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 .
Response to Amendment
The Amendment filed 10/02/2025 in which claims 1, 9, 10-14, 16, were amended, and claims 3-5 were canceled, has been entered. Claims 17-28 were previously canceled.
Claims 1, 2, 6-16 are under examination on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) was submitted on 05/01/2025 and 11/11/2025 after the Non-Final Office Action mailed on 05/02/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
(Previous objection, withdrawn) Applicant’s amendments to the Drawings submitted on 10/02/2025 have overcome the objection previously set forth in the Non-Final Office Action mailed 05/02/2025.
Specification
(Previous objection, withdrawn) Applicant’s amendments to the Specification submitted on10/02/2025 have overcome the objection previously set forth in the Non-Final Office Action mailed 05/02/2025.
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.
(previous rejection, withdrawn as to claims 3-5) Claims 3-5 were rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
See claims 3-5 submitted on 10/02/2025.
The previous rejections of claims 3-5 is moot in view of Applicant’s cancelation of these 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
(previous rejection, withdrawn as to claims 1, 2, 6-12, 15 and 16) Claims 1, 2, 6-12, 15 and 16 were rejected under 35 U.S.C. 103 as being unpatentable over Wu et al., in view of clinical study NCT04336410 and Sardesai et al. (prior art of record).
See claims 1, 2, 6-12, 15 and 16 as submitted on 10/02/2025.
Applicant’s amendments to claims 1, 2, 6-12, 15 and 16, which recite the new limitation of “a plasmid comprising a nucleic acid sequence encoding residues 19-1279 of SEQ ID NO: 1 or a plasmid comprising nucleotides 55-3837 of SEQ ID NO: 2” have overcome the previous rejections to those claims.
(new rejection, necessitated by amendment as to claims 1, 2, 6-12, 15, and 16) Claims 1, 2, 6-12, 15 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Wu et al., in view of patent application CN-115671273-A to Jiang et al. filed on 07/23/2021 (See PTO-892: Notice of References Cited.)
See claims 1, 2, 6-12, 15 and 16 as submitted on 10/02/2025.
Regarding amended claim 1, Wu et al. teach a method of inducing an immune response comprising an antibody response (humoral immune response) against Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2) variant B.1.351, and SARS-CoV-2 variant B.1.1.7, in a subject in need thereof (Abstract, page 4, Table 1) comprising administering nucleic acids. Wu et al. do not teach wherein the method comprises administering a plasmid comprising a nucleic acid sequence encoding residues 19-1279 of SEQ ID NO: 1 or a plasmid comprising nucleotides 55-3837 of SEQ ID NO: 2.
Jiang et al. teach a method for immunizing against SARS-CoV-2 comprising administering a DNA composition comprising a consensus SARS-CoV-2 spike gene sequence (SEQ ID NO: 3) for the benefit of eliciting an enhanced immune response with a synergistic cellular and humoral effect against the target antigen (Abstract, pages 1-3). Jiang et al.’s nucleotide sequence shares 100% identity with instant SEQ ID NO: 2 (Abstract, pages 10-11). See alignment below (Qy is instant SEQ ID NO: 2; Db is Jiang’s SEQ ID NO: 3). Note that the alignment below shows only the first ~ 500 nucleotides, however the sequences share 100% identity along all 3837 nucleotides.
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It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have incorporated the nucleic acid sequence of Jiang et al. into the method of inducing an immune response, as previously taught by Wu et al., for the benefit of eliciting an enhanced immune response with a synergistic cellular and humoral effect against the target antigen. See MPEP 2144.07. The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
One of ordinary skill in the art would have had reasonable expectation of success in modifying the method of Wu et al. with the nucleic acid of Jiang et al. given that the methods of formulating DNA vaccine vectors are well known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Regarding claim 2, as indicated above, Wu et al. teach a method of inducing an immune response comprising an antibody response (humoral immune response) (Abstract, page 4, Table 1). Further, Jiang et al. teach a method of eliciting an enhanced immune response with a synergistic cellular and humoral effect against the target antigen (page 2).
Regarding claims 6-8, Jiang et al. teach intramuscular administration of the DNA vaccine of claim 1 drug product intradermally (parenteral administration, as recited in claim 6), followed by an electric pulse or electroporation (EP) (pages 7, 11).
Regarding claims 9 and 10, Jiang et al. teach administration of the DNA vaccine of claim 1 wherein an initial dose is 0.1-10 mg. (Figs. 4A-4B; pages, 7, 11).
Regarding claims 11 and 12, Jiang et al. teach administration of the DNA vaccine of claim 1 wherein each administration/inoculation has an interval time of 7-180 days,
preferably 14-90 days, or 28-60 day (about four weeks, as recited in claims 11 and 12) and the clinical dose is 0.1-10 mg (Figs. 4A-4B; pages 6, 7, 11).
Regarding claims 15 and 16, as noted above, Wu et al. teaches a method of inducing an immune response against SARS-CoV-2 variant B.1.351, and SARS-CoV-2 variant B.1.1.7 comprising administering the mRNA-1273 vaccine; and Wu et al. and Jiang et al. in combination teach a plasmid comprising a nucleic acid sequence encoding residues 19-1279 of instant SEQ ID NO: 1 which is the same as a plasmid comprising nucleotides 55-3837 of instant SEQ ID NO: 2 to induce an immune response against SARS-CoV-2.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have combined both compounds, the mRNA-1273 as previously taught by Wu et al., and the plasmid according to Wu et al. in view of Jiang et al., into one formulation administered concurrently for the benefit of eliciting an for the benefit of eliciting an enhanced immune response with a synergistic cellular and humoral effect against SARS-CoV-2 variants of interest. See MPEP 2144.06. I. COMBINING EQUIVALENTS KNOWN FOR THE SAME PURPOSE “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.”
One of ordinary skill in the art would have had reasonable expectation of success in combining the mRNA-1273 of Wu et al. with the plasmid according to Wu et al. in view of Jiang et al., given that the methods of combining vaccine formulations are well known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Accordingly, claims 1, 2, 6-12, 15 and 16 the claimed invention were prima facie obvious to one of ordinary skill in the art at the time of filing especially in the absence of evidence to the contrary.
(previous rejection, withdrawn as to claims 13 and 14) Claims 13 and 14 were rejected under 35 U.S.C. 103 as being unpatentable over Wu et al., in view of clinical study NCT04336410 and Sardesai et al., further in view of Wang (prior art of record).
See claims 13 and 14 as submitted on 10/02/2025.
Applicant’s amendments to claims 13 and 14, which recite the new limitation of “the plasmid comprising a nucleic acid sequence encoding residues 19-1279 of SEQ ID NO: 1 or a plasmid comprising nucleotides 55-3837 of SEQ ID NO: 2” have overcome the previous rejections to those claims.
(new rejection, necessitated by amendment as to claims 13 and 14) Claims 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Wu et al., and Jiang et al., as applied to claims 1, 2, 6-12, 15 and 16 above, further in view of Wang S (prior art of record).
See claims 13 and 14 as submitted on 10/02/2025.
Regarding claims 13 and 14, as explained above Wu et al. and Jiang et al. in combination teach the method of claim 11. Neither Wu et al. nor Jiang et al. teach the method further comprising one or more subsequent doses administered to the subject at least twelve weeks after the initial dose.
As previously explained, Wang S et al. teaches methods of nucleic acid immunization (Abstract). Wang S et al. further teaches common immunization schedules and the need of more than two immunizations to reach peak level antibody responses for large animals (page 5). One immunization schedule taught by Wang S et al. involves immunizations at weeks 0-4-8-12 (page 6).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have modified the method of inducing an immune response, as previously taught by Wu et al., in view of Jiang et al. to include one more additional booster shot for the benefit of reaching peak level antibody responses for large animals such as humans.
One of ordinary skill in the art would have had reasonable expectation of success in modifying the method of Wu et al., in view of Jiang et al. with the teachings of Wang S et al. given that the methods of designing vaccine immunization schedules are well known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Accordingly, the limitations of claims 13 and 14 would have been prima facie obvious to one of ordinary skill in the art before the effective filing date especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed 10/02/2025 have been fully considered but they are not persuasive.
Applicant contends on page 9 of the Remarks submitted on 10/02/2025:
The mRNA-1273 disclosed by Wu, however, is mRNA and, as such, is much smaller than the DNA vaccine recited by NCT04336410. Even Sardesai's disclosure of the use of electroporation is limited to use in the context of DNA vaccines. There is no teaching or suggestion in any of the cited references of the use of electroporation with mRNA. The Office has thus failed to establish a motivation for one skilled in the art to combine Wu with either NCT04336410 or Sardesai. Moreover, the Office has failed to provide any reasoning to explain why one skilled in the art would have modified the method of Wu to include INO-4800.
In response:
A new set of rejections relying in new references is set forth in the present Office Action. With respect to a teaching of the use of electroporation, note that Jiang et al. teach the use of electroporation for a DNA vaccine comprising the exact nucleotide sequence of the claimed invention (see above). Further, it is noted that the use of electroporation for enhanced delivery of nucleic acids into cells is widely used in the art (see Jiang et al. pages 7, 11; see Sardesai pages 1-3). Furthermore, the motivations for combining the teachings of the new references in explained in detail above.
Applicant contends on page 10 of the Remarks submitted on 10/02/2025:
Claims 13 and 14 depend from claim 11. Claims 13 and 14 thus recite an initial dose at week 0, a boost at about week 4, and a subsequent dose at lease 12 weeks after the initial dose. This schedule is not taught by Wang. Even Wang states that, "[i]t is also not clear how many immunzations are optimal for prime or boost, and how long the optimal resting period is, either with the prime phase or during the boost phase." One skilled in the art armed with a combination of Wang with Wu, NCT04336410, and Sardesai would have failed to arrive at the claimed methods.
In response:
As explained in detail above, Jiang et al. teach an initial dose at week 0, followed by a boost about week 4. Wang teaches the need of more than two immunizations to reach peak level antibody responses for large animals (page 5). One immunization schedule taught by Wang S et al. involves immunizations at weeks 0-4-8-12 (page 6). Therefore, on the contrary, the cited prior art provides clear teachings and suggestions to arrive at the exact claimed invention as recited in claims 13 and 14.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARLENE V BUCKMASTER whose telephone number is (703)756-5371. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas J 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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/MARLENE V BUCKMASTER/Examiner, Art Unit 1672
/THOMAS J. VISONE/ Supervisory Patent Examiner, Art Unit 1672
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