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
1. Claims 1-8, 12, 13, 15, 16, 18-21, 34, 107, 109, 110, 113, 114 are under consideration.
Information Disclosure Statement
2. The information disclosure statements (IDS) were submitted on 11/8/2024; 5/13/2025; 12/30/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
3. Claims 1-8, 15, 16, 18-21, 34, 107, 109, 110, 113, 114 are rejected under 35 U.S.C. 103 as being unpatentable over Campbell et al. (WO2021183540A1)(See PTO-892: Notice of References Cited) in view of Fearon et al. (WO02052002A2)(See PTO-892: Notice of References Cited).
See claims 1-8, 15, 16, 18-21, 34, 107, 109, 110, 113, 114 as submitted 5/13/2025.
Campbell et al. teaches: immunogenic compositions comprising VZV glycoprotein E antigen (abstract); for administration [0053](as recited in claim 1); oligonucleotide with CpG [0053] (as recited in claim 1); truncated gE [0038; claim 9](as recited in claim 1); first and second doses [0010](as recited in claim 1); aluminum salt [0049](as recited in claims 15, 16).
As to amounts of CpG including 1500 µg; 6000 µg [0036](as recited in claims 2-8, 107, 109, 110); about 10-100 µg antigen [0041](as recited in claims 2-8, 107, 109, 110); Al3+ , 0.3-0.4 mg [0049](as recited in claims 18, 19, 20, 21, 113, 114), such teachings or suggestions are considered to render the concentrations obvious to one of ordinary skill in the art in view of Campbell et al. (See MPEP 2144.05: I. OVERLAPPING, APPROACHING, AND SIMILAR RANGES, AMOUNTS, AND PROPORTIONS: In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In reWertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In reWoodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)); … Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of Americav.Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of “having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium” as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. “The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties.”) … "[A] prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness." In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003); … See MPEP 2144.05: II. ROUTINE OPTIMIZATION: A.Optimization Within Prior Art Conditions or Through Routine Experimentation: Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. [W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
Campbell et al. does not teach: SEQ ID NO: 1 (as recited in claims 1, 6, 107).
Fearon et al. teaches: immunomodulatory nucleotide for modulating immune response in subject suffering from infectious disease; including SEQ ID NO: 2, which has 100% identity with instant SEQ ID NO: 1 (See Result 3 of STIC Sequence Search Result 20260824_192349_us-18-723-407-1.rng in Supplemental Content Tab); with viral antigen (p. 36).
One of ordinary skill in the art would have been motivated to use sequence as taught by Fearon et al. with the composition as taught by Campbell et al. Campbell et al. teaches using immunostimulatory sequence with viral antigen, and Fearon et al., which also teaches use of viral antigen, teaches such a sequence (See MPEP 2144.06: Substituting equivalents known for the same purpose).
As to amounts and dose timing as recited in claim 1, such a recitation is considered to be that determined by routine optimization to one of ordinary skill in the art in view of Campbell et al. in view of Fearon et al. (See MPEP 2144.05: II. ROUTINE OPTIMIZATION: A.Optimization Within Prior Art Conditions or Through Routine Experimentation: Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. [W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
One of ordinary skill in the art would have had a reasonable expectation of success for using sequence as taught by Fearon et al. with the composition as taught by Campbell et al. There would have been a reasonable expectation of success given the underlying materials (immunostimulatory oligonucleotides as taught by Campbell et al. and Fearon 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.
4. Claims 12, 13 are rejected under 35 U.S.C. 103 as being unpatentable over Campbell et al. in view of Fearon et al. as applied to claims 1-8, 15, 16, 18-21, 34, 107, 109, 110, 113, 114 above, and further in view of Hanon et al. (WO2006094756)(See PTO-892: Notice of References Cited).
See claims 12, 13 as submitted 5/13/2025.
See the teachings of Campbell et al. in view of Fearon et al. above.
Campbell et al. in view of Fearon et al. does not teach: SEQ ID NO: 4.
Hanon et al. teaches: VZV gE (abstract); including SEQ ID NO: 1, which has 100% identity with instant SEQ ID NO: 4 (See Result 1 of STIC Sequence Search Result 20260824_192349_us-18-723-407-4.rag in Supplemental Content Tab).
One of ordinary skill in the art would have been motivated to use antigen as taught by Hanon et al. with the composition as taught by Campbell et al. in view of Fearon et al. Campbell et al. in view of Fearon et al. teaches use of gE antigen, and Hanon et al. teaches such an antigen (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 antigen as taught by Hanon et al. with the composition as taught by Campbell et al. in view of Fearon et al. There would have been a reasonable expectation of success given the underlying materials (VZV gE antigens as taught by Campbell et al. and Fearon et al. and Hanon 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.
5. Claims 1, 15 are rejected under 35 U.S.C. 103 as being unpatentable over Bollen et al. (WO0043527A1)(See PTO-892: Notice of References Cited) in view of Fearon et al. (WO02052002A2)(cited above).
See claims 1, 15 as submitted 5/13/2025.
Bollen et al. teaches: Varicella-Zoster Virus vaccines (title); administration (p. 4); including gE (abstract)(as recited in claim 1); with adjuvants such as CpG oligonucleotides (p. 5)(as recited in claim 1); truncated gE (p. 7)(as recited in claim 1); including from 1-1000 µg (p. 4); aluminum salt adjuvant (p. 5)(as recited in claim 15); initial dose and booster (p. 4)(as recited in claim 1).
Bollen et al. does not teach: SEQ ID NO: 1 (as recited in claim 1).
See the teachings of Fearon et al. above.
One of ordinary skill in the art would have been motivated to use sequence as taught by Fearon et al. with the composition as taught by Bollen et al. Bollen et al. teaches using oligonucleotide sequence with viral antigen, and Fearon et al., which also teaches use of viral antigen, teaches such a sequence (See MPEP 2144.06: Substituting equivalents known for the same purpose).
As to amounts and dose timing as recited in claim 1, such a recitation is considered to be that determined by routine optimization to one of ordinary skill in the art in view of Bollen et al. in view of Fearon et al. (See MPEP 2144.05: II. ROUTINE OPTIMIZATION: A.Optimization Within Prior Art Conditions or Through Routine Experimentation: Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. [W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
One of ordinary skill in the art would have had a reasonable expectation of success for using sequence as taught by Fearon et al. with the composition as taught by Bollen et al. There would have been a reasonable expectation of success given the underlying materials (immunostimulatory oligonucleotides as taught by Bollen et al. and Fearon 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.
6. Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Bollen et al. in view of Fearon et al. as applied to claims 1, 15 above, and further in view of Hanon et al. (WO2006094756)(cited above).
See claim 12 as submitted 5/13/2025.
See the teachings of Bollen et al. in view of Fearon et al. above.
Bollen et al. in view of Fearon et al. does not teach: SEQ ID NO: 4.
See the teachings of Hanon et al. above.
One of ordinary skill in the art would have been motivated to use antigen as taught by Hanon et al. with the composition as taught by Bollen et al. in view of Fearon et al. Bollen et al. in view of Fearon et al. teaches use of gE antigen, and Hanon et al. teaches such an antigen (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 antigen as taught by Hanon et al. with the composition as taught by Bollen et al. in view of Fearon et al. There would have been a reasonable expectation of success given the underlying materials (VZV gE antigens as taught by Bollen et al. in view of Fearon et al. and Hanon 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
7. 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
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