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
Receipt is acknowledged that application is a National Stage application of PCT PCT/FR2021/052468. Priority to PCT/FR2021/052468 with a priority date of 12/29/2021 is acknowledged under 35 USC 119(e) and 37 CFR 1.78.
Information Disclosure Statement
The IDSs dated 6/24/2024 and 6/30/2025 has been considered and placed in the application file.
Claim Interpretation
Claim 22 recites “wherein the concentration of the phosphotungstic acid solution is from 0.1% to 20%” and claim 23 recites “… 2% to 10%.” "When, as by a recitation of ranges or otherwise, a claim covers several compositions, the claim is ‘anticipated’ if one of them is in the prior art." Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (citing In re Petering, 301 F.2d 676, 682, 133 USPQ 275, 280 (CCPA 1962)) (emphasis in original) (Claims to titanium (Ti) alloy with 0.6-0.9% nickel (Ni) and 0.2-0.4% molybdenum (Mo) were held anticipated by a graph in a Russian article on Ti-Mo-Ni alloys because the graph contained an actual data point corresponding to a Ti alloy containing 0.25% Mo and 0.75% Ni and this composition was within the claimed range of compositions.). "If the prior art discloses a point within the claimed range, the prior art anticipates the claim." UCB, Inc. v. Actavis Labs. UT, Inc., 65 F.4th 679, 687, 2023 USPQ2d 448 (Fed. Cir. 2023). Thus, if prior art discloses a range which touches or overlaps the claimed range, it anticipates the claim.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification.
When discussing adjusting the pH of the PTA solution, the specification ONLY recites: “in a specimen stained with a PTA aqueous solution whose pH is adjusted to neutral.” Therefore, the pH adjustment recited in claim 21: “wherein the phosphotungstic acid solution is an acidic solution which is adjusted from pHO.0 to pH3.0,” cannot be given patentable weight and will be treated as an arbitrary range of pH.
Claim Objections
Claims 16 through 24 is/are objected to because of the following informalities:
Claim 16, lines 16, should be “the fourth step.”
Claim 24, line 3, should be “fixatives which contain.”
Claims 17-23 depend either directly or indirectly from the objection of claims 16, therefore they are also objected.
Appropriate correction is required.
1st Claim Rejections - 35 USC § 103
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 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 16, 17, and 18 are rejected under 35 U.S.C. 103 as obvious over US Patent Publication 2021 0172931 A1, (Larsen et al.) in view of Quantification of uncultured microorganisms by fluorescence microscopy and digital image analysis. (Daims et al.) and US Patent Publication 2014 0017382 A1, (Gunes et al.).
Claim 16
Regarding claim 16, Larsen et al. teach a microbial image analysis method, comprising: a first step for obtaining an image of a specimen in which a sample including microbes is stained; ("brightfield imaging the treated cells, as well as applying fluorescent stains to at least a portion of the cells and fluorescent imaging the cells," par. 243) a second step for obtaining a brightness profile regarding a brightness distribution range of the image; ("the raw brightfield and ground truth fluorescent images can have pixel intensities ranging from [0, 2.sup.16]," par. 252) and he fourth step is for identifying the life or death of individual microbe and/or individual microbes which are morphologically damaged in each of the first and the second standard brightness ranges and/or for calculating microbial viability and/or a ratio of microbe which is morphologically damaged based on the number of microbes and/or a microbial image area ("measuring the fitness of cells, e.g., using a cellular viability assay or cell death assay, in the one or more organoids following the exposure to the one or more amounts of the therapeutic agent, thereby obtaining the one or more cellular fitness measurements," par. 132).
Larsen et al. do not explicitly teach all of an electron microscope, a third step for setting a first standard brightness range which meets a first condition regarding a brightness out of the profile up as a region where a first microbe group exists, and setting a second standard brightness range which meets a second condition regarding a brightness out of the profile up as a region where a second microbe group exists; and a fourth step for identifying individual microbes which exist in each of the first and the second standard brightness ranges and/or for calculating a ratio of the microbe which exists in each of the first and the second standard brightness ranges, wherein the first condition includes a first peak of the brightness profile and does not include a second peak which is different from the first peak, the second condition does not include the first peak and includes the second peak, and the number of image pixels in each of the first and the second standard brightness ranges.
[AltContent: textbox (Figure 1 shows the image segmentation based on the microbial fluorescence intensity analysis.)]
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However, Daims et al. teach a third step for setting a first standard brightness range which meets a first condition regarding a brightness out of the profile up as a region where a first microbe group exists, ("Every bordered region will be segmented with an individual (local) pixel intensity threshold," pg. 241, fig. 1) and setting a second standard brightness range which meets a second condition regarding a brightness out of the profile up as a region where a second microbe group exists; ("This approach increases the likelihood that all parts of an image, which contain distinct features (here: microbial cells), are segmented with individual thresholds," pg. 241, par. 1) and a fourth step for identifying individual microbes which exist in each of the first and the second standard brightness ranges ("This approach increases the likelihood that all parts of an image, which contain distinct features (here: microbial cells), are segmented with individual thresholds," pg. 241, par. 1) and/or for calculating a ratio of the microbe which exists in each of the first and the second standard brightness ranges, ("The cells labelled by the specific and/or the general probes are counted, and the percentage of the target organism relative to all microbial cells is calculated," pg. 239, par. 4) wherein the first condition includes a first peak of the brightness profile and does not include a second peak which is different from the first peak, ("Every bordered region will be segmented with an individual (local) pixel intensity threshold," pg. 241, fig. 1) the second condition does not include the first peak and includes the second peak, ("Every bordered region will be segmented with an individual (local) pixel intensity threshold," pg. 241, fig. 1) and the number of image pixels in each of the first and the second standard brightness ranges ("After image segmentation, the total pixel area of all cells (or cell clusters) detected by probe A and the pixel area of the whole biomass labelled by probe B are measured in each image pair," pg. 243, par. 2).
Therefore, taking the teachings of Larsen et al. and Daims et al. as a whole, it would have been obvious to a person having ordinary skill in the art before the time of the effective filing date of the claimed invention of the instant application to modify microbial imaging and intensity analysis techniques as taught by Larsen et al. to use image segmentation based on microbial intensity range as taught by Daims et al. The suggestion/motivation for doing so would have been that, “The most flexible of these techniques is local thresholding (see Wilkinson 1998a and references therein). This approach does not rely on one single (“global”) threshold to segment the entire image, but instead finds suitable (“local”) thresholds for all image regions that contain objects. This is advantageous in many situations because images containing brighter and darker labelled cells are difficult to segment by using only one global threshold.” as noted by the Daims et al. disclosure in pg. 240 par. 3, which also motivates combination because the combination would predictably have a greater accuracy as there is a reasonable expectation that applying local thresholding would accurately segment both brightly and dimly labeled microbial cells across varying image regions; and/or because doing so merely combines prior art elements according to known methods to yield predictable results.
Additionally, Gunes et al. teach using an electron microscope ("Electron micrographs were acquired on a CCD camera using a Philips CM100 Biotwin Transmission Electron Microscope," par. 62).
Therefore, taking the teachings of Larsen et al., Daims et al., and Gunes et al. as a whole, it would have been obvious to a person having ordinary skill in the art before the time of the effective filing date of the claimed invention of the instant application to modify microbial imaging and intensity analysis techniques as taught by Larsen et al. and image segmentation based on microbial intensity range as taught by Daims et al. to use an electron microscope as taught by Gunes et al. Microbial imaging and intensity analysis techniques using image segmentation based on microbial intensity ranges using an electron microscope can yield a predictable result of superior magnification and resolution capabilities that allow precise visualization of fine structural details corresponding to the segmented intensity ranges. Thus, a person of ordinary skill would have appreciated including in microbial imaging and intensity analysis techniques using image segmentation based on microbial intensity ranges the ability to obtain images using an electron microscope since the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable.
Claim 17
Regarding claim 17, Larsen et al., Daims et al., and Gunes et al. teach the microbial image analysis method according to claim 16 as noted above.
Larsen et al. do not explicitly teach all of wherein the specimen is a smear specimen which is prepared from a microbial suspension in order to prevent microbes and solids from overlapping each other.
However, Daims et al. teach wherein the specimen is a smear specimen which is prepared from a microbial suspension in order to prevent microbes and solids from overlapping each other ("the plankton cells were immobilized on filter sections, which were later put onto microscope slides for automated scanning by the microscope," pg. 242, par. 3).
Larsen et al., Daims et al., and Gunes et al. are combined as per claim 16.
Claim 18
Regarding claim 18, Larsen et al., Daims et al., and Gunes et al. teach the microbial image analysis method according to claim 16 as noted above.
Larsen et al. teach wherein the first step is for performing a chemical fixation process on microbes using at least one of glutaraldehyde, formalin, and alcohol in order to stop a morphological change and preserve a microbial shape ("In some embodiments, a solid tissue sample is a formalin-fixed tissue," par. 108).
Larsen et al., Daims et al., and Gunes et al. are combined as per claim 16.
2nd Claim Rejections - 35 USC § 103
Claims 19, 20, 21, 22, 23 and 24 are rejected under 35 U.S.C. 103 as obvious over US Patent Publication 2021 0172931 A1, (Larsen et al.), Quantification of uncultured microorganisms by fluorescence microscopy and digital image analysis. (Daims et al.), and US Patent Publication 2014 0017382 A1, (Gunes et al.) in view of US Patent Publication 2010 0183212 A1, (Purchio et al.).
Claim 19
Regarding claim 19, Larsen et al., Daims et al., and Gunes et al. teach the microbial image analysis method according to claim 16 as noted above.
Larsen et al. do not explicitly teach all of wherein the first step is for staining the sample by using a phosphotungstic acid solution.
However, Purchio et al. teach wherein the first step is for staining the sample by using a phosphotungstic acid solution ("the staining agent used in staining compositions of the invention is phosphotungstic acid (PTA)," par. 63).
Therefore, taking the teachings of Larsen et al., Daims et al., Gunes et al., and Purchio et al. as a whole, it would have been obvious to a person having ordinary skill in the art before the time of the effective filing date of the claimed invention of the instant application to modify microbial imaging and intensity analysis techniques as taught by Larsen et al., image segmentation based on microbial intensity range as taught by Daims et al., and an electron microscope as taught by Gunes et al. to use the PTA staining agent as taught by Purchio et al. The suggestion/motivation for doing so would have been that, “staining agents of use in the present invention include an electron dense staining agent which produces an electron dense staining of one or more components of the specimen. Electron dense staining agents often include a metal atom or ion” as noted by the Purchio et al. disclosure in paragraph [0051], which also motivates combination because the combination would predictably have a necessary utility as there is a reasonable expectation that the electron-dense metal atom or ion of the PTA staining agent would successfully enhance contrast and improve the clarity of the targeted microbial components during electron microscopy and intensity analysis; and/or because doing so merely combines prior art elements according to known methods to yield predictable results.
Claim 20
Regarding claim 20, Larsen et al., Daims et al., Gunes et al., and Purchio et al. teach the microbial image analysis method according to claim 19 as noted above.
Larsen et al. do not explicitly teach all of wherein the phosphotungstic acid solution is an acidic solution which is adjusted from pHO.0 to pH7.0.
However, Gunes et al. teach wherein the phosphotungstic acid solution is an acidic solution which is adjusted from pHO.0 to pH7.0 ("negative staining by adding a droplet of Phosphotungstic acid solution 1% (PTA, pH 7," par. 62).
Larsen et al., Daims et al., and Gunes et al. are combined as per claim 19.
Claim 21
Regarding claim 21, Larsen et al., Daims et al., Gunes et al., and Purchio et al. teach the microbial image analysis method according to claim 19 as noted above.
Larsen et al. do not explicitly teach all of wherein the phosphotungstic acid solution is an acidic solution which is adjusted from pHO.0 to pH3.0.
However, Gunes et al. teach wherein the phosphotungstic acid solution is an acidic solution which is adjusted from pHO.0 to pH3.0 ("negative staining by adding a droplet of Phosphotungstic acid solution 1% (PTA, pH 7," par. 62 wherein the pH of 3 is an arbitrary range and holds no patentable weight).
Larsen et al., Daims et al., and Gunes et al. are combined as per claim 19.
Claim 22
Regarding claim 22, Larsen et al., Daims et al., Gunes et al., and Purchio et al. teach the microbial image analysis method according to claim 19 as noted above.
Larsen et al. do not explicitly teach all of wherein the concentration of the phosphotungstic acid solution is from 0.1% to 20%.
However, Purchio et al. teach wherein the concentration of the phosphotungstic acid solution is from 0.1% to 20% ("the PTA solution may range from a 1% to a 20% solution. In yet further embodiments the PTA solution may range from 2%-18%, 3%-16%, 4%-14%, 5%-12%, 6%-10%, and 7%-8%," par. 65).
Larsen et al., Daims et al., and Gunes et al. are combined as per claim 19.
Claim 23
Regarding claim 23, Larsen et al., Daims et al., Gunes et al., and Purchio et al. teach the microbial image analysis method according to claim 19 as noted above.
Larsen et al. do not explicitly teach all of wherein the concentration of the phosphotungstic acid solution is from 2% to 10%.
However, Purchio et al. teach wherein the concentration of the phosphotungstic acid solution is from 2% to 10% ("the PTA solution may range from a 1% to a 20% solution. In yet further embodiments the PTA solution may range from 2%-18%, 3%-16%, 4%-14%, 5%-12%, 6%-10%, and 7%-8%," par. 65).
Larsen et al., Daims et al., and Gunes et al. are combined as per claim 19.
Claim 24
Regarding claim 24, Larsen et al., Daims et al., Gunes et al., and Purchio et al. teach the microbial image analysis method according to claim 19 as noted above.
Larsen et al. teach a solution containing chemical fixasives which contains at least one of glutaraldehyde, formalin, and alcohol ("In some embodiments, a solid tissue sample is a formalin-fixed tissue," par. 108).
Larsen et al. do not explicitly teach all of a stain which contains at least the phosphotungstic acid; and a washing solvent which contains at least one of a physiological saline, water, and a buffer solution.
However, Purchio et al. teach a stain which contains at least the phosphotungstic acid; ("the staining agent used in staining compositions of the invention is phosphotungstic acid (PTA)," par. 63) and a washing solvent which contains at least one of a physiological saline, water, and a buffer solution ("a 10.times. phosphate buffer (10-fold dilution of a phosphate buffer," par. 65).
Larsen et al., Daims et al., and Gunes et al. are combined as per claim 19.
3rd Claim Rejections - 35 USC § 103
Claims 25 and 28 are rejected under 35 U.S.C. 103 as obvious over US Patent Publication 2021 0172931 A1, (Larsen et al.) in view of US Patent Publication 2002 0123089 A1, (Felkner et al.) and US Patent Publication 2014 0017382 A1, (Gunes et al.).
Claim 25
Regarding claim 25, Larsen et al. teach a microbial image analysis method, comprising: a first step for obtaining a first image of a specimen in which a sample including microbes is stained without executing a treatment which affects microbes, ("brightfield imaging the treated cells, as well as applying fluorescent stains to at least a portion of the cells and fluorescent imaging the cells," par. 243) a second step for obtaining a second image of a specimen in which a sample including microbes is stained with executing a treatment which affects microbes, ("brightfield imaging the treated cells, as well as applying fluorescent stains to at least a portion of the cells and fluorescent imaging the cells," par. 243) a third step for obtaining a brightness profile regarding a brightness of the first image, and a first peak of the brightness of the profile; ("the raw brightfield and ground truth fluorescent images can have pixel intensities ranging from [0, 2.sup.16]," par. 252) and a fourth step for obtaining a brightness profile regarding a brightness of the second image, and a second peak of the brightness of the profile ("the raw brightfield and ground truth fluorescent images can have pixel intensities ranging from [0, 2.sup.16]," par. 252).
Larsen et al. do not explicitly teach all of a control specimen, a test specimen, and using an electron microscope.
However, Felkner et al. teach a control specimen ("spores in the control sample," par. 149) and a test specimen ("spores in the BI test samples," par. 149).
Therefore, taking the teachings of Larsen et al. and Felkner et al. as a whole, it would have been obvious to a person having ordinary skill in the art before the time of the effective filing date of the claimed invention of the instant application to modify microbial imaging and intensity analysis techniques as taught by Larsen et al. to use control and test samples as taught by Felkner et al. The suggestion/motivation for doing so would have been that, “the present invention encompasses assays that assess the changes in a biological indicator comprising microorganisms using multiangle light scattering analysis to assess the efficacy of various sterilization methods” as noted by the Felkner et al. disclosure in paragraph [0070], which also motivates combination because the combination would predictably have a greater utility as there is a reasonable expectation that there would be a predictable ability to measure baseline microorganism states against treated samples to accurately evaluate the effectiveness of different treatment methods; and/or because doing so merely combines prior art elements according to known methods to yield predictable results.
Additionally, Gunes et al. teach using an electron microscope ("Electron micrographs were acquired on a CCD camera using a Philips CM100 Biotwin Transmission Electron Microscope," par. 62).
Therefore, taking the teachings of Larsen et al., Felkner et al., and Gunes et al. as a whole, it would have been obvious to a person having ordinary skill in the art before the time of the effective filing date of the claimed invention of the instant application to modify microbial imaging and intensity analysis techniques as taught by Larsen et al. and control and test samples as taught by Felkner et al. to use an electron microscope as taught by Gunes et al. Microbial imaging and intensity analysis techniques using image segmentation based on microbial intensity ranges using an electron microscope can yield a predictable result of superior magnification and resolution capabilities that allow precise visualization of fine structural details corresponding to the segmented intensity ranges. Thus, a person of ordinary skill would have appreciated including in microbial imaging and intensity analysis techniques using image segmentation based on microbial intensity ranges the ability to obtain images using an electron microscope since the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable.
Claim 28
Regarding claim 28, Larsen et al., Felkner et al., and Gunes et al. teach the microbial image analysis method according to claim 25 as noted above.
Larsen et al. do not explicitly teach all of wherein the treatment which affects the microbes is to give the microbes at least one of an antimicrobial, heat, oxygen, a detergent, and a bacteriophage.
However, Felkner et al. teach wherein the treatment which affects the microbes is to give the microbes at least one of an antimicrobial, heat, oxygen, a detergent, and a bacteriophage ("These changes are detected immediately (2-6 minutes) in the case of autoclaved spores and ozonated spores," par. 105).
Larsen et al., Felkner et al., and Gunes et al. are combined as per claim 25.
4th Claim Rejections - 35 USC § 103
Claims 26, 27, and 29 are rejected under 35 U.S.C. 103 as obvious over US Patent Publication 2021 0172931 A1, (Larsen et al.), US Patent Publication 2002 0123089 A1, (Felkner et al.), and US Patent Publication 2014 0017382 A1, (Gunes et al.) in view of Quantification of uncultured microorganisms by fluorescence microscopy and digital image analysis. (Daims et al.) and US Patent Publication 2010 0183212 A1, (Purchio et al.).
Claim 26
Regarding claim 26, Larsen et al., Felkner et al., and Gunes et al. teach the microbial image analysis method according to claim 25 as noted above.
Larsen et al. do not explicitly teach all of the microbial image analysis method according to claim 25, wherein the third step is for obtaining a first standard brightness range including the first peak based on microbial species, a type of treatment which affects microbes and a type of stain, and the fourth step is for obtaining a second standard brightness range including the second peak based on microbial species, a type of treatment which affects microbes and a type of stain.
However, Daims et al. teach wherein the third step is for obtaining a first standard brightness range including the first peak based on microbial species, and the fourth step is for obtaining a second standard brightness range including the second peak based on microbial species ("Every bordered region will be segmented with an individual (local) pixel intensity threshold," pg. 241, fig. 1) ("This approach increases the likelihood that all parts of an image, which contain distinct features (here: microbial cells), are segmented with individual thresholds," pg. 241, par. 1).
Therefore, taking the teachings of Larsen et al., Felkner et al., Gunes et al., and Daims et al. as a whole, it would have been obvious to a person having ordinary skill in the art before the time of the effective filing date of the claimed invention of the instant application to modify microbial imaging and intensity analysis techniques as taught by Larsen et al., control and test samples as taught by Felkner et al., and an electron microscope as taught by Gunes et al. to use image segmentation based on microbial intensity range as taught by Daims et al. The suggestion/motivation for doing so would have been that, “The most flexible of these techniques is local thresholding (see Wilkinson 1998a and references therein). This approach does not rely on one single (“global”) threshold to segment the entire image, but instead finds suitable (“local”) thresholds for all image regions that contain objects. This is advantageous in many situations because images containing brighter and darker labelled cells are difficult to segment by using only one global threshold.” as noted by the Daims et al. disclosure in pg. 240 par. 3, which also motivates combination because the combination would predictably have a greater accuracy as there is a reasonable expectation that applying local thresholding would accurately segment both brightly and dimly labeled microbial cells across varying image regions; and/or because doing so merely combines prior art elements according to known methods to yield predictable results.
Additionally, Purchio et al. teach a type of treatment which affects microbes and a type of stain ("the stained specimen may further be submitted to treatment with an organic solvent or a mixture of an organic solvent in water," par. 80).
Therefore, taking the teachings of Larsen et al., Felkner et al., Gunes et al., and Daims et al. as a whole, it would have been obvious to a person having ordinary skill in the art before the time of the effective filing date of the claimed invention of the instant application to modify microbial imaging and intensity analysis techniques as taught by Larsen et al., control and test samples as taught by Felkner et al., an electron microscope as taught by Gunes et al., and image segmentation based on microbial intensity range as taught by Daims et al. to use the PTA staining agent as taught by Purchio et al. The suggestion/motivation for doing so would have been that, “staining agents of use in the present invention include an electron dense staining agent which produces an electron dense staining of one or more components of the specimen. Electron dense staining agents often include a metal atom or ion” as noted by the Purchio et al. disclosure in paragraph [0051], which also motivates combination because the combination would predictably have a necessary utility as there is a reasonable expectation that the electron-dense metal atom or ion of the PTA staining agent would successfully enhance contrast and improve the clarity of the targeted microbial components during electron microscopy and intensity analysis; and/or because doing so merely combines prior art elements according to known methods to yield predictable results.
Claim 27
Regarding claim 27, Larsen et al., Felkner et al., Gunes et al., Daims et al., and Purchio et al. teach the microbial image analysis method according to claim 26 as noted above.
Larsen et al. do not explicitly teach all of a fifth step for obtaining the number of microbes, a microbial image area, and/or the number of pixels and calculating a ratio of microbe which exists in each of the first and the second standard brightness range, and quantifying an effect of treatments that affect microbes by comparing the control specimen with the test specimen.
However, Daims et al. teach a fifth step for obtaining the number of microbes, a microbial image area, and/or the number of pixels and calculating a ratio of microbe which exists in each of the first and the second standard brightness range ("The cells labelled by the specific and/or the general probes are counted, and the percentage of the target organism relative to all microbial cells is calculated," pg. 239, par. 4).
Additionally, Felkner et al. teach quantifying an effect of treatments that affect microbes by comparing the control specimen with the test specimen ("Response to sterilization treatments is detected through decreased normal cell numbers and/or cell shape changes compared to control (untreated) cell suspensions," par. 105).
Larsen et al., Felkner et al., Gunes et al., Daims et al., and Purchio et al. are combined as per claim 26.
Claim 29
Regarding claim 29, Larsen et al., Felkner et al., Gunes et al., Daims et al., and Purchio et al. teach the microbial image analysis method according to claim 26 as noted above.
Larsen et al. do not explicitly teach all of wherein the stain is phosphotungstic acid.
However, Purchio et al. teach wherein the stain is phosphotungstic acid ("the staining agent used in staining compositions of the invention is phosphotungstic acid (PTA)," par. 63).
Larsen et al., Felkner et al., Gunes et al., Daims et al., and Purchio et al. are combined as per claim 26.
Reference Cited
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure.
US Patent Publication 2021 0079442 A1 to Lallemand et al. discloses illumination to differentiate between yeast and bacterial strains based on reflectance or transmission light intensity analysis.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARSTEN F LANTZ whose telephone number is (571) 272-4564. The examiner can normally be reached Monday-Friday 8:00-4:00.
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/Karsten F. Lantz/Examiner, Art Unit 2664
Date: 7/28/2026
/PING Y HSIEH/Primary Examiner, Art Unit 2664
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