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 .
This office action is in response to a claim set filed 5/18/2026.
Claims 1-45 are pending.
This application is a 371 filing of PCT/US2022/035858 which claims the benefit of and priority to co-pending U.S. Provisional Patent Application No. 63/217,177, filed on June 30, 2021.
Election/Restrictions
Applicants’ election without traverse of Group I (claims 1-34) in the reply filed on 5/18/2026 is acknowledged. Claims 35-45 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subject matter, there being no allowable generic or linking claim.
As to species, applicants elect gamma nodavirus RNA2, the 5’ UTR of native gamma nodavirus, MrNV (claim 5), interfering RNA (claim 10 and 13), shrimp pathogen (claim 14), Virus (Claim 15, WWSSV (claim 16), shrimp (claim 31), insect cell or population (claim 30), feed for shrimp (claim 34).
Information Disclosure Statement
An IDS filed 12/28/2023 has been identified and the documents considered. The signed and initialed PTO Form 1449 has been mailed with this action. Initials indicate that the document has been considered even if the reference is lined through. In the case that only an English abstract was identified, this is indicated.
Sequence Compliance
This application contains sequence disclosures that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR 1.821 through 1.825 for the reason(s) set forth below or on the attached Notice To Comply With Requirements For Patent Applications Containing Nucleotide Sequence And/Or Amino Acid Sequence Disclosures.
Specifically, page 41 contains sequences that are not identified by sequence identifier numbers. If the sequences can be found in the sequence listing it would be remedial to insert the appropriate SEQ ID NO:s. If not, a substitute paper copy of the “Sequence Listing”, as well as an amendment directing its entry into the specification, CRF and letter stating that the contents of the sequence listing and the CRF are the same and contain no new matter is required. The nature of the non-compliance did not preclude the examination on the merits of the instant application, the results of which follow.
Drawings
Figures 1 are objected to under 37 CFR 1.83(a) because they fail to show any details as described in the specification. Specifically, figure 1 has text that is not legible as it is so small, specifically in the figures embedded therein. In figure 6, the brightfield images have no contrast to see details. In figure 8, the term RdRp is not legible in the vector diagram. The screenshots in figures 12-14 are not legible. The numbering around the vector in figure 15 is not legible nor is the sequence in figure 29. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). A proposed drawing correction or corrected drawings are required in reply to the Office action to avoid abandonment of the application. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because it contains several embedded hyperlinks and/or other form of browser-executable codes on page 43. Applicants are required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claims 1, 3, 5, 7, 12 and 16 are objected to because of the following informalities: claim 1 recites that the polynucleotide comprises “a nodavirus capsid polypeptide construct” which should recite that it is a polypeptide coding sequence. Furthermore, when referencing the gamma and the beta nodavirus, each require their own articles as they are not compound nouns but independent limitations. There are multiple references to beta nodavirus that should be preceded by “a” or “the”. Typically, a term is introduced with the article “a” and thereafter referenced with “the”.
In claim 3, “UTR” has been previously abbreviated and therefore does not need the full spelling. As well, the beta limitations require articles as above. Finally, the preposition “to” appears to be missing form line 6 prior to “the 5’ UTR”.
Claim 5 only includes an article on the last of the series of viruses and for consistency should include articles prior to each.
In claim 7, the article “the” is required prior to “beta”.
In claim 12, Pol is abbreviated without a full spelling. It should be spelled out on the first occurrence.
Claim 16 misspells “fungi” in line 13. And in line15, there is a missing comma prior to “Viral”. As well, in claim 16, the phrase “infection with” in line 21-22 is grammatically incorrect and appears to be intended to be infected with.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 5-7, 16 and 22-28 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 5 recites the limitation "the native gamma or beta nodavirus" in claim 1. There is insufficient antecedent basis for this limitation in the claim. There are two references to “a native nodavirus” in claim 1, one is the source of the 5’ UTR and the other the 3’ ITR and claim 5 does not clarify if it is all or only one and if one which one. MPEP 2173 Clear Notice Requirement “Optimizing patent quality by providing clear notice to the public of the boundaries of the inventive subject matter protected by a patent grant ... “’“ ... to ensure that the scope of the claims is clear so the public is informed of the boundaries of what constitutes infringement of the patent.” This issue arises in claims 6 and 7.
Claim 7 indicates ranges of the translated and/or untranslated region of the nodavirus RNA2. While it appears the ranges indicate nucleotides, the lack of indication of what these regions correlates to leaves the claim unclear.
Regarding claim 16, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). As well, the claim is in improper form by reciting in multiple locations “or” making unclear the breakup of the groups. The claim should to be properly formatted list all choices and then end with “or” and the final group.
Claim 22 recites the limitation "the engineered polynucleotide nodavirus capsid polypeptide construct" in claim 21. There is insufficient antecedent basis for this limitation in the claim. Claim 21, which depends from claim 1 recites an engineered gamma or beta nodavirus polynucleotide which comprises a nodavirus capsid polypeptide construct but nowhere is recited an engineered nodavirus capsid polypeptide construct. This is true of claim 23.
Claims 23-27 recite the limitation “the engineered cargo delivery vector of claim 19 or vector system thereof” in claim 19. There is insufficient antecedent basis for this limitation.
Claim 25 recites the limitation “the engineered nodavirus or nodaviral like particles” in claim 19. There is insufficient antecedent basis for this limitation in the claim.
Claim 28 recite the limitation “engineered cargo delivery vector” of claim 19. There is insufficient antecedent basis for this limitation.
Claim Rejections - 35 USC § 112, 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.
Claims 1-34 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims are drawn to a polynucleotide that can be part of a vector system, a vector or cell and is for the purposes of making a noraviral like particle or engineered nodavirus. The art teaches that (Shetty et al, Indian J. Virol, 2012, pages 114–123)
betanodavirus are non-enveloped ss RNA viruses composed of two segments designated RNA1 and RNA2 and sometimes possesses an additional segment designated RNA3. The RNA1 segment encodes two non-structural viral replicase proteins, while the RNA2 encodes the structural capsid protein. RNA3, a sub genomic RNA (371 nt) has a 62 % GC composition, containing an ORF encoding a peptide of 75 amino-acids corresponding to a hypothetical B2 protein which is a non-structural protein having a suppressor function for post-transcriptional gene silencing [19, 34, 61, 110]. RNA3 is formed only in infected cells and is not packaged into the viral particles (not in chronically infected fish) [79, 90, 110] and is transcribed from the 30 end of RNA1
Gammanodavirus were identified as shown by NaveebKumar (Virus Research 173 (2013) 377– 385) based on the capsid protein of each (see Figure 6 and discussion)
In the present study, based on the sequence analysis of RNA1 and RNA2, the MrNV could be clearly distinguished from other nodavirus (alphanodavirus and betanodavirus). MrNV-I showed good homology with other geographical isolates of MrNVs and to PvNV. Based on the sequence homology in the present study, MrNV and PvNV can be largely classified as Gammanodavirus.
The claimed polynucleotide is called “an engineered cargo delivery system polynucleotide”. This polynucleotide comprises two components; 1) An engineered gamma or beta nodavirus polynucleotide (comprising a nodavirus capsid polypeptide construct which comprises a gamma or beta nodavirus RNA2 encoding polynucleotide or capsid forming domain thereof), and 2) a cargo delivery construct (comprising a 5’ UTR and a 3’ UTR from a native nodavirus RNA1 flanking a cargo polynucleotide and one or more regulatory elements). The first issue of description arises with this claim by reciting first that the engineered nodavirus polynucleotide comprises a nodavirus polypeptide construct. This is a polypeptide construct that comprises an RNA2 polynucleotide which is not supported by the disclosure. The disclosure teaches that the cargo delivery system comprises a vector encoding capsid and not the capsid polypeptide. Secondly, the claim recites “a capsid forming domain thereof” wherein this language means a domain (part of the CP) that forms a capsid, the domain (all of CP) that forms the full capsid or a sequence encoding a function that aids in the capsid formation. The disclosure only teaches a sequence encoding a full capsid and hence all of RNA2.
This notation is confused by the disclosure which teaches that while MrNV comprises RNA1 and RNA2(CP), XSV only comprises RNA1(CP).
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Hence, the generality of using a vector with RNA2 and another with the UTR of RNA1 is not obvious. What is obvious is that the entirety of RNA2 (or RNA1 for XSV) encoding the capsid is necessary. This also provides sufficient description claims 24-29, 32 and 34 to produce nodavirus. However, neither the claims nor the disclosure provides details on how to engineer the polynucleotide such that nodaviral like particles are produced.
Claims 19, 21, 28, 29 and 33 recite “an engineered cargo delivery system polynucleotide” or “an engineered cargo delivery vector or vector system thereof comprising the engineered cargo delivery system polynucleotide”. Hence, reference to a polynucleotide implies partial sequences wherein this arrangement would not support the intent of the claimed vectors to produce nodavirus or nordaviral like particles. What is required is “the engineered cargo delivery system polynucleotide”. To this end, the MPEP provides such guidance (emphasis added). If the application as filed does not disclose the complete structure (or acts of a process) of the claimed invention as a whole, determine whether the specification discloses other relevant identifying characteristics sufficient to describe the claimed invention in such full, clear, concise, and exact terms that a skilled artisan would recognize applicant was in possession of the claimed invention. For example, if the art has established a strong correlation between structure and function, one skilled in the art would be able to predict with a reasonable degree of confidence the structure of the claimed invention from a recitation of its function. Thus, the written description requirement may be satisfied through disclosure of function and minimal structure when there is a well-established correlation between structure and function. In contrast, without such a correlation, the capability to recognize or understand the structure from the mere recitation of function and minimal structure is highly unlikely. In this latter case, disclosure of function alone is little more than a wish for possession; it does not satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (written description requirement not satisfied by merely providing "a result that one might achieve if one made that invention"); In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming a rejection for lack of written description because the specification does "little more than outline goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate"). Compare Fonar, 107 F.3d at 1549, 41 USPQ2d at 1805 (disclosure of software function adequate in that art). As recited, the method lacks critical elements that provide necessary function. What is necessary is the full coding sequence of the RNA2(CP) with consideration of species without this gene. As well, to make a nodavirus particle, the claims require the engineered cargo delivery system polynucleotide in its entirety.
Conclusion
Alenton et al (PNAS Nexus, 2023, 2, 1–9) is a publication of applicants work and demonstrates the development of MrNVdRdRp-GFP, Recombinant RNA1 containing the 5′ and 3′ untranslated region (UTR) but a different coding region instead of RdRp, which is expressed with RNA2in Sf9 cells using baculoviral vectors wherein the GFP is packaged into a nonreplicating mature virion.
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/MARIA MARVICH/ Primary Examiner, Art Unit 1634
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