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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 Apr. 10, 2026 has been entered.
DETAILED ACTION
Acknowledgement is hereby made of receipt and entry of the communication filed on Apr. 10, 2026. Claims 10-22 are pending and currently examined.
Sequence Analysis
Alignment between SEQ ID NO: 20 and a simple direct fusion construct of HPV52 E6 and E7 antigens (52E6E7) is shown below:
Score
Expect
Method
Identities
Positives
Gaps
Frame
446 bits(1147)
1e-165()
Compositional matrix adjust.
225/251(90%)
229/251(91%)
15/251(5%)
SEQ20 19 FEDPATSGRTLHELCEVLEESVHEIRLQCVQCKKELQRREVYK---TDLRIVYRDNNPYG 75
FEDPAT RTLHELCEVLEESVHEIRLQCVQCKKELQRREVYK TDLRIVYRDNNPYG
52E6E7 2 FEDPATRPRTLHELCEVLEESVHEIRLQCVQCKKELQRREVYKFLFTDLRIVYRDNNPYG 61
Query 76 VCIMCLRFLSKISEYRHYQYSLYGKTLEERVRKPLSEITIRCIICQTPL-----ERHVNA 130
VCIMCLRFLSKISEYRHYQYSLYGKTLEERV++PLSEITIRCIICQTPL ERHVNA
Sbjct 62 VCIMCLRFLSKISEYRHYQYSLYGKTLEERVKRPLSEITIRCIICQTPLCPEEKERHVNA 121
Query 131 NKRFHNIMGRWTGRCSECWRPRPVTQVRGRKRRSRGDKATIKDYILDLQPETTDLHGYGQ 190
NKRFHNIMGRWTGRCSECWRPRPVTQV RGDKATIKDYILDLQPETTDLH Y Q
Sbjct 122 NKRFHNIMGRWTGRCSECWRPRPVTQV-------RGDKATIKDYILDLQPETTDLHCYEQ 174
Query 191 LGDSSDEEDTDGVDRPDGQAEQATSNYYIVTYCHSCDSTLRLCIHSTATDLRTLQQMLLG 250
LGDSSDEED DGVDRPDGQAEQAT NYYIVT C+SC+STLRLCIHSTATDLRTLQQMLLG
Sbjct 175 LGDSSDEEDIDGVDRPDGQAEQATDNYYIVTDCYSCNSTLRLCIHSTATDLRTLQQMLLG 234
Query 251 TLQVVCPGCAR 261
TLQVVCPGCAR
Sbjct 235 TLQVVCPGCAR 245
SEQ ID NO: 20 presents a fusion protein containing four parts: 1) a 18-aa IgE leader peptide sequence (MDWTWILFLVAAATRVHS), 2) a mutated HPV52 E6 sequence (underlined), 3) an endoproteolytic cleavage site (RGRKRRS), and 4) a mutated HPV52 E7 sequence (Italic).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
(Previous Rejection – Withdrawn) Claims 10-21 were rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Cassetti et al. (US 2007/0275003 A1, published on Nov. 29, 2007) in view of GenBank: ABQ44353.1 (E6 protein [human papillomavirus 52]. Dated May 21, 2007) and GenBank: AEI61551.1 (E7 Protein [human papillomavirus 52]. Dated Jun. 27, 2011), and further in view of Yan et al. (Vaccine. 2009 January 14; 27(3): 431–440).
This rejection is withdrawn in view of the amendment filed on Apr. 10, 2026.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/forms/. The 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
(Previous Rejection – Maintained) Claims 10-22 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 2, 4-10, 12, and 16-22 of US 10232030 B2.
Although the conflicting claims are not identical, they are not patentably distinct from each other. The instant claims are directed to a fusion HPV52 E6E7 antigen comprising a sequence at least 98% identical to a fragment of at least 244 amino acids of SEQ ID NO: 20. The patented claims are directed to a composition that comprises a nucleic acid sequence encoding an HPV E6E7 fusion antigen at least 95% identical to SEQ ID NO: 20. Since a peptide sequence is obvious over a nucleic acid sequence encoding it, the instant claims which are directed to an HPV52 E6E7 fusion antigen involving SEQ ID NO: 20 is obvious over that nucleic acid encoding SEQ ID NO: 20 recited in claims 2, 4-10, 12, and 16-22 of US 10232030 B2.
Therefore, claims 10-22 are obvious over claims 2, 4-10, 12, and 16-22 of US 10232030 B2.
(Previous Rejection – Maintained) Claims 10-22 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-20 of US 10905755 B2.
Although the conflicting claims are not identical, they are not patentably distinct from each other. The instant claims are directed to a fusion HPV52 E6E7 antigen comprising a sequence at least 98% identical to a fragment of at least 244 amino acids of SEQ ID NO: 20. The patented claims are directed to a composition that encompasses a nucleic acid sequence encoding an HPV E6E7 fusion antigen at least 98% identical to SEQ ID NO: 20. Since a peptide sequence is obvious over a nucleic acid sequence encoding it, the instant claims which are directed to an HPV52 E6E7 fusion antigen involving SEQ ID NO: 20 is obvious over that nucleic acid encoding SEQ ID NO: 20 recited in claims 1-20 of US 10905755 B2.
Therefore, claims 10-22 are obvious over claims 1-20 of US 10905755 B2.
Response to Applicant’s Arguments
Applicant’s arguments filed on Apr. 10, 2026 have been fully considered and are addressed as follows.
To the obviousness double patenting rejections, Applicant requests that the rejections be held in abeyance until the claims are allowed. The rejections are, thus, maintained.
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 on Monday - Friday, 8:30 am - 5:00 pm, EST. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MICHAEL ALLEN on (571) 270-3497, can be reached. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NIANXIANG ZOU/ Primary Examiner, Art Unit 1671
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