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 without traverse of Group I (claims 31-49) and Species 3 (claims 43-49) in the reply filed on 5/19/2026 is acknowledged.
Claims 31-42 and 50-51 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/19/2026.
Drawings
Figure 1 should be designated by a legend such as --Prior Art-- because only that which is old is illustrated. See MPEP § 608.02(g). Corrected drawings in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 43-45 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by US 2019/0381231 A1 to Tsoory et al. (hereinafter “Tsoory”).
Regarding claim 43, Tsoory discloses a device for detecting infection in a patient undergoing peritoneal dialysis (paragraph [0195]; paragraph [0197] - paragraph [0201]), the device comprising:
a housing module (1336) (Fig. 13F; paragraphs [0198], [0370]);
a fluidic element (1301, 1334) removably coupled to the housing module (1336), the fluidic element configured for receiving waste dialysate fluid from the patient (Fig. 13A,13F; paragraphs [0198], [0370]);
a set of lighting elements disposed on the housing module and configured for emitting light into the fluidic element (Fig. 13F; paragraphs [0198], [0200], [0370]);
a set of optical sensors (206, 1340) disposed on the housing module and configured for:
measuring optical properties of the light that has interacted with the waste dialysate fluid in the fluidic element; and
measuring color information of a reagent test element disposed in the fluidic element that has reacted with the waste dialysate fluid in the fluidic element (Fig. 13F; paragraphs [0198], [0200]-[201]: colorimeter, [0257], [0304], [0369]-[0370]);
wherein the fluidic element (1301, 1334) comprises a flow control mechanism (flow regulators: 1306, 1312) configured to selectively control inflow of the waste dialysate fluid into the fluidic element;
wherein the flow control mechanism is further configured to selectively control outflow of the waste dialysate fluid from the fluidic element after a predefined duration from said inflow of the waste dialysate fluid into the fluidic element, thereby retracting the waste dialysate fluid from the fluidic element (paragraphs [0367]-[0369]); and
wherein the predefined duration controls a wetting time of the reaction between the reagent test element and the waste dialysate fluid (see paragraph [0369]); and
a control module (204)(Fig. 2; paragraphs [0255]-[0256]) configured for:
measuring turbidity of the waste dialysate fluid based on the optical properties, the measured dialysate turbidity indicative of infection in the patient if the measured dialysate turbidity and historical dialysate turbidity of the patient satisfy a set of predefined conditions (paragraphs [0198], [0255]-[0256]); and
detecting the infection based on the color information, the color information representing enzyme activity in the waste dialysate fluid that is indicative of the infection (Fig. 7B; paragraphs [0201], [0255]-[0256], [0304], [0369]).
Regarding claim 44, Tsoory discloses a scattered light sensor for measuring the light that has been scattered by the waste dialysate fluid; a transmitted light sensor for measuring the light that has been transmitted through the waste dialysate fluid; and a color sensor for measuring the color information (at least one optical sensor for light absorption, light scattering and color: paragraphs [0200]-[0201]).
Regarding claim 45, Tsoory discloses implicitly that the optical properties comprise an optical ratio between the scattered light and transmitted light (paragraphs [0200]-[0201]: the optical sensor measures the reduction in light intensity while the light travels through the drained dialysate).
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 46-49 are rejected under 35 U.S.C. 103 as being unpatentable over US Tsoory as applied to claim 43 above and further in view of US 2014/0072189 A1 to Jena et al. (hereinafter “Jena”).
Tsoory discloses the device for detecting infection in a patient undergoing peritoneal dialysis as described above.
Claims 46-49 differ from Tsoory in reciting that the optical sensors comprises an RGB color sensor for measuring the color information and the control module is configured for: extracting RGB color data from the color information; converting the RGB color data into second color data in a second color space; and determining the enzyme activity based on the second color data (claim 46), the control module is configured for denoising the RGB color data and converting the denoised RGB color data into the second color data (claim 47), the control module is configured for deriving an index parameter from the second color data, wherein the enzyme activity is determined based on the index parameter (claim 48) and the second color space comprises CIELAB, CIE XYZ, or YCbCr color space (claim 49).
Claimed limitations in claims 46-49 are known CIELAB, an industry standard for digital color detection and processing. Using it to read out reagent tests is known from Jena (abstract; paragraphs [0119]-[0127]; paragraphs [0141]-[0144]).
It would have been obvious to a person of ordinary skill in the art to incorporate known CIELAB in the device of Tsoory to analyze reagent tests or colorimetric test strip for disease management platform as suggested by Jena (see abstract; paragraph [0009]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN KIM whose telephone number is (571)272-1142. The examiner can normally be reached Maxi Flex.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, IN SUK BULLOCK can be reached at 571-272-5954. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/John Kim/Primary Examiner, Art Unit 1777
JK
6/2/26
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