DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicant’s election without traverse of invention I in the reply filed on 12/6/2024 is acknowledged.
Claims 47-52, 58 and 59 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 4/1/2022.
Claims 42-46 and 54-57 are examined on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 9/15/25 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Allowable Subject Matter
Claims 54-57 are allowed.
Claim Objections
Claim 43 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 —
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
(New Rejection Necessitated by Amendments) Claims 42 and 44-46 are rejected under pre-AIA 35 U.S.C. 102b as being anticipated by Blaney et al. (US PGPub 2014/0212434).
The claimed composition comprising a nucleic acid sequence (a DNA plasmid or an RNA sequence) that encodes a fragment of an amino acid sequence that is at least 95% identical to SEQ ID NO:2. The nucleic acid molecule is a plasmid that comprises a promoter operably linked to the nucleic acid.
Blaney et al. teach ebola virus nucleic acid and amino acid sequences and the use of vectors (recombinant rabies virus) for expressing the DNA sequence which encode these amino acid sequences in a cell. [see plasmids 46 and 48] Blaney et al. also teach that RNA or DNA molecules can comprise the sequence for the ebola virus glycoprotein. [see paragraph 104] In addition, the plasmids employed by Blaney et al. would inherently possess promoters operably linked to inserted ebolavirus GP sequences. [see paragraph 138] Specific examples of the ebolavirus GP amino acid sequences SEQ ID NO: 2, which is 99.6% identical to SEQ ID NO: 2 of the instant invention. Therefore, Blaney et al. anticipate the instant invention.
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 §§ 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/patent/patents-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 www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
(Prior rejections maintained)
Claims 42 and 44-46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 and 14 of U.S. Patent No. 9597388 in view of Grogan et al. (US PGPub 2003/0108560). Although the claims at issue are not identical, they are not patentably distinct from each other because the patented invention and the instant invention both claim plasmid based compositions which possess obvious combinations of ebola and marburg virus sequences (SEQ ID NO:s 1-6), which are identical. In addition, Grogan et al. teach ebola virus nucleic acid and amino acid sequences and the use of vectors/plasmids for expressing the DNA sequence which encode these amino acid sequences in a cell. [see plasmids 46 and 48] Grogan et al. also teach that RNA molecules, such VEE replicons, which possess RNA sequences, can encode Ebola virus GPs. [see paragraphs 46-47 and 69-71] In addition, promoters can be operably linked to the nucleic acid sequences. [see paragraph 48] Specific examples of the nucleic acid and amino acid sequences, respectively, are SEQ ID NO: 11 and 12. SEQ ID NO: 12 is 98.8% identical to SEQ ID NO: 1 of the instant invention. Therefore, the patented inventions in view of Grogan et al. renders obvious the instant invention.
Claims 42 and 44-46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 10765733 in view of Grogan et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other because the patented invention and the instant invention both claim plasmid based compositions which possess obvious combinations of ebola and marburg virus sequences (SEQ ID NO:s 1-6), which are identical. In addition, the teachings of Grogan et al. summarized above render obvious the specific use of RNA or DNA sequences, which would possess promoters operably linked to the glycoprotein specific sequences that encode for SEQ ID NO:s 1-6 of the instant invention. Therefore, the patented inventions in view of Grogan et al. renders obvious the instant invention.
Claims 42 and 44-46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 and 14 of U.S. Patent No. 10034930 in view of Grogan et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other because the patented invention and the instant invention both claim plasmid based compositions which possess obvious combinations of ebola and marburg virus sequences (SEQ ID NO:s 1-6), which are identical. In addition, the teachings of Grogan et al. summarized above render obvious the specific use of RNA or DNA sequences, which would possess promoters operably linked to the glycoprotein specific sequences that encode for SEQ ID NO:s 1-6 of the instant invention. Therefore, the patented inventions in view of Grogan et al. renders obvious the instant invention.
Claims 42 and 44-46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 and 11 of U.S. Patent No. 11723969 in view of Grogan et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other because the patented invention and the instant invention both claim plasmid based compositions which possess obvious combinations of ebola and marburg virus sequences (SEQ ID NO:s 4-6), which are identical. In addition, the teachings of Grogan et al. summarized above render obvious the specific use of RNA or DNA sequences, which would possess promoters operably linked to the glycoprotein specific sequences that encode for SEQ ID NO:s 4-6 of the instant invention. Therefore, the patented inventions in view of Grogan et al. renders obvious the instant invention.
Conclusion
No claims are allowed.
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 BENJAMIN P. BLUMEL whose telephone number is (571)272-
4960. The examiner can normally be reached on M-F, 8-5.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Janet Andres can be reached on 571-272-0867. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BENJAMIN P BLUMEL/
Primary Examiner, Art Unit 1671