DETAILED ACTION
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 .
Applicant’s amendment filed on December 3, in response to the Office action on November 19, 2025 is acknowledged. Claims 1 and 4 are pending and under examination in this Office action.
Claim Rejections - 35 USC § 112
Rejection of Claims 1 and 4 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in view of Applicant’s amendment.
Claim Rejections - 35 USC § 102
Rejection of Claims 1 and 4 under 35 U.S.C. 102(a)(2) as being anticipated by Smith (US Patent Application Publication US 2015/0328305) is withdrawn in view of Applicant’s amendment.
Claim Rejections - 35 USC § 103
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, 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.
Claims 1 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Smith (US Patent Application Publication US 2015/0328305) in view of Apostolico et al. (Frontiers in Immunology, 2019, p. 1-12).
Smith in view of Apostolico render the present claims obvious because Smith teaches a method of treating a viral outbreak and/or pandemic comprising vaccinating individuals with a liposomal vaccine comprising multiple immunostimulatory agents incorporated into a liposome, wherein the agents are poly IC, poly ICLC, ssRNA, CpG-ODN, and MPL-A (see claims 1-19), paragraphs [0014], [0017], [0018], [0039-0042] and [0063]). Smith disclose an antigen from a virus that causes a pandemic such as an influenza virus (see paragraphs [0057-0062]). Smith discloses a booster/second injection of the vaccine (see claims 1-5 and paragraph [0019]). Smith discloses alum adjuvant (see paragraph [0015]).
Apostolico teaches that poly IC, poly ICLC, ssRNA, CpG-ODN, and MPL-A potentiate T cell immunity in an antigen independent manner, including triggering of the costimulatory molecules to induce type I IFN production by dendritic cells (see Introduction).
It would have been prima facie obvious to use poly IC, poly ICLC, ssRNA, CpG-ODN, and MPL-A, alone without the viral antigen, in a method of preventing a viral outbreak, because Smith and Apostolico teach that poly IC, poly ICLC, ssRNA, CpG-ODN, and MPL-A potentiate T cell immunity in an antigen independent manner, including triggering of the costimulatory molecules to induce type I IFN production by dendritic cells.
Applicant amended the claims to recite a closed language with regard to the immune stimulatory molecules. The skilled artisan would have been motivated to choose the four immune stimulatory molecules because they all have been known to act as adjuvants in vaccines. Applicant did not provide any unexpected results showing that poly IC, poly ICLC, ssRNA, CpG-ODN, and MPL-A together have any synergistic effect when compared to a different combination of molecules.
One would have been motivated to use poly IC, poly ICLC, ssRNA, CpG-ODN, and MPL-A, alone without the viral antigen, because it has been well known in the prior art that poly IC, poly ICLC, ssRNA, CpG-ODN, and MPL-A, stimulate the immune response without the need of the antigen being present.
Thus, the present invention would have been prima facie obvious at the time the invention was made.
Double Patenting
Rejection of Claims 1 and 4 on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of U.S. Patent No.11,590,078 is withdrawn in view of Applicant’s amendment and arguments.
Contact Information
THIS ACTION IS MADE FINAL. 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 extension fee 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 AGNIESZKA BOESEN whose telephone number is (571)272-8035. The examiner can normally be reached on 8:30 - 5:00 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
/AGNIESZKA BOESEN/Primary Examiner, Art Unit 1648