DETAILED ACTION
Disposition of Claims
Claims 1-3, 5-13, 19, 21, 27-30, and 33-34 are pending.
Examiner’s Note
All paragraph numbers (¶) throughout this office action, unless otherwise noted, are from the US PGPub of this application US20230285544A1, Published 09/14/2023.
Applicant is encouraged to utilize the new web-based Automated Interview Request (AIR) tool for submitting interview requests; more information can be found at https://www.uspto.gov/patent/laws-and-regulations/interview-practice.
Optional Authorization to Initiate Electronic Communications
The Applicant’s representative may wish to consider supplying a written authorization in response to this Office action to correspond with the Examiner via electronic mail (e-mail). This authorization is optional on the part of the Applicant’s representative, but it should be noted that the Examiner may not initiate nor respond to communications via electronic mail unless and until Applicant’s representative authorizes such communications in writing within the official record of the patent application. A sample authorization is available at MPEP § 502.03, part II. If Applicant’s representative chooses to provide this authorization, please ensure to include a valid e-mail address along with said authorization.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 02/28/2025 and 01/27/2023 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Notably, the disclosure statement filed lists a Search Report. The listing of the references cited in a Search Report itself is not considered to be an information disclosure statement (IDS) complying with 37 CFR 1.98. 37 CFR 1.98(a)(2) requires a legible copy of: (1) each foreign patent; (2) each publication or that portion which caused it to be listed; (3) for each cited pending U.S. application, the application specification including claims, and any drawing of the application, or that portion of the application which caused it to be listed including any claims directed to that portion, unless the cited pending U.S. application is stored in the Image File Wrapper (IFW) system; and (4) all other information, or that portion which caused it to be listed. In addition, each IDS must include a list of all patents, publications, applications, or other information submitted for consideration by the Office (see 37 CFR 1.98(a)(1) and (b)), and MPEP § 609.04(a), subsection I. states, "the list ... must be submitted on a separate paper." Therefore, the references cited in the Search Report have not been considered. Applicant is advised that the date of submission of any item of information or any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the IDS, including all "statement" requirements of 37 CFR 1.97(e). See MPEP § 609.05(a).
Note: If copies of the individual references cited on the Search Report are also cited separately on the IDS (and these references have not been lined-through) they have been considered.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because of the use of implied phraseology (e.g. “The present disclosure is directed…”). A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claim 1 is objected to because of the following informalities: a period is required at the end of the claim. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b); Second Paragraph
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.
Claim 1 and dependent claims 2-3, 5-13, 19, 21, 27-30, and 33-34 thereof 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.
Claim 1 provides the limitation “wherein said nucleotide sequence of said recombinant nucleic acid construct does not encode one or more functional coronaviridae proteins.” From the wording of the claim, it is unclear if the nucleotide sequence:
only encodes non-functional Coronaviridae (CoV) proteins (e.g. nucleotide sequence comprises all CoV proteins, translates all proteins, but one or more of said CoV proteins is not functional);
if the nucleotide sequence is a CoV genome that is deleted for at least one CoV protein;
if the nucleotide sequence comprises all CoV proteins but has a failure to translate one or more of said CoV proteins; or
is a nucleotide sequence that only comprises CoV 5’/3’ UTRs and no other CoV sequences.
While there are multiple alternate embodiments, and large breadth does not necessarily equal indefiniteness, in the instant claims, it is unclear as to what exactly is intended to be encompassed, or not encompassed, by the claim limitations. For instance, if situation 4 is the defective-interfering coronavirus virus-like particle (DI-CoV-VLP) generated, then it is unclear how dependent claim 6 would further limit claim 1 if there are to be no CoV proteins present.
One suggestion, following the guidance of the specification at ¶[0021], is to amend the claims along the lines of the following to make it clear that 1) the 5’ and 3’ CoV UTRs must be present, and 2) the nucleotide sequence is one that comprises a CoV genome that is shorter than full-length wild-type genomes due to deletions in the overall genome that allow it to replicate and package faster.
“1. A recombinant nucleic acid construct encoding a defective interfering (DI) coronaviridae (CoV) virus-like particle (VLP), said recombinant construct comprising:
a nucleotide sequence that comprises a CoV genome that comprises one or more deletions compared to a full-length, wild-type CoV genome, wherein said nucleotide sequence encodes CoV replication signals comprising:
a nucleotide sequence from the CoV virus 5′ untranslated region (5′ UTR), and
a nucleotide sequence from the CoV virus 3′ untranslated region (3′ UTR),
wherein said 3′ UTR nucleotide sequence is positioned 3′ to the 5′ UTR nucleotide sequence, and wherein said one or more deletions results in the structural and/or functional deletion of at least one or more CoV protein open reading frames (ORFs).”
Since a skilled artisan would not be reasonably apprised as to the metes and bounds of the claimed invention, instant Claim 1 is rejected on the grounds of being indefinite. Claims 2-3, 5-13, 19, 21, 27-30, and 33-34 are also rejected since they depend from claim 1, but do not remedy these deficiencies of claim 1.
Claims 6-7 and 9-10 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.
Claim 6 recites the limitation "the coronaviridae virus non-structural protein 1 (nsp1)" in lines 4-5 of the claim. There is insufficient antecedent basis for this limitation in the claim, as there is no singular sequence for all species of coronaviridae virus nsp1 proteins, and each nsp1 is unique to the species of coronaviridae virus and should therefore utilize the indefinite article “a” instead of the definite article “the” (e.g. …a nucleotide sequence encoding a portion of a coronaviridae virus non-structural protein 1 (nsp1)…"). Claims 7 and 9-10 are rejected for similar reasoning with respect to the coronavirus proteins recited in each claim.
For at least these reasons, claims 7 and 9-10 are rejected on the grounds of being indefinite.
Claim 34 is 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.
Claim 34 recites the limitation "the patient" in line 4. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, “the patient” in line 4 will be interpreted as reading on “said subject.”
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.
Claims 1-3, 5-12, 27-30, and 33-34 are rejected under 35 U.S.C. 101 because the claimed invention is directed to naturally-occurring coronavirus (CoV) defective-interfering (DI) particles which form virus-like particles (DI-CoV-VLP) without significantly more. The claims recite a recombinant nucleic acid construct encoding a defective interfering (DI) coronaviridae (CoV) virus-like particle (VLP), said recombinant construct comprising:
a nucleotide sequence encoding coronaviridae replication signals comprising:
a nucleotide sequence from the coronaviridae virus 5′ untranslated region (5′ UTR), and
a nucleotide sequence from the coronaviridae virus 3′ untranslated region (3′ UTR),
wherein said 3′ UTR nucleotide sequence is positioned 3′ to the 5′ UTR nucleotide sequence, and wherein said nucleotide sequence of said recombinant nucleic acid construct does not encode one or more functional CoV proteins.
This judicial exception is not integrated into a practical application because the art has shown that DI particles are a natural part of the viral replication process, especially in CoV, and evidence has shown these arise naturally in SARS CoV-2 (See e.g. Makino S, et. al. Adv Exp Med Biol. 1987;218:187-95.; Makino S, et. al. Virology. 1988 Mar;163(1):104-11.; Girgis S, et. al. Commun Biol. 2022 Oct 27;5(1):1140.). The claims does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there is nothing structurally claimed to distinguish these DI-CoV-VLP from those DI-CoV-VLP which occur naturally, which replicate and arise naturally in a host during the normal course of infection, or DI-CoV-VLP which may be naturally transmitted from one host or subject to another. For instance, the method of treatment claimed using the DI-CoV-VLP is claimed generically enough that it reads upon any mode of delivery, such as mucosal, which is a reasonable natural transmission method of DI-CoV-VLP from one host to another. The pharmaceutical compositions also are ineligible as a “pharmaceutically acceptable carrier” includes carriers that will not markedly change the DI-CoV-VLP, such as water (¶[0086-0087]). One suggestion is to incorporate limitations from claims not included in this rejection into the independent claim. Another suggestion is to claim specific DI-CoV-VLP constructs that cannot read on natural products, such as DI-CoV-VLP which utilize heterologous sequences, such as heterologous genes, tags, or replication elements (e.g. promoters, IRES, etc.)
For at least these reasons, claims 1-3, 5-12, 27-30, and 33-34 are rejected on the grounds of being drawn to ineligible subject matter.
Claim 28 is rejected under 35 U.S.C. 101 because Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 28 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). It is suggested that claim 28 be amended to read upon “An isolated host cell” in order to overcome this rejection.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art.
Claim 1 is drawn to a recombinant nucleic acid construct encoding a defective interfering (DI) coronaviridae (CoV) virus-like particle (VLP), said recombinant construct comprising:
a nucleotide sequence encoding coronaviridae replication signals comprising:
a nucleotide sequence from the coronaviridae virus 5′ untranslated region (5′ UTR), and
a nucleotide sequence from the coronaviridae virus 3′ untranslated region (3′ UTR),
wherein said 3′ UTR nucleotide sequence is positioned 3′ to the 5′ UTR nucleotide sequence, and wherein said nucleotide sequence of said recombinant nucleic acid construct does not encode one or more functional CoV proteins.
Further limitations on the recombinant nucleic acid construct of claim 1 are wherein the CoV is a human CoV (claim 2), such as severe acute respiratory syndrome coronavirus 2 (SARS CoV-2)(claim 3); wherein the construct comprises the entire 5′ UTR nucleotide sequence and the entire 3′ UTR nucleotide sequence of the CoV (claim 5); wherein the nucleotide sequence encoding the CoV replication signals further comprises:
a nucleotide sequence encoding a portion of a CoV non-structural protein 1 (nsp1), wherein said nsp1 encoding nucleotide sequence is positioned 3′ to the 5′ UTR nucleotide sequence of the construct (claim 6); wherein the nucleotide sequence encoding the CoV replication signals further comprises:
a nucleotide sequence encoding a portion of a CoV ORF10, wherein said ORF10 encoding nucleotide sequence is positioned 5′ to the 3′ UTR nucleotide sequence of the construct (claim 7); wherein the recombinant nucleic acid construct further comprises:
a nucleotide sequence encoding a CoV packaging signal, wherein said packaging signal nucleotide sequence is positioned 3′ to the 5′ UTR nucleotide sequence of the construct (claim 8), wherein the nucleotide sequence encoding the CoV packaging signal comprises a nucleotide sequence encoding a portion of a CoV non-structural protein 15 (nsp15)(claim 9), wherein the nucleotide sequence encoding the CoV packaging signal comprises a nucleotide sequence encoding a portion of a CoV N protein (claim 10); wherein the recombinant nucleic acid construct further comprises:
a further nucleotide sequence encoding a portion of an ORF3a, a portion of an E protein, or a portion of an ORF3a and a E protein, wherein said further nucleotide sequence portion is positioned 5′ to the 3′ UTR nucleotide sequence (claim 11); further comprising a promoter sequence operatively coupled to the 5′ UTR nucleotide sequence of the construct (claim 12); wherein the nucleic acid construct comprises:
a nucleotide sequence selected from the group consisting of SEQ ID NO: 27, SEQ ID NO: 29, SEQ ID NO: 31, SEQ ID NO: 33 and SEQ ID NO: 35, or
a nucleotide sequence having at least 80% sequence identity to SEO ID NO: 27, SEO ID NO: 29, SEQ ID NO: 31, SEQ ID NO: 33 or SEQ ID NO: 35 (claim 13), wherein the construct further comprises one or more primer/probe nucleotide sequences selected from the group consisting of SEQ ID NO: 37, SEQ ID NO: 38, and SEQ ID NO: 39 (claim 19); wherein the nucleic acid construct comprises:
a nucleotide sequence selected from the group consisting of SEQ ID NO: 28, SEQ ID NO: 30, SEO ID NO: 32, SEO ID NO: 34, and SEQ ID NO: 36, or
a nucleotide sequence having at least 80% sequence identity to SEQ ID NO: 28, SEQ ID NO: 30, SEQ ID NO: 32, SEQ ID NO: 34, or SEQ ID NO: 36 (claim 21); a vector comprising the recombinant nucleic acid construct of claim 1 (claim 27); an isolated host cell comprising the vector of claim 27 (claim 28), wherein said host cell further comprises a helper virus (claim 29); a defective interfering coronaviridae virus-like particle (DI-CoV-VLP) produced from the recombinant nucleic acid construct of claim 1 (claim 30); a pharmaceutical composition comprising the defective interfering coronaviridae virus-like particle (DI-CoV-VLP) of claim 30, and a pharmaceutically acceptable carrier (claim 33)
Claim 34 is drawn to a method of treating a subject infected with a CoV, said method comprising:
administering to said subject the pharmaceutical composition of claim 33 in an amount effective to impair replication and spread of the CoV in said subject.
Claim Rejections - 35 USC § 112(a); First Paragraph
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.
Claim 34 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for pharmaceutical compositions comprising specific DI-SARS CoV-2-VLPs (See e.g. ¶[0100], synthetic defective genomes 1 and 2; ¶[0105] DI and DI0) to treat or inhibit a SARS CoV-2 infection in a subject, does not reasonably provide enablement for any DI-CoV-VLP of claim 1 to impair replication and spread of any CoV in any subject. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
The legal considerations that govern enablement determinations pertaining to undue experimentation have been clearly set forth. Enzo Biochem, Inc., 52 U.S.P.Q.2d 1129 (C.A.F.C. 1999). In re Wands, 8 U.S.P.Q.2d 1400 (C.A.F.C. 1988). See also MPEP § 2164.01(a) and § 2164.04. Ex parte Forman 230 U.S.P.Q. 546 (PTO Bd. Pat. App. Int., 1986). The courts concluded that several factual inquiries should be considered when making such assessments including: the quantity of experimentation necessary, the amount of direction or guidance presented, the presence or absence of working examples, the nature of the invention, the state of the prior art, the relative skill of those in that art, the predictability or unpredictability of the art and the breadth of the claims. In re Rainer, 52 C.C.P.A. 1593, 347 F.2d 574, 146 U.S.P.Q. 218 (1965). The disclosure fails to provide adequate guidance pertaining to a number of these considerations as follows:
Nature of the invention/Breadth of the claims. The claims are drawn to a method of treating a subject infected with a CoV, said method comprising administering to said subject the pharmaceutical composition of claim 33 in an amount effective to impair replication and spread of the CoV in said subject. The breadth of “subject” is any subject that may be infected with any coronavirus (CoV). The breath of “administering” is drawn to any means of administering a composition to a subject, such as oral, nasal, buccal, intraperitoneal, subcutaneous, intradermal, intravenous, or mucosal. The breadth of the CoV which is infecting said subject is any CoV, and the breadth of the CoV used to make the defective interfering CoV virus-like particle (VLP) is any CoV which may be homologous or heterologous to the CoV which is infecting said subject.
State of the prior art/Predictability of the art. Defective interfering (DI) particles arise naturally during virus propagation, are conditional on parental virus for replication and packaging, and interfere with viral expansion, and over the years there has been much interest in developing DIs as anti-viral agents, especially with the emerging COVID-19 pandemic (see e.g. U of Wisconsin-Madison, College of Engineering. “How a UW-Madison engineer could help beat a virus at its own game.” Online 04/08/2020, https://engineering.wisc.edu/news/how-a-uw-madison-engineer-could-help-beat-a-virus-at-its-own-game/.)
Coronaviruses (CoVs) are positive-sense, single-stranded RNA viruses whose genomes are 26–32 kb. The first two-thirds of the coronavirus genome consists of two large open reading frames (ORFs) encoding non-structural proteins that function in viral replication. The rest of the viral genome includes ORFs that are transcribed into subgenomic mRNAs through a process of discontinuous transcription that encodes structural and accessory proteins. The 5′ and 3′ untranslated regions (UTRs) contain structural features essential for replication.
As noted with other positive-strand RNA viruses, coronaviruses show high rates of recombination. Replication-induced errors, coupled with recombination between coronavirus genomes, add to the genetic diversity of the viral pool, are responsible for the emergence of new viral variants2, and generate defective viral genomes (DVGs) harboring large deletions. On occasion, DVGs that maintain the ability to replicate and be packaged in the presence of helper virus emerge, and these are known as defective interfering (DI) particles. Naturally selected DI genomes have been characterized for several coronavirus members, including murine hepatitis virus, transmissible gastroenteritis virus, bovine coronavirus, and infectious bronchitis virus. As well, synthetic DIs based on the human 229E and SARS-CoV-2 coronavirus genomes were recently designed and shown capable of reducing viral genomic RNA (gRNA) levels or viral titers in vitro and in vivo; presumably a consequence of competition with the parental virus for limiting cellular and/or viral resources (See e.g. Girgis S, et. al. Commun Biol. 2022 Oct 27;5(1):1140.)
CoV cross-protection can vary, depending on the host and CoV. Infectious bronchitis virus (IBV) is a chicken CoV that has a vaccine; however, the efficacy of said vaccine is short-lived and affords poor protection from heterologous strains of IBV. The strength of cross-protection between variants is predicted by differences in the S1 subunit of the spike (S) protein, the site of most neutralizing antibody epitopes. Of note for live attenuated vaccine strategies, high rates of recombination and frequent exposure of chickens to multiple vaccine and field IBV strains can contribute to the generation of novel virus strains and reversion to virulence (Jackwood MW. Avian Dis (2012) 56 (4): 634–641.) Intriguingly, immunization with a Venezuelan equine encephalitis replicon particle (VRP) encoding a SARS-CoV N protein CD4+ T cell epitope resulted in some degree of cross-protection against MERS-CoV, resulting in reduced viral load. This epitope is fairly well conserved between these two and related bat coronaviruses. It was observed that mice immunized with the MERS-CoV-specific epitope mediated some protection upon SARS-CoV infection, and the homologous epitope in a MERS-like bat coronavirus (HKU4) mediated protection against MERS-CoV challenge. (Sariol A, et. al. Immunity. 2020 Aug 18;53(2):248-263. Epub 2020 Jul 14.)
Working examples. The working example disclosed in the specification focuses on generation of SARS CoV-2 defective genomes, and the DI-CoV-VLPs generated therefrom and their ability to inhibit homologous SARS CoV-2 challenge (See e.g. Examples 1-5 starting at ¶[0100]). It does not appear as though any non-SARS CoV-2 DI-CoV-VLPs were generated and tested for their ability to inhibit SARS CoV-2 infection or infection from any other heterologous or homologous CoV.
Guidance in the specification. The specification provides guidance towards the generation of specific SARS CoV-2 defective genomes which produce specific DI-CoV-VLPs. It does not appear as though said DI-CoV-VLPs have been tested for their ability to generate cross-protective immune responses, nor does it appear as though any other non-SARS CoV-2 DI-CoV-VLPs were generated and tested for their ability to inhibit SARS CoV-2 replication, replication from a homologous CoV, or replication from any other heterologous CoV. It is unclear what CoV open reading frames (ORFs) would/would not need to be retained in said DI-CoV-VLPs in order to confer cross-protection. It is unclear if these DI-CoV-VLP constructs would be able to confer protection against CoV in all species affected by CoV infections.
Amount of experimentation necessary. Additional research is required in order to determine how effective any DI-CoV-VLP of claim 1 delivered through any means can impair replication and spread of any heterologous or homologous CoV in any subject.
In light of the Supreme Court decision in Amgen Inc. et al. v. Sanofi et al., 143 S. Ct. 1243 (2023) (hereafter Amgen), updated guidelines were provided regarding the assessment of enablement (Federal Register, pp. 1563-1566; Pub. Jan. 10, 2024.) In Amgen, the Supreme Court unanimously affirmed that a genus of monoclonal antibodies were not enabled because when a range within a genus is claimed, there must be reasonable enablement of the scope of the range. The Court found in Amgen that due to the large number of possible candidates within the scope of the claims and the specification's corresponding lack of structural guidance, it would have required undue experimentation to synthesize and screen each candidate to determine which compounds in the claimed class exhibited the claimed functionality. In the instantly claimed invention, the breadth of DI-CoV-VLPs which may be assembled, combined with the breadth of possible subjects which may be treated, and the CoV which may be susceptible to said DI-CoV-VLP, along with the breath of administration methods, generates enough permutations encompassed by the claimed invention that makes the experimentation required undue to determine if said methods are enabled.
For the reasons discussed above, it would require undue experimentation for one skilled in the art to make and/or use the claimed methods.
Claim Rejections - 35 USC § 102
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 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.
Claims 1-3, 5-12, 27-30, and 33-34 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Hauser (US20230227830A1; Priority 06/20/2020; hereafter “Hauser”.)
The Prior Art
Hauser teaches defective interfering RNA genomes and particles from coronaviruses (¶[0022-0023]), and teaches defective coronavirus (CoV) genomes which are packaged into particles and comprise a 5’ leader (which comprises a 5’ UTR, see Fig. 8; instant claim 5) and 3’ UTR, wherein said defective genome lacks CoV sequences and/or comprises mutated sequences or deleted elements that prevent expression of the entire genome (¶[0024-0030]; Figs. 6-7; instant claims 1, 30). Hauser teaches the CoV may be SARS CoV-2 (¶[0011-0014][0019]; Fig. 7; instant claims 2-3) and may include nsp1 (¶[0078]; Fig. 8; instant claim 6), ORF10 (¶[0072]; Fig. 8; instant claim 7), packaging signals (¶[0075]; Fig. 8; instant claim 8), ORF1b (which includes the information for nsp15; ¶[0028-0029][0033][0045]; Figs. 13-14, 18; instant claim 9); N protein (¶[0016][0078]; Fig. 1; instant claim 10); and at least portions of ORF3a (Fig. 3; ¶[0018]; instant claim 11), wherein the noted loci are in between the 5’ upstream and 3’ downstream UTR elements. Hauser teaches in one construct, a T7 promoter flanks the defective-interfering genome (reference claim 50; Figs. 17-18; instant claim 12), wherein the DI-genome is expressed in a heterologous expression vector (¶[0034][0037]; instant claim 27) from a variety of cell lines which may additionally comprise helper viruses (Figs. 4-8, 17;¶[0040-0041]; instant claims 28-29). The defective-interfering genome may be within a vaccine composition which comprises pharmaceutically-acceptable excipients (¶[0014][0050-52]; reference claims 46, 50; instant claim 33). Hauser teaches the use of the vaccine compositions in therapeutic applications to inhibit CoV replication in a subject (¶[0015][0071]; instant claim 34).
For at least these reasons, Hauser teaches the limitations of instant claims 1-3, 5-12, 27-30, and 33-34, and anticipates the invention encompassed by said claims.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: SEQ ID NOs: 27-39 appear to be free of the prior art.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHEL B GILL whose telephone number is (571)272-3129. The examiner can normally be reached on M to F 8:00 AM to 5:00 PM Eastern.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JANET ANDRES can be reached on 571-272-0867. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/RACHEL B GILL/
Primary Examiner, Art Unit 1671