DETAILED ACTION
Acknowledgements
The present application is being examined under the pre-AIA first to invent provisions.
Claims 21-40 are pending.
This action is Non-Final.
Internet communication is authorized by the filing of 11/5/2024.
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 21, 27-30, 36-39 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. The claim(s) recite(s):
Claim 21
converting at least the first data to analyte data using a conversion function based at least on one or more parameters (mathematical concepts/mental processes including pen and paper)
determining, based at least on the first data and the second data, a measure of an ability of the transcutaneous analyte sensor to produce calibrated sensor data that accurately predicts an analyte concentration in a host, wherein the measure is different from the one or more parameters (mathematical concepts/mental processes including pen and paper); and
calibrating the transcutaneous analyte sensor based at least on the measure of the ability of the transcutaneous analyte sensor to produce calibrated sensor data that accurately predicts the analyte concentration in the host (mathematical concepts/mental processes including pen and paper)
Claim 30
converting at least the first data to analyte data using a conversion function based at least on one or more parameters (mathematical concepts/mental processes including pen and paper)
determining, based at least on the first data and the second data, a measure of an ability of the transcutaneous analyte sensor to produce calibrated sensor data that accurately predicts an analyte concentration in a host, wherein the measure is different from the one or more parameters (mathematical concepts/mental processes including pen and paper)
calibrating the transcutaneous analyte sensor based at least on the measure of the ability of the transcutaneous analyte sensor to produce calibrated sensor data that accurately predicts the analyte concentration in the host (mathematical concepts/mental processes including pen and paper)
Claim 39
converting at least the first data to analyte data using a conversion function based at least on one or more parameters (mathematical concepts/mental processes including pen and paper);
determining, based at least on the first data and the second data, a measure of an ability of the transcutaneous analyte sensor to produce calibrated sensor data that accurately predicts an analyte concentration in a host, wherein the measure is different from the one or more parameters (mathematical concepts/mental processes including pen and paper); and
calibrating the transcutaneous analyte sensor based at least on the measure of the ability of the transcutaneous analyte sensor to produce calibrated sensor data that accurately predicts the analyte concentration in the host (mathematical concepts/mental processes including pen and paper)
These claim limitations fall within the identified groupings of abstract ideas:
Mathematical Concepts:
mathematical relationships
mathematical formulas or equations
mathematical calculations
Mental Processes
concepts performed in the human mind (including an observation, evaluation, judgment, opinion)
This judicial exception is not integrated into a practical application because:
Under the step 2A, analysis is conducted on the additional features of the claim. Under this analysis, the additional features beyond the judicial exception are:
Claim 21
receiving sensor data from a transcutaneous analyte sensor comprising a first electrode configured to generate an analyte signal and a second electrode configured to generate a non- enzyme background signal, wherein the sensor data includes first data associated with the analyte signal and second data associated with the non-enzyme background signal (insignificant extra solution data gathering)
Claim 30
one or more processors (generic computer structures used as tools for implementation)
a memory storing instructions that are executable by the one or more processors to cause the system to perform operations including: (generic computer structures used as tools for implementation)
receiving sensor data from a transcutaneous analyte sensor comprising a first electrode configured to generate an analyte signal and a second electrode configured to generate a non-enzyme background signal, wherein the sensor data includes first data associated with the analyte signal and second data associated with the non-enzyme background signal (insignificant extra solution data gathering)
Claim 39
a non-transitory computer storage component storing instructions that are executable by one or more processors to perform operations comprising: (generic computer structures used as tools for implementation)
receiving sensor data from a transcutaneous analyte sensor comprising a first electrode configured to generate an analyte signal and a second electrode configured to generate a non- enzyme background signal, wherein the sensor data includes first data associated with the analyte signal and second data associated with the non-enzyme background signal (insignificant extra solution data gathering)
These features in the claim do not integrate the exception into a practical application of the exception as the additional elements in the claim do not apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is no more than a drafting effort designed to monopolize the exception.
Limitation concepts that are indicative of integration into a practical application:
Improvements to the functioning of a computer, or to any other technology or technical field - see MPEP 2106.05(a)
Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition – see Vanda Memo
Applying the judicial exception with, or by use of, a particular machine - see MPEP 2106.05(b)
Effecting a transformation or reduction of a particular article to a different state or thing - see MPEP 2106.05(c)
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 - see MPEP 2106.05(e) and Vanda Memo
Limitation concepts that are not indicative of integration into a practical application:
Adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f)
Adding insignificant extra-solution activity to the judicial exception - see MPEP 2106.05(g)
Generally linking the use of the judicial exception to a particular technological environment or field of use – see MPEP 2106.05(h)
Under Step 2B, the claim limitations are evaluated for an inventive concept. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because, when considered separately and in combination, they do not add significantly more to the exception. Analyzing the additional claim limitations individually, the additional limitation that is not directed to the abstract idea are the same as those identified above in 2A. Such limitations related to the sensors are recognized by the courts as routine data gathering in order to input data to the mathematical algorithm/mental process, and thus, do not add a meaningful limitation to the method as it would be routinely used by those of ordinary skill in the art in order to apply the mathematical algorithm. In addition, these sensor structures are known from US 6275717, US 6931327, US 2005/0192557, and US 2005/0027463, and in general producing the expected related data signals. The method does not contain any computing structure, such that the steps can all be analog/mental processing of the equation from the data gathered which further supports that the claims are directed to a judicial exception without significantly more. The computer structures cited above are claimed as performing generic computer functions routinely used in computer applications. Generic computer components recited as performing generic computer functions that are well-understood, routine and conventional activities amount to no more than implementing the abstract idea with a computerized system. The dependent claims are directed to further aspects of the judicial exception and/or details related to the data gathering. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. Therefore, analyzing the claims as an ordered combination under the Mayo/Alice analysis the features claimed are directed to patent ineligible limitations. The additional limitations recited in the dependent claims 22, 31, 40 are sufficient.
Allowable Subject Matter
Claims 22-26, 31-35, 40 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The most pertinent art of record teaches similar concepts of calibrating sensors, and determining accuracy including US 2005/0004439, US 2008/0161664, US 6,919,566, US 2006/0258929, US 2005/0027180, but for the claimed priority date, the art of record fails to teach, suggest, or reasonably make obvious the features of: wherein the sensor data includes first data associated with the analyte signal and second data associated with the non-enzyme background signal; converting at least the first data to analyte data using a conversion function based at least on one or more parameters; determining, based at least on the first data and the second data, a measure of an ability of the transcutaneous analyte sensor to produce calibrated sensor data that accurately predicts an analyte concentration in a host, wherein the measure is different from the one or more parameters; and calibrating the transcutaneous analyte sensor based at least on the measure of the ability of the transcutaneous analyte sensor to produce calibrated sensor data that accurately predicts the analyte concentration in the host, in view of the remaining elements of the claims, and when considered as a whole.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL R BLOCH whose telephone number is (571)270-3252. The examiner can normally be reached M-F 11-8 EST.
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/MICHAEL R BLOCH/Primary Examiner, Art Unit 3791
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