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
Election Restrictions
1. Applicant’s election without traverse of Group II in the reply filed on 10/13/2025 is acknowledged.
Claims 1-11, 19-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim.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 10/13/2025.
Claims 12-18 are under consideration.
Information Disclosure Statement
2. The information disclosure statements (IDS) were submitted on 12/5/2022; 9/4/2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
3. The instant specification refers to drawings in colors green, red and blue (p. 4). Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Specification
4. The disclosure is objected to because of the following informalities:
The use of the trademarked terms has been noted in this specification on page 44. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Appropriate correction is required.
Claim Objections
5. Claim 12 is objected to because of the following informalities: For internal consistency among the claims, claim 12 should recite “SARS-CoV-2”. Appropriate correction is required.
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.
6. Claims 12-18 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
See claims 12-18 as submitted 12/5/2022.
As to claim 12, the claim depends on claim 10, which depends on claim 9, which depends on claim 1. It is noted that claims 10, 9 recite Sindbis virus (“Sindbis viruses”) but claim 1 only recites Alphavirus. The claim dependency is unclear as alphavirus reads on a Sindbis virus, yet the plural of Sindbis virus (Sindbis viruses as recited in claims 9, 10), as well as “Sindbis virus” are not recited in claim 1.
Further as to claim 13, the claim recites the limitation "the at least one immunomodulatory protein". There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
7. Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Rappuoli et al. (US20060257852)(cited in applicant’s IDS submitted 12/5/2022) in view of Wu et al. (“A new coronavirus associated with human respiratory disease in China,” Nature, Vol. 579: 265-269 (2020))(See PTO-892: Notice of References Cited).
See claim 12 as submitted 12/5/2022.
See also the 35 U.S.C. 112(b) rejection above.
Rappuoli et al. teaches: nucleic acids and proteins from the SARS coronavirus (abstract); used in the preparation and manufacture of vaccine formulations and methods for treating SARS (abstract); preparing SARS spike protein subunit vaccine [0660]; including use of DNA expression cassette encoding SARS virus S protein [0661]; using including replication-incompetent virus-based expression vector (alphavirus vector) encoding SARS virus S protein [0661](as recited in claims 1, 9); alphavirus particle [0772](as recited in claim 1); wherein Sindbis virus is prototype virus for studying alphavirus [0763]; using gene based delivery systems derived from alphaviruses for in vivo administration of heterologous genes including one or more SARS genes having therapeutic or prophylactic applications [0762](as recited in claim 12); pharmaceutical composition [0957](as recited in claim 10); multiple doses of antigen [1532](interpreted to also read upon or render obvious a plurality as recited in claim 9) .
Rappuoli et al. does not teach SARS-CoV-2.
Wu et al. teaches: RNA virus strain 2019-nCoV (also known in the art as SARS-CoV-2)(abstract); spike protein for the virus genome (p. 270).
One of ordinary skill in the art would have been motivated to use strain as taught by Wu et al. in composition as taught by Rappuoli et al. Rappuoli et al. teaches use of SARS-CoV and spike protein, and Wu et al., which also teaches SARS-CoV, teaches a known strain of SARS-CoV, SARS-CoV-2, as well as such a protein (See MPEP 2144.06: Substituting equivalents known for the same purpose).
One of ordinary skill in the art would have had a reasonable expectation of success for using strain as taught by Wu et al. in composition as taught by Rappuoli et al. There would have been a reasonable expectation of success given the underlying materials (spike proteins of SARS-CoV as taught by Rappuoli et al. and Wu et al.) and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
8. Claims 13-18 are rejected under 35 U.S.C. 103 as being unpatentable over Rappuoli et al. as applied to claim 12 above, and further in view of Scherwitzl et al. (“Sindbis Virus with Anti-OX40 Overcomes the Immunosuppressive Tumor Microenvironment of Low-Immunogenic Tumors,” Molecular Therapy Oncolytics, Vol. 17: 431-447 (2020))(cited in applicant’s IDS submitted 12/5/2022).
See claims 13-18 as submitted 12/5/2022.
See also the 35 U.S.C. 112(b) rejection above.
See the teachings of Rappuoli et al. in view of Wu et al. above. It is reiterated that Rappuoli et al. teaches: wherein Sindbis virus is prototype virus for studying alphavirus [0763].
Rappuoli et al. in view of Wu et al. does not teach: IL-12 (as recited in claims 13-15); anti-OX40 antibody (as recited in claim 16).
Scherwitzl et al. teaches: administration of replication deficient Sindbis virus vector (p. 431); as well as interleukin-12; with anti-OX40 (p. 431); wherein OX40 is a co-stimulatory receptor expressed on activated T cells (p. 431); wherein OX40 stimulation prolongs survival of effector T cells and enhances T cell activation (p. 431); as well as combining vector with anti-OX40 antibody (Figure 2).
One of ordinary skill in the art would have been motivated to administer IL-12 and anti-OX40, including separately and not encoded by vector (as recited in claim 16), as taught by Scherwitzl et al. with the vector as taught by Rappuoli et al. in view of Wu et al. Rappuoli et al. in view of Wu et al. teaches administration of Sindbis virus vector, and Scherwitzl et al., which also teaches administration of Sindbis virus vector, teaches the advantage of administering with IL-12 and anti-OX40 for enhancing T cell activation.
As to claims 17, 18, the wherein clauses are considered to flow from the compositions and steps as recited in claims 15, 16 (see also MPEP 2111.04: The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. See, e.g., Griffin v. Bertina, 283 F.3d 1029, 1034, 62 USPQ2d 1431 (Fed. Cir. 2002) (finding that a wherein clause limited a process claim where the clause gave meaning and purpose to the manipulative steps ); In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a whereby clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention. Id. However, the court noted that a whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited. Id. (quoting Minton v. Nat l Ass n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)).
One of ordinary skill in the art would have had a reasonable expectation of success for administering IL-12 and anti-OX40 as taught by Scherwitzl et al. with the vector as taught by Rappuoli et al. in view of Wu et al. There would have been a reasonable expectation of success given the underlying materials (administering Sindbis vector as taught by Rappuoli et al. and Wu et al. and Scherwitzl et al.) and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Conclusion
9. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to M FRANCO G SALVOZA whose telephone number is (571)272-4468. The examiner can normally be reached M-F 8:00 to 5:00.
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/M FRANCO G SALVOZA/Primary Examiner, Art Unit 1672