DETAILED ACTION
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 an amendment filed 6/19/2026.
Claims 1-34 are pending.
This application claims priority to U.S. provisional application 63/433,781, filed 20 December 2022.
Election/Restrictions
Applicant's election without traverse of Claims 1, 2, 12 and 28, drawn to an oncolytic HSV-1 comprising a) a cassette integrated in one or both of the HSV-1 34.5 loci comprising in order, a CMV promoter, a polynucleotide encoding hFLT3L, a P2A cleavage sequence, a polynucleotide encoding UL49.5, and a polyadenylation signal; and b) “another” cassette integrated in the HSV-1 US10-12 locus comprising in order, a polynucleotide comprising a variant US 11 gene encoding native US 11 protein, an additional polynucleotide encoding native US 11 protein, a polynucleotide encoding US 10 protein, a polyadenylation signal that is operably linked to the polynucleotide encoding the US 10 protein, a CMV promoter, a polynucleotide encoding a CTLA-4 binding protein, a polyadenylation signal that is operably linked to the polynucleotide encoding the CTLA-4 binding protein, a polyadenylation signal that is operably linked to a polynucleotide encoding a CD40 agonist, a polynucleotide encoding a CD40 agonist, an AoHV1 promoter that controls expression of the CD40 agonist, an MMLV promoter that controls expression of an IL-12, a polynucleotide encoding an IL-12, and a polyadenylation signal that is operably linked to the polynucleotide encoding the IL-12 and method of making in the reply filed on 6/19/2026 is acknowledged. Claim 3-11, 13-27 and 29-34 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subject matter, there being no allowable generic or linking claim.
Claim Objections
Claims 1, 2, 12 and 28 are objected to because of the following informalities: Abbreviations on the first occurrence should be presented in their full spelling. Although claims are allowed abbreviations, if an abbreviation is not spelled out upon first use in a claim, MPEP §2429 states that Applicant only use abbreviations that are specifically defined in "WIPO Standard ST.25 (1998)" or that are well known and would be clear to someone who had not read the invention description. In claim 1 at least FLT3L, AoHV1, CTLA-4 and MMLV require spelling.
Alternatively, in claim 2 once the abbreviation has been established (HSV-1), it need not be spelled out a second time.
When referencing “a polynucleotide encoding a CD40 agonist” in lines 14 of claim 1 and line 13 of claim 2 should be to –the polynucleotide encoding the CD40 agonist--. This is true of subsequent references to –the polynucleotide encoding the IL-12--. This provides consistency and simplification of the claims.
Claims 12 and 28 are objected to as comprising non-elected subject matter.
Appropriate correction is required.
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.
Claim 28 is 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.
Claim 28 is drawn to methods of making the virus of claim 1 which is HSV01 comprising two integrated cassettes. This method entails, culturing a cell comprising the oncolytic virus of claim 1 or claim 3, lysing the cell to produce a cell lysate, and purifying the oncolytic virus from the cell lysate. However, research has shown that the impact of producer cells are varied on genomic alterations and viral replication (see Dunn and Taylor, J Virology, 2025, pages 1-24, see especially abstract. Applicants only demonstrate use of Vero and hence given the complexity of the virus and the limited producer cells; this is the single cell used to produce the virus as set forth in the method of claim 28.
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 disclosure lacks description of the generic means by which the virus is produced.
Conclusion
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/MARIA MARVICH/ Primary Examiner, Art Unit 1634
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