DETAILED ACTION
Claim Status
Claims 1-20 are rejected.
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
This application is a 371 of PCT/US2021/037603, filed 06/16/2021. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
This application claims Domestic Benefit to application # 63040837, filed 06/18/2020. Domestic Benefit is acknowledged. Therefore, the effective filing date of claim(s) is 06/18/2020.
Drawings
There are no drawings filed herein.
Information Disclosure Statement
The Information Disclosure Statement(s) filed on 12/06/2023, 12/14/2022 are in
compliance with the provisions of 37 CFR 1.97 and have been considered in full. A signed copy of list of
references cited from each IDS is included with this Office Action.
Claim Objections
Claim 7 objected to because of the following informalities: claim does not end with a period. Appropriate correction is required.
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 8-9 and 17-18 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 claims 8-9 and 17-18, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Additionally, claims 8-9 recite “the preservative chemical” and claim 1 recites “a preservative chemical” in the limitation regarding urine sample (B) and urine sample (D). It is unclear if “the preservative chemical” is intended to limit the reference in urine sample (B), urine sample (D), or both.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
In accordance with MPEP § 2106, claims found to recite statutory subject matter ( Step 1 : YES) are then 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 claims recite the following limitations that equate to an abstract idea:
1. comparing the detection results of the one or more analytes of interest for the one or more urine samples from the first automated sediment analyzer and the second automated sediment analyzer to determine any deviation between the two detection results;
1. validating the accuracy characteristic determinations of the first automated sediment analyzer by determining whether the deviation between the detection results of the first sediment analyzer and the second automated sediment analyzer exceeds a predefined threshold level.
14. comparing the detection results of the one or more analytes of interest for the one or more urine samples from each of the two or more times that the first automated sediment analyzer was used to determine any deviation between the two or more times that the first automated sediment analyzer was used;
14. validating the precision characteristic determinations of the first automated sediment analyzer by determining whether the deviation between the two or more times that the first automated sediment analyzer was used exceeds a predefined threshold level.
The steps for “comparing” and “validating” are verbal equivalents for comparisons between variables, i.e. the detection results, which could be performed practically by a human being with access to the data and a pen and paper. Therefore, these limitations fall under the “Mental process” grouping of abstract ideas. As such, claims 1-20 recite an abstract idea ( Step 2A, Prong 1 : YES).
Claims found to recite a judicial exception under Step 2A, Prong 1 are then further analyzed to determine if the claims as a whole integrate the recited judicial exception into a practical application or not (Step 2A, Prong 2). This judicial exception is not integrated into a practical application because the claims do not recite an additional element that reflects an improvement to technology or applies or uses the recited judicial exception to effect a particular treatment for a condition. Rather, the instant claims recite additional elements that amount to mere instructions to implement the abstract idea. Specifically, the claims recite the following additional elements:
1. A method for validating the accuracy characteristic determinations of an automated urine sediment analyzer, comprising: analyzing one or more urine samples for one or more analytes of interest, using a first automated sediment analyzer within a time period of less than or equal to 10 hours from collection of the one or more urine samples, wherein the one or more urine samples are selected from:(a) urine sample (A) is not subject to a temperature of below 8 °C prior to analyzing urine sample (A); (b) urine sample (B) has not had a preservative chemical applied to urine sample (B) prior to analyzing urine sample (B); (c) urine sample (C) was treated using predetermined separation techniques prior to analyzing urine sample (C); (d) urine sample (D) has had a preservative chemical applied to urine sample (D), and further wherein urine sample (D) was treated using predetermined storage conditions prior to analyzing urine sample (D); or (e) any combination of (a)-(d); obtaining detection results of the one or more analytes of interest for the one or more urine samples from the first automated sediment analyzer; analyzing the same one or more urine samples as analyzed by the first automated sediment analyzer for the one or more analytes of interest using a second automated sediment analyzer; obtaining detection results of the one or more analytes of interest for one or more urine samples from the second automated sediment analyzer;
2. The method of claim 1, wherein the second sediment analyzer is an established reference analyzer.
3. The method of claim 1, wherein the one or more analytes of interest can be selected from red blood cells, white blood cells, sperm cells, pathological casts, hyaline casts, bacteria, yeast, crystals, pus cells, squamous epithelial cells, non-squamous epithelial cells, and mucus.
4. The method of claim 1, wherein the first sediment analyzer utilizes a detection technology selected from a flow cytometry-based method of detection or image-based method of detection.
5. The method of claim 1, wherein the second sediment analyzer utilizes a detection technology selected from a flow cytometry-based method of detection, image-based method of detection, and a manual microscopy method of detection.
6. The method of claim 1, wherein the second automated sediment analyzer utilizes a detection technology different than that of the first sediment analyzer.
7. The method of claim 1, wherein the second automated sediment analyzer utilizes a detection technology that is the same as that of the first sediment analyzer
8. The method of claim 1, wherein the first sediment analyzer utilizes an image-based detection technology, and further wherein the preservative chemical is selected from biological cell preservatives such as aldehydes, aldehyde releasing chemicals, or biomolecule fixatives.
9. The method of claim 1, wherein the first sediment analyzer utilizes a flow cytometry- based detection technology, and further wherein the preservative chemical is selected from biological cell preservatives such as aldehydes, aldehyde releasing chemicals, or biomolecule fixatives.
10. The method of claim 1, wherein the one or more analytes of interest is selected from red blood cells, white blood cells, epithelial cells, sperm cells, pathological casts, hyaline casts, bacteria, or yeast, and further wherein the predetermined storage conditions include a temperature at which urine sample (D) is stored prior to analysis of urine sample (D), wherein the temperature is 0-100C.
11. The method of claim 1, wherein the one or more analytes of interest are crystals, and further wherein the predetermined storage conditions include a temperature at which urine sample (D) is stored prior to analysis of urine sample (D), wherein the temperature is 20-30°C.
12. The method of claim 1, wherein the second sediment analyzer utilizes an image-based detection technology or a flow cytometry-based detection technology, and further wherein the urine sample (C) is subjected to a separation technique prior to analysis of urine sample (C).
13. The method of claim 1, wherein the second sediment analyzer utilizes a manual microscopy detection technology, and further wherein urine sample (C) is not subjected to a separation technique prior to analysis of urine sample (C).
14. A method for validating the precision characteristic determinations of an automated urine sediment analyzer, comprising: analyzing one or more urine samples for one or more analytes of interest, using a first automated sediment analyzer two or more times within a time period of less than or equal to 10 hours from collection of the one or more urine samples, wherein the one or more urine samples are selected from: (i) urine sample (1) has had a preservative chemical applied to urine sample (1); (ii) urine sample (2) was treated using predetermined storage conditions prior to analyzing urine sample (2); (iii) any combination of (i)-(ii); obtaining detection results of the one or more analytes of interest for one or more urine samples from the first automated sediment analyzer for the two or more times that the first automated sediment analyzer was used to analyze the one or more urine samples;
15. The method of claim 14, wherein the one or more analytes of interest can be selected from red blood cells, white blood cells, sperm cells, pathological casts, hyaline casts, bacteria, yeast, crystals, pus cells, squamous epithelial cells, non-squamous epithelial cells, and mucus.
16. The method of claim 14, wherein the first sediment analyzer utilizes a detection technology selected from a flow cytometry-based method of detection, image-based method of detection, and a manual microscopy method of detection.
17. The method of claim 16, wherein the first sediment analyzer utilizes an image-based detection technology, and further wherein the preservative chemical is selected from biological cell preservatives such as aldehydes, aldehyde releasing chemicals, or biomolecule fixatives.
18. The method of claim 16, wherein the first sediment analyzer utilizes a flow cytometry- based detection technology, and further wherein the preservative chemical is selected from biological cell preservatives such as aldehydes, aldehyde releasing chemicals, or biomolecule fixatives.
19. The method of claim 16, wherein the one or more analytes of interest is selected from red blood cells, white blood cells, epithelial cells, sperm cells, pathological casts, hyaline casts, bacteria, or yeast, and further wherein the predetermined storage conditions include a temperature at which urine sample (2) is stored prior to analysis of urine sample (2), wherein the temperature is 0-100C.
20. The method of claim 16, wherein the one or more analytes of interest are crystals, and further wherein the predetermined storage conditions include a temperature at which urine sample (2) is stored priorto analysis of urine sample (2), wherein the temperature is 20-30°C.
The additional elements set forth using urine sediment analyzers to obtain the data to perform the comparing and validating steps. Performing clinical tests on individuals to obtain input for an equation, In re Grams, 888 F.2d 835, 839-40; 12 USPQ2d 1824, 1827-28 (Fed. Cir. 1989), is considered to be a type of “mere data gathering.” As such, claims 1-20 are directed to an abstract idea ( Step 2A, Prong 2 : NO).
Claims found to be directed to a judicial exception are then further evaluated to determine if the claims recite an inventive concept that provides significantly more than the judicial exception itself (Step 2B). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims recite additional elements that equate to mere instructions to apply the recited exception in a generic way or in a generic computing environment. The instant claims recite additional elements recited above, in the section on step 2A.
Claim 5 of the instant application sets forth the three types of urine sediment analyzers used across the application: flow cytometry, image-based, and manual microscopy based. Mahoney et al. (Journal of The Electrochemical Society, 2019 167 037518) discuss flow cytometry (pg 3 ¶ 1), imaging (pg 11 ¶ 2), and microscopy (pg 2 ¶ 2). Mahoney discusses a combination of imaging and flow cytometry (pg 2 left col ¶ 1). Mahoney also discusses systems with multiple analyzers that use the same kind of detection technology, namely imaging (pg 4 left col ¶ 3). Mahoney continues to list the types of analytes screened by urinalysis (pg 2, table 1). Mahoney discusses the possible need for the refrigeration of samples (pg 2 left col ¶ 3). Mahoney discusses the concept of separation techniques in flow cytometry (pg 3 left col ¶ 6). Mundt et al. (Graff’s textbook of urinalysis and body fluids. Third edition. Philadelphia, PA: Wolters Kluwer, 2017, henceforth “Mundt”) discusses the use of aldehyde preservatives (pg 41 right col ¶ 2).. All of the other additional elements simply modify the data intake for these analyzers. The additional elements 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). As such, claims 1-20 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.
Claims 1-7 and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Fujuan et al (CN108709987A, IDS reference, translation provided, henceforth “Fujuan”) and Mahoney et al. (Journal of The Electrochemical Society, 2019 167 037518), as evidenced by Meyer et al. (Clinical Pathology Focused Scientific Session I, 2016) .
Regarding claim 1, applicant’s claimed invention is directed to a urinalysis device. Fujuan’s invention is also a urinalysis device (¶ 05, ¶ 46).
Fujuan teaches that samples can be analyzed in less than ten hours (¶ 16, ¶ 12, samples are analyzed immediately “in time” upon receipt. Samples not immediately analyzed on the spot are stored in a refrigerator for 24 hours.)
Fujuan teaches that medical staff place certain samples in a refrigerator for 24 hours, which is contrasted with “places the sample that needs to be tested in time in the test tube hole.” (¶ 14) This means that some samples are not refrigerated and instead immediately analyzed.
Fujuan’s urine samples are then analyzed to receive detection results (¶ 15-20).
Fujuan’s second analyzer then runs an analysis and obtains detection results for the same urine samples (¶ 46) and then determines the deviation between the results of the two analyzers (¶ 50-53, table 1).
Regarding claim 2, Evidentiary reference Meyer et al. (Clinical Pathology Focused Scientific Session I, 2016) shows that an “established reference analyzer” is a term that refers to one analyzer in a system where two analyzers are compared. Fujuan’s second analyzer is thus equivalent to an established reference analyzer (¶ 46).
Regarding claim 3, red and white blood cells are analyzed by Fujuan’s method (¶ 4).
Regarding claim 4, Fujuan uses an imaging device (abstract).
Regarding claim 5, Fujuan’s second analyzer uses image-based detection (¶ 46-49).
Regarding claim 6, Fujuan’s first analyzer uses microscopy as opposed to the second (¶ 4, ¶ 12).
Regarding claim 7, MPEP 2144.06 states that substituting equivalents known for the same purpose is obvious. The invention is comparing two urinalysis devices that are recognized as being used for the same purpose (Fujuan abstract), so the substitution of the imaging device for a second microscopy device would be obvious.
Regarding claim 10, red and white blood cells are analyzed in Fujuan (¶ 4). The refrigerated samples are kept at 3-5 C, which is within the range of 0-10 C (¶ 14).
Regarding claim 11, crystals are analyzed in Fujuan (¶ 7).
Regarding claim 11, Fujuan is silent as to the exact temperature that the immediately analyzed samples are kept at. Regarding claim 1, Fujuan is silent as to validating an accuracy characteristic. Regarding claim 1, Fujuan found that the deviation of the results of the two tests was between .01% and .1% (¶ 54). By carrying out this test, Fujuan is trying to set forth that their method is reliable. Fujuan states that their error testing saves the time of medical staff (¶ 54). This means that there could be an unacceptable result of the error test to a member of medical staff. This makes it a disclosure of an error calculation that is unacceptable at a certain threshold.
Under Rationale E of MPEP 2143, an invention is prima facie obvious if the inventor is found to be choosing from a finite number of identified, predictable solutions with a reasonable expectation of success. Mahoney writes in their abstract: “Complete urinalysis testing faces many limitations due to the large quantity of samples processed, the time required for testing, and the labor involved in sample preparation and processing,” which demonstrates the market pressure to solve these problems in urinalysis. Fujuan explains that non-refrigerated samples are immediately sent for “just-in-time” analysis, but is silent as to what temperature the non-refrigerated samples are kept at. There are practically a finite number of identified, predictable solutions to the issue, as there are a limited number of ways the non-refrigerated samples could be stored. One of ordinary skill in the art could have arrived at storing the samples at 20-30 C, as there Is nothing stopping the ordinary artisan from leaving the samples at a normal room temperature such as this. The error calculation of Fujuan (¶ 54) shows a design need to validate the accuracy characteristic. There are a finite number of ways that an accuracy characteristic can be validated. One of ordinary skill in the art could have pursued the solution of a step of validating the accuracy characteristic, as it is a common mathematical tool that is being pointed towards with the error calculation of Fujuan (¶ 54). Therefore, the invention is prima facie obvious.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Fujuan as applied to claims 1-7 and 10-11 above, and further in view of Mundt et al. (Graff’s textbook of urinalysis and body fluids. Third edition. Philadelphia, PA: Wolters Kluwer, 2017, henceforth “Mundt”).
Regarding claim 8, Fujuan teaches an imaging device (abstract). Fujuan is silent as tothe type of preservative chemical used . Mundt discloses the use of an aldehyde preservative (pg 41 right col ¶ 2).
Regarding claim 8, An invention would have been prima facie obvious to one of ordinary
skill in the art at the time of the effective filing date of the invention if some teaching, suggestion, or motivation in the prior art would have led that person to combine the prior art teachings to arrive at the claimed invention. There is a teaching to use formaldehyde preservative in the text of Mundt to preserve the urine (pg 41 right col ¶ 2). There would be a reasonable expectation of success in making this combination to a person of ordinary skill in the art, as this is a known technique in the urinalysis art as evidenced by it being in a textbook. Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time to modify the device of Fujuan by adding formaldehyde preservative, in order to preserve the samples.
Claim(s) 9 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Fujuan and Mahoney as applied to claims 1-7and 10-11 above, and further in view of Mundt and Wesarachkitti et al. (Laboratory Medicine, Volume 47, Issue 2, 1 May 2016, Pages 124–133, IDS reference, henceforth “Wesarachkitti”).
Regarding claim 9, Mundt teaches the use of fomaldehyde preservative (pg 41 right col ¶ 2).
Regarding claim 9, Fujuan and Mundt are silent as to a flow cytometry analyzer.
Regarding claim 9, Wesarachkitti teaches a flow cytometry analyzer (introduction ¶ 3).
Regarding claim 13, Wesarachkitti teaches manual microscopy (abstract). None of the applied art teaches a separation technique, so no separation technique is applied.
Regarding claims 9 and 13, An invention would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date of the invention if some teaching, suggestion, or motivation in the prior art would have led that person to combine the prior art teachings to arrive at the claimed invention. There is a teaching to use flow cytometry and manual microscopy in the text of Wesarachkitti, in order to make use of new urinalysis devices (introduction ¶ 1-5). Mundt teaches the use of formaldehyde preservative, because it preserves the samples (pg 41 right col ¶ 2). There would be a reasonable expectation of success in making this combination to a person of ordinary skill in the art, as these are both urinalysis methods similar to the imaging and automated microscopy. Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time to modify the device of Fujuan by incorporating different urinalysis methods, in order to make use of different commercially available urinalysis devices.
Claim(s) 14-20 are rejected under 35 U.S.C. 103 as being unpatentable over Fujuan, Mahoney, Mundt and Wesarachkitti..
Claim 14 is similar to claim 1, but it differs in that it stipulates that the measurement and error calculation process is carried out multiple times, and there are a smaller number of groups the urine samples are selected from. Applicant’s claimed invention is directed to a urinalysis device. Fujuan’s invention is also a urinalysis device (¶ 05, ¶ 46).
Fujuan teaches that samples can be analyzed in less than ten hours (¶ 16, ¶ 12, samples are analyzed immediately “in time” upon receipt. Samples not immediately analyzed on the spot are stored in a refrigerator for 24 hours.)
Fujuan teaches that medical staff place certain samples in a refrigerator for 24 hours, which is contrasted with “places the sample that needs to be tested in time in the test tube hole.” (¶ 14) This means that some samples are not refrigerated and instead immediately analyzed.
Fujuan’s urine samples are then analyzed to receive detection results (¶ 15-20).
Fujuan’s second analyzer then runs an analysis and obtains detection results for the same urine samples (¶ 46) and then determines the deviation between the results of the two analyzers (¶ 50-53, table 1).
Fujuan mentions an embodiment where the method was carried out 135 times (¶ 51). Mundt teaches the use of fomaldehyde preservative (pg 41 right col ¶ 2).
Regarding claim 15, red and white blood cells are analyzed by Fujuan’s method (¶ 4).
Regarding claim 16, Fujuan uses an imaging device (abstract). Wesarachkitti teaches a flow cytometry analyzer (introduction ¶ 3). Wesarachkitti teaches manual microscopy (abstract).
Regarding claim 17, Fujuan uses an imaging device (abstract). Mundt teaches the use of fomaldehyde preservative (pg 41 right col ¶ 2).
Regarding claim 18, Wesarachkitti teaches a flow cytometry analyzer (introduction ¶ 3). Mundt teaches the use of fomaldehyde preservative (pg 41 right col ¶ 2).
Regarding claim 19, red and white blood cells are analyzed in Fujuan (¶ 4). The refrigerated samples are kept at 3-5 C, which is within the range of 0-10 C (¶ 14).
Regarding claim 20, crystals are analyzed in Fujuan (¶ 7). There are samples which are not to be refrigerated in Fujuan (¶ 14), which would mean they could be stored at a room temperature such as 20-30 C. See the arguments against claims 1-7 and 10-11.
Regarding claims 14-20, An invention would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date of the invention if some teaching, suggestion, or motivation in the prior art would have led that person to combine the prior art teachings to arrive at the claimed invention. There is a teaching to use flow cytometry and manual microscopy in the text of Wesarachkitti, in order to make use of new urinalysis devices (introduction ¶ 1-5). Mundt teaches the use of formaldehyde preservative, because it preserves the samples (pg 41 right col ¶ 2). There would be a reasonable expectation of success in making this combination to a person of ordinary skill in the art, as these are both urinalysis methods similar to the imaging and automated microscopy. Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time to modify the device of Fujuan by incorporating different urinalysis methods, in order to make use of different commercially available urinalysis devices.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Fujuan, Mahoney, Mundt and Wesarachkitti as applied to claims 1-7, 9, 10-11, and 13 above, and further in view of Fisher et al (Proteomics Clin Appl. 2011;5(11-12):603-612, henceforth “Fisher”).
Fujuan and Mahoney teach the limitations these claims are dependent upon.
Regarding claim 12, Wesarachkitti teaches a flow cytometry analyzer (introduction ¶ 3).
Wesarachkitti is silent as to a separation technique.
Fisher teaches a separation technique (abstract).
Regarding claim 12, An invention would have been prima facie obvious to one of ordinary
skill in the art at the time of the effective filing date of the invention if some teaching, suggestion, or motivation in the prior art would have led that person to combine the prior art teachings to arrive at the claimed invention. There is a teaching to use a separation technique in the text of Fisher, in order to detect specific biomarkers (Fisher abstract). There is a teaching to use a flow cytometry analyzer in the text of Wesarachkitti, in order to make use of new urinalysis devices (introduction ¶ 1-5). There would be a reasonable expectation of success in making this combination to a person of ordinary skill in the art, as these are all urinalysis methods. Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time to modify the device of Fujuan by adding a separation technique and flow cytometry, in order to measure specific biomarkers and make use of new urinalysis devices.
Conclusion
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/G.M.H./ Examiner, Art Unit 1685
/OLIVIA M. WISE/ Supervisory Patent Examiner, Art Unit 1685
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