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 reply to the application filed on 01/15/25 with preliminary amendment filed on 02/07/25.
Claims 1-147 have been canceled.
Claims 148-167 have been added.
Claims 148-167 are currently pending and have been examined.
Priority/Continuity
Status of this application as a continuation application of 15/867,625, filed on 01/10/2018, which claims the befit and priority to US Provisional Applications 62/445,168 (filed 01/11/2016) and 62/597,816 (filed 12/12/2017), is acknowledged. Accordingly, a priority date of 01/11/2017 has been given to this application.
IDS
The information disclosure statement (IDS) submitted on 01/15/25 has been considered by the examiner. The submission is in compliance with the provisions of 37 CFR 1.97.
Objections
Claim 148 is objected to because of the following informalities: Claim 148 includes a semi-colon “;” in line 7 (“the reader device comprising;”) rather than a colon (“the reader device comprising:”)
Claim 158 is objected to because of the following informalities: Claim 158 includes a semi-colon “;” in line 17 (“the reader device comprising;”) rather than a colon (“the reader device comprising:”)
Appropriate correction is required. Dependent claims 149-157 and 159-167 are objected to as they inherit the deficiencies of their respective parent claims.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 148-167 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 148 recites the limitation "the display" in line 21. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, it is being interpreted as “a display”.
Claim 158 recites the limitation "the display" in line 29. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, it is being interpreted as “a display”.
Dependent claims 149-157 and 159-167 are rejected as they inherit the deficiencies of their respective parent 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.
Claims 148-167 are rejected under 35 U.S.C.101 because the claimed invention is directed to a judicial exception (an abstract idea) without significantly more.
Step 1
Claims 148-167 are drawn to a system, which is within the four statutory categories. Claims 148-167 are further directed to an abstract idea on the grounds set out in detail below.
Step 2A Prong 1
Claim 1 recites implementing the steps of:
detect, based on received data indicative of glucose level, whether one or more glucose episodes occurred in a subject during a time period,
generate episode data describing the detected one or more glucose episodes;
filter the episode data to identify whether the detected one or more glucose episodes meets a subject criteria;
generate a request for the subject to provide episode information about at least one detected episode of the detected one or more glucose episodes if the at least one detected episode meets the subject criteria;
provide the generated request to the subject, and
receive episode information from the subject in response to the generated request.
These steps amount to managing personal behavior or relationships or interactions
between people and therefore recite certain methods of organizing human activity. The steps represent personal behaviors of a healthcare provider and subsequent interactions of a healthcare provider with a subject that could be performed in analyzing the subject’s glucose levels; e.g., a healthcare provider could analyze glucose data of a subject to detect a glucose episode, generate data and filter data regarding the glucose episode, generate a request for the subject to provide more information about a detected glucose episode which is then provided to the subject, and subsequently receive episode information from the subject in response to the request.
Independent Claim 158 recites similar limitations and also recites an abstract idea under the same analysis.
The above claims are therefore directed to an abstract idea.
Step 2A Prong 2
This judicial exception is not integrated into a practical application because the additional
elements within the claims only amount to:
A. Instructions to Implement the Judicial Exception. MPEP 2106.05(f)
The independent claims additionally recite:
- a reader device comprising: second wireless communication circuitry configured to receive the data indicative of the glucose level from the sensor control device; processing circuitry; and non-transitory memory having stored thereon a plurality of instructions to be executed by the processing circuitry as implementing the steps of the abstract idea (Claim 148)
- a reader device comprising; third wireless communication circuitry configured to receive the data indicative of the glucose level from the sensor control device and the episode data from the server, and to communicate the data indicative of the glucose level to the server; second processing circuitry; second non-transitory memory having stored thereon a second plurality of instructions as implementing the steps of filter the episode data…; and generate a request for the subject…; output the generated request to the subject; and receive episode information from the subject in response to the generated request (Claim 158)
- a server comprising: second wireless communication circuitry configured to receive the data indicative of the glucose level from the reader device and communicate episode data to the reader device; processing circuitry; non-transitory memory having stored thereon a plurality of instructions that, when executed, causes the processing circuitry to implement the steps of detect, based on the received data indicative of the glucose level, whether one or more glucose episodes occurred in the subject during the time period, and generate the episode data describing the detected one or more glucose episodes (Claim 158)
- a display as implementing the step of outputting the generated request to the subject (Claims 148, 158)
The broad recitation of general purpose computing elements at a high level of generality only amounts to mere instructions to implement the abstract idea using computing components as tools.
Regarding a reader device comprising wireless communication circuitry, processing circuitry, and non-transitory memory having stored thereon a plurality of instructions, para. [0048] discloses, “Non-limiting examples of reader devices 120 can include the meter device of an ex-vivo monitoring system, the reader device of an in-vivo monitoring system, combinations of the two such as an in vivo reader operating with a test strip port and meter functionality, and various other devices such as smartphones, tablets, proprietary readers, other computing devices, etc.”; para. [0050] discloses “FIG. 1B is a block diagram of an example embodiment of a reader device 120 in the form of a smartphone. Here, reader device 120 includes an input component 121, display 122, and processing circuitry (or hardware) 206, which can include one or more processors, microprocessors, controllers, and/or microcontrollers, each of which can be a discrete chip or distributed amongst (and a portion of) a number of different chips. Processing hardware 206 can include a communications processor 202 having on-board memory 203 and an applications processor 204 having on-board memory 205. Additional processors can and will likely be present. Reader device 120 further includes an RF transceiver 208 coupled with an RF antenna 209, a memory 210, multi-functional circuitry 212 with one or more associated antennas 214, a power supply 216, and power management circuitry 218.” Therefore, the reader device and the associated wireless communication circuitry, processing circuitry and non-transitory memory are all given the broadest reasonable interpretation as a general purpose computing device functioning in its ordinary capacity.
Regarding a server comprising wireless communication circuitry, processing circuitry, and non-transitory memory having stored thereon a plurality of instructions, per paras. [0041]-[0042], this is understood to be a general purpose server computer functioning in its ordinary capacity (e.g., [0042], “For example, server 130 includes processing circuitry 131 communicatively coupled with non-transitory memory 132, local computing device 150 includes processing circuitry 124 communicatively coupled with non-transitory memory 125, and remote computing device 160 includes processing circuitry 126 communicatively coupled with non-transitory memory 127”).
Regarding “a display”, this is understood to be the display of a general purpose computing device, e.g., a smartphone functioning its ordinary capacity (para. [0072] discloses that the glucose monitoring application can be installed on smartphones running various operating systems, e.g., Android, IOS, others). No particulars of the display appear to be provided. Therefore, this element is given its broadest reasonable interpretation as a general purpose computing element functioning in its ordinary capacity.
B. Generally Linking a Judicial Exception to a Field of Use/Technological Environment: MPEP 2106.05(h)
Claims 148, 158 additionally recite a sensor control device comprising: a sensor configured to be inserted into a body of a subject and to measure a glucose level of the subject over a time period; and first wireless communication circuitry configured to communicate data indicative of the glucose level to a reader device, which only amounts to generally linking the judicial exception to a particular technological environment or field of use. Examiner submits that in the instant claims, the recitation of a sensor control device comprising: a sensor configured to be inserted into a body of a subject and to measure a glucose level of the subject over a time period; and first wireless communication circuitry configured to communicate data indicative of the glucose level to a reader device does not impact how other functions in the claim are performed. None of the limitations provide a nexus to limit or improve the sensor control device. Therefore, recitation of a sensor control device only amounts to generally linking the judicial exception to a particular technological field/field of use.
These elements in Sections A and B above are therefore not sufficient to integrate the abstract idea into a practical application. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually.
The above claims, as a whole, are therefore directed to an abstract idea.
Step 2B
The present claims do not include additional elements that are sufficient to amount to
more than the abstract idea because the additional elements or combination of elements amount to no more than a recitation of:
A. Instructions to Implement the Judicial Exception. MPEP 2106.05(f)
As explained above, claims 148, 158 only recite the aforementioned computing elements as tools for performing the steps of the abstract idea, and mere instructions to perform the abstract idea using a computer is not sufficient to amount to significantly more than the abstract idea. MPEP 2106.05(f).
B. Generally Linking a Judicial Exception to a Field of Use/Technological Environment: MPEP 2106.05(h)
Likewise, as explained above, recitation of a sensor control device comprising: a sensor configured to be inserted into a body of a subject and to measure a glucose level of the subject over a time period; and first wireless communication circuitry configured to communicate data indicative of the glucose level to a reader device only amounts to generally linking the use of a judicial exception to a particular technological environment or field of use. Employing generic computing components and functions to execute an abstract idea, even when limiting the use of the idea to one particular environment such as a sensor control device comprising a sensor configured to be inserted into a body of a subject and first wireless communication circuitry, does not add significantly more.
Thus, taken alone, the additional elements do not amount to significantly more than the
above-identified judicial exception. Looking at the limitations as an ordered combination adds
nothing that is not already present when looking at the elements taken individually. Their
collective functions merely provide conventional computer implementation.
Depending Claims
Dependent claims recite additional subject matter which further narrows or defines the abstract idea embodied in the claims. Claims 149-157 and 159-167 recite limitations which further narrow the scope of the independent claims as set out above. These limitations are not sufficient to integrate the judicial exception into a practical application or amount to significantly more than the abstract idea.
The dependent claims have been given the full two-part analysis including analyzing the additional limitations both individually and in combination. The dependent claims, when analyzed individually, and in combination, are also held to be patent ineligible under 35 U.S.C. 101 as they include all of the limitations of claim 148 or claim 158 respectively. The additional recited limitations of the dependent claims fail to establish that the claims do not recite an abstract idea because the additional recited limitations of the dependent claims merely further narrow the abstract idea. Accordingly, these additional elements do not integrate the abstract idea into a practical application or amount to significantly more than the abstract idea because it does not impose any meaningful limits on practicing the abstract idea.
Dependent claims 149-157 and 159-167, when analyzed as a whole, 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 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.
For the reasons stated, Claims 148-167 fail the Subject Matter Eligibility Test and are consequently rejected under 35 U.S.C. 101.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 148-156 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Simpson et. al. (US Publication 20160328990A1).
Regarding Claim 148, Simpson discloses: A glucose monitoring system comprising (Fig. 2):
(a) a sensor control device comprising: a sensor configured to be inserted into a body of a subject and to measure a glucose level of the subject over a time period ([0005] teaches on a continuous glucose monitor (CGM) which diabetics can use to monitor blood glucose via a continuous analyte sensor; the sensor is placed invasively and measures the concentration of a given analyte within the body, e.g., glucose and generates a raw signal using electronics associated with the sensor; [0356] teaches on receiving CGM data which constitutes currently measured CGM data, or data that may have been measured in the past; the CGM data is analyzed/evaluated; the signal is converted to an output value which is expressed in a way meaningful to the user, e.g., blood glucose expressed in mg/dL; [0187] teaches, with respect to Fig. 2, a “sensor and transmitter 22” which provides data from a sensor; [0020] teaches on outputting a trend graph indicating a trace signal representing glucose concentration value over a time period; [0332] further teaches on tracking a user’s glucose level over a duration of a week – a period of time; any of Figs. 26A-C, 27, 28C, 20A-C, 30A-C are understood to teach on measuring a glucose level of the subject over a time period); and first wireless communication circuitry configured to communicate data indicative of the glucose level to a reader device ([0187] teaches on the sensor/transmitter 22 providing data to a monitoring device which may be connected via local network hotspot or other cloud-based source of data; the sensor/transmitter 22 may provide data as needed by the described methods; [0157] teaches that “operably linked” and “operable connected allow transmission of signals between components; one or more electrodes can be used to detect the amount of glucose in a sample and convert that information into a signal which is transmitted to an electronic circuit; [0157] further discloses that these terms are broad enough to include “wireless connectivity”; [0378]-[0382] teach on device 518 running an application 523 being coupled to a sensor through a transmitter 526; the sensor of the generates an electrical signal and the transmitter sends the measured electrical analyte signal wirelessly to device 518; the “transmitter” is interpreted as being “first wireless communication circuitry” which communicates glucose measurement data to a reader deice such as a smartphone or other dedicated device); and
(b) the reader device comprising (Fig. 2; [0187] teaching on monitoring device 21 may be a “mobile device”; [0185] teaches on the monitoring device being a smart phone or other mobile device running monitoring applications): second wireless communication circuitry configured to receive the data indicative of the glucose level from the sensor control device ([0187] teaches on monitoring device 21 receiving data from a sensor and transmitter 22; [0378] teaches on the device running an application and being coupled to sensor through a transmitter – interpreted as wireless communication circuitry); processing circuitry ([0187] teaches on monitoring device being a “mobile device” which may be a “smart phone” per [0185] which is understood to contain “processing circuitry”; further, [0568] teaches on implementing the system and method in any number of computing devices which allow a processor in the computing device to implement the method); and non-transitory memory having stored thereon a plurality of instructions that, when executed by the processing circuitry, causes the processing circuitry to ([0187] teaches on the monitoring device 21 including non-transitory computer readable memory running an application or app which includes functionalities for receiving data from sensors 22 and analyzing such and other data to perform the methods described herein):
detect, based on the received data indicative of the glucose level, whether one or more glucose episodes occurred in the subject during the time period ([0164] teaches on a continuous glucose sensor as being a device that continuously or continually measures the glucose concentration of a bodily fluid; [0182] teaches on an example of determination of detected patterns of a user based on analysis of glucose data over time; patterns or events representing deviations from same in subsequent time periods may be detected; for example, the system may detect a pattern of “overnight lows” (interpreted as “one or more glucose episodes” occurring in a subject during a time period; the user may be detected as having “hyperglycemic excursions” on Sunday afternoons (also interpreted as “one or more glucose episodes”; [0330] teaches on an “unhealthy excursion”, e.g., glucose concentration value exceeds 200 mg/dL; see Fig. 34 showing blood sugar over 3 hours and notification “blood sugar is LOW” with “75 mg/dL” shown on the graph – interpreted as detecting a glucose episode has occurred in the 3 hour time period, if it has been output to the display),
generate episode data describing the detected one or more glucose episodes (see Fig. 34 showing blood sugar over 3 hours and notification “blood sugar is LOW” with “75 mg/dL” shown on the graph – outputting a notice that blood sugar is “LOW” along with value of 75 is interpreted as generating episode data that describes the glucose episode; similarly see Figs. 32A, C which also show episode data for a low and high blood sugar episodes respective; [0330] teaches on an “unhealthy excursion”, e.g., a user’s glucose concentration value exceeds 200 mg/dL);
filter the episode data to identify whether the detected one or more glucose episodes meets a subject criteria ([0330] teaches on following an “unhealthy excursion” (synonymous with “episode”), e.g., a glucose concentration value exceeds 200 mg/dL or a change in glucose concentration value over a predetermined time period meets a certain criteria, the user may be prompted for extra information – Examiner interprets a particular glucose concentration value (e.g., 200 mg/dL) and criteria pertaining to change in glucose concentration value over time to both read on a “subject criteria”; if the user is only prompted by the system for extra information when this certain criteria is met, it is interpreted as “filtering” the episode data to determine whether or not the threshold is met, as only values exceeding a threshold precipitate prompting the user for additional information);
generate a request for the subject to provide episode information about at least one detected episode of the detected one or more glucose episodes if the at least one detected episode meets the subject criteria (see Fig. 34/[0285], showing an application screen on the user’s device which prompts the user to enter information about an event that may have precipitated an episode, in this case, a downward trend in blood sugar; the display of Fig. 34 asks the user “What happened 2 hours ago?” with icons for user to select – Examiner interprets prompting the user / outputting a the query of Fig. 34 to display to indicate that the request for episode information has necessarily been generated; [0330] teaches on detection of an “unhealthy excursion” (episode) prompting a user for extra information, e.g., meal details or the last time they exercised, only when a glucose value threshold is exceeded (e.g., 200 mg/dL) or a change in glucose concentration value over a period of time meets a criteria; the user is prompted to enter data only if a “significant event” is detected such that requests for information do not exceed a predetermined threshold to avoid user interaction fatigue – Examiner interprets a particular glucose concentration over a threshold value or concentration value change over predetermined time period to be a detected episode that meets the subject criteria);
output the generated request to the subject to the display (Para. [0285] with respect to Fig. 34, showing an alert “Blood sugar is LOW” with a graph and asking the user “what happened 2 hours ago?” where the user can select from food, activity, other; [0330] teaches on when certain criteria are met, the user may be prompted for extra information such as meal or exercise details), and
receive episode information from the subject in response to the generated request (Fig. 34 display asks the user “what happened 2 hours ago?” where the user can select from food, activity, other; Fig. 35 shows the same graph of Fig. 34 with an “activity” icon added to the graph, interpreted as indicating that the user provided the answer of “activity” to the query; [0285] indicates that the user selected that they exercised – leading to the running icon added to the graph to log an activity, which is interpreted as indicating that episode information from the subject has been received in response to the request).
Regarding Claim 149, Simpson discloses the limitations of Claim 148. The system of claim 148, wherein the at least one detected episode is a most recent detected episode of the detected one or more glucose episodes ([0329] teaches on asking the user questions relating to retrospective and current events, e.g., “current excursions” or “recently-experienced” excursions”; Examiner submits that a “current excursion” would be also be the “most recent”).
Regarding Claim 150, Simpson discloses the limitations of Claim 148. Simpson further discloses wherein the subject criteria comprises an episode type ([0330] teaches on an “unhealthy excursion” for a subject being a glucose concentration value exceeding 200 mg/dL (interpreted as a high episode) or a change in glucose concentration value over a predetermined time period (interpreted as encompassing a rapid rise or drop episode)).
Regarding Claim 151, Simpson discloses the limitations of Claim 150. Simpson further discloses wherein the episode type comprises a low episode, a high episode, and a rapid rise episode ([0330] teaches on an “unhealthy excursion” for a subject being a glucose concentration value exceeding 200 mg/dL which is interpreted as reading on a “high episode”; Fig 31C shows display screen which indicates “Your Blood sugar is High” – also interpreted as a high episode; Fig. 32 A shows display screen indicating “Your blood sugar is LOW” – interpreted as a low episode; [0249] teaches on the user being provided with analyte values as an image showing a deviation, a “sudden rise” – interpreted as a rapid rise episode).
Regarding Claim 152, Simpson discloses the limitations of Claim 150. Simpson further discloses wherein the subject criteria comprises a type of the request to be displayed to the subject during a time-of-day period (See Fig. 36, which shows a phone screen showing “12:00” and a pop-up message reading “Your blood sugar is usually low around this time. Consider having a snack”).
Regarding Claim 153, Simpson discloses the limitations of Claim 148. Simpson further discloses wherein the subject criteria comprises a sensitivity level for the detecting whether the one or more glucose episodes occurred ([0239]/Fig. 12 teach on a trend graph with target range, hyperglycemia, hypoglycemia; [0244]/Fig. 15 teach on a gauge type indicator showing the different glycemic zones for a user; [0245] teaches on a user or HCP being able to configure the ranges; [0246] teaches on ranges being configurable based on how well as user has learned to control their glucose; ranges may be set to “wider”, “medium”, and “narrow” (see also Fig. 3); for a new user, ranges may be wider so that a measure of success is more easily attained (interpreted as a low sensitivity as the user has wider ranges); once the user becomes more skilled at controlling analyte levels, their ranges may be narrowed to a “medium” level (medium sensitivity); for advanced users, acceptable ranges may be made “narrow” (high sensitivity) with the goal of even better increasing their healthy lifestyle; Examiner submits that the wider the bands, the lower the sensitivity (e.g., less excursions as bands are larger) and the narrower the bands, the higher the sensitivity (e.g., potential for more excursions as bands are narrower; Examiner submits that the wider, medium and narrow ranges of Simpson read on the broadest reasonable interpretation of “sensitivity level” when read in view of instant specification para. [0235]).
Regarding Claim 154, Simpson discloses the limitations of Claim 153. Simpson further discloses wherein the sensitivity level comprises low, medium, or high ([0246] teaches on ranges being configurable based on how well as user has learned to control their glucose; ranges may be set to “wider”, “medium”, and “narrow” (see also Fig. 3); for a new user, ranges may be wider so that a measure of success is more easily attained (interpreted as a low sensitivity as the user has wider ranges); once the user becomes more skilled at controlling analyte levels, their ranges may be narrowed to a “medium” level (interpreted as medium sensitivity); for advanced users, acceptable ranges may be made “narrow” (interpreted as high sensitivity) with the goal of even better increasing their healthy lifestyle; Examiner submits that the wider the bands, the lower the sensitivity (e.g., less excursions as bands are larger and users have more band area to stay in range) and the narrower the bands, the higher the sensitivity (e.g., potential for more excursions as bands are narrower; with narrow band, user has less band area to stay in to avoid an excursion); Examiner submits that the wider, medium and narrow ranges of Simpson read on the broadest reasonable interpretation of “sensitivity level” being low, medium or high, when read in view of instant specification para. [0235]).
Regarding Claim 155, Simpson discloses the limitations of Claim 150. Simpson further discloses wherein the generated request comprises a request regarding a potential cause for the at least one detected episode ([0330] teaches on following an unhealthy excursion, prompting a user for extra information, e.g., meal details or last time the user exercised; [0285]/Fig. 34 teach on the application prompting the user to enter an event (potential cause) that may be precipitated a downward trend in blood sugar which may be a dangerous situation for the user).
Regarding Claim 156, Simpson discloses the limitations of Claim 148. Simpson further discloses, wherein the generated request comprises a request regarding a potential treatment of the at least one detected episode ([0253] teaches on a “glucose coach” feature; upon occurrence of “insufficient glucose control” (synonymous with “episode”), the glucose coach may prompt for additional user activity; it may ask “did the user miss a medication” – medication is interpreted as a “potential treatment”; [0276/Fig. 28H teach on the display providing suggestions for users for remedial actions to take to address certain glucose situations; [0348] teaches on using glucose level and other data to evaluate a regimen for user, where the output may include a “change to the type, timing and or amount of medicament, wherein the medicament is insulin a change to basal insulin dose, an addition to the regimen of insulin sensitizers or secretagogues, a change of type of insulin, and the like, may be included within the scope of recommendation” – outputting changes to insulin are interpreted as “potential treatment” for an episode).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 157 is/are rejected under 35 U.S.C. 103 as being unpatentable over Simpson et. al. (US Publication 20160328990A1) as applied to claim 148 above, and further in view of Christiansen et. al. (US Publication 20160328527A1).
Regarding Claim 157, Simpson discloses the limitations of Claim 148. Simpson does not disclose, but Christiansen, which is directed to a blood glucose management system, teaches: wherein the generated request comprises a request regarding a potential symptom of the at least one detected episode ([0049]-[0072] teach on asking questions of the patient related to symptoms the patient may be experiencing, e.g., examples of questions that the patient may be asked to answer include: Do you have sores on your feet?”, Are you feeling well today?, Is your breathing normal?, Do you have any numbness or tingling in your feet?, Do you have any numbness or tingling in your fingers?, Have you lost consciousness or don't recall a period of time due to blood sugar? – Examiner interprets all of these questions (‘generated request’) as regarding a potential symptom).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify Simpson with these teachings of Christiansen, for the system of Simpson to request a potential symptom of the at least one detected episode of symptom, with the motivation of using context-related information collected from the patient pertaining to a blood glucose measurement to provide context for the corresponding measurement, which can allow for more informed diabetes management and better overall diabetes care (Christiansen [0045]).
Claim(s) 158-166 is/are rejected under 35 U.S.C. 103 as being unpatentable over Simpson et. al. (US Publication 20160328990A1) as applied to claim 148 above, and further in view of Mensinger et. al. (US Publication 20140187890A1).
Regarding Claim 158, Simpson discloses: A glucose monitoring system comprising (Fig. 2):
(a) a sensor control device comprising: a sensor configured to be inserted into a body of a subject and to measure a glucose level of a subject over a time period ([0005] teaches on a continuous glucose monitor (CGM) which diabetics can use to monitor blood glucose via a continuous analyte sensor; the sensor is placed invasively and measures the concentration of a given analyte within the body, e.g., glucose and generates a raw signal using electronics associated with the sensor; [0356] teaches on receiving CGM data which constitutes currently measured CGM data, or data that may have been measured in the past; the CGM data is analyzed/evaluated; the signal is converted to an output value which is expressed in a way meaningful to the user, e.g., blood glucose expressed in mg/dL; [0187] teaches, with respect to Fig. 2, a “sensor and transmitter 22” which provides data from a sensor; [0020] teaches on outputting a trend graph indicating a trace signal representing glucose concentration value over a time period; [0332] further teaches on tracking a user’s glucose level over a duration of a week – a period of time; any of Figs. 26A-C, 27, 28C, 20A-C, 30A-C are understood to teach on measuring a glucose level of the subject over a time period); and first wireless communication circuitry configured to communicate data indicative of the glucose level to a reader device ([0187] teaches on the sensor/transmitter 22 providing data to a monitoring device which may be connected via local network hotspot or other cloud-based source of data; the sensor/transmitter 22 may provided data as needed by the described methods; [0157] teaches that “operably linked” and “operable connected allow transmission of signals between components; one or more electrodes can be used to detect the amount of glucose in a sample and convert that information into a signal which is transmitted to an electronic circuit; [0157] further discloses that these terms are broad enough to include “wireless connectivity”; [0378]-[0382] teach on device 518 running an application 523 being coupled to a sensor through a transmitter 526; the sensor of the generates an electrical signal and the transmitter sends the measured electrical analyte signal wirelessly to device 518; the “transmitter” is interpreted as being “first wireless communication circuitry” which communicates glucose measurement data to a reader deice such as a smartphone or other dedicated device); and
and
(b) the reader device comprising (Fig. 2; [0187] teaching on monitoring device 21 may be a “mobile device”; [0185] teaches on the monitoring device being a smart phone or other mobile device running monitoring applications):
third wireless communication circuitry configured to receive the data indicative of the glucose level from the sensor control device ([0187] teaches on monitoring device 21 receiving data from a sensor and transmitter 22; [0378] teaches on the device running an application and being coupled to sensor through a transmitter – interpreted as wireless communication circuitry; [0378]-[0382] teach on device 518 running an application 523 being coupled to a sensor through a transmitter 526; the sensor of the generates an electrical signal and the transmitter sends the measured electrical analyte signal wirelessly to device 518; the “transmitter” is interpreted as being “wireless communication circuitry” which communicates glucose measurement data to a reader deice such as a smartphone or other dedicated device); processing circuitry ([0187] teaches on monitoring device being a “mobile device” which may be a “smart phone” per [0185] which is understood to contain “processing circuitry”; further, [0568] teaches on implementing the system and method in any number of computing devices which allow a processor in the computing device to implement the method), ; second processing circuitry ([0187] teaches on monitoring device being a “mobile device” which may be a “smart phone” per [0185] which is understood to contain “processing circuitry”; further, [0568] teaches on implementing the system and method in any number of computing devices which allow a processor in the computing device to implement the method) ; second non-transitory memory having stored thereon a second plurality of instructions that, when executed, causes the second processing circuitry to ([0187] teaches on the monitoring device 21 including non-transitory computer readable memory running an application or app which includes functionalities for receiving data from sensors 22 and analyzing such and other data to perform the methods described herein):
filter the episode data to identify whether the detected one or more glucose episodes meets a subject criteria ([0330] teaches on following an “unhealthy excursion” (synonymous with “episode”), e.g., a glucose concentration value exceeds 200 mg/dL or a change in glucose concentration value over a predetermined time period meets a certain criteria, the user may be prompted for extra information – Examiner interprets a particular glucose concentration value (e.g., 200 mg/dL) and criteria pertaining to change in glucose concentration value over time to both read on a “subject criteria”; if the user is only prompted by the system for extra information when this certain criteria is met, it is interpreted as “filtering” the episode data to determine whether or not the threshold is met, as only values exceeding a threshold precipitate prompting the user for additional information); and
generate a request for the subject to provide episode information about at least one detected episode of the detected one or more glucose episodes if the at least one detected episode meets the subject criteria (see Fig. 34/[0285], showing an application screen on the user’s device which prompts the user to enter information about an event that may have precipitated an episode, in this case, a downward trend in blood sugar; the display of Fig. 34 asks the user “What happened 2 hours ago?” with icons for user to select – Examiner interprets prompting the user / outputting a the query of Fig. 34 to display to indicate that the request for episode information has necessarily been generated; [0330] teaches on detection of an “unhealthy excursion” (episode) prompting a user for extra information, e.g., meal details or the last time they exercised, only when a glucose value threshold is exceeded (e.g., 200 mg/dL) or a change in glucose concentration value over a period of time meets a criteria; the user is prompted to enter data only if a “significant event” is detected such that requests for information do not exceed a predetermined threshold to avoid user interaction fatigue – Examiner interprets a particular glucose concentration over a threshold value or concentration value change over predetermined time period to be a detected episode that meets the subject criteria);
output the generated request to the subject to the display (Para. [0285] with respect to Fig. 34, showing an alert “Blood sugar is LOW” with a graph and asking the user “what happened 2 hours ago?” where the user can select from food, activity, other; [0330] teaches on when certain criteria are met, the user may be prompted for extra information such as meal or exercise details), and
receive episode information from the subject in response to the generated request (Fig. 34 display asks the user “what happened 2 hours ago?” where the user can select from food, activity, other; Fig. 35 shows the same graph of Fig. 34 with an “activity” icon added to the graph, interpreted as indicating that the user provided the answer of “activity” to the query; [0285] indicates that the user selected that they exercised – leading to the running icon added to the graph to log an activity).
Simpson discloses, at [0558], “the device can be coupled to a server to facilitate transfer of means for performing the methods described herein” but does not teach on the following limitations of the instant invention with respect to a server. Mensinger, which is directed to remote monitoring of analyte measurements, teaches:
(b) a server comprising ([0007], a server): second wireless communication circuitry configured to receive the data indicative of the glucose level from the reader device ([0007] teaches on establishing a connection between the remote monitor (“reader device”) and the server to enable the receiving of information including analyte sensor data (“data indicative of the glucose level”); the remote monitor (“reader device”) may be a wireless terminal, tablet, smartphone, multi-mode wireless device, etc.; Per Fig. 1 showing high level architecture of the remote monitoring system, the communication between server and remote monitor is understood to include wireless networks such as cellular networks, LAN, WAN, Wi-Fi, internet and the like; see Fig. 2A, with secure server 110 receiving “sensor data” via a communication channel from remote monitor 114A which is understood to be a smartphone, tablet, etc. per [0047]; see paras. [0042]-[0045] with respect to Fig. 2A) and communicate episode data to the reader device ([0007] teaches on the server receiving the analyte sensor data, processing the analyte sensor data to detect an event (synonymous with “episode” per [0045]), and when an event is detected, a notification message (“episode data”) to the remote monitor (reader device); see Fig. 2A, paras. [0042]-[0045], the remote monitor (reader device) shows a message with “Alert: Glucose level Low” – interpreted as communicating “episode data” (low glucose), where [0047] teaches on the remote monitor comprising one or more of a mobile station, tablet, wireless terminal, smart phone, or the like); processing circuitry ([0007] teaches on the server having at least one processor configured to receive analyte data from the receiver); non-transitory memory having stored thereon a plurality of instructions that, when executed, causes the processing circuitry to ([0007] teaching on server and architecture, a computer-readable storage medium may include code which when executed by at least one processor causes the method, where [0258] teaches on this encompassing non-transitory computer program product, apparatus and/or device):
detect, based on the received data indicative of the glucose level, whether one or more glucose episodes occurred in the subject during the time period ([0007] teaches on the server receiving analyte sensor data from the receiver and processing the analyte data to detect an “event”; the event may be detected by a first set of rules at the server; where an “event” is understood to be a glucose-related event per [0045], “an event may comprise one or more of the following: a measured analyte sensor value above or below a predetermined threshold, a rate of change or a level of glucose measurements above a predetermined threshold, a predicted glucose value approaching (or predicted to approach) a predetermined threshold”; Examiner interprets “event” to be synonymous with “episode”; see Fig. 19 showing measurements over a time period; per [0225] data can be viewed in 3, 6, 12, 24 hour views – interpreted as detecting episodes over a time period), and
generate the episode data describing the detected one or more glucose episodes ([0007] teaches on receiving analyte sensor data at the server; the server processes the analyte data to detect an “event” based on a set of rules at the server; the first set of rules is used to generate a notification message which is forwarded to a remote monitor, which is understood to be a smart phone, tablet or similar mobile device per [0047]; see paras. [0042]-[0045]; see Fig. 2A where remote monitor outputs message regarding “glucose level low”, e.g., episode data describing a detected glucose episode).
a reader device which receives the episode data from the server ([0007] teaches on the server receiving and processing analyte sensor data to detect an event, and subsequently forwarding a notification message (“episode data”) regarding the detected event to a remote monitor (reader device), where [0047] teaches on the remote monitor being a smart phone, tablet, or similar mobile electronic device, interpreted as the reader device; see paras. [0042]-[0045] and Fig. 2A, the remote monitor (reader device) has received episode data via the server which shows an alert for “glucose level low”) and communicates the data indicative of the glucose level to the server (Paras. [0042]-[0045] with respect to Fig. 2A; Fig. 2A shows remote monitor (reader device) sharing “sensor data” via communication channel to secure server; [0007] teaching on the remote monitor and server are connected to enable the receiving of analyte sensor data (data indicative of glucose level)).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed, to modify Simpson with these teachings of Mensinger, to use a server as taught by Mensinger for receiving and processing analyte data to detect an event and communicating event information to a reader device, and using a reader device to receive episode data from the server and communicate data indicative of glucose level to the server, with the motivation of using a secure server for managing information from patients at a plurality of locations; rather than gathering an analyzing information solely from a single host-patient, data may be gathered at a secure server and compared on a macro level spanning a plurality of host patients and/or across a plurality of geographic regions (Mensinger [0172]).
Regarding Claim 159, Simpson/Mensinger teach the limitations of Claim 148. Simpson further discloses wherein the at least one detected episode is a most recent detected episode of the detected one or more glucose episodes ([0329] teaches on asking the user questions relating to retrospective and current events, e.g., “current excursions” or “recently-experienced” excursions”; Examiner submits that a “current excursion” would be also be the “most recent”).
Regarding Claim 160, Simpson/Mensinger teach the limitations of Claim 158. Simpson further discloses wherein the subject criteria comprises an episode type ([0330] teaches on an “unhealthy excursion” for a subject being a glucose concentration value exceeding 200 mg/dL (interpreted as a high episode) or a change in glucose concentration value over a predetermined time period (interpreted as encompassing a rapid rise or drop episode)).
Regarding Claim 161, Simpson/Mensinger teach the limitations of Claim 160. Simpson further discloses wherein the episode type comprises a low episode, a high episode, and a rapid rise episode ([0330] teaches on an “unhealthy excursion” for a subject being a glucose concentration value exceeding 200 mg/dL which is interpreted as reading on a “high episode”; Fig 31C shows display screen which indicates “Your Blood sugar is High” – also interpreted as a high episode; Fig. 32 A shows display screen indicating “Your blood sugar is LOW” – interpreted as a low episode; [0249] teaches on the user being provided with analyte values as an image showing a deviation, a “sudden rise” – interpreted as a rapid rise episode).
Regarding Claim 162, Simpson/Mensinger teach the limitations of Claim 158. Simpson further discloses wherein the subject criteria comprises a type of the request to be displayed to the subject during a time-of-day period (See Fig. 36, which shows a phone screen showing “12:00” and a pop-up message reading “Your blood sugar is usually low around this time. Consider having a snack.”)
Regarding Claim 163, Simpson/Mensinger teach the limitations of Claim 158. Simpson further discloses wherein the subject criteria comprises a sensitivity level for the detecting whether the one or more glucose episodes occurred ([0239]/Fig. 12 teach on a trend graph with target range, hyperglycemia, hypoglycemia; [0244]/Fig. 15 teach on a gauge type indicator showing the different glycemic zones for a user; [0245] teaches on a user or HCP being able to configure the ranges; [0246] teaches on ranges being configurable based on how well as user has learned to control their glucose; ranges may be set to “wider”, “medium”, and “narrow” (see also Fig. 3); for a new user, ranges may be wider so that a measure of success is more easily attained (interpreted as a low sensitivity as the user has wider ranges); once the user becomes more skilled at controlling analyte levels, their ranges may be narrowed to a “medium” level (medium sensitivity); for advanced users, acceptable ranges may be made “narrow” (high sensitivity) with the goal of even better increasing their healthy lifestyle; Examiner submits that the wider the bands, the lower the sensitivity (e.g., less excursions as bands are larger) and the narrower the bands, the higher the sensitivity (e.g., potential for more excursions as bands are narrower; Examiner submits that the wider, medium and narrow ranges of Simpson read on the broadest reasonable interpretation of “sensitivity level” when read in view of instant specification para. [0235]).
Regarding Claim 164, Simpson/Mensinger teach the limitations of Claim 163. Simpson further discloses wherein the sensitivity level comprises low, medium, or high ([0246] teaches on ranges being configurable based on how well as user has learned to control their glucose; ranges may be set to “wider”, “medium”, and “narrow” (see also Fig. 3); for a new user, ranges may be wider so that a measure of success is more easily attained (interpreted as a low sensitivity as the user has wider ranges); once the user becomes more skilled at controlling analyte levels, their ranges may be narrowed to a “medium” level (interpreted as medium sensitivity); for advanced users, acceptable ranges may be made “narrow” (interpreted as high sensitivity) with the goal of even better increasing their healthy lifestyle; Examiner submits that the wider the bands, the lower the sensitivity (e.g., less excursions as bands are larger and users have more band area to stay in range) and the narrower the bands, the higher the sensitivity (e.g., potential for more excursions as bands are narrower; with narrow band, user has less band area to stay in to avoid an excursion); Examiner submits that the wider, medium and narrow ranges of Simpson read on the broadest reasonable interpretation of “sensitivity level” being low, medium or high, when read in view of instant specification para. [0235]).
Regarding Claim 165, Simpson/Mensinger teach the limitations of Claim 158. Simpson further discloses wherein the generated request comprises a request regarding a potential cause for the at least one detected episode ([0330] teaches on following an unhealthy excursion, prompting a user for extra information, e.g., meal details or last time the user exercised; [0285]/Fig. 34 teach on the application prompting the user to enter an event (potential cause) that may be precipitated a downward trend in blood sugar which may be a dangerous situation for the user).
Regarding Claim 166, Simpson/Mensinger teach the limitations of Claim 158. Simpson further discloses, wherein the generated request comprises a request regarding a potential treatment of the at least one detected episode ([0253] teaches on a “glucose coach” feature; upon occurrence of “insufficient glucose control” (synonymous with “episode”), the glucose coach may prompt for additional user activity; it may ask “did the user miss a medication” – medication is interpreted as a “potential treatment”; [0276/Fig. 28H teach on the display providing suggestions for users for remedial actions to take to address certain glucose situations; [0348] teaches on using glucose level and other data to evaluate a regimen for user, where the output may include a “change to the type, timing and or amount of medicament, wherein the medicament is insulin a change to basal insulin dose, an addition to the regimen of insulin sensitizers or secretagogues, a change of type of insulin, and the like, may be included within the scope of recommendation” – outputting changes to insulin are interpreted as “potential treatment” for an episode).
Claim(s) 167 is/are rejected under 35 U.S.C. 103 as being unpatentable over Simpson et. al. (US Publication 20160328990A1) in view of Mensinger et. al. (US Publication 20140187890A1) as applied to claim 158 above, and further in view of Christiansen et. al. (US Publication 20160328527A1).
Regarding Claim 157, Simpson/Mensinger teach the limitations of Claim 158. Simpson/Mensinger do not teach, but Christiansen, which is directed to a blood glucose management system, teaches: wherein the generated request comprises a request regarding a potential symptom of the at least one detected episode ([0049]-[0072] teach on asking questions of the patient related to symptoms the patient may be experiencing, e.g., examples of questions that the patient may be asked to answer include: Do you have sores on your feet?”, Are you feeling well today?, Is your breathing normal?, Do you have any numbness or tingling in your feet?, Do you have any numbness or tingling in your fingers?, Have you lost consciousness or don't recall a period of time due to blood sugar? – Examiner interprets all of these questions (‘generated request’) as regarding a potential symptom
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to further modify Simpson/Mensinger with these teachings of Christiansen, for the system of Simpson/Mensinger to request a potential symptom of the at least one detected episode of symptom, with the motivation of using context-related information collected from the patient pertaining to a blood glucose measurement to provide context for the corresponding measurement, which can allow for more informed diabetes management and better overall diabetes care (Christiansen [0045]).
Conclusion
Examiner respectfully requests that Applicant provides citations to relevant paragraphs of specification for support for amendments in future correspondence.
The following relevant prior art not cited is made of record:
US Publication 20160098540A1, teaching on data analytics and visualization of blood glucose data excursions for diabetic patients using data from a continuous glucose monitor
US Publication 20140114161A1, teaching on methods and systems for promoting glucose management, using a continuous glucose monitor to detect glycemic episodes
US Publication 20160081597A1, teaching on dynamic monitoring using a continuous analyte sensor such as a CGM which may prompt a user to input data when a glycemic excursion occurs
US Publication 20170106144 A1, teaching on monitoring event patterns for diabetes management
US Publication 20160128571A1, teaching on systems and methods for transmitting glucose meter readings from a glucometer to a server which is in communication with a personal electronic device of the user
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/ANNE-MARIE K ALDERSON/Primary Examiner, Art Unit 3682