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 .
DETAILED ACTION
Priority
This application is a continuation application of U.S. Patent Application No. 18/067,565, filed December 16, 2022, which is a continuation application of U.S. Patent Application No. 17/070,334, filed October 14, 2020, now U.S. Patent No. 11,560,409, which is a division of U.S. Patent Application No. 16/231,294, filed December 21, 2018, now US Patent No. 10,836,797, issued November 17, 2020, which is a continuation of U.S. Patent Application No. 15/833,365, filed December 6, 2017, now U.S. Patent No. 10,196,427, which is a continuation of U.S. Patent Application No. 14/398,084, filed on October 30, 2014, now U.S. Patent No. 9,884,893, which is a U.S. National Stage Entry of International Application No. PCT/US2013/042098, filed May 21, 2013, which claims the benefit to U.S. Provisional Application 61/649,392, filed May 21, 2012 and U.S. Provisional Application 61/801,135, filed March 15, 2013 that is hereby acknowledged by the Examiner.
Status of the Claims
The amendment dated 01/24/2025 is acknowledged. Claims 33-47 are pending and under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/23/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) is/are being considered by the Examiner.
Drawings
The drawing filed on 06/10/2024 are acknowledged and accepted by the Examiner.
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 Langi, 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
on line using web-screens. An eTerminal Disclaimer that meets all requirements is autoprocessed
and approved immediately upon submission. For more information about eTerminal
Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 33-47 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12043647. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are coextensive in scope and species with one another.
The claims are directed to a nucleic acid vaccine for eliciting an immune response in a subject, the nucleic acid vaccine comprising one or more nucleic acids that collectively encode at least six different antigens that each comprise a common target epitope, and wherein, upon administration of the vaccine, each individual antigen of the at least six different antigens is expressed at a level that if administered alone at the level of the individual antigen would elicit a weaker immune response to the common target epitope than the nucleic acid vaccine comprising the one or more nucleic acids that collectively encode at least six different antigens.
The patented claims are directed to:
1. A nucleic acid vaccine for eliciting an immune response in a subject, the nucleic acid vaccine comprising one or more nucleic acids that collectively encode at least six different antigens that each comprise a common target epitope, and wherein, upon administration of the vaccine, each individual antigen of the at least six different antigens is expressed at a level that alone is insufficient to elicit an immune response (instant claim 33).
2. The nucleic acid vaccine of claim 1, wherein the at least six different antigens are viral antigens (instant claim 34).
3. A method for treating or reducing the likelihood of a disease in a human subject in need thereof, the method comprising administering the nucleic acid vaccine of claim 1 to the human subject, whereby the disease or the likelihood of disease is treated (instant claim 35).
4. The method of claim 3, wherein the disease is an infectious disease, an autoimmune disease, an inflammatory disease, a neurological disease, an addiction, a cardiovascular disease, an endocrine disease, or a cancer (instant claim 36).
5. The method of claim 3, wherein each antigen of the at least six antigens is selected from the group consisting of Pneumococcal antigens, tuberculosis antigens, anthrax antigens, Human Immunodeficiency Virus (HIV) antigens, influenzae antigens, Pertussis antigens, Staphylococcus aureus antigens, Meningococcal antigens, Haemophilus antigens, Human Papillomavirus (HPV) antigens, and combinations thereof (instant claim 37).
6. The method of claim 3, wherein each antigen of the at least six antigens is a protein (instant claim 38).
7. The method of claim 3, further comprising administering to the subject an agent selected from the group consisting of a B-cell targeting moiety, a T-cell targeting moiety, an anti-viral agent, a chemotherapeutic agent, a toxin, an immunostimulatory agent, an adjuvant, and a hapten (instant claim 39).
8. The method of claim 3, wherein each antigen of the at least six antigens is a bacterial protein (instant claim 40).
9. The method of claim 3, wherein each antigen of the at least six antigens comprises an influenzae antigen (instant claim 41).
10. The method of claim 9, wherein each influenzae antigen is a seasonal flu antigen (instant claim 42).
11. The method of claim 9, wherein each influenzae antigen is an epidemic flu antigen (instant claim 43).
12. The method of claim 3, wherein the disease comprises influenza (instant claim 44).
13. The method of claim 3, wherein the common target epitope has at least 90% identity across each of the at least six antigens (instant claim 45).
14. The method of claim 13, wherein each antigen of the at least six antigens shares at most 85% sequence identity outside of the common target epitope (instant claim 46).
15. The method of claim 3, wherein the common target epitope is a portion of an influenza virus hemagglutinin (HA) protein (instant claim 47).
There is no patentable difference between the claimed composition and the patented composition in that the U.S. Patent No. 12043647 discloses a nucleic acid vaccine for eliciting an immune response in a subject, the nucleic acid vaccine comprising one or more nucleic acids that collectively encode at least six different antigens that each comprise a common target epitope, and wherein, upon administration of the vaccine, each individual antigen of the at least six different antigens is expressed at a level that if administered alone at the level of the individual antigen would elicit a weaker immune response to the common target epitope than the nucleic acid vaccine comprising the one or more nucleic acids that collectively encode at least six different antigens. The MPEP states “where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Barry Chestnut whose telephone number is (571)270-3546. The examiner can normally be reached on M-Th 8:00 to 4:00.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Visone can be reached on 571-270-0684. 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.
/BARRY A CHESTNUT/Primary Examiner, Art Unit 1672
Prosecution Insights