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 1/30/2026, have been fully considered and are considered persuasive in light of the newly amended claim limitations within claim 1. However, the newly added limitations of “at least one LED light source comprising a first LED light source, a second LED light source, a third LED light source, and a fourth 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, wherein the second LED light source is configured to emit light with a second wavelength of between 200 nm and 600 nm, 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 first wavelength, the second wavelength, the third wavelength, and the fourth wavelength are different wavelengths,” and “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,” are now rejected over Song et al. (US 2006/0019265 A1) in view of Ayyub (US 2017/0198329 A1), Iida (US 2006/0292039), and Sekimoto (US 2010/0259747).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Song et al. (US 2006/0019265 A1) and Ayyub (US 2017/0198329 A1) and further in view of Iida (US 2006/0292039), and Sekimoto (US 2010/0259747).
Regarding claim 1, Song et al. teaches an analyte measurement system (system for detecting an analyte in a test sample, see [0004]) comprising:
a test strip (chromatographic-based assay device 20, see Fig. 1 and [0032]), comprising:
a handling portion (support 21 for carrying chromatographic material 23, see Fig. 1 and [0034]); a liquid sample insertion site (sample pad, see [0037]); a lateral flow pathway connected to the liquid sample insertion site (sample pad is coupled to chromatographic material 23 (lateral flow pathway), see [0037]),
and a measurement window coupled with the lateral flow pathway (the chromatographic material 23 is transparent, including at detection areas 31 (transparent window), see Fig. 1 and [0032]);
wherein the measurement window comprises a reactant configured to create an optically obstructive dye when it reacts with a at least a portion of a liquid sample (the detection area 31 comprises an optically functional dye that forms a colored dye upon reaction with the sample, see Fig. 1 and [0087]);
wherein the optically obstructive dye affects light passing through the measurement window (detection zone 31) according to an analyte concentration in the liquid sample (the signal intensity of the color displayed at detection window 31 corresponds to the concentration of the analyte within the sample, see [0098]);
a testing device (luminescent detection system 320, see Fig. 8-9, and [0082]), comprising: a cartridge port configured to receive the test strip (sample holders 377 for receiving test strip 375, see Fig. 8 and [0082]);
a light source configured to emit light wherein when the test strip is inserted into the cartridge port, light from the light source passes through a collimating optic, through the optically transparent measurement window and toward the photon sensor (LEDs 353 (light source) provide light that is collimated by a lens (optic) prior to reaching the test strip detection area 31 (optically transparent measurement window) and a photodiode 359 (photon sensor), see Fig. 3b, 8, [0064], [0082], and [0085]);
an analog-to-digital converter (ADC) (A/D converter 64) configured to convert an analog signal from the photon sensor into a digital signal, wherein the analog signal corresponds to the light received by the photon sensor after it has passed through the optically obstructive dye (A/D converter 64 that converts input signals into a digital signal wherein the signal corresponds to the light transmitted through the detection zone 31 to photodiode 359 (photon sensor), see Claim 25, [0032], and [0094]);
and a microcontroller configured to measure an analyte concentration based on the digital signal (A/D converter 64 that converts input signals into a digital signal that is used to measure and determine analyte levels at a microprocessor 60, see Fig. 4 and [0095])
and a first filter, wherein the first filter is positioned between the at least one LED light source and the measurement window, (optical filter disposed adjacent to light source 52, and is therefore between light and measurement window, see [0083]).
While the current embodiment of Song et al. does not teach that the system comprises a cut-on or dichroic filter, the invention does teach that the implementation of a dichroic filter within the current system would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to allow for the selection of a wavelength of interest of analysis, see [0083].
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 Song et al. to incorporate a dichroic filter between the light source and measurement window of the system for the benefit of filtering out background noise in the form of undesired wavelengths in fluorescence readings. Further, the system of Song et al. was ready for the implementation of an optical filter in a limited number of forms, see [0083], thus leading a person of ordinary skill in the art to have implemented a dichroic filter with no deviation to the prior art’s scope or function. Modifying Song et al. to incorporate the dichroic filter following the light source would have resulted in the predictable result of filtering out undesired wavelengths in fluorescence readings.
While Song teaches that an array of LEDs may be employed to provide relatively diffuse illumination to the test device, see [0065], the reference does not explicitly teach that the device comprises at least one LED light source comprising a first LED light source, a second LED light source, a third LED light source, and a fourth 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,
wherein the second LED light source is configured to emit light with a second wavelength of between 200 nm and 600 nm,
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.
However, in the analogous art of transmission-based detection systems, Sekimoto teaches a substrate, analogous to an array, containing a plurality of LEDs 40-43 used to illuminate sample for detection by a photodiode, see Fig. 3 and [0039]-[0040]. The first two LEDs emit light at 500-590nm, third at 600-700nm, and the fourth with a wavelength at 800-910nm, each analogous to the instant invention’s claimed ranges, see [0038]. The modification of a light source to have three LEDs that emit light at wavelengths of 200-600nm with an additional higher wavelength LED to use as a reference light was known in the art of test strip measurement systems as evidenced by Sekimoto as it was known that different biological analytes emit light at different frequencies, 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 light source of Song et al. to comprise an array of LEDs comprising three lights that emit light at 200-600nm and one light that emits a wavelength of 700-4000nm as exemplified by Sekimoto for the benefit of detecting a target analyte concentration by using its intrinsic optical properties, see [0038] in Sekimoto. Further, modifying the light source of Song et al. to comprise the four LEDs of Sekimoto would have resulted in the predictable result of facilitating detection of fluorescent species in a sample.
Song does not teach that the lateral flow pathway comprises a plasma separation membrane and does not teach that the measurement window comprises a salt that creates an optically obstructive dye.
In the analogous art of test strips for measuring the concentration of an analyte, Ayyub teaches a test strip (referred to as the test strip, see [0196]) comprising a plasma separation membrane (the test strip comprises a plasma separating membrane, see [0196]) with a measurement window (the reaction surface, see [0135]) comprising a salt (the reaction surface comprises a tetrazolium dye, or salt, see [0135]).
The invention of Song describes the test sample being subjected to pretreatment to release plasma from the blood sample (see [0028]); therefore, 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 test strip including the lateral flow pathway of Song to include the plasma separation membrane of Ayyub to arrive at the invention of the lateral flow pathway including a plasma separation membrane as described by the instant application for the benefit of extracting a specific metabolite or protein within the plasma of a whole blood sample, see [0004] in Ayyub. Further, the addition of the plasma separating membrane of Ayyub to the lateral flow test strip of Song et al. would have a reasonable expectation of successfully filtering unwanted blood particles from the sample to provide more accurate assay results.
Additionally, given that the flow pathway of Song et al. consists of an optically transmissible support 21 that overlays the detection zone, 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 test strip and the support to include the salt as exemplified by Ayyub et al. to arrive at the invention of the instant application of the measurement window comprising a salt configured to create a dye when it reacts with at least a portion of a liquid sample. A person of ordinary skill in the art before the effective filing date of the instant application would have been motivated to incorporate the dye of Ayyub et al. into the support of Song et al. for the benefit of providing a substrate that is capable of a colorimetric reaction to a specific target analyte within a sample. The addition of the tetrazolium dye as described in Ayyub to the assay cassette of Song would have a reasonable expectation of successfully facilitating a visual reaction following the assay of the sample.
Further, the combination of Song et al. in view of Ayyub et al. does not teach that the test strip comprises a slot that is configured to ensure the test strip is seated and positioned properly upon insertion into the testing device, and a memory device, wherein the memory device is configured to authenticate the test strip when the test strip is inserted into the cartridge port; where the testing device comprises a latching interface guide rail, wherein the latching interface guide rail is configured to removably couple to the slot when the test strip is inserted into the cartridge port, wherein when the latching interface guide rail is coupled to the slot the test strip is positioned properly in the testing device.
However, in the analogous art of analyte metering systems using transmission-based optical measurements, Iida teaches a test strip that comprises a slot that is configured to ensure the test strip is seated and positioned properly upon insertion into the testing device (concave portions 125 formed in substrate, see Fig. 3 and [0099]), and a memory device, wherein the memory device is configured to authenticate the test strip when the test strip is inserted into the cartridge port (positioning target on bar-code on chip, see [0346], where the code is used to verify positional relationship on test strip which would necessarily provide authentication as it would allow the system to know when a test strip is inserted); where the testing device comprises a latching interface guide rail, wherein the latching interface guide rail is configured to removably couple to the slot when the test strip is inserted into the cartridge port, wherein when the latching interface guide rail is coupled to the slot the test strip is positioned properly in the testing device (convex portions 139 located within reader to ensure that the test strip is situated properly for irradiation, see [0116]).
While Song et al. does not teach that the test strip includes a slot and an associated memory device where the reader engages with the slot using the latching interface guide rail, the reference teaches a sample holder that holds the test strip in place for illumination (see [0082]). 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 test strip of Song et al. to include the concave portions and bar-code on the test strip, and the convex portions of the testing device for interfacing with the test strip as exemplified by Iida for the benefit of securing the a positional relationship between a test strip and a reader for obtaining the visual results of an assay, see [0116] in Iida. Further, the modification of the test strip of Song et al. to include a bar-code acting as the memory device and the concave and convex portions of the test strip and associated reader of Iida would have facilitated the predictable result of ensuring that a test strip will be properly situated for optical analysis as required by the instant invention.
Regarding claim 2, modified Song et al. teaches the analyte measurement system of claim 1, wherein modified Song teaches that the salt comprises a tetrazolium salt (the reaction surface comprises a tetrazolium dye, or salt, see [0135] in Ayyub).
Regarding claim 3, modified Song et al. teaches the analyte measurement system of claim 1, wherein Song teaches that the analyte comprises an amino acid (analyte detected is an amino acid, see [0027] in Song et al.).
Regarding claim 4, modified Song et al. teaches the analyte measurement system of claim 3, wherein Song teaches that the analyte comprises an amino acid (analyte detected is an amino acid, see [0027] in Song et al.), but does not explicitly teach that the amino acid comprises phenylalanine.
However, Ayyub teaches that the amino acid comprises phenylalanine (the device is used to detect phenylalanine in blood, wherein phenylalanine is an amino acid see [0008]).
It would have been obvious to a person possessing ordinary skill in the art before the effective
date of the instant application to modified the test strip of Song to have included the detection of phenylalanine of Ayyub for the benefit of diagnosing metabolic diseases based on the concentration of the essential amino acid in the bloodstream (see [0020] in Ayyub). The modification of the to include the amino acid analyte of Ayyub would have a reasonable expectation of successfully facilitating the testing of a specific biomarker within the blood of a user.
Regarding claim 5, modified Song et al. teaches the analyte measurement system of claim 1, wherein the lateral flow pathway further comprises at least one of a nitrocellulose membrane, an asymmetric polysulfone, a hydrophilic glass fiber, and hydrophilic cotton linter materials (the chromatographic material 23 (lateral flow pathway) is constructed of nitrocellulose, see [0032] in Song et al.).
Regarding claim 6, modified Song et al. teaches the analyte measurement system of claim 1, wherein Song et al. explicitly teaches a liquid sample insertion site (sample pad, see [0037] in Song et al.), but does not explicitly teach that the liquid sample site comprises a second plasma separation membrane.
However, Ayyub teaches a device wherein the liquid sample insertion site comprises a second plasma separation membrane layer, a conjugate pad layer, and a nitrocellulose sub-layer (the device contains another sample application site, see [0147], where the site comprises another filter membrane (or a second plasma separation membrane layer), see [0161] – [0162], an absorbent pad to distribute plasma (which functions as the conjugate pad layer), and a nitrocellulose sub-layer, see [0197]).
It would have been obvious to a person possessing ordinary skill in the art before the effective date of the instant application to have modified the analyte measurement system comprising the liquid sample insertion site (sample pad of Song et al.) to have included the second plasma membrane as described in Ayyub for the benefit of thoroughly separating a whole blood sample in less than 5 minutes (see [0214] in Ayyub). Further, the addition of the second plasma membrane from Ayyub to the system of Song et al. would have a reasonable expectation of facilitating fluid analysis using only the desired fluid input into the analysis system.
Claims 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Song et al. (US 2006/0019265 A1), Ayyub (US 2017/0198329 A1), Iida (US 2006/0292039), and Sekimoto (US 2010/0259747), and further in view of Fu et al. (US 2017/0010472).
Regarding claim 17, modified Song et al. teaches the analyte measurement system of claim 1, but does not teach an electromagnetic coupling receiver pad, wherein the electromagnetic coupling receiver pad is configured to enable the testing device to charge using a wireless charging protocol.
However, in the analogous art of portable analyte meters, Fu et al. teaches a device that comprises an electromagnetic coupling receiver pad, wherein the electromagnetic coupling receiver pad is configured to enable the testing device to charge using a wireless charging protocol (rechargeable battery and wireless charging component 51 and 52, see Fig. 1 and [0041]).
While modified Song et al. does not teach that the testing device comprises an electromagnetic coupling receiver pad, the reference of Song et al. teaches that the device must comprise a power circuit and remain portable (see [0077] – [0079]). 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 power source of the invention of modified Song et al. to comprise an electromagnetic coupling receiver pad, or wireless charging pad, as exemplified by Fu et al. for the benefit of providing a small-scale point-of-care analyzer that does not require wires and external power sources to function, see [0007] – [0009] in Fu et al. The modification of the power source of Song et al. to comprise a wireless charging station of Fu et al. would have facilitated the expected result of providing power to a portable sensing apparatus.
Regarding claim 18, modified Song et al. teaches the analyte measurement system of claim 1, but does not teach that the system comprises 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.
However, in the analogous art of portable analyte meters, Fu et al. teaches a device that comprises 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 (first and second supporting members 14 and 15 covered by an opaque material, see [0038]).
The modification of a luminescent detection system as outlined by Song et al. to include an opaque material near the detector as an ambient light diffuser was known in the art before the effective filing date of the instant application see [0083] in Song et al.). 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 Song et al. to include the opaque material near the blocker of Fu et al. for the benefit of preventing the distortion of the image of the biochip/test strip (see [0038] in Fu et al.). Further, the modification of the detection system of Song et al. to include the opaque layer of Fu et al. within the testing device would have yielded the predictable result of blocking outside light that would interfere with optical detection.
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.
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/A.N.M./ Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758
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