DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Amendments
2. The amendment filed May 21, 2026 has been entered. Claim 23 has been amended. Claims 1-12 and 15-22 are cancelled. Claims 13-14 and 23-32 are under consideration in this Office Action.
Information Disclosure Statement
3. The information disclosure statement (IDS) submitted on June 19, 2026 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
New Grounds of Rejection Necessitated By Applicants Amendment
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
4. Claim 23 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 23 recites the limitation "the nucleotide" in the claim. There is insufficient antecedent basis for this limitation in the claim. Clarification is required to overcome the rejection.
Maintained Grounds of Rejection
Double Patenting
5. 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.
6. Claims 13-14 and 23-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 23 and 24 of U.S. Patent No.11,091,775. Although the claims at issue are not identical, they are not patentably distinct from each other because while the two sets of claims are not identical; they are also not patentably distinct. The instant claims are drawn to a fusion protein consisting of two Mycobacterium tuberculosis (Mtb) antigens, wherein the Mtb antigens are Rv1733 and Rv2626c, wherein Rv1733 comprises the amino acid sequence set forth in SEQ ID NO:28 or SEQ ID NO:29, and Rv2626c comprises the amino acid sequence set forth in SEQ ID NO:30 and 31.
That patented claim is drawn a recombinant rhesus cytomegalovirus (RhCMV) or human cytomegalovirus (HCMV) vector comprising a nucleic acid sequence encoding an expressible Mycobacterium tuberculosis (Mtb) antigen, wherein said Mtb antigen is a fusion protein, wherein said fusion protein is selected from the following two fusion proteins which comprise the following Mtb proteins or antigenic fragments thereof in the order listed: Rv1733-Rv2626c and Ag85A-ESAT6-Rv3407-Rv2626c-RpfA-RpfD. The patent teach SEQ ID NO: 8 aligns with instant SEQ ID NO:29. The patent teach SEQ ID NO: 10 aligns with instant SEQ ID NO:31. U.S. Patent No.11,091,775 claims 23 and 24 are drawn to a pharmaceutical composition comprising an acceptable carrier and method for eliciting an immune response to a Mtb antigen comprising administration to the subject. Therefore the claims are rejected.
Response to Arguments
7. Applicant's arguments filed May 21, 2026 have been fully considered and the rejection is maintained.
Applicants argue that the US Patent recites a recombinant rhesus cytomegalovirus (RhCMV) or human cytomegalovirus (HCMV) vector. Therefore Applicants attention is drawn to the fact that the vector comprises a nucleic acid sequence encoding an expressible Mycobacterium tuberculosis (Mtb) antigen. In this case, the instant claim 23 recites the same nucleic acid sequence which encodes the same expressible fused Mtb antigens. In the claim 13 recites the same Rv1733-Rv2626c fusion is encoded. Therefore the patented vector comprises the same nucleic acid sequence to encoded the same fusion. Thus, Applicants argument that vectors and fusion proteins are distinct products is not persuasive when this specific vector comprises same the nucleic acid sequences which encode the same fusion protein.
Applicants point to the restriction dated November 29, 2024 requiring the restriction between the two products. However, the instant claims no longer distinguish between nucleic acid sequences comprised within vectors and the fusion proteins. Applicants amended their claims to comingle the products. In fact, the Restriction dated Nov. 24, 2026 grouped together the host cell and vector comprising the nucleic acid encoding the fusion protein. See Group IV. Moreover, the original restriction is further distinguished because elected Group II and non-elected Group IV did not recite any of the same Mtb antigens separately or as a fusion. Therefore, this argument is not persuasive.
Finally, US Patented claim 1 clearly recites the Rv1733-Rc2626c fusion; therefore the instant claims are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No.11,091,775 because the patent recites the Rv1733-Rv2626c fusion protein. None of Applicants arguments prove the US Patent and the instant claims do not recite overlapping subject matter.
Pertinent Art
8. The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure.
Hone et al., (US20090304750) teach a TB vaccine can include attenuated Mycobacterium strains that over express at least one Mycobacterium antigen, including Rv1733c, Rv2626c and/or other antigens. The over expressed Mycobacterium antigens can be in the form of a fusion protein comprised of one or more said Mycobacterium fusion proteins.
Spencer et al., (WO 2011045612) describe a fusion protein wherein the second domain comprises a mycobacterial antigen selected from Rv1733c, Rv2029c, Rv2032, Rv2626c, Rv2627c, Rv2628, Rv01 1 1 , Rv1806/1807, Rv0198, or Rv3812 or an antigenic fragment thereof.
Conclusion
9. No claims allowed.
10. 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.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JA-NA A HINES whose telephone number is (571)272-0859. The examiner can normally be reached Monday thru Thursday.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor Peter Paras, can be reached on 571-272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JANA A HINES/Primary Examiner, Art Unit 1645
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