DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Claims 1-16 are pending upon entry of amendment filed on 9/6/23.
Claims 1-16 are under consideration in the instant application.
3. Applicant’s IDS filed on 9/6/23 and 3/12/26 have been acknowledged.
4. The oaths filed on 1/25/24 have been acknowledged.
5. The mark up or clean copy of the specification filed on 2/15/24 is entered.
6. 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.
7. Claims 1, 3-16 are 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 pre-AIA the applicant regards as the invention.
The use of the terms “preferably” , “preferably of”, “more particularly”, “in particular”, “such as”, “in such a way”, “preferentially” or “most preferably” in claims 1, 3-16, respectively, renders the claim indefinite because it is unclear whether the limitations following such terms or phrases are part of the claimed invention. See MPEP 2173.05 (h).
Further, claims 4 and 16 is missing a conjunction between items (c) and (d) and claim 4 uses improper Markush Group. Appropriate correction.
8. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
9. 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 of this title, 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
10. Claims 1-16 are rejected under 35 U.S.C. 103(a) as being unpatentable over U.S. Pub. 2020/0121776 in view of U.S. Pat 10,238,741 and Hoang et al (Plos One, vol. 8, issue 12, p. 1-12, 2013).
The ‘776 publication reaches lentiviral vectors comprising Pb antigens (Fig 1) that readable upon antigenic peptide of a pathogen. Further, the ‘776 publication teaches the lentiviral vector comprising at least 3 antigens ([0009]) or upto 8 antigens at any order including CD8 or CD4 epitopes ([0014, 52, 159], SEQ ID NO88-94). In addition, the lentiviral vector encoding protein of interest is transfected in mammalian cells including 293T (host cells), making stable cell lines in vector comprising HIV-gag-pol in DNAflap (p. 9-10, 13 [155]) and claim 16 is included.
In addition, the ‘776 publication teaches formulation comprising lentiviral vector encoding antigenic compound (claims 42-62). The nucleotides encoding antigen and host cells are disclosed, claims 6-10 are included in this rejection and the formulation comprising lentiviral vector treats infections ([0049]).
Given that the prior art lentiviral vector components of DNAflap including SV40, SV40bGHpolyA, WPRE, b2m promoters of cPPT/CTS, U3, U5, GFP and XhoI/BamHI site (Fig. 11, 21, [121-157], p. 11-13) are identical to pFlap-Sp1beta2m-GFP-WPREm of Fig14 of the instant application readable upon claimed SEQ ID NO:21, claims 5-6 are included in this rejection. The lentiviral vectors utilizes V-SVG or New Jersey serotype ([0034]).
The disclosure of the ‘776 publication differs from the instant claimed invention in that it does not teach the use of MHC-II associated chain set forth in SEQ ID NO:13 and MTb antigenic combinations of EsxH as in claims 1 and 4 of the instant application.
The ‘741 patent teaches the use of MHC-II targeting sequences (note claimed SEQ ID NO:13 is identical to the prior art SEQ ID NO:2) in retroviral vectors including lentiviral vectors (col. 39) and addition of adjuvant of poly(lactide-co-glycolide) derivative (col. 15, 43). The MHC-II targeting epitopes improve antigenicity and targeting (col. 27).
Likewise, Hoang et al. teach EsxH-Ag85A constructs in tuberculosis vaccination and ESAT6 vaccination allows DDA/MPL adjuvants (p. 13). Mtb is a major threat and EsxH vaccines remain unique in prevention and treatment of tuberculosis infection (p. 8).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize MHC-II targeting epitope and ESAT Mtb peptides as in the ‘741 patent and Hoang reference in to the lentiviral vector delivery system taught by the ‘776 publication.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because the utilization of MHC-II targeting peptide helps to induce antigenic effect and the Mtb antigenic peptides are known to optimize in treatment of tuberculosis and the lentiviral vectors are known to improve delivery of protein of interest and the expression.
From the teachings of references, it would have been obvious to one of ordinary skill in art to combine the teachings of the references and there would have been a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of the ordinary in the art at the time of invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
11. 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.
12. Claims 1-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Application No. 18/030102.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘102 application recites recombinant lentiviral vectors comprising MHC-II and antigenic peptide. Given that the SEQ ID NO:21 is identical, the vector comprises the fusion of the MHC II and antigenic peptide. Further, the antigenic peptide include EsxH.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
13. No claims are allowable.
14. Any inquiry concerning this communication or earlier communications from the examiner should be directed to YUNSOO KIM whose telephone number is (571)272-3176. The examiner can normally be reached Mon-Fri 8:30-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached at 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Yunsoo Kim
Patent Examiner
Technology Center 1600
August 10, 2026
/YUNSOO KIM/Primary Examiner, Art Unit 1641
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