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
Applicant’s amendment submitted on 4/8/2026 is acknowledged.
Claims 21-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 9/16/2025.
Claims 7-20 are under examination on the merits.
Withdrawn Objections
The following objection is hereby withdrawn due to Applicant’s amendment submitted 4/8/2026:
Claim objection: claim 12.
Withdrawn Rejections
The following rejections are hereby withdrawn due to Applicant’s amendment submitted 4/8/2026:
35 U.S.C. §112(a): claim 12
35 U.S.C. §112(b): claims 8, 10, 12, 14, and 16.
Maintained Rejections
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
(Previous Rejection Maintained) Claims 7-16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more.
Applicant’s arguments have been carefully considered but have found to be unpersuasive:
Applicant presents the following arguments:
Claims 7-16 were rejected under 35 U.S.C. §101 as being directed to a natural product without significantly more. This rejection cannot be sustained in view of the merger of a limitation from to rejected claim 17 requiring modification of the bacteriophage and excluding RKP180. This rejection cannot be sustained for the claim.
Applicant’s arguments are not persuasive:
Applicant’s amendment to claim 7 now requires “wherein said bacteriophage is a genetically engineered bacteriophage that has been engineered to comprise a gene encoding lysozyme fused to DarB; and wherein said bacteriophage is not RKP180 identified by NITE BP-03185.
Notably, amended claim 7 did not incorporate all of the limitations of the claim 17. Claim 17 states (now and previously) “the bacteriophage [..] that is an engineered bacteriophage produced by modifying or mutating genomic DNA of a bacteriophage to contain a gene encoding lysozyme fused to DarB”. However, amended claim 17 does not require the modification or mutation of genomic DNA of a bacteriophage, but instead merely “said bacteriophage is a genetically engineered bacteriophage that has been engineered to comprise a gene encoding lysozyme fused to DarB; and wherein said bacteriophage is not RKP180 identified by NITE BP-03185”. Accordingly, claim 7 does not require modifying or mutating genomic DNA, which is what differentiates claim 17 from being directed to a natural product without significantly more. Additionally, the limitation “wherein said bacteriophage is not RKP180 identified by NITE BP-03185” does not rule out structurally identical phage that were not deposited. The claims do not appear to require a structural difference from RKP180 identified by NITE BP-03185.
Thus, the amended claim 7, and its dependent claims 8-16 are still directed to a natural product without significantly more, and remain rejected under 35 U.S.C. §101.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Due to Applicant’s argument against each rejection under 35 U.S.C. §103 being essentially the same, they are addressed together below.
(Previous Rejection Maintained) Claims 7, 10, 11, 13, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Gill, et al. (J Bacteriol. 2011 Oct;193(19):5300-13. doi: 10.1128/JB.05287-11. Epub 2011 Jul 29. PMID: 21804006; hereinafter referred to as “Gill”) in view of Fokine, et al. (J Biol Chem. 2008 Mar 14;283(11):7242-50. doi: 10.1074/jbc.M709398200. Epub 2007 Dec 26. PMID: 18160394; hereinafter referred to as “Fokine”), Iyer (J Bacteriol. 2017 Jul 11;199(15):e00245-17. doi: 10.1128/JB.00245-17. PMID: 28559295; hereinafter referred to as “Iyer”) and Kumar (Dissertation by Denish Kumar Piya, Interactions Between Host and Phage Encoded Factors Shape Phage Infection, Texas A&M University, December 2018; hereinafter referred to as “Kumar”).
(Previous Rejection Maintained) Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Gill, Fokine, Iyer, and Kumar (supra) as applied to claims 7, 10, 11, 13, and 17 above, and further in view of Summer, et al. (J Mol Biol. 2007 Nov 9;373(5):1098-112. doi: 10.1016/j.jmb.2007.08.045. Epub 2007 Aug 24. PMID: 17900620; hereinafter referred to as “Summer”).
(Previous Rejection Maintained) Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Gill, Fokine, Iyer, Kumar, and Summer (supra), as applied to claim 8 above, and further in view of Sobrero, et al. (Front Mol Biosci. 2020 Jul 10;7:127. doi: 10.3389/fmolb.2020.00127. PMID: 32754614; hereinafter referred to as “Sobrero”).
(Previous Rejection Maintained) Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Gill, Fokine, Iyer, and Kumar (supra) as applied to claims 7, 10, 11, 13, and 17 above, and further in view of Wang, et al. (Arch Virol. 2019 Sep;164(9):2339-2343. Epub 2019 Jun 18. PMID: 31214785; hereinafter referred to as “Wang”).
(Previous Rejection Maintained) Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Gill, Fokine, Iyer, Kumar, and Wang (supra) as applied to claim 15 above, and further in view of JP 2007252351 A (published 10/4/2007, machine translation due to original document being in Japanese language; hereinafter referred to as “‘351”).
(Previous Rejection Maintained) Claims 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Gill, Fokine, Iyer, Kumar, Wang, and ‘351 (supra) as applied to claim 16 above, and further in view of Murthy, et al. (WO 2006047870 A1, published 5/11/2006, priority date 11/2/2004; hereinafter referred to as “Murthy”).
Applicant’s arguments have been carefully considered but have found to be unpersuasive:
Applicant presents the following arguments:
The rejections cannot be maintained in view of the amendments to claim 7 to include limitations from claim 14, which was not rejected and merger of limitations from claim 17 requiring an engineered phage and excluding the naturally occurring phage RKP 180.
Applicant’s arguments are not persuasive:
Applicant did not incorporate all of the limitations from claim 14 into amended claim 7. The cited references still render obvious the amended claims.
The modified bacteriophage BcepIL02 or Bcep22 wherein the genes gp75 or gp70 have swapped in DarB in place of the genes' DarB-like domains, to generate a fused gene where DarB is fused to the remainder of the gp75 or gp70, which is rendered obvious in the rejection under 35 U.S.C. §103 over Gill, in view of Fokine, et al., Iyer, and Kumar would meet each of the limitations of amended claim 7.
Gill, et al. discloses that Bcep22 has a head diameter of 71 nm, tail length of 15 nm, tail width of 14 nm, dsDNA genome (Fig. 2 indicates the genomes have forward and reverse strands), 77 protein coding genes, and a genome size of 63,882 bases, with 65.3% G+C content, while BcepIL02 has a head diameter of 72 nm, tail length of 18 nm, tail width of 15 nm, dsDNA genome (Fig. 2 indicates the genomes have forward and reverse strands), 76 protein coding genes, genome size of 62,714 bases, and 66.2% G+C content (Fig. 1, p. 5302, col. 2, paras. 2-3).
Thus, Applicant’s argument is unpersuasive and each rejection under 35 U.S.C. §103 is maintained.
New Objection
(New Objection) Claim 10 is objected to because of the following informalities: claim 10 recites “a host recognition and binding binding domain” on lines 2-3, which appears to be a typographical mistake. Appropriate correction is required.
Conclusion
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.
No claim is allowed.
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/JEFFREY MARK SIFFORD/Examiner, Art Unit 1671 /Michael Allen/Supervisory Patent Examiner, Art Unit 1671
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