DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment to the claims filed 31 December 2025 has been entered. Claim(s) 1, 12, 14 and 25 is/are currently amended. Claim(s) 2-8, 10-11, 15-21 and 23-24 has/have been canceled. New claim(s) 27-35 has/have been added. Claim(s) 1, 9, 12-14, 22, 25-35 is/are pending.
Objections and/or Rejections Withdrawn
Objections to the claims, rejections under 35 U.S.C. 112(a) (pre-AIA 35 U.S.C. 112, first paragraph) and/or rejections under 35 U.S.C. 112(b) (pre-AIA 35 U.S.C. 112, second paragraph) not reproduced below has/have been withdrawn in view of Applicant's amendments to the claims and/or submitted remarks.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of pre-AIA 35 U.S.C. 112, first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 1, 9, 12-14, 22, 25-35 is/are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1, claim 14 and claims dependent thereon, the limitations "determine a glucose metric based on the glucose level information corresponding to an overnight period for a day in which a medication dose was administered during a time of day period; determine, by a glucose response training unit, a glucose response pattern based on the glucose metric for a plurality of days in a moving window of time in which a medication dose was administered during the time of day period; receive medication intake information in a subsequent day; determine a glucose metric based on the glucose level information corresponding to the overnight period for the subsequent day; update, by the glucose response training unit, the glucose response pattern based on the glucose metric for the plurality of days in the moving window of time in which a dose was administering during the time of day period, wherein the moving window of time includes the subsequent day; receive medication intake information in a current day; predict a glucose fluctuation in an overnight period for the current day, based on the medication intake information associated with the current day and the updated glucose response pattern" of claim 1 and the comparable limitations of claim 14 lack sufficient support in the application as filed.
Applicant contends the pending claims are adequately supported by the application as filed, asserting, "one skilled in the art in view of the Specification would appreciate that a glucose metric can be determined based on glucose data in an overnight period for a plurality of days in which a medication dose was administered in a time of day period. The dynamic glucose response pattern can be determined based on the glucose metric for a plurality of days in a moving window of time in which medication intake information was received," and citing paragraphs [0005], [0040], [0045], [0150] in support of said assertion (Remarks, pgs. 9-10).
The examiner respectfully disagrees. Applicant discloses collecting data over a pre-determined period and/or number of days, categorizing each day of the data based on activity level, determining an overnight glucose pattern based on the categorized data, and using the determined overnight glucose pattern to predict an overnight glucose fluctuation in response to performed and/or planned activity (e.g., Fig. 4; ¶ [0069]). While Applicant broadly discloses the impact of a different event, such as medication intake, can be similarly determined (e.g., ¶ [0045]), the only algorithms disclosed with any specificity for determining an overnight glucose pattern are disclosed with respect to the impact of significant activity on following overnight glucose levels. Even if the application sufficiently supports assessing overnight glucose patterns associated with a different event, such as medication administered during a time of day period, using the same and/or similar algorithm as disclosed with respect to activity, the pending claims do not appear to require the data necessary to determine said pattern using the disclosed algorithms. For example, each of the disclosed algorithms requires calculating a glucose metric based on days without the event (e.g., significant activity) in order to determine the correlation between the event and the overnight glucose levels (see, e.g., Figs. 4-5). However, the pending claims encompass determining the glucose response pattern based only on glucose metrics for days in which "a medication dose was administered during the time of day period."
Further, the pending claims do not require the medication administered in each day to be the same dosage or even the same medication. While one of ordinary skill in the art would appreciate that different types of activities (particularly if of comparable duration and/or intensity) may have similar effects on overnight glucose levels, the same cannot be said for different types and amounts of medications. The pending claims additionally do not require the received medication intake information in a current day to be associated with the same time of day period for which the glucose response pattern was determined. Applicant fails to disclose an algorithm for determining a glucose response pattern based only on days having data indicative of an event, fails to disclose determining a glucose response pattern based on days having any medication (as opposed to the same medication and/or dose) given in the same time of day period, and fails to disclose that a glucose response pattern determined based on medication administered in a specific time of day period can be used with medication administered at any time of day to predict overnight glucose levels. For at least the reasons above, Applicant fails to sufficiently disclose an algorithm commensurate in scope with the pending claims.
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.
Claim(s) 1, 9, 12-14, 22 and 25-35 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial without significantly more.
The claims recite the steps of determining a glucose metric based on overnight glucose levels; determining a glucose response pattern based on the glucose metric for a plurality of days when sufficient data exists for determining said pattern; repeating these two determinations at least once to generate an updated glucose response pattern; predicting a glucose fluctuation in an overnight period for a current day based on medication intake information associated with the current day and the updated glucose response pattern; and determining what actions (e.g., therapy, how much food to consume, additional medication to administer, etc.) should be taken based on the predicted fluctuation to ensure overnight glucose levels remain in a desired range.
These limitations, as drafted, are a process that, under its broadest reasonable interpretation (BRI), covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting the steps are performed by a processor or "unit" nothing in the claim element precludes the step from practically being performed in the mind. But for the processor/unit language, determining a glucose metric based on overnight glucose levels encompasses a user mentally/manually calculating an average or median of glucose levels measured overnight; determining and/or updating a glucose response pattern only requires a user, such as a doctor, diabetic user, etc., to mentally/manually consider past (e.g., a log, record, etc. of) medication, such as insulin, information and corresponding and/or resulting (e.g., a log, record, etc. of) overnight glucose levels of a patient in any manner he or she desires/chooses to assess, form a judgment about, etc. the patient's glucose overnight response pattern. Similarly, predicting a glucose fluctuation in an overnight period for the current day merely requires the user to judge, given the assessed pattern and current medication information, if glucose values will exceed a normal/target range at a future time, e.g., overnight. Lastly, determining a therapy recommendation encompasses said user mentally deciding the best course of action, such as a modification to therapy and/or diet, for a patient to follow to avoid overnight glucose values falling outside of a target range. If claim limitations, under their BRI, cover performance of the limitations in the mind but for the recitation of generic computer components, then it falls within the "mental processes" grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim only recites the additional elements of receiving data, including glucose information and medication information; generically outputting an alert/notification of the result(s) of performing the abstract idea, such as the response pattern, predicted glucose fluctuation, recommended therapy, etc. using a generic data output interface (e.g., to a display, via a speaker, etc.); and generic computer components, such as a processor, "units," and/or software to perform the abstract idea. The computer component(s) is recited at a high-level of generality (i.e., as software, a processor executing said software, etc.) performing generic computer functions such as calculating metrics, identifying a pattern, making predictions based on said pattern, etc. such that it amounts no more than mere instructions to apply the exception using a generic computer component. The steps of/elements for receiving/sensing glucose and medication/insulin information and outputting the results of performing the abstract idea as a generic notification are comparable to concepts identified by the courts as insignificant extra-solution activity, such as determining the level of a biomarker in blood (see MPEP 2106.05(g)), and/or well-understood, routine and/or conventional computer functions, such as receiving or transmitting data over a network, storing and retrieving information in memory, etc. (see MPEP 2106.05(d)). Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Therefore, the claims are directed to an abstract idea.
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 element of using computer components to perform the abstract idea amounts to no more than mere instructions to apply the exception using a generic computer component(s). Additionally, the steps of/elements for receiving data are recited broadly enough to cover generically receiving data over a network, which has been identified by the courts as well-understood, routine and/or conventional as noted above; receiving a manual user input and outputting results via a generic interface (keyboard, mouse, touchscreen, etc.); etc. Further, the recited sensor structure for sensing the glucose levels is similarly well-understood, routine and/or conventional, with commercially-available devices as far back as 1999 (see "CGM," previously cited). Even when viewed in combination, the additional elements in this claim do no more than automate the mental processes that, e.g., a doctor and/or diabetic patient, typically perform (e.g., the mental evaluation of glucose patterns and factors present affecting said patterns to determine what actions/therapy to take), using computer components as a tool (e.g., using software to tailor information and provide it to the user on a generic computer), and/or represent mere instructions to apply an exception and insignificant, well-understood, routine and/or conventional extra-solution activity, which cannot provide an inventive concept. Therefore, the pending claims are not patent eligible.
Response to Arguments
Applicant's arguments have been fully considered but they are not persuasive.
With respect to eligibility under 35 U.S.C. 101, Applicant contends claims 1 and 14 are eligible at Step 2A, prong II of the test for subject matter eligibility, contending the claimed invention "provides an improvement to glucose monitoring systems by outputting a notification to alert a user of a predicted glucose fluctuation in an overnight period based on a dynamically determined glucose response pattern" (Remarks, pgs. 11-12).
The examiner respectfully disagrees. First, as discussed with respect to rejections under 35 U.S.C. 112(a), the pending claims are not commensurate in scope with disclosed algorithms for determining a glucose response pattern associated with significant activity. Accordingly, there is no evidence of record or sufficient reasoning provided by Applicant that the alleged improvements of the disclosed algorithm(s) are equally applicable to the method as claimed. Second, prong two requires that the claim recites additional elements that integrate the judicial exception into a practical application. The additional elements of the present claims merely require a generic output of a notification/alert of a predicted glucose fluctuation in the overnight period. When considered in combination with the remaining limitations of the pending claims, this is comparable to concepts identified by the courts as additional elements that amount to mere instructions to apply an exception and/or merely invoke computers or machinery as a tool to perform an existing process. See MPEP 2106.05(f). For example, diabetic patients and/or doctors treating said patients routinely log blood glucose levels and events (e.g., medication, activity, meals) in order to assess impact of said events, identify patterns or changes therein, etc., and take this learned information into account when making therapy (what/when to eat, insulin to dose, etc.) decisions (see, e.g., Choudhary et al., mailed herewith).
Conclusion
The prior art made of record and not relied upon is considered pertinent to Applicant's disclosure: see attached PTO-892.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Meredith Weare whose telephone number is 571-270-3957. The examiner can normally be reached Monday - Friday, 9 AM - 5 PM.
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/Meredith Weare/Primary Examiner, Art Unit 3791
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