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 I and species (DNA; Ad6) in the reply filed on 9/4/2025 is acknowledged.
Claims 15-23, 30-35 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim.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 9/4/2025.
Claims 1-14, 24-29 are under consideration.
Information Disclosure Statement
2. The information disclosure statements (IDS) were submitted on 10/20/2022; 1/26/2024; 7/26/2024; 4/23/2025. 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 Objections
3. Claim 14 is objected to because of the following informalities:
For improved language, claim 14 should recite “The vaccine of claim 13…”.
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.
4. Claims 3, 7, 8, 11, 13, 14, 25, 28, 29 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 3, 7, 8, 11, 13, 14, 25, 28, 29 as submitted 9/4/2025.
As to claim 3, the claim recites “”fully deleted … all endogenous genes”. It is not clear what the metes and bounds of such a recitation are.
As to claims 8, 29, it is not clear what “the receptor binding domain sequences” refers to.
As to claim 25, the claim recites “the β-CoV RNA sequence”. There is insufficient antecedent basis for this limitation in the claim.
As to claims 7, 28, it is not clear if “the receptor binding domain” refers to the entire domain or not.
As to claims 11, 13, it is not clear what a “packaging cell is encapsidated in a capsid” means.
As to claim 13, it is not clear what a “packing plasmid” is. It is noted claim 9 recites a “packaging plasmid”. It is not clear if these two are the same thing or not.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
5. Claims 1, 4-6, 10, 24-27 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
See claims 1, 4-6, 10, 24-27 as submitted 9/4/2025.
See also the 35 U.S.C. 112(b) rejection above.
In view of the 2019 PEG (“The 2019 Revised Patent Subject Matter Eligibility Guidance” (2019 PEG) found at https://www.govinfo.gov/content/pkg/FR-2019-01-07/pdf/2018-28282.pdf ), based upon an analysis with respect to the claims as a whole, claims 1, 4-6, 10, 24-27 do not recite something significantly different than a judicial exception. The rationale for this determination is explained below:
The claims do not fall within at least one of the four categories of patent eligible subject matter because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more (these claims are interpreted in light of the most recent Guidelines (See “Subject Matter Eligibility” found at https://www.uspto.gov/patent/laws-and-regulations/examination-policy/subject-matter-eligibility ; as well as Subject Matter Eligibility Examples: Life Sciences at https://www.uspto.gov/sites/default/files/documents/ieg-may-2016-ex.pdf )
These claims are analyzed for eligibility in accordance with their broadest reasonable interpretation. In view of the Subject Matter Eligibility Test for Products and Processes and the Steps cited below (See flowchart at pages 10-11 at https://www.uspto.gov/sites/default/files/documents/peg_oct_2019_update.pdf ), the claims are directed to an ineligible product as further detailed below.
In this case, claims 1, 4-6, 10, 24-27 recite, read on, or are directed to a composition of matter (Step 1) and recite natural phenomenon(s) (in this case, nucleic acid sequence coding for S protein of β-CoV and host cell comprising said sequence) that is directed to a judicial exception (in this case, a natural phenomenon)(Step 2A)
Claim 1 recites a vaccine for preventing B-CoV infection, comprising: at least one viral vector comprising a β-CoV DNA sequence which codes the S protein for the β-CoV. Claim 24 recites a vaccine for preventing β-CoV infection, comprising: at least one β -CoV protein sequence which codes the S protein for the β-CoV. Such recitations, including as to claims 4-6, 25-27 merely read on naturally occurring genomic nucleic acid sequence coding for S protein of β-CoV, as well as naturally occurring protein sequence of S protein of β-CoV. Claim 10 reads on a naturally occurring host cell comprising said nucleic acid sequence.
Thus, the claimed product of β-CoV DNA sequence which codes the S protein for the β-CoV and at least one β -CoV protein sequence which codes the S protein for the β-CoV are not markedly different from its naturally occurring counterpart (See Nature-Based Products, Example 4 (“Purified Proteins”) at https://www.uspto.gov/sites/default/files/documents/mdc_examples_nature-based_products.pdf ; see also Subject Matter Eligibility Examples: Life Sciences, 28. Vaccines, Claim 3). Claims 1, 4-6, 10, 24-27 read on naturally occurring nucleic acid sequence encoding S protein of β-CoV and naturally occurring sequence of S protein of β-CoV and does not show a difference in characteristics between the claimed nucleic acid sequence and protein and naturally occurring nucleic acid sequence and protein. Thus the claims also read upon naturally occurring nucleic acid sequence and protein, or a composition of matter as recited in Step 1 and a natural phenomenon as recited in Step 2A.
Thus the claimed product of β-CoV DNA sequence which codes the S protein for the β-CoV and at least one β -CoV protein sequence which codes the S protein for the β-CoV are not markedly different from its naturally occurring counterpart (see Part I. A.3 of the Interim Eligibility Guidance, Example 2, p. 29). Thus the claims also read upon naturally occurring β-CoV DNA sequence which codes the S protein for the β-CoV and at least one β -CoV protein sequence which codes the S protein for the β-CoV, or a composition of matter as recited in Step 1 and a natural phenomenon as recited in Step 2A.
The claims thus recite a nature-based product limitation that does not exhibit markedly different characteristics from its naturally occurring counterpart, or is directed to a “product of nature” exception.
Further as to Step 2A in view of the 2019 PEG, in view of Prong 1 of Revised Step 2A, the claims recite a natural phenomenon.
As to Prong 2 of Step 2A, the instant claims do not recite additional elements that integrate the judicial exception (natural phenomenon according to MPEP 2106.04(b)) into a practical application. “Integration into a practical application’ requires an additional element(s) or combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the exception (See for example, Slide 18 of 2019 PEG training at http://ptoweb.uspto.gov/patents/exTrain/101.html )
Further, in view of Step 2B and the “No” pathway, the claims do not recite additional elements that amount to significantly more than the judicial exception.
Therefore, claims 1, 4-6, 10, 24-27 do not recite eligible subject matter under 35 U.S.C.101 in view of the Subject Matter Eligibility Test for Products and Processes, and the claimed invention is directed to non-statutory subject matter.
Claim Rejections - 35 USC § 102
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.
6. Claims 1-6, 10, 24-27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chen et al. (CN110974950A)(cited in applicant’s IDS submitted 10/20/2022)(See also the WIPO English translation of CN110974950A)(See PTO-892: Notice of References Cited).
See claims 1-6, 10, 24-27 as submitted 9/4/2025.
See also the 35 U.S.C. 112(b) rejection above. In view of the uncertainty, claim 25 is interpreted as SARS-2 β-CoV protein sequence.
Chen et al. teaches: adenovirus vector vaccine for preventing SARS-CoV-2 infection (title)(as recited in claims 1, 2); empty vector [0006](as recited in claim 3); DNA [0011](as recited in claims 1, 4); nucleic acid coding spike protein of SARS-CoV-2 [0007](as recited in claims 1, 5, 26). It is noted claims 6, 27 are interpreted as reciting “comprising” partial sequence coding the S protein (See MPEP 2111). Thus, spike protein is interpreted as comprising partial sequence; cell [0063](as recited in claim 10); amino acid sequence of spike protein (S) of SARS-CoV-2 [0042](as recited in claims 24, 25).
Thus, Chen et al. anticipates the instant claims.
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. Claims 7, 28 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. as applied to claims 1-6, 10, 24-27 above, and further in view of Hotez et al. (US20160376321)(See PTO-892: Notice of References Cited).
See claims 7, 28 as submitted 9/4/2025.
See also the 35 U.S.C. 112(b) rejection above.
See the teachings of Chen et al. above.
Chen et al. does not teach: wherein the SARS-2 B-CoV DNA sequence is a partial sequence coding the S protein from which the receptor binding domain has been removed; wherein the SARS-2 B-CoV protein sequence is a partial S protein sequence, from which the receptor binding domain has been removed.
Hotez et al. teaches: treating or preventing SARS (abstract); including mutated version of a portion of the RBD (abstract); including RBD modification comprising deletion and/or mutation of one or more glycosylation sites of the RBD sequence [0009]; including RBDs that are modified to include deletion of an amino acid that is glycosylated under normal conditions [0009]; including deletions such like that are made in antigenic composition component, such as a vaccine, will preferably not substantially interfere with the antibody recognition of the epitopic sequence [0048]; deletion of N1 [0173].
One of ordinary skill in the art would have been motivated to delete or mutate RBD of SARS-CoV as taught by Hotez et al. with the construct as taught by Chen et al. Chen et al. teaches use of a SARS-CoV spike protein, and Hotez et al., which also teaches use of SARS-CoV spike protein, teaches the advantage of deletion or mutation for treatment of prevention of SARS [0009].
One of ordinary skill in the art would have had a reasonable expectation of success for deleting or mutating RBD of SARS-CoV as taught by Hotez et al. with the construct as taught by Chen et al. There would have been a reasonable expectation of success given the underlying materials (SARS-CoV spike proteins as taught by Hotez et al. and Chen 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 9, 11 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. as applied to claims 1-6, 10, 24-27 above, and further in view of Tang et al. (US20150071964)(See PTO-892: Notice of References Cited).
See claims 9, 11 as submitted 9/4/2025.
See also the 35 U.S.C. 112(b) rejection above.
See the teachings of Chen et al. above. Chen et al. also teaches wherein vaccines contain S protein nucleic acid sequences (plural) expressed in cells and can induce the production of more S protein [0036]; including use of plasmids containing S gene nucleic acid sequence [0039].
Chen et al. does not teach: Ad6. It is noted Chen et al. teaches adenovirus is a commonly used vector [0006].
Tang et al. teaches: adenoviral vector vaccines (abstract); including Ad6 [0043].
One of ordinary skill in the art would have been motivated to use Ad6 taught by Tang et al. with the construct as taught by Chen et al. Chen et al. teaches use of adenovirus vector, and Tang et al., which also teaches use of adenovirus vector, teaches such a vector (See MPEP 2144.06: Substituting equivalents known for the same purpose). Further, it would have been obvious to use additional vectors or plasmids in view of claim 9 as Chen et al. teaches or suggests using nucleic acid sequences (plural) for producing more S protein (as recited in claims 9, 13, 14).
One of ordinary skill in the art would have had a reasonable expectation of success for using Ad6 taught by Tang et al. with the construct as taught by Chen et al. There would have been a reasonable expectation of success given the underlying materials (vector as taught by Tang et al. and Chen 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.
9. Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. as applied to claims 1-6, 10, 24-27 above, and further in view of Wang et al. (“Serological Evidence of Bat SARS-Related Coronavirus Infection in Humans, China,” Virologica Sinica (2018))(See PTO-892: Notice of References Cited).
See claim 12 as submitted 9/4/2025.
See the teachings of Chen et al. above. Chen et al. also teaches wherein vaccines contain S protein nucleic acid sequences (plural) expressed in cells and can induce the production of more S protein [0036].
Chen et al. does not teach: SARSr.
Wang et al. teaches: SARSr-CoV (p. 1); spike protein of SARSr-CoV (p. 2).
One of ordinary skill in the art would have been motivated to use SARSr spike protein taught by Wang et al. with the construct as taught by Chen et al. Chen et al. teaches SARS-CoV and use of multiple sequences for inducing production of more S protein and Wang et al., which also teaches use of SARS-CoV, teaches additional known strains of SARS-CoV such as SARS-CoV as well as such a spike 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 SARSr spike protein taught by Wang et al. with the construct as taught by Chen et al. There would have been a reasonable expectation of success given the underlying materials (S protein as taught by Wang et al. and Chen 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.
10. Claims 13, 14 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. in view of Tang et al. (references cited above).
See claims 13, 14 as submitted 9/4/2025.
See also the 35 U.S.C. 112(b) rejection above.
See the teachings of Chen et al. above. Chen et al. also teaches wherein vaccines contain S protein nucleic acid sequences (plural) expressed in cells and can induce the production of more S protein [0036]; including use of plasmids containing S gene nucleic acid sequence [0039].
Chen et al. does not teach: Ad6. It is noted Chen et al. teaches adenovirus is a commonly used vector [0006].
Tang et al. teaches: adenoviral vector vaccines (abstract); including Ad6 [0043].
One of ordinary skill in the art would have been motivated to use Ad6 taught by Tang et al. with the construct as taught by Chen et al. Chen et al. teaches use of adenovirus vector, and Tang et al., which also teaches use of adenovirus vector, teaches such a vector (See MPEP 2144.06: Substituting equivalents known for the same purpose). Further, it would have been obvious to use additional plasmids in view of claim 13 as Chen et al. teaches or suggests using nucleic acid sequences for producing more S protein (as recited in claims 9, 13, 14).
One of ordinary skill in the art would have had a reasonable expectation of success for using Ad6 taught by Tang et al. with the construct as taught by Chen et al. There would have been a reasonable expectation of success given the underlying materials (vector as taught by Tang et al. and Chen 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.
11. Claims 24-27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-61 of copending Application No. 18/016344.
See claims 24-27 as submitted 9/4/2025.
See also the 35 U.S.C. 112(b) rejection above.
Claims 1-61 of copending Application No. 18/016344 recite a multivalent vaccine for preventing CoV infection comprising more than one protein antigen derived from antigens encoded within a CoV genome; SARS-2; CoV spike protein.
Although the claims at issue are not identical, they are not patentably distinct from each other because both instant claims 24-27 and claims 1-61 of copending Application No. 18/016344 recite at least one β-CoV protein sequence which codes for S protein.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
12. Claims 1, 4, 6, 24, 25, 27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of copending Application No. 17/998607.
See claims 1, 4, 6, 24, 25, 27 as submitted 9/4/2025.
Claims 1-22 of copending Application No. 17998607 recite a vaccine for preventing CoV infection, comprising: at least one sequence selected from the group consisting of a CoV DNA sequence which codes at least a portion of a modified S protein for the CoV, a CoV RNA sequence which codes at least a portion of a modified S protein for the CoV, and a protein sequence for at least a portion of a modified S protein of the CoV, wherein the modified S protein contains at least one modification; comprising deletion.
Although the claims at issue are not identical, they are not patentably distinct from each other because both instant claims 1, 4, 6, 24, 25, 27 and claims 1-22 of copending Application No. 17998607 recite partial sequence coding the S protein; β-CoV virus.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
13. 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 1671