259 AAPEPERTPVGQGSWAHPGRTRGPSDRGFCVVSPARPAEEATSLEGALSGTRHSHPSVGR 318
Qy 301 QHHAGPPSTSRPPRPWDTPCPPVYAETKHFLYSSGDKEQLRPSFLLSSLRPSLTGARRLV 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 319 QHHAGPPSTSRPPRPWDTPCPPVYAETKHFLYSSGDKEQLRPSFLLSSLRPSLTGARRLV 378
Qy 361 ETIFLGSRPWMPGTPRRTPRLPQRYWQMRPLFLELLGNHAQCPYGALLRTHCPLRAAVTP 420
||||||||||||||||| ||||||||||||||||||||||||||| ||:|||||||||||
Db 379 ETIFLGSRPWMPGTPRRLPRLPQRYWQMRPLFLELLGNHAQCPYGVLLKTHCPLRAAVTP 438
Qy 421 AAGVCAREKPQGSVAAPEEEDTDPRRLVQLLRQHSSPWQVYGFLRACLRRLVPPGLWGSR 480
|||||||||||||||||||||||||||||||||||||||||||:||||||||||||||||
Db 439 AAGVCAREKPQGSVAAPEEEDTDPRRLVQLLRQHSSPWQVYGFVRACLRRLVPPGLWGSR 498
Qy 481 HNERRFLRNTKKFISLGKHAKLSLQELTWKMSVRDCAWLRRSPGVGCVPAAEHRLREEIL 540
|||||||||||||||||||||||||||||||||| |||||||||||||||||||||||||
Db 499 HNERRFLRNTKKFISLGKHAKLSLQELTWKMSVRGCAWLRRSPGVGCVPAAEHRLREEIL 558
Qy 541 AKFLHWLMSVYVVELLRSFFYVTETTFQKNYLFFYRKSVWSKLQSIGIRQHLKRVQLREL 600
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 559 AKFLHWLMSVYVVELLRSFFYVTETTFQKNYLFFYRKSVWSKLQSIGIRQHLKRVQLREL 618
Qy 601 SEAEVRQHREARPALLTSRLRFLPKPDGLRPIVNMDYVVGARTFRREKRAERLTSRVKTL 660
||||||||||||||||||||||:||||||||||||||||||||||||||||||||||| |
Db 619 SEAEVRQHREARPALLTSRLRFIPKPDGLRPIVNMDYVVGARTFRREKRAERLTSRVKAL 678
Qy 661 FSVLNYERARRPGLLGASVLGLDDIHRAWRAFVLRVRAQDPPPELYFVKVAVTGAYDTIP 720
|||||||||||||||||||||||||||||| ||||||||||||||||||| |||||||||
Db 679 FSVLNYERARRPGLLGASVLGLDDIHRAWRTFVLRVRAQDPPPELYFVKVDVTGAYDTIP 738
Qy 721 QDRLTEVIASIIKPQNTYCVRRYAVVRRAAHGHVRKSFKRHVSTLTDLQPYMRQFVAHLQ 780
||||||||||||||||||||||||||::||||||||:|| ||||||||||||||||||||
Db 739 QDRLTEVIASIIKPQNTYCVRRYAVVQKAAHGHVRKAFKSHVSTLTDLQPYMRQFVAHLQ 798
Qy 781 ETSPLRDAVVIEQSSSLNEASSGLFDVFLRFVCHHAVRIGGKSYVQCQGIPQGSILSTLL 840
|||||||||||||||||||||||||||||||:||||||| ||||||||||||||||||||
Db 799 ETSPLRDAVVIEQSSSLNEASSGLFDVFLRFMCHHAVRIRGKSYVQCQGIPQGSILSTLL 858
Qy 841 CSLCYGDMENKLFAGIRRDGLLLRLVAAFLLVTPHLTHAKAFLRTLVRGVPEYGCVVNLR 900
|||||||||||||||||||||||||| |||||||||||| |||||||||||||||||||
Db 859 CSLCYGDMENKLFAGIRRDGLLLRLVDDFLLVTPHLTHAKTFLRTLVRGVPEYGCVVNLR 918
Qy 901 KTVVNFPVEDEALGGTAFVQLPAHGLFPWCGLLLDTRTLEVQSDYSSYARTSIRASLTFN 960
||||||||||||||||||||:|||||||||||||||||||||||||||||||||||||||
Db 919 KTVVNFPVEDEALGGTAFVQMPAHGLFPWCGLLLDTRTLEVQSDYSSYARTSIRASLTFN 978
Qy 961 RGFKAGRNMRRKLFGVLRLKCHSLFLYLQVNSLQTVCTNVYKIFLLQAYRFHACVLQLPF 1020
|||||||||||||||||||||||||||||||||||||||:||| ||||||||||||||||
Db 979 RGFKAGRNMRRKLFGVLRLKCHSLFLYLQVNSLQTVCTNIYKILLLQAYRFHACVLQLPF 1038
Qy 1021 HQQVRKNPTFFLRVISDTASLCYSILKAKNAGMSLGAKGAAGPFPSEAAQWLCHQAFLLK 1080
|||| |||||||||||||||||||||||||||||||||||||| |||| |||||||||||
Db 1039 HQQVWKNPTFFLRVISDTASLCYSILKAKNAGMSLGAKGAAGPLPSEAVQWLCHQAFLLK 1098
Qy 1081 LARHRVTYRCLLGALRTAQTQLCRKLPGATLAALEAAADPALTSDFKTILD 1131
| |||||| |||:|||||||| ||||| || ||||||:||| ||||||||
Db 1099 LTRHRVTYVPLLGSLRTAQTQLSRKLPGTTLTALEAAANPALPSDFKTILD 1149
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 1-4,8-11,13-15, 17-20, and 24-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11464841.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claim 1 and claim 1 of Patent ‘841 encompass an immunogenic composition comprising a nucleic acid molecule encoding a consensus TERT antigen, wherein the nucleic acid encodes a peptide that comprises an amino acid sequence selected from the group consisting of:
a) an amino acid sequence selected from the group consisting of SEQ ID NO: 46, SEQ ID NO:48, SEQ ID NO:50, SEQ ID NO:52, SEQ ID NO:54, and SEQ ID NO:56, and
b) an amino acid sequence that is at least 96% identical to an amino acid sequence selected from the group consisting of SEQ ID NO: 46, SEQ ID NO:48, SEQ ID NO:50, SEQ ID NO:52, SEQ ID NO:54, and SEQ ID NO:56. Part c of the instant claims is not required, therefore parts a) and b) of Patent ‘841 anticipate the instantly claimed invention. Both the instant claims and that of Patent ‘841 claim: immunogenic composition wherein the immunogenic composition further comprises one or more additional nucleotide sequences encoding one or more additional amino acid sequence selected from the group consisting of
a) an amino acid sequence selected from the group consisting of: SEQ ID NO:2, SEQ ID NO:4, SEQ ID NO:6, SEQ ID NO:8, SEQ ID NO:10, SEQ ID NO:12, SEQ ID NO: 14, SEQ ID NO:16, SEQ ID NO:18, SEQ ID NO:20, SEQ ID NO:22, SEQ ID NO:24, SEQ ID NO; 58, SEQ ID NO:60, SEQ ID NO:62, SEQ ID NO:64, SEQ ID NO:66, SEQ ID NO:68, SEQ ID NO:70;
b) an amino acid sequence that is 95% identical or greater to the amino acid selected from the group consisting of: SEQ ID NO:2, SEQ ID NO:4, SEQ ID NO:6, SEQ ID NO:8, SEQ ID NO:10, SEQ ID NO:12, SEQ ID NO:14, SEQ ID NO:16, SEQ ID NO:18, SEQ ID NO:20, SEQ ID NO:22, SEQ ID NO:24, SEQ ID NO; 58, SEQ ID NO:60, SEQ ID NO:62, SEQ ID NO:64, SEQ ID NO:66, SEQ ID NO:68, SEQ ID NO:70, and
c) a fragment of an amino acid sequence selected from the group consisting of SEQ ID NO:2, SEQ ID NO:4, SEQ ID NO:6, SEQ ID NO:8, SEQ ID NO:10, SEQ ID NO:12, SEQ ID NO:14, SEQ ID NO:16, SEQ ID NO:18, SEQ ID NO:20, SEQ ID NO:22, SEQ ID NO:24, SEQ ID NO; 58, SEQ ID NO:60, SEQ ID NO:62, SEQ ID NO:64, SEQ ID NO:66, SEQ ID NO:68, SEQ ID NO:70, wherein the fragment comprises at least 95% of the full length amino acid sequence. The immunogenic composition in the instant claims and the claims of Patent ‘841 can further comprise one or more antigens selected from MAGE A1 and gp100, and a viral antigen wherein the viral antigen is selected from the group consisting of a Hepatitis B virus (HBV) antigen, a Hepatitis C virus (HCV) antigen, a Human Papilloma Virus (HPV) antigen, a HBV core antigen, a HBV surface antigen, a HCV NS34A antigen, a HCV NS5A antigen, a HCV NS5B antigen, an HCV NS4B antigen, a HPV type 6 E6 antigen, a HPV type 6 E7 antigen, a HPV type 11 E6 antigen, a HPV type 11 E7 antigen, a HPV type 16 E6 antigen, a HPV type 16 E7 antigen, a HPV type 18 E6 antigen, an HPV type 18 E7 antigen and combinations thereof. In both the instant claims and that of Patent ‘841, the method includes treatment and prevention of melanoma. Both the instant claims comprise the same nucleic acid molecules of instant claim 21 where Patent ‘841 recites parts a and b. Accordingly, the claims of Patent ‘841 are obvious embodiments of the instant claims where the fragment at part c is not required (instant claims 1 and 21 and 24).
Although the claims of Patent ‘841 do not recite a vaccine with the intended use of inducing an immune response against cancers, the immunogenic composition of the ‘841 claims is intended to be used for vaccines, see columns 45 lines 57-67 to column 46 lines 1-25. Furthermore, the composition of Patent ‘841 is used to treat cancers, see claim 11. Accordingly, Patent ‘841 renders obvious the instant claims.
Response to remarks regarding Double Patenting.
Applicants wish to hold the rejection in abeyance.
Examiner respectfully submits that a request to hold a rejection in abeyance is not a proper response to a rejection. Rather, a request to hold a matter in abeyance may only be made in response to an OBJECTION or REQUIREMENTS AS TO FORM (see MPEP 37 CFR 1.111(b) and 714.02). Thus, the double patenting rejections of record have been maintained as no action regarding these rejections has been taken by applicants at this time.
Conclusion
The amendment to the claims necessitated new ground of rejections. 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).
Currently, no claims are allowed and all claims are rejected.
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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH ALAWADI whose telephone number is (571)270-7678. The examiner can normally be reached Monday-Friday 10:00am-6:30pm EST.
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/SARAH ALAWADI/Primary Examiner, Art Unit 1619