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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. NL 2028727, filed on 07/14/2021.
Claim Interpretation
For all claims examined, it is noted by the examiner that any claim elements following “optionally” and “and/or” are not limiting elements.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 46-51, 54-55, 59-61 and 67-69 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Profitt (WO 2010059537 A1, as cited in the IDS).
Regarding claim 46, Profitt teaches an apparatus for analyzing a biological sample for diagnostics purposes (see Abstract, [0001], [0024], disclosing a photometric diagnostic instrument with liquid specimens such as urine or blood), the apparatus comprising: a sample cartridge receptacle for receiving a sample cartridge for holding the biological sample, wherein the sample cartridge comprises at least two sample reaction zones for containing said biological sample (see [0012], [0024], Fig. 1-2, disclosing spectrophotometer 10 includes a front face 17 having an opening 18 (i.e., a receptacle) formed therein, within which a tray (e.g., holder) 42 for carrying the reagent strip 40 (i.e., sample cartridge) may be retractably disposed. The reagent strip 40 has a thin, non-reactive substrate 28 on which a plurality of reagent test areas (i.e., reaction zones) 30 are disposed.); at least one light source associated with the sample cartridge receptacle for illuminating the at least two sample reaction zones of a sample cartridge when received in the sample cartridge receptacle (see [0028], Fig. 2-3, disclosing readhead 12 includes one or more light sources 20 configured to illuminate the test areas (e.g., pads) 30 of the sample media (e.g., test strip) 40.); at least two measurement sections associated with the sample cartridge receptacle, wherein each of the at least two measurement sections is arranged to perform measurements on a respective sample reaction zone of the at least two sample reaction zones of a sample cartridge when received in the sample cartridge receptacle, wherein each measurement section comprises at least one light detector for receiving light illuminated onto the respective sample reaction zone by the at least one light source (see [0012], [0028], Fig. 3., disclosing one or more light or color detectors 70 is also disposed within readhead 12 to detect diffuse reflections from each of the plurality of test areas 30 when the sample media is indexed within holder 42. The color of the non-specular reflectances is determined, to derive the amount of constituent or property in the sample. An output signal is then generated, which corresponds to the amount of the constituent or property.); a processing unit arranged for controlling the at least one light source and for receiving data from the measurement sections (see [0032], [0058], Fig. 3, disclosing a processor 44 may be operatively coupled to detector (s) 70 and light source (s) 20. In particular embodiments, processor 44 is configured to analyze reflectances (colors) captured by the detector (s) 70, to derive a diagnosis value from the analysis, and generate an output corresponding thereto. The light source 20 may be actuated at 80 to illuminate media 40, 40', 40''. Detector 70 may also be actuated 82 to detect the color of light reflected from the media, and optionally store 84 the color information to memory 47.).
Regarding claim 47, Profitt teaches the apparatus according to claim 46, wherein each measurement section comprises a respective light source for illuminating the respective reaction zone of a sample cartridge when received in the sample cartridge receptacle (see [0028], Fig. 2-3, disclosing readhead 12 includes one or more light sources 20 configured to illuminate the test areas (e.g., pads) 30 of the sample media (e.g., test strip) 40.), and/or wherein at least two of the light sources are arranged to emit light with different wavelengths (see [0067], disclosing for each portion of interest of the sample media (e.g., each test pad and each detector), and optionally, for each of a plurality of light sources, light sources of distinct wavelengths (e.g., colors) are used individually.).
Regarding claim 48, Profitt teaches the apparatus according to claim 47, wherein at least two measurement sections comprise at least two light sources arranged to emit light with different wavelengths (see [0067], disclosing for each portion of interest of the sample media (e.g., each test pad and each detector), and optionally, for each of a plurality of light sources, light sources of distinct wavelengths (e.g., colors) are used individually.), wherein optionally the processing unit is arranged to individually control the at least two light sources for illuminating the at least two sample reaction zones with light having different wavelengths and to receive data from the respective measurement sections obtained from illumination of the respective sample reaction zones illuminated with light having mutually different wavelengths (see [0032], [0058], Fig. 3, disclosing a processor 44 may be operatively coupled to detector (s) 70 and light source (s) 20. The light source 20 may be actuated at 80 to illuminate media 40, 40', 40''. Detector 70 may also be actuated 82 to detect the color of light reflected from the media, and optionally store 84 the color information to memory 47. The OS may actuate 86 the processor in a conventional manner to analyze the color information, such as by comparing the captured color information to a database of known color- coded diagnostic values, and can be repeated for additional test media.).
Regarding claim 49, Profitt teaches the apparatus according to claim 46, wherein the processing unit is arranged to control at least two measurement sections for simultaneously taking measurements on two sample reactions zones of a sample cartridge when received in the sample cartridge receptacle.(see [0006], [0028], Fig. 3, disclosing one or more light or color detectors 70 is also disposed within readhead 12 to detect diffuse reflections from each of the test areas 30 when the sample media is indexed within holder 42. Bulk illumination and bulk detection are done to avoid to the need to properly sequence the detection, allowing to read multiple test pads or test strips.).
Regarding claim 50, the examiner is using broadest reasonable interpretation of "multi-spectral" to mean multiple different wavelengths of light.
Profitt teaches the apparatus according to claim 46, wherein the light detector comprises a multi-spectral sensor (see [0054], disclosing a light detector without color filters.), wherein optionally the processing unit is arranged to receive multi-spectral data from the sensor (see [0059], Fig. 3, disclosing detector 70 may also be actuated 82 to detect the color of light reflected from the media, and optionally store 84 the color information to memory 47. The OS may actuate 86 the processor in a conventional manner to analyze the color information, such as by comparing the captured color information to a database of known color- coded diagnostic values.).
Regarding claim 51, Profitt teaches the apparatus according to claim 46, wherein at least two measurement sections have a different configuration (see [0053]-[0055], disclosing that a plurality of light detectors may be used with or without color filters for differing color detection.).
Regarding claim 54, the examiner is interpreting a "light shielding mechanism" based on the specification (see specs, pg. 6/lines 28-35) to be an object, wall, or barrier that prevents light from passing.
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Profitt teaches the apparatus according to claim 46, further comprising a light shielding mechanism arranged between a light source and a light sensor (see Fig. 3 and annotated Fig. 3 below, which shows light source 20 and detector 70 as two separate components affixed on the readhead 12, configured in such a way that a wall (not labeled) separates the light source 20 and the detector 70 with light only being able to pass through the optical filters 72 and 74 and a transparent cover 22, where the light source 20 reflects light off the reagent test strip and into the detector 70. This would prevent direct light reaching the detector 70 from the source 20 and causing incorrect readings.).
[AltContent: textbox (Annotation of Fig. 3 from Profitt, directing to unlabeled walls that direct and block light, preventing the light source 20 from directly affecting the detector 70)]
Regarding claim 55, Profitt teaches the apparatus according to claim 46, wherein the sample cartridge receptacle is at least partly defined by a transparent member arranged between at least the light detector in a measurement section and a sample cartridge when received in the sample cartridge receptacle, wherein optionally the transparent member comprises a heat reflecting layer (see [0044], Fig. 3, disclosing a transparent or translucent cover 22, such as fabricated from glass or plastic, may be optionally superposed with sample media 40 and holder 42 to help prevent dirt, debris, splashing, etc., from entering and obscuring light sources 20 or detectors 70. It is positioned between the light detector 70/source 20 and the test area 30 of the sample media 40).
Regarding claim 59, Profitt teaches the apparatus according to claim 46, wherein the apparatus is arranged to perform a plurality of different measurements including at least two of a PCR test, LAMP test, antigen test, ELISA, pH test, a (neutralizing) antibody test and any other reaction based test that results in a change in the optical properties of a sample (see [0025], Fig. 2 disclosing when urinalysis tests are performed, they may include, for example, a test for leukocytes in the urine, a test of the pH of the urine, a test for blood in the urine, etc. When each reagent pad 30 comes into contact with a urine sample, the pad changes color over a time period, depending on the reagent used and the characteristics of the urine sample.).
Regarding claim 60, Profitt teaches the apparatus according to claim 46, further comprises an output module for outputting the received data from the measurement sections, wherein optionally the output module is a wireless module for wirelessly transmitting the data (see [0032], Fig. 1, disclosing processor 44 is configured to analyze reflectances (colors) captured by the detector(s) 70, to derive a diagnosis value from the analysis, and generate an output corresponding thereto. The output may be fed to a port 46, e.g., for remote display, and/or displayed on an integral display 16.).
Regarding claim 61, Profitt teaches the apparatus according to claim 46, wherein the apparatus is a handheld device and/or the apparatus further comprising a battery (see [0057], Fig. 1, Fig. 3, which shows the full instrumental diagnostic device, which may be powered with a portable power supply such as a battery 49. While not explicitly stated, the diagnostic device is sized to be hand portable.).
Regarding claim 67, Profitt teaches a method for analyzing a biological sample for diagnostics purposes with an apparatus according to claim 46 (see [0010], [0012], disclosing a readhead for a photometric diagnostic instrument, for illuminating a target area and detecting color information from the target area. It includes a method for reading reagent sample media)., comprising the steps of: providing a biological sample in a sample cartridge having least one sample reaction zone for containing said biological sample (see [0012], disclosing that for reading reagent sample media, the sample media having a plurality of test areas disposed in spaced relation thereon, each of the test areas configured to react with a sample when disposed in contact with the sample and to change color according to an amount of an analyte in the sample. See also [0012], [0024], Fig. 1-2, disclosing spectrophotometer 10 includes a front face 17 having an opening 18 (i.e., a receptacle) formed therein, within which a tray (e.g., holder) 42 for carrying the reagent strip 40 (i.e., sample cartridge) may be retractably disposed. The reagent strip 40 has a thin, non-reactive substrate 28 on which a plurality of reagent test areas (i.e., reaction zones) 30 are disposed.); illuminating the at least one sample reaction zone of the sample cartridge (see [0012], disclosing the method includes receiving the sample media into a sample holder of a readhead of a photometric diagnostic device, and placing a polarization filter optically between the sample media and at least one of a light source and a light detector. Light is emitted onto the test areas, and diffuse, non-specular reflectances of the test areas are captured with the light detector.); performing measurements with a measurement section on the respective sample reaction zone of the sample cartridge, wherein a measurement section comprises at least one light detector for receiving light illuminated onto the respective sample reaction zone (see [0012], [0028], Fig. 3., disclosing the color of the non-specular reflectances is determined, to derive the amount of constituent or property in the sample. One or more light or color detectors 70 is also disposed within readhead 12 to detect diffuse reflections from each of the plurality of test areas 30 when the sample media is indexed within holder 42.); and receiving and outputting data from the measurement sections (see [0012], disclosing that an output signal is then generated, which corresponds to the amount of the constituent or property.).
Regarding claim 68, Profitt teaches the method according to claim 67, wherein the sample cartridge comprises at least two reaction zones, wherein the step of performing measurements comprises performing measurements on two respective sample reaction zones at the same time with two respective measurement sections (see [0006], [0028], Fig. 3, disclosing one or more light or color detectors 70 is also disposed within readhead 12 to detect diffuse reflections from each of the test areas 30 when the sample media is indexed within holder 42. Bulk illumination and bulk detection is done to avoid to the need to properly sequence the detection, allowing to read multiple test pads or test strips.), wherein optionally the step of illuminating comprises illuminating a reaction zone with light having different wavelengths (see [0067], disclosing for each portion of interest of the sample media (e.g., each test pad and each detector), and optionally, for each of a plurality of light sources, light sources of distinct wavelengths (e.g., colors) are used individually.).
Regarding claim 69, Profitt teaches the method according to claim 67, wherein the sample cartridge comprises at least two reaction zones, wherein the step of illuminating comprises illuminating the at least two sample reaction zones (see [0028], Fig. 3, disclosing readhead 12 includes one or more light sources 20 configured to illuminate the plurality of test areas (e.g., pads) 30 of the sample media (e.g., test strip) 40.).
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.
Claims 52-53 and 56 are rejected under 35 U.S.C. 103 as being unpatentable over Profitt as applied to claim 46 above, and further in view of Nowakowski et al. (US PG-Pub 20160310948 A1, as cited in the IDS).
Regarding claim 52, Profitt teaches one or more light sources 20 included on the readhead 12 which are configured to illuminate the test areas 30, as well as one or more light or color detectors 70 are disposed on the readhead 1 to detect diffuse reflections from each of the plurality of the test areas 30 (see Profitt, [0028], Fig. 3).
Profitt fails to teach wherein the apparatus further comprises a Printed Circuit Board (PCB), wherein the light source and the light detector are arranged on the PCB.
However, in the analogous art of fluidic test cassette, Nowakowski et al. teaches nucleic acid amplification and detection devices, which comprises a circuit board. The circuit board may contain a variety of surface-mount components such as resistors, thermistors, light-emitting diodes (LEDs), photo-diodes (i.e., light detector), and microcontrollers (see Nowakowski et al., [0096]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the light sources and light/color detectors of Profitt to incorporate disposing the light sources and detectors onto a circuit board (as taught by Nowakowski et al.), for the benefit of being able to mount a number of components onto the board while connecting said components via conductive traces (see Nowakowski et al., [0096]).
Regarding claim 53, Profitt teaches one or more light sources 20 included on the readhead 12 which are configured to illuminate the test areas 30, as well as one or more light or color detectors 70 are disposed on the readhead 1 to detect diffuse reflections from each of the plurality of test areas 30. The plurality of light detectors may be used with or without color filters for differing color detection. (see Profitt, [0028], [0053]-[0055], Fig. 3).
Profitt fails to teach wherein the PCB comprises a plurality of light detectors and light sources.
However, Nowakowski et al. teaches nucleic acid amplification and detection devices, which comprises a circuit board. The circuit board may contain a variety of surface-mount components such as resistors, thermistors, light-emitting diodes (LEDs), photo-diodes (i.e., light detector), and microcontrollers (see Nowakowski et al., [0096]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the plurality of light sources and light/color detectors of Profitt to incorporate disposing the plurality of light sources and detectors onto a circuit board (as taught by Nowakowski et al.), for the benefit of being able to mount a number of components onto the board while connecting said components via conductive traces (see Nowakowski et al., [0096]).
Regarding claim 56, Profitt fails to teach the apparatus further comprising at least one heating element arranged for heating a respective sample reaction zone of a sample cartridge when received in the sample cartridge receptacle, wherein the processing unit is arranged for controlling the at least one heating element, wherein optionally:- at least two measurement sections have associated therewith a respective heating element arranged for heating the respective sample reaction zones of a sample cartridge when received in the sample cartridge receptacle, wherein the processing unit is arranged for individually controlling the at least two heating elements; and/or - the apparatus further comprises a heat sink associated with the light detector; and/or - the measurement section is arranged at first side of the sample cartridge receptacle and wherein the heating element is arranged at an opposite side of the sample cartridge receptacle for receiving a sample cartridge therebetween.
However, Nowakowski et al. teaches the microfluidic component of the detector cassette comprising a series of chambers in controlled fluid communication where the chambers are optionally temperature-controlled, thereby subjecting the fluid contained therein to programmable temperature regimens, by microcontrollers and the like. One of the samples is a sample input chamber, where it comprises an input orifice where the sample is added. The input sample chamber is then heated (in the case of nucleic acid samples, to accomplish lysis of cells or viruses present in the sample) by heater elements in sufficient proximity on the heater circuit board to provide thermal conduction (see Nowakowski et al., [0098], [0100]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the photometric diagnostic device of Profitt to incorporate a controlled heating element in proximity to the sample input and test area for heating (as taught by Nowakowski et al.), for the benefit of being able to manage temperature based biochemical reaction (see Nowakowski et al., [0096]).
Claims 57 and 64-66 are rejected under 35 U.S.C. 103 as being unpatentable over Profitt as applied to claim 46 above, and further in view of Bachi (US PG-Pub 20040241691 A1).
Regarding claim 57, Profitt teaches a reagent strip 40, which has a thin, non-reactive substrate 28 that has a number of reagent test areas (e.g., pads) 30 disposed onto, to be inserted into the opening 18 from within a tray 42, arranged along a two-dimensional array configuration (as seen in Fig. 3) (see Profitt, [0024], Fig. 3).
Profitt fails to teach wherein the reaction zones are separated in a first direction and a second direction orthogonal to the first direction optionally comprising a plurality of measurement sections, wherein the measurement sections are arranged in a corresponding two-dimensional array configuration.
However, in the analogous art of thermo-optical analysis system for biological reactions, Bachi teaches an apparatus for carrying out and evaluating chemical reactions. In the sample chamber matrix (1) shown in FIG. 1, the reaction chambers (2) are arranged in vertical and horizontal rows with respect to one another. The reaction chambers (2) are illuminated by two mutually orthogonal rows of light sources (2 each in the case of FIG. 1) (see Bachi, [0040], Fig. 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reagent strip and test areas of Profitt to incorporate having the reaction chambers (or test areas) arranged in vertical and horizontal rows with respect to one another (as taught by Bachi), for the benefit of being able to selectively illuminate individual reaction chambers for measurement (see Bachi, [0040]). Additionally, the rearrangement of parts is obvious to one of ordinary skill in the art and is hence considered routine (see MPEP 2144.04.VI C. "In reJapikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.); In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice).").
Regarding claim 64, Profitt teaches the reagent strip 40 has a thin, non-reactive substrate 28 on which a plurality of reagent sample media test areas (i.e., reaction zones) 30 are disposed, which are to be contacted by a liquid specimen such as urine or blood (see Profitt [0001], [0025], Fig. 2)
Profitt fails to teach wherein optionally the reaction zones are arranged in a two-dimensional array configuration, wherein the reaction zones are separated in a first direction and a second direction orthogonal to the first direction.
However, Bachi teaches an apparatus for carrying out and evaluating chemical reactions. In the sample chamber matrix (1) shown in FIG. 1, the reaction chambers (2) are arranged in vertical and horizontal rows with respect to one another. The reaction chambers (2) are illuminated by two mutually orthogonal rows of light sources (2 each in the case of FIG. 1) (see Bachi, [0040], Fig. 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reagent strip and test areas of Profitt to incorporate having the reaction chambers (or test areas) arranged in vertical and horizontal rows with respect to one another (as taught by Bachi), for the benefit of being able to selectively illuminate individual reaction chambers for measurement (see Bachi, [0040]). Additionally, the rearrangement of parts is obvious to one of ordinary skill in the art and is hence considered routine (see MPEP 2144.04.VI C. "In reJapikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.); In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice).").
Regarding claim 65, the combination of Profitt and Bachi teaches the exact limitations of claim 66. Specifically, Profitt teaches the sample cartridge according to claims 64, wherein at least two reaction zones are arranged for two different assays or tests and/or wherein a reaction zone comprises a heat conducting section for cooperating with a heating element and/or wherein a reaction zone comprises a substantially planar wall of heat conducting material (see [0025], Fig. 2, disclosing that the reagent strip 40 has a thin, non-reactive substrate 28 on which a number of reagent test areas (e.g., pads) 30 are disposed. Each reagent pad 30 includes a relatively absorbent material impregnated with a respective reagent, each reagent and reagent pad 30 being associated with a particular test to be performed.).
Regarding claim 66, the combination of Profitt and Bachi teaches the exact limitations of claim 66. Specifically, Profitt teaches the sample cartridge according to claim 64, wherein at least one of the reaction zones is arranged for a PCR test, LAMP test, antigen test, ELISA, pH test, a (neutralizing) antibody test and any other reaction based test that results in a change in the optical properties of a sample (see [0025], Fig. 2 disclosing when urinalysis tests are performed, they may include, for example, a test for leukocytes in the urine, a test of the pH of the urine, a test for blood in the urine, etc. When each reagent pad 30 comes into contact with a urine sample, the pad changes color over a time period, depending on the reagent used and the characteristics of the urine sample.).
Claim 58 is rejected under 35 U.S.C. 103 as being unpatentable over Profitt as applied to claim 46 above, and further in view of Low et al.
Regarding claim 58, Profitt fails to teach the apparatus further comprising a memory, wherein the memory contains instructions for controlling the light source, the detection section and optionally the heating element, for performing predetermined measurements on a reaction zone of a received sample cartridge.
However, in the analogous art of devices, systems, and methods for performing optical assays, Low et al. teaches systems for performing optical assays on a biological sample, the analyzer comprising: a port, a multi-terminal connector, a processor, memory coupled to the processor, and universal channel circuitry. The system further comprises a test cartridge comprising a plurality of discrete connector contacts, a sample receiving chamber fluidically connected to a conduit, and an analyte assay region comprising: a portion of the conduit, a light emitter, and a light detector. The memory is encoded with a set of instructions configured to perform the optical assay, of which is performed by: configuring the light emitter connected by the universal channel circuitry to generate light, the light detector configured to convert light received from a portion of the conduit to an output signal, and the universal channel circuitry configured to convert the output signal of the light detector to an analyte signal proportional to the light received from the portion of the conduit (see Low et al., [0007]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the photometric diagnostic device of Profitt to incorporate a memory component encoded with instructions for performing the assay by controlling the light source and detector (as taught by Low et al.), for the benefit of automating assay protocols and keeping repetition of measurements consistent.
Claims 62-63 are rejected under 35 U.S.C. 103 as being unpatentable over Profitt as applied to claim 46 above, and further in view of (US PGPub 2021/0016271).
Regarding claim 62, Profitt teaches readhead 12 being easily incorporated into a variety of photometric diagnostic instruments, such as a CLINITEK® instrument. In such a configuration, readhead 12 may be electrically coupled to the instrument, which would supply power and operate the readhead 12 in a conventional manner, and may be communicably coupled, such as via a network. The operating system of the CLINITEK® instrument may may actuate 86 the processor 44 in a conventional manner to analyze the color information, such as by comparing the captured color information to a database of known color- coded diagnostic values. The processor 44 may be used to analyze the reflectance(s) and derive the amount of an analyte in the sample therefrom, e.g., to generate an output signal corresponding to the amount. The output may be fed to a port 46, e.g., for remote display, and/or displayed on an integral display 16. (see Profitt, [0032]-[0033], [0056]-[0057], [0058], Fig. 1, Fig. 3).
While Profitt teaches a device coupled to the apparatus that analyzes color information of the test areas by comparing with a database of known color-coded diagnostic values, and an output to display to the user, Profitt fails to teach that it is performed by a server.
However, in the analogous art of in-line testing development diagnostic analysis, Markovsky et al. teaches in-line analyte detection of biochemicals and the like. Performing diagnostic tests include receiving a test strip sample apparatus and imaging the test strip sample apparatus to generate the test result. Data associated with the test, such as least one sample identifier corresponding to an individual sample test result selected from the group consisting of an operator identification, a sample identification, a lot number, a geographical location, a geographical coordinate, a sample note, and a test result note is transmitted to an external storage, such as a remote host server (see Markovsky et al., [0075]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the CLINITEK® instrument and the processor of Markovsky et al. to incorporate storing the received data onto a server (as taught by Markovsky et al.), and to perform the diagnostic parameter analysis that the CLINITEK® instrument via a color-coded diagnostic database, for the benefit of storing a quantity of test results for later comparison and analysis.
Regarding claim 63, Profitt fails to teach wherein the central server is arranged to receive the data via an electronical device from a user, such as a mobile phone, a tablet or a laptop, coupled to the apparatus.
However, Markovsky et al. teaches that a partner device, such as a smart phone, has an authorized connection between the instrument, of which it may include real time exporting of the result output from the testing instrument. It can also relay said results to an external storage configuration, such as a remote host server (see Markovsky et al., [0072], [0075]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the photometric diagnostic instrument of Profitt to be operably connected to a smart phone, which can retrieve test data, to then relay to a server (as taught by Markovsky et al.), for the benefit of storing a quantity of test results for later comparison and analysis.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Tracy C Colena whose telephone number is (571)272-1625. The examiner can normally be reached Mon-Thus 8:00am-5:00pm.
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/JENNIFER WECKER/Primary Examiner, Art Unit 1797
/TRACY CHING-TIAN COLENA/Examiner, Art Unit 1797
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