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, 10, 13, 25, 26, 29, 43, 46 are amended. Claims 2, 4-6, 15-22, 27, 28, 30, 47, 48 are canceled. New claims 49, 50 are added. Claims 1, 3, 7-14, 23-26, 29, 31-46, 49, 50 are under consideration.
2. Due to the new rejection below, this Action is a Non-Final Action.
Information Disclosure Statement
3. The information disclosure statements (IDS) were submitted on 7/28/2026. 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
4. (previous objection, withdrawn) The disclosure was objected to because of informalities.
Applicant contends: the specification has been amended.
In view of applicant’s amendments, the objection is withdrawn.
Claim Rejections - 35 USC § 112
5. (previous rejection, withdrawn) Claim 8 was rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and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.
Applicant contends: the claim has been amended.
In view of applicant’s amendments, the rejection is withdrawn.
6. (previous rejection, withdrawn) Claims 1, 3-14, 23-26, 29, 31-46 were rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being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.
Applicant contends: the claim has been amended.
In view of applicant’s amendments, the rejection is withdrawn.
Claim Rejections - 35 USC § 102/103
7. (previous rejection, withdrawn) Claims 1, 3-5, 7, 9, 10, 13, 14, 23-26, 29, 31-40, 42-46 were rejected under 35 U.S.C. 102((a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Moon et al. (WO2017223085)(cited in applicant's IDS submitted 1/23/2023).
Applicant contends: claims 1, 29 have been amended.
In view of applicant’s amendments, the rejection is withdrawn.
Claim Rejections - 35 USC § 103
8. (previous rejection, withdrawn) Claims 6, 8, 44 were rejected under 35 U.S.C. 103 as being unpatentable over Moon et al. as applied to claims 1, 3-5, 7, 9, 10, 13, 14, 23-26, 29, 31-40, 42-46 above.
In view of the withdrawal of the rejection over Moon et al. on which the instant rejection depends, the instant rejection is also withdrawn.
9. (previous rejection, withdrawn) Claims 11, 12, 41 were rejected under 35 U.S.C. 103 as being unpatentable over Moon et al. as applied to claims 1, 3-5, 7, 9, 10, 13, 14, 23-26, 29, 31-40, 42-46 above, and further in view of Vilalata et al. (WO2005021707A2; previously cited).
In view of the withdrawal of the rejection over Moon et al. on which the instant rejection depends, the instant rejection is also withdrawn.
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.
10. (new rejection) Claims 1, 3, 7, 8, 9, 10, 13, 14, 23-26, 29, 31-40, 42-46, 49, 50 are rejected under 35 U.S.C. 103 as being unpatentable over Moon et al. (WO2017223085)(cited in applicant's IDS submitted 1/23/2023)(previously cited).
See claims 1, 3, 7, 8, 9, 10, 13, 14, 23-26, 29, 31-40, 42-46, 49, 50 as submitted 7/28/2026.
Applicant contends with respect to the instant reference: claims 1, 29 have been amended; Moon et al. does not teach the specific combination of DPPC, DPPG, cholesterol and DPPE-PEG-2000; DPPE-PEG2000 is not explicitly disclosed in Moon et al.; rather components are included in long lists of possible components; the examples report the use of DMPC and DOPE-PDP or DOPE; there is no motivation to select the combination as claimed; Moon et al. does not teach or suggest the specific molar ratio claimed; there would be no expectation of success.
Applicant’s arguments are considered and found unpersuasive.
See the teachings of Moon et al. in the previous Office Action as to claims 1, 3, 7, 8, 9, 10, 13, 14, 23-26, 29, 31-40, 42-46, 49, 50. To reiterate in part, Moon et al. teaches: compositions comprising nanoparticles (abstract); including liposomes (claim 53 of Moon et al.)(as recited in claims 1, 3); examples of lipid molecules applicable with embodiments of the present invention include, but are not limited to (p. 17); DPPG (claim 214 of Moon et al., p. 17)(as recited in claims 1, 29, 49, 50); DPPC, cholesterol (claim 214 of Moon et al., p. 17)(as recited in claims 1, 29, 49, 50); DPPE (p. 17)(as recited in claims 1, 29, 49, 50); lipid molecule modified with PEG, PEG2000 (p. 18)(as recited in claims 1, 29, 49, 50).
As to claims 1, 29, 49, 50, such a ratio as recited is considered that to be determined by routine optimization to one of ordinary skill of the art in view of the teachings or suggestions of Moon et al., absent a showing of unexpected results (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)).
In view of the foregoing, all the claimed limitations are found in one reference and are taught to be optional variations to a ‘base’ composition they exemplify. As such, the claimed composition is within the scope of Moon et al., and thus Moon et al. renders the composition prima facie obvious. The rationale to support this conclusion of obviousness is that Moon et al. provides a teaching, suggestion, and motivation to substitute different variables disclosed within the reference. Furthermore, there is no evidence on the record that indicates that the claimed supplement exhibits any unexpected results compared to the prior art.
Response to Arguments
Turning to applicant’s arguments, with respect to the claimed combination, Moon et al. already teaches or suggests use of the lipid components as indicated above. In view of such teachings or suggestions, any combination of expressly cited components would be as obvious as any other absent a showing of unexpected results commensurate in scope with the claims (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)); … see also MPEP 2121.01: II. 35 U.S.C. 103 REJECTIONS AND USE OF INOPERATIVE PRIOR ART: “Even if a reference discloses an inoperative device, it is prior art for all that it teaches.” Beckman Instrumentsv.LKB Produkter AB, 892 F.2d 1547, 1551, 13 USPQ2d 1301, 1304 (Fed. Cir. 1989). Therefore, “a non-enabling reference may qualify as prior art for the purpose of determining obviousness under 35 U.S.C. 103.” Symbol Techs. Inc. v. Opticon Inc., 935 F.2d 1569, 1578, 19 USPQ2d 1241, 1247 (Fed. Cir. 1991); … See also MPEP 2121: I. PRIOR ART IS PRESUMED TO BE OPERABLE/ENABLING: When the reference relied on expressly anticipates or makes obvious all of the elements of the claimed invention, the reference is presumed to be operable. Once such a reference is found, the burden is on applicant to rebut the presumption of operability. In re Sasse, 629 F.2d 675, 207 USPQ 107 (CCPA 1980). See also MPEP 716.07. See also In re Antor Media Corp., 689 F.3d 1282, 103 USPQ2d 1555 (Fed. Cir. 2012)). In response, applicant has not appeared to provide evidence, rather, attorney argument (See MPEP 716.01(c): The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965)).
As to a reasonable expectation of success, Moon et al. teaches or suggests the claimed combination as indicated (See MPEP 2143.02, part II (requiring only at least some degree of predictability, not complete confidence in a desired outcome).
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.
11. (new rejection) Claims 11, 12, 41 are rejected under 35 U.S.C. 103 as being unpatentable over Moon et al. as applied to claims 1, 3, 7, 8, 9, 10, 13, 14, 23-26, 29, 31-40, 42-46, 49, 50 above, and further in view of Vilalata et al. (WO2005021707A2; previously cited).
See claims 11, 12, 41 as submitted 7/28/2026.
Applicant contends with respect to the instant references: the claims are amended.
Applicant’s arguments are considered but found unpersuasive.
See the rejection as recited in the previous Office Action as to the instant references. To reiterate, see the teachings of Moon et al. above.
Moon et al. does not teach wherein the antigen comprises a spike protein or portion
thereof; wherein the antigen comprises a nucleocapsid protein or portion thereof; wherein the
virus is selected from a severe acute respiratory syndrome coronavirus (SARS-CoV), a severe
acute respiratory syndrome-related coronavirus (SARSr-CoV), a human coronavirus 229E
(HCoV-229E), a human coronavirus NL63 (HCoV-NL63), a human coronavirus OC43 (HCoV-
OC43), a human coronavirus HKU1 (HCoV-HKU1), a Middle East respiratory syndrome-related
coronavirus (MERS-CoV), a severe acute respiratory syndrome-related coronavirus 2 (SARS-
CoV-2), a variant of SARS-CoV-2, or combinations thereof.
Vilalata et al. teaches: raising immune response against SARS; SARS CoV polypeptide
[0014]; use of spike, nucleocapsid proteins [0026].
One of ordinary skill in the art would have been motivated to use antigen as taught by
Vilalata et al. with the composition as taught by Moon et al. Moon et al. teaches use of antigen,
and Vilalata et al., which also teaches use of antigen, teaches such an antigen already known and
used in the art (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 Vilalata et al. with the composition as taught by Moon et al. There
would have been a reasonable expectation of success given the underlying materials (antigens as taught by Moon et al. and Vilalata 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.
Response to Arguments
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
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.
12. (previous rejection, withdrawn as to canceled claims 4-6; maintained as to claims 1, 7, 9-14, 23-26, 29, 31-44, 46, 49, 50; new, necessitated by amendment as to claims 49, 50) Claims 1, 7, 9-14, 23-26, 29, 31-44, 46, 49, 50 are provisionally rejected on the ground of
nonstatutory double patenting as being unpatentable over claims 1-14, 17-40 of copending
Application No 18/100456.
See claims 1, 7, 9-14, 23-26, 29, 31-44, 46, 49, 50 as submitted 7/28/2026.
Applicant contends: claims 1-14, 17-40 of copending Application No 18/100456 do not recite the molar ratio as claimed; further, co-pending application ‘456 is not a proper reference since it is a later-filed, later-expiring application.
Applicant’s arguments are considered but found unpersuasive.
See the rejection as recited in the previous Office Action. As to claims 1, 29, 49, 50, it is noted claim 11 of copending Application No 18/100456 already recites wherein the lipid-based particle comprises DPPC, DPPG, cholesterol, and DPPE-PEG2000 in a 10:1:1:1 ratio.
Response to Arguments
As to the molar ratio, it is noted claim 11 of copending Application No 18/100456 already recites the molar ratio.
With respect to co-pending application ‘456, it is noted that such rejections over co-pending applications are proper (See MPEP 804(I)(B)).
The rejection is maintained and extended for reasons of record.
13. (previous rejection, maintained) Claims 3, 8, 45 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14, 17-40 of copending Application No 18/100456 as applied to claims 1, 7, 9-14, 23-26, 29, 31-44, 46, 49, 50 above and further in view of Moon et al. (cited above).
See claims 3, 8, 45 as submitted 7/28/2026.
Applicant contends: in view of applicant’s amendments, the rejection does not apply.
Applicant’s arguments are considered but found unpersuasive.
See the rejection as recited in the previous Office Action.
Response to Arguments
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
The rejection is maintained for reasons of record.
14. (previous rejection, maintained as to claims 1, 3, 7-10, 13, 14, 23-26, 29, 31-40, 42-46; withdrawn as to canceled claims 4-6, new, necessitated by amendment as to claims 49, 50) Claims 1, 3, 7-10, 13, 14,23-26, 29, 31-40, 42-46, 49, 50 are provisionally rejected on the
ground of nonstatutory double patenting as being unpatentable over claims 97-100, 105-120
of copending Application No. 18/034312 in view of Moon et al. (cited above).
See claims 1, 3, 7-10, 13, 14,23-26, 29, 31-40, 42-46, 49, 50 as submitted 7/28/2026.
Applicant contends: co-pending application ‘312 is not a proper reference since it is a later-filed, later-expiring application.
Applicant’s arguments are considered but found unpersuasive.
See the rejection as recited in the previous Office Action. As to claims 1, 29, 49, 50, it is noted claim 108 of copending Application No 18/034312 already recites wherein the lipid-based particle comprises DPPC, DPPG, cholesterol, and DPPE-PEG2000 in a 10:1:1:1 ratio.
Response to Arguments
With respect to co-pending application ‘312, it is noted that such rejections over co-pending applications are proper (See MPEP 804(I)(B)).
The rejection is maintained and extended for reasons of record.
15. (previous rejection, maintained) Claims 11, 12, 41 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 97-100, 105-120 of copending Application No. 18/034312 in view of Moon et al. as applied to claims 1, 3-10, 13, 14, 23-26, 29, 31-40, 42-46 above and further in view of Vilalata et al. (cited above).
See claims 11, 12, 41 as submitted 7/28/2026.
Applicant contends: in view of applicant’s amendments, the rejection does not apply.
Applicant’s arguments are considered but found unpersuasive.
See the rejection as recited in the previous Office Action.
Response to Arguments
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
The rejection is maintained for reasons of record.
Conclusion
16. 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
