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
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 May 8, 2026 has been entered.
Applicant’s amendments to claims 21 and 26, and cancellation of claims 25, 27, 28 and 33 in the paper filed 4/17/2026 are acknowledged.
As a result, claim 39 are withdrawn from consideration for being drawn to non-elected invention.
Claims 21, 23, 26, 31, 34, 36-38 and 40-41 and SEQ ID NO: 1-4 and 17-20 as well as construct pr44-BAASS:C0v-S1 are examined on the merits.
2. The rejections and objections not recited in this action are withdrawn.
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.
3. Claim(s) 21, 23 and 40-41 remain rejected under 35 U.S.C. 103 as being unpatentable over Virtanen et al. (WO 2021/2113311) in view of Howard et al. (WO 97/10347) and Conrad et al. (CA2246242) and Hauser et al. (WO 2021/163622).
Instant claims are drawn to a method of expressing Spike(S1) protein of SARS-CoV-2 comprising introducing into a plant a construct comprising a sequence that is with 95%/98%/99% homology to SEQ ID NO:1 and wherein the construct comprises: a) a promoter preferentially directing expression to seed tissue; b) a nucleic acid encoding a S1 polypeptide of said SARS-CoV-2 or a sequence having at least 95% identity thereto operably linked to the promoter and c) a nucleic acid molecule targeting expression of said polypeptide in the endoplasmic reticulum of said plant and selecting a plant expressing said plant levels of at least 50mg/kg of seed of said plant; or wherein said construct comprises two copies of said nucleic acid molecule encoding a S1 polypeptide; or wherein expression of said polypeptide in the endoplasmic reticulum of said plant and expressing said plant levels of at least 50mg/kg of seed of said plant.
.
Virtanen et al. teach using plant as a host to express spike protein of SARS-CoV-2 (paragraph [0236].
Virtanen et al. do not teach seed preferential promoter, or using leader sequence targeting expression in ER or expressing said plant levels of at least 1mg/kg of seed of said plant or two copies of S1 encoding sequence. Virtanen et al. do not teach a construct comprising a sequence that is with 95% homology to SEQ ID NO:1.
Howard et al. a method of expressing spike protein of TGEV under seed specific promoter (Claims 3 and 9).
Conrad et al. teach expression of heterologous protein in plant using seed specific promoter with ER retention signal, KDEL (claim 1).
Hauser et al. teach spike protein that is 98% homology to SEQ ID NO:17 (alignment below).
Given the importance to obtained spike protein of SARS-CoV-2 expressed from plant host, would have been obvious for skilled in the art to adopt expression system of Conrad which comprises both seed preferential promoter and leader sequence targeting expression in ER with reasonable expectation for success given the teaching of Howard that spike protein can be produced in plant seed using seed specific promoter.
Although the combined teaching does not teach a construct comprising a sequence that is with 95%/98%/99% homology to SEQ ID NO:1, such construct is considered as an obvious design choice as skilled in the art can readily use different codon usage to design a nucleotide sequence that is at least 95%/98%/99% to SEQ ID NO:1 encoding the spike protein of Hauser et al.
Although combined teachings do not teach expressing said plant levels of at least 10mg/kg or 50 mg/kg of seed of said plant, such feature would have been obviously exhibited by the modified method
Although combined teachings do not teach two copies of S1 encoding sequence, such limitation is merely considered as a design choice.
Although the combined teaching does not teach spike protein that is 98% homology to SEQ ID NO:17, such protein is considered obvious design choice given that homology could be further improved by conserved amino acid substitution.
Applicants traverse in the paper filed 4/17/2026. Applicants’ arguments have been fully considered but were not found persuasive.
Applicants argue that the combined teachings may, in some case, result in seed having at least 50 mg of S1 polypeptide per kg of seed, but the result is not with certainty (response, pages 7-9).
The Office contends that the modified method of combined teachings use the same promoter to express the same gene as claimed method, therefore, the expression level of 50 mg/kg are considered obvious results. Further, there is no requirement for 100% of the modified plant of combined teaching to have 50 mg/kg of S1 polypeptide expressed. The variance of the expression level is likely due to the location effect of the transgene not from the structure of the transgene of combined teaching itself.
RESULT 16
BJU96677
ID BJU96677 standard; protein; 1269 AA.
XX
AC BJU96677;
XX
DT 30-SEP-2021 (first entry)
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DE MARV GPS-truncated-S-GPTM sequence, SEQ ID 113.
XX
KW Glycoprotein; coronavirus infection; immune stimulation;
KW prophylactic to disease; respiratory-gen.; vaccine, antiviral; virucide.
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OS Marburg marburgvirus.
OS Synthetic.
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CC PN WO2021163622-A1.
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CC PD 19-AUG-2021.
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CC PF 12-FEB-2021; 2021WO-US018033.
XX
PR 14-FEB-2020; 2020US-0976913P.
PR 16-FEB-2020; 2020US-0977402P.
PR 20-MAR-2020; 2020US-0992710P.
PR 18-MAY-2020; 2020US-0026580P.
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CC PA (GEOV-) GEOVAX INC.
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CC PI Hauser MJ, Domi A, Guirakhoo F;
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DR WPI; 2021-95768R/072.
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CC PT New recombinant modified vaccinia Ankara viral vector useful for reducing
CC PT or preventing severe acute respiratory syndrome-coronavirus 2 infection
CC PT in human, comprises heterologous nucleic acid sequence encoding spike,
CC PT membrane, and envelope proteins linked to promoter with systems.
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CC PS Disclosure; SEQ ID NO 113; 392pp; English.
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CC The present invention relates to a novel recombinant modified vaccinia
CC Ankara viral vector, useful for reducing or preventing severe acute
CC respiratory syndrome-coronavirus 2 infection in human. The invention
CC further relates to a vaccine composition for reducing or preventing a
CC SARS-CoV2 infection in human. The rMVA viral vector is useful for
CC reducing or preventing SARS-CoV2 infection.
XX
SQ Sequence 1269 AA;
Query Match 97.5%; Score 3577; Length 1269;
Best Local Similarity 98.0%;
Matches 671; Conservative 4; Mismatches 6; Indels 4; Gaps 1;
Qy 7 SLSLFLVLLGLSAS----LASGVQLPPAYTNSFTRGVYYPDKVFRSSVLHSTQDLFLPFF 62
:| :||||| | :| | : |||||||||||||||||||||||||||||||||||||
Db 18 TLFVFLVLLPLVSSQCVNLTTRTQLPPAYTNSFTRGVYYPDKVFRSSVLHSTQDLFLPFF 77
Qy 63 SNVTWFHAIHVSGTNGTKRFDNPVLPFNDGVYFASTEKSNIIRGWIFGTTLDSKTQSLLI 122
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 78 SNVTWFHAIHVSGTNGTKRFDNPVLPFNDGVYFASTEKSNIIRGWIFGTTLDSKTQSLLI 137
Qy 123 VNNATNVVIKVCEFQFCNDPFLGVYYHKNNKSWMESEFRVYSSANNCTFEYVSQPFLMDL 182
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 138 VNNATNVVIKVCEFQFCNDPFLGVYYHKNNKSWMESEFRVYSSANNCTFEYVSQPFLMDL 197
Qy 183 EGKQGNFKNLREFVFKNIDGYFKIYSKHTPINLVRDLPQGFSALEPLVDLPIGINITRFQ 242
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 198 EGKQGNFKNLREFVFKNIDGYFKIYSKHTPINLVRDLPQGFSALEPLVDLPIGINITRFQ 257
Qy 243 TLLALHRSYLTPGDSSSGWTAGAAAYYVGYLQPRTFLLKYNENGTITDAVDCALDPLSET 302
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 258 TLLALHRSYLTPGDSSSGWTAGAAAYYVGYLQPRTFLLKYNENGTITDAVDCALDPLSET 317
Qy 303 KCTLKSFTVEKGIYQTSNFRVQPTESIVRFPNITNLCPFGEVFNATRFASVYAWNRKRIS 362
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 318 KCTLKSFTVEKGIYQTSNFRVQPTESIVRFPNITNLCPFGEVFNATRFASVYAWNRKRIS 377
Qy 363 NCVADYSVLYNSASFSTFKCYGVSPTKLNDLCFTNVYADSFVIRGDEVRQIAPGQTGKIA 422
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 378 NCVADYSVLYNSASFSTFKCYGVSPTKLNDLCFTNVYADSFVIRGDEVRQIAPGQTGKIA 437
Qy 423 DYNYKLPDDFTGCVIAWNSNNLDSKVGGNYNYLYRLFRKSNLKPFERDISTEIYQAGSTP 482
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 438 DYNYKLPDDFTGCVIAWNSNNLDSKVGGNYNYLYRLFRKSNLKPFERDISTEIYQAGSTP 497
Qy 483 CNGVEGFNCYFPLQSYGFQPTNGVGYQPYRVVVLSFELLHAPATVCGPKKSTNLVKNKCV 542
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 498 CNGVEGFNCYFPLQSYGFQPTNGVGYQPYRVVVLSFELLHAPATVCGPKKSTNLVKNKCV 557
Qy 543 NFNFNGLTGTGVLTESNKKFLPFQQFGRDIADTTDAVRDPQTLEILDITPCSFGGVSVIT 602
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 558 NFNFNGLTGTGVLTESNKKFLPFQQFGRDIADTTDAVRDPQTLEILDITPCSFGGVSVIT 617
Qy 603 PGTNTSNQVAVLYQDVNCTEVPVAIHADQLTPTWRVYSTGSNVFQTRAGCLIGAEHVNNS 662
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 618 PGTNTSNQVAVLYQDVNCTEVPVAIHADQLTPTWRVYSTGSNVFQTRAGCLIGAEHVNNS 677
Qy 663 YECDIPIGAGICASYQTQTNSPRRA 687
|||||||||||||||||||||||||
Db 678 YECDIPIGAGICASYQTQTNSPRRA 702
.
4. Claim(s) 21, 23, 26, 31, 34, 36-38 and 40-41 remain rejected under 35 U.S.C. 103 as being unpatentable over Virtanen et al. (WO 2021/2113311) in view of Howard et al. (WO 97/10347) and Conrad et al. (CA2246242) as applied for claims 21, 23 and 40-41 further in view of Yang et al. (US Patent No. 11,020,474).
Instant claims 21, 23 and 40-41 are discussed above.
The teachings of Virtanen et al., Conrad et al., Howard et al. and Hauser et al. are discussed above.
Claims 26, 31, 34 and 36-38 further contain limitations that a method for using purified SARS-CoV-2 spike protein as vaccine by combining with a recipient.
The combined teachings do not teach using purified SARS-CoV-2 spike protein as vaccine by combining with a recipient.
Howard et al. teach isolate the vaccine antigen from the plant (claim 29). Howard et al. teach a method to administer the immunogenic composition orally to an animal (claim 25).
Yang et al. teach using SARS-CoV-2 spike protein as vaccine. Teach using SARS-CoV-2 spike protein carrier protein combined with spike protein (claims 1-7).
It would have been obvious to use the SARS-CoV-2 spike protein isolated from the combined teaching of Virtanen et al., Conrad et al. and Howard et al. to further combine with carrier protein as taught by Yang et al. and administer the composition as a vaccine orally to animals given such combined method would prevent or reduce the disease caused by the virus.
Although the combined teachings do not teach nasal administration, such limitation would be merely regarded as an obvious design choice for applying vaccine.
Applicants traverse in the paper filed 4/17/2026. Applicants’ arguments have been fully considered but were not found persuasive.
Applicants presented same argument as above. Therefore for the same reason the rejection is maintained.
Conclusion
No claim is allowable.
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/LI ZHENG/Primary Examiner, Art Unit 1662
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