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 Amendment
The Amendment filed 05/29/2026 has been entered. Claims 1-3 and 5 remain pending in the application. New grounds of rejections necessitated by amendments are discussed below.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-3 and 5 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 1 recites the limitations: “calculate, based on the converted electric signal, the number of microorganisms contained in the sample container from the number of light emissions”.
In accordance with MPEP 2106, the claims are found to recite statutory subject matter (Step 1: YES) and are analyzed to determine if the claims recite any concepts that equate to an abstract idea, law of nature or natural phenomenon (Step 2A: Prong 1).
In the instant application, the limitations of “calculate, based on the converted electric signal, the number of microorganisms contained in the sample container from the number of light emissions” of claim 1 covers performance of a limitation in the mind, i.e. mental process or mathematical calculation. As elaborated in the instant specification (page 7), the number of microorganisms is calculated, which covers performance of a limitation in the mind, i.e. mathematical calculation. Other than “a controller”, if the claim limitations, under its broadest reasonable interpretation, covers performance of the limitations in the mind but for the recitation of generic computer components, then the claim limitations fall within the “Mental Processes” grouping of abstract ideas (MPEP 2106.05(f)). Accordingly, the claims recite abstract ideas (Step 2A: Prong 1: Yes).
This judicial exception is not integrated into a practical application because the claims do not recite any additional elements that reflects an improvement to technology or applies or uses the judicial exception in some other meaningful way (Step 2A, Prong 2: No). In claim 1, once the device performs the step of “calculate, based on the converted electric signal, the number of microorganisms…”, no additional steps are performed. The claimed limitations do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. Claim 1 does recite additional controller steps of “convert the fluorescence beam…into an electrical signal…”, however these limitations generally link the judicial exception to a particular field of use (MPEP 2106.05(h)) and are used for data gathering, wherein data gathering to be used in the abstract idea is an insignificant extra-solution activity, and not a practical application (see MPEP 2106.05(g)). The claims only recites the “controller” to perform the steps, but this broadly claimed element do not appear to be a particular machine. The controller is recited at a high-level of generality (i.e., as generic computer) such that it amounts no more than mere instructions to apply the exception using a generic computer component; wherein a general purpose computer is not a particular machine (MPEP 2106.05(b)). Claim 1 does recite additional elements of a sample container, stirrer, an excitation light source, excitation filter, diaphragm, a light receiver, optical guide bar, and a direction of flow of a sample, however these elements generally link the judicial exception to a particular field of use (MPEP 2106.05(h)) and are used for data gathering, wherein data gathering to be used in the abstract idea is an insignificant extra-solution activity, and not a practical application (see MPEP 2106.05(g)). Thus, the claims are directed to an abstract idea that is not integrated into a practical application (Step 2A, Prong 2: No).
The claims 1-3 and 5 do not include additional elements that are sufficient to amount to significantly more than the judicial exception. Claim 1 does recite additional steps of “convert the fluorescence beam…into an electrical signal…”, however these elements generally link the judicial exception to a particular field of use (MPEP 2106.05(h)) and are used for data gathering, wherein data gathering to be used in the abstract idea is an insignificant extra-solution activity, and not a practical application (see MPEP 2106.05(g)). The controller of claim 1 is recited at a high-level of generality (i.e., as generic computer) such that it amounts no more than mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea (MPEP 2106.05(b)). Dependent claims 2-3 and 5 further recites limitations of which alone or in combination do not amount to significantly more. Additionally, the limitations of claims 1-3 and 5 are well-understood, routine and conventional activities as evidenced by Nakata et al. (US 20150219548 A1; cited in the IDS filed 02/22/2022), Xia et al. (US 20100205139 A1; cited in the IDS filed 08/30/2023), Ye et al. (US 20050168749 A1), Goguen (WO 2005085810 A1), El-Hage et al. (US 20030127609 A1), Konishi et al. (US 20180259460 A1). See MPEP 2106.05(d). The additional elements of the claims 1-5 do not comprise an inventive concept when considered individually or as an ordered combination that transforms the claimed judicial exception into a patent-eligible application of the judicial exception. Therefore, the claims do not amount to significantly more than the judicial exception itself (Step 2B: No). The claims are not patent eligible.
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 1-2 are rejected under 35 U.S.C. 103 as being unpatentable over Nakata et al. (US 20150219548 A1; cited in the IDS filed 02/22/2022) in view of Xia et al. (US 20100205139 A1; cited in the IDS filed 08/30/2023), Ye et al. (US 20050168749 A1), and Goguen (WO 2005085810 A1).
Regarding claim 1, Nakata teaches a microorganism inspection apparatus (abstract; Figs. 1-5) for measuring a number of microorganisms in a sample solution (interpreted as an intended use of the apparatus, see MPEP 2114; abstract), comprising:
a sample container (Fig. 3, sample container 5) formed of a light-transmitting material (Fig. 3 and paragraphs [0018]-[0019] teaches the sample container formed of a material to allow light to pass through, i.e. light-transmitting material);
a stirrer (Fig. 3, stirring and mixing means 7 and/or magnetic stirrer 27) for adding a sample and a fluorescent staining reagent into the sample container formed of the light-transmitting material, and stirring and mixing a sample solution (interpreted as an intended use of the stirrer, see MPEP 2114; Fig. 3 and paragraphs [0018]-[0019] teaches the stirring and mixing means having a sample container, a sample and fluorescent staining reagent is added into the sample, and then the stirring and mixing means stirs and mixes the sample solution);
an excitation light source including a light source (Fig. 3, light source section 13 comprising light sources 10) that irradiates an irradiation plane of the sample container with an excitation light beam while the sample solution is stirred by the stirrer (interpreted as an intended use of the excitation light source, see MPEP 2114; paragraph [0019] teaches with the sample solution being stirred, excitation light enters the sample container);
an excitation filter (Fig. 2, excitation light band pass filter 12; note that Fig. 3 appears to show the unlabeled excitation filter to the right of element 11) provided on a front face side of the excitation light source (Fig. 2 shows filter 12 on a front face side of light source 10);
a light receiver (Fig. 3, light receiving section 19 comprising PMT 14) arranged on a lateral face side of the sample container (Fig. 3), the light receiver being configured to detect a fluorescence beam emitted in response to the excitation light beam from the excitation light source (interpreted as a functional limitation; Fig. 3 and paragraph [0072] teaches the PMT detects fluorescence emitted in response to the excitation light source section); and
a controller (Figs. 3 and 6, interpreted as comprising CPU board 23, an arithmetic amplifier 35, a high pass filter circuit 36, and a low pass filter circuit 37) programed to convert the fluorescence beam detected by the light receiver into an electric signal to detect the number of light emissions (paragraph [0018] teaches the control means, i.e. controller, detects the number of emissions based on an electrical signal from fluorescent emission detected by the light receiving means, and therefore is programmed to convert the fluorescent beam detected into an electrical signal as claimed; paragraph [0085] teaches the arithmetic amplifier converts an output current generated from the PMT into a voltage), and calculate, based on the converted electrical signal, the number of microorganisms contained in the sample in the sample container from the number of light emissions (abstract and paragraph [0018] teaches the control means, i.e. controller, calculates the amount of the microorganisms contained in the sample in the sample container based on the number of emissions), wherein
a direction of flow of the sample solution caused by the stirring and mixing by the stirrer and a direction of irradiation of the excitation light from the excitation light source are parallel to each other (interpreted as a intended use of the claimed stirrer and excitation light, see MPEP 2114; Figs. 2-3 shows a stirring and mixing means 7 and/or magnetic stirrer 27, which rotates and causes a flow of sample solution, which is parallel to the direction of the excitation light from the LED light source 10).
While Nakata teaches embodiments (Figs. 2, 9) wherein excitation light is oriented orthogonal or perpendicular to the light receiver in order to prevent excitation light to directly enter the light receiver (paragraphs [0024], [0072]), Nakata fails to teach: the excitation light source including a light source that irradiates an irradiation plane of the sample container with an excitation light beam in a vertical direction while the sample solution is stirred by the stirrer; a diaphragm provided on a front face side of the excitation filter, the diaphragm configured to adjust a shape of the excitation light beam; an optical guide bar between the excitation light source and the irradiation plane, the optical guide bar is arranged in a range including air and water, and the optical guide bar is formed of transparent resin and guides the excitation light beam utilizing internal reflection to reduce influence between the air and the water; and wherein a direction of flow of the sample solution caused by the stirring and mixing by the stirrer and a direction of irradiation of the excitation light from the excitation light source are perpendicular to each other.
Xia teaches a method and device for estimating cell count in a fluid sample (abstract; paragraph [0003]; Figs. 1-2). Xia teaches estimating cell count in known fluid volumes using light scattering techniques include measuring turbidity to provide estimation of cell count (paragraph [0003]). Xia teaches an embodiment (Fig. 2) comprising a light source (202) that irradiates a sample (212) within a sample container (250) in a vertical direction (Fig. 2 shows the light source 202 is emitting light from below the sample container, therefore the light is in a vertical direction); a sample detector (208) arranged on a lateral face side of the sample container (Fig. 2). Xia teaches emitted and detected light travels through beam channels which can reduce background arising from ambient light, and from light scattered from defects in sample container (paragraph [0074]). Xia teaches one or more light sources are situated to transmit light across a location on the sample container that is unlikely to be scratched in use and/or during production (claim 7).
Since Xia teaches an apparatus for optical analysis of a sample container to determine the number of microorganisms, similar to Nakata, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the excitation light source of Nakata to incorporate the teachings of a light source that irradiates a sample container from below with a light in a vertical direction of Xia (Fig. 2; paragraph [0074]) to provide: the excitation light source including a light source that irradiates an irradiation plane of the sample container with an excitation light beam in a vertical direction while the sample solution is stirred by the stirrer, wherein a direction of flow of the sample solution caused by the stirring and mixing by the stirrer and a direction of irradiation of the excitation light from the excitation light source are perpendicular to each other. Doing so would have a reasonable expectation of successfully improving irradiation and detection of a sample as discussed by Xia (paragraph [0074]; claim 7), and allowing for prevention of excitation light to directly enter the light receiver as desired by Nakata (paragraphs [0024], [0072]). Additionally, doing so would be an obvious rearrangement of parts, where shifting the position of the excitation light source to be above or below the sample container to provide the excitation light beam in a vertical direction would not have modified the operation of the device (i.e. irradiating the sample container and detecting fluorescence; wherein excitation light is oriented orthogonal or perpendicular to the light receiver and direction of flow in order to prevent excitation light to directly enter the light receiver as desired by Nakata, paragraphs [0024], [0072]) and the particular placement of the excitation light source is an obvious matter of design choice as evidenced by Xia (Fig. 2) (see MPEP 2144.04(VI)(C); In reJapikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950); In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975)).
Modified Nakata fails to teach: a diaphragm provided on a front face side of the excitation filter, the diaphragm configured to adjust a shape of the excitation light beam; and an optical guide bar between the excitation light source and the irradiation plane, the optical guide bar is arranged in a range including air and water, and the optical guide bar is formed of transparent resin and guides the excitation light beam utilizing internal reflection to reduce influence between the air and the water.
Ye teaches a device for optical detection of vapors (abstract). Ye teaches that depending on the desired sensor system configuration, the sensor system can additionally comprise a variety of elements (paragraph [0029]). Ye teaches beam shaping elements such as lenses, curved mirrors, filters, apertures, i.e. diaphragm, line generators, and static holographic elements can be used to change the beam diameter and/or to change the beam shape and/or tailor its intensity (paragraph [0029]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of modified Nakata to incorporate the teachings of optical detection sensor systems including beam shaping elements, such as filters and apertures of Ye (paragraph [0029]) to provide: a diaphragm provided on a front face side of the excitation filter, the diaphragm configured to adjust a shape of the excitation light beam. Doing so would have a reasonable expectation of successfully improving tailoring and optimization of a beam shape and intensity of the filtered excitation light beam.
Furthermore, the claimed limitations are obvious because all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements (i.e. a diaphragm configured to adjust a shape of the excitation light beam) by known methods with no change in their respective functions (i.e. adjusting the excitation light beam shape and intensity), and the combinations yielded nothing more than predictable results (i.e. adding a diaphragm configured to adjust a shape of the excitation light beam would yield nothing more than the obvious and predictable result of tailoring and optimization of a beam shape and intensity of the filtered excitation light beam). See MPEP 2143(A).
Modified Nakata fails to teach: an optical guide bar between the excitation light source and the irradiation plane, the optical guide bar is arranged in a range including air and water, and the optical guide bar is formed of transparent resin and guides the excitation light beam utilizing internal reflection to reduce influence between the air and the water.
Nakata teaches transparent materials can include glass, quarts, or a resin (paragraph [0063]).
Goguen teaches a system including a biological agent detector that determines the presence and amount of a biological agent (abstract; Fig. 4E). Goguen teaches the system includes a sample container (Fig. 4E, element 300), an excitation light source including a light source (220) that irradiates the sample container (300) with an excitation light beam in a vertical direction (Fig. 4E); wherein a light receiver (Fig. 4E, elements 420, 430, 440, 500) is arranged on a lateral face side of the sample container (300) to detect light emitted by fluorophores (page 16, lines 7-10). Goguen teaches an optical guide bar (Fig. 4E, waveguide array 282) between the excitation light source and an irradiation plane (Fig. 4E shows waveguide array 282 includes a portion between light source 220 and an irradiation plate of an analyte-reagent interaction 320), the optical guide bar is arranged in a range including air and water (Fig. 4E teaches the waveguide array 282 is arranged in a range including air and reagent mixture 310, which is interpreted as including water since it includes a sample solution), and the optical guide bar is formed of transparent material and guides the excitation light beam utilizing internal reflection (Fig. 4E and page 15, lines 4-14 teaches the waveguide guides light by internal reflection).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of modified Nakata to incorporate Goguen’s teachings of a transparent optical guide bar to guide light to a sample solution (Fig. 4E; page 15, lines 4-14 ) and Nakata’s teachings of transparent materials, such as resin (paragraph [0063]) to provide: an optical guide bar between the excitation light source and the irradiation plane, the optical guide bar is arranged in a range including air and water, and the optical guide bar is formed of transparent resin and guides the excitation light beam utilizing internal reflection to reduce influence between the air and the water. Doing so would have a reasonable expectation of successfully improving guiding and directing the excitation light beam from the excitation light source and into a desired location in the sample solution as taught by Goguen (Fig. 4E).
Furthermore, the claimed limitations are obvious because all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements (i.e. optical guide bar formed of transparent resin arranged in a range including air and water to guide light utilizing internal reflection) by known methods with no change in their respective functions (i.e. directing light to a sample solution), and the combinations yielded nothing more than predictable results (i.e. providing the claimed optical guide bar would yield nothing more than the obvious and predictable result of enabling guiding and directing the excitation light beam from the excitation light source from an area including air into a desired location in the sample solution). See MPEP 2143(A).
Note that the limitations that describe the microorganism inspection apparatus, the stirrer, the excitation light source, the light receiver, optical guide bar, and the direction of flow of the sample solution are interpreted as intended uses and functional limitations of the claimed apparatus and are given patentable weight to the extent which effects the structure of the claimed apparatus. As discussed above, the prior art structure is capable of performing the intended use (see MPEP 2114). Additionally, the apparatus of modified Nakata is identical to the presently claimed structure. Since modified Nakata discloses the stirrer, the excitation light source, the light receiver, optical guide bar, and controller as claimed and therefore, would have the ability to perform the use recited in the claim (e.g. the direction of flow and the direction of irradiation being perpendicular to each other; reduce influence between the air and the water). See MPEP 2112.01(I).
Note that microorganisms, sample solution, sample, fluorescent staining reagent, and direction of flow of the sample solution are not positively recited structurally and are interpreted as intended uses and functional limitations of the claimed microorganism inspection apparatus. A claim is only limited by positively recited elements; thus, inclusion of the material or article (microorganisms, sample solution, sample, fluorescent staining reagent, and direction of flow of the sample solution) worked upon by a structure (microorganism inspection apparatus) being claimed does not impart patentability to the claims (see MPEP 2115).
Regarding claim 2, while Nakata teaches embodiments (Figs. 2, 9) wherein excitation light is oriented orthogonal or perpendicular to the light receiver in order to prevent excitation light to directly enter the light receiver (paragraphs [0024], [0072]), modified Nakata fails to explicitly teach: wherein the excitation light source is arranged above or below the sample container.
Xia teaches an embodiment (Fig. 2) comprising a light source (202) that irradiates a sample (212) within a sample container (250) in a vertical direction (Fig. 2 shows the light source 202 is emitting light from below the sample container, therefore the light is in a vertical direction); a sample detector (208) arranged on a lateral face side of the sample container (Fig. 2). Xia teaches emitted and detected light travels through beam channels which can reduce background arising from ambient light, and from light scattered from defects in sample container (paragraph [0074]). Xia teaches one or more light sources are situated to transmit light across a location on the sample container that is unlikely to be scratched in use and/or during production (claim 7).
Since Xia teaches an apparatus for optical analysis of a sample container to determine the number of microorganisms, similar to Nakata, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the excitation light source of modified Nakata to incorporate the teachings of a light source that irradiates a sample container from below of Xia (Fig. 2; paragraph [0074]) to provide: wherein the excitation light source is arranged above or below the sample container. Doing so would have a reasonable expectation of successfully improving irradiation and detection of a sample as discussed by Xia (paragraph [0074]; claim 7), and allowing for prevention of excitation light to directly enter the light receiver as desired by Nakata (paragraphs [0024], [0072]). Additionally, doing so would be an obvious rearrangement of parts, where shifting the position of the excitation light source to be above or below the sample container would not have modified the operation of the device (i.e. irradiating the sample container and detecting fluorescence; wherein excitation light is oriented orthogonal or perpendicular to the light receiver in order to prevent excitation light to directly enter the light receiver as desired by Nakata, paragraphs [0024], [0072]) and the particular placement of the excitation light source is an obvious matter of design choice as evidenced by Xia (Fig. 2) (see MPEP 2144.04(VI)(C); In reJapikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950); In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975)).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Nakata in view of Xia, Ye, and Goguen as applied to claim 1 above, and further in view of El-Hage et al. (US 20030127609 A1).
Regarding claim 3, while Nakata teaches an embodiment where the excitation light source is arranged on a lateral side of the sample container (Figs. 2,3, 5,9, light sources 10 arranged on a lateral side of sample container 5), modified Nakata fails to teach wherein: a reflective member is provided in the sample container, the excitation light source is arranged on a lateral side of the sample container, and the excitation light beam emitted from the excitation light source irradiates the irradiation plane in the vertical direction by being reflected by the reflective member.
El-Hage teaches systems for analyzing systems by generating, transmitting, detecting, and analyzing light (abstract). El-Hage teaches embodiments where light can be delivered using mirrors (paragraph [0140]). El-Hage teaches an embodiment (Fig. 80; paragraph [0939]) wherein a reflective surface, i.e. reflective member, includes a mirror placed inside the sample container (paragraph [0939]), wherein a light source is positioned on a lateral side of a sample container (Fig. 80 shows the “source” being positioned to the right side of the container), and the light beam emitted from the source irradiates an irradiation plane in a vertical direction by being reflected by the reflective surface (Fig. 80). El-Hage teaches because luminescence levels are typically very low compared to incident light levels and reflected light levels, the majority of the light reaching the detector will consist of reflected light that has passed twice through the sample in the described arrangement; and where reflected light levels are lower, it is also possible to filter out luminescence light or other light sources so that primarily reflected light reaches the detector (paragraph [0938]). El-Hage teaches reflective absorbance can be used in high throughput screening to detect and potentially correct for potential interferences from absorbing, scattering, compounds, targets, reagents, contaminants, etc. (paragraph [0950]). El-Hage teaches the use of PMT to determine the amount of detected light in units of counts (paragraph [0831]). El-Hage teaches absorbance assays are a powerful method for determining the presence and concentration of an analyte in a sample (paragraph [0693]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified apparatus of modified Nakata to incorporate the teachings of reflective members used to reflect light to a sample container of El-Hage (Fig. 80; paragraph [0939]) to provide: a reflective member is provided in the sample container, the excitation light source is arranged on a lateral side of the sample container, and the excitation light beam emitted from the excitation light source irradiates the irradiation plane in the vertical direction by being reflected by the reflective member. Doing so would have a reasonable expectation of successfully improving detection of optical signals from a sample and improve determination of the presence and concentration of a target in a sample as discussed by El-Hage (paragraphs [0693],[0831],[0938]-[0939],[0950]).
Furthermore, the claimed limitations are obvious because all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements (i.e. the reflective member and excitation light source) by known methods with no change in their respective functions (i.e. directing light to irradiate a sample container), and the combinations yielded nothing more than predictable results (i.e. providing the claimed arrangement of the reflective member and excitation light source would yield nothing more than the obvious and predictable result of directing light to irradiate a sample container). See MPEP 2143(A).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Nakata in view of Xia, Ye, and Goguen as applied to claim 1 above, and further in view of Konishi et al. (US 20180259460 A1).
Regarding claim 5, modified Nakata fails to teach the microorganism inspection apparatus according to claim 1, further comprising a shielding plate on a side opposite to the excitation light source across the irradiation plane.
Konishi teaches an automated analyzer that makes light from a light source incident on a liquid mixture consisting of a sample and reagent in a reaction vessel and performing quantitative and qualitative analysis with a photodetector (abstract). Konishi teaches shielding plates opposite to excitation light sources cross an irradiation plane (Figs. 3-4 shows light shielding mechanisms 117,118 opposite of light sources 115), wherein the photodetector units (116) are positioned on a lateral side of sample containers (105). Konishi teaches the analysis port performing photometry of the sample is reliably shielded from light and the other arbitrary analysis ports are opened meanwhile so that the dispensation mechanism or the like accesses the analysis ports; therefore, an influence of noise on a measurement result is reduced, which contributes to realization of high precise and high speed analysis (paragraph [0017]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of modified Nakata to incorporate the teachings of a shielding plate opposite of light sources of Konishi (Fig. 3; abstract) to provide: the microorganism inspection apparatus according to claim 1, further comprising a shielding plate on a side opposite to the excitation light source across the irradiation plane. Doing so would have a reasonable expectation of successfully reducing noise from undesired light and thus improve precision and speed of optical analysis of a sample container as discussed by Konishi (paragraph [0017]).
Response to Arguments
Applicant's arguments, see pages 4-7, filed 05/29/2026, with respect to the rejections under 35 U.S.C. 101, have been fully considered but they are not persuasive.
In response to applicant’s argument that the claim as a whole and specific limitations cannot be performed in the mind and therefore is not an abstract idea, the examiner disagrees.
In accordance with MPEP 2106, the claims are found to recite statutory subject matter (Step 1: YES) and are analyzed to determine if the claims recite any concepts that equate to an abstract idea, law of nature or natural phenomenon (Step 2A: Prong 1).
Step 2A: Prong 1: The limitations of “calculate, based on the converted electric signal, the number of microorganisms contained in the sample container from the number of light emissions” of claim 1 covers performance of a limitation in the mind, i.e. mental process or mathematical calculation. As elaborated in the instant specification (page 7), the number of microorganisms is calculated, which covers performance of a limitation in the mind, i.e. mathematical calculation. Other than “a controller”, if the claim limitations, under its broadest reasonable interpretation, covers performance of the limitations in the mind but for the recitation of generic computer components, then the claim limitations fall within the “Mental Processes” grouping of abstract ideas (MPEP 2106.05(f)). Accordingly, the claims recite abstract ideas (Step 2A: Prong 1: Yes).
Step 2A, Prong 2: Claim 1 does recite additional controller steps of “convert the fluorescence beam…into an electrical signal…”, however these limitations generally link the judicial exception to a particular field of use (MPEP 2106.05(h)) and are used for data gathering, wherein data gathering to be used in the abstract idea is an insignificant extra-solution activity, and not a practical application (see MPEP 2106.05(g)). The claims only recites the “controller” to perform the steps, but this broadly claimed element do not appear to be a particular machine. The controller is recited at a high-level of generality (i.e., as generic computer) such that it amounts no more than mere instructions to apply the exception using a generic computer component; wherein a general purpose computer is not a particular machine (MPEP 2106.05(b)). Claim 1 does recite additional elements of a sample container, stirrer, an excitation light source, excitation filter, diaphragm, a light receiver, optical guide bar, and a direction of flow of a sample, however these elements generally link the judicial exception to a particular field of use (MPEP 2106.05(h)) and are used for data gathering, wherein data gathering to be used in the abstract idea is an insignificant extra-solution activity, and not a practical application (see MPEP 2106.05(g)). Therefore, the judicial exception is not integrated into a practical application because the claims do not recite any additional elements that reflects an improvement to technology or applies or uses the judicial exception in some other meaningful way (Step 2A, Prong 2: No).
Step 2B: Claim 1 does recite additional steps of “convert the fluorescence beam…into an electrical signal…”, however these elements generally link the judicial exception to a particular field of use (MPEP 2106.05(h)) and are used for data gathering, wherein data gathering to be used in the abstract idea is an insignificant extra-solution activity, and not a practical application (see MPEP 2106.05(g)). The controller of claim 1 is recited at a high-level of generality (i.e., as generic computer) such that it amounts no more than mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea (MPEP 2106.05(b)). Dependent claims 2-3 and 5 further recites limitations of which alone or in combination do not amount to significantly more. Additionally, the limitations of claims 1-5 are well-understood, routine and conventional activities as evidenced by Nakata et al. (US 20150219548 A1; cited in the IDS filed 02/22/2022), Xia et al. (US 20100205139 A1; cited in the IDS filed 08/30/2023), Ye et al. (US 20050168749 A1), Goguen (WO 2005085810 A1), El-Hage et al. (US 20030127609 A1), Konishi et al. (US 20180259460 A1). See MPEP 2106.05(d). The additional elements of the claims 1-3 and 5 do not comprise an inventive concept when considered individually or as an ordered combination that transforms the claimed judicial exception into a patent-eligible application of the judicial exception. Therefore, the claims do not amount to significantly more than the judicial exception itself (Step 2B: No).
Thus, while the claim includes limitations that cannot be performed in the mind, the claim still contains an abstract idea, wherein the additional limitations of the claims are not integrated into a practical application and do not amount to significantly more than the judicial exception itself. Therefore, the claims are not patent eligible.
Applicant’s arguments, see pages 7-10, filed 05/29/2026, with respect to the rejection(s) of claims 1-5 under 35 U.S.C. 103, specifically regarding amended claim 1, have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Nakata et al. (US 20150219548 A1; cited in the IDS filed 02/22/2022) in view of Xia et al. (US 20100205139 A1; cited in the IDS filed 08/30/2023), Ye et al. (US 20050168749 A1), and Goguen (WO 2005085810 A1).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Amirkhanian et al. (US 20020196442 A1) teaches a bio-separation system including a detection zone for optical detection of sample analytes (abstract). Amirkhanian teaches the detection zone is a zone in which light from the excitation fiber is directed to cause fluorescence emissions and the detection optics is aimed to capture part of such fluorescence emissions; wherein since the excitation fiber is inside the gel or buffer, it is more index-matched, and there is no air interface, then less light scattering (which means proportionally less background) leads to lower detection noise or better signal/noise or detection sensitivity (paragraph [0052]). Amirkhanian teaches an excitation beam is wave-guided to the detection zone by total internal reflection using a waveguide (paragraph [0059]).
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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/HENRY H NGUYEN/Primary Examiner, Art Unit 1758
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