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 of Group I and species (influenza; 2’-3’ cGAMP; DPPC, DPPG, cholesterol and PEG-lipid; DPPC, DPPG, cholesterol, DPPE-PEG2000; intranasal) in the reply filed on 8/5/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 103, 119, 120 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim.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 5/5/2026.
Claims 97-102, 104-118 are under consideration.
Information Disclosure Statement
2. The information disclosure statements (IDS) were submitted on 4/27/2023; 8/5/2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
3. The disclosure is objected to because of the following informalities:
The use of trademarked terms has been noted in this application on pages 61, 71. 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 Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
4. Claims 97-102, 104-118 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112
(pre-AIA ), first paragraph, because the specification, while being enabling for treatment uses and methods, does not reasonably provide enablement for uses and methods of prevention. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
See claims 97-102, 104-118 as submitted 8/5/2026.
In making a determination as to whether an application has met the requirements for
enablement under 35 U.S.C. 112 P 1, the courts have put forth a series of factors. See, In re
Wands, 8 USPQ2d 1400, at 1404 (CAFC 1988). The factors considered include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims. Id. While it is not essential that every factor be examined in detail, those factors deemed most relevant should be considered. In the present case, the factors deemed relevant are those of: the breadth of the claims; the amount of direction and the working examples provided, and the quantity of experimentation necessary.
Breadth of the claims: Claim 97 recites method of preventing or treating a (read on “any”) disease or condition comprising administering comprising modulator. Such recitations read on complete prevention or prophylaxis of a (or "any") disease or condition by administration or use of a mere modulator.
The amount of direction and the working examples provided: The present specification
appears to only disclose elicitation of immune responses. For example, Example 4 teaches
elicitation in vivo in mice of IgG, T cell responses to the disclosed NanoSTING Trimer
compositions (comprising spike protein of SARS-CoV-2); Examples 5, 10, 12, 14 further teach
elicitation of antibody immune responses and T cells using protein antigens of
SARS-CoV-2.
However, in view of the breadth of the claims, the present specification does not teach or provide evidence of prevention or prophylaxis of disease using antigens, much less for the breadth of recitation towards "any" disease. Thus, the skilled artisan would be required to
conduct undue amount of experimentation in order to use the instantly claimed compositions
for use or methods in preventing a or any disease (See also MPEP 2164.01(c): When a
compound or composition claim is limited by a particular use, enablement of that claim should
be evaluated based on that limitation. See In re Vaeck, 947 F.2d 488, 495, 20 USPQ2d 1438,
1444 ).
As discussed above undue experimentation would be required to practice the claimed
invention commensurate with the scope of the claims. Reasonable correlation must exist between the scope of the claims and scope of enablement set forth. In view of the quantity of
experimentation necessary, the limited working examples, the lack of sufficient guidance
in specification, and the breadth of the claims, it would take undue trials and errors to
practice the claimed invention.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
5. Claims 97-102, 105-107, 109, 111-115, 118 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Moon et al. (WO2017223085)(cited in applicant’s IDS submitted 4/27/2023).
See claims 97-102, 105-107, 109, 111-115, 118 as submitted 8/5/2026.
Moon et al. teaches: nanoparticles associated with biomacromolecule agents for treating or preventing disorders (abstract); including: administration (claim 40 of Moon et al.)(as recited in claim 97); STING agonist (p. 3)(as recited in claim 97); therapeutic composition (p. 116)(as recited in claim 98); phospholipid nanoparticles (p. 4)(as recited in claim 99); influenza (p. 83)(as recited in claims 100, 102); administering nucleic acids (p. 22)(as recited in claim 101(d)); DPPC (p. 26)(as recited in claims 105, 107); DPPG (p. 26)(as recited in claims 105, 107); cholesterol (p. 26)(as recited in claims 105, 107); PEG-lipid (p. 27)(as recited in claim 105); PEG2000 (p. 27)(as recited in claims 106, 107); dose and multiple doses (p. 118)(as recited in claim 109, 110); preventing (p. 53)(as recited in claims 111, 115); intransasal administration (p. 111)(as recited in claim 112); human subject (p. 8)(as recited in claim 113;) treatment of cancer (p. 36)(as recited in claim 114); antigen (p. 12)(as recited in claim 118).
As to claim 115, such a recitation is considered to flow from the composition and step as already recited in claim 97 (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)).
Thus Moon et al. anticipates the instant claims.
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.
6. Claims 108, 110 is rejected under 35 U.S.C. 103 as being unpatentable over Moon et al. as applied to claims 97-102, 105-107, 109, 111-115, 118 above.
See claims 108, 110 as submitted 8/5/2026.
See the teachings of Moon et al. above.
As to claims 108, 110, such recitations as to molar ratios and timing of administration are considered to be those determined by routine optimization to one of ordinary skill in the art in view of the teachings or suggestions of Moon 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)).
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.
7. Claims 104, 116, 117 are rejected under 35 U.S.C. 103 as being unpatentable over Moon et al. as applied to claims 97-102, 105-107, 109, 111-115, 118 above, and further in view of Jang et al. (WO2019183578A1)(cited in applicant’s IDS submitted 4/27/2023).
See claims 104, 116, 117 as submitted 8/5/2026.
See the teachings of Moon et al. above.
Moon et al. does not teach: 2’-3’cGAMP.
Jang et al. teaches vesicles comprising Sting-agonist (title); including: therapeutic amounts (abstract); including use of lipid nanoparticle [0006]; treating cancer [0027]; 2’3’ cGAMP [00205](as recited in claims 104, 116).
One of ordinary skill in the art would have been motivated to use agonist as taught by Jang et al. with the method as taught by Moon et al. Moon et al. teaches the use of Sting agonists and treating cancer, and Jang et al., which also teaches treating cancer, teaches such a STING agonist (See MPEP 2144.06: Substituting equivalents known for the same purpose).
As to claim 117, such a recitation is considered to flow from the composition and step as already recited in claim 116 (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 using agonist as taught by Jang et al. with the method as taught by Moon et al. There would have been a reasonable expectation of success given the underlying materials (STING agonists as taught by Moon et al. and Jang 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.
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 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 § 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 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/apply/applying-online/eterminal-disclaimer.
8. Claims 97-102, 105-113, 115, 118 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-14, 23-26, 29, 31-46 of copending Application No. 18/017659.
See claims 97-102, 105-113, 115, 118 as submitted 8/5/2026.
Claims 1, 3-14, 23-26, 29, 31-46 of copending Application No. 18/017659 recite: a composition for use in treating or preventing a disease in an animal comprising: a lipid-based particle comprising an antigen and a modulator, wherein the modulator is a pattern recognition receptor agonist; a method of treating or preventing a disease in a subject, said method comprising: administering to the subject a composition comprising a lipid-based particle, wherein the lipid-based particle comprises an antigen and a modulator, wherein the modulator is a pattern recognition receptor agonist; lipids; pathogen; influenza; intranasal; dose.
Although the claims at issue are not identical, they are not patentably distinct from each other because both instant claims 97-102, 105-113, 115-118 and claims 1, 3-14, 23-26, 29, 31-46 of copending Application No. 18/017659 recite a method of preventing or treating a disease or condition in a subject, the method comprising administering to the subject a composition comprising a modulator, wherein the modulator induces activation or inhibition of the stimulator of interferon genes (STING) pathway in a subject.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
9. Claims 104, 114, 116, 117 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-14, 23-26, 29, 31-46 of copending Application No. 18/017659 as applied to claims 97-102, 105-113, 115, 118 above and further in view of Jang et al. (cited above).
See claims 104, 114, 116, 117 as submitted 8/5/2026.
See the recitations of claims 1, 3-14, 23-26, 29, 31-46 of copending Application No. 18/017659 above.
Claims 1, 3-14, 23-26, 29, 31-46 of copending Application No. 18/017659 do not recite: 2’-3’cGAMP; cancer.
See the teachings of Jang et al. above.
One of ordinary skill in the art would have been motivated to use agonist as taught by Jang et al. with the method as recited in claims 1, 3-14, 23-26, 29, 31-46 of copending Application No. 18/017659. Claims 1, 3-14, 23-26, 29, 31-46 of copending Application No. 18/017659 recite the use of Sting agonists, and Jang et al., teaches such a STING agonist (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 agonist as taught by Jang et al. with the method as recited in claims 1, 3-14, 23-26, 29, 31-46 of copending Application No. 18/017659. There would have been a reasonable expectation of success given the underlying materials 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.
This is a provisional nonstatutory double patenting rejection.
10. Claims 97-102, 105-113, 115, 118 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-9, 11-17, 19-40 of copending Application No. 18/100456.
See claims 97-102, 105-113, 115, 118 as submitted 8/5/2026.
Claims 1, 3-9, 11-17, 19-40 of copending Application No. 18/100456 recite a method comprising: administering a composition to a subject, wherein the composition comprises: a lipid-based particle; a modulator encapsulated within the particle; and a modulator not encapsulated by, bound to, or incorporated in the particle; wherein the modulator is a stimulator of interferon genes (STING) agonist; lipids; pathogen; influenza; intranasal; dose.
Although the claims at issue are not identical, they are not patentably distinct from each other because both instant claims 97-102, 105-113, 115-118 and claims 1, 3-9, 11-17, 19-40 of copending Application No. 18/100456 recite a method of preventing or treating a disease or condition in a subject, the method comprising administering to the subject a composition comprising a modulator, wherein the modulator induces activation or inhibition of the stimulator of interferon genes (STING) pathway in a subject.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
11. Claims 104, 114, 116, 117 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-9, 11-17, 19-40 of copending Application No. 18/100456 as applied to claims 97-102, 105-113, 115, 118 above and further in view of Jang et al. (cited above).
See claims 104, 114, 116, 117 as submitted 8/5/2026.
See the recitations of claims 1, 3-9, 11-17, 19-40 of copending Application No. 18/100456 above.
Claims 1, 3-9, 11-17, 19-40 of copending Application No. 18/100456 do not recite: 2’-3’cGAMP; cancer.
See the teachings of Jang et al. above.
One of ordinary skill in the art would have been motivated to use agonist as taught by Jang et al. with the method as recited in claims 1, 3-9, 11-17, 19-40 of copending Application No. 18/100456. Claims 1, 3-9, 11-17, 19-40 of copending Application No. 18/100456 recite the use of Sting agonists, and Jang et al., teaches such a STING agonist (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 agonist as taught by Jang et al. with the method as recited in claims 1, 3-9, 11-17, 19-40 of copending Application No. 18/100456. There would have been a reasonable expectation of success given the underlying materials 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.
This is a provisional nonstatutory double patenting rejection.
Conclusion
12. 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Visone can be reached at 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M FRANCO G SALVOZA/Primary Examiner, Art Unit 1672
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