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 .
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.
Claims 1-20 are drawn to a method, an electronic device, and a system, which is/are statutory categories of invention (Step 1: YES).
Independent claim 1 recites receiving a default data presentation template, the default data presentation template having a second set of available data fields and data visualizations for analyte measurement values and patterns based on the second set of available data fields; modifying the default data presentation template, the modifying comprising: removing data fields from the second set that are not in the first set or are not determinable from the first set; and removing data visualizations not determinable from the first set; and populating the modified default data presentation template, including the data fields and the data visualizations, with the received set of the available continuous sensor data.
Independent claim 19 recites receive a set of available continuous sensor data associated with the analyte concentration of the user, the set corresponding to a first set of available data fields; receive a default data presentation template, the default data presentation template having a second set of available data fields and data visualizations for analyte measurement values and patterns based on the second set of available data fields; modify the default data presentation template by: removing data fields from the second set that are not in the first set or are not determinable from the first set; and removing data visualizations not determinable from the first set; and populate the modified default data presentation template, including the data fields and the data visualizations, with the received set of the available continuous sensor data;.
Independent claim 20 recites receive a set of available continuous sensor data associated with the analyte concentration of the user, the set corresponding to a first set of available data fields; receive a default data presentation template, the default data presentation template having a second set of available data fields and data visualizations for analyte measurement values and patterns based on the second set of available data fields; modify the default data presentation template by: removing data fields from the second set that are not in the first set or are not determinable from the first set; and removing data visualizations not determinable from the first set; and populate the modified default data presentation template, including the data fields and the data visualizations, with the received set of the available continuous sensor data.
The respective dependent claims 2-18, but for the inclusion of the additional elements specifically addressed below, provide recitations further limiting the invention of the independent claim(s).
The recited limitations, as drafted, under their broadest reasonable interpretation, cover certain methods of organizing human activity, as reflected in the specification, which states that the invention “relates to data processing of medical measurements of a host, and in particular ways to present such data” (see: specification paragraph 2) and are “generally described in the field of diabetes management” (see: specification paragraph 11). The invention is described as to the “design of the report may accommodate a variety of user types and use cases” (see: specification paragraph 14) such as “to guide a doctor-patient conversation” (see: specification paragraph 15). 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, for example, where “important recognized patterns could be buried in a report because of the set format” a problem exists when reporting important information to a user because “[n]ot only could a user expend considerable time and effort in recognizing the information, but a user could miss the important information altogether” (see: specification paragraph 7). The invention also addresses these problems by “provid[ing] a useful tool for patients/users and health care providers/practitioners (“HCP”s) and caregivers to guide disease management” (see: specification paragraph 67). Accordingly, the claims recite an abstract idea(s) (Step 2A Prong One: YES).
This judicial exception is not integrated into a practical application. The claims are abstract but for the inclusion of the additional elements including an “a memory comprising executable instructions; and a processor in data communication with the continuous analyte sensor and configured to execute the instructions to:…” (claim 19), and “a memory comprising executable instructions; and a processor in data communication with the memory and configured to execute the instructions to:…” (claim 20), which are additional elements that are recited at a high level of generality (e.g., the “processor” communicating data and performing the processing functions through no more than a statement than that it is “configured to execute the instructions”; the “memory” in communication with the processor is configured though no more than a statement than that it is for “comprising executable instructions”) such that they amount to no more than mere instruction to apply the exception using generic computer elements. See: MPEP 2106.05(f).
The claims recite the additional element of “receiving, from a continuous analyte sensor, a set of available continuous sensor data associated with an analyte concentration of the user, the set of available continuous sensor data corresponding to a first set of available data fields…” (claim 1), “wherein the continuous analyte sensor continuously measures the analyte concentration of the user” (claim 18), “a continuous analyte sensor configured to measure an analyte concentration of a user…from the continuous analyte sensor…” (claim 19), and “a continuous analyte sensor configured to measure an analyte concentration of the user…from the continuous analyte sensor…” (claim 20), which are considered nominal or tangential additions to the abstract idea(s) and amount to extra-solution activity concerning mere data gathering. 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 the recited abstract idea(s) as outlined in the recitations above. Similarly, the claims recite the additional elements of “displaying the populated modified default data presentation template” (claim 1), “wherein the modifying includes: displaying continuous glucose monitor (CGM) fields if available, and if not, displaying self-monitoring blood glucose meter (SMBG) fields” (claim 3), “displaying the data visualizations corresponding to higher priority patterns above data visualizations corresponding to lower priority patterns” (claim 8), “wherein: the data visualization corresponding to the identified pattern is a chart, and the data visualization corresponding to the identified at least one event is an icon placed on the chart” (claim 10), “cause a display to display the populated modified default data presentation template” (claim 19), and “a display…cause the display to display the populated modified default data presentation template” (claim 20), which are considered an insignificant post-solution activity concerning an insignificant application, and similarly, the addition of insignificant extra-solution activity 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 the recited abstract idea(s) 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 elements and limitations directed toward extra-solution activity. Accordingly, even in combination, these additional elements do not integrate the abstract idea(s) into a practical application because they do not impose any meaningful limits on practicing the abstract idea(s). Accordingly, the claims are directed to an abstract idea(s) (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(s) into a practical application, using the additional elements to perform the abstract idea(s) amounts to no more than mere instructions to apply the exception using generic elements. Mere instructions to apply an exception using generic elements 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 elements 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(s). The originally filed specification supports this conclusion:
Paragraph 125, where “The terms "microprocessor" and "processor" as used herein are broad terms and are to be given their ordinary and customary meaning to a person of ordinary skill in the art (and are not to be limited to a special or customized meaning), and furthermore refer without limitation to a computer system, state machine, and the like that performs arithmetic and logic operations using logic circuitry that responds to and processes the basic instructions that drive a computer.”
Paragraph 139, where “The term "continuous analyte (or glucose) sensor" as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and furthermore refers without limitation to a device that continuously or continually measures a concentration of an analyte, for example, at time intervals ranging from fractions of a second up to, for example, 1, 2, or 5 minutes, or longer…”
Paragraph 140, where “The term "continuous analyte (or glucose) sensing" as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and furthermore refers without limitation to the period in which monitoring of an analyte is continuously or continually performed, for example, at time intervals ranging from fractions of a second up to, for example, 1, 2, or 5 minutes, or longer.”
Paragraph 151, where “In this exemplary environment, a host having diabetes is monitored by several different caregivers. The host has a continuous glucose monitoring system, such as the DexCom G4® Platinum continuous glucose monitoring system, commercially available from DexCom, Inc., which provides measurements of the host's glucose levels on a display device, such as the DexCom G4® Platinum Receiver, also commercially available from DexCom, Inc.”
Paragraph 165, where “An aspect of systems and methods according to present principles is the dynamic generation of reports, and these reports can be displayed on the screen of a computing device such as a computer or smart phone, and may also be printed for placement in a patient file and/or to guide a doctor-patient conversation…”
Paragraph 324, where “Fig. 47 is a schematic view of a receiver or monitor 2550 including representations of estimated glucose values on its user interface. The monitor 2550 comprises systems to receive, process, and display sensor data from the glucose sensor (e.g., 2450), such as described herein. Particularly, the monitor 2550 can be a mobile phone type device, for example, and comprise a user interface that has a physical button 730 and a display screen 732, as well as one or more input/output (1/0) devices, such as one or more buttons and/or switches, which when activated or clicked perform one or more functions. In the illustrated embodiment, the electronic device is a smartphone, and the display 732 comprises a touchscreen, which also functions as an 1/0 device. In some embodiments, the user interface can also include a keyboard, a speaker, and a vibrator. The functions of the monitor or smart phone can also be implemented as functions within an application running on a tablet computer, laptop computer, desktop computer, or like device. In other embodiments, the receiver may comprise a device or devices other than a smartphone, such as a smartwatch, a tablet computer, a mini-tablet computer, a handheld personal digital assistant (PDA), a game console, a multimedia player, a wearable device, such as those described above, a screen in an automobile or other vehicle, a dedicated receiver device, etc. In any case, the display screen of such computing environments may be employed to display dynamically created reports, and the computing environment may further be employed to print the dynamic reports noted herein.”
Paragraph 332, where “In some implementations, the continuous analyte sensor system includes a DexCom G4® Platinum glucose sensor and transmitter commercially available from DexCom, Inc., for continuously monitoring a host's glucose levels.”
Paragraph 336, where “The various illustrative logical blocks, modules and circuits described in connection with the present disclosure (such as the blocks of Fig. 48) may be implemented or performed with a general purpose processor, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field programmable gate array signal (FPGA) or other programmable logic device (PLD), discrete gate or transistor logic, discrete hardware components or any combination thereof designed to perform the functions described herein. A general purpose processor may be a microprocessor, but in the alternative, the processor may be any commercially available processor, controller, microcontroller or state machine. A processor may also be implemented as a combination of computing devices, e.g., a combination of a DSP and a microprocessor, a plurality of microprocessors, one or more microprocessors in conjunction with a DSP core, or any other such configuration.”
The claims recite the additional elements directed to pre-solution and post-solution activity, as recited and indicated above, each of which amount to extra-solution activity. 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 presently). Further, the claimed receiving of available continuous sensor data from a continuous analyte sensor further corresponds to the concept of performing clinical tests on individuals to obtain input for an equation has been identified by the courts as insignificant extra-solution activity. See: MPEP 2106.05(g). As per concepts of related to receiving or transmitting data over a network, such as using the Internet to gather data, and storing and retrieving information in memory have been identified by the courts as well-understood, routine, and conventional activities. See: MPEP 2106.05(d)(II).
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(s) with routine, 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(s) (Step 2B: NO).
Dependent claim(s) 2-18, 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 limitation(s) fail(s) to establish that the claim(s) is/are not directed to an abstract idea(s) without significantly more. These claims fail to remedy the deficiencies of their parent claims above, and are therefore rejected for at least the same rationale as applied to their parent claims above, and incorporated herein.
Novelty of Claims
As per claims 1-20, the closest prior art of record, U.S. Patent Application Publication 2014/0068487 to Steiger and U.S. Patent Application Publication 2013/0338629 to Agrawal, neither alone nor in combination teach the invention of independent claims 1, 19, and 20. Steiger teaches a glucose meter including measurement engine and biosensor that provide a biomarker value for anaytes such as glucose, heart rate, blood pressure measurement, where the data is provided over the course of time periods such as breakfast (see: Steiger, Fig. 3; and paragraph 33, 48, 49, 56, 63, and 83). Data is received including carbs, bolus, insulin amount and time (see: Steiger, paragraph 61-64 and 83), and meal comparison analysis is displayed with windows for at least breakfast and lunch (see: Steiger, Fig. 2-6; and paragraph 61-64 and 83) such that bolus icons for indicating a bolus amount and a bolus time, carbohydrate icons for indicating a carbohydrate amount and a carbohydrate time, and glucose data can be displayed contemporaneously without obscuring one another (see: Steiger, Fig. 2-6; and paragraph 61-64 and 83). However, Steiger fails to specifically teach, for example, in combination with the other claimed limitations, “modifying the default data presentation template, the modifying comprising: removing data fields from the second set that are not in the first set or are not determinable from the first set; and removing data visualizations not determinable from the first set; and populating the modified default data presentation template, including the data fields and the data visualizations, with the received set of the available continuous sensor data; and displaying the populated modified default data presentation template.” Therefore, the closest prior art of record does not anticipate or otherwise render the claimed invention obvious.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure can be found on the attached PTO-892 form, including:
U.S. Patent App Pub 2010/0179833 (para 58 “The client data 158 can also include historical data as well as current data, which can be utilized provide an indication of progress (e.g., in the form of graph or other plot) for one or more criteria over a designated time period. As mentioned above, such current and historical data can include data entered (or logged) manually by the client into the tracking system 150 (e.g., weight, food choices, waist size, exercise activity) as well as data automatically entered based on client devices (e.g., a pedometer, glucose monitor, heart rate monitor or other device capable of monitoring and recording a condition of the client) that has been input into the coaching system. The historical client data can be integrated into the template 152, such as corresponding to any number of one or more conditions at defined time intervals to track trends or progression of selected client conditions and/or characteristics.”);
U.S. Patent App Pub 2009/0150771 (para 19 “The standard week graph 68 (which displays blood glucose measurements for a week) has also been dragged and dropped into template section 50. A text box 70 has also been dragged and dropped into the template section 50 and populated with the phrase "your blood glucose readings are displayed above." The user may, of course, select any desired combination of the content items for use in template section 50. If the user desires to preview the template prior to saving it, the user simply activates the "preview" icon 72. This causes a "letter preview" window 74 to be displayed which shows the format of the letter produced by the template (FIG. 9). To return to the "create new letter" template 46, the user simply selects the "close" icon 76.” Para 27 “The basal profiles graph 126 (which displays information relating to insulin) has also been dragged and dropped into template section 120. As with building letters templates, the user may select any desired combination of the content items for use in template section 120. If the user desires to preview the template prior to saving it, the user simply activates the "preview" icon 128. This causes a "report preview" window 130 to be displayed which shows the format of the report produced by the template (FIG. 19). To return to the "create new report" template 116, the user simply selects the "close" icon 132.”);
U.S. Patent App Pub 2009/0083664 (para 73 “FIG. 5 shows another aspect of the present invention. The graphics display 100 offers a further feature of adjusting the template 50. If the user wishes to see additional ones of the time points 15 than can fit into the template 50, then either a scroll bar is added and/or some of the previously displayed time points 15 are hidden. The exact behaviour of the graphics display 100 is configurable by the user. In the example in FIG. 5 on the left hand side, the graphics display 100 is configured to permanently display certain designated ones of the time points 15. In this example the time points 15 associated with the items of data 5 ranked CURRENT and BASELINE are permanently displayed. Alternatively, on the right hand side of FIG. 5, the user configured the graphics display 100 such as to only show permanently the one of time point 15 associated with the items of data 5 ranked as CURRENT.” Para 77 “The graphics display 100 then displays in step 620 the aggregated data descriptors as the IDEs 40 within the template 50. According to one aspect of the invention, the time point 15 is visually associated with the aggregated data descriptors 10 displayed as the IDEs 40. For example, on FIG. 1 the IDEs 40 are displayed underneath the time point 15. However, other arrangements that allow the user to easily understand the association between the time points 15 and the IDEs 40 are also within the scope of the invention. In order to assist the user in examining the items of data 5 the invention automatically suppresses display in step 615 of the time points 15 if there are no items of data 5 associated with the time points 15. The graphics display 100 displays in step 630 a further template 60 displaying further ones of the data descriptors 10 if an event 52 is detected in step 635. Such an event can be triggered, for example, by selecting the IDE 40 with the navigation device 120. Additional ones of the time points 15 are displayed in step 640 on the ITL 20 if the additional ones of the time points fit into the template 50. Otherwise, a format of the template 50 is adjusted in step 645 by, for example, hiding some of the IDEs 40 or by providing a scrolling element 55. Upon receiving in step 650 an ITE event 30a the item of data 5 is being retrieved. The ITE event 30a is indicative to the navigation device 120 interacting with an ITE 30. The ITE event 30a triggers retrieving in step 655 of an item of data 5 associated with the time point 15 displayed as the ITE 30. The invention therefore provides an alternative way to retrieve the items of data 5 other than using the IDEs 40 described above.”);
U.S. Patent App Pub 2009/0132598 (para 39 “In response to a request, data entry monitor 25 compiles statistics from the labeled data. The compiled statistics include, the number of items selected or copied from a template with or without modification of those items, the number of template items displayed but not used, the number of items users added on an ad-hoc basis because they were not in the template. These statistics may be filtered based on one or more criteria such as (but not limited to), manually selected templates versus templates selected by system 10 at the point of use, specialty of a user, template selection criteria used by system 10 at point of use of the template (such as patient age and gender, identified patient problems, goals) and time period during which the templates were used. System 10 may exclude from analysis those template items that have been identified as mandatory due to regulations or hospital policies. In one embodiment user interface 26 displays or renders ROC curve scatter diagrams as previously described facilitating user selection of templates to be updated by update processor 29. In another embodiment, data processor 15 automatically analyzes scatter diagram data to identify templates to update and the data items to be added, deleted or modified and update processor 29 automatically updates identified templates and data items based on the analysis. Data processor 15 does this by identifying templates in particular quadrants via predetermined quadrant thresholds, for example. Data processor 15 identifies items to be automatically added, modified and removed based on statistics recorded by data entry monitor 25 and automatically adds, modifies or removes items based on template quadrant.”);
U.S. Patent App Pub 2014/0324469 (para 204, “In the event that certain types of data are repeatedly being underutilized (i.e., ignored or passed over quickly), the program 110 can provide automated prompts to alert the end-user of the cursory or incomplete data review, along with the option of removing this data category from future automated data templates (specific to the task being performed).”); and
U.S. Patent 6,498,657 (col. 14, lines 6-18, “A template defines a generalized document or report that includes many possible variations. Through the processing of a template and any given page of incoming information, the template is transformed into a highly customized document or report containing only a selection of the possible alternatives defined by the template and also containing specific information removed from the page of incoming information, possibly processed in some manner and converted as to format and position, and inserted into the document or report such that the resulting printed document is highly customized both in its standardized aspects, defined by the template, and also in its variable aspects, defined by the page of incoming information.”).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT A SOREY whose telephone number is (571)270-3606. The examiner can normally be reached Monday through Friday, 8am to 5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fonya Long can be reached at (571) 270-5096. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ROBERT A SOREY/ Primary Examiner, Art Unit 3682
Prosecution Insights