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 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 1-15 are rejected under 35 U.S.C. §101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
Claims 1-12 are directed to a method (i.e., a process). Accordingly, claims 1-12 are all within at least one of the four statutory categories.
Claims 13-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because they are drawn to software per se (e.g., unit). Software per se intrinsically require no tangible physical structure, thus do not constitute tangible physical articles or other forms of matter. Therefore, software per se is not considered to be statutory subject matter. Products that do not have a physical or tangible form, such as information (often referred to as "data per se") or a computer program per se (often referred to as "software per se") when claimed as a product without any structural recitations are not directed to any of the statutory categories.
Step 2A - Prong One:
Regarding Prong One of Step 2A, the claim limitations are to be analyzed to determine whether, under their broadest reasonable interpretation, they “recite” a judicial exception or in other words whether a judicial exception is “set forth” or “described” in the claims. An “abstract idea” judicial exception is subject matter that falls within at least one of the following groupings: a) certain methods of organizing human activity, b) mental processes, and/or c) mathematical concepts.
Representative independent claim 1 includes limitations that recite at least one abstract idea. Specifically, independent claim 1 recites:
1. A method of controlling biometric data, comprising:
obtaining a first biometric data collected according to a first sampling rate;
acquiring at least one first indicator value related to a first time interval of the first biometric data;
acquiring at least one second indicator value related to a second time interval of the first biometric data;
obtaining a first comparison result based on (ⅰ) a difference value between the at least one first indicator value and the at least one second indicator value and (ⅱ) threshold values set related to the first indicator value and the second indicator value;
obtaining a first adjustment result for the first sampling rate based on the first comparison result; and
determining a first variable sampling rate for the first biometric data based on the first adjustment result.
The Examiner submits that the foregoing underlined limitations constitute “a mental process” because obtaining a first biometric data collected according to a first sampling rate; acquiring at least one first indicator value related to a first time interval of the first biometric data; acquiring at least one second indicator value related to a second time interval of the first biometric data; obtaining a first comparison result based on (ⅰ) a difference value between the at least one first indicator value and the at least one second indicator value and (ⅱ) threshold values set related to the first indicator value and the second indicator value; obtaining a first adjustment result for the first sampling rate based on the first comparison result; and determining a first variable sampling rate for the first biometric data based on the first adjustment result amount to observations/evaluations/judgments/analyses that can, at the currently claimed high level of generality, be practically performed in the human mind or via pen and paper.
Accordingly, the claim recites at least one abstract idea.
Step 2A - Prong Two:
Regarding Prong Two of Step 2A, it must be determined whether the claim as a whole integrates the abstract idea into a practical application. It must be determined whether any additional elements in the claim beyond the abstract idea integrate the exception into a practical application in a manner that imposes a meaningful limit on the judicial exception. The courts have indicated that additional elements merely using a computer to implement an abstract idea, adding insignificant extra solution activity, or generally linking use of a judicial exception to a particular technological environment or field of use do not integrate a judicial exception into a “practical application.”
The limitations of claim 13, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitations in the mind but for the recitation of generic computer components. That is, other than reciting an apparatus comprising units to perform the limitations, nothing in the claim elements precludes the steps from practically being performed in the mind. 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. Accordingly, the claims recite an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the units are recited at a high-level of generality (i.e., as generic computer components performing generic computer functions of obtaining data, acquiring data, and determining data) such that it amounts no more than mere instructions to apply the exception using generic computer components. Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claims are directed to an abstract idea.
Thus, taken alone, the additional elements do not amount to significantly more than the above-identified judicial exception (the abstract idea). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. For instance, there is no indication that the additional elements, when considered as a whole, reflect an improvement in the functioning of a computer or an improvement to another technology or technical field, apply or use the above-noted judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, implement/use the above-noted judicial exception with a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing, 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 not more than a drafting effort designed to monopolize the exception (see MPEP § 2106.05). Their collective functions merely provide conventional computer implementation.
Claims 2-12, 14, and 15 are ultimately dependent from Claim(s) 1 and 13 and include all the limitations of Claim(s) 1 and 13. Therefore, claim(s) 2-12, 14, and 15 recite the same abstract idea. Claims 2-12, 14, and 15 describe further limitations regarding wherein the first time interval is arranged with priority over the second time interval; determining whether a size of the difference value is greater than the threshold value and determining a sign of the difference value; obtaining the first adjustment result as a adjustment result which maintains the first sampling rate based on that the size of the different value is less than or equal to the threshold value; obtaining the first adjustment result as a adjustment result which increases the first sampling rate based on that the difference value is greater than the threshold value and the sign of the difference value is a first sign; obtaining the first adjustment result as a adjustment result which decreases the first sampling rate based on that the difference value is greater than the threshold value and the sign of the difference value is a second sign; at least one of an increment and a decrement of the first sampling rate is determined based on the size of the difference value; acquiring at least one third indicator value; acquiring at least one fourth indicator value; obtaining a second comparison result; obtaining a second adjustment result for the first sampling rate based on the second comparison result; determining a second variable sampling rate for the first biometric data based on the second adjustment result; determining a third variable sampling rate; determining the third variable sampling rate applied a weight related to each of the first variable sampling rate determined based on the first biometric data and the at least one second variable sampling rate determined based on the at least one second biometric data; wherein, in the determining of the third variable sampling rate, a set number of variable sampling rates among the first variable sampling rate determined based on the first biometric data and the at least one second variable sampling rate determined based on the at least one second biometric data are selected according to a preset condition, and the third variable sampling rate is determined based on the selected variable sampling rate; and collect the first biometric data according to the first variable sampling rate or the third variable sampling rate. These are all just further describing the abstract idea recited in claims 1 and 13, without adding significantly more.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply the exception using generic computer components. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. The claims are not patent eligible.
Step 2B:
Regarding Step 2B, the independent claims do not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for reasons the same as those discussed above with respect to determining that the claim does not integrate the abstract idea into a practical application.
Regarding the additional limitations directed to units obtaining and acquiring data, all of which the Examiner submits merely add insignificant extra-solution activity to the abstract idea or are claimed in a merely generic manner (e.g., at a high level of generality), the Examiner further submits that such steps are not unconventional as they merely consist of receiving and transmitting data over a network and/or storing and retrieving information in memory. See MPEP 2106.05(d)(II).
The dependent claims do not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for the same reasons to those discussed above with respect to determining that the dependent claims do not integrate the at least one abstract idea into a practical application.
Therefore, claims 1-15 are ineligible under 35 USC §101.
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 8-12, 14, and 15 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 8 recites the limitation "wherein the obtaining of the at least one second biometric data includes" in lines 1-2. Note that there is no “at least one second biometric data” in claim 1. As such, there is insufficient antecedent basis for the limitation “the at least one second biometric data” recited in claims 8-11, and the claims are therefore rejected.
Claim 14 recites the limitation "the first time interval of each of the at least one second biometric data" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation "the second time interval of each of the at least one second biometric data" in lines 5-6. There is insufficient antecedent basis for this limitation in the claim.
Claims 12 and 15 incorporate the deficiencies of claims 8 and 14, through dependency, and are therefore also rejected.
Claim Objections
Claims 3-6 are objected to because of the following informalities: claim 3 recites “the set threshold value” and “the threshold value.” Claims 4-6 recite “the threshold value.” However, independent claim 1 recites “threshold values set.” Examiner requests using consistent language throughout the claims to clarify if there is one threshold value or more than one threshold value. Appropriate correction is required.
Claims 9 and 15 are objected to because of the following informalities: claims 9 and 15 recite “at least one second variable sampling rate.” It is unclear if the “at least one second variable sampling rate” is the same as the “a second variable sampling rate” recited in claims 8 and 14, or if it is a different rate. Appropriate correction is required.
Claims 8 and 14 are objected to because of the following informalities: change “the third indicator value and the fourth indicator value” to “the at least one third indicator value and the at least one fourth indicator value.“ Appropriate correction is required.
Claims 1 and 13 are objected to because of the following informalities: change “the first indicator value and the second indicator value” to “the at least one first indicator value and the at least one second indicator value.” Appropriate correction is required.
Claim 5 is objected to because of the following informalities: delete the comma at line 4. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: change “the third variable sampling rate” to “a third variable sampling rate” at line 3 and “a third variable sampling rate “ to “the third variable sampling rate “ at line 4. Appropriate correction is required.
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) 1-7 and 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zade et al. (US 2022/0379029 A1)
(A) Referring to claim 1, Zade discloses A method of controlling biometric data, comprising (para. 105 & 58 of Zade; receive commands that cause the CGM to increase (or decrease) the frequency of sampling of blood glucose and outputting the blood glucose measurement values obtained from sampling the blood of the user. In addition, after selection of the different set time interval, the processor may replace the set time interval with the selected different set time interval for future receipt of blood glucose measurement values.):
obtaining a first biometric data collected according to a first sampling rate (Fig. 2, para. 44, 45, and 84 of Zade; In block 202, the processor of the wearable drug delivery device executing process 200 may be operable to receive data, such as a blood glucose measurement value, from an analyte sensor remote from or integrated with the wearable drug delivery device at set time interval and may receive a number of blood glucose measurement values over a period of time.);
acquiring at least one first indicator value related to a first time interval of the first biometric data (Fig. 2, para. 44 & 45 of Zade; In block 202, the processor of the wearable drug delivery device executing process 200 may be operable to receive data, such as a blood glucose measurement value, from an analyte sensor remote from or integrated with the wearable drug delivery device at set time interval and may receive a number of blood glucose measurement values over a period of time.);
acquiring at least one second indicator value related to a second time interval of the first biometric data (Fig. 2 & para. 44-46 of Zade; The set time interval may, for example, be selected by the processor and the period of time may span multiple set time intervals, such as 15 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, or the like. In block 204, the processor determines a rate of change of the blood glucose measurement values received from the analyte sensor over a period of time that may span multiple time intervals. For example, the CGM may output a blood glucose measurement value at time 102. This processor may identify the blood glucose measurement value associated with time 102 as CGM (t=0)), but as time proceeds and the next blood glucose measurement value is received at time 104, the processor may relabel the blood glucose measurement value at time 102 as CGM (t=(−)1) and store the relabeled blood glucose measurement value in a memory.);
obtaining a first comparison result based on (ⅰ) a difference value between the at least one first indicator value and the at least one second indicator value and (ⅱ) threshold values set related to the first indicator value and the second indicator value (Fig. 2, para. 46-50 of Zade; In block 204, the processor determines a rate of change of the blood glucose measurement values received from the analyte sensor over a period of time that may span multiple time intervals. As the blood glucose measurement values are received and stored, the processor, when determining the rate of change of blood glucose measurement values over the period of time that spans multiple time intervals, may be operable to utilize a sample threshold equation to determine whether a rate of change between the blood glucose measurement values at the different times exceeds a sample threshold value. Alternatively, the processor may be operable to utilize several select samples (e.g., blood glucose measurement values from the past five times (e.g., time=(−) 4 to time=0) or the like in the sample threshold equation to determine whether a rate of change between blood glucose measurement values at different times exceeds a sample threshold value.);
obtaining a first adjustment result for the first sampling rate based on the first comparison result (para. 48-55 of Zade; the processor may select a different set time interval based on the CGM output settings and the wearable drug delivery device receipt settings as well as the determined rate of change. For example, the processor may consider the CGM output settings are already at their highest rate of output of blood glucose measurement values, while the wearable drug delivery device settings are at a more relaxed rate for receiving the blood glucose measurement values from the CGM. As such, in response to a negative rate of change, the processor may determine that the wearable drug delivery device settings (e.g., set time interval) are to be adjusted to increase the frequency at which the wearable drug delivery device is set to receive the more frequent outputs from the CGM. For example, the frequency at which the wearable drug delivery device is set to receive outputs from the CGM may be increased to match or closely match the output frequency of the CGM.); and
determining a first variable sampling rate for the first biometric data based on the first adjustment result (para. 55-57 & 68 of Zade; in response to a negative rate of change, the processor may determine that the wearable drug delivery device settings (e.g., set time interval) are to be adjusted to increase the frequency at which the wearable drug delivery device is set to receive the more frequent outputs from the CGM. For example, the frequency at which the wearable drug delivery device is set to receive outputs from the CGM may be increased to match or closely match the output frequency of the CGM. The CGM may be set to output values at an increased frequency, but the processor of the wearable drug delivery device may be operable to, via selectable settings of the wearable drug delivery device, receive the outputted blood glucose measurement values at the set interval. For example, the wearable drug delivery device may have a user interface used to set up the CGM, or a controller may have a user interface that enables, via a communication session with the CGM an initial set up of the CGM settings and the wearable device or controller settings. During the setup of the CGM, the respective user interface may enable the user (or guardian or health care provider) to select a set time interval when the wearable drug delivery device (or controller) receives the blood glucose measurement values from the CGM. Alternatively, the setting of the output of the blood glucose measurement values from the CGM may be according to a default setting of a set time interval, such as every 5 minutes. Either the user-selected set time interval or the default set time interval may correspond to the set time interval for the AGC application to receive the blood glucose measurement values from the CGM.).
(B) Referring to claim 2, Zade discloses wherein the first time interval is arranged with priority over the second time interval (para. 45-47, 53, and 69 of Zade).
(C) Referring to claim 3, Zade discloses wherein the obtaining of the first comparison result based on the set threshold value includes: determining whether a size of the difference value is greater than the threshold value; and determining a sign of the difference value based on that the size of the difference value is greater than the threshold value (para. 47-50, 54, 61, and 29 of Zade).
(D) Referring to claim 4, Zade discloses wherein the obtaining of the first adjustment result for the first sampling rate includes obtaining the first adjustment result as a adjustment result which maintains the first sampling rate based on that the size of the different value is less than or equal to the threshold value (para. 47-55 of Zade).
(E) Referring to claim 5, Zade discloses wherein the obtaining of the first adjustment result for the first sampling rate includes obtaining the first adjustment result as a adjustment result which increases the first sampling rate based on that the difference value is greater than the threshold value and the sign of the difference value is a first sign (para. 47-55, 58, 61, and 62 of Zade).
(F) Referring to claim 6, Zade discloses wherein the obtaining of the first adjustment result for the first sampling rate includes obtaining the first adjustment result as a adjustment result which decreases the first sampling rate based on that the difference value is greater than the threshold value and the sign of the difference value is a second sign (para. 47-55, 58, and 61 of Zade).
(G) Referring to claim 7, Zade discloses wherein, in the obtaining the first adjustment result for the first sampling rate, at least one of an increment and a decrement of the first sampling rate is determined based on the size of the difference value (para. 47-55, 58, 61, and 62 of Zade).
(H) Referring to claim 13, Zade discloses An apparatus for controlling biometric data, comprising (see Fig. 6, para. 105, 116, & 58 of Zade; receive commands that cause the CGM to increase (or decrease) the frequency of sampling of blood glucose and outputting the blood glucose measurement values obtained from sampling the blood of the user. In addition, after selection of the different set time interval, the processor may replace the set time interval with the selected different set time interval for future receipt of blood glucose measurement values.):
an obtaining unit that obtains first biometric data collected according to a first sampling rate (Figures 2 & 6, para. 44, 45, and 84 of Zade; In block 202, the processor of the wearable drug delivery device executing process 200 may be operable to receive data, such as a blood glucose measurement value, from an analyte sensor remote from or integrated with the wearable drug delivery device at set time interval and may receive a number of blood glucose measurement values over a period of time.);
an indicator acquisition unit that acquires at least one first indicator value related to a first time interval of the first biometric data and acquires at least one second indicator value related to a second time interval of the first biometric data (Figures 2 & 6, para. 44-46 of Zade; In block 202, the processor of the wearable drug delivery device executing process 200 may be operable to receive data, such as a blood glucose measurement value, from an analyte sensor remote from or integrated with the wearable drug delivery device at set time interval and may receive a number of blood glucose measurement values over a period of time. The set time interval may, for example, be selected by the processor and the period of time may span multiple set time intervals, such as 15 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, or the like. In block 204, the processor determines a rate of change of the blood glucose measurement values received from the analyte sensor over a period of time that may span multiple time intervals. For example, the CGM may output a blood glucose measurement value at time 102. This processor may identify the blood glucose measurement value associated with time 102 as CGM (t=0)), but as time proceeds and the next blood glucose measurement value is received at time 104, the processor may relabel the blood glucose measurement value at time 102 as CGM (t=(−)1) and store the relabeled blood glucose measurement value in a memory.);
a comparison unit that obtains a first comparison result based on (ⅰ) a difference value between the at least one first indicator value and the at least one second indicator value and (ⅱ) threshold values set related to the first indicator value and the second indicator value (Figures 2 & 6, para. 46-50 of Zade; In block 204, the processor determines a rate of change of the blood glucose measurement values received from the analyte sensor over a period of time that may span multiple time intervals. As the blood glucose measurement values are received and stored, the processor, when determining the rate of change of blood glucose measurement values over the period of time that spans multiple time intervals, may be operable to utilize a sample threshold equation to determine whether a rate of change between the blood glucose measurement values at the different times exceeds a sample threshold value. Alternatively, the processor may be operable to utilize several select samples (e.g., blood glucose measurement values from the past five times (e.g., time=(−) 4 to time=0) or the like in the sample threshold equation to determine whether a rate of change between blood glucose measurement values at different times exceeds a sample threshold value.);
a result obtaining unit that obtains a first adjustment result for the first sampling rate based on the first comparison result (Figures 2 & 6, para. 48-55 of Zade; the processor may select a different set time interval based on the CGM output settings and the wearable drug delivery device receipt settings as well as the determined rate of change. For example, the processor may consider the CGM output settings are already at their highest rate of output of blood glucose measurement values, while the wearable drug delivery device settings are at a more relaxed rate for receiving the blood glucose measurement values from the CGM. As such, in response to a negative rate of change, the processor may determine that the wearable drug delivery device settings (e.g., set time interval) are to be adjusted to increase the frequency at which the wearable drug delivery device is set to receive the more frequent outputs from the CGM. For example, the frequency at which the wearable drug delivery device is set to receive outputs from the CGM may be increased to match or closely match the output frequency of the CGM.); and
a sampling rate determination unit that determines a first variable sampling rate for the first biometric data based on the first adjustment result (Fig. 6, para. 55-57 & 68 of Zade; in response to a negative rate of change, the processor may determine that the wearable drug delivery device settings (e.g., set time interval) are to be adjusted to increase the frequency at which the wearable drug delivery device is set to receive the more frequent outputs from the CGM. For example, the frequency at which the wearable drug delivery device is set to receive outputs from the CGM may be increased to match or closely match the output frequency of the CGM. The CGM may be set to output values at an increased frequency, but the processor of the wearable drug delivery device may be operable to, via selectable settings of the wearable drug delivery device, receive the outputted blood glucose measurement values at the set interval. For example, the wearable drug delivery device may have a user interface used to set up the CGM, or a controller may have a user interface that enables, via a communication session with the CGM an initial set up of the CGM settings and the wearable device or controller settings. During the setup of the CGM, the respective user interface may enable the user (or guardian or health care provider) to select a set time interval when the wearable drug delivery device (or controller) receives the blood glucose measurement values from the CGM. Alternatively, the setting of the output of the blood glucose measurement values from the CGM may be according to a default setting of a set time interval, such as every 5 minutes. Either the user-selected set time interval or the default set time interval may correspond to the set time interval for the AGC application to receive the blood glucose measurement values from the CGM.).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The cited but not applied prior art teaches device and method to determine blood glucose sensing data (US 2020/0008750 A1).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LENA NAJARIAN whose telephone number is (571)272-7072. The examiner can normally be reached Monday - Friday 9:30 am-6 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mamon Obeid can be reached at (571)270-1813. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LENA NAJARIAN/Primary Examiner, Art Unit 3687
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