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 .
Response to Amendment
Applicant amendments filed 12/05/2025 have been entered. Applicant amendments overcomes the previous claim objection set forth in the Office Action mailed 08/05/2025, the previous claim objection is withdrawn. Applicant amendments do not overcome each and every 112(b) rejection set forth in the Office Action mailed 08/05/2025, please see 112 section below.
Status of Claims
Claims 1, 3, 5-11, 13-24 remain pending in the application, with claims 1, 3, 5-8, 11, 13-24 being examined and claims 9-10 being withdrawn pursuant to the election filed 11/07/2023.
Claim Objections
Claims 1, 11, 21-22 are objected to because of the following informalities:
Claim 1 line 14 recites “first change of an at least one measurable optical property” where this should be amended to recite “first change of [[an]] the at least one measurable optical property” to have proper antecedent basis. Line 14 is referring back to lines 3-4 which has at least one measurable optical property.
Claim 11 line 4 recites “the sample of body fluid” where it is suggested that for consistency, to amend line 1 to recite “an analyte in a sample of body fluid”.
Lines 17-18 recites “change of an at least one optically or electrochemically measurable property” which should be amended to recite “change of [[an]] the at least one measurable optically or electrochemically measurable property” to have proper antecedent basis. Lines 17-18 are referring back to lines 5-6 which has at least one optically or electrochemically measurable property.
Claim 21 recites “performs at least one optically or electrochemically detectable detection reaction” on lines 3-4, where it should be amended to recite “performs the at least one optically or electrochemically detectable reaction” to have proper antecedent basis. Lines 3-4 are referring back to line 9 of claim 11 which has an optically or electrochemically detectable detection reaction.
Claim 22 recites “The test element of claim 11” where for consistency and proper antecedent basis, it should be amended to be “The test device .
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 3, 13-20, 24 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.
Claim 3 recites “The optical test element according to claim 2” on line 1, where the scope of claim 3 is unclear because claim 2 has been cancelled.
For examination, it will be interpreted that claim 3 is dependent on claim 1.
Claim 13 recites “an optically or electrochemically detectable reaction” on line 5, where it is unclear if this is the same or different from the optically or electrochemically detectable reaction described in claim 11 on line 9.
For examination, it will be interpreted that they are the same reaction.
It is suggested to amend claim 13 to recite “[[an]] the optically or electrochemically detectable reaction”
Claim 14 recites “an analyte-induced optical or electrochemical change of the test material” on lines 6-7, where it is still unclear if the analyte-induced change is the same or different from the test material having at least one optically or electrochemically measurable property which is changed in the presence of the analyte in the sample as described by lines 5-6 of claim 11.
For examination, it will be interpreted that they are related to each other.
If they are the same thing, it is suggested to amend claim 14 to use the same phrasing as the phrasing used in claim 11. Additionally, it is noted that claims 16 and 19 use the same phrasing as claim 14 and would need be changed as well to reflect changes made to claim 14.
Claims 15-20 are rejected by virtue of being dependent on a rejected claim.
Claim 24 recites “performs at least one optically or electrochemically detectable reaction” on lines 1-2, where it is unclear if this reaction is the same or different from the one described on line 9.
For examination, it will be interpreted that they are the same.
It is suggested to amend claim 24 to recite “performs the at least one optically or electrochemically detectable reaction”
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1, 3, 5-8, 11, 13-19, 21-24 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Tsai (US-2013/0267032-A1).
Regarding claim 1, Tsai teaches an optical test element (test strip 1300) for detecting an analyte in a sample of body fluid, comprising ([0073], Figures 13A-D):
a test field comprising a continuous test material (reagent), the test material (reagent) having at least one measurable optical property which is changed in the presence of the analyte in the sample, said test material (reagent) including a first measurement location (reaction area 1302B) at which a first measurement is made, and a second measurement location (reaction area 1302C) at which a second measurement is made, the test material (reagent) performing an optically detectable detection reaction at the first measurement location (1302B) and at the second measurement location (1302C) ([0007] see determining a color intensity change of the reaction area and correlating the color intensity change and time difference to a value of the characteristic of the analyte, [0073] see reaction areas 1302 have different concentrations of one or more of the reagents, Figure 13A where the different concentrations of reagent in each area is continuous with the next area), the first and second measurement locations (1302B and 1302C) including the same test material ([0073] see reaction areas have different concentrations of one or more of the same reagents); and
a capillary element configured to guide the sample across said test field in a flow direction over both the first and second measurement locations (1302B and 1302C), the second measurement (1302C) location being offset from the first measurement location (1302B) in the flow direction ([0074] see specimen test strip 1300 may include a capillary entrance and a capillary running through contacting reaction areas 1302 to deliver a specimen sample, from Figures 13B-D that show different concentrations of glucose specimen sample being applied the fluid will flow from 1302A to 1302D),
the test material (reagent) at the first measurement location (1302B) being adapted to provide in response to contact with the analyte a first change of an at least one measurable optical property of the test material (reagent) at the first measurement location (1302B) ([0073], [0076] describes Figure 13C where the test strip 1300 receives a 300 mg/dL glucose specimen sample where the concentration in areas 1302A and 1302B have oversaturated colors so they aren’t used to determine glucose levels, but reaction areas 1302C and 1302D may be used, where the color reaction in 1302C has good saturation so can be used), and
the test material (reagent) at the second measurement location (1302C) being adapted to provide in response to contact with the analyte a second change of the at least one measurable optical property of the test material (reagent) at the second measurement location (1302C) ([0073], [0076]).
Regarding claim 3, Tsai further teaches in which the test material (reagent) comprises at least one enzyme adapted for performing at least one enzymatic reaction on the analyte causing the change of the at least one measurable optical property of said test material (reagent) in the presence of the analyte ([0035] see reagents may be analyte specific and may include one or more enzymes).
Regarding claim 5, Tsai further teaches in which said test material (reagent) includes a third measurement location (reaction area 1302A) located within the test field ([0073], Figure 13A).
Regarding claim 6, Tsai further teaches wherein the third measurement location (1302A) is located within the first third of the test field in view of the flow direction (Figure 13A).
Regarding claim 7, Tsai further teaches wherein the third measurement location (1302A) is located within the first quarter of the test field in view of the flow direction (Figure 13A).
Regarding claim 8, Tsai further teaches in which the first, second and third measurement locations (1302A, 1302B, 1302C) include the same test material ([0073]).
Regarding claim 11, Tsai teaches a test device for detecting an analyte in a body fluid, comprising:
at least one test element, the test element comprising
a test field for detecting the analyte in the sample of body fluid, the test field comprising a continuous test material (reagent), the test material (reagent) having at least one optically measurable property which is changed in the presence of the analyte in the sample, said test material (reagent) including a first measurement location (reaction area 1302B) and a second measurement location (reaction area 1302C), the test material (reagent) performing an optically detectable detection reaction at the first measurement location (1302B) and at the second measurement location (1302C) ([0007] see determining a color intensity change of the reaction area and correlating the color intensity change and time difference to a value of the characteristic of the analyte, [0073] see reaction areas 1302 have different concentrations of one or more of the reagents, Figure 13A where the different concentrations of reagent in each area is continuous with the next area), the first and second measurement locations (1302B and 1302C) including the same test material ([0073] see reaction areas have different concentrations of one or more of the same reagents); and
a capillary element configured to guide the sample across said test field in a flow direction over both the first and second measurement locations (1302B and 1302C), the second measurement location (1302C) being offset from the first measurement location (1302B) in the flow direction ([0074] see specimen test strip 1300 may include a capillary entrance and a capillary running through contacting reaction areas 1302 to deliver a specimen sample, from Figures 13B-D that show different concentrations of glucose specimen sample being applied the fluid will flow from 1302A to 1302D),
the test material (reagent) at the first measurement location (1302B) being adapted to provide in response to contact with the analyte a first change of an at least one optically measurable property of the test material (reagent) at the first measurement location (1302B) ([0073], [0076] describes Figure 13C where the test strip 1300 receives a 300 mg/dL glucose specimen sample where the concentration in areas 1302A and 1302B have oversaturated colors so they aren’t used to determine glucose levels, but reaction areas 1302C and 1302D may be used, where the color reaction in 1302C has good saturation so can be used), and
the test material (reagent) at the second measurement location (1302C) being adapted to provide in response to contact with the analyte a second change of the at least one optically measurable property of the test material (reagent) at the second measurement location (1302C) ([0073], [0076]);
at least one receptacle receiving the at least one test element, the receptacle being adapted to locate the test element in at least one application position in which the sample of the body fluid is applicable to the test element ([0032] describes Figure 21 which shows a specimen test strip in one or more examples of the disclosure, where it includes a capillary entrance 1202, capillary 2104, and a reaction area 2106 connected to capillary 2104. The test strip 1300 will have a similar configuration as [0074] describes it having a capillary entrance and capillary running through contacting reaction areas 1302 to deliver sample. The reaction areas 1302 and capillary (making up the test element) will be similarly received by the components indicated in annotated Figure 21 below, which makes up a receptacle);
at least one detector (imaging device 208) for measuring the at least one optically measurable property, said detector (208) being adapted to measure the at least one optically measurable property in the first measurement location (1302B) of the test field, thereby generating at least one first measurement value, and in the second measurement location (1302C) of the test field, thereby generating at least one second measurement value ([0006] see computing device with an imaging device to read a specimen test strip to detect a characteristic of an analyte in a specimen sample, [0039], [0082] see method 1700 for a computing device (e.g. 210 in Figure 2) executing a diagnostic application to read specimen test strip 1300, [0083] see computing device 210 determines the color of each reaction area 1302); and
at least one evaluation unit (computing device 210) adapted to determine the concentration of the analyte ([0006], [0007], [0036], [0082]).
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Regarding claim 13, Tsai further teaches in which said test material (reagent) comprises at least one enzyme adapted for performing at least one enzymatic reaction on the analyte causing the change of the at least one optically measurable property of said test material (reagent) in the presence of the analyte, the at least one enzyme in the test material performing an optically detectable detection reaction at the first measurement location (1302B) and at the second measurement location (1302C) ([0005] see determine a color of the reaction area after receiving specimen sample, [0035] see reagents may be analyte specific and may include one or more enzymes).
Regarding claim 14, Tsai further teaches in which said evaluation unit (210) is adapted to determine the concentration of the analyte by using an evaluation algorithm (method 1700) having at least two input variables ([0082], Figure 17), at least one first input variable of the at least two input variables including an information on a difference between the first measurement value and the second measurement value ([0084] see where computing device 210 examines each reaction area 1302 and compares the average RGB value to its noise level to indicate if the analyte concentration has exceed its detection limit until the computing device 210 selects a reaction area 1302 where the average RGB values are greater than its noise level. This process will have information on a difference between reaction area 1302B and 1302C (proper saturation or not)), and at least one second input variable of the at least two input variables including a measurement information on an analyte-induced optical change of the test material in at least part of the test field ([0085] see computing device 210 correlates the color or the color and color intensity of the selected reaction area 1302 to an analyte characteristic value. This will be measurement information on an analyte-induced optical change of the test material).
Regarding claim 15, Tsai further teaches wherein the at least one first input variable includes an information on a gradient of measurement values over at least part of the test field ([0084], where information on the average RGB values for the reaction areas 1302 is information on a gradient of measurement values over the reaction areas 1302).
Regarding claim 16, Tsai further teaches wherein the test device is adapted to measure the analyte-induced change of the optically measurable property in at least one third measurement location (reaction area 1302A) of the test field, thereby generating an at least one third measurement value, the third measurement value being used as the measurement information ([0073], [0085], Figure 13A).
Regarding claim 17, Tsai further teaches in which the first, second and third measurement locations (1302A-C) include the same test material ([0073]).
Regarding claim 18, Tsai further teaches wherein the test device further comprises at least one temperature sensor (temperature calibration area) for determining an ambient temperature ([0038] see temperature calibration area is a chip, mechanical device, or electrochemical device that indicates a temperature, [0074]).
Regarding claim 19, Tsai further teaches wherein the measurement information on the analyte-induced change of the optically measurable property of the test material (reagent) in at least part of the capillary element is generated by using an average value of the first measurement value and the second measurement value as the measurement information ([0084] see where the average RGB value for each of the reaction areas are determined where then in [0085] the computing device correlates color or the color and color intensity to an analyte characteristic value).
Regarding claim 21, Tsai teaches a test system for detecting an analyte in a body fluid, the test system comprising at least one test device according to claim 11 (see claim 11 supra); and
wherein the test material (reagent) performs at least one optically detectable detection reaction in the presence of the analyte ([0005] see determine a color of the reaction area after receiving specimen sample, [0035] see reagents may be analyte specific and may include one or more enzymes).
Regarding claim 22, Tsai further teaches wherein the test element is adapted to provide at least two measurement values, wherein the at least one first measurement value is generated by measuring the measurable property in the first measurement location (1302B), and wherein the at least one second measurement value is generated by measuring the measurable property in the second measurement location (1302C) ([0084]).
Regarding claim 23, Tsai further teaches in which the at least one enzyme in the test material performs an optically detectable detection reaction at the first measurement location (1302B) and at the second measurement location (1302C) ([0005], [0035], [0084]).
Regarding claim 24, Tsai further teaches wherein the test material (reagent) performs at least one optically detectable detection reaction in the presence of the analyte ([0005], [0084]).
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.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tsai (US-2013/0267032-A1).
Regarding claim 20, Tsai teaches the test device according to claim 14. The test strip 1300 is seen to detect glucose level ([0073]), but does not teach correcting the analyte detection based on the presence of particulate matter in the sample.
Tsai teaches where Figure 20 shows a test strip 2000 where there is a reaction area 2006 that detects glucose and reaction area 2004 detects the level of hematocrit (HCT) in the blood sample ([0091], [0092]). [0092] further describes where the diagnostic application determines the HCT level and then corrects the glucose level using a known relationship between HCT and glucose levels.
It would have been obvious to one skilled in the art to modify the test strip seen in Figure 13 of Tsai such that it includes a reaction area that would detect HCT because Tsai teaches that one analyte in the specimen sample is known to affect the detection of another analyte, and that determining HCT level allows for the correction of glucose levels ([0092]).
Response to Arguments
Due to amendments to the claims, incorporating the limitations of claim 2 into claim 1 and the limitations of claim 12 into 11, the rejections in view of Tsai under 102(a)(1) have been modified to address this amendment.
Applicant arguments filed 12/05/2025 have been fully considered but are not persuasive.
Applicant argues on page 10 of 11 that the teaching of Tsai where the “same test material” is directed to the test material having the same components but not the same concentration is, in the context of the present application, an improper interpretation well beyond the limits of a broadest reasonable interpretation, and that a skilled person would understand that two test materials being different in a concentration of at least one compound are not “the same”.
Examiner respectfully disagrees. The claim only requires that the first and second measurement locations include the same test material. In one example of Tsai, they detect glucose using glucose oxidase, heteropoly acid, and tetradecyl ammonium nitrate, and in Figure 13A they are detecting different levels of glucose by having reaction areas with different concentrations of one or more reagents (Tsai; [0035], [0073]). As such, each of the reaction areas will have the same reagents, but just in different concentration. The claim is not specifying that the first and second measurement locations have identical amounts or identical concentrations of the test material. Therefore, Tsai still reads on the limitation.
Applicant further argues on page 10 of 11 that if a concentration of constituents of a test material changes within the test material, it is not a continuous material.
Examiner respectfully disagrees. Even if the concentrations of the reagents are changing, they are still the same reagents across all areas and therefore would still be continuous. Further, it is seen in Figure 13A of Tsai that each of the regions are continuous with each other, as there are no spaces between each region.
Applicant argues on page 10 of 11 that selecting a reaction area with an appropriate color saturation includes “information on a difference” between two reaction areas is over-interpreting the disclosure of Tsai in view of claim 14, and that there is no teaching in Tsai that a difference between two reaction areas shall be used to decide on which reaction area to use. Further, that it is expressly specified that the color of the selected reaction area (singular) is correlated with a value of the analyte, thus even if a difference between two areas were detected, it is not used for analyte measurement.
Examiner respectfully disagrees. Firstly, claim 14 only describes that the evaluation algorithm having at least two input values, the first having information on a difference between the first measurement value and the second measurement value and the second input variable including a measurement information on an analyte-induced optical or electrochemical change of the test material. Tsai teaches where each reaction area is examined to determine if there is proper saturation or not. Having either proper saturation or not is a difference between the reaction areas. There are no additional limitations in the claim that would limit “the difference”, and as such Tsai still teaches the limitations of the first input variable.
Further, there is nothing in the claim that limits a singular reaction area to be correlated with a value of the analyte. Therefore, after determination of a properly saturated reaction area (first input variable having information on a difference between the first and second measurement value) and then correlation of the color or color and intensity of the selected reaction area to an analytic characteristic value (second input variable including a measurement information on an analyte-induced change) reads on the limitations of claim 14.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/S.Y.L./Examiner, Art Unit 1796
/ELIZABETH A ROBINSON/Supervisory Patent Examiner, Art Unit 1796