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 .
Election/Restrictions
Applicant’s election without traverse of Group I, corresponding to claims 1 – 9 in the reply filed on 06/09/2026 is acknowledged.
Claims 10 – 18 are withdrawn from further consideration pursuant to 37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.
Claims 1 – 9 are under examination.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency - Sequences appearing in the drawings are not identified by sequence identifiers in accordance with 37 CFR 1.831(c). Sequence identifiers for sequences (i.e., “SEQ ID NO:X” or the like) must appear either in the drawings or in the Brief Description of the Drawings. FIGS. 1D and 5D contain sequences that are not accompanied with sequences identifiers (i.e., “SEQ ID NO:X).
Required response – Applicant must provide:
Amended drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required sequence identifiers (i.e., “SEQ ID NO:X” or the like) into the Brief Description of the Drawings, consisting of:
• A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
• A copy of the amended specification without markings (clean version); and
• A statement that the substitute specification contains no new matter.
Specific deficiency - The Incorporation by Reference paragraph required by 37 CFR 1.821(c)(1) is missing or incomplete. See item 1) a) or 1) b) above.
The file must be submitted in bytes not kilobytes.
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Claim Rejections - 35 USC § 112 - Indefiniteness
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.
Claims 1 – 9 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. The claims are generally narrative and indefinite, failing to conform with current U.S. practice. They appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors.
Claim 1 is rejected for claiming “causing any change, including mutations and/or deletions, that affect the stability or activity of the nsp15. It is unclear as to what causes any change that affects the stability or activity of the nsp15 encompasses. Broadly, any mutation of the virus or even then host cell can cause “any change” that affects the stability or activity of the nsp15, yet it is unclear what “change” beyond mutations is encompassed by the claims. Furthermore, it is unclear as to what “any change” can also include. For example, “change” encompasses increases, decreases, and total inhibition of nsp15 activity. The dependent claims fail to add additional clarity and, therefore, are also indefinite. For purposes of compact prosecution, claim 1 was interpreted to include a live, attenuated coronavirus comprising a variant replicase gene encoding a mutation within the nsp15 gene that affects stability or activity of nsp15 through increasing or decreasing activity.
Claim 2 is rejected for claiming the limitation of amino acid positions within a protein sequence without providing an appropriate frame of reference for said sequence. Accordingly, it is unclear which protein the mutations at positions 98 and 262 are directed towards. Said frame of reference can be provided by referencing a sequence disclosed within the application (i.e. a sequence comprising of SEQ ID NO: identifier) or by referencing a start position for said sequence (i.e. wherein said amino acid is at position X from the starting methionine of the protein..."). For purposes of compact prosecution, the mutations of claim 2 are understood as mutations within and relative to the full-length, wild-type nsp-15 sequence.
Claims 3 – 5 are rejected for claiming the coronavirus is a mutation of a wild-type coronavirus. It is unclear how a coronavirus is a mutation of a wild-type coronavirus. For purposes of compact prosecution, claim 3 is interpreted as a wild-type coronavirus that has a mutation that affects the stability or activity of the nsp15 through increasing or decreasing activity.
Claim Rejections - 35 USC § 112- Written Description
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.
Claims 1 and 3 – 9 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus. See, e.g., Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1340, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010); University of California v. Eli Lilly & Co., 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997) at 1406; Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1337, 2021 USPQ2d 893 (Fed. Cir. 2021) ("[T]he written description must lead a person of ordinary skill in the art to understand that the inventor possessed the entire scope of the claimed invention. Ariad, 598 F.3d at 1353–54 ('[T]he purpose of the written description requirement is to ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification.' (internal quotation marks omitted).").
A “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014). The issue is whether the skilled artisan would understand inventor to have invented, and been in possession of, the invention as claimed.
The Federal Circuit has clarified the application of the written description requirement to inventions in the field of biotechnology. See University of California v. Eli Lilly and Co., 119 F.3d 1559, 1568,43 USPQ2d l398, 1406 (Fed. Cir. 1997). The Court stated that a written description of an invention requires a precise definition, one that defines the structural features of the chemical genus that distinguishes it from other chemical structures. A definition by function does not suffice to define the genus because it is only an indication of what the genus does, rather than what it is. Further, the Court held that to adequately describe a claimed genus, an applicant must describe a representative number of species of the claimed genus, and that one of skill in the art should be able to “visualize or recognize the identity of the members of the genus.”
Instant claims 1 and 3 – 9 broadly encompass a live, attenuated coronavirus with any “change,” including mutations, that affects the stability or activity of the nsp15 protein.
The Specification has failed to sufficiently describe the structural features that must be retained by members of the claimed genus as to establish a structure-function relationship with respect to generating a live, attenuated virus due to instability or non-functionality of the nsp15 protein through increasing or decreasing activity.
The claims only limit a live, attenuated coronavirus comprising a variant replicase gene that encodes nsp15 and a mutation without any identification of the key regions or sequences. For instance, it is not clear if any mutations at any position nsp15 would result in a live, attenuated virus i.e., it is not clear which amino acids within the nsp15 protein can be mutated to produce a live, attenuated virus. Moreover, the claims and Specification do not identify which residues, positions, or structures must be mutated and how they must be mutated in order to achieve the claimed function of arriving at a live, attenuated coronavirus. It is also unclear if the mutations that result in an increase of decrease of activity that ultimately results in instability or non-functionality of the nsp15 protein are limited to the nsp15 gene, any viral gene, and/or any mutation within the host cell or organism. The claims and Specification, as written, fail to describe of any substantive structure or structural limitations needed for the function of successfully to generating a live, attenuated virus due to instability or non-functionality of the nsp15 protein through increasing or decreasing activity.
While the instant claims are drawn to a genus that comprises innumerable possible variants, the Specification has only adequately described and successfully reduced to practice T98M and H262A mutations of the MHV-A59 virus (Figure 1, ¶0026, 0045). The Specification also appears to note a nsp15 deficient porcine epidemic diarrhea virus (PEDV), but it is not clear what mutation causes the deficiency (Figure 9, ¶0022). As such, the Specification reasonably demonstrates that Applicant was in possession of variants having only T98M and H262A mutations in nsp15 of MHV-A59 and a mutated PEDV. However, this is not representative of the extremely large genus of variants claimed, since there is no evidence of the innumerable mutations and viruses contained within a genus of sequences would function to produce a live, attenuated virus due to instability or non-functionality of the nsp15 protein through increasing or decreasing activity. The Specification also fails to disclose which regions, key amino acids, etc. must be must be mutated to affect nsp15 function. The claims improperly define the genus based on what it does—not what it is.
The data generated for the select mutations and viruses described in the Specification and Drawings cannot reasonably be extrapolated and applied to support possession of the entire claimed genus of variants thereof because there are no indications that the genus of mutations and viruses would function to generate a live, attenuated virus due to instability or non-functionality of the nsp15 protein through increasing or decreasing activity. As in Ariad, merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species. “A patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion.” Brenner v. Manson, 383 U.S. 519, 536 (1966).
Guarino et al (J Mol Biol, 10.1016/j.jmb.2005.09.007, 2005, hereinafter, “Guarino”) evidences large scale mutagenesis of nsp15 of a SARS coronavirus and the role of mutations in viral fitness (Abstract). Guarino evidences a comprehensive mutagenetic probing of nsp15 using an alanine scan approach (Abstract, Section: Structure–function analysis of Nsp15, Figure 2). Guarino evidences that mutations in nsp15 does not necessarily result in the stability or activity of nsp15 (Figure 2). Guarino states that the “Most of the mutants showed a level of activity that was within twofold of the wild-type enzyme, indicating that their activities were not affected significantly by the substitution.” Therefore, Guarino evidences that any catalytic histidine to alanine mutation will not predictably result in a change in the stability or activity of nsp15 (figure 2). The Specification fails to describe any substantive structural limitations as to establish a structure-function relationship with respect to generating a live, attenuated virus due to instability or non-functionality of the nsp15 protein through increasing or decreasing activity.
In the absence of a representative number of examples, the Specification must at least
describe the structural features that are required for the claimed function, in this case to generate a live, attenuated virus due to instability or non-functionality of the nsp15 protein through increasing or decreasing activity. However, as discussed above, the Specification fails to describe any substantive structural limitations as to establish a structure-function relationship with respect to generating a live, attenuated virus due to instability or non-functionality of the nsp15 protein through increasing or decreasing activity.
Accordingly, the claims as currently written are not adequately described and one of skill in the art would readily appreciate that Applicant was not in possession of the claimed genus at the time of filing.
Claim Rejections - 35 USC § 112 – Dependency
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 4 and 5 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 4 recites the limitation “wherein the wild-type coronavirus is a Coronavirinae virus." As evidenced by Khursheed et al (MIcrobila Pathogenesis, 2021, 10.1016/j.micpath.2021.104933, hereinafter, “Khursheed”), coronaviruses are a species of viruses belonging to the subfamily Coronavirinae, in the family of Coronaviridae (Section: Classification of coronaviruses). Coronavirinae encompasses a broader group that includes coronaviruses. Therefore, claiming that the coronavirus is a Coronavirinae virus does not further limit the claim from which it depends, and may be construed as broadening the breadth of the claimed invention.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 – 4 and 6 – 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Deng et al (PNAS, 2017, 10.1073/pnas.1618310114, hereinafter, “Deng”), as evidenced by Yount et al (J Virology, 2002, 10.1128/jvi.76.21.11065-11078.2002, hereinafter, “Yount”).
Deng discloses the function of mouse coronavirus nonstructural protein 15 (nsp15) in the evasion of dsRNA sensors during infection (Abstract). Deng characterizes nsp15 mutations within mouse bone marrow-derived macrophages (Abstract). Deng discloses that mutations to nsp15 can result in the stability of the mutant virus (Abstract). Furthermore, Deng discloses that mutations of nsp15 can be leveraged to generate live-attenuated vaccines (Abstract).
Regarding claim 1, Deng discloses mutant mouse hepatitis virus strain A59 (MHV-A59) with mutations in nsp15 (¶2, Figure 1). Deng also discloses the use of the mutant virus as a live attenuated coronavirus to immunize mice (Figure 8, Section: MHV nsp15 Mutant Viruses Confer Protective Immunity against WT Virus Infection).
Regarding claim 2, Deng discloses T98M and H262A mutations of nsp15 (Figure 1).
Regarding claims 3 and 4, Deng discloses mutating the threonine to methionine at position 98 of nsp15 in the wild-type coronavirus, MHV-A59 (¶2, Figure 1).
Regarding claim 6, Deng discloses a variant replicase gene of claim 1 (Section: Mutant Viruses and Deep Sequencing).
Regarding claim 7, Deng discloses a protein encoded by the variant replicase gene of claim 6 (Figure 5, S5).
Regarding claim 8, Deng discloses a variant replicase gene of claim 1 (Section: Mutant Viruses and Deep Sequencing). Deng also discloses that MHV-A59 mutant viruses were generated using reverse genetics as described by Yount (Section: Mutant Viruses and Deep Sequencing). Yount evidences cloning MHV-A59 PCR amplicons into the plasmids Topo II TA, pGEM-TA, or pSMART vectors, which includes replicase genes (Section: Mutagenesis, cloning, and sequencing of the MHV-A59 genome).
Regarding claim 9, Deng discloses the live, attenuated, mutant coronavirus with a carrier in the form of serum-free media (Section: Infection and Mouse Experiments). As defined by the Specification, a carrier can be aqueous solution (¶0056 of instant application).
Accordingly, the claimed invention was anticipated by Deng.
Claim(s) 1 – 9 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Baker et al (US20180333482A1, hereinafter, “Baker”), as evidenced by Xie et al (Nature protocols, 2021, 10.1038/s41596-021-00491-8, hereinafter, “Baker”).
Baker discloses the characterization of MHV nsp15 in its role in virus infection (Abstract). Baker also discloses live, attenuated coronavirus with mutated nsp15(Abstract). Furthermore, Baker discloses that this mutation can be in many different species of coronavirus (Abstract).
Regarding claim 1, Baker discloses comprising a variant replicase gene encoding polyproteins comprising a nsp15 with mutations that affects the stability or activity of the nsp15 (Claim 1).
Regarding claim 2, Baker discloses T98M and H262A mutations of nsp15 (Claim 2).
Regarding claims 3 and 4, Baker discloses mutating wild-type coronavirus (Claims 3 and 4).
Regarding claim 5, Baker discloses the coronavirus can be porcine epidemic diarrhea virus (PEDV) (Claim 5).
Regarding claim 6, Baker discloses a variant replicase gene of claim 1 (Claims 6 and 8).
Regarding claim 7, Baker discloses a protein encoded by the variant replicase gene of claim 6 (Claim 7).
Regarding claim 8, Baker discloses a variant replicase gene of claim 1 (Claims 6 and 8). Baker discloses using a reverse genetics system to generate MHV-A29 mutant viruses (¶0064). Xie evidences a protocol for reverse genetics for the coronavirus SARS-CoV-2 (Abstract). Xie evidences reverse genetics involves taking nucleic acid fragments of the virus and inserting them into plasmids (Figure 1, Section: Stage 1: Propagation of plasmids containing SARS-CoV-2 fragments).
Regarding claim 9, Baker discloses the live, attenuated, mutant coronavirus with a carrier (Claim 9).
Accordingly, the claimed invention was anticipated by Baker.
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.
Claims 1 – 6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of U.S. Patent No. US11684667B2 in view of Deng. Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant application and U.S. Patent No. US11684667B2 are drawn to a live, attenuated coronavirus where a wild-type coronavirus comprising a variant replicase gene encoding a nsp15 with mutations.
Instant claims 1 – 6 are drawn to a live, attenuated coronavirus where a wild-type coronavirus comprising a variant replicase gene encoding a nsp15 with mutations. These mutations can be comprised of a T98M or H262A mutation. The coronavirus can be a porcine epidemic diarrhea virus (PEDV). US Patent ‘667 claim 1 is drawn to a method of stimulating an immune response by administering a composition comprising a live, attenuated PEDV comprising one or more mutations in nsp15. US Patent ‘667 claim is drawn to the method of claim 2 wherein the nsp15 mutation comprises a histidine to alanine substitution.
The scope of the conflicting U.S. Patent and the instant application significantly
overlaps. These claims make claim 1 – 6 of the instant application obvious. While ‘667 does not teach the exact histidine to alanine substitution of nsp15, ‘667 does teach that the nsp-15 can have a histidine to alanine mutation in nsp15.
As discussed above, Deng discloses mutant MHV-A59 with mutations in nsp15 (¶2, Figure 1). Deng also discloses the use of the mutant virus as a live attenuated coronavirus to immunize mice (Figure 8, Section: MHV nsp15 Mutant Viruses Confer Protective Immunity against WT Virus Infection). Deng discloses T98M and H262A mutations of nsp15 in the wild-type coronavirus, MHV-A59 establishing that the idea of is well known in the art (¶2, Figure 1).
Both ‘667 and Deng aim to create live, attenuated coronavirus by mutating nsp15. Therefore, it would have been prima facie obvious before effective filing date of the claimed invention to have included a H262A mutation in the nsp15 of Coronaviridae because mutations of catalytic histidine that result in a loss of endoribonuclease enzymatic activity altering nsp15 activity. One of ordinary skill in the art would have reasonable expectation of success in mutating catalytic histidines of nsp15 given that this method is well known, has been successfully demonstrated, and commonly used in the prior art.
Conclusion
NO CLAIMS ARE ALLOWED
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Danyal H Alam whose telephone number is (571)272-1102. The examiner can normally be reached M - F 9am - 5pm.
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/DANYAL HASSAN ALAM/Examiner, Art Unit 1672
/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672
Prosecution Insights