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
This action is in response to the papers filed on 10/07/2025. Claims 1-2, 4-5, 7-10,
18, 20-22, and 57-61 are currently pending as per claims filed on 07/01/2025.
Applicant’s election of Group I, claims 1-2, 4-5, 7-10, and 18, drawn to a construct comprising a promoter operably linked to a polynucleotide encoding a full length antisense Jurona virus genome and a cell containing the construct, the sequences corresponding to SEQ ID NO: 1-5 (together) in claim 1, the sequence from claim 4 corresponding to SEQ ID NO: 6, and the sequence from claim 5 corresponding to SEQ ID NO: 11, in the reply filed on 10/07/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 20-22, and 57-61 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subject matter, there being no allowable generic or linking claim.
The requirement for restriction between Groups I-IV is still deemed proper and is therefore made FINAL.
Therefore, claims 1-2, 4-5, 7-10, and 18 are subject to examination to which the following grounds of rejection are applicable.
Priority
The instant application is a 371 of PCT/US2023/067252 filed 05/19/2023, PCT/US2023/067252 claims priority to provisional application PRO 63/344,395 filed 05/20/2022.
Thus, the earliest possible priority for the instant application is 05/20/2022.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 11/20/2024 and 08/06/2025 were filed before the mailing date of the non-final office action. 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 Interpretation
The election of species requirement specified that the sequences of SEQ ID NO: 1-5 of claim 1 would be examined as comprising a polynucleotide comprising the nucleotides of SEQ ID NO: 1-5 together. As this species was elected by the applicant, the claims will be interpreted to require all five of these sequences pertaining to SEQ ID NOs:1-5 within the claimed polynucleotide.
Claim Rejections - 35 USC § 112(b)
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 1-2, 4-5, 7-10, and 18 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 recites the phrase “A construct comprising a promoter operably linked to a polynucleotide encoding a full length antisense Jurona virus genome and allowing production of a negative sense viral genome when transfected into mammalian cells, wherein the polynucleotide encoding the Jurona virus genome comprises SEQ ID NOs: 1-5 (elected species)”. However, it is unclear what exactly the applicant intended for placement of SEQ ID NOs: 1-5 within the polynucleotide and whether that placement is direct (i.e. sequence to sequence). The examiner suggests amending the claim language to at minimum recite “comprising the full length of these sequences in the order of (supply the sequence order here) in a 5’ to 3’ direction”, or a similar amendment that would provide clarity.
Claims 4 and 5 are also rejected because of their recitation of “ the Jurona virus genome comprises SEQ ID NOs: 1-5,” because it is unclear whether the term “1-5” is used to mean the nucleotides of sequences SEQ ID NOs: 1-5 in a 5’-3’ order or selection of at least one of these sequences. As such the metes and bounds of the claim are indefinite. Claim 1 is vague and indefinite in the recitation of “…allowing production…” , since this phrase refers to a latent ability, and it is unknown whether the ability is expressed or observed in the invention. One of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Appropriate action is required.
Claims 2, 4-5, 7-10 and 18 are dependent upon and inherit the deficiencies of claim 1.
Claim 5 is indefinite in its recitation of “at least one of SEQ ID NOs: 8-11, 21, and 22 as intergenic regions” 1. Claim 5 is in improper Markush form; a Markush group should be in the form “a nucleotide sequence selected from the group consisting of A, B, and C”. Currently, it is not clear which species are included in the Markush group and which are not.
Claim 7 is vague and indefinite in the recitation of “…capable of…” , since this phrase refers to a latent ability, and it is unknown whether the ability is expressed or observed in the invention. Note, it has been held that the recitation that an element is “capable of” performing a function is not a positive limitation, but only requires the ability to so perform. It does not constitute a limitation in any patentable sense. In re Hutchinson, 69 USPQ 138.
Claims 8-10 are dependent upon and inherit the deficiencies of claim 7.
Claim 10 recites the phrase “The construct of claim 9, wherein the polynucleotide comprises SEQ ID NO: 13 (JURV-eGFP) (elected species)”, however construct containing the polynucleotide from which the claim ultimately depends upon (claim 1) comprises the sequences of SEQ ID NOs:1-5. The sequence of SEQ ID NO: 13 comprises polynucleotides with sequences that encode the same proteins of those encoded by the sequences of SEQ ID NOs: 1-5. Therefore, it is unclear how what the applicants intended structure of this polypeptide actually is. Does the applicant intend for a polynucleotide that comprises both the entire sequence of SEQ ID NO: 13 and additional sequences of SEQ ID NOs: 1-5? Applicant must amend the claims to provide clarification.
Claim Rejections - 35 USC § 112(a)
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 1-2, 4-5, 7-10, and 18 are 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 a construct comprising a T7 promoter operably linked to a polynucleotide encoding a full length antisense Jurona virus genome and allowing production of a negative sense viral genome when transfected into mammalian cells, wherein the polynucleotide encoding the Jurona virus genome comprises SEQ ID NO: 12 (JURV-XN-2) comprising SEQ ID NOs: 1-5 (elected species of codon optimized ORFs encoding 5 individual viral proteins),; and mammalian cells comprising said construct, does not reasonably provide enablement for a construct comprising a genus of promoters operably linked to a polynucleotide encoding a full length antisense Jurona virus genome and allowing production of a negative sense viral genome when transfected into mammalian cells, wherein the polynucleotide encoding the Jurona virus genome comprises SEQ ID NO: 1-5 (for claim 1) in any direction within the polynucleotide and lacking a leader sequence of SEQ ID NO: 6 and/or a trailer sequence of SEQ ID NO: 7. Furthermore, the claims are not enabling for a claim genus of promoters allowing production of a negative sense viral genome when transfected into mammalian cells.
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 use the invention commensurate in scope with these claims.
The test of enablement is whether one skilled in the art could make and use the claimed invention from the disclosures in the patent coupled with information known in the art without undue experimentation (United States v. Telectronics, Inc., 8 USPQ2d 1217 (Fed. Cir. 1988)). Whether undue experimentation is required is not based on a single factor but is rather a conclusion reached by weighing many factors (See Ex parte Forman, 230 USPQ 546 (Bd. Pat. App. & Inter, 1986) and In re Wands, 8USPQ2d 1400 (Fed. Cir. 1988); these factors include the following:
Scope of the invention
An undefined number of constructs comprising a genus of promoters operably linked to a polynucleotide encoding a full length antisense Jurona virus genome and allowing production of a negative sense viral genome when transfected into mammalian cells, wherein the polynucleotide encoding the Jurona virus genome comprises SEQ ID NO: 1-5 (for claim 1) in any direction within the polynucleotide and lacking a leader sequence of SEQ ID NO: 6 and/or a trailer sequence of SEQ ID NO: 7.
Number of working examples and guidance
With respect to claim 1 and 4, the instant specification provides support for a construct comprising the T7 promoter operably linked to a polynucleotide encoding a full length antisense Jurona virus genome and allowing production of a negative sense viral genome when transfected into mammalian cells, wherein the polynucleotide encoding the Jurona virus genome comprises SEQ ID NO: 12 (JURV-XN-2) comprising SEQ ID NOs: 1-5 (elected species of codon optimized ORFs encoding all 5 individual viral proteins in a 5’ to 3’ direction) (Pg. 34, full page).
The specification does not reasonably provide enablement for a construct comprising any promoter operably linked to a polynucleotide encoding a full length antisense Jurona virus genome and allowing production of a negative sense viral genome when transfected into mammalian cells, wherein the polynucleotide encoding the Jurona virus genome comprises SEQ ID NO: 1-5 (for claim 1) arranged in any order or the SEQ ID NO:1-5 lacking a leader sequence of SEQ ID NO: 6 and/or a trailer sequence of SEQ ID NO: 7.
Guidance Provided by the Art
The prior art was generally searched for Jurona Virus characterization, codon optimization of Jurona Virus proteins, and the requirements for a polynucleotide to successfully encode a full length antisense Jurona virus genome that would function as negative sense viral genome when transfected into mammalian cells.
Post filing art by Tesfay et al. (Tesfay MZ, Mol Ther Oncol. 2024) teaches a full length Jurona Virus genome to be 10,993 base pairs in length and further describes the full-length gene to contain nucleoprotein (JURV-N), phosphoprotein (JURV-P), matrix protein (JURV-M), glycoprotein (JURV-G), and RNA-directed RNA polymerase L protein (JURV-L) (page 2, Results, 1st Paragraph). These Jurv proteins are encoded by codon optimized sequences of the instant application, SEQ ID NO: 1-5 (Pg. 2, 1st full paragraph of instant specification) and together only total 10,680.
The art is silent on whether a polynucleotide encoding only nucleoprotein (JURV-N), phosphoprotein (JURV-P), matrix protein (JURV-M), glycoprotein (JURV-G), and RNA-directed RNA polymerase L protein (JURV-L) organized in any direction and lacking a leader sequence of SEQ ID NO: 6 and/or a trailer sequence of SEQ ID NO: 7 would have the functionality to encode a full length antisense Jurona virus genome that would function as negative sense viral genome when transfected into mammalian cells.
The teachings of Rose et al. (US 2005/0238656 A1) and GenBank (GenBank Accession No. HM566194 "Jurona virus, complete genome) provided below are adopted from page 5 of the INTERNATIONAL SEARCHING AUTHORITY, International Search Report and Written Opinion for corresponding International Patent Application No. PCT/US2023/067252, mailed November 3, 2023, 18 pages. Of record, IDS filed on 11/20/2024.
- Rose et al. discloses a construct comprising a promoter operably linked to a polynucleotide encoding a full length antisense vesiculovirus genome and allowing production of a negative sense viral genome when transfected into mammalian cells (para [0031]-[0033], [0047]) . Further, Rose et al. teaches a Jurona Virus to genus of vesiculovirus that can be made recombinant and further describes that “Any DNA that can be transcribed to produce vesiculovirus antigenomic ( +) RNA (complementary to the VSV genome) can be used for the construction of a recombinant DNA containing foreign DNA encoding an Antigen, for use in producing the recombinant vesiculovirus of the invention. DNA that can be transcribed to produce vesiculovirus antigenomic ( +) RNA (such DNA being referred to herein as "vesiculovirus (-) DNA") is available in the art and/or can be obtained by standard methods. (Pg. 4, Table 1; Paragraph [0045]). However, Rose does not teach a full length Jurona virus sequence.
GenBank Accession No. HM566194 "Jurona virus, complete genome” (of record IDS filed on 11/20/2024; hereinafter 'HM566194') discloses a Jurona virus genome (pg 1 - "DEFINITION Jurona virus, complete genome.") comprising sequences similar to SEQ ID NOs: 1-5 (Sequence of HM566194 exhibits, from residues 10-1277, 69.8% identity with SEQ ID NO: 1 of the instant application, from residues 1384-2277, 75.8% identity with SEQ ID NO: 2 of the instant application, from residues 2358-3035, 68.6% identity with SEQ ID NO: 3 of the instant application, from residues 3068 -4642, 63.9% identity with SEQ ID NO: 4 of the instant application, and from residues 4726-5725, 6.1 % identity with SEQ ID NO: 5 of the instant application).”
However, neither Rose nor HM566194 render obvious the full length of nucleotides of SEQ ID NOS 1-5 in a 5’ to 3’ direction, let alone the full length of SEQ ID NO: 12 (JURV-XN-2) comprising SEQ ID NOs: 1-5 (elected species of codon optimized ORFs encoding 5 individual viral proteins).
In relation to the claimed genus of promoters operably linked to a polynucleotide encoding a full length antisense Jurona virus genome to allow production of a negative sense viral genome when transfected into mammalian cells, one of ordinary skill in the art would readily appreciate that a multitude of promoters were available for use in gene therapy constructs, but selection of a particular promoter depends on the detailed goal of the system and at least in part, on previous examples of promoters used successfully with a particular gene and transfected type of cell. Moreover, transcriptional activity of promoters is specific to the type of promoter used and transformed host cells with specific transcription factors. There is unpredictability in using a genus of promoters operably linked to a polynucleotide encoding a full length antisense Jurona virus genome and allowing production of a negative sense viral genome when transfected into mammalian cells.
The teachings in the specification are directed to using a T7 promoter to express a full length antisense Jurona virus genome in mammalian cells.
Specifically, the Specification disclose using plasmids to express the antigenomic sense RNA of JURV under the bacteriophage T7 promoter to generate recombinant JURV(Pg. 34, Lines 1-14). Moreover, the only exemplary promoter throughout the specification is T7 promoter (Pg. 4, Lines 1-4 and 23; Pg. 5 Lines 4-5 and 13-16; Pg. 15, Lines 29-31; Pg. 26, Lines 28-29).
State of the art and unpredictability of the art
Recombinant technology for the generation of new protein fragments is highly developed. However, the ability to determine a priori whether a polynucleotide encoding for a full length antisense Jurona virus genome comprising the nucleoprotein (JURV-N), phosphoprotein (JURV-P), matrix protein (JURV-M), glycoprotein (JURV-G), and RNA-directed RNA polymerase L protein (JURV-L) identified as SEQ ID NOS 1-5, in any order will generate a functional polynucleotide is not. Moreover, there is unpredictability in using any promoter for transcriptional expression in mammalian cells. The art must therefore be considered to be poorly developed.
Amount of Experimentation Required
In view of the unpredictability of the art in relation to the functional nature of a full length antisense Jurona virus genome and allowing production of a negative sense viral genome comprising the nucleotides of SEQ IDs NOS 1-5 in any orientation, the disclosed sequences of HM566194 having partial sequence identity to the nucleotides of SEQ IDs NOS 1-5 (e.g., SEQ ID NO: 1 of the instant application, from residues 1384-2277, 75.8% identity with SEQ ID NO: 2 of the instant application, from residues 2358-3035, 68.6% identity with SEQ ID NO: 3 of the instant application, from residues 3068 -4642, 63.9% identity with SEQ ID NO: 4 of the instant application, and from residues 4726-5725, 61.1 % identity with SEQ ID NO: 5 of the instant application), the claimed genus of promoters for transcriptional expression in mammalian cells;
undue experimentation would be required to practice the claimed construct for expression of a full length antisense Jurona virus genome and allowing production of a negative sense viral genome when transfected into mammalian cells, with reasonable expectation of success, absent a specific and detailed description in the specification. Given the unpredictability of the art, the poorly developed state of the art with regard to predicting the structural/ functional characteristics of the Jurona virus genome comprises SEQ ID NOs: 1-5, the lack of working examples and the lack of guidance provided by applicants, the skilled artisan would have to have conducted undue, unpredictable experimentation to practice the claimed invention.
Claims 1-2, 4-5, 7-10, and 18 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 MPEP states that the purpose of the written description requirement is to ensure that
the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by him. The courts have stated:
“To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that “the inventor invented the claimed invention.” Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gostelli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (“[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.”). Thus, an applicant complies with the written description requirement “by describing the invention, with all its claimed limitations, not that which makes it obvious,” and by using “such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention.” Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.” Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co. the court stated:
“A written description of an invention involving a chemical genus, like a description of a chemical species, ‘requires a precise definition, such as by structure, formula, [or] chemical name,’ of the claimed subject matter sufficient to distinguish it from other materials.” Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) (“In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus ...”) Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is “not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.” MPEP § 2163. The MPEP does state that for a generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. MPEP § 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP § 2163. Although the MPEP does not define what constitute a sufficient number of representative species, the courts have indicated what do not constitute a representative number of species to adequately describe a broad generic. In Gostelli, the courts determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872, F.2d at 1012, 10 USPQ2d at 1618.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include “level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient.” MPEP § 2163. While all of the factors have been considered, a sufficient amount for a prima facie case are discussed below.
Claim 1 recites “A construct comprising a promoter operably linked to a polynucleotide
encoding a full length antisense Jurona virus genome and allowing production of a negative sense viral genome when transfected into mammalian cells, wherein the polynucleotide encoding the Jurona virus genome comprises SEQ ID NOs: 1-5 (elected species).”
Claim 1 is interpreted as requiring SEQ ID NOs: 1-5 to function as a full length antisense Jurona virus genome and allowing production of a negative sense viral genome when transfected into mammalian cells.
Claim 4 recites “The construct of claim 1, wherein when the polynucleotide encoding the Jurona virus genome comprises SEQ ID NOs: 1-5, the polynucleotide encoding the Jurona virus genome further comprises a leader sequence of SEQ ID NO: 6 and/or a trailer sequence of SEQ ID NO: 7.
Claim 4 is interpreted as requiring as requiring SEQ ID NOs: 1-5 with either a leader sequence of SEQ ID NO: 6, a trailer sequence of SEQ ID NO: 7 or both to function as a full length antisense Jurona virus genome and allowing production of a negative sense viral genome when transfected into mammalian cells.
Specification Disclosure
With respect to claim 1 and 4, the instant specification provides support for a construct comprising the T7 promoter operably linked to a polynucleotide encoding a full length antisense Jurona virus genome and allowing production of a negative sense viral genome when transfected into mammalian cells, wherein the polynucleotide encoding the Jurona virus genome comprises SEQ ID NO: 12 (JURV-XN-2) comprising SEQ ID NOs: 1-5 (elected species of codon optimized ORFs encoding all 5 individual viral proteins in a 5’ to 3’ direction) (Pg. 34, full page).
The specification does not provide a written description for obtaining a functional “full length antisense Jurona virus genome” with all possible variations (any promoter, multiple orientations of SEQ ID NO:1-5), presence or absence of leader (SEQ ID NO: 6) and trailer sequence (SEQ ID NO: 7), that would result in a sequence encoding a functional full length antisense Jurona virus genome with the capacity for allowing production of a negative sense viral genome when transfected into mammalian cells. The specification does not identify what changes, combinations, and absolute requirements from the above would still allow for the polynucleotide to produce a functional full length antisense Jurona virus genome.
In summary, the specification describes minimal species within the claimed genus’s – a polynucleotide encoding a full length antisense Jurona virus genome and allowing production of a negative sense viral genome when transfected into mammalian cells. The specification does not provide predictability for all possible variations of promoter selection, orientation of SEQ ID NO: 1-5, and presence or absence of leader and trailer sequences with respect to a polynucleotide comprising a functional “full length antisense Jurona virus genome”.
The limitations of claims 2, 5, 7-10, and 18, do not remedy the written description deficiencies of the claims on which they depend.
Guidance Provided by the Art
The prior art was generally searched for Jurona Virus characterization, codon optimization of Jurona Virus proteins, and the requirements for a polynucleotide to successfully encode a full length antisense Jurona virus genome that would function as negative sense viral genome when transfected into mammalian cells.
Post filing art by Tesfay et al. (Tesfay MZ, Mol Ther Oncol. 2024) teaches a full length Jurona Virus genome to be 10,993 base pairs in length and further describes the full-length gene to contain nucleoprotein (JURV-N), phosphoprotein (JURV-P), matrix protein (JURV-M), glycoprotein (JURV-G), and RNA-directed RNA polymerase L protein (JURV-L) (page 2, Results, 1st Paragraph). These Jurv proteins are encoded by codon optimized sequences of the instant application, SEQ ID NO: 1-5 (Pg. 2, 1st full paragraph of instant specification) and together only total 10,680.
The art is silent on whether a polynucleotide encoding only nucleoprotein (JURV-N), phosphoprotein (JURV-P), matrix protein (JURV-M), glycoprotein (JURV-G), and RNA-directed RNA polymerase L protein (JURV-L) organized in any direction and lacking a leader sequence of SEQ ID NO: 6 and/or a trailer sequence of SEQ ID NO: 7 would have the functionality to encode a full length antisense Jurona virus genome that would function as negative sense viral genome when transfected into mammalian cells.
The teachings of Rose et al. (US 2005/0238656 A1) and Genbank (GenBank Accession No. HM566194 "Jurona virus, complete genome) provided below are adopted and modified from page 5 of the INTERNATIONAL SEARCHING AUTHORITY, International Search Report and Written Opinion for corresponding International Patent Application No. PCT/US2023/067252, mailed November 3, 2023, 18 pages. Of record, IDS filed on 11/20/2024.
- Rose et al. discloses a construct comprising a promoter operably linked to a polynucleotide encoding a full length antisense vesiculovirus genome and allowing production of a negative sense viral genome when transfected into mammalian cells (para [0031]-[0033], [0047]) . Further, Rose et al. teaches a Jurona Virus to genus of vesiculovirus that can be made recombinant and further describes that “Any DNA that can be transcribed to produce vesiculovirus antigenomic ( +) RNA ( complementary to the VSV genome) can be used for the construction of a recombinant DNA containing foreign DNA encoding an Antigen, for use in producing the recombinant vesiculovirus of the invention. DNA that can be transcribed to produce vesiculovirus antigenomic ( +) RNA (such DNA being referred to herein as "vesiculovirus (-) DNA") is available in the art and/or can be obtained by standard methods. (Pg. 4, Table 1; Paragraph [0045]). However, Rose does not teach a full length Jurona virus sequence.
GenBank Accession No. HM566194 "Jurona virus, complete genome” (of record IDS filed on 11/20/2024; hereinafter 'HM566194') discloses a Jurona virus genome (pg 1 - "DEFINITION Jurona virus, complete genome.") comprising sequences similar to SEQ ID NOs: 1-5 (Sequence of HM566194 exhibits, from residues 10-1277, 69.8% identity with SEQ ID NO: 1 of the instant application, from residues 1384-2277, 75.8% identity with SEQ ID NO: 2 of the instant application, from residues 2358-3035, 68.6% identity with SEQ ID NO: 3 of the instant application, from residues 3068 -4642, 63.9% identity with SEQ ID NO: 4 of the instant application, and from residues 4726-5725, 61.1 % identity with SEQ ID NO: 5 of the instant application).”
However, neither Rose nor HM566194 render obvious the full length of nucleotides of SEQ ID NOS 1-5 in a 5’ to 3’ direction, let alone the full length of SEQ ID NO: 12 (JURV-XN-2) comprising SEQ ID NOs: 1-5 (elected species of codon optimized ORFs encoding 5 individual viral proteins).
The instant specification does not provide support that would allow one of ordinary skill in the art to determine the necessary steps to overcome this source of incompatible structure – function relationship. Without this guidance, it is unclear that the claimed recitation could produce a polynucleotide able to successfully encode a full length antisense Jurona virus genome that would function as negative sense viral genome when transfected into mammalian cells.
An applicant may show that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics which provide evidence that applicant was in possession of the claimed invention, i.e., complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics. Enzo Biochem, 323 F.3d at 964, 63 USPQ2d at 1613.
The written description requirement for a polynucleotide comprising only 1) SEQ ID NOs:1-5 or 2) SEQ ID NOs: 1-5 with either or both of a leader and trailer sequence, is capable of functioning as a polynucleotide encoding a full length antisense Jurona virus genome and allowing production of a negative sense viral genome when transfected into mammalian cells, may be satisfied through sufficient evidence of this specific polynucleotide sequence combination functioning as a polynucleotide that can encode a full length antisense Jurona virus genome and allowing production of a negative sense viral genome when transfected into mammalian cells.
As discussed above, one of ordinary skill would not be able envision a polynucleotide encompassing all possible variations that is capable of functioning as a polynucleotide encoding a full length antisense Jurona virus genome and allowing production of a negative sense viral genome when transfected into mammalian cells. The genus claimed is very broad, including multiple possibilities (any promoter, multiple orientations of SEQ ID NO:1-5), presence or absence of leader (SEQ ID NO: 6) and trailer sequence (SEQ ID NO: 7). Applicant has not provided adequate description to support the breadth of the inventions encompassed by the claims when only minimal polynucleotide sequences that can function as a full length antisense Jurona virus genome is taught by the instant specification.
Therefore, the specification does not describe the claimed fragments in such full, clear, concise and exact terms so as to indicate that Applicant has possession of these fragments at the time of filing the present application. Thus, the written description requirement has not been satisfied.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KODYE LEE ABBOTT whose telephone number is (703)756-1111. The examiner can normally be reached M-F 8-5.
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, Maria G. Leavitt can be reached at (571) 272-1085. 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.
/KODYE LEE ABBOTT/Examiner, Art Unit 1634
/MARIA G LEAVITT/Supervisory Patent Examiner, Art Unit 1634