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 .
Status of Claims
This action is in response to the reply filed 3/11/2026.
Claims 1 and 11 were amended 3/11/2026.
Claims 1-18 are currently pending with claims 8-10 withdrawn.
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 1-7 and 11-18 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.
Claims 1-7 and 11-18 are drawn to a non-transitory computer readable medium and a system which are statutory categories of invention (Step 1: YES).
Independent claims 1 and 11 recite: access blood glucose measurement values and insulin data; identify blood glucose measurement values that exceed an upper target blood glucose set point as a high events and blood glucose measurement values that are below a lower target blood glucose set point as low events; apply a high event overlap rule set to the high events and a low event overlap rule set to the low events, wherein each of the high event overlap rule set and the low event overlap rule set includes a degree of overlap in duration of overlapping time across a number of days; based on the application of the high event overlap rule set to the high events and the low event overlap rule to the low events, identify overlapping high events and overlapping low events for analysis; identify as a high event pattern of the overlapping high events those high events that fall within a set high event overlap duration and day range; identify as a low event pattern of the overlapping low events those low events that fall within a set low event overlap duration and day range; drop, from the high event patterns and the low event patterns, singular high events and singular low events occurring in the overlapping time that do not constitute a pattern; apply a respective pattern weight to each identified high event and each identified low event based on criteria specific to high events and specific to low events; a low pattern section comprising, for each identified low event pattern, a time window during which the low event pattern was identified; and a high pattern section comprising, for each identified high event pattern, a time window during which the high event pattern was identified.
Claim 11 further recites: store a user’s continuous blood glucose monitor data and data, wherein the user’s continuous blood glucose monitor data includes blood glucose measurement values and the data includes insulin delivery data; obtain blood glucose measurement values and insulin delivery data and the data for a predetermined time period; identify in the blood glucose measurement values that exceed an upper target blood glucose set point as high events and blood glucose measurement values that are less than a lower target blood glucose set point as low events.
The recited limitations, as drafted, under their broadest reasonable interpretation, cover certain methods of organizing human activity between a user and a healthcare provider, as reflected in the specification, which states that “a data visualization system that provides a user, such as a person with diabetes, with a dashboard that shows the user's blood glucose measurement data over a progression of days. However, the user is left to draw their own inferences from the data presented in the dashboard and/or rely on a healthcare provider to interpret the data.” (see: specification paragraph 1). If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or relationships or interactions between people, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. The present claims cover certain methods of organizing human activity because they address “beneficial to users to have a system that utilized techniques for data visualization of information drawn from a user's blood glucose measurement values as well as analytical techniques that are also incorporated into the data visualization” (see: specification paragraph 4). This problem is addressed “the computing device 132 may be a healthcare provider device and be operable to communicate with a user's controller 104 and interact to obtain information, store and/or update settings of the wearable drug delivery device 102, the controller 104 and/or analyte sensor 106, and the like” (see: specification paragraph 46).
The judicial exception is not integrated into a practical application. The claims are abstract but for the inclusion of the additional elements including “system”, “memory”, “user’s personal diabetes management device”, “graphical user interface”, “data warehouse memory”, “processor” and “non-transitory computer readable medium”, are recited at a high level of generality (e.g., that the identifying and displaying is performed using generic computer components with instructions are executed to perform the claimed limitations). Such that they amount to no more than mere instructions to apply the exception using generic computer components. See: MPEP 2106.05(f).
The claims recite the additional elements of “data analysis processor, including circuitry operable to execute programming code stored in the memory”, which are nominal or tangential addition to the abstract idea and amount to insignificant post-solution activity concerning an insignificant application. The addition of an insignificant extra-solution activity limitation does not impose meaningful limits on the claim such that is it not nominally or tangentially related to the invention. In the claimed context, these claimed additional elements are incidental to the performance of identifying health data as outlined in the recitations above. See: MPEP 2106.05(g).
The combination of these additional elements is no more than mere instructions to apply the exception using generic computer and extra-solution elements. Accordingly, even in combination, 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.
Hence, the 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. Accordingly, the claims are directed to an abstract idea (Step 2A Prong Two: NO).
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, using the additional elements to perform the abstract idea amounts to no more than mere instructions to apply the exception using generic components. Mere instructions to apply an exception using a generic component cannot provide an inventive concept. See MPEP 2106.05(f).
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are configured to perform well-understood, routine, and conventional activities previously known to the industry. See MPEP 2106.05(d). Said additional elements are recited at a high level of generality and provide conventional functions that do not add meaningful limits to practicing the abstract idea. The originally filed specification supports this conclusion at Figure 1A, Figure 1B and
Paragraph 171, where “The various elements of the devices, apparatuses or systems as previously described with reference to the FIGs. may include various hardware elements, software elements, or a combination of both. Examples of hardware elements may include structural members, logic devices, components, processors, microprocessors, circuits, processors, circuit elements ( e.g., transistors, resistors, capacitors, inductors, and so forth), integrated circuits, application specific integrated circuits (ASIC), programmable logic devices (PLD), digital signal processors (DSP), field programmable gate array (FPGA), memory units, logic gates, registers, semiconductor device, chips, microchips, chip sets, and so forth. Examples of software elements may include software components, programs, applications, computer programs, application programs, system programs, software development programs, machine programs, operating system software, middleware, firmware, software modules, routines, subroutines, functions, methods, procedures, software interfaces, application program interfaces (API), instruction sets, computing code, computer code, code segments, computer code segments, words, values, symbols, or any combination thereof.”
Paragraph 58, where “The system 170 may include a data repository 175, a data extraction, transformation and loading component 177, a data analysis processor 180 and a data storage/ memory 186. The data repository 175 may be operable to store continuous glucose monitors/ personal diabetes management device parquet files. The CGM/PDM parquet files may store all received CGM/PDM readings, Bolus/extended bolus dosage amounts, basal dosage amounts, patient history buffer (PHB) measurements, AID algorithm settings including target blood glucose setpoints and the like, basal programs and attachment site information.”
Paragraph 59, where “The memory 186 may be operable to store a user's continuous blood glucose monitor data and data from the user's personal diabetes management device. Data extraction, transformation and loading circuitry 177 may be coupled to the memory 186 operable to normalize data for evaluation and analysis by the data analysis processor 180. The data analysis processor 180 may include a combination of circuitry and software. The data analysis processor 180 may include pattern processing 181 and bolus determination 183. The pattern processing 181 may include processing circuitry and/ or programming code or instructions that when executed by the processing circuitry may be operable to identify patterns in the user's continuous blood glucose monitor data and data from the user's personal diabetes management device.”
Paragraph 172, where “The computer readable medium or article may include, for example, any suitable type of memory unit, memory, memory article, memory medium, storage device, storage article, storage medium and/or storage unit, for example, memory (including non-transitory memory), removable or non-removable media, erasable or non-erasable media, writeable or re-writeable media, digital or analog media, hard disk, floppy disk, Compact Disk Read Only Memory (CD-ROM), Compact Disk Recordable (CD-R), Compact Disk Rewriteable (CD-RW), optical disk, magnetic media, magneto-optical media, removable memory cards or disks, various types of Digital Versatile Disk (DVD), a tape, a cassette, or the like. The instructions may include any suitable type of code, such as source code, compiled code, interpreted code, executable code, static code, dynamic code, encrypted code, programming code, and the like, implemented using any suitable high-level, low-level, object-oriented, visual, compiled and/or interpreted programming language. The non-transitory computer readable medium embodied programming code may cause a processor when executing the programming code to perform functions, such as those described herein”
The claims recite additional elements for extra-solution activity, as recited above, each of which amounts to mere post-solution activity concerning an insignificant application. The specification (e.g., as excerpted above) does not indicate that the additional element(s) provide anything other than well‐understood, routine, and conventional functions when claimed in a merely generic manner (as they are here). See: MPEP 2106.05(g).
Viewing the limitations as an ordered combination, the claims simply instruct the additional elements to implement the concept described above in the identification of abstract idea with route, conventional activity specified at a high level of generality in a particular technological environment.
Hence, the claims as a whole, considering the additional elements individually and as an ordered combination, do not amount to significantly more than the abstract idea (Step 2B: NO).
Dependent claims 2-7, 12-18 when analyzed as a whole, considering the additional elements individually and/or as an ordered combination, are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitations fail to establish that the claims are directed to an abstract idea without significantly more. The dependent claims obtain data and apply calculations to the data to populate and format the user interfaces regarding the data using the generically recited computing devices as shown above. These claims fail to remedy the deficiencies of their parent claims above, and therefore rejected for at least the same rationale as applied to their parent claims above, and incorporated herein.
Response to Arguments
The arguments filed 3/11/2026 have been fully considered.
The arguments pertaining to the 101 rejection are not persuasive. Applicant argues that Examiner has not followed proper USPTO guidelines. Examiner respectfully disagrees as all current USPTO guidelines have been followed and the rejection above is proper.The claimed invention is directed towards Certain Method of Organizing Human Activity as it is directed towards a user interacting with a healthcare provider when obtaining healthcare measurements (paragraph 1, 4, 46). Further, Applicant argues that the claimed invention is similar to Core Wireless in that the claimed invention is directed towards an improvement to the functioning of a computer or to any other technology or technical field. Applicant argues that the claimed invention provides an improvement to the technical field of blood glucose data processing and visualization. Examiner respectfully disagrees. The processing and displaying of the blood glucose data is performed using generic computing components that do not provide significantly more to the abstract idea as shown in the rejection above. Core Wireless provided a technical solution to a technological problem by providing an improved user interface with particular data selectable by a user. The current claimed invention is merely displaying data on a generic interface (Figure 1A) and does not positively recite the user interacting with the specific GUI in a specific way to provide a technological improvement like in Core Wireless.
Applicant further argues that the claimed invention does not merely apply a judicial exception using a computer as a tool, but rather recites specific technological improvements to computer functionality in diabetes data processing and data visualization. Examiner respectfully disagrees. Applicant purports that the claimed invention recites specific technological improvements to computer functionality, but independent claim limitations of how the data is calculated to be output is not a technological improvement. An output of specific data to treat a patient as recited is not a technological improvement, but is rather related to the medical field of interactions between a healthcare provider treating a patient and is part of the abstract idea. Calculating data using threshold algorithmic functions on a generic computing device is not a technological improvement. A data processing pipeline is not a technological improvement as the input/output of data using generic computing devices do not provide a practical application to overcome the abstract idea.
Applicant further argues that the claim limitations are not directed towards insignificant extra solution activity. Applicant further argues that the detection, filtering and weighting of the data provides a specific technical configuration of the output that constitutes the particular improvement to data visualized technology over prior art systems. Examiner respectfully disagrees. The processing circuitry is executing code (the additional element being analyzed) on the computing device such that it is incidental to the performance of identifying health data and does not provide a practical application to overcome the abstract idea.
Applicant further argues that the claimed invention provides specific technological ilimitations that provide an inventive concept of automated diabetes pattern detection with intelligent data filtering and visualization. Applicant argues that the claimed invention is solving the technical problem of enabling automated diabetes pattern analysis previously requiring manual healthcare provider review. This is not a technical problem but a medical problem of solving interactions between a patient and healthcare provider and is directly related to the abstract idea of “Certain Methods of Organizing Human Activity”.
The generic computing device’s functionality is not being improved upon, however the data output is the functionality of the claimed invention and does not provide a practical application to overcome the abstract idea. The specific algorithms are run on a generically recited computing device and do not alter the computing device to perform a technological improvement. An improved algorithm that provides improved medical data to help a provider treat a diabetic patient on a generic computing device is part of the abstract idea of certain methods of organizing human activity and does not provide significantly more to the abstract idea. An improvement of analysis of data does not alter the computer’s functionality nor does algorithmic rules that filter data. The functions argued are representative of the abstract idea. The claims here are not directed to a specific improvement to computer functionality that amount to a practical application. Rather, they are directed to the use of conventional or generic technology in a well-known environment, without any claim that the invention reflects an inventive solution to a technical problem presented by combining the two. In the present case, the claims fail to recite any elements that individually or as an ordered combination transform the identified abstract idea(s) in the rejection into a patent-eligible application of that idea.
Further, not every claim that recites concrete, tangible components escapes the reach of the abstract-idea inquiry. (See, e.g., Alice, 134). It is well-settled that mere recitation of concrete, tangible components that are generic is insufficient to confer patent eligibility to an otherwise abstract idea. In order to amount to an inventive concept, the components must involve more than performance of “’well-understood, routine, conventional activities’ previously known to the industry.” (Alice, 134 S. Ct. at 2359 (quoting Mayo, 132 S.Ct. at 1294)). The originally filed specification was investigated and found to support this conclusion and are dissimilar from BASCOM as the additional elements do not provide significantly more to that abstract idea as shown in the rejection above.
The dependent claims rely on the arguments of the independent claims and are rejected for the reasons stated above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Galley (US 2012/0165640 A1) teaches managing glucose data with time frames on a GUI.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KIMBERLY A SASS whose telephone number is (571)272-4774. The examiner can normally be reached 7AM-5PM (EST).
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/K.A.S./Examiner, Art Unit 3686
/JASON B DUNHAM/Supervisory Patent Examiner, Art Unit 3686
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