DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are: “data processing device” and “receiver unit” in claims 1 and 9; and “data processing terminal” and “drug delivery device” in claims 5 and 14.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
According to the specification, the data processing device is a portable data processing device or computer such as a laptop computer or handheld device (e.g., personal digital assistants, smartphone, mp3player); the receiver unit includes an analog interface section including an RF receiver and an antenna, and is any one of a smartphone, a wristwatch, or an armband; the data processing terminal may include a personal computer, portable data processing device, or computers such as a laptop computer or a handheld device; and the drug delivery device may include an infusion device such as an insulin infusion pump.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth 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 1-4, 6-13, 15, and 16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 9 follows.
Regarding claim 9, the claim recites a series of steps or acts, including receiving data from a sensor, processing the data, making determinations based on the processed data, and displaying the determinations. Thus, the claim is directed to a process, which is one of the statutory categories of invention.
The claim is then analyzed to determine whether it is directed to any judicial exception. The steps of determining a value of a glucose level concentration based on a first weighted combination of one or more first processed data points and one or more second processed data points, and determining a rate of change of the concentration based on a second weighted combination of the one or more first processed data points and the one or more second processed data points set forth a judicial exception. These steps describe concepts performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea.
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Claim 9 recites displaying the determined concentration value of the glucose level and the determined rate of change of the concentration, which is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The display of the concentration value and of the rate of change does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the displayed concentration value or rate of change, nor does the method use a particular machine to perform the Abstract Idea.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites additional steps of receiving a first data stream comprising data points, generating a second data by processing the first data stream, generating one or more first processed data points by applying one or more first data processing algorithms to the data points of the second data stream, and generating one or more second processed data points by applying one or more second data processing algorithms to the data points of the second data stream. The receiving and generating steps are each recited at a high level of generality such that they amount to insignificant presolution activity, e.g., mere data gathering steps necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes the steps from well-understood, routine, and conventional data gathering and processing activity engaged in by medical professionals prior to Applicant's invention.
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
Regarding claim 1, the device recited in the claim is a generic device comprising generic components configured to perform the Abstract Idea. The recited glucose sensor is a generic sensor configured to perform pre-solutional data gathering activity, the recited data processing device and receiver unit are also generically claimed devices configured to perform routine data gathering and processing, and the data processing device, a computer, is also configured to perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an Abstract Idea does not integrate the Abstract Idea into a practical application.
The dependent claims also fail to add something more to the abstract independent claims as they generally recite method steps pertaining to highly general data gathering and processing steps. The receiving, generating, and determining steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
It is noted that claims 5 and 14, by virtue of effecting a particular treatment based on the determined concentration of the glucose level, recite statutory subject matter.
Allowable Subject Matter
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hayter et al.’761 (US Pub No. 2008/0287761) discloses a method for monitoring interstitial glucose using a glucose monitoring system including a glucose sensor configured to have at least a portion disposed in interstitial fluid of a user (page 5, section [0057], page 10, section [0113]); and a data processing device, a receiver unit, and a drug delivery device (page 2, sections [0027-0031], page 3, section [0038]) communicatively coupled with the glucose sensor, the method comprising: generating, using the data processing device of the glucose monitoring system, one or more first data points from a plurality of data points related to a concentration of a glucose level in the interstitial fluid (page 5, section [0057], page 9, sections [0097-0098], page 10, section [0113], page 13, section [0140]); generating, using the data processing device of the glucose monitoring system, one or more second data points from the plurality of data points related to the concentration of a glucose level in the interstitial fluid (page 9, sections [0097-0098], page 13, section [0140]); determining, using the data processing device of the glucose monitoring system, an interstitial glucose concentration based on a first weighted combination, wherein the first weighted combination comprises the one or more first data points and the one or more second data points with more weight placed on the one or more first data points than the one or more second data points (page 9, sections [0097-0098], page 13, section [0140]); and delivering, using the drug delivery device of the glucose monitoring system, a drug based on the determined interstitial glucose concentration (page 3, section [0038]).
Hayter et al.’118 (US Pub No. 2009/0198118) teaches the use of a lag correction algorithm on a plurality of data points related to an analyte, the lag correction being performed to provide a more accurate final glucose value (see TITLE, page 1, sections [0004-0005], page 5, section [0050] – page 6, section [0056], and page 7, section [0062]).
Dunn et al.’022 (US Pub No. 2002/0019022) discloses a method for monitoring an analyte (interstitial glucose) using a glucose monitoring system including a glucose sensor, and a data processing device (see TITLE and ABSTRACT), the method comprising: generating, using the data processing device of the glucose monitoring system, one or more first data points from a plurality of data points related to the analyte (page 2, sections [0014-0018]); generating, using the data processing device of the analyte monitoring system, one or more second data points from the plurality of data points related to the analyte (page 2, sections [0014-0018]); and determining, using the data processing device of the analyte monitoring system, an analyte concentration based on a first weighted combination, wherein the first weighted combination comprises the one or more first data points and the one or more second data points with more weight placed on the one or more first data points than the one or more second data points (page 2, sections [0014-0018] – because the weights are determined individually for each of the three individual data points (BG1, BG2, BG3), it would be obvious to one of ordinary skill in the art that one of the data points would be weighted higher than the others).
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 1, none of the prior art discloses or suggests, either alone or in combination, a glucose monitoring system comprising a data processing device configured to determine a rate of change of a concentration of an interstitial glucose level based on a second weighted combination of one or more of first processed data points and one or more second processed data points, in combination with the other claimed elements.
Regarding claim 9, none of the prior art discloses or suggests, either alone or in combination, a method for monitoring a glucose level in interstitial fluid, the method comprising determining a rate of change of a concentration of the glucose level based on a second weighted combination of one or more first processed data points and one or more second processed data points, in combination with the other claimed steps.
Conclusion
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/ETSUB D BERHANU/Primary Examiner, Art Unit 3791
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