Detailed Notice
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 .
Status of Claims
Claims 1-20 are currently pending.
Claims 1 and 13 are amended.
Claims 1-20 are rejected.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Step 1:
In the instant case, claims 1-12 are directed toward a computer system (i.e. machine) and claims 13-20 are directed toward a method (i.e., process). Thus, each of the claims falls within one of the four statutory categories. Nevertheless, the claims fall within the judicial exception of an abstract idea.
Step 2A—Prong 1:
Independent claims 1 and 13 recites steps that, under their broadest reasonable interpretations, cover performance of the limitations of a certain method of organizing human activity but for the recitation of generic computer components.
Claim 1 recites: “A computer system, comprising: one or more processors; and memory storing instructions which, when executed by the one or more processors, cause the computer system to perform operations comprising: generating simulated measurements for a first sensor based on historical measurements associated with a second sensor, wherein: the second sensor has a different design or configuration than the first sensor, the historical measurements comprise electrochemical signal values, including one or more of electrical current values, electrochemical impedance values, or counter electrode voltage values that represent changes in a physiological condition as observed by different instances of the second sensor, and generating the simulated measurements comprises applying a translation model to convert the historical measurements into measurements that would have been produced by the first sensor, wherein the translation model is determined based on relationships between concurrent measurement data obtained from paired instances of the first sensor and the second sensor monitoring common patients, the concurrent measurement data temporally correlating electrochemical responses of the paired instances to common physiological conditions; determining an estimation model using the simulated measurements, wherein the estimation model is configured to estimate a value of the physiological condition given an actual measurement from the first sensor, wherein: the estimation model is trained based on a plurality of training examples, wherein a training example includes (i) a calibration data point associated with the historical measurements that functions as an output variable of the training example, the calibration data point including a ground-truth clinical measurement value and (ii) one of the simulated measurements that is temporally associated with the calibration data point that functions as an input variable of the training example, wherein the determined estimation model addresses limited availability of measurement data for the first sensor by leveraging the historical measurement data from the second sensor; and causing calibration of a corresponding instance of the first sensor by providing one or more electronic devices with access to the estimation model for determination of calibrated glucose measurement values without requiring fingerstick measurements, the one or more electronic devices comprising at least one device configured to apply the estimation model to a measurement from the corresponding instance of the first sensor, wherein the estimation model maps the measurement to a calibrated glucose measurement value”.
The limitations of generating simulated measurements… based on historical measurements…, the historical measurements comprise electrochemical signal values, including one or more of electrical current values, electrochemical impedance values, or counter electrode voltage values that represent changes in a physiological condition as observed by different instances, and generating the simulated measurements… to convert the historical measurements into measurements that would have been produced, wherein the translation model is determined based on relationships between concurrent measurement data obtained from paired instances of the first sensor and the second sensor monitoring common patients, the concurrent measurement data temporally correlating electrochemical responses of the paired instances to common physiological conditions; using the simulated measurements…, estimate a value of the physiological condition given an actual measurement…, wherein a training example includes (i) a calibration data point associated with the historical measurements that functions as an output variable of the training example, the calibration data point including a ground-truth clinical measurement value and (ii) one of the simulated measurements that is temporally associated with the calibration data point that functions as an input variable of the training example, wherein the determined estimation model addresses limited availability of measurement data… by leveraging the historical measurement data; and causing calibration of a corresponding instance… with access to the estimation model for determination of calibrated glucose measurement values without requiring fingerstick measurements…, maps the measurement to a calibrated glucose measurement value, given the broadest reasonable interpretation, cover the abstract idea of a certain method of organizing human activity because they recite managing personal behavior or relationships or interactions between people (i.e. social activities, teaching, and following rules or instructions—in this case the aforementioned steps recite a process of generate, using, observe, convert, causing, map, leveraging, and training, which is properly interpreted as a “personal behavior”), but instead automates the process via a computer model, e.g. see MPEP 2106.04(a)(2). Additionally, the limitations of the estimation model is trained based on a plurality of training examples, wherein a training example includes (i) a calibration data point associated with the historical measurements that functions as an output variable of the training example, the calibration data point including a ground-truth clinical measurement value and (ii) one of the simulated measurements that is temporally associated with the calibration data point that functions as an input variable of the training example, given their broadest reasonable interpretation, amount to mathematical concepts. Any limitations not identified above as part of the abstract idea are deemed “additional elements”, and will be discussed in further detail below.
Further, the abstract idea of claim 13 is identical as the abstract idea of claim 1. This limitation, given the broadest reasonable interpretation, also falls under the abstract idea of a certain method of organizing human activity because it recites managing personal behavior or relationships or interactions between people, and/or mathematical concepts.
Dependent claims 2-12 and 14-20 include other limitations, as well as specific step of data to be processed, received, and applied, but these only serve to further limit the abstract idea and do not add and additional elements, and hence are nonetheless directed towards fundamentally the same abstract idea as independent claims 1 and 13. However, recitation of an abstract idea is not the end of the 35 U.S.C. 101 analysis. Each of the claims must be analyzed for additional elements that indicate the abstract idea is integrated into a practical application to determine whether the claim is considered to be “directed to” an abstract idea.
Step 2A—Prong 2:
Claims 1-20 are not integrated into a practical application because the additional elements (i.e. any limitations that are not identified as part of the abstract idea) amount to no more than limitations which:
Amount to mere instructions to apply an exception—for example, the recitation of “processors”, “memory”, “computer system”, “sensor”, “translation model”, “estimation model”, “electronic devices”, and “device”, which amount to merely invoking a computer as a tool to perform the abstract idea, e.g. see FIG. 1, FIG. 3, and [0007]-[0011], of the present specification, and see further MPEP 2106.05(f);
Generally linking the abstract idea to a particular technological environment or field of use, for example, “one or more processors; and memory storing instructions which, when executed by the one or more processors, cause the computer system to perform operations comprising”, “for a first sensor”, “associated with a second sensor, wherein: the second sensor has a different design or configuration than the first sensor”, “of the second sensor”, “comprises applying a translation model”, “by the first sensor”, “determining an estimation model”, “wherein the estimation model is configured to”, “from the first sensor, wherein: the estimation model is trained based on a plurality of training examples”, “for the first sensor”, “from the second sensor”, “of the first sensor by providing one or more electronic devices”, and “the one or more electronic devices comprising at least one device configured to apply the estimation model to a measurement from the corresponding instance of the first sensor, wherein the estimation model”, which amounts to limiting the abstract idea to the field of technology/the environment of computers, see MPEP 2106.05(h); and/or
Merely acquiring information for further analysis by the system and the particular manner of acquisition is not described or shown to be important, for example, “obtained from paired instances of the first sensor and the second sensor monitoring common patients”, which amounts to insignificant extra-solution activity in the form of mere data gathering because it merely functions tangentially to the main idea of the invention and serves only to bring in the data necessary for the inventions main analysis, see MPEP 2106.05(g).
Additionally, dependent claims 2-12 and 14-20 include other limitations, but as stated above, the limitations recited by these claims do not include any additional elements beyond those already recited in independent claims 1 and 13, and hence also do not integrate the aforementioned abstract idea into a practical application.
Step 2B:
The claims do not include additional elements that are sufficient to amount to “significantly more” than the judicial exception because the additional elements (i.e. the elements other than the abstract idea), as stated above, are directed towards no more than limitations that amount to mere instructions to apply the exception, and/or generally link the abstract idea to a particular technological environment or field of use, which even when reevaluated under the considerations of Step 2B of the analysis, do not amount to “significantly more” than the abstract idea.
Dependent claims 2-12 and 14-20 include other limitations, but none of these limitations are deemed significantly more than the abstract idea because, as stated above, the aforementioned dependent claims do not recite any additional elements not already recited in independent claims 1 and 13, and hence do not amount to “significantly more” than the abstract idea.
Additionally, the additional elements (i.e., “obtained from paired instances of the first sensor and the second sensor monitoring common patients”), add extra solution activity, which comprises limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in a particular field as demonstrated by:
Relevant court decisions (See MPEP 2106.05(d)(II)):
Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network); but see DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1258, 113 USPQ2d 1097, 1106 (Fed. Cir. 2014) (“Unlike the claims in Ultramercial, the claims at issue here specify how interactions with the Internet are manipulated to yield a desired result‐‐a result that overrides the routine and conventional sequence of events ordinarily triggered by the click of a hyperlink.” (emphasis added)).
Thus, taken alone, the additional elements do not amount to significantly more than the abstract idea identified above. Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually, and there is no indication that the combination of elements improves the functioning of a computer or improves any other technology, and their collective functions merely provide conventional computer implementation.
Therefore, whether taken individually or as an ordered combination, claims 1-20 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Response to Arguments
Applicant's arguments filed 02/11/2026 have been fully considered but they are not persuasive. Regarding the 35 U.S.C. 101 Rejection, Applicant argues the now amended claims do not recite a judicial exception in the form of a mental process, certain method of organizing human activity, and mathematical concepts. Examiner respectfully disagrees. The claims recite “generating simulated measurements…”, “determining… using the simulate measurements…”, and “causing calibration…” are all steps that recite the abstract idea of a certain method of organizing human activity, more specifically instructions that person can perform via pen and paper or through interactions between a person, persons, or via computer tools (see MPEP 2106.04(a)(2)II: “Finally, the sub-groupings encompass both activity of a single person (for example, a person following a set of instructions or a person signing a contract online) and activity that involves multiple people (such as a commercial interaction), and thus, certain activity between a person and a computer (for example a method of anonymous loan shopping that a person conducts using a mobile phone) may fall within the “certain methods of organizing human activity” grouping. It is noted that the number of people involved in the activity is not dispositive as to whether a claim limitation falls within this grouping. Instead, the determination should be based on whether the activity itself falls within one of the sub-groupings”). Furthermore, the training of the estimation model by the training examples can be interpreted at mathematical concepts that a person would perform in sensor calibration (see MPEP 2106.04(a)(2)A: “Examples of mathematical relationships recited in a claim include”). Furthermore, Applicant’s argument pertaining to the abstract idea of a mental step is moot because Examiner never asserted the limitations recite that abstract idea of mental process. Therefore, the claims still recite a judicial exception(s).
Applicant further argues the claims implement an alleged judicial exception into a practical application. Applicant argues the claimed invention enables calibration of new sensor designs without requiring extensive new clinical trials, thereby improving sensor development cycles. Applicant also argues the elimination of fingerstick calibration requirements through the claimed estimation model is a concrete technological benefit that improves the function of glucose sensor technology. Applicant also argues the specific methodology of monitoring common patients with concurrent paired sensor and temporally correlating their electrochemical responses is a particular technological approach to cross-sensor calibration that is not a generic or conventional processing technique. Applicant also argues the specific paired sensor correlation methodology recited in the amended claim is analogous to Thales Visionix, Inc. v. United States, 850 F.3d 1343 (Fed. Cir. 2017) (hereinafter Thales). Examiner respectfully disagrees. The calibration of sensors without new clinical trial data is not a technological improvement, but an improvement upon the judicial exception/abstract idea itself. An abstract idea cannot integrate itself into practical application. Additionally, generation of simulated measurements to use instead of new clinical trial data is being linked/applied to the additional element (models), which is also not an improvement. Furthermore, the claims are not analogous to Thales because the claims still recite an abstract idea, whereas the court determined that Thales did not (see MPEP 2106.04(a): “See, e.g., Thales Visionix, Inc. v. United States, 850 F.3d 1343, 121 USPQ2d 1898, 1902 (Fed. Cir. 2017) (“That a mathematical equation is required to complete the claimed method and system does not doom the claims to abstraction”). The courts also determined the claims to a particular configuration of inertial sensors and a particular method of using the raw data from the sensors in order to more accurately calculate the position and orientation of an object on a moving platform did not merely recite “the abstract idea of using ‘mathematical equations for determining the relative position of a moving object to a moving reference frame’”, which is not the same as the present claims. Therefore, the additional elements do not integrate the judicial exception into a practical application.
Applicant further argues the claims recite features that amount to significantly more than any alleged judicial exception. More specifically, Applicant argues the claims recite a specific ordered combination of features that is not well-understood, routine, or conventional in the field of sensor calibration. Applicant argues the non-conventional ordered combination recited in the amended claims is analogous to BASCOM Global Internet v. AT&T Mobility LLC, 827 F.3d 1341 (Fed Cir. 2016), hereinafter BASCOM. Examiner respectfully disagrees. BASCOM was eligible under Step 2b because the combination of additional elements amounted to significantly more. More specifically, the filtering (both local and server-side) performed by the remote ISP server while still having individual customization per user, was shown to overcome the 101 Rejection. Additionally, the additional elements are recited at a high level and are being linked or applied to the judicial exception, which does not amount to significantly more (see MPEP 2106.05(a)-(d) and MPEP 2106.05(h): “employing generic computer functions to execute an abstract idea, even when limiting the use of the idea to one particular environment, does not add significantly more, similar to how limiting the abstract idea in Flook to petrochemical and oil-refining industries was insufficient”).The current claims do not use similar additional elements and filtering methods. Therefore, the claims are not similar to BASCOM, and the 35 U.S.C. 103 Rejection is maintained.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/R.S.S./Examiner, Art Unit 3681
/PETER H CHOI/Supervisory Patent Examiner, Art Unit 3681
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