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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.
Applicant's submission filed on 10/15/2025 has been entered.
DETAILED ACTION
Claim 16 is canceled. Claims 1-15, and 17-22 are pending. Claims 1-14 and 17-22 are withdrawn from consideration as being drawn to a non-elected invention. Accordingly, claim 15 is under consideration.
Response to Amendment
The amendment filed 10/15/2025 is entered.
The § 103 rejection of claims 15-16 over Jones is withdrawn in light of the amendment.
Applicants' amendments and arguments filed on 10/15/2025 have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.
Priority
The instant claims are entitled to an effective filing date of 03/24/2019.
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.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Pronovost (US 5,804,452) in view of Talalak (Talanta, 2015, 144, 915-921) .
Regarding claim 15, Pronovost teaches devices and methods for detection of creatinine in urine samples. Se column 1 lines 6-7. Pronovost teaches an assay strip 10, in which a sample moves by lateral flow (e.g. a controlled movement) from a sample pad 12 to a reagent pad 14. The particular reagents placed on the reagent pad 14 depend upon the particular assay being used. An assay suitable for the detection of creatinine are those which convert creatinine to creatine, creatine to sarcosine, and sarcosine to glycine + formaldehyde + hydrogen peroxide. In these assays, creatininase, creatinase and an appropriate horse radish peroxidase (HRP) substrate are placed on the reagent pad 14 (e.g. a first spatial region). Sarcosine oxidase and HRP are immobilized on the detection strip 16 (e.g. second spatial region). As the sample flows through the sample pad 12, creatininase and creatinase convert creatinine in the sample to sarcosine (e.g. a first set of reactions). In addition, the sample picks up the HRP substrate on the reagent pad 14. When the sarcosine in the sample (e.g. processed biological fluid) reaches the sarcosine oxidase in the detection strip 16 [by lateral flow movement], the hydrogen peroxide resulting from the conversion of
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sarcosine in combination with the HRP and its substrate result in a colored precipitate which is then detected. See column 9 lines 32-49. Pronovost discloses that the devices generally comprise a matrix defining a flow path (e.g. controlled movement). See column 3 lines 12-13. Bibulous materials, such as untreated paper, and the like may be used following processing to provide non-bibulous flow. See column 3 lines 61-62. Usually, the membrane pore diameter is about 0.2 to about 50 µm. See column 3 lines 44-46. In summation, Pronovost indicates that a urine sample moves from the sample pad 12 to a first spatial region 14 where the creatininase converts creatinine to creatine, which is in turn is converted to sarcosine by creatinase; the sarcosine containing sample then moves via lateral flow through a defined flow path to a second spatial region 16 that converts the sarcosine to a colored detectable entity; and Pronovost suggests that the test strip may be a paper material with a pore diameter from about 0.2 to about 50 µm.
Pronovost is silent as to retaining, at the first spatial region, the biological fluid for a predefined period of time.
Talalak teaches a paper-device for determining urinary creatinine. The paper allows liquid to flow through it without the use of external forces. Because of this property, paper is extensively used in lateral-flow immunochromatography. See the last paragraph of section 1. Talalak teaches designing a paper-device that includes two reagent absorption zones, a sample dipping zone and a detection zone. See section 2.3. The assay is initiated as the sample zone is dipped into wells of urine solutions to allow creatinine in the sample to react with the pre-impregnated R1 and R2 reagents via natural capillary force for 4 minutes. See the first paragraph on page 918. R1 reagents include creatinase, sarcosine oxidase and R2 reagents include creatininase, and peroxidase. See the first paragraph of section 2.3. Talalak suggests that the pore size differences lead to different wicking rates. Talalak teaches using Whatman No. 3 paper, which has a pore size of 6 µm and a wicking flow rate of 90s per 100 mL. See section 3.1.
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to adjust the duration of the flow through the reagent pad 14 (e.g. retention time) of Pronovost in view of the 4-minute reaction time of Talalak. One would be motivated to adjust the duration of the flow through the reagent pad 14 of Pronovost because Talalak suggests allowing a urine sample to react with reagents such as creatininase and creatinase for 4 minutes. There would be a reasonable expectation of success because Talalak teaches selecting a 6 µm membrane pore size in order to control the wicking rate and, consequently, the reaction time in the reagent zone; and Pronovost suggests that the membrane pore diameter can be between about 0.2 to about 50 µm.
Response to Arguments
Applicant's arguments filed 10/15/2025 have been fully considered but they do not apply to the new grounds of rejection set forth above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KIMBERLY C BREEN whose telephone number is (571)272-0980. The examiner can normally be reached M-Th 7:30-4:30, F 8:30-1:30 (EDT/EST).
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/K.C.B./Examiner, Art Unit 1657
/MELENIE L GORDON/Supervisory Patent Examiner, Art Unit 1657