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 .
DETAILED ACTION
Acknowledgement is hereby made of receipt and entry of the communication filed on Apr. 16, 2026. Claims 1-12 are pending and currently examined.
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.
(Previous Rejection – Withdrawn) Claims 1-5 were rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and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.
This rejection is withdrawn in view of the amendment filed on Apr. 16, 2026.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
(Previous Rejection – Maintained) Claims 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over Xie et al. (Viruses 2018, 10, 189; submitted in IDS filed on Aug. 4, 2023), Henry et al. (Bacteriophage, 2012, 2:3, 159–167), Fischer et al. (PLoS ONE, 2013, 8(1): e53899; submitted in IDS filed on Aug. 4, 2023), and Paczesny et al. (Viruses 2020, 12, 845; submitted in IDS filed on Aug. 4, 2023).
Applicant argues that the luciferase reporter phage assays taught in Paczesny use different operating principle from that of the claimed invention. Applicant argues that in systems of Paczesny, luciferase is genetically encoded within the phage genome and expressed during productive infection, and that detection is therefore contingent on intracellular expression of the phage genome. Applicant argues that, in contrast, the claimed measuring system does not rely on reporter gene expression; that, instead, its detection principle is based on phage-mediated lysis of the host bacterium; and that luciferase is used only as a biochemical probe to detect ATP released upon cell lysis and the signal therefore arises from extracellular ATP liberated by lysed cells, not from intracellular expression of a phage-encoded reporter.
Applicant’s arguments are not persuasive. The claims do not exclude that luciferase used in the assay as claimed is introduced by the bacteriophage used in the assay. The claims specify “wherein said at least one reagent or additive comprises at least one of the following: a Luciferin/Luciferase complex configured to allow detection of bacterial cell lysis through depletion of ATP and concomitant fluorescein light emission, a Luciferin/Luciferase complex compatible solvent, or a Luciferin/Luciferase complex compatible enzyme”. By specifying that the at least one reagent may comprise “a Luciferin/Luciferase complex compatible solvent, or a Luciferin/Luciferase complex compatible enzyme”, the claims encompass bacterial phage-sensitivity assays using luciferase reporter phages. In this case, the reagents used in the detection of the luciferase reporter in the phage reporter assay systems of Paczesny are expected to comprise at least a “Luciferin/Luciferase complex compatible solvent”, such as H2O.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 extension fee 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NIANXIANG (NICK) ZOU whose telephone number is (571)272-2850. The examiner can normally be reached on Monday - Friday, 8:30 am - 5:00 pm, EST. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MICHAEL ALLEN, on (571) 270-3497, can be reached. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NIANXIANG ZOU/
Primary Examiner, Art Unit 1671
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