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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/28/2026 has been entered.
Response to Amendment
This is an office action in response to applicant's arguments and remarks filed on 1/28/2026. Claims 1, 5, 7-8, and 21 are pending in the application.
Status of Objections and Rejections
New grounds of rejection under 35 U.S.C. 103 are necessitated by the amendments.
Response to Arguments
Applicant’s arguments, see Page 9, filed 1/28/2026, with respect to the 112(a) rejection of claims 1, 4-5, and 7-8 have been fully considered and are not considered persuasive. The 112(a) rejection of 10/30/2025 is maintained in the action below.
On Page 9 of the Remarks, the Applicant states that the addition of a fourth light source is not new matter as the “at least one light source” suggests a minimum of one light source with no upper limit. In response to this argument, the Examiner agrees. However, the Specification is silent to the configuration of an LED with the wavelength limits of “220 – 4000nm” as recited in the previously presented claims, and the newly amended limit of 700 – 4000nm. There is no reference within the specification to the range, and it is unclear how the light source is configured to emit the claimed range.
Applicant’s arguments, see Pages 10-13, filed 1/28/2026, with respect to the rejections of claims 1, 4-5, 7-8, and 21 under 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn as the previous Office Action fails to establish that Takinami would anticipate the newly amended aspects to independent Claim 1, specifically the fourth LED programmed to emit a wavelength between 700-4000nm. Applicant therefore submits that independent Claim 1 is patentable over the asserted reference. However, upon further consideration, a new grounds of rejection is made in view of Takinami (Machine Translated WO2018/061771) in view of Sekimoto (US 2010/0259747) and Walters (US 20160033328 A1).
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, 5, and 7-8 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 claims 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.
Regarding claim 1, the specification has support for "one or more LEDs," but does not specify that the invention comprises 4 LEDs programmed to different wavelengths, wherein the 4th LED is specifically programmed to be between 700nm to 4000 nm. Because the specification does not specify 4 LEDs where the 4th LED is configured to emit a wavelength between 700 and 4000nm, the recitation of the fourth LED with a specific LED emission range is considered new matter.
Claims 5 and 7-8 are rejected due to their dependence 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, 5, 7-8, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Takinami (Machine Translated WO2018/061771) in view of Sekimoto (US 2010/0259747) and Walters (US 20160033328 A1).
Regarding claim 1, Takinami teaches a non-electrochemical substance detection device (colorimetric measuring device 1, see [0061]), comprising:
An optical system (optical system 64, see [0037]) consisting essentially of:
at least one LED light source comprising a first LED light source, a second LED light source wherein the first LED light source is configured to emit light having a first wavelength of between 200 nm and 600 nm (device comprises first LED that emits light at 600-900nm, which overlaps the instant range, where a prima facie case of obviousness exists in the case of overlapping ranges. See MPEP 2144.05), wherein the second LED light source is configured to emit light with a second wavelength of between 200 nm and 600 nm, (second LED that emits wavelength of 510-590nm, which falls within the instant range, see [0042]), wherein each of the first wavelength and the second wavelength are different wavelengths (the wavelengths of the first and second LEDs are different, see [0042])
a substrate, wherein the substrate is configured to activate the at least one LED light source (a light
emission control circuit 70 to control lights 66, see Fig. 5 and [0040]);
a photon sensor (photodiode 72, see Fig. 5 and [0044]);
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Annotated Fig. 4
a cartridge port (gap-like chip mounting space S, se Fig. 1-3 and [0033]), configured to receive a liquid biological sample test strip and comprising a sample insertion site and a measurement window (measuring chip 2 with cylindrical supply portion 24 for supplying sample, and transparent covers 21/25 to show reagent 22, see Fig. 5, [0026], [0029], and [0033]-[0034]),
wherein the sample insertion site (24) and the measurement window (22) are fluidically connected by a fluid flow pathway (the supply unit 24 is connected to reagent location 22 by flow path 23, see Fig. 2 and [0026]), wherein the sample insertion site has a diameter that is larger than a width of the flow pathway, (see annotated Fig. 4), wherein the measurement window has a width larger than the width of the flow pathway (the cover 25 and base member 21 are wider than the color developing region 22 and flow path 23, see [0027], [0029], and Fig. 4),
wherein the cartridge port is configured to, upon insertion of the liquid biological sample test strip, position the measurement window between a) the substrate and b) the photon sensor (mounting space S positions reagent 22 between light circuit 66/70, see Figs. 2 and 5 and [0041] – [0042]);
an analog-to-digital converter (ADC) ((light-receiving control circuit 74, see Fig. 5 and [0045]) configured to convert at least one analog signal from the photon sensor into a digital signal, wherein the at least one analog signal corresponds to light emitted from the at least one LED light source that is received by the photon sensor after it has passed through the measurement window, wherein the at least one LED light source are configured to direct the emitted light through an optically obstructive dye disposed on the measurement window (circuit 74 receives and converts light signal transmitted from lights 66 through reagent 22 to detectors 72, see Fig. 5 and [0045]);
a microcontroller configured to measure an analyte concentration based on the digital signal (calculation unit 60 calculates glucose concentration based off digital signal, see [0045] – [0047]);
a touch-based display configured to display at least one of: testing results, battery level and menu options (display 11 with operational button 14 that shows results and menu options, see Fig. 1 and [0035]),
wherein the optically obstructive dye is formed according to the analyte concentration in a liquid biological sample and comprises a salt (reagent 22 produces color corresponding to analyte concentration and comprises salt, see [0031]);
wherein, upon reaching the photon sensor, the optically obstructive dye has modified at least one characteristic of the at least one LED light source (wavelength from LED is altered by reagent 22 and received by detector 72, see Fig. 5, [0038], and [0046]); and
wherein the photon sensor is configured to measure and communicate the at least one characteristic of the at least one LED light source using the touch-based display (detector 72 detects modification in wavelength after color change, see [0042] – [0044]),
but does not teach that the device comprises a third LED light source, and a fourth LED light source,
wherein the third LED light source is configured to emit light with a third wavelength of between 200 nm and 600 nm,
wherein the fourth LED light source is configured to emit light with a fourth wavelength of between 700 nm and 4000 nm,
wherein each of the third wavelength, and the fourth wavelength are different wavelengths.
However, in the analogous art of optical sample detectors, Sekimoto teaches a device that comprises a third LED light source, and a fourth LED light source (the optical substrate 44 comprises 4 LEDs, 40-43, see Fig. 3 and [0038]),
wherein the third LED light source is configured to emit light with a third wavelength of between 200 nm and 600 nm (the LED 42 emits light with wavelength of 600-700nm to detect glucose, see [0038], which overlaps the instant range, where a prima facie case of obviousness exists in the case of overlapping ranges. See MPEP 2144.05).
wherein the fourth LED light source is configured to emit light with a fourth wavelength of between 700 nm and 4000 nm (the LED 43 emits a wavelength of 800-910nm to detect glucose, see [0038])
wherein each of the third wavelength, and the fourth wavelength are different wavelengths (LEDs 40 and 41 emit light at different wavelengths, see Fig. 6, where LEDs 42 and 43 also emit different wavelengths, see [0038]).
While the invention of Takinami does not teach that the plurality of light sources includes four light sources, it was known in the art before the effective filing date to modify a substrate containing lights to contain two additional LEDs to detect glucose in addition to a hematocrit level within a blood sample, as exemplified by Sekimoto, see [0038]. Therefore, it would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have modified the invention of Takinami comprising the two light sources to include the additional third and fourth light sources as exemplified by Sekimoto for the benefit of detecting the concentration of a target analyte within the sample, i.e., glucose, see [0038]. Further, the modification would have resulted in the expected result for detecting different analytes within a sample using different wavelengths of light as each analyte exhibits different behavior at predetermined wavelengths While the invention of Takinami does not teach that the plurality of light sources includes four light sources, it was known in the art before the effective filing date to modify a substrate containing lights to contain two additional LEDs to detect glucose in addition to a hematocrit level within a blood sample, as exemplified by Sekimoto, see [0038]. Therefore, it would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have modified the invention of Takinami comprising the two light sources to include the additional third and fourth light sources as exemplified by Sekimoto for the benefit of detecting the concentration of a target analyte within the sample, i.e., glucose, see [0038]. Further, the modification would have resulted in the expected result for detecting different analytes within a sample using different wavelengths of light as each analyte exhibits different behavior at predetermined wavelengths (see [0042] in Takinami and [0038] in Sekimoto).
Further, modified Takinami does not teach a first filter, wherein the first filter is positioned between the at least one LED light source and the measurement window, wherein the first filter is at least one of a dichroic filter and a cut-on optical filter and a second filter, wherein the second filter is configured to filter the light between the at least one LED light source and the photon sensor.
However, in the analogous art of portable color detectors for biomedical chips, Walters teaches a first filter, wherein the first filter is positioned between the at least one LED light source and the measurement window (filter 118 located between LED and sample 140 that is transparent, where the sample is analogous to the test strip of Takinami, see Fig. 1 and [0015]), wherein the first filter is at least one of a dichroic filter and a cut-on optical filter (the filter 118 is a longpass filter, or cut-on filter, see [0021]) and a second filter, wherein the second filter is configured to filter the light between the at least one LED light source and the photon sensor (the collimating optic 116 filters light from light source toward detector 150, see Fig. 1 and [0015]).
The modification of a spectroscopic system to incorporate an optical filter and lens was known in the art before the effective filing date of the instant invention, as exemplified by Walters, see [0028]. While the inventions of Takinami and Sekimoto are silent to the use of filters to alter the light signal, and state that the use of lenses would make the system more expensive, the system of Walters has found a low-cost implementation of additional lenses and filters within an optical detection system, see [0028]. Therefore, it would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have further modified the invention of Takinami to include the optical filter and collimating lens for the benefit of ensuring the desired light wavelength illuminates the correct location along a sample, see [0056] in Walters. The modification of the optical system of Takinami to incorporate the filters of Walters would have resulted in the expected result of facilitating illumination of a test strip/target analyte.
Additionally, before the effective filing date of the claimed invention, there had been a recognized problem or need in the art to solve the problem of filters to select for wavelengths for analyte detection, whether by using an LED with a specific emission wavelength or by using a general light with an additional filter, see [0043] in Takinami. There were a finite number of identified and predictable potential solutions to the recognized need or problem as evidenced by Walters teaching that there are eight types of pass-filter that can be substituted in for a general optical filter.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to try each of the known filters to yield a light and filter fixture for detecting an analyte. The results would have been predictable, and since Walters teaches that there are a known limited number of pass filters, one of ordinary skill in the art would have pursued the known potential solutions with a reasonable expectation of success.
Regarding claim 5, modified Takinami teaches the non-electrochemical substance detection device of claim 4, wherein the second filter is at least one of a collimating optic, a dichroic filter, and a cut-on optical filter (the lens 116 is a collimating optic, see [0015] in Walters).
Regarding claim 7, modified Takinami teaches the non-electrochemical substance detection device of claim 1, further comprising at least one light blocker, wherein the at least one light blocker is configured to reduce the amount of ambient light received by the photon sensor (housing 10, see Fig. 5, wherein the housing is used to contain the LED unit of the prior art and therefore reduces the amount of outside light that reaches the detector; an intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See In re Casey, 152 USPQ 235 (CCPA 1967) and In re Otto, 136 USPQ 458,459 (CCPA 1963).
Regarding claim 8, modified Takinami teaches the non-electrochemical substance detection device of claim 1, wherein generation of light by the at least one LED light source is adjusted by changes in input current and/or voltage to the at least one LED light source, thereby modulating the wavelength and/or intensity of the light emitted by the at least one LED light source (LED light would necessarily require current and voltage supplied from power source to change wavelength and intensity, and voltage as LEDs do not supply their own power, see [0043] – [0046] in Takinami).
Regarding claim 21, Takinami teaches a non-electrochemical substance detection device (colorimetric measuring device 1, see [0061]), comprising:
An optical system (optical system 64, see [0037]) consisting essentially of:
a plurality of LED light sources comprising a first LED light source, a second LED light source (device comprises first and second LEDs, see [0042]),
a substrate, wherein the substrate is configured to activate the LED light source (a light
emission control circuit 70 to control lights 66, see Fig. 5 and [0040]);
a photon sensor (photodiode 72, see Fig. 5 and [0044]);
a cartridge port (gap-like chip mounting space S, se Fig. 1-3 and [0033]), configured to receive a liquid biological sample test strip and comprising a measurement window (measuring chip 2 with transparent covers 21/25 to show reagent 22, see Fig. 5, [0029] and [0033]-[0034]), wherein the cartridge port is configured to, upon insertion of the liquid biological sample test strip, position the measurement window between a) the substrate and b) the photon sensor (mounting space S positions reagent 22 between light circuit 66/70, see Figs. 2 and 5 and [0041] – [0042]) ;
an analog-to-digital converter (ADC) (light-receiving control circuit 74, see Fig. 5 and [0045]) configured to convert at least one analog signal from the photon sensor into a digital signal, wherein the at least one analog signal corresponds to light emitted from one LED light sources that is received by the photon sensor after it has passed through the measurement window, wherein the LED light sources are configured to direct the emitted light through an optically obstructive dye disposed on the measurement window (circuit 74 receives and converts light signal transmitted from lights 66 through reagent 22 to detectors 72, see Fig. 5 and [0045]);
a microcontroller configured to measure an analyte concentration based on the digital signal (calculation unit 60 calculates glucose concentration based off digital signal, see [0045] – [0047]);
a touch-based display configured to display at least one of: testing results, battery level and menu options (display 11 with operational button 14 that shows results and menu options, see Fig. 1 and [0035]),
wherein the optically obstructive dye is formed according to the analyte concentration in a liquid biological sample and comprises a salt (reagent 22 produces color corresponding to analyte concentration and comprises salt, see [0031]);
wherein, upon reaching the photon sensor, the optically obstructive dye has modified at least one characteristic of the at least one LED light source (wavelength from LED is altered by reagent 22 and received by detector 72, see Fig. 5, [0038], and [0046]); and
wherein the photon sensor is configured to measure and communicate the at least one characteristic of the at least one LED light source using the touch-based display (detector 72 detects modification in wavelength after color change, see [0042] – [0044]),
but does not teach that the device comprises a third LED light source, wherein each of the first wavelength, the second wavelength, the third wavelength are different wavelengths, and
However, in the analogous art of optical sample detectors, Sekimoto teaches a device that comprises a third LED light source (the optical substrate 44 comprises 4 LEDs, meaning there is a third, 40-43, see Fig. 3 and [0038]),
wherein the third LED light source is configured to emit light with a third wavelength of between 200 nm and 600 nm (the LED 42 emits light with wavelength of 600-700nm to detect glucose, see [0038], which overlaps the instant range, where a prima facie case of obviousness exists in the case of overlapping ranges. See MPEP 2144.05).
first wavelength, the second wavelength, the third wavelength are different wavelengths (LEDs 40 and 41 emit light at different wavelengths (510-590, represented by different relative absorbance values), see Fig. 6, where LED 42 emits a higher wavelength (600-700nm) see [0038]).
While the invention of Takinami does not teach that the plurality of light sources includes three light sources, it was known in the art before the effective filing date to modify a substrate containing lights to contain at least one additional LED to detect glucose in addition to a hematocrit level within a blood sample, as exemplified by Sekimoto, see [0038]. Therefore, it would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have modified the invention of Takinami comprising the two light sources to include the additional third light source exemplified by Sekimoto for the benefit of detecting the concentration of a target analyte within the sample, i.e., glucose, see [0038]. Further, the modification would have resulted in the expected result for detecting different analytes within a sample using different wavelengths of light as each analyte exhibits different behavior at predetermined wavelengths (see [0042] in Takinami and [0038] in Sekimoto).
Further, modified Takinami does not teach a first filter, wherein the first filter is positioned between the at least one LED light source and the measurement window, wherein the first filter is at least one of a dichroic filter and a cut-on optical filter and a second filter, wherein the second filter is configured to filter the light between the at least one LED light source and the photon sensor.
However, in the analogous art of portable color detectors for biomedical chips, Walters teaches a first filter, wherein the first filter is positioned between the at least one LED light source and the measurement window (filter 118 located between LED and sample 140 that is transparent, where the sample is analogous to the test strip of Takinami, see Fig. 1 and [0015]), wherein the first filter is at least one of a dichroic filter and a cut-on optical filter (the filter 118 is a longpass filter, or cut-on filter, see [0021]) and a second filter, wherein the second filter is configured to filter the light between the at least one LED light source and the photon sensor (the collimating optic 116 filters light from light source toward detector 150, see Fig. 1 and [0015]).
The modification of a spectroscopic system to incorporate an optical filter and lens was known in the art before the effective filing date of the instant invention, as exemplified by Walters, see [0028]. While the inventions of Takinami and Sekimoto are silent to the use of filters to alter the light signal, and state that the use of lenses would make the system more expensive, the system of Walters has found a low-cost implementation of additional lenses and filters within an optical detection system, see [0028]. Therefore, it would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have further modified the invention of Takinami to include the optical filter and collimating lens for the benefit of ensuring the desired light wavelength illuminates the correct location along a sample, see [0056] in Walters. The modification of the optical system of Takinami to incorporate the filters of Walters would have resulted in the expected result of facilitating illumination of a test strip/target analyte.
Additionally, before the effective filing date of the claimed invention, there had been a recognized problem or need in the art to solve the problem of filters to select for wavelengths for analyte detection, whether by using an LED with a specific emission wavelength or by using a general light with an additional filter, see [0043] in Takinami. There were a finite number of identified and predictable potential solutions to the recognized need or problem as evidenced by Walters teaching that there are eight types of pass-filter that can be substituted in for a general optical filter.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to try each of the known filters to yield a light and filter fixture for detecting an analyte. The results would have been predictable, and since Walters teaches that there are a known limited number of pass filters, one of ordinary skill in the art would have pursued the known potential solutions with a reasonable expectation of success.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEA MARTIN whose telephone number is (571)272-5283. The examiner can normally be reached M-F 10AM-5:00PM (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at (571)270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.N.M./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758