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
The amendment filed 10/6/2025 has been entered. Claims 8, 25, 29, and 30 are cancelled. Claims 31 and 32 are newly added. Claims 1-7, 9-24, 26-28, 31, and 32 are pending. Claims 1-7 and 9-23 are withdrawn. Claims 24, 26-28, 31, and 32 are under examination.
Response to Arguments
Applicant’s arguments, with respect to claims 24 and 26-28 under 35 USC 103, have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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, 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 24, 26-28, 31, and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Besant et al., (Rapid electrochemical phenotypic profiling of antibiotic-resistant bacteria. Lab Chip. 2015 Jul 7;15(13):2799-807).
Regarding claims 24 and 26, Besant teaches a device and system for electrochemical phenotyping that identifies the antibiotic susceptibility profile of bacteria (p. 2800, col. 1, para. 2). Besant teaches that the bacteria are incubated with culture media, antibiotics, and a redox reporter, resazurin, (p. 2800, col. 2, para. 1; Figure 1) i.e., a redox mediator. Besant teaches that the device contained nanoliter culture chambers with each well equipped with electrodes to electrochemically readout the antibiotic susceptibility profile of the bacteria captured within (p. 2802, col. 2, para. 4; Figure 1). Because the electrodes measure the reduction of resazurin by metabolically active bacteria it is considered that the electrodes are in contact with the bacterial culture media, i.e., the first substance. Although Besant teaches that the culture media comprising the redox mediator and antibiotic is in the form of liquid LB media (p. 2801, col. 1, Electrochemical detection of bacteria), Besant also teaches LB agar plates (p. 2801, col. 1, Determination of bacterial capture efficiency). It would be obvious to one of ordinary skill in the art that the LB culture media in the device may be agar gel or solid, as such are known to support microbial growth.
Regarding claims 27 and 28, Besant teaches a system comprising culture media, antibiotics, and a redox reporter, resazurin, (p. 2800, col. 2, para. 1; Figure 1) i.e., a redox mediator. Besant teaches that the device contained nanoliter culture chambers with each well equipped with electrodes to electrochemically readout the antibiotic susceptibility profile of the bacteria captured within (p. 2802, col. 2, para. 4; Figure 1). Because the electrodes measure the reduction of resazurin by metabolically active bacteria it is considered that the electrodes are in contact with the bacterial culture media, i.e., the first substance. Although Besant teaches that the culture media comprising the redox mediator and antibiotic is in the form of liquid LB media (p. 2801, col. 1, Electrochemical detection of bacteria), Besant also teaches LB agar plates (p. 2801, col. 1, Determination of bacterial capture efficiency). Besant also teaches electrochemical measurements using a potentiostat and a three-electrode set-up (p. 2801, col. 2, Electrochemical measurements).
Regarding claim 31, Besant teaches that plugs are formed within the sensor wells, i.e., the wells containing the culture media, bacteria, and antibiotic, by introducing immiscible oil (Figure 1D). Therefore, it is considered that the substance containing the redox mediator and antibiotic is sealed from the atmosphere.
Regarding claim 32, Besant teaches that the electrodes were scanned using differential pulse voltammetry (p. 2801, col. 2, Electrochemical measurements).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, 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 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHEL EMILY MARTIN whose telephone number is (703)756-1416. The examiner can normally be reached M-Th 8:30-16:00, F 8:30-10:00 EST.
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/RACHEL EMILY MARTIN/Examiner, Art Unit 1657