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 .
Response to Arguments
Applicant's arguments filed 05/11/2026 have been fully considered but they are not persuasive. Applicant first argues that Radhakrishnan teaches away from the proposed combination. This argument is not persuasive since a reference is understood as teaching away when it criticizes, discredits, or otherwise discourages the proposed course. Merely identifying a preferred alternative or advantageous implementation is generally insufficient. Radhakrishnan does not appear to state that extrinsic fluorophores must not be used, would prevent pathogen classification, or would produce unreliable results and claim 1 does not require intrinsic or label-free sensing. Applicant’s argument that the modification would render Radhakrishnan unsuitable for its intended purpose is also not persuasive. Radhakrishnan’s intended purpose can reasonably characterized as detecting and classifying pathogens. Adding extrinsic fluorophore would not necessarily prevent that function.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
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 1, 3, 4, and 7-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Radhakrishnan (US 20210106231 A1) in view of Yang (US 20180088053 A1).
With regards to claim 1, Radhakrishnan discloses a device and method for detection and classification comprising:
determining an identity or characteristic of a chemical/biological species (Abstract) by combining optical emission information, including steady-state and time resolved fluorescence information [0044-0045]:
a first electromagnetic radiation signal comprising at least a steady-state photon emission event [0053-0054], and a second electromagnetic radiation signal comprising at least a non-steady-state photon emission event [0053-0054]. Radhakrishnan does not teach the second electromagnetic radiation signal comprising at least a non-steady-state photon emission event having a delayed emission of greater than or equal to 10 ns.
Yang teaches a method for sensing applications comprising selecting an emissive species chosen for long exited-state lifetimes, including delayed fluorescence emissions of at least 10 ns, to provide high resolution imaging and/or quantitative sensing thus enabling improved discrimination in biological sensing (Abstract) [0005, 0010]. It would have been well known, obvious, and predictably suitable to one with ordinary skill in the art to modify Radhakrishnan’s combined steady-state and time-resolved fluorescence classification method to include the long-lifetime emissive species and delayed emission measurement taught by Yang. The modification would have predictable supplemented Radhakrishnan’s combined steady state and time resolved fluorescence analysis with a delayed emission signal of at least 10 ns.
With regards to claims 3 and 4, Radhakrishnan does not specifically teach the claimed excited state lifetimes. Nevertheless, those skilled in the art recognize that the excited state lifetimes are generally understood to depend upon the species under analysis. As such, it would have been well known, obvious, and predictably suitable to one with ordinary skill in the art to modify Kubota with the claimed excited state lifetimes in order to analyze a desired species.
With regards to claim 7, Radhakrishnan discloses a system, comprising:
an excitation component 108 configured to excite a first emissive species such that the first emissive species produces a detectable steady-state photon emission signal [0053-0055];
the excitation component is configured to excite a second emissive species such that the second emissive species produces a detectable non-steady-state photon emission signal [0053-0055]; and
a sensor 114 configured to detect at least a portion of the detectable steady-state photon emission signal and at least a portion of the detectable non-steady-state emission signal [0053-0057]. Radhakrishnan does not teach the second electromagnetic radiation signal comprising at least a non-steady-state photon emission event having a delayed emission of greater than or equal to 10 ns. Yang teaches a method for sensing applications comprising selecting an emissive species chosen for long exited-state lifetimes, including delayed fluorescence emissions of at least 10 ns, to provide high resolution imaging and/or quantitative sensing thus enabling improved discrimination in biological sensing (Abstract) [0005, 0010]. It would have been well known, obvious, and predictably suitable to one with ordinary skill in the art to modify Radhakrishnan’s combined steady-state and time-resolved fluorescence classification method to include the long-lifetime emissive species and delayed emission measurement taught by Yang. The modification would have predictable supplemented Radhakrishnan’s combined steady state and time resolved fluorescence analysis with a delayed emission signal of at least 10 ns.
With regards to claim 8, Radhakrishnan discloses an electronic hardware component configured to combine the detectable steady-state emission and the detectable non-steady-state emission into a determinable signal [0044-0045].
With regards to claim 9, Radhakrishnan discloses wherein the detectable steady-state emission and/or the detectable non-steady-state emission correspond to a characteristic of the first emissive species and/or the second emissive species [0044-0045].
With regards to claim 10, Radhakrishnan discloses wherein the determinable signal corresponds to a quantity of a target biological species [0037, 0072].
With regards to claim 11, Radhakrishnan discloses wherein at least one emission is selected from the group consisting of subtractive color, reflected/scattered color, chemiluminescence, prompt-fluorescence, delayed-fluorescence, prompt-phosphorescence, or delayed-phosphorescence [0042-0054].
With regards to claims 12-17, Radhakrishnan does not teach the claimed signals. Nevertheless, the claimed signals were generally known in the art and considered obvious design choices depending upon the particular needs of the application. It would have been well known, obvious, and predictably suitable to one with ordinary skill in the art to modify Radhakrishnan with the claimed signals in order to perform a desired particle analysis.
With regards to claim 18, Radhakrishnan discloses wherein at least one signal is collected in a steady-state mode and at least one other signal is collected using a time synchronized light source [0042-0044, 0053-0055].
With regards to claim 19, Radhakrishnan discloses wherein at least one signal is collected when a time synchronized electromagnetic radiation source is off and at least another signal is collected when a time synchronized electromagnetic radiation source is on [0049, 0052-0055].
With regards to claim 20, Radhakrishnan discloses wherein at least one signal is collected while the assay is illuminated by one or more LED light sources [0101].
With regards to claim 21, Radhakrishnan discloses wherein the excitation component is a source of electromagnetic radiation [0042].
With regards to claim 22, Radhakrishnan discloses wherein the source of electromagnetic radiation comprises a flash from a smartphone or digital camera [0050].
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCUS H TANINGCO whose telephone number is (571)272-1848. The examiner can normally be reached Monday-Friday 9am-6pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Uzma Alam can be reached on 571-272-3995. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARCUS H TANINGCO/ Primary Examiner, Art Unit 2884
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