SYNTHETIC VIRUSES

DETAILED ACTION Applicant's amendment and remarks filed August 4, 2026 are acknowledged and entered. Claims 1, 17-19 and new claims 44-55 are under examination with regard to the elected species of claim 1(a)(i). Any prior objection or rejection that is not repeated or addressed below is either moot or withdrawn in view of Applicant’s amendment. Response to Amendment The rejection of claims 1, 17 and 18 on the ground of nonstatutory double patenting as being unpatentable over claim 9 of U.S. Patent 12,076,375 B2 (cited in the IDS filed 2/18/2026) is withdrawn. The instant claims as amended now require a deletion and an insertion, whereas the patented claim is directed to an insertion. The provisional rejection of claims 1, 17 and 18 on the ground of nonstatutory double patenting as being unpatentable over claim 14 of copending Application No. 18/778,686 (reference application) is withdrawn. The instant claims as amended now require a deletion and an insertion, whereas the copending claim is directed to an insertion. Specification The disclosure remains objected to because it contains an embedded hyperlink and/or other form of browser-executable code. The specification filed August 4, 2026 still has a hyperlink on page 13, paragraph [00048], and on page 15, paragraph [00058]. Applicant is required to delete the embedded hyperlinks 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. There should not be any underlined portion of the address. Claims Summary Claim 1 is directed to a synthetic phage capable of replication in a host cell (e.g., bacterial cell (claim 19)) wherein the synthetic phage is a T-even phage comprising a deletion of DNA from, and an insertion of a heterologous DNA into, (elected species) a Deletion Permissive Region (DPR) of the genome of the phage, the region being between the pin (protease inhibitor) gene and the iPII (internal protein) gene. A T-even phage (T2, T4, T6, etc., is one that infects E. coli). According to Miller et al. (Microbiology and Molecular Biology Reviews, March 2003, 67(1):86-156, “Miller”), which provides a table of all the coordinates of a wild-type 168903-nt T4 genome in Table 1 (pages 90-96), the pin gene begins at nt 47382, and the iPII gene begins at nt 66415. Claim 19 is directed to an embodiment wherein the region of the genome that comprises the deletion and insertion is between coordinates nt 9067 and nt 16673 (elected species), wherein the coordinates are with reference to the distances from the end of the pin gene towards the mobD and iPII genes of the wiltype T4 genome, SEQ ID NO: 129. Also claimed is a population of synthetic phage of claim 1 that is suitable for administration to a human or animal subject for reducing infection by pathogenic host bacterial, or archaeal cells, or a first species or strain, wherein the population of phage is capable of infecting the species or strain (claim 18). The genome of the synthetic phage is comprised by a chromosome of a bacterial cell, such as the phage host cell (claim 45), or a plasmid comprised by a bacterial cell (claim 44). The heterologous DNA comprises or encodes one or more components of a CRISPR/Cas system or a guided nuclease, among other choices (claims 46 and 47). Specifically, the heterologous DNA encodes a guide RNA, Cas, or a guide RNA and a Cas (claim 48). Up to 8000 bp of DNA are deleted and up to 8000 bp are inserted (claim 49). The insertion comprises inserting a total number (X) of base pairs of heterologous DNA and the deletion comprises deleting a total number (Y) of base pairs of DNA, wherein Y is at least 50% of X (claim 50). The DPR of the T-even phage comprises at least 100 bp of DNA, or at least 1000 bp (claim 52), between the pin gene and the iPII gene. The deletion comprises deleting one or more genes from the synthetic phage, selected from genes that encodes a protein, such as thioredoxin, among others (claim 53), or wherein the deletion comprises deleting a T4 gene, such as nrdC, among others, or a sequence that is at least 80% identical to the sequence of the gene, from the synthetic phage genome (claim 53 and 54). The synthetic phage is Escherichia phage T4 (claim 55, elected species). Claim 17 is directed to a method of producing a pharmaceutical composition, comprising combining a population of synthetic phage of claim 1, with a pharmaceutically acceptable excipient, carrier or diluent. 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 19, 44, 53 and 54 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 19 is directed to an embodiment wherein the region of the genome that comprises the deletion and insertion is between coordinates nt 9067 and nt 16673 (elected species), wherein the coordinates are with reference to the distances from the end of the pin gene towards the mobD and iPII genes of the wildtype T4 genome, SEQ ID NO: 129. This language prompts several questions: Is nt 9067 (of SEQ ID NO: 129) the last nt of the pin gene? Is nt 16673 (of SEQ ID NO: 129) the last nt before the iPII gene? It remains unclear how the coordinates of nt 9067-16673 correspond to the region between the pin gene and the IPII gene. If Applicant could provide the relevant sequence region labeled with the end of the pin gene and the start of the IPII gene, with nucleotide numbering, as well as explain how it coordinates with SEQ ID NO: 129, that would be very helpful to resolve the metes and bounds of the claim. Regarding new claim 44, it is not clear what is meant by “wherein the genome of the synthetic phage is comprised by a chromosome of a bacterial cell or a plasmid comprised by a bacterial cell”. The structure cannot be determined based on this language. Claim 45 is included in this rejection because it depends from claim 44. Regarding new claims 53 and 54, the limitation “a sequence that is at least 80% identical to the sequence of said gene”, renders the metes and bounds unclear. Since there is no base sequence with which to derive 80% identity, one would not be able to determine whether the 80% variant is encompassed by the claims or not. Conclusion No claim is allowed. Claims 1, 17, 18, 46-52 and 55 are objected to for reciting non-elected subject matter, but would otherwise be allowable if non-elected subject matter is removed. THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a). A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action. 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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Stacy B. Chen whose telephone number is 571-272-0896. The examiner can normally be reached on M-F (7:00-4:30). If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Visone, can be reached on 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. /STACY B CHEN/Primary Examiner, Art Unit 1672