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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/26/24 has been considered by the examiner.
Amendment Entered
In response to the amendment filed on June 25, 2025, amended claims 1, 2, 8, 9 and 15 have been entered. Claims 4-6, 11-13 and 18-20 have been cancelled.
Response to Arguments
Applicant's remarks and amendments with respect to the rejections under U.S.C. 101 have been fully considered, but were not persuasive. Examiner argues that nothing from the claims, accompanying specification, and/or drawings suggest that the method steps cannot be practically performed mentally, or using pen/paper. Applicant argues the invention is not an abstract idea. Examiner notes that although the claims include a medical detection device, a processor, a storage device, a temperature sensor, and a test strip no physical aspect of the device mentioned in the claims is novel. The claims merely recite data gathering/outputting steps. Applicant further argues the claims integrate into a practical application. Examiner notes that according to MPEP 2106.04(d)(2), the practical application consists of administering a specific medication in response to the collected data. Alternately, a practical application would consist of incorporating additional structure to the device. Lastly, Applicant argues the invention is significantly more based on the additional elements. Examiner notes the components of the invention are all well known in the art and conventional. Therefore, as currently claimed, the invention is not an improvement in technology. Accordingly, Examiner maintains that the identified judicial exception recites a mathematical equation and mental process that is not integrated into a practical application. As such, the 35 USC 101 rejections are maintained. Examiner notes that incorporating a particular treatment based on the results or more structure to the claims would help move prosecution forward. Please see corresponding rejection heading below for more detailed analysis.
Applicant’s arguments filed with respect to the prior art rejections raised in the previous office action were fully considered, but were not persuasive. Applicant argues Wu fails to disclose that the function f(Index)Temp is determined according to the average value of a number of measurement values corresponding to each temperature and the average value of a number of measurement values corresponding to the room temperature. Examiner respectfully disagrees and notes that Wu teaches the plot represents the average temperature effect on the entire data population [par. 98]. Therefore, this equates to calculating the measurement error rate corresponding to the temperature according to an average value al of a plurality of measurement values corresponding to each temperature and an average value a2 of the plurality of measurement values corresponding to different room temperatures, when taking into consideration broadest reasonable interpretation.
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 1-3, 7, 9, 10 and 14-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 1 follows.
Regarding claim 1, the claim recites a medical detection device for compensating for the measurement value according to the measurement error rate, and obtaining a correction value of the physiological parameter. Thus, the claim is directed to a machine, which is one of the statutory categories of invention
The claim is then analyzed to determine whether it is directed to any judicial exception. The following limitations set forth a judicial exception:
“determine a measurement error rate corresponding to the temperature of the test strip, according to a relationship between temperatures and measurement error rates of physiological parameters; establish a table and recording a relationship between temperatures and physiological parameters in the table according to the measurement value of each of the plurality of physiological parameters and the corresponding temperature; calculate the measurement error rate corresponding to the temperature according to an average value al of a plurality of measurement values corresponding to each temperature and an average value a2 of the plurality of measurement values corresponding to different room temperatures, wherein the measurement error rate k=(al-a2) a2; receive signals generated by a chemical reaction between the plurality of enzymes and at least one of glucose, uric acid, and cholesterol in the blood, the signals being transmitted by the plurality of electrodes: convert the signals into at least one of blood glucose concentration, uric acid concentration, or cholesterol concentration and compensate for the measurement value according to the measurement error rate, and obtain a correction value of the physiological parameter.”
These limitations describe a mental process as the skilled artisan is capable of performing the judicial exception mentally, or using pen and paper. These limitations describe a mathematical calculation. Furthermore, nothing from the claims or applicant’s accompanying specification shows that the skilled artisan would not be able to perform the judicial exception mentally, or using pen and paper.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, integrates the identified judicial exception into a practical application.
For this part of the 101 analysis, the following additional limitations are considered:
“in response to a detection instruction, control a temperature sensor to detect a temperature of a test strip, and obtain the temperature of the test strip from the temperature sensor; measure a plurality of physiological parameters of different blood samples from a plurality of test strips at different temperatures, and obtain the measurement value of each of the plurality of the physiological parameters; in response that the medical detection device receives the test strip and detects presence of blood on the test strip, measure at least one physiological parameter based on the blood on the test strip, and obtain a measurement value of each of the at least one physiological parameter; wherein the medical detection device comprises a plurality of test strips, each of the plurality of test strips comprises a plurality of electrodes and enzymes”
These additional limitations do not integrate the judicial exception into a practical application. Rather, the additional limitations are each recited at a high level of generality such that it amounts to insignificant pre-solution and post-solution activity, e.g., mere receiving data, displaying of data and/or outputting, and general monitoring device components.
Furthermore, the additional limitations do not add significantly more to the judicial exception as the recited limitations amount to well-known and conventional data gathering techniques in the art. Examiner takes official notice that the additional limitations are conventional components in prior analyte monitoring systems. Wu teaches these additional elements, showing these additional elements are well known and conventional [par. 20, 23, 120, 122, 124].
Dependent claims 2, 3, 7, 9, 10, 14, 16 and 17 also fail to add something more to the abstract independent claims as they merely further limit the abstract idea.
Therefore, claims 1-3, 7, 9, 10 and 14-17 are not patent eligible under 35 USC 101.
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 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.
Claims 1-3, 7, 9, 10 and 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Wu (U.S. Patent Application Publication 2020/0348306 A1) and in further view of Novak (U.S. Patent Application Publication 2022/0017936 A1).
Wu and Novak were applied in the previous office action
Regarding claims 1 and 8, Wu teaches a medical detection device and method [par. 20] comprising:
at least one processor [par. 23]; and a storage device coupled to the at least one processor [par. 23] and storing instructions for execution by the at least one processor [par. 124] to cause the at least one processor to:
in response to a detection instruction, control a temperature sensor to detect a temperature of a test strip, and obtain the temperature of the test strip from the temperature sensor [par. 120, 122];
determine a measurement error rate corresponding to the temperature of the test strip, according to a relationship between temperatures and measurement error rates of physiological parameters [par. 87-90];
measure a plurality of physiological parameters of different blood samples from a plurality of test strips at different temperatures, and obtain the measurement value of each of the plurality of the physiological parameters [par. 89, 90];
establish a table and recording a relationship between temperatures and physiological parameters in the table according to the measurement value of each of the plurality of physiological parameters and the corresponding temperature [fig. 7A; par. 90];
calculate the measurement error rate corresponding to the temperature according to an average value a1 of a plurality of measurement values corresponding to each temperature and an average value a2 of the plurality of measurement values corresponding to different room temperatures [par. 90, Examiner notes multiple measurement values are obtained for different temperatures, which are then related to a reference temperature to determine measurement error, par. 98 “difference in intercept of the ΔS vs. R6/5 plots represents the average temperature effect on the entire data population”];
in response that the medical detection device receives the test strip and detects presence of blood on the test strip, measure at least one physiological parameter based on the blood on the test strip [par. 23, 59], and obtain a measurement value of each of the at least one physiological parameter [par. 23]; the test strip comprises electrodes and enzymes, the enzymes are designed for chemically reacting with glucose, uric acid, or cholesterol in the blood [par. 116, 117].
receive signals generated by a chemical reaction between the enzyme and at least one of the glucose, uric acid, and cholesterol in the blood, the current signal being transmitted by the electrodes; and convert the signals into at least one of blood glucose concentration, uric acid concentration, or cholesterol concentration [par. 116, 117, 119, 121].
and compensate for the measurement value according to the measurement error rate, and obtain a correction value of the physiological parameter [par. 23, 93].
Although Wu does not explicitly teach the measurement error rate k=(al-a2)/a2, this would be obvious to a person having ordinary skill in the art when the invention was filed since Wu also suggests multiple measurement values are obtained for different temperatures, which are then related to a reference temperature to determine measurement error [fig. 7A; par. 90]. Additionally, difference in intercept of the ΔS vs. R6/5 plots represents the average temperature effect on the entire data population [fig. 8C, 8D; par. 98]. Therefore, incorporating the equation measurement error rate k=(al-a2)/a2 would only involve routine skill in the art.
However, Wu does not teach the medical detection device comprises a plurality of test strips.
Novak teaches the medical detection device comprises a plurality of test strips [par. 29].
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Wu, to incorporate the medical detection device comprises a plurality of test strips, as this is preferable in terms of device price-number of use ratio, as evidence by Novak [par. 29].
Regarding claims 2, 9 and 16, Wu teaches the at least one processor is further caused to: store the relationship between the temperatures and the measurement error rates in the storage device [par. 90].
Regarding claims 3, 10 and 17, Wu further teaches a medical detection device and method, as disclosed above, and the medical detection device defines a slot, the slot receives the test strip [par. 11; Examiner notes where the sensor strip is placed in the measurement device can be interpreted as a slot for the test strip]; the temperature sensor is an infrared temperature sensor or a contact temperature sensor [par. 89].
Although Wu does not explicitly teach the temperature sensor is arranged in the slot, this would be obvious to a person having ordinary skill in the art when the invention was filed since Wu also suggests the sensor strip may be placed in the measurement device before, after, or during the introduction of the sample for analysis [par. 11]. Additionally, Wu teaches temperature of the sample may be determined using a thermocouple [par. 89]. Examiner notes that when the sensor strip is placed in the measurement device before introduction of the sample, and temperature of the sample is being measured, the thermocouple would need to be placed within the measurement device. Therefore, incorporating the temperature sensor is arranged in the slot would only involve routine skill in the art.
Regarding claims 7 and 14, Wu further teaches the at least one processor is further caused to: display the correction value of the at least one physiological parameter on a display device [par. 68, 124].
Regarding claim 15, Wu teaches a computer-readable storage medium having instructions stored thereon, when the instructions are executed by a processor of a medical detection device, the processor is configured to perform a method for medical detection [par. 23, 124, 125], wherein the method comprises:
in response to a detection instruction, controlling a temperature sensor to detect a temperature of a test strip, and obtaining the temperature of the test strip from the temperature sensor [par. 120, 122];
determining a measurement error rate corresponding to the temperature of the test strip, according to a relationship between temperatures and measurement error rates of physiological parameters [par. 87-90];
measure a plurality of physiological parameters of different blood samples from a plurality of test strips at different temperatures, and obtain the measurement value of each of the plurality of the physiological parameters [par. 89, 90];
establish a table and recording a relationship between temperatures and physiological parameters in the table according to the measurement value of each of the plurality of physiological parameters and the corresponding temperature [fig. 7A; par. 90];
calculate the measurement error rate corresponding to the temperature according to an average value a1 of a plurality of measurement values corresponding to each temperature and an average value a2 of the plurality of measurement values corresponding to different room temperatures [par. 90, Examiner notes multiple measurement values are obtained for different temperatures, which are then related to a reference temperature to determine measurement error, par. 98 “difference in intercept of the ΔS vs. R6/5 plots represents the average temperature effect on the entire data population”];
in response that the medical detection device receives the test strip and detects presence of blood on the test strip, measuring at least one physiological parameter based on the blood on the test strip [par. 23, 59], and obtaining a measurement value of each of the at least one physiological parameter [par. 23]; the test strip comprises electrodes and enzymes, the enzymes are designed for chemically reacting with glucose, uric acid, or cholesterol in the blood [par. 116, 117].
receive signals generated by a chemical reaction between the enzyme and at least one of the glucose, uric acid, and cholesterol in the blood, the current signal being transmitted by the electrodes; and convert the signals into at least one of blood glucose concentration, uric acid concentration, or cholesterol concentration [par. 116, 117, 119, 121].
and compensating for the measurement value according to the measurement error rate, and obtaining a correction value of the physiological parameter [par. 23, 93].
Although Wu does not explicitly teach the measurement error rate k=(al-a2)/a2, this would be obvious to a person having ordinary skill in the art when the invention was filed since Wu also suggests multiple measurement values are obtained for different temperatures, which are then related to a reference temperature to determine measurement error [fig. 7A; par. 90]. Additionally, difference in intercept of the ΔS vs. R6/5 plots represents the average temperature effect on the entire data population [fig. 8C, 8D; par. 98]. Therefore, incorporating the equation measurement error rate k=(al-a2)/a2 would only involve routine skill in the art.
However, Wu does not teach the medical detection device comprises a plurality of test strips.
Novak teaches the medical detection device comprises a plurality of test strips [par. 29].
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Wu, to incorporate the medical detection device comprises a plurality of test strips, as this is preferable in terms of device price-number of use ratio, as evidence by Novak [par. 29].
Conclusion
Applicant’s amendment necessitated the new grounds 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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GRACE ROZANSKI whose telephone number is (571)272-7067. The examiner can normally be reached M-F 8 AM - 5 PM.
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/GRACE L ROZANSKI/Examiner, Art Unit 3791
/ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791