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. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/24/2026 has been entered.
2. Claims 2, 6, 7, 10, 14-16, 18, 19, 23, 26-29, 33-38, 40-43, 48, 50-55, 60-64, 67-82, 84, 85, 88 are canceled. Claims 22, 24, 39, 44-47, 49, 56-59, 65, 66, 83 are withdrawn. Claims 1, 3-5, 8, 9, 11-13, 17, 20, 21, 25, 30-32, 86, 87 are under consideration.
Information Disclosure Statement
3. The information disclosure statement (IDS) was submitted on 6/5/2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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. (new rejection) Claims 1, 3-5, 8, 9, 11-13, 17, 20, 21, 25, 30-32, 86, 87 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 1, 3-5, 8, 9, 11-13, 17, 20, 21, 25, 30-32, 86, 87 as submitted 3/24/2026.
Claims 1, 20 recite “chemically synthesized”. It is not clear what the metes and bounds of such language are.
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.
5. (previous rejection, maintained) Claims 1, 3-5, 8, 9, 12, 13, 17, 20, 25, 30-32, 86 are
rejected under 35 U.S.C. 103 as being unpatentable over Anderson et al. (US20130216566;
previously cited) in view of Wu et al. ("A new coronavirus associated with human respiratory disease in China," Nature, Vol. 579: 265-269 (2020); previously cited) and further in view of
Evans et al. (US20180251736; previously cited) and Tartaglia et al. (U.S. Patent No. 6004777;
previously cited).
See claims 1, 3-5, 8, 9, 12, 13, 17, 20, 25, 30-32, 86 as submitted 3/24/2026.
Applicant contends: poxviruses produced by chemical synthesis are not the same or obvious over the prior art PCR generated poxviruses; rather they likely have sequence differences; poxviruses produced by chemical synthesis have unobvious advantages as indicated in [0077]; the claimed orthopoxvirus is different in structure and superior; taken as a whole, Anderson et al. would have directed the skilled worked to use baculovirus; Anderson et al. neither mentions nor suggests invention as claimed; any supposed motivation would be rooted in hindsight; Wu et al. does not cure the defects of Anderson et al.; Evans et al. does not remedy the defects in Anderson et al. and Wu et al.; Tartaglia et al. does not remedy the defects.
Applicant’s arguments are considered but found unpersuasive.
See the rejection as recited in the previous Office Action.
Response to Arguments
Turning to applicant’s arguments, first, 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). Further, applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
As to the instant claims, it is reiterated that based on the language of the claims the orthopoxvirus is interpreted as a product by process (See MPEP 2113: I. PRODUCT-BY-PROCESS CLAIMS ARE NOT LIMITED TO THE MANIPULATIONS OF THE RECITED STEPS, ONLY THE STRUCTURE IMPLIED BY THE STEPS: "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted) ... II. ONCE A PRODUCT APPEARING TO BE SUBSTANTIALLY IDENTICAL IS FOUND AND A PRIOR ART REJECTION IS MADE, THE BURDEN SHIFTS TO THE APPLICANT TO SHOW AN NONOBVIOUS DIFFERENCE: "The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature" than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an nonobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 799, 803, 218 USPQ 289, 292-33 (Fed. Cir. 1983)). With respect to features or differences, it does not appear that applicant has presented evidence, rather merely 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)). Further with respect to features, in response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
With respect to Anderson et al., the teachings are not so limited as applicant contends,
including as to vectors and promoters. As previously indicated, Anderson et al. teaches or
suggests recombinant viruses such as recombinant poxvirus and baculovirus [0144, 0104], as
well as promoters [0104](See also MPEP 2123: A reference may be relied upon for all that it
would have reasonably suggested to one having ordinary skill in the art, including nonpreferred
embodiments. Merck & Co. V. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.
1989), cert. denied, 493 U.S. 975 (1989)); see also MPEP 2121.01: I. 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 Instruments V. LKB Produkter
AB, 892 F.2d 1547, 1551, 13 USPQ2d 1301, 1304 (Fed. Cir. 1989)).
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
The rejection is maintained for reasons of record.
6. (previous rejection, maintained) Claim 11 is rejected under 35 U.S.C. 103 as being
unpatentable over Anderson et al. in view of Wu et al. and further in view of Evans et al. and
Tartaglia et al. as applied to claims 1, 3-5, 8, 9, 12, 13, 17, 20,25, 30-32, 86 above, and further in
view of He et al. (US20200407402; previously cited).
See claim 11 as submitted 3/24/2026.
Applicant contends: He et al.’s modified SARS protein does not remedy the deficiencies.
Applicant’s arguments are considered but found unpersuasive.
See the rejection as recited in the previous Office Action.
Response to Arguments
Turning to applicant’s arguments, first, 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.
7. (previous rejection, maintained) Claim 87 is rejected under 35 U.S.C. 103 as being
unpatentable over Anderson et al. in view of Wu et al. and further in view of Evans et al. and Tartaglia et al. as applied to claims 1, 3-5, 8, 9, 12, 13, 17, 20, 25, 30-32, 86 above, and further in
view of Haruta (US20180326039; previously cited).
See claim 87 as submitted 3/24/2026.
Applicant contends: Haruta et al.’s modified SARS protein does not remedy the deficiencies.
Applicant’s arguments are considered but found unpersuasive.
See the rejection as recited in the previous Office Action.
Response to Arguments
Turning to applicant’s arguments, first, 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.
8. (new rejection) Claims 1, 8, 9, 25, 86 are rejected under 35 U.S.C. 103 as being unpatentable over Cottingham et al. (US20130195912A1)(cited in applicant’s IDS submitted 6/5/2026) in view of Burt et al. (US20060286124A1)(See PTO-892: Notice of References Cited) and Wu et al. ("A new coronavirus associated with human respiratory disease in China," Nature, Vol. 579: 265-269 (2020); previously cited).
See claims 1, 8, 9, 25, 86 as submitted 3/24/2026.
Cottingham et al. teaches: recombinant poxvirus [0019](as recited in claim 1); vaccinia virus poxvirus [0062]; poxvirus vector comprising transgene, comprising poxvirus promoter and nucleic acid sequence encoding foreign peptide [0079](as recited in claim 1); composition and carrier [0134](as recited in claims 25, 86).
Cottingham et al. does not teach: a nucleic acid encoding a SARS-CoV-2 virus protein, wherein the SARS-CoV-2 virus protein is a spike protein (S),
Burt et al. teaches: coronavirus S (spike) protein [0048](as recited in claims 1, 8); with modifications [0074](as recited in claim 9); nucleic acids encoding immunogens [0061].
Wu et al. teaches: 2019-nCoV (abstract)(also known as SARS CoV-2); spike protein
thereof (p. 267)(as recited in claim 1).
As to claim 1 reciting "derived from chemically synthesized DNA", such a recitation is
interpreted as a product by process claim (See MPEP 2113: I. PRODUCT-BY-PROCESS CLAIMS ARE NOT LIMITED TO THE MANIPULATIONS OF THE RECITED STEPS, ONLY THE STRUCTURE IMPLIED BY THE STEPS: "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted) ... II. ONCE A PRODUCT APPEARING TO BE SUBSTANTIALLY IDENTICAL IS FOUND AND A PRIOR ART REJECTION IS MADE, THE BURDEN SHIFTS TO THE APPLICANT TO SHOW AN NONOBVIOUS DIFFERENCE: "The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature" than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an nonobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 799, 803, 218 USPQ 289, 292-33 (Fed. Cir. 1983)).
One of ordinary skill in the art would have been motivated to use gene as taught by Burt et al. with the virus as taught by Cottingham et al. Cottingham et al. teaches use of transgene, and Burt et al. teaches such a transgene (See MPEP 2144.06: Substituting equivalents known for the same purpose). Further, one of ordinary skill in the art would have been motivated to use coronavirus as taught by Wu et al. with the virus as taught by Cottingham et al. in view of Burt et al. Cottingham et al. in view of Burt et al. teaches use of coronavirus, and Wu et al. teaches such a coronavirus (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 gene and virus as taught by Burt et al. and Wu et al. with the virus as taught by Cottingham et al. There would have been a reasonable expectation of success given the underlying materials (transgene as taught by Burt et al. and Cottingham 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. (new rejection) Claims 3-5, 12, 13, 20 are rejected under 35 U.S.C. 103 as being unpatentable over Cottingham et al. in view of Burt et al. and Wu et al. as applied to claims 1, 8, 9, 25, 86 above, and further in view of Evans et al. (US20180251736; previously cited).
See claims 3-5, 12, 13, 20 as submitted 3/24/2026.
See the teachings of Cottingham et al. in view of Burt et al. and Wu et al. above.
Cottingham et al. in view of Burt et al. and Wu et al. does not teach: wherein the orthopoxvirus is horsepox virus (HPXV); wherein the orthopoxvirus is a horsepox virus; wherein the horsepox virus is strain MNR-76; wherein the nucleic acid encoding the SARS-CoV-2 virus protein is located in a region of the poxvirus that is not essential for replication of the poxvirus; the nucleic acid encoding a SARS-CoV-2 virus protein is located in the thymidine kinase (TK) gene locus of the poxvirus.
Evans et al. teaches: poxvirus for virus vaccine (abstract); orthopoxvirus [0003]; horsepox virus [0003](as recited in claims 3, 4); based on genome of MNR-76 [0027] (as recited in claim 5); lacking TK gene [0192](as recited in claim 13); wherein heterologous nucleic acid is inserted into non-essential region [0198](as recited in claim 12).
As to claim 20, it is noted Evans et al. already teaches wherein the viral genome comprises terminal hairpin loops [0011]. Further, claim 20 recites orthopox virus reactivated from DNA derived from chemically synthesized overlapping DNA fragments and terminal hairpin loops derived from chemically synthesized DNA. Such language as to orthopoxvirus as well as DNA and hairpin loops are interpreted as products by process (See MPEP 2113: I. PRODUCT-BY-PROCESS CLAIMS ARE NOT LIMITED TO THE MANIPULATIONS OF THE RECITED STEPS, ONLY THE STRUCTURE IMPLIED BY THE STEPS: "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product docs not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted)).
One of ordinary skill in the art would have been motivated to use poxvirus as taught by
Evans et al. as vector as taught by Cottingham et al. in view of Burt et al. and Wu et al. Cottingham et al. in view of Burt et al. and Wu et al. teach use of poxvirus vector and use of heterologous nucleic acid, and Evans et al. teaches such a poxvirus vector as well as position of insertion of heterologous nucleic acid (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 poxvirus as taught by Evans et al. as vector as taught by Cottingham et al. in view of Burt et al. and Wu et al. There would have been a reasonable expectation of success given the underlying materials (poxvirus as taught by Cottingham et al. in view of Burt et al. and Wu et al. and Evans 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. (new rejection) Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Cottingham et al. in view of Burt et al. and Wu et al. as applied to claims 1, 8, 9, 25, 86 above, and further in view of He et al. (US20200407402; previously cited).
See claim 11 as submitted 3/24/2026.
See the teachings of Cottingham et al. in view of Burt et al. and Wu et al. above.
Cottingham et al. in view of Burt et al. and Wu et al. does not teach: wherein the amino acid sequence of the SARS-CoV-2 virus S protein comprises one or more substitution K986P with reference to a wild type S protein (SEQ ID NO: 47)
He et al. teaches: coronavirus S protein immunogens (abstract); S immunogen
polypeptides derived from SARS-CoV-2 with mutations at K986P [0006].
One of ordinary skill in the art would have been motivated to use immunogen as taught
by He et al. with the virus as taught by Cottingham et al. in view of Burt et al. and Wu et al. Cottingham et al. in view of Burt et al. and Wu et al. teaches use of SARS-CoV-2 spike protein, and He et al. teaches such a known 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 immunogen as taught by He et al. with the virus as taught by Cottingham et al. in view of Burt et al. and Wu et al. There would have been a reasonable expectation of success given the underlying materials (SARS coronavirus antigens as taught by Cottingham et al. in view of Burt et al. and Wu et al. and He 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.
11. (new rejection) Claims 17, 30-32 are rejected under 35 U.S.C. 103 as being unpatentable over Cottingham et al. in view of Burt et al. and Wu et al. as applied to claims 1, 8, 9, 25, 86 above, and further in view of Tartaglia et al. (U.S. Patent No. 6004777;
previously cited).
See claims 17, 30-32 as submitted 3/24/2026.
See the teachings of Cottingham et al. in view of Burt et al. and Wu et al. above. It is noted that Cottingham et al. teaches use of: host cells [0100].
Cottingham et al. in view of Burt et al. and Wu et al. does not teach; wherein the promoter is a poxvirus-specific promoter; the poxvirus specific promoter is a tandem of a vaccinia virus early and late promoter; wherein the cell is an adherent cell; wherein the cell is a mammalian cell; wherein the mammalian cell is an MRC-5 cell.
Tartaglia et al. teaches: poxvirus vector (abstract); including use of carly and late vaccinia promoter (column 7, line 33); use of MRC-5 cell (Example 2).
One of ordinary skill in the art would have been motivated to use components as taught
by Tartaglia et al. with the vector as taught by Cottingham et al. in view of Burt et al. and Wu et al. Cottingham et al. in view of Burt et al. and Wu et al. teaches use of poxvirus vector and cells, and Tartaglia et al., which also teaches poxvirus vector and cells, teaches components known and used in the art with poxvirus vector (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 components as taught by Tartaglia et al. with the vector as taught by Cottingham et al. in view of Burt et al. and Wu et al. There would have been a reasonable expectation of success given the underlying materials (poxvirus vectors as taught by Cottingham et al. in view of Burt et al. and Wu et al. and Tartaglia 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.
12. (new rejection) Claim 87 is rejected under 35 U.S.C. 103 as being unpatentable over Cottingham et al. in view of Burt et al. and Wu et al. as applied to claims 1, 8, 9, 25, 86 above, and further in view of Haruta (US20180326039; previously cited).
See claim 87 as submitted 3/24/2026.
See the teachings of Cottingham et al. in view of Burt et al. and Wu et al. above.
Cottingham et al. in view of Burt et al. and Wu et al. does not teach: bivalent vaccine.
Haruta teaches: bivalent vaccine [0001]; use of coronavirus antigen [0001].
One of ordinary skill in the art would have been motivated to use vaccine as taught by
Haruta with the composition as taught by Cottingham et al. in view of Burt et al. and Wu et al. Cottingham et al. in view of Burt et al. and Wu et al. teaches antigen for coronavirus (SARS CoV-2), and Haruta also teaches antigen for coronavirus (See MPEP 2144.06: Art Recognized Equivalence for the Same Purpose: 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." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980)).
One of ordinary skill in the art would have had a reasonable expectation of success for
using vaccine as taught by Haruta with the composition as taught by Cottingham et al. in view of Burt et al. and Wu et al. There would have been a reasonable expectation of success given the underlying materials (coronavirus antigens as taught by Haruta and Cottingham et al. in view of Burt et al. and Wu 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
13. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
A. Martyn et al. (WO2021161043A1)(See PTO-892: Notice of References Cited) teaches: TNX-1800 (p. 20). It is noted that Martyn et al. has support for TNX-1800 in WO2021161043A1 priority application 2004007.7.
14. 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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