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 .
Claim Objections
Claims 1-16 are objected to because of the following informalities:
Claim 1 line 15: “a closest typical pair-data set Dzj to z pair-data sets” should be corrected to “a closest typical pair-data set Dzj to the z pair-data sets”.
Claim 1 line 18: “obtain a adjusted typical pair-data set Dzkj” should be corrected to “obtain [[a]]an adjusted typical pair-data set Dzkj”.
Claims 2-12: “According to the sensor calibration method mentioned in claim” should be corrected to “of claim”.
Claim 3 line 4: “a first parameter value unz of z pair-data” should be corrected to “a first parameter value unz of the z pair-data”.
Claim 3 line 5: “wherein the typical pair-data set Dzj is the closest to a z pair-data” should be corrected to “wherein the closest typical pair-data set Dzj is the closest to a z pair-data”.
Claim 13 line 7: “as mentioned in claim 1 is pre-stored” should be corrected to “as recited in claim 1 is pre-stored”.
Claims 14-16: “According to the analyte detection device mentioned in claim” should be corrected to “of claim”.
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 1-16 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 1 recites the limitations “i batch pair-data sets (xni, f(xn))” in lines 2-3. It is unclear from the language of the claim what the elements “I,” “x,” “n,” and “f” are defined as. The claim is indefinite because it is unclear what is required by the claim. When possible it is preferred that mathematical parameters be defined in the claims. This rejection could be overcome by amending the claim language to clarify what the recited elements are defined as.
Claim 1 recites the limitation “providing the sensors to be delivered” in line 12. There is insufficient antecedent basis for this limitation in the claim. It is unclear from the language of the claim if the recited “the sensors” as a new limitation or are referring to the previously recited “a lot of sensors”. For the purposes of examination the recited ‘the sensors” shall be interpreted as referring to either the lot of sensors or to new sensors. This rejection could be overcome by amending the claim language to clarify what sensors are being referred to at any given point in the claim.
Claim 1 recites the limitation “obtaining z pair-data sets (unz, f(xn)) in line 13. It is unclear from the language of the claim what the elements “z” and “u” are defined as. The claim is indefinite because it is unclear what is required by the claim. When possible it is preferred that mathematical parameters be defined in the claims. This rejection could be overcome by amending the claim language to clarify what the recited elements are defined as.
Claim 1 recites the limitation “obtain a closest typical pair-data set Dzj to z pair-data sets and a difference between them” in line 15. It is unclear from the language of the claim which limitations are referred to by the element “them”. The use of the term “them” renders the limitation “difference” indefinite, because it is unclear what limitations are used to determine the difference. For the purposes of examination the recited limitation shall be interpreted as requiring that a difference is determined using “a closest typical pair-data set” and “z pair-data sets”. This rejection could be overcome by amending the claim language to clarify what limitations are used to determine the difference.
Claim 1 recites the limitations “a difference between them,” “a difference in a physical characteristics,” and “adjusted based on the difference”. It is unclear from the language of the claim which of the recited differences the limitation “based on the difference” is intended to refer to. The claim is indefinite because it is unclear what is required by the claim. For the purposes of examination the recited “based on the difference” shall be interpreted to refer to either previously recited differences. This rejection could be overcome by amending the claim language to clarify which difference is being referred to at any given point in the claim. For example, the claim could be amended to recite “the difference is caused by physical differences in physical characteristics of the sensors to be delivered”.
Claim 3 recites the limitation “the first test parameter value x” in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 3 recites the limitation “the closest to a z pair-data” in line 6. It is unclear from the language of the claim if the recited “a z pair-data” is intended to be a new limitation or is referring to the previously recited “z par-data”. The claim is indefinite because it is unclear if the claim requires a new limitation or is referring to a previously recited limitation. For the purposes of examination the recited “z pair-data” shall be interpreted as referring to any of the previously recited “z pair-data” or a new limitation. This rejection could be overcome by amending the claim language to clarify what pair-data is being referred to at any given point in the claims.
Claim 13 recites the limitations “obtain a first parameter value” and “a memory in which”. It is unclear from the language of the claim if the recited limitations are intended to be new limitations or refer to limitations previously recited in claim 1. The claim is indefinite because it is unclear what is required by the claim. For the purposes of examination the recited “first parameter value” and “a memory” shall be interpreted as either a new limitation or referring to a previously recited limitation. This rejection could be overcome by amending the claim language to clarify what limitations are being referred to at any given point in the claim.
Claims that depend on the above rejected claims are also rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), Second paragraph.
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 1-12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
With respect to claim 1 the limitation(s):
A sensor calibration method, comprising:
providing a lot of sensors, testing the lot to obtain i batch pair-data sets (xni, f(xn)) composed of a first test parameter value and a second parameter value, and
summarizing the batch pair-data set based on the first test parameter value to obtain a summary pair-data set Di:
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;
classifying and dividing the summary pair-data set Di to obtain a typical pair-data set Dj:
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;
providing a computer storing the typical pair-data set Dj;
providing the sensors to be delivered, testing the sensors to be delivered, and obtaining z pair-data sets (unz, f(xn));
providing the computer, wherein the computer is also used to obtain a closest typical pair-data set Dzj to z pair-data sets and a difference between them, wherein the difference is caused by a difference in a physical characteristics of the sensors to be delivered,
wherein the typical pair-data set is adjusted based on the difference to obtain a adjusted typical pair-data set Dzkj, and
wherein the adjusted typical pair-data set Dzkj is input into a memory corresponding to the sensors to be delivered as a predetermined pair-data set.
These limitation(s) highlighted in (bold) is/are directed to an abstract idea and would fall within the “Mental Processes” and “Mathematical Concepts” groupings of abstract ideas. The above portion(s) of the claim(s) constitute(s) an abstract idea because:
The limitation(s) regarding “summarizing the batch pair-data set based on the first test parameter value to obtain a summary pair-data set Di:
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,” as drafted, is an act of observation and evaluation that, under its broadest reasonable interpretation, covers performance of the limitation(s) in the mind. That is, other than reciting “a computer,” nothing in the claim language precludes the Step(s) from practically being performed in the mind. For example, but for the “a computer” language, “summarizing” in the context of this claim encompasses the user manually summarizing data.
The limitation(s) regarding “classifying and dividing the summary pair-data set Di to obtain a typical pair-data set Dj:
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”, as drafted, is an act of observation and evaluation that, under its broadest reasonable interpretation, covers performance of the limitation(s) in the mind. That is, other than reciting “a computer,” nothing in the claim language precludes the Step(s) from practically being performed in the mind. For example, but for the “a computer” language, “classifying” in the context of this claim encompasses the user manually classifying data.
Further, the limitation regarding “classifying and dividing the summary pair-data set Di to obtain a typical pair-data set Dj:
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”, as drafted, falls within the “Mathematical Concepts” groupings of abstract ideas. This interpretation is supported in the specification as shown by “classified according to the hold out method or cross validation method” recited in page 16 of the specification as filed which is an explicit recitation of an equation corresponding to the claimed limitation. It is important to note that a mathematical concept need not be expressed in mathematical symbols, because "[w]ords used in a claim operating on data to solve a problem can serve the same purpose as a formula." In re Grams, 888 F.2d 835, 837 and n.1, 12 USPQ2d 1824, 1826 and n.1 (Fed. Cir. 1989).
The limitation(s) regarding “providing the computer, wherein the computer is also used to obtain a closest typical pair-data set Dzj to z pair-data sets and a difference between them, wherein the difference is caused by a difference in a physical characteristics of the sensors to be delivered”, as drafted, is an act of observation and evaluation that, under its broadest reasonable interpretation, covers performance of the limitation(s) in the mind. That is, other than reciting “a computer,” nothing in the claim language precludes the Step(s) from practically being performed in the mind. For example, but for the “a computer” language, “obtain” in the context of this claim encompasses the user manually obtain a data set closest to another data set.
Further, the limitation regarding “providing the computer, wherein the computer is also used to obtain a closest typical pair-data set Dzj to z pair-data sets and a difference between them, wherein the difference is caused by a difference in a physical characteristics of the sensors to be delivered”, as drafted, falls within the “Mathematical Concepts” groupings of abstract ideas. This interpretation is supported in the specification as shown by equation “sum of square differences” recited in page 17 of the specification as filed which is an explicit recitation of an equation corresponding to the claimed limitation. It is important to note that a mathematical concept need not be expressed in mathematical symbols, because "[w]ords used in a claim operating on data to solve a problem can serve the same purpose as a formula." In re Grams, 888 F.2d 835, 837 and n.1, 12 USPQ2d 1824, 1826 and n.1 (Fed. Cir. 1989).
The limitation(s) regarding “wherein the typical pair-data set is adjusted based on the difference to obtain a adjusted typical pair-data set Dzkj”, as drafted, is an act of observation and evaluation that, under its broadest reasonable interpretation, covers performance of the limitation(s) in the mind. That is, other than reciting “a computer,” nothing in the claim language precludes the Step(s) from practically being performed in the mind. For example, but for the “a computer” language, “adjusted” in the context of this claim encompasses the user manually adjusting data.
Further, the limitation regarding “wherein the typical pair-data set is adjusted based on the difference to obtain a adjusted typical pair-data set Dzk”, as drafted, falls within the “Mathematical Concepts” groupings of abstract ideas. This interpretation is supported in the specification as shown by equation “adjustment function” recited in page 18 of the specification as filed which is an explicit recitation of an equation corresponding to the claimed limitation. It is important to note that a mathematical concept need not be expressed in mathematical symbols, because "[w]ords used in a claim operating on data to solve a problem can serve the same purpose as a formula." In re Grams, 888 F.2d 835, 837 and n.1, 12 USPQ2d 1824, 1826 and n.1 (Fed. Cir. 1989).
Further, referring to the MPEP 2106.04, the claim limitations are analogous to a claim to "collecting information, analyzing it, and displaying certain results of the collection and analysis," where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind, Electric Power Group v. Alstom, S.A., 830 F.3d 1350, 1353-54, 119 USPQ2d 1739, 1741-42 (Fed. Cir. 2016).
If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Further, if a claim limitation, under its broadest reasonable interpretation, recites mathematical relationships, mathematical formulas or equations, and mathematical calculations, then it fall within the “Mathematical Concepts” groupings of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application because the non- abstract additional elements of the claims do not impose meaningful limits on practicing the abstract idea(s) recited in the preceding claim(s). In particular, the claims recited the additional elements of:
The limitation(s) regarding “providing a lot of sensors, testing the lot to obtain i batch pair-data sets (xni, f(xn)) composed of a first test parameter value and a second parameter value” and “providing the sensors to be delivered, testing the sensors to be delivered, and obtaining z pair-data sets (unz, f(xn))” does/do not integrate the abstract idea into a practical application because the claim does not specify what practical application the claim is directed to. Rather the limitation is recited at such a high-level of generality that it amounts to no more than adding insignificant extra-solution activity to the judicial exception, i.e. data gathering. Accordingly, these additional elements do not integrate the abstract idea into a practical application because they are regarded as data gathering steps necessary or routine to implement the abstract idea.
The limitation(s) regarding “wherein the adjusted typical pair-data set Dzkj is input into a memory corresponding to the sensors to be delivered as a predetermined pair-data set” does/do not integrate the abstract idea into a practical application because the claim does not specify what practical application the claim is directed to. Rather the limitation is recited at such a high-level of generality that it amounts to no more than adding insignificant extra- solution activity to the judicial exception, i.e. insignificant application. Accordingly, these additional elements do not integrate the abstract idea into a practical application because they are regarded as data outputting steps necessary or routine to implement the abstract idea. Further, referring to the MPEP 2106.05(g), the claim limitations are analogous to a claim to Printing or downloading generated menus, Ameranth, 842 F.3d at 1241-42, 120 USPQ2d at 1854-55.
The limitation(s) regarding “providing a computer storing the typical pair-data set Dj” and “a memory” does/do not integrate the abstract idea into a practical application because the claim limitation is a generic computer component performing the generic computer function of receiving, storing, and comparing data such that it amounts to no more than mere instruction to apply the exception using a generic computer component.
As such Examiner does NOT view that the claims:
-Improve the functioning of a computer, or to any other technology or technical field;
-Apply the judicial exception with, or by use of, a particular machine - see MPEP 2106.05(b);
-Effect a transformation or reduction of a particular article to a different state or thing - see MPEP 2106.05(c); or
-Apply or use the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception – see MPEP 2106.05(e) and Vanda Memo.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements amount to no more than mere instructions to apply the exception using a generic computer component, or are well-understood, routine, and conventional (WURC) data gathering functions.
As discussed above with respect to integration of the abstract idea into a practical application, the additional element(s) of “providing a lot of sensor,” “providing the sensors to be delivered,” and “input” is/are viewed as insignificant extra-solution activity, such as mere data gathering in a conventional way and, therefore, does not provide an inventive concept. Similarly, with regards to the additional element(s) of “a computer” and “a memory” is/are view as a generic computer component performing the generic computer function of receiving, storing, and comparing data such that it amounts to no more than mere instruction to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept.
Examiner further notes that such additional elements are viewed to be well- understood, routine, and conventional (WURC) as evidenced by: Scott et al. (US 20190274598 A1), Rosenthal (US 5204532 A), Hsiung et al. (US 20110125409 A1), Li et al. (US 20090076398 A1), Garcia et al. (US 20170071512 A1), and Gupta et al. (US 20220214301 A1).
Considering the claim as a whole, one of ordinary skill in the art would not know the practical application of the present invention since the claims do not apply or use the judicial exception in some meaningful way. As currently claimed, Examiner views that the additional elements do not apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, because the claims fails to recite clearly how the judicial exception is applied in a manner that does not monopolize the exception because the limitation regarding “providing a lot of sensor,” “providing the sensors to be delivered,” “input,” “a computer” and “a memory” can be viewed as a field of use, necessary data gathering, and any device and do not impose a meaningful limitation describing what problem is being remedied or solved.
Dependent claims 2-12 when analyzed as a whole are held to be patent ineligible under 35 U.S.C. 101 because the additionally recited limitation(s) fail(s) to establish that the claim(s) is/are not directed to an abstract idea, as detailed below: there are no additional element(s) in the dependent claims that adds a meaningful limitation to the abstract idea to make the claims significantly more than the judicial exception (abstract idea).
Claims 4-10 recite limitations regarding data gathering steps and insignificant application necessary or routine to implement the abstract idea and thus are not significantly more than the abstract idea and viewed to be well known routine and conventional as evidenced by the prior art shown above.
Claims 2-3 and 11-12 further limit the abstract idea with an abstract idea, such as an “Mathematical Concepts”, and thus the claims are still directed to an abstract idea without significantly more.
Claim 13 is seen as applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. As such, claims 13-16 are not rejected under 35 USC 101.
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(s) 1 and 4-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Scott et al. US 20190274598 A1) in view of Rosenthal (US 5204532 A).
Regarding Claim 1. Scott teaches:
A sensor calibration method, comprising:
providing a lot of sensors, testing the lot to obtain i batch pair-data sets (xni, f(xn)) composed of a first test parameter value and a second parameter value (See Fig. 19A, Fig. 19B, Fig. 20C, Fig. 26A, Fig. 26B, Fig. 27E, para[0270], para[0285], and para[0288]: 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. 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 (amperometric) or electrical charge (coulometric).), and
summarizing the batch pair-data set based on the first test parameter value to obtain a summary pair-data set Di:
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(See Fig. 19A, Fig. 19B, Fig. 20C, Fig. 26A, Fig. 26B, Fig. 27E, para[0270], para[0285], and para[0288]: This 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.);
classifying and dividing the summary pair-data set Di to obtain a typical pair-data set Dj:
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(See para[0289], and para[0306]: In some embodiments, 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.);
providing a computer storing the typical pair-data set Dj (See Fig. 19A, Fig. 19B, Fig. 20C, Fig. 26A, Fig. 26B, Fig. 27E, Fig. 29A, and para[0334]: a computer system 2900 that can be used to implement the calibration embodiments described herein.);
providing the sensors to be delivered, testing the sensors to be delivered, and obtaining z pair-data sets (unz, f(xn)) (See Fig. 19A, Fig. 19B, Fig. 20C, Fig. 26A, Fig. 26B, Fig. 27E, and para[0074]: One or more individualized manufacturing parameter can be measured from each medical device in a different second subset of medical devices (e.g., a distribution subset intended for distribution from the manufacturer to third party users).);
wherein the difference is caused by a difference in a physical characteristics of the sensors to be delivered (See para[0006] and para[0075]: These variations can cause sensors of the same design and manufacturing process to have measurable differences in their performance.),
wherein the typical pair-data set is adjusted based on the difference to obtain a adjusted typical pair-data set Dzkj (See Fig. 27A, Fig. 27D, Fig. 27E, and para[0308]: At 2705, individualized calibration information is determined for the respective medical device that corresponds to the representation of the in vitro sensing characteristic of the respective medical device. This individualized calibration information can be determined directly from the in vitro sensing characteristic of 2702, or the in vitro sensing characteristic can be modified or converted to another value, in one or more steps, and the resulting modified or converted value can then be used to determine the individualized calibration information.), and
wherein the adjusted typical pair-data set Dzkj is input into a memory corresponding to the sensors to be delivered as a predetermined pair-data set (See Fig. 20C, Fig. 27A, Fig. 27D, Fig. 27E, para[0291], and para[0308]: For example, for in vivo devices, this can be achieved by storing the individualized calibration information within non-transitory memory of electronics assigned to the individual in vivo device, or by storing the individualized calibration information in non-transitory memory associated with a server such that the calibration information can be communicated to a device in the field (e.g., a reader device) that is operating with the individual in vivo sensor.).
Scott is silent as to the language of:
providing the computer, wherein the computer is also used to obtain a closest typical pair-data set Dzj to z pair-data sets and a difference between them.
Nevertheless Rosenthal teaches:
providing the computer, wherein the computer is also used to obtain a closest typical pair-data set Dzj to z pair-data sets and a difference between them (See Col. 4 lines 10 – 20 and Col. 4 lines 42 - 58: The general calibration method of the present invention utilizes means for identifying and assigning a particular cluster from among the six clusters that most closely matches the individual near-infrared optical measurements. The cluster with the highest R.sup.2 value to that individual measurement, i.e. typically a finger measurement, would be the appropriate cluster for application of calibration constants.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Scott by providing the computer, wherein the computer is also used to obtain a closest typical pair-data set Dzj to z pair-data sets and a difference between them such as that of Rosenthal. Rosenthal teaches, “The calibration constants associated with the cluster identified as being most closely corresponding to the measured individual spectrum are then used to calibrate the analysis instrument. Accurate blood glucose level measurements are thereby obtained without having to custom calibrate the analysis for the individual user” (See Col. 4 lines 21 - 26). One of ordinary skill would have been motivated to modify Scott, because obtaining a closest typical pair-data set would have helped to accurately determine a blood glucose level measurement without having to custom calibrate each sensor, as recognized by Rosenthal.
Regarding Claim 4. Scott teaches:
According to the sensor calibration method mentioned in claim 3,
wherein the z pair-data is randomly distributed (See para[0292]: The manufacturing parameter is preferably specific to one individual medical device such that it can vary between medical devices in the same group or lot, in which case it is referred to herein as an individualized manufacturing parameter.).
Regarding Claim 5. Scott teaches:
According to the sensor calibration method mentioned in claim 3,
wherein the z pair-data is equidistant distributed (See para[0164]: the analyte-responsive enzyme may be distributed uniformly throughout the sensing region.).
Regarding Claim 6. Scott teaches:
According to the sensor calibration method mentioned in claim 1,
wherein the first parameter value is a current value or a voltage value (See para[0085]: A value for the current associated with the working electrode is determined. If multiple working electrodes are used, current values from each of the working electrodes may be determined.).
Regarding Claim 7. Scott teaches:
According to the sensor calibration method mentioned in claim 1,
wherein the second parameter value at least comprises a blood glucose concentration value (See para[0083]: 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 8. Scott teaches:
According to the sensor calibration method mentioned in claim 1,
wherein the predetermined pair-data set is at least partially derived from in vitro tests (See para[0009]: in certain embodiments a subset of one or more sensors from that group or batch are subjected to in vitro testing, and the resulting test data is used with one or more manufacturing parameters obtained from a different subset of sensors of the same group or batch to predict the performance of that different subset of sensors when distributed to users.).
Regarding Claim 9. Scott teaches:
According to the sensor calibration method mentioned in claim 1,
wherein a number i of the batch pair-data sets shall not be less than 100 (See para[0319] – para[00320]: After placement (e.g., deposition) of the membrane on the N sensors and measurement thereof, 1000 different measurements of membrane sizes will have been obtained, or 2000 measurements in total.).
Regarding Claim 10. Scott teaches:
According to the sensor calibration method mentioned in claim 1,
wherein a number j of the typical pair-data sets shall not be less than 10 (See para[0319] – para[0320]: X can be a relatively small fraction of N, such as 5, 10, or 20 medical devices when N=1000.).
Regarding Claim 11. Scott teaches:
According to the sensor calibration method mentioned in claim 1,
wherein an adjustment of pair-data is fixed (See para[0271]: b is the intercept of the sensitivity, where the intercept generally corresponds to a background signal (e.g., noise).).
Regarding Claim 12. Scott teaches:
According to the sensor calibration method mentioned in claim 1,
wherein an adjustment of pair-data is linear (See para[0271]: m is the slope of the sensitivity.).
Regarding Claim 13. Scott teaches:
An analyte detection device, comprising:
a shell (See Fig. 11 and para[0194]: On body electronics 1110 includes on body housing 1119 that defines an interior compartment.);
a sensor comprising an internal part and an external part (See Fig. 5A, Fig. 11, Fig. 10, para[0134], and para[0194]: an 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.),
wherein the internal part is used to penetrate into a subcutaneous skin to obtain a first parameter value (See Fig. 5A and para[0134]: 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.);
a memory in which the adjusted typical pair-data set Dzkj as mentioned in claim 1 is pre-stored (See Fig. 12 and para[0221]: memory 1220 operatively coupled to control unit 1210 for storing data.);
a processor programmed to call the typical pair-data set Dzkj from the memory (See Fig. 12 and para[0221]: processors.), and
obtaining the second parameter value based on the first parameter value in typical pair-data set Dzkj by an index (See para[0318]: 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 used to send the first parameter value and/or the second parameter value to a remote device (See Fig. 12 and para[0086]: 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 (See Fig. 12 and para[0223]: a battery.).
Regarding Claim 14. Scott teaches:
According to the analyte detection device mentioned in claim 13,
wherein the transmitter (See Fig. 11, Fig. 12, and para[0227]: antenna 1230.), the memory (See Fig. 11, Fig. 12, and para[0221]: memory 1220.), the sensor (See Fig. 11, Fig. 12, and para[0221]: analyte sensor 1101.), the processor (See Fig. 12 and para[0221]: control unit 1210.) and the battery (See Fig. 12 and para[0222]: power supply 1260.) are located in the shell (See Fig. 11 and para[0194]: body housing 1119.).
Regarding Claim 15. Scott teaches:
According to the analyte detection device mentioned in claim 13,
wherein the transmitter (See Fig. 11, Fig. 12, and para[0227]: antenna 1230.), the sensor (See Fig. 11, Fig. 12, and para[0221]: analyte sensor 1101.) and the battery (See Fig. 12 and para[0222]: power supply 1260.) are located in the shell (See Fig. 11 and para[0194]: body housing 1119.), and the memory and/or the processor is located in the remote device (See Fig. 11, Fig. 13, and para0233]: display device 1120 (FIG. 11) includes control unit 1310, such as one or more processors (or processing circuitry) operatively coupled to a display 1122, and an input component (e.g., user interface) 1121.).
Regarding Claim 16. Scott teaches:
According to the analyte detection device mentioned in claim 13,
wherein at least two of the transmitter, the processor and the memory are integrated (See para[0127]: In certain embodiments, 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.).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Scott et al. US 20190274598 A1) in view of Rosenthal (US 5204532 A) as applied to claim 1 above, and further in view of Hsiung et al. (US 20110125409 A1).
Regarding Claim 2. Scott is silent as to the language of:
According to the sensor calibration method mentioned in claim 1,
wherein the typical pair-data set Dj is obtained by classifying and dividing the summary pair-data set Di according to a multiple reservation method or a cross validation method.
Nevertheless Hsiung teaches:
wherein the typical pair-data set Dj is obtained by classifying and dividing the summary pair-data set Di according to a multiple reservation method or a cross validation method (See para[0074]: The present technique uses cross-validation, which is an operation process used to validate models built with chemometrics algorithms based on training data set. During the process, the training data set is divided into calibration and validation subsets.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Scott wherein the typical pair-data set Dj is obtained by classifying and dividing the summary pair-data set Di according to a multiple reservation method or a cross validation method such as that of Hsiung. Hsiung teaches, “The present technique uses cross-validation, which is an operation process used to validate models built with chemometrics algorithms based on training data set. During the process, the training data set is divided into calibration and validation subsets” (See para[0074]). One of ordinary skill would have been motivated to modify Scott, because using cross validation to classify and divide a data set would have helped to validate any models build using the data set, as recognized by Hsiung.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Scott et al. US 20190274598 A1) in view of Rosenthal (US 5204532 A) as applied to claim 1 above, and further in view of Li et al. (US 20090076398 A1).
Regarding Claim 3. Scott is silent as to the language of:
According to the sensor calibration method mentioned in claim 1,
further comprising:
calculating, by the computer, a minimum value of a sum of the squares of differences between a first parameter value unz of z pair-data and the first test parameter value x of each typical pair-data set respectively to obtain the typical pair-data set Dzj,
wherein the typical pair-data set Dzj is the closest to a z pair-data.
Nevertheless Li teaches:
calculating, by the computer, a minimum value of a sum of the squares of differences between a first parameter value unz of z pair-data and the first test parameter value x of each typical pair-data set respectively to obtain the typical pair-data set Dzj (See para[0032] – para[0036]: Various metrics may be used to quantify the difference between a set of parameters measured at a particular time and the corresponding parameters of a stored template 21. In simple cases, each of the parameters is compared to its counterpart in the stored template 21. An average of the sum of squares of differences between corresponding ones of the points of the two pulse waves.),
wherein the typical pair-data set Dzj is the closest to a z pair-data (See para[0076]: in some embodiments of the invention, a template may be stored for each of a number of different prior calibration events. Measured parameters may be compared to each of the stored templates to find a stored template which is closest to the measured parameters. A calibration associated with that closest template may be used.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Scott by calculating, by the computer, a minimum value of a sum of the squares of differences between a first parameter value unz of z pair-data and the first test parameter value x of each typical pair-data set respectively to obtain the typical pair-data set Dzj, wherein the typical pair-data set Dzj is the closest to a z pair-data such as that of Li. Li teaches, “Measured parameters may be compared to each of the stored templates to find a stored template which is closest to the measured parameters. A calibration associated with that closest template may be used” (See para[0076]). One of ordinary skill would have been motivated to modify Scott, because using a sum of the squares of difference would have helped to find the closest calibration data set to the currently measured parameters, as recognized by Li.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Garcia et al. (US 20170071512 A1) discloses dividing a batch of sensors into a first and second portion and calibrating the first portion using data from the second portion (See para[0193] – para[0194]).
Gupta et al. (US 20220214301 A1) discloses matching precalculated calibration curves to measured data and selecting the curve that minimizes a least mean absolute relative difference (See para[0029]).
Facco et al. (Facco, Pierantonio, Fabrizio Bezzo, and Massimiliano Barolo. "Nearest-neighbor method for the automatic maintenance of multivariate statistical soft sensors in batch processing." Industrial & Engineering Chemistry Research 49.5 (2010): 2336-2347.) discloses updating the estimation model following a nearest-neighbor strategy, which determines the most appropriate reference data set for model recalibration by inspecting the similarity between batches (See Abstract).
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/CARTER W FERRELL/Examiner, Art Unit 2857
/Catherine T. Rastovski/Supervisory Primary Examiner, Art Unit 2857
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