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, see Pages 7-10, filed 10/22/2025, with respect to the rejection(s) of claims 1-20 under U.S.C. 102 have been fully considered and are persuasive, specifically in response to Applicant’s assertion that the current prior art of record does not teach the use of a spectrometer comprising a light source that transmits input light through the storage chamber. However, upon further consideration, a new ground(s) of rejection is made in view of McCord et al. (US PG Pub 2020/0015791, PG Pub of US Patent 10,383,606) in view of Mimura et al. (US 2015/0185242).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3-10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 refers to a controller that selects from of the plurality of wavelength bands, however the Specification and the previous set of claims do not refer to a controller with this capability. The Specification instead refers to the spectrometer itself being used to select the appropriate wavelength following diffraction, see [0048]- [0049], and makes no reference to a controller or the recited CPU being capable of the selecting function.
Claims 3-10 are rejected due to their dependency on Claim 1.
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 1, 3-11, and 13-20 are rejected under 35 U.S.C. 103 as being unpatentable over McCord et al. (US PG Pub 2020/0015791, PG Pub of US Patent 10,383,606) in view of Mimura et al. (US 2015/0185242).
teaches a cartridge-based biofluid monitoring system (test media-based urinalysis system, see [0006]) comprising:
a rotatable biofluid cartridge housing (test matrix conveyor 213, see Fig. 8) ; and
a plurality of biofluid cartridges that are circularly distributed about the rotatable biofluid cartridge housing (a plurality of test matrices 212 are disposed to circle the conveyor 213a, see Fig. 8 and [0074]), the biofluid cartridge configured to be removably inserted into the biofluid cartridge housing (the test strip is moved from storage into and out of the test chamber 210 by the actuator 213a, see [0054], and is therefore removably inserted),
wherein the each biofluid cartridge comprises comprising a storage chamber configured to store biofluid (perforations 724 of test matrices 212 contain sample following placement, see Fig. 7A-F, [0054], and [0069] - [0071]); and
a spectrometer (spectrophotometer, see [0049] and [0076]) comprising:
a prism that diffracts the output light to form diffracted light across a plurality of wavelength bands (diffraction grating used to separate output light, see [0076]):
a controller that selects one of the plurality of wavelength bands and an optical detector that detects an intensity of the diffracted light in the selected wavelength band (controller 230 is used to control wavelengths of light directed toward CMOS detector 224 and detects an associated intensity, see [0065] and [0076]).
However, while the prior art of McCord et al. teaches that the associated optical detector of the invention is a spectrophotometer, the reference does not teach that the spectrometer includes a light source that transmits input light through the storage chamber of an adjacent biofluid cartridge to form output light.
However, in the analogous art of sample analyzers for urine, Mimura et al. teaches a sample analyzer wherein the light source of the photometer is located within a center of a rotating reaction platform (light source 14, with detector 15 located directly opposite with rotating reaction vessel located therebetween, see Fig. 4 and [0039]), which is analogous to the conveyor of McCord et al.
The modification of the cartridge monitoring system of McCord et al. to relocate the light source to the center of the rotating sample platform while maintaining the detector on a side opposite the rotating platform as exemplified by Mimura et al. would have had the benefit of improving measurement accuracy by providing a scattered light measurement of a target analyte within the associated chamber during analysis, see [0051] in Mimura et al. Additionally, the modification of the spectrophotometer also referred to within McCord et al. to be arranged for a transmission based measurement as exemplified by Mimura et al. would have facilitated the expected result of providing quantification of a target analyte with a biological sample.
Regarding claim 3, modified McCord et al. teaches the monitoring system of claim 1 further comprising a tube configured to transport the biofluid to the storage chamber of each of the biofluid cartridges upon rotation of the rotatable biofluid cartridge housing (tube 802 for delivering urine to the test matrix 212, see Fig. 8 and [0074]).
Regarding claim 4, modified McCord et al. teaches the monitoring system of claim 1 further comprising a tube and a toilet (tube 802 is connected to toilet, see Fig. 8, device is drawn to toilet-based sensing system, see Abstract), wherein the tube is configured to transport the biofluid from the toilet to the storage chamber of each of the biofluid cartridges upon rotation of the rotatable biofluid cartridge housing, and wherein the biofluid is urine (tube 802 for delivering urine to the test matrix 212, see Fig. 8 and [0074]).
Regarding claim 5, modified McCord et al. teaches the monitoring system of claim 1, wherein the storage chamber has a chemical coating, or the biofluid cartridge is further configured to hold a testing strip (test matrix 212 contains lateral flow assay, see Fig. 7A and [0066]), in contact with biofluid stored within the storage chamber (test strip contacts fluid from perforations 724, see Figs. 7A and 7F, and [0070]), and wherein the chemical coating or the testing strip is configured to initiate a chemical reaction that causes a color change within the storage chamber that is indicative of a biological marker (lateral flow assay test line 715 changes color in response to the amount of a target analyte in a sample, see Fig. 7A and [0066]).
Regarding claim 6, modified McCord et al. teaches the monitoring system of claim 5, wherein the optical detector detects the intensity of the diffracted light that has been transmitted through the chemically coated storage chamber or the testing strip (CMOS detector is used to detect diffracted light, see [0076], where detecting the intensity of the diffracted light that has been transmitted through the chemically coated storage chamber or the testing strip is an intended use of the claimed invention. This limitation is only given patentable weight to the extent which it effects the structure of the claimed invention. Please see MPEP 2114.).
Regarding claim 7, modified McCord et al. teaches the monitoring system of claim 1, wherein:
the light source is positioned within a center area of the rotatable biofluid cartridge housing surrounded by the circularly distributed biofluid cartridges and the optical detector is located outside the rotatable biofluid cartridge housing (light source 14 of Mimura is centrally located within the cartridge housing, previously identified as analogous to the conveyor of McCord et al., see Fig. 4 and [0051] in Mimura et al. and the detector is located outside of the conveyor, see Fig. 8 and [0076] in McCord et al.).
Regarding claim 8, modified McCord et al. teaches the monitoring system of claim 2 further comprising a cleaning fluid container (250) and a cleaning fluid conduit (801) configured to dispense cleaning fluid from the cleaning fluid container to the storage chamber of each of the biofluid cartridges subsequent analysis of the biofluid and upon rotation of the rotatable biofluid cartridge housing (cleaning fluid container 250 uses tube 801 to dispense a cleaning fluid to the test chamber, see [0074]).
Regarding claim 9, modified McCord et al. teaches the monitoring system of claim 3 further comprising cleaning fluid container and a cleaning fluid conduit connected to the tube, wherein the cleaning fluid conduit is configured to dispense cleaning fluid from the cleaning fluid container to the tube subsequent analysis of the biofluid (cleaning fluid container 250 uses tube 801 to dispense a cleaning fluid to the test chamber where analysis of the test matrix occurs following analysis, see [0074] – [0075]).
Regarding claim 10, modified McCord et al. teaches the monitoring system of claim 2, wherein the biofluid cartridge comprises a barcode or QR code and the monitoring system further comprises a barcode reader or QR code reader, to identify a particular biofluid analysis to be performed by the monitoring system (the test matrix comprises a barcode 703, where an imager, or reader, with a controller uses the code to identify the test being executed by the matrix, see [0065]).
Regarding claim 11, McCord teaches a method for using a cartridge-based biofluid monitoring system (process for using device, see Fig. 4 for Illustrative Concept), the method comprising:
providing a cartridge-based biofluid monitoring system (test media-based urinalysis system, see [0006]) comprising:
a rotatable biofluid cartridge housing (test matrix conveyor 213, see Fig. 8) ; and
a plurality of biofluid cartridges that are circularly distributed about the rotatable biofluid cartridge housing (a plurality of test matrices 212 are disposed to circle the conveyor 213a, see Fig. 8 and [0074]);
removably inserting one of the biofluid cartridges into the biofluid cartridge housing and storing biofluid in the storage chamber (the test strip is moved from storage into and out of the test chamber 210 by the actuator 213a, see [0054], where perforations 724 of test matrices 212 contain sample following placement, see Fig. 7A-F, [0054], and [0069] - [0071]),
diffracting the output light to form diffracted light across a plurality of wavelength bands selecting one of the plurality of wavelength bands: and detecting an intensity of the diffracted light in the selected wavelength band (diffraction grating separates the output light where the controller 230 is used to control wavelengths of light directed toward CMOS detector 224 and detects an associated intensity, see [0065] and [0076]).
The prior art of McCord et al. does not teach that the method comprises transmitting input light through the storage chamber to form output light. While the invention mentions using transparent layers to ensure visualization of the entire sample, the reference does not refer to using transmission to detect the analyte of interest.
However, in the analogous art of sample analyzers for urine using photometry, Mimura et al. teaches a photometric method where the sample analyzer provided comprises a light wherein the light source of the photometer is located within a center of a rotating reaction platform (light source 14, with detector 15 located directly opposite with rotating reaction vessel located therebetween to provided transmission-based detection, see Fig. 4 and [0039]), where the rotating platform is analogous to the conveyor of McCord et al.
The modification of the cartridge monitoring system of McCord et al. to relocate the light source to the center of the rotating sample platform while maintaining the detector on a side opposite the rotating platform as exemplified by Mimura et al. would have had the benefit of improving measurement accuracy by providing a scattered light measurement of a target analyte within the associated chamber during analysis, see [0051] in Mimura et al. Additionally, the modification of the spectrophotometer also referred to within McCord et al. to be arranged for transmission based measurement as exemplified by Mimura et al. would have facilitated the expected result of providing quantification of a target analyte with a biological sample.
Regarding claim 13, modified McCord et al. teaches the method of claim 11, wherein the monitoring system further comprises a tube, and wherein the method further comprises transporting, via a tube, the biofluid to the storage chamber of each of the biofluid cartridges upon rotation of the rotatable biofluid cartridge housing (tube 802 delivers urine to the test matrix 212 following rotation into place, see Figs. 2-3, 8, [0054], and [0074]).
Regarding claim 14, modified McCord et al. teaches the method of claim 11, wherein the monitoring system further comprises a tube and a toilet (tube 802 is connected to toilet, see Fig. 8, device is drawn to toilet-based sensing system, see Abstract), wherein the method further comprises transporting, via the tube, the biofluid from the toilet to the storage chamber of each of the biofluid cartridges upon rotation of the rotatable biofluid cartridge housing, and wherein the biofluid is urine (tube 802 delivers urine to the test matrix 212 following rotation into place, see Fig. 8, [0054], and [0074]).
Regarding claim 15, modified McCord et al. teaches the method of claim 11, wherein the storage chamber has a chemical coating, or the biofluid cartridge holds a testing strip, (test matrix 212 contains lateral flow assay, see Fig. 7A and [0066]), in contact with biofluid stored within the storage chamber (test strip contacts fluid from perforations 724, see Figs. 7A and 7F, and [0070]), and wherein the chemical coating or the testing strip initiates a chemical reaction that causes a color change within the storage chamber that is indicative of a biological marker (lateral flow assay test line 715 changes color in response to the amount of the target analyte in a sample, see Fig. 7A and [0066] – [0067], where the reaction is indicative of different biomarkers such as hydration, amino acids, hormone levels, see [0078]).
Regarding claim 16, McCord et al. teaches the method of claim 15, wherein detecting the intensity of the diffracted light in the selected wavelength band comprises detecting the intensity of the diffracted light in the selected wavelength band that has been transmitted through the chemically coated storage chamber or the testing strip (the test matrix 212 is transparent to allow light to pass from LEDs 221 to the imager 224 of the photosensor system 220, see Figs. 2-3, 7B, 8, [0049], and [0069], where the intensity measured is the intensity signal after diffraction, see [0079]).
Regarding claim 17, modified McCord et al. teaches the method of claim 11, wherein:
the input light is transmitted through the storage chamber by a spectrometer positioned within a center area of the rotatable biofluid cartridge housing surrounded by the circularly distributed biofluid cartridges (light source 14 of Mimura is centrally located within the cartridge housing, previously identified as analogous to the conveyor of McCord et al., see Fig. 4 and [0051] in Mimura et al.); and the intensity of the diffracted light in the selected wavelength band is detected by an optical detector located outside the rotatable biofluid cartridge housing (the detector is located outside of the conveyor, see Fig. 8 and [0076] in McCord et al.).
Regarding claim 18, modified McCord et al. teaches the method of claim 11, wherein the monitoring system further comprises a cleaning fluid container (250) and a cleaning fluid conduit (801) that dispenses cleaning fluid from the cleaning fluid container to the storage chamber of each of the biofluid cartridges subsequent analysis of the biofluid and upon rotation of the rotatable biofluid cartridge housing (cleaning fluid container 250 uses tube 801 to dispense a cleaning fluid to perforations of blank test matrices following analysis and rotation, see [0074] – [0075]).
Regarding claim 19, modified McCord et al. teaches the method of claim 13, wherein the monitoring system further comprises a cleaning fluid container and a cleaning fluid conduit connected to the tube, wherein the cleaning fluid conduit dispenses cleaning fluid from the cleaning fluid container to the tube subsequent analysis of the biofluid (cleaning fluid container 250 uses tube 801 to dispense a cleaning fluid to the test chamber where analysis of the test matrix occurs following analysis, see [0074] – [0075]).
Regarding claim 20, modified McCord et al. teaches the method of claim 11, wherein the biofluid cartridge comprises a barcode or QR code and the monitoring system further comprises a barcode reader or QR code reader, to identify a particular biofluid analysis to be performed by the monitoring system (the test matrix comprises a barcode 703, where an imager, or reader, with a controller uses the code to identify the test being executed by the matrix, see [0065]).
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.
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/A.N.M./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758