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 .
Election/Restrictions
Applicant's election with traverse of Group 1, claims 1-9, in the reply filed on 01/21/2026 is acknowledged. The traversal is on the grounds that Groups 1 and 2 are directed to a product and process of use of said product, and therefore have unity of invention, and a special technical feature is not needed to establish unity of invention. This is not found persuasive because under PCT Rule 13.2, even though the inventions of the groups require similar technical features (see Restriction filed 11/21/2025, pages 3-6), the technical feature is not a special technical feature as it does not make a contribution over the prior art, and therefore they are not related to a single general inventive concept under PCT Rule 13.1 and lack unity of invention. MPEP 1893.03(d) states a group of inventions is considered linked to form a single general inventive concept where there is a technical relationship among the inventions that involves at least one common or corresponding special technical feature; wherein the expression special technical features is defined as meaning those technical features that define the contribution which each claimed invention, considered as a whole, makes over the prior art. Since the shared technical features of Groups 1 and 2 does not make a contribution over the prior art, the groups are not related to a single general inventive concept and therefore has lack of unity.
The requirement is still deemed proper and is therefore made FINAL.
Claim 10 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 01/21/2026.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, claim 1 recites the limitation "the measuring instrument" in the last paragraph. There is insufficient antecedent basis for this limitation in the claim. For examination purposes “the measuring instrument” is interpreted as the “analysis instrument” established in line 2. Claims 2-9 are rejected by virtue of their dependency on claim 1. Note that claim 2 also refers to “the measuring instrument”.
Regarding claim 1, claim 1 recites steps of “wherein, the method comprises, for a plurality of measurement times…an acquisition of a holographic image…determination…of a value of a distribution parameter”. It is unclear if the acquisition of a holographic image and determination steps are in addition to or further describing the first “acquiring an image” and “determining” steps in lines 7-10. For the method, are two images acquired, i.e. “an image” and “a holographic image”? Or is claim 1 intended to further define the first “acquiring an image” step as “acquisition of a holographic image”? Claims 2-9 are rejected by virtue of their dependency on claim 1.
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 1-9 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 “determining, from the acquired image, a biological sample criterion”, “determination, from the acquired holographic image, of a value of a distribution parameter…”, and “comparing the value…with at least one threshold value…”.
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 “determining, from the acquired image, a biological sample criterion”, “determination, from the acquired holographic image, of a value of a distribution parameter…”, and “comparing the value…with at least one threshold value…” covers performance of a limitation in the mind, i.e. mental process or mathematical calculation. Other than an analysis instrument, 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 (e.g. analysis instrument), 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). The preceding steps and limitations are used for data gathering in the abstract idea; wherein, data gathering to be used in the abstract idea is insignificant extra-solution activity, and not a particular practical application. Additionally, the step of “issuing a biological sample non-compliance alert if the value of the distribution parameter is outside the compliance range” is insignificant extra-solution activity. See MPEP 2106.05(g). Additionally, if the value of the distribution parameter is inside the compliance range, no additional steps are performed, therefore there is no application of the abstract idea. Therefore, 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. Thus, the claims are directed to an abstract idea that is not integrated into a practical application (Step 2A, Prong 2: No).
The claims 1-9 do not include additional elements that are sufficient to amount to significantly more than the judicial exception. Claim 1 and dependent claims 2-9 further recite limitations, 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)), which alone or in combination do not amount to significantly more. Further, while claim 1 recites an analysis instrument and holographic imager, those elements are broad and the claim does not include particular elements of a machine or apparatus (see MPEP 2106.05(b)(I)). Additionally, the limitations of claims 1-9 are well-understood, routine and conventional activities as evidenced by the prior art of over Masutani et al. (US 20210073979 A1; effectively filed 10/06/2017), Neugebauer et al. (US 20190162655 A1), Fisher et al. (US 20030020907 A1), Nakatomi et al. (US 20210142474 A1; effectively filed 06/07/2018), Hammond et al. (US 20150118708 A1), and Ozcan et al. (US 20190137932 A1). See MPEP 2106.05(d). The additional elements of the claims 1-9 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 1-5 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Masutani et al. (US 20210073979 A1; effectively filed 10/06/2017) in view of Neugebauer et al. (US 20190162655 A1) and Fisher et al. (US 20030020907 A1).
Regarding claim 1, Masutani teaches a method for analyzing a biological sample by means of an analysis instrument (abstract and Figs. 3,6 teaches a method for analyzing cells using an image-processing device), wherein, after the biological sample has been placed in an analysis receptacle in a field-of-view of a holographic imager (paragraphs [0021]-[0022] teaches biological samples placed in a well plate, i.e. analysis receptacle, is placed on a stage of a microscope for imaging, i.e. in a field of view; paragraph [0034] teaches the microscope device has functions of a holographic microscope, i.e. holographic imager), the receptacle comprising at least one reagent intended to interact with biological agents present in the biological sample (paragraphs [0037] and [0042] teach fluorescent proteins or chemical reagents for staining or dying cells for imaging; therefore, the well plate with the samples are interpreted as including reagents intended to react with cells in the sample), the method comprises the following steps carried out in a repeated manner for a plurality of measurement times during a measurement period (Fig. 6 and paragraphs [0093]-[0095] teaches steps of imaging and determining number of cells is repeated, therefore is repeated for a plurality of measurement times during a period):
- acquiring an image of the biological sample (Fig. 6, step S520),
- determining, from the acquired image, a biological sample analysis criterion (Fig. 6 and paragraph [0093] teach determining number of cells from the image, i.e. biological sample analysis criterion),
wherein, the method comprises:
- an acquisition of an image of the biological sample by the holographic imager (Fig. 6 and paragraph [0097], step S560 teaches capturing a main image),
- a determination, from the acquired image, of a value of a distribution parameter representative of the quantitative spatial distribution of biological agents in the field-of-view (Fig. 6, step S570 teaches analysis of the main image; paragraph [0063] teaches determination of quantities, i.e. value of a distribution parameter, of cells imaged in the main captured image), the biological sample analysis criterion from which the analysis results are obtained being a value of the distribution parameter representative of the quantitative spatial distribution of biological agents (Fig. 6 and paragraph [0093] teach determining quantity or number of cells from the image, i.e. biological sample analysis criterion), and
the method also comprising, for at least one measurement time within a first half of the measurement period, an initial compliance check for the biological sample (Fig. 6 and paragraphs [0094]-[0096] teaches step S550 of determining whether or not imaging conditions are satisfied for each pre-captured image on the basis of the number of cells calculated by the cell number calculating unit, wherein step S550 is interpreted as within a first half of a measurement period from the start to end of the method of Fig. 6), comprising comparing the value of the distribution parameter with at least one threshold value defining a limit of a compliance range (Fig. 6 and paragraphs [0094]-[0096] teaches determining whether or not imaging conditions are satisfied for each pre-captured image on the basis of the number of cells calculated by the cell number calculating unit, therefore the number is implied to be compared to a threshold value, i.e. imaging condition, that defines a limit of a compliance range, in order to determine whether to proceed to step S555 or S560).
Masutani fails to teach: obtaining analysis results from the biological sample analysis criterion at the end of the measurement period; wherein, the method comprises, for a plurality of measurement times during the measurement period within a first half and a second half of the measurement period; the acquisition of a holographic image of the biological sample by the holographic imager; the determination, from the acquired holographic image, of a value of a distribution parameter representative of the quantitative spatial distribution of biological agents in the field-of-view, the determination of the value of the distribution parameter comprising the determination, for each of a plurality of zones of the holographic image, of the presence or absence of biological agents in the zone, and the measuring instrument issuing a biological sample non-compliance alert if the value of the distribution parameter is outside the compliance range.
Masutani teaches a holographic microscope (paragraph [0034]). Masutani teaches observation of number of cells at a first time and a second time (paragraph [0038]). Masutani teaches imaging a plurality of number of times (paragraph [0131]). Masutani teaches presence/absence of a cell may be set as conditions for selecting imaging positions of an image (paragraph [0057]). Masutani teaches selecting a plurality of imaging areas and determining if the imaging areas satisfy imaging conditions in order to select an imaging position for analysis (paragraph [0061]).
Neugebauer teaches methods for determination of a microbial pathogen and its anti-infective resistance (abstract), including optical detection performed by holographic detection (paragraphs [0013],[0115]). Neugebauer teaches using holographic approaches, averaged data can be captured on the image section and the characteristics of the individual microbes can also be determined by data evaluation (paragraph [0126]). Neugebauer teaches optical detection of a sample at at least two time points during cultivation of a sample (paragraph [0023]). Neugebauer teaches an indicator of the resistance of the microbial pathogen to the anti-infective agent is an unchanged cell growth of the microbial pathogen compared to negative control data (paragraph [0110]). Neugebauer teaches cell growth, i.e. analysis result, can be determined by observing cell number over time (paragraph [0111]).
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 method of Masutani to incorporate the teachings of a holographic microscope, observing number of cells at different times, and presence/absence of cells as conditions for selecting images of Masutani (paragraphs [0034],[0038],[0057],[0131]) and the teachings of analysis of a sample of cells based on holographic detection and observing number of cells over time (paragraphs [0013], [0023],[0110],[0111],[0115],[0126]) to provide: obtaining analysis results from the biological sample analysis criterion at the end of the measurement period (e.g. cell growth); wherein, the method comprises, for a plurality of measurement times during the measurement period within a first half and a second half of the measurement period; the acquisition of a holographic image of the biological sample by the holographic imager; the determination, from the acquired holographic image, of a value of a distribution parameter representative of the quantitative spatial distribution of biological agents in the field-of-view, the determination of the value of the distribution parameter comprising the determination, for each of a plurality of zones of the holographic image, of the presence or absence of biological agents in the zone. Doing so would have a reasonable expectation of successfully improving image analysis and characterization of a sample over the measurement period and ensuring the areas of the holographic image contains desired biological agents to be analyzed.
Modified Masutani fails to teach: the measuring instrument issuing a biological sample non-compliance alert if the value of the distribution parameter is outside the compliance range.
Masutani teaches checking if imaging conditions are satisfied within a first half of a measurement period (Fig. 6, step S550 and paragraph [0094]), wherein a determination unit determines whether or not imaging conditions are satisfied for each pre-captured image on the basis of the number of cells calculated by the cell number calculating unit and the distribution of the cells calculated by the cell distribution calculating unit (paragraph [0094]).
Fisher teaches methods for controlling concentration in a composition (abstract). Fisher teaches a check standard stage is typically run after a calibration stage and before a sample measurement stage to verify the measurement instrument is accurately determining concentration and is properly calibrated; wherein if the measured concentration and/or standard deviation are not within the predefined range limits, this indicates that the instrument is not in calibration and a sample failure alarm, for example, a visual and/or aural alarm, activates (paragraph [0031]).
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 method of modified Masutani to incorporate the teachings of checking if imaging conditions are satisfied of Masutani (paragraph [0094]) and the teachings of activating an alarm if measured conditions such as measured concentration are not within predefined range limits of Fisher (paragraph [0031]) to provide: the measuring instrument issuing a biological sample non-compliance alert if the value of the distribution parameter is outside the compliance range. Doing so would have a reasonable expectation of successfully improving notification to a user to indicate whether or not the biological sample meets desired conditions for image analysis, therefore preventing inaccurate or undesired analysis of a sample.
Regarding claim 2, modified Masutani fails to teach: wherein the threshold value is a bottom threshold value corresponding to a bottom limit of the compliance range, and if the value of the distribution parameter is lower than the bottom threshold value, the measuring instrument issues a biological sample non-compliance alert and/or the threshold value is a top threshold value corresponding to a top limit of the compliance range, and if the value of the distribution parameter is higher than the top threshold value, the measuring instrument issues a biological sample non-compliance alert.
Masutani teaches checking if imaging conditions are satisfied within a first half of a measurement period (Fig. 6, step S550 and paragraph [0094]), wherein a determination unit determines whether or not imaging conditions are satisfied for each pre-captured image on the basis of the number of cells calculated by the cell number calculating unit and the distribution of the cells calculated by the cell distribution calculating unit (paragraph [0094]). Masutani teaches the number of cells as the imaging conditions is in the range of 100 to 500 (paragraph [0061]).
Fisher teaches methods for controlling concentration in a composition (abstract). Fisher teaches a check standard stage is typically run after a calibration stage and before a sample measurement stage to verify the measurement instrument is accurately determining concentration and is properly calibrated; wherein if the measured concentration and/or standard deviation are not within the predefined range limits, this indicates that the instrument is not in calibration and a sample failure alarm, for example, a visual and/or aural alarm, activates (paragraph [0031]).
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 method of modified Masutani to incorporate the teachings of checking if imaging conditions, such as if a number of cells are within a range, are satisfied of Masutani (paragraphs [0061],[0094]) and the teachings of activating an alarm if measured conditions such as measured concentration are not within predefined range limits of Fisher (paragraph [0031]) to provide: wherein the threshold value is a bottom threshold value corresponding to a bottom limit of the compliance range, and if the value of the distribution parameter is lower than the bottom threshold value, the measuring instrument issues a biological sample non-compliance alert and/or the threshold value is a top threshold value corresponding to a top limit of the compliance range, and if the value of the distribution parameter is higher than the top threshold value, the measuring instrument issues a biological sample non-compliance alert. Doing so would have a reasonable expectation of successfully improving notification to a user to indicate whether or not the biological sample have conditions that are within desired ranges for image analysis, therefore preventing inaccurate or undesired analysis of a sample.
Regarding claim 3, modified Masutani fails to teach: wherein the biological sample initial compliance check is carried out for at least one measurement time within the first quarter of the measurement period.
Masutani teaches checking if imaging conditions are satisfied within a first half of a measurement period (Fig. 6, step S550 and paragraph [0094]), wherein a determination unit determines whether or not imaging conditions are satisfied for each pre-captured image on the basis of the number of cells calculated by the cell number calculating unit and the distribution of the cells calculated by the cell distribution calculating unit (paragraph [0094]).
Neugebauer teaches optical detection can take place at the beginning of cultivations and intervals of not more than 15 or 5 minutes (paragraph [0036]). Neugebauer teaches tracking growth of bacteria every 15 minutes via imaging (paragraph [0172]).
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 biological sample initial compliance check of modified Masutani to incorporate the teachings of checking if imaging are conditions are satisfied of Masutani (paragraph [0094]; Fig. 6) and the teachings of optical detecting at the beginning of cultivations at intervals of not more than 15 or minutes (paragraphs [0036],[0172]) to provide: wherein the biological sample initial compliance check is carried out for at least one measurement time within the first quarter of the measurement period. Doing so would have a reasonable expectation of successfully ensuring the biological sample meets desired conditions prior to continuing the method, therefore preventing inaccurate or undesired analysis of a sample.
Regarding claim 4, modified Masutani fails to teach wherein the biological sample initial compliance check is carried out for at least one measurement time within the first hour of the measurement period, or within the first 30 minutes of the measurement period.
Masutani teaches checking if imaging conditions are satisfied within a first half of a measurement period (Fig. 6, step S550 and paragraph [0094]), wherein a determination unit determines whether or not imaging conditions are satisfied for each pre-captured image on the basis of the number of cells calculated by the cell number calculating unit and the distribution of the cells calculated by the cell distribution calculating unit (paragraph [0094]).
Neugebauer teaches optical detection can take place at the beginning of cultivations and intervals of not more than 15 or 5 minutes (paragraph [0036]). Neugebauer teaches tracking growth of bacteria every 15 minutes via imaging (paragraph [0172]).
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 biological sample initial compliance check of modified Masutani to incorporate the teachings of checking if imaging are conditions are satisfied of Masutani (paragraph [0094]; Fig. 6) and the teachings of optical detecting at the beginning of cultivations at intervals of not more than 15 or minutes (paragraphs [0036],[0172]) to provide: wherein the biological sample initial compliance check is carried out for at least one measurement time within the first hour of the measurement period, or within the first 30 minutes of the measurement period. Doing so would have a reasonable expectation of successfully ensuring the biological sample meets desired conditions prior to continuing the method, therefore preventing inaccurate or undesired analysis of a sample.
Regarding claim 5, modified Masutani further teaches wherein the distribution parameter is derived from a number of biological agents appearing in the holographic image (Masutani, paragraph [0063] teaches determination of quantities of cells, i.e. number of biological agents, imaged in the main captured image; see above claim 1, modified Masutani teaches the image is the holographic image).
Regarding claim 8, modified Masutani fails to teach wherein the holographic image is a hologram or an image reconstructed from a hologram.
Masutani teaches the microscope device has functions of a holographic microscope (paragraph [0034]).
Neugebauer teaches methods for determination of a microbial pathogen and its anti-infective resistance (abstract), including optical detection performed by holographic detection (paragraphs [0013],[0115]). Neugebauer teaches using holographic approaches, averaged data can be captured on the image section and the characteristics of the individual microbes can also be determined by data evaluation (paragraph [0126]). Neugebauer teaches optical detection of a sample at at least two time points during cultivation of a sample (paragraph [0023]). Neugebauer teaches an indicator of the resistance of the microbial pathogen to the anti-infective agent is an unchanged cell growth of the microbial pathogen compared to negative control data (paragraph [0110]). Neugebauer teaches cell growth, i.e. analysis result, can be determined by observing cell number over time (paragraph [0111]).
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 method of Masutani to incorporate the teachings of a holographic microscope of Masutani (paragraphs [0034]) and the teachings of analysis of a sample of cells based on holographic detection and observing number of cells over time (paragraphs [0013], [0023],[0110],[0111],[0115],[0126]) to provide: wherein the holographic image is a hologram or an image reconstructed from a hologram. Doing so would have a reasonable expectation of successfully improving image analysis and characterization of a sample over the measurement period and ensuring the areas of the holographic image contains desired biological agents to be analyzed.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Masutani in view of Neugebauer and Fisher as applied to claim 1 above, and further in view of Nakatomi et al. (US 20210142474 A1; effectively filed 06/07/2018).
Regarding claim 6, modified Masutani fails to teach: wherein a zone of the holographic image is between 5 and 20 times larger than a typical size of the biological agents of the biological sample.
Masutani teaches selecting a plurality of imaging areas and determining if the imaging areas satisfy imaging conditions in order to select an imaging position for analysis (paragraph [0061]). Masutani teaches eight image areas (paragraph [0074]).
Nakatomi teaches an imaging processing device including a cell analyzer that analyzes an image of cells cultured within a culture container (abstract). Nakatomi teaches dividing an image into a plurality of regions (paragraphs [0092]-[0094]), wherein the size of the regions are set in accordance with the size of each cell in the image (paragraph [0093]). Nakatomi teaches calculating a number of cell divisions within each region (paragraph [0094]).
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 a zone of the holographic image of modified Masutani to incorporate the teachings of a plurality of imaging areas of Masutani (paragraphs [0061],[0071]) and the teachings of size of regions of an image are set according to size of each cell in an image of Nakatomi (paragraphs [0092]-[0094]) to provide: wherein a zone of the holographic image is between 5 and 20 times larger than a typical size of the biological agents of the biological sample through routine experimentation. Doing so would have a reasonable expectation of successfully ensuring the size of the zones encompass desired biological agents at an optimal size for quantification and analysis. See MPEP 2144.05 (II).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Masutani in view of Neugebauer and Fisher as applied to claim 1 above, and further in view of Hammond et al. (US 20150118708 A1).
Regarding claim 7, modified Masutani fails to teach wherein the presence or absence of biological agents in a zone is determined by comparing a value of level of grey of the zone with a threshold, or by comparing a pattern of the zone with reference patterns of a database.
Hammond teaches a method for detecting bacteria and determining the concentration thereof in a liquid sample (abstract). Hammond teaches differentiating bacteria from non-bacteria in a sample (paragraph [0114]), wherein a straight forward measurement can be made by thresholding the image and identifying the objects from the background (e.g., turning each pixel into a grayscale value and then choosing any pixel above a certain threshold value to be white while all other pixels are black); and counting all of the individual white areas (each connected white pixel will be considered as one element) will yield the object count (paragraph [0114]).
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 method of modified Masutani to incorporate the teachings of detecting the presence of bacteria and counting bacteria by thresholding an image and comparing to a threshold value of Hammond (paragraph [0114]) to provide: wherein the presence or absence of biological agents in a zone is determined by comparing a value of level of grey of the zone with a threshold, or by comparing a pattern of the zone with reference patterns of a database. Doing so would have a reasonable expectation of successfully improve differentiation and detection of the biological agents in the zone for analysis of the desired biological agents.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Masutani in view of Neugebauer and Fisher as applied to claim 1 above, and further in view of Ozcan et al. (US 20190137932 A1).
Regarding claim 9, modified Masutani fails to teach wherein the analysis receptacle has at least two opposite transparent faces, and the holographic imager is configured so that the field-of-view extends over a field depth of at least 100 um between the two opposite transparent faces of the analysis receptacle.
Ozcan teaches imaging a sample contained on a sample holder (abstract). Ozcan teaches a microscope that uses holographic imaging to produce high-resolution images, wherein a sample is contained on an optically transparent substrate to be holographically imaged (paragraph [0008]). Ozcan teaches an optically transparent sample holder holds a sample along an optical path (paragraph [0012]). Ozcan teaches the holographic microscope has an enhanced depth of field which spans several hundreds microns, and the holograms over a large sample area can thus be easily focused by autofocusing and digital back-propagation algorithms (paragraph [0088]).
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 analysis receptacle and holographic imager of modified Masutani to incorporate the teachings of transparent substrates for samples and holographic microscopes with enhanced depth of fields of several hundreds microns of Ozcan (paragraphs [0008],[0012],[0088]) to provide: wherein the analysis receptacle has at least two opposite transparent faces, and the holographic imager is configured so that the field-of-view extends over a field depth of at least 100 um between the two opposite transparent faces of the analysis receptacle. Doing so would have a reasonable expectation of successfully improving the resolution of images of the biological agents and allowing for improved focusing of the biological agents over a large sample area as taught by Ozcan (paragraph [0088]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Osman et al. (US 20130260396 A1) teaches a method for characterizing a population of cells (abstract). Osman teaches the holographic fluctuation microscopy apparatus and method (technique) described herein is readily applicable to low-magnification measurements (allowing increased throughput) and has less stringent focusing requirements (paragraph [0014]). Osman teaches a sample is modified by introducing reagents onto a sample holder before, during, or after measurements (paragraph [0100]), and a transparent surface of a sample holder (paragraph [0100]).
Ozcan et al. (US 20180052425 A1) teaches a method for label-free sizing of small objects including particles, including a holographic microscope (abstract). Ozcan teaches to identify and measure objects, holographic images are taken (paragraph [0044]; Fig. 3), and counting objects (Fig. 3, step 540).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HENRY H NGUYEN whose telephone number is (571)272-2338. The examiner can normally be reached M-F 7:30A-5:00P.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at (571) 270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HENRY H NGUYEN/ Primary Examiner, Art Unit 1758