DETAILED ACTION
Election/Restrictions
Applicant's election without traverse of Group I, claims 1, 17-19, 21 and 40, and various elected species, in the reply filed on February 18, 2026 is acknowledged. Although Applicant states that the election is without traverse, there are also remarks to traverse the lack of unity set forth in the restriction requirement of November 19, 2025. The traversal is on the grounds that the elected species is not disclosed in the prior art reference Miller et al. (J. Bacteriology, 2003, 185(17):5220-5233, cited in the IDS filed 12/4/2023).
The elected species is a synthetic phage capable of replication in a host cell, wherein the synthetic phage is a T-even phage comprising a deletion of DNA from and an insertion into 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.
In Applicant’s remarks field February 18, 2026, Applicant points out that Miller’s KVP40 phage does not have the internal protein iPII, among others, thus Miller’s phage does not have a deletion between pin and iPII. The Office agrees with Applicant regarding Miller’s teachings not anticipating the elected species. However, Chace et al. (J. Virology, August 1973, 12(2):343-348, “Chace”) discloses a mutant T4 phage lacking the tk gene, which is in the region between pin and iPII. Chace’s phage meets the structural limitations of another of the claimed species (i.e., T-even phage comprising a deletion of DNA from a DPR of the genome between pin and iPII).
Therefore, lack of unity between the inventions exists and the requirement is still deemed proper and is therefore made FINAL.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. The specification filed December 4, 2023 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.
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 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. 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 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 21 is directed to a phage produced by the method of claim 20. Claim 20 is not under examination, however, the pertinent structural features of the phage produced in claim 20 is the presence of a heterologous DNA comprising an insert, in a T4 phage, introduced via homologous recombination between a region that is nt 8454-9067 (with reference to SEQ ID NO: 129 (sequence of a wild-type T4 phage genome)) and the heterologous DNA, and homologous recombination between a region that is nt 16673-17479 (with reference to SEQ ID NO: 129) and the heterologous DNA, wherein the insert is between the two regions.
Claim Objections
Claim 18 is objected to because of the following informalities:
It appears that the phrase “pathogenic host bacterial or archaeal cells or a first species or strain” should be “pathogenic host bacterial or archaeal cells of a first species or strain” [emphasis added]. Clarification or 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 19 and 21 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 deletion of DNA from, and insertion (of heterologous DNA (claim 19)) into a DPR between pin and iPII is located at, specifically, nt 9067-16673, with reference to wild-type T4 phage genome (SEQ ID NO: 129). However, it is not clear that nt 9067-16673 are actually located between pin and iPII. Miller et al. (Microbiology and Molecular Biology Reviews, March 2003, 67(1):86-156, “Miller”) provides a table of all the coordinates of the T4 genome in Table 1 (pages 90-96). The region between pin and iPII appears to be, approximately, between nt 47416 and nt 66414 (see Table 1, page 91, last three lines of the page, through page 92). The region of nt 9067-16673 appears to refer to genes outside of pin and iPII. Therefore, it is not clear whether nt 9067-16673 is referring to the region between pin and iPII.
Similarly, the phage of claim 21 comprises an insert between the region of nt 9067-16673. Claim 21 depends from claim 20, which depends from claim 1. Claim 1 requires deletion/insertion between pin and iPII. Claim 20 requires an insertion between the region of nt 9067-16673. It is not clear whether nt 9067-16673 is referring to the region between pin and iPII. The metes and bounds of the claim cannot be determined.
Claim Rejections - 35 USC § 102
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.
Claims 1, 17 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chace et al. (J. Virology, August 1973, 12(2):343-348, “Chace”), evidenced by the instant specification (published application US 2025/0268963 A1, cited in the IDS filed 2/18/2026). The claims are summarized above and correlated with the teachings of the prior art in bold font below.
Chace discloses mutant T4 phage lacking the tk gene, which is in the region between pin and iPII (see Chace, abstract, and the published application, Table 7). Chace’s phage are propagated from other mutant phage in E. coli that lack tk activity (see abstract), thus they replicate in a host cell and qualify as synthetic (see abstract and pages 343-344, section “Bacterial strains, phage, and media”) (claim 1). Chace did not engineer the deletion of the tk gene from the phage, nevertheless, the phage already have the deletion, thus the phage meet the structural limitations. The phage propagated by Chace qualify as a population of phage that are capable of infecting bacterial cells of a species, E. coli (see abstract and pages 343-344, Materials and Methods section) (claims 17 and 18). Phage are present in various types of buffers/media which are reasonably considered a pharmaceutically acceptable carrier and suitable for administration to human or animal subjects (see page 344, sections “Preparation of extracts for enzyme assays” and “Thymidine kinase assay” for descriptions of the buffers/media), thus pharmaceutical compositions are produced (claims 17 and 18). Although Chace does not administer the phage to a human or animal subject, however, they are expected to reduce infection by a corresponding pathogenic host in a human or animal, since they produce plaques (see page 344, section “Selection of tk mutants”) (claim 17). Therefore, the claimed embodiments are anticipated by the prior art.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 and 18 are rejected 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). Although the claims at issue are not identical, they are not patentably distinct from each other. The patented claim is directed to a method of treating or preventing an E. coli infection by administering a plurality of synthetic T-even phage capable of targeting E. coli comprising an insertion of a nucleotide sequence encoding a Cas nuclease into the genome of the phage between pin and iPII. The method of using the phage renders obvious the phage. Although the patented claim does not indicate that the phage can replicate in E. coli, they are expected to do so because they have an insertion in the same region that Applicant identifies as a deletion permissive region.
Claim 17 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 9 of U.S. Patent 12,076,375 B2 as applied to claim 1 above, and further in view of WO 2015/104388 A1. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 17 is directed to an embodiment of a method of producing a population of synthetic phage and mixing it with a pharmaceutically acceptable excipient, carrier or diluent. The patented claim does not indicate a method of production of a pharmaceutical composition by mixing the claimed phage with a pharmaceutically acceptable carrier, however, it would have been obvious to have claimed such with a reasonable expectation of success. WO 2015/104388 A1 discloses compositions of lytic phage for therapy of E. coli infections, wherein the phage composition comprises a pharmaceutically acceptable excipient or carrier (see abstract and page 6, lines 15-16). One would have been motivated to mix the phage of the patented claim with a pharmaceutically acceptable carrier in order to render the composition more suitable for administration.
Claims 1 and 18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 14 of copending Application No. 18/778,686 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claim is a species of the instantly claimed genus. The copending claim is directed to a composition comprising a plurality of synthetic T-even phage capable of targeting E. coli comprising an insertion of a nucleotide sequence encoding a Cas nuclease into the genome of the phage between pin and iPII. A species anticipates a genus. Although the copending claim does not indicate that the phage can replicate in E. coli, they are expected to do so because they have an insertion in the same region that Applicant identifies as a deletion permissive region. Further, although the copending claim does not indicate that the phage are suitable for administration to a human or animal subject for reducing infection of a pathogenic host bacterial species or strain, the phage are expected to have that property because they target the genomes of E. coli with a nuclease. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 17 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 14 of copending Application No. 18/778,686 (reference application) as applied to claim 1 above, and further in view of WO 2015/104388 A1. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 17 is directed to an embodiment of a method of producing a population of synthetic phage and mixing it with a pharmaceutically acceptable excipient, carrier or diluent. The copending claim does not indicate a method of production of a pharmaceutical composition by mixing the claimed phage with a pharmaceutically acceptable carrier, however, it would have been obvious to have claimed such with a reasonable expectation of success. WO 2015/104388 A1 discloses compositions of lytic phage for therapy of E. coli infections, wherein the phage composition comprises a pharmaceutically acceptable excipient or carrier (see abstract and page 6, lines 15-16). One would have been motivated to mix the phage of the copending claim with a pharmaceutically acceptable carrier in order to render the composition more suitable for administration.
Conclusion
No claim is allowed.
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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
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