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
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Objections
Claim 13 objected to because of the following informalities: line 5 of the claim recites "obtain" which should be "obtains". 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 8-15 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 8 recites the limitation "a predetermined pair-data set" in line 7 of the claim. There is insufficient antecedent basis for this limitation in the claim. Claim 1 also recites the limitation “a predetermined pair-data set in line 12 of claim 1. For examination purposes, the limitation “a predetermined pair-data set” in claim 8 will be interpreted as “the predetermined pair-data set”.
Claims 9-15 depend on claim 8, therefore claims 9-15 inherit the same issues as claim 8 and are rejected for the same reasons.
Claim 13 recites the limitation "the batch sensor" in line 4 of the claim. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, “the batch sensor” will be interpreted as “a batch sensor”.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 8-15 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Dependent Claim 8 recites the limitation “a memory in which a predetermined pair-data set obtained by the above sensor calibration method as mentioned in claim 1 is prestored”. Claim 8 is a product-by-process claim and is limited only to the recited structure and not the process by which it is produced (see MPEP 2113). As such claim 8 would require “a memory with a predetermined pair-data set” but not necessarily the step of obtaining the data set with the method of claim 1. Therefore claim 8 is not a proper dependent claim because it does not include all limitations of the claim 1; claim 8 could be infringed without infringing claim 1.
Dependent Claims 9-15 depend on claim 8, therefore claims 9-15 inherit the same issues as claim 8 and are rejected for the same reasons.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-7 rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite an abstract idea as discussed below. This judicial exception is not integrated into a practical application for the reasons discussed below. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception for reasons discussed below.
Step 1 of the 2019 Guidance requires the examiner to determine if the claims are to one of the statutory categories of invention. Applied to the present application, the claims belong to the statutory class of a process.
Step 2A of the 2019 Guidance is divided into two Prongs. Prong 1 requires the examiner to determine if the claims recite an abstract idea, and further requires that the abstract idea belong to one of three enumerated groupings: mathematical concepts, mental processes, and certain methods of organizing human activity.
Claim 1 is copied below, with limitations belonging to an abstract idea being underlined.
A sensor calibration method, comprising:
providing a lot of sensors, wherein m sample sensors are taken out from the lot of sensors for testing to obtain a sample pair-data set composed of a first test parameter value and a second parameter value, wherein the second parameter value is associated with an in vivo analyte parameter information;
averaging the first test parameter value of the sample pair-data set to obtain an average first test parameter value of the sample;
giving the average first test parameter value of samples or a range value composed of adjacent average values of the average first test parameter value of adjacent samples as a first parameter value of the lot of sensors to obtain a predetermined pair-data set of the sensors;
storing the predetermined pair-data set is-stored-in a memory.
The limitations underlined can be considered to describe a mathematical calculation, namely a mathematical operation to determine the average of a test parameter and a pair-data set. The lack of specific equation in the claim merely points out that the claim would monopolize all possible appropriate equations for accomplishing this purpose in all possible systems.
The additional limitations of “providing a lot of sensors”, “a sample pair-data set”, “first test parameter”, “second parameter”, and “in vivo analyte parameter information” only limit the abstract idea to a field on use (see MPEP 2106.05(h)).
The additional limitation of “storing” is insignificant extra-solution activity (see MPEP 2106.05(g)).
The claim does not recite a particular machine applying or being used by the abstract idea. The claim does not integrate the abstract idea into a practical application. Various considerations are used to determine whether the additional elements are sufficient to integrate the abstract idea into a practical application. The claim does not recite a particular machine applying or being used by the abstract idea. The claim does not effect a real-world transformation or reduction of any particular article to a different state or thing. The claim does not contain additional elements which describe the functioning of a computer, or which describe a particular technology or technical field, being improved by the use of the abstract idea.
Step 2b of the 2019 Guidance requires the examiner to determine whether the additional elements cause the claim to amount to significantly more than the abstract idea itself. The considerations for this particular claim are essentially the same as the considerations for Prong 2 of Step 2a, and the same analysis leads to the conclusion that the claim does not amount to significantly more than the abstract idea.
Therefore, Claim 1 is rejected as ineligible under 35 USC 101.
Dependent Claims 2-7 are similarly ineligible. Dependent Claim 2 adds the recited “number m of samples is 1/1000 ~ 1/10” to the abstract idea limitations discussed above. Dependent Claim 3 adds the recited “number m of samples is 1/50” to the abstract idea limitations. Dependent Claim 4 additionally recites “a current value or a voltage value” which only limits the abstract idea to a field of use. Dependent Claim 5 additionally recites “blood glucose concentration value” which only limits the abstract idea to a field of use. Dependent Claim 6 additionally recites “in vivo” which only limits the abstract idea to a field of use. Dependent Claim 7 additionally recites “in vitro” which only limits the abstract idea to a field of use. None of these dependent claims recite any further additional elements which would cause the claim as a whole to integrate the recited abstract idea into a particular practical application at Prong 2, or provide significantly more than the recited abstract idea at Step 2B. Claims 2-7 are therefore rejected as ineligible under 35 USC 101 as well.
Examiner’s Note Concerning Eligibility Under 35 USC § 101
Claims 8-15 are eligible under 35 USC 101.
Claim 8 recites “an analyte detection device” comprising “a shell”, “a sensor comprising an internal part and an external part”, “a memory”, “a processor”, “a transmitter”, and “a battery”. This integrates the judicial exception into a particular machine. Claim 8 is therefore eligible.
Claims 9-15 depend on claim 8 and are therefore eligible.
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 1, 2, 4-11, 14, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Scott (US 20190274598 A1).
Regarding Claim 1, Scott teaches a sensor calibration method, comprising:
providing a lot of sensors, wherein m sample sensors are taken out from the lot of sensors for testing (Fig. 20C Para 288: “In still other embodiments, the baseline subset can be taken from two or more different production lots and the distribution subset can be taken from a production lot from which no sensor is included within the baseline subset”) to obtain a sample pair-data set composed of a first test parameter value and a second parameter value, wherein the second parameter value is associated with an in vivo analyte parameter information (Para 270: “a measure of the sensor's responsiveness to the concentration of the chemical or composition it is designed to detect. For electrochemical sensors, this response can be in the form of an electrical current” and Para 285: “first subset can be referred to herein as a sample subset, or a baseline subset, and the sensing characteristic taken from the first subset can be referred to herein as a sample sensing characteristic or baseline sensing characteristic”);
averaging the first test parameter value of the sample pair-data set to obtain an average first test parameter value of the sample (Fig. 26B; Para 306: “the baseline in vitro sensitivity can be a central tendency of sensitivities 2604-1 through 2604-5, such as a mean or median of sensitivities 2604-1 through 2604-5”);
giving the average first test parameter value of samples (Para 306: “the baseline in vitro sensitivity can be a central tendency of sensitivities 2604-1 through 2604-5, such as a mean or median of sensitivities”) or a range value composed of adjacent average values of the average first test parameter value of adjacent samples as a first parameter value of the lot of sensors to obtain a predetermined pair-data set of the sensors (2019 Fig. 20C; Para 286 “calibration information can be independently determined for each medical device within a second subset of medical devices using at least a representation of an individualized manufacturing parameter of each device within the second subset and a representation of the sensing characteristic of the first subset of medical devices”);
storing the predetermined pair-data set is-stored-in a memory (1220 memory Fig. 12; Para 221: “memory 1220 operatively coupled to control unit 1210 for storing data”).
Regarding Claim 2, Scott teaches wherein the number m of the sample is 1/1000 ~ 1/10 of the lot of sensors (Para 289: “the baseline subset can be approximately 0.01-10% (e.g., 0.01%, 0.1%, 0.5%, 1.0%, 5%, or 10%) of the medical devices within a production lot”).
Regarding Claim 4, Scott teaches wherein the first parameter value is a current value or a voltage value (Fig. 19A; Para 85: “The sensor operates to electrolyze an analyte of interest in the subcutaneous fluid or blood such that a current is generated between the working electrode and the counter electrode. A value for the current associated with the working electrode is determined”).
Regarding Claim 5, Scott teaches wherein the second parameter at least comprises a blood glucose concentration value (Fig. 19A; Para 83: “In certain embodiments, an analyte sensor may be positioned in contact with interstitial fluid to detect the level of glucose, which detected glucose may be used to infer the glucose level in the user's bloodstream”).
Regarding Claim 6, Scott teaches at least part of the sample pair-data set comes from in vivo testing (Para 274: “After using an in vivo sensor to obtain a raw measurement signal from the user's body, the on body electronics can apply analog signal conditioning to the raw signal and convert the signal into a digital form of the conditioned raw signal”).
Regarding Claim 7, Scott teaches at least part of the sample pair-data set comes from in vitro testing (Para 9: “in certain embodiments a subset of one or more sensors from that group or batch are subjected to in vitro testing”).
Regarding Claim 8, Scott teaches an analyte detection device (Fig. 11; Para 194) comprising:
a shell (Fig. 11; Para 194: “On body electronics 1110 includes on body housing 1119 that defines an interior compartment”);
a sensor comprising an internal part and an external part, wherein the internal part is used to penetrate into a subcutaneous skin to obtain the first parameter (Fig. 5A; Para 134: “analyte sensor 500 having a first portion (which in this embodiment may be characterized as a major portion) positionable above a surface of the skin 510, and a second portion (which in this embodiment may be characterized as a minor portion) that includes an insertion tip 530 positionable below the surface of the skin, e.g., penetrating through the skin and into, e.g., the subcutaneous space 520”);
a memory in which a predetermined pair-data set obtained by the above sensor calibration method as mentioned in claim 1 is prestored (Fig. 12; Para 221: “memory 1220 operatively coupled to control unit 1210 for storing data”);
a processor (Control Unit 1210 Fig. 12; Para 221: “a control unit 1210 such as, for example but not limited to, one or more processors”) programmed to call the predetermined pair-data set from the memory, and obtaining the second parameter value in the predetermined pair-data set based on the first parameter value by index (Para 318: “The individualized calibration information can capture the sensing characteristic in the form of a factor or code that can be recorded or stored in a manner such that it is accessible to the processing circuitry that processes the raw or conditioned data collected by the individual medical device”);
a transmitter, which is used to send the first parameter value and/or the second parameter value to a remote device (Antenna 1230 Fig. 12; Para 86: “If an analyte concentration is successfully determined, it may be displayed, stored, transmitted, and/or otherwise processed to provide useful information”);
and a battery, which is used to provide electric energy (Power supply 1260 Fig. 12; Para 223: “power supply 1260 in on body electronics 1110 may be toggled between its internal power source (e.g., a battery)”).
Regarding Claim 9, Scott teaches wherein the transmitter, the memory, the sensor, the processor, and the battery are located in the shell (Fig. 11 and Fig. 12; Para 194: “On body electronics 1110 includes on body housing 1119” and Para 221: “FIG. 12 is a block diagram of the on body electronics 1110”).
Regarding Claim 10, Scott teaches wherein the transmitter, the sensor and the battery are located in the shell (Fig. 11 and Fig. 12; Para 194: “On body electronics 1110 includes on body housing 1119” and Para 221: “FIG. 12 is a block diagram of the on body electronics 1110”).), and wherein the memory and/or the processor is located in the remote device (Fig. 11; Para 205: “also shown in analyte monitoring system 1100 are data processing module 1160 and remote terminal 1170”).
Regarding Claim 11, Scott teaches wherein at least two of the transmitter, the processor and the memory are integrated (Para 127: “one or more application-specific integrated circuits (ASIC) (e.g., having processing circuitry and non-transitory memory for storing software instructions for execution by the processing circuitry) may be used to implement one or more functions or routines associated with the operations of the data processing unit”).
Regarding Claim 14, Scott teaches wherein the first parameter or the second parameter value is set with at least one threshold value, and when the first parameter or second parameter value exceeds the at least one threshold value, the remote device sends an alert indication (Fig. 11; Para 86: “an alarm is activated to alert a user if the rate of change of analyte concentration exceeds the predefined threshold” and Para 202: “display device 1120 may be additionally, or instead of visual display, configured to output alarms notifications such as alarm and/or alert notifications”).
Regarding Claim 15, Scott teaches wherein the threshold is set by a user or a non-user (Para 86: “a predetermined threshold amount”).
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 3 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Scott.
Regarding Claim 3, Scott teaches the limitations of claim 1, but Scott does not explicitly teach wherein the number m of the sample is 1/50 of the lot of sensors (Para 289: “the baseline subset can be approximately 0.01-10% (e.g., 0.01%, 0.1%, 0.5%, 1.0%, 5%, or 10%) of the medical devices within a production lot”).
However, Scott does teach wherein the recited number m of the sample being 1/50 is within the disclosed range of the lot of sensors (Para 289: “the baseline subset can be approximately 0.01-10% (e.g., 0.01%, 0.1%, 0.5%, 1.0%, 5%, or 10%) of the medical devices within a production lot”).
A prima facie case of obviousness exists when the claimed range overlaps or lies inside ranges disclosed by the prior art (see MPEP 2144.05). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the invention of Scott to have the number of samples be 1/50 of the production lot. Doing so would allow for accurate calibration without excessively decreasing the production lot of sensors (Para 289: “Thus, the quantity of devices in the baseline subset can be determined by balancing the ability to obtain accurate and representative results against the decrease to production yields and cost resulting therefrom”).
Regarding Claim 12, Scott teaches the limitation of claim 8, and Scott further teaches wherein
However Scott does not explicitly teach when the average first test parameter value of sample is given as the first parameter value of the lot of sensors, the first parameter value is interpolated to obtain the second parameter value.
Scott further teaches when the average first test parameter value of sample is given as the first parameter value of the lot of sensors (Para 306: “the baseline in vitro sensitivity can be a central tendency of sensitivities 2604-1 through 2604-5, such as a mean or median of sensitivities” and 2019 Fig. 20C; Para 286 “calibration information can be independently determined for each medical device within a second subset of medical devices using at least a representation of an individualized manufacturing parameter of each device within the second subset and a representation of the sensing characteristic of the first subset of medical devices”),
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to combine the parameter interpolation of Scott with the average first parameter of Scott by applying the interpolation of Scott on the average first parameter of Scott to determine the second parameter. Doing so would allow for determination of the accuracy of the average first parameter by being able to compare the interpolated second parameter to other known second parameters.
Examiner’s Note
The Examiner notes that Claim 13 is distinguishable from the prior art of record.
Regarding Claim 13, Scott teaches an average of the first test parameter value (Para 306: “the baseline in vitro sensitivity can be a central tendency of sensitivities 2604-1 through 2604-5, such as a mean or median of sensitivities”). Scott does not teach a range value formed by the average value of the first test parameter value of adjacent samples.
Desai (US 20030050546 A1) teaches a ratio of signals to average a first test parameter value (Para 59: “before performing said calibration method, a ratio of the signals obtained from the first sensor (A) and the second sensor (B) may be determined based on a series of signals obtained from first sensor (A) and second sensor (B), said ratio representing the relationship between sensor signals”). Desai does not teach a range value formed by the average value of the first test parameter value of adjacent samples.
Chen (CN 105180995 A) teaches various calibration formulas to determine a calibration value (Para 45: “based on the sampling information or control information, one or more calibration formulas or calibration parameters can be selected to calculate the calibration value. Calibration formulas may include Steinhart-Hart formulas, Chebyshev polynomial fitting, lookup tables (LUTs), polynomial equations, exponential polynomials, Fourier polynomials, Gaussian polynomials, interpolation polynomials, power exponential polynomials, rational polynomials, smooth spline polynomials, series of sine polynomials, Veber polynomials, or similar formulas and any combination thereof.”) Chen does not teach a range value formed by the average value of the first test parameter value of adjacent samples.
None of the prior art discloses or fairly suggests “when the range value formed by the average value of the first test parameter value of the adjacent samples is given as the first parameter value of the batch sensor, the processor determines the range in which the first parameter value falls, and obtain the second parameter value in the predetermined pair-data set by the index”.
Conclusion
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/RODGER STEWART MENSING/ Examiner, Art Unit 2857
/ANDREW SCHECHTER/ Supervisory Patent Examiner, Art Unit 2857
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