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 .
Abstract
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it exceeds 150 words in length. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Drawings
Many of the figures (especially Figures 13D, 13E, 13F, 13I, 13K, 15D, 15E, 16C, and 16F) of the drawings are not of sufficient quality to permit examination. Accordingly, replacement drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to this Office action. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action.
Applicant is given a shortened statutory period of TWO (2) MONTHS to submit new drawings in compliance with 37 CFR 1.81. Extensions of time may be obtained under the provisions of 37 CFR 1.136(a) but in no case can any extension carry the date for reply to this letter beyond the maximum period of SIX MONTHS set by statute (35 U.S.C. 133). Failure to timely submit replacement drawing sheets will result in ABANDONMENT of the application.
Claim Objections
Claims 50, 56, and 60 are objected to because of the following informality:
Claim 50 recites “insulin injection” in line 3, but should read “insulin injections”
Claim 56 recites “system if claim” in line 1, but should read “system of claim”
Claim 60 recites “system if claim” in line 1, but should read “system of claim”
Appropriate correction is required.
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 46-65 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 46 recites “a target level of interaction” in lines 7-8. It is unclear as to whether this limitation is referring to the previously introduced “a target level of interaction” from line 1 of Claim 46, or a separate element.
Claim 50 recites “at least one of” in line 2. Further in line 3, Claim 50 recites “and”. These two terms conflict one another. Examiner cannot definitively ascertain whether this is an alternative limitation or if all limitations are required. The Examiner will interpret the claim as in the alternative.
Claim 62 recites “an interaction level” in line 2. It is unclear as to whether this limitation is referring to the previously introduced “interaction level” from line 2 of Claim 60, or a separate element.
Claim 62 recites “a user” in line 2. It is unclear as to whether this limitation is referring to the previously introduced “user” from line 2 of Claim 60, or a separate element.
Claim 65 recites “a target level of interaction” in line 13. It is unclear as to whether this limitation is referring to the previously introduced “a target level of interaction” from line 1 of Claim 65, or a separate element.
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 46-65 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.
Each of Claims 46-65 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 1
Claims 46-65 recite analyte monitoring systems for determining a target level of interaction. Thus, the claims are directed to a machine, which is one of the statutory categories of invention.
Step 2A, Prong 1
Each of Claims 46-65 recites at least one step or instruction for determining a target level of interaction, which is grouped as a mental process under the 2019 PEG.
Both Claims 46 and 65 recite abstract ideas in the form of mental processes. If a claim, under its broadest reasonable interpretation, covers performance in the mind but for the recitation of generic computer components, then it is still in the mental processes category unless the claim cannot practically be performed in the mind, see Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1318 (Fed. Cir. 2016). Determining a target level of interaction for the user based on contextual information are assessments that may be performed by a human. This applies for all claims dependent on claims 46 and 65. Accordingly, each of Claims 46-65 recites an abstract idea.
Specifically, Claim 46 recites the abstract idea of “determin[ing] a target level of interaction for the user based on the custom model”, and Claim 65 recites the abstract idea of “determin[ing] a frequency of interaction of the user” and “determin[ing] a target level of interaction for the user based on the custom model”. The other limitations are considered insignificant extra-solution activity, in the forms of data-gathering and data-outputting.
Further, dependent Claims 47-64 merely include limitations that either further define the abstract idea (and thus don’t make the abstract idea any less abstract) or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they’re merely incidental or token additions to the claims that do not alter or affect how the process steps are performed.
Accordingly, as indicated above, each of the above-identified claims recites an abstract idea.
Step 2A, Prong 2
The above-identified abstract idea in each of independent Claims 46 and 65 (and the dependent Claims 47-64) is not integrated into a practical application under 2019 PEG because the additional elements (identified above in independent Claims 46 and 65), either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use. More specifically, the additional elements of: “reader”, “analyte sensor”, “server” in independent claim 46; “position sensor” in dependent claim 48, “smartphone”, “accelerometer” in dependent claim 49, “sensor control device” in dependent claim 58; “analyte sensor”, “reader”, “memory”, “one or more processors”, “server” in independent claim 65 are generically recited computer elements in independent Claims 46 and 65 (and the dependent claims) which do not improve the functioning of a computer, or any other technology or technical field and/or serve as data-gathering elements. Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. For at least these reasons, the abstract idea identified above in independent Claims 46 and 65 (and the dependent claims) is not integrated into a practical application under 2019 PEG.
Moreover, the above-identified abstract idea is not integrated into a practical application under 2019 PEG because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process) using rules (e.g., computer instructions) executed by a computer (e.g., “one or more processors” as claimed). In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent Claims 46 and 65 (and the dependent claims) is not integrated into a practical application under the 2019 PEG.
Accordingly, independent Claims 46 and 65 (and the dependent claims) are each directed to an abstract idea under 2019 PEG.
Step 2B
None of Claims 46-65 include additional elements that are sufficient to amount to significantly more than the abstract idea for at least the following reasons.
These claims require the additional elements of: “reader”, “analyte sensor”, “server” in independent claim 46; “position sensor” in dependent claim 48, “smartphone”, “accelerometer” in dependent claim 49, “sensor control device” in dependent claim 58; “analyte sensor”, “reader”, “memory”, “one or more processors”, “server” in independent claim 65. The above-identified additional elements are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks and/or serve as data-gathering elements. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, Versata Dev. Group, Inc. v. SAP Am., Inc. , 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Those in the relevant field of art would recognize the above-identified additional elements as being well-understood, routine, and conventional means for data-gathering and computing, as demonstrated by the Applicant’s specification (e.g. paragraphs [0063-0070]) which discloses that the processor(s) comprise generic computer components that are configured to perform the generic computer functions (e.g. determining) and that the data-gathering/data-outputting elements are well-understood, routine, and conventional activities previously known to the pertinent industry; the Applicant’s Background in the specification; and the non-patent literature of record and cited prior art in the application.
Accordingly, in light of Applicant’s specification, the claimed term “one or more processors” is reasonably construed as a generic computing device. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process.
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the “one or more processors”. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
The recitation of the above-identified additional limitations in Claims 46-65 amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the systems of Claims 46-65 are directed to applying an abstract idea as identified above on a general purpose computer without (i) improving the performance of the computer itself, or (ii) providing a technical solution to a problem in a technical field. None of Claims 46-65 provides meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in independent Claims 46 and 65 (and their dependent claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment. That is, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity. When viewed as a combination, these above-identified additional elements simply implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. Thus, Claims 46-65 merely apply an abstract idea to a computer and do not (i) improve the performance of the computer itself (as in Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
Therefore, none of the Claims 46-65 amounts to significantly more than the abstract idea itself. Accordingly, Claims 46-65 are not patent eligible and rejected under 35 U.S.C. 101.
Claim Rejections - 35 USC § 103
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 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.
Claims 46-57 and 59-63 are rejected under 35 U.S.C. 103 as being unpatentable over Taub et al (U.S. Publication No. 2018/0192927; cited by Applicant) in view of Memmelaar et al (U.S. Publication No. 2020/0027535).
Regarding Claim 46, Taub discloses an analyte monitoring system for determining a target level of interaction (Analyte Monitoring and Management Device and Method to Analyze the Frequency of User Interaction with the Device; Abstract), the system comprising:
a reader configured to collect analyte data from an analyte sensor (a data processing unit 102 connectable to the sensor 101, and a primary receiver unit 104, which is configured to communicate with the data processing unit 102 via a communication link 103…the data processing terminal 105 may be configured to receive data directly from the data processing unit 102 via a communication link which may optionally be configured for bi-directional communication. Further, the data processing unit 102 may include a transmitter or a transceiver to transmit and/or receive data to and/or from the primary receiver unit 104 and/or the data processing terminal 105 and/or optionally the secondary receiver unit 106; [0032]);
a server operatively coupled to the reader and configured to receive the collected analyte data (a communication link 103…the data processing terminal 105 may be configured to receive data directly from the data processing unit 102 via a communication link which may optionally be configured for bi-directional communication. Further, the data processing unit 102 may include a transmitter or a transceiver to transmit and/or receive data to and/or from the primary receiver unit 104 and/or the data processing terminal 105 and/or optionally the secondary receiver unit 106; [0032]); and wherein the system is configured to determine a target level of interaction for the user based on contextual information of the user (In order to achieve the full benefit of the analyte monitoring system 100, the user should maintain a predetermined target rate of interaction with the system. In one exemplary embodiment, the predetermined target level of user interaction is set by an HCP, or the user's health care team. Thus, each predetermined target level of interaction will likely depend on the specific user. However, in one exemplary embodiment, factors affecting the predetermined level of user interaction with the system may be: the particular analyte to be measured, the user's general state of health, (for example, more frequent during sick days), symptoms exhibited by the user, time of day, time since or until meal, activity level and other events. In one exemplary embodiment, the target level may be programmed (or user modifiable) to vary during the course of the day or week (work week vs. weekend), with these rates being easily adjustable to account for events or changes, such as, during sick days, times of high activity, or other times when more frequent interactions should be encouraged; [0060-0061]).
However, Taub fails to specifically teach a population model operatively coupled to the server and the reader, the population model configured to execute a custom model of a user and to determine a target level of interaction for the user based on the custom model, wherein the custom model comprises machine learning based on contextual information of the user.
In a similar technical field, Memmelaar discloses a population model operatively coupled to the server and the reader, the population model configured to execute a custom model of a user and to determine a target level of interaction for the user based on the custom model, wherein the custom model comprises machine learning based on contextual information of the user (In an illustrative embodiment, IDM history data 142 is data generated and stored during a user's previous interactions with the IDM system 100. This can include previous inquiries submitted by the user; previous responses provided by the user; user-entered preferences; and/or a log indicating the timing of the user's interactions with the IDM system 100, among other things. The IDM system 100 can automatically add IDM history data 142 as the user continues to use and/or interact with the IDM system 100. The IDM history data 142 can be used by a predictive analytics module 136 and a machine learning module 138 of the interactive engine 130 (or other modules of the IDM system 100) to customize future interactions between the IDM system 100 and the user. As a user interacts with the IDM system 100, the IDM history data 142 associated with the user's account in the user database 140 grows, allowing the IDM system 100 to know the user better, provide better content, and create a more engaging experience. In some embodiments, this increases the efficacy of the IDM system 100; [0052]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the machine learning teachings of Memmelaar into those of Taub in order to customize interactions between the system and the user, allowing the system to know the user better, provide better content, and create a more engaging experience (Memmelaar [0052]).
Regarding Claim 47, Taub discloses wherein the analyte monitoring system is configured to automatically adjust the target level of interaction based on an activity level or state of general wellness of the user (In order to achieve the full benefit of the analyte monitoring system 100, the user should maintain a predetermined target rate of interaction with the system. In one exemplary embodiment, the predetermined target level of user interaction is set by an HCP, or the user's health care team. Thus, each predetermined target level of interaction will likely depend on the specific user. However, in one exemplary embodiment, factors affecting the predetermined level of user interaction with the system may be: the particular analyte to be measured, the user's general state of health, (for example, more frequent during sick days), symptoms exhibited by the user, time of day, time since or until meal, activity level and other events. In one exemplary embodiment, the target level may be programmed (or user modifiable) to vary during the course of the day or week (work week vs. weekend), with these rates being easily adjustable to account for events or changes, such as, during sick days, times of high activity, or other times when more frequent interactions should be encouraged; [0060-0061]).
Regarding Claim 48, Taub discloses a position sensor configured to detect contextual information of the user (the system may automatically adjust the target level of interaction based upon the user's activity level or state of general wellness. In this exemplary embodiment, the system may use pulse rate, body temperature, respiration rate or other indicators to adjust the analyte level. Alternatively, position sensors, accelerometers or the like may be used to detect sleep and reduce (or even suspend) the target interaction frequency; [0063]).
Regarding Claim 49, Taub discloses wherein the reader is a smartphone (the data processing terminal 105 may include a personal computer, a portable computer such as a laptop or a handheld device (e.g., personal digital assistants (PDAs), telephone such as a cellular phone (e.g., a multimedia and Internet-enabled mobile phone such as an iPhone or similar phone); [0040]) and comprises an accelerometer configured to detect contextual information of the user (the system may automatically adjust the target level of interaction based upon the user's activity level or state of general wellness. In this exemplary embodiment, the system may use pulse rate, body temperature, respiration rate or other indicators to adjust the analyte level. Alternatively, position sensors, accelerometers or the like may be used to detect sleep and reduce (or even suspend) the target interaction frequency; [0063]).
Regarding Claim 50, Taub discloses wherein the contextual information of the user comprises at least one of steps per day, pulse rate, body temperature, respiration rate, time in target range, estimated HbAlec level, and number of insulin injection over a period of time (the system may automatically adjust the target level of interaction based upon the user's activity level or state of general wellness. In this exemplary embodiment, the system may use pulse rate, body temperature, respiration rate or other indicators to adjust the analyte level. Alternatively, position sensors, accelerometers or the like may be used to detect sleep and reduce (or even suspend) the target interaction frequency; [0063]).
Regarding Claim 51, Taub discloses wherein the custom model is configured to at least one of gradually or incrementally increase the target level of interaction over a period of time (the level of interaction may be adjusted to an increased or decreased target level of interaction based upon the monitoring results, based upon some user interaction with the device (e.g., meal or activity level entry), or may be pre-programmed to vary with the time of day or day of the week. The monitoring results may include, analyte levels, the rate of change of analyte levels, etc.; [0065]).
Regarding Claim 52, Taub discloses wherein the custom model is configured to adjust the target level of interaction for the user based on a baseline level of interaction of the user over a period of time (In one exemplary embodiment, the target level may be programmed (or user modifiable) to vary during the course of the day or week (work week vs. weekend), with these rates being easily adjustable to account for events or changes, such as, during sick days, times of high activity, or other times when more frequent interactions should be encouraged. Although HCPs may recommend only general interaction levels (e.g., once per hour during waking hours), these levels may be tailored to the individual user. For example, if a user feels overwhelmed with CGM technology, lower target levels of interaction may be needed, whereas a user who feels empowered by the technology may be encouraged to interact with the device at a higher frequency. Generally, HCPs will review interaction levels during routine visits when assessing general health and reviewing data uploads (e.g., approximately every 3 months for patients with diabetes). However, this approach may differ depending on the user, or other factors; [0061]).
Regarding Claim 53, Taub discloses wherein the period of time includes at least one of one day, seven days, fourteen days, thirty days or ninety days (In one exemplary embodiment, the target level may be programmed (or user modifiable) to vary during the course of the day or week (work week vs. weekend), with these rates being easily adjustable to account for events or changes, such as, during sick days, times of high activity, or other times when more frequent interactions should be encouraged. Although HCPs may recommend only general interaction levels (e.g., once per hour during waking hours), these levels may be tailored to the individual user. For example, if a user feels overwhelmed with CGM technology, lower target levels of interaction may be needed, whereas a user who feels empowered by the technology may be encouraged to interact with the device at a higher frequency. Generally, HCPs will review interaction levels during routine visits when assessing general health and reviewing data uploads (e.g., approximately every 3 months for patients with diabetes). However, this approach may differ depending on the user, or other factors; [0061]).
Regarding Claim 54, Taub discloses wherein the baseline level of interaction is settable by the user or a health care professional (HCP) (the predetermined target level of user interaction is set by an HCP, or the user's health care team; [0060]).
Regarding Claim 55, Taub discloses wherein the reader is configured to collect analyte data from the analyte sensor using a wireless communication protocol (the communication link 103 as well as one or more of the other communication interfaces shown in FIG. 1, may use one or more of: a radio frequency (RF) communication protocol, an infrared communication protocol, a Bluetooth® enabled communication protocol, an 802.11x wireless communication protocol, or an equivalent wireless communication protocol which would allow secure, wireless communication of several units (for example, per HIPAA requirements), while avoiding potential data collision and interference; [0041]).
Regarding Claim 56, Taub discloses wherein the wireless communication protocol is one of a Near Field Communication (NFC) protocol, a Radio Frequency Identification (RFID) protocol, a Bluetooth protocol, or a Bluetooth Low Energy protocol (the communication link 103 as well as one or more of the other communication interfaces shown in FIG. 1, may use one or more of: a radio frequency (RF) communication protocol, an infrared communication protocol, a Bluetooth® enabled communication protocol, an 802.11x wireless communication protocol, or an equivalent wireless communication protocol which would allow secure, wireless communication of several units (for example, per HIPAA requirements), while avoiding potential data collision and interference; [0041]).
Regarding Claim 57, Taub discloses wherein the reader is configured to collect data from the analyte sensor continuously without prompting the analyte sensor (The analyte monitoring system 100 may be a continuous monitoring system; [0035]).
Regarding Claim 59, Taub discloses wherein the analyte is at least one of glucose, lactate, or ketone (the analyte monitoring system may include an analyte management system, such as an insulin pump. Thus, it is to be understood that the following description is directed to an analyte (for example, glucose) monitoring system for convenience only and such description is in no way intended to limit the scope of the disclosure. Analytes that may be monitored include, but are not limited to, acetyl choline, amylase, bilirubin, cholesterol, chorionic gonadotropin, creatine kinase (e.g., CK-MB), creatine, creatinine, DNA, fructosamine, glucose, glutamine, growth hormones, hormones, ketone bodies, lactate, peroxide, prostate-specific antigen, prothrombin, RNA, thyroid stimulating hormone, and troponin; [0029-0030]).
Regarding Claim 60, Taub discloses wherein the reader is configured to determine an interaction level of the user relative to the target level of interaction (the present disclosure may include an “ideal” level of interaction, an “acceptable” level of interaction and a “critical” level of interaction. These levels may shift based on several factors. In one exemplary embodiment, the level of interaction may be adjusted to an increased or decreased target level of interaction based upon the monitoring results, based upon some user interaction with the device (e.g., meal or activity level entry), or may be pre-programmed to vary with the time of day or day of the week. The monitoring results may include, analyte levels, the rate of change of analyte levels, etc. In another exemplary embodiment, the interaction frequency level may be relative to the predetermined target interaction frequency. For example “ideal” may be approximately 90% or more of the target level; “acceptable” may be 70-90% of the target level; and “critical” may be below 70% of the target level; [0065-0066]).
Regarding Claim 61, Taub discloses wherein the reader is configured to output a first notification on a user interface of the reader if the determined frequency of interaction is at or below the target level of interaction (The display 24 may contain symbols or other indicators that are activated under certain conditions (e.g., an alert to the user may become visible on the display when the user's frequency of interaction with the receiver units 104 and 106 falls below the predetermined target level of interaction); [0046]; [0075-0077]) and output a second notification on the user interface of the reader if the determined frequency of interaction is above the target level of interaction, wherein the first notification and the second notification are different (That is, by frequently interacting with the cartoon-like character, the user will keep the health, or life, level of the cartoon-like character above the predetermined target level. In one exemplary embodiment, the user may “feed” the cartoon-like character by interacting with the device. The user's analyte level, or other relevant information should also be displayed on the screen of the device during interaction between the user and the cartoon-like character; [0057]; By interacting with the cartoon-like character, the user may also be educated as to the benefits of maintaining a proper target rate of interaction with the device, or may at least stay informed as to his own state of health. This embodiment may be particularly interesting to children as it may help ensure that children maintain the necessary level of interaction with the monitoring device of this disclosure. This exemplary embodiment may also be coupled with education regarding treatment options, helpful hints and tips; [0058]; the method may include rewarding the user when the actual frequency of interaction stays above the at least one predetermined level of interaction for a predetermined time; [0099]).
Regarding Claim 62, Taub discloses wherein the determined frequency of interaction corresponds to an interaction level of a user, wherein the interaction level is determined based on one or more instances of user operation of the reader over a first period of time (the user may be rewarded when the actual frequency of interaction stays above the at least one predetermined level of interaction for a predetermined time; [0015]; the user will be limited in the amount of interaction in a predetermined time. That is, the user will not be able to front-load the amount of interaction with the device, and then ignore the device for a prolonged period of time. As such, the device may only record a predetermined number of interactions within a certain period of time; [0057]).
Regarding Claim 63, Taub discloses wherein the first notification provides a recommendation for user to increase interaction with the reader to target a first improvement in a metabolic parameter of the user (as shown in FIG. 5, the display 24 also provides a message 60 to the user to direct the user in an action. Such messages may include, for example, “Check Analyte Level”, if the user's frequency of interaction with a receiver unit falls below the predetermined target level. In another exemplary embodiment, the messages may provide helpful hints or tips to the user; [0047]) and the second notification indicates the frequency of interaction with the reader and provides a recommendation for user to maintain the frequency of interaction with the reader (the software may offer educational information related to treatment as well as helpful hints and tips, thereby educating the user as to the importance of maintaining a predetermined target level of interaction with the receiver unit; [0056]; That is, by frequently interacting with the cartoon-like character, the user will keep the health, or life, level of the cartoon-like character above the predetermined target level. In one exemplary embodiment, the user may “feed” the cartoon-like character by interacting with the device. The user's analyte level, or other relevant information should also be displayed on the screen of the device during interaction between the user and the cartoon-like character; [0057]; By interacting with the cartoon-like character, the user may also be educated as to the benefits of maintaining a proper target rate of interaction with the device, or may at least stay informed as to his own state of health. This embodiment may be particularly interesting to children as it may help ensure that children maintain the necessary level of interaction with the monitoring device of this disclosure. This exemplary embodiment may also be coupled with education regarding treatment options, helpful hints and tips; [0058]; the method may include rewarding the user when the actual frequency of interaction stays above the at least one predetermined level of interaction for a predetermined time; [0099]).
Claim 65 is rejected under 35 U.S.C. 103 as being unpatentable over Taub et al in view of Memmelaar et al and Hayter et al (U.S. Publication No. 2018/0226150; cited by Applicant).
Regarding Claim 65, Taub discloses an analyte monitoring system for determining a target level of interaction (Analyte Monitoring and Management Device and Method to Analyze the Frequency of User Interaction with the Device; Abstract), the system comprising:
an analyte sensor configured to generate data indicative of an analyte of interest (the analyte monitoring system 100 includes a sensor 101; [0032]);
a reader having a user interface (the data processing terminal 105 may include a personal computer, a portable computer such as a laptop or a handheld device (e.g., personal digital assistants (PDAs), telephone such as a cellular phone (e.g., a multimedia and Internet-enabled mobile phone such as an iPhone or similar phone), mp3 player, pager, and the like), or a drug delivery device (e.g., an insulin pump), each of which may be configured for data communication with the receiver via a wired or a wireless connection; [0040]), the reader comprising one or more processors coupled with a memory (a memory operatively coupled to the processor unit, wherein the processor unit is configured to record in the memory a history of the frequency of interaction; Claim 11), the memory configured to store instructions that, when executed by the one or more processors, cause the one or more processors to:
receive the data indicative of the analyte level from the analyte sensor (a data processing unit 102 connectable to the sensor 101, and a primary receiver unit 104, which is configured to communicate with the data processing unit 102 via a communication link 103…the data processing terminal 105 may be configured to receive data directly from the data processing unit 102 via a communication link which may optionally be configured for bi-directional communication. Further, the data processing unit 102 may include a transmitter or a transceiver to transmit and/or receive data to and/or from the primary receiver unit 104 and/or the data processing terminal 105 and/or optionally the secondary receiver unit 106; [0032]), and
determine a frequency of interaction of the user with the reader (monitoring a user's actual frequency of interaction with the medical device; [0087]);
a server operatively coupled to the reader and configured to receive the data indicative of the analyte level (a communication link 103…the data processing terminal 105 may be configured to receive data directly from the data processing unit 102 via a communication link which may optionally be configured for bi-directional communication. Further, the data processing unit 102 may include a transmitter or a transceiver to transmit and/or receive data to and/or from the primary receiver unit 104 and/or the data processing terminal 105 and/or optionally the secondary receiver unit 106; [0032]); and
wherein the system is configured to determine a target level of interaction for the user based on contextual information of the user (In order to achieve the full benefit of the analyte monitoring system 100, the user should maintain a predetermined target rate of interaction with the system. In one exemplary embodiment, the predetermined target level of user interaction is set by an HCP, or the user's health care team. Thus, each predetermined target level of interaction will likely depend on the specific user. However, in one exemplary embodiment, factors affecting the predetermined level of user interaction with the system may be: the particular analyte to be measured, the user's general state of health, (for example, more frequent during sick days), symptoms exhibited by the user, time of day, time since or until meal, activity level and other events. In one exemplary embodiment, the target level may be programmed (or user modifiable) to vary during the course of the day or week (work week vs. weekend), with these rates being easily adjustable to account for events or changes, such as, during sick days, times of high activity, or other times when more frequent interactions should be encouraged; [0060-0061]).
wherein the reader is configured to output a first notification on the user interface if the determined frequency of interaction is at or below the target level of interaction (The display 24 may contain symbols or other indicators that are activated under certain conditions (e.g., an alert to the user may become visible on the display when the user's frequency of interaction with the receiver units 104 and 106 falls below the predetermined target level of interaction); [0046]; [0075-0077]) and output a second notification on the user interface of the reader device if the determined frequency of interaction is above the target level of interaction (That is, by frequently interacting with the cartoon-like character, the user will keep the health, or life, level of the cartoon-like character above the predetermined target level. In one exemplary embodiment, the user may “feed” the cartoon-like character by interacting with the device. The user's analyte level, or other relevant information should also be displayed on the screen of the device during interaction between the user and the cartoon-like character; [0057]; By interacting with the cartoon-like character, the user may also be educated as to the benefits of maintaining a proper target rate of interaction with the device, or may at least stay informed as to his own state of health. This embodiment may be particularly interesting to children as it may help ensure that children maintain the necessary level of interaction with the monitoring device of this disclosure. This exemplary embodiment may also be coupled with education regarding treatment options, helpful hints and tips; [0058]; the method may include rewarding the user when the actual frequency of interaction stays above the at least one predetermined level of interaction for a predetermined time; [0099]), wherein the first notification provides a recommendation for the user to increase interaction with the reader device to target a first improvement in a metabolic parameter of the user (as shown in FIG. 5, the display 24 also provides a message 60 to the user to direct the user in an action. Such messages may include, for example, “Check Analyte Level”, if the user's frequency of interaction with a receiver unit falls below the predetermined target level. In another exemplary embodiment, the messages may provide helpful hints or tips to the user; [0047]) and the second notification indicates the frequency of interaction of the user with the reader device and provides a recommendation for user to maintain the frequency of interaction with the reader (the software may offer educational information related to treatment as well as helpful hints and tips, thereby educating the user as to the importance of maintaining a predetermined target level of interaction with the receiver unit; [0056]; That is, by frequently interacting with the cartoon-like character, the user will keep the health, or life, level of the cartoon-like character above the predetermined target level. In one exemplary embodiment, the user may “feed” the cartoon-like character by interacting with the device. The user's analyte level, or other relevant information should also be displayed on the screen of the device during interaction between the user and the cartoon-like character; [0057]; By interacting with the cartoon-like character, the user may also be educated as to the benefits of maintaining a proper target rate of interaction with the device, or may at least stay informed as to his own state of health. This embodiment may be particularly interesting to children as it may help ensure that children maintain the necessary level of interaction with the monitoring device of this disclosure. This exemplary embodiment may also be coupled with education regarding treatment options, helpful hints and tips; [0058]; the method may include rewarding the user when the actual frequency of interaction stays above the at least one predetermined level of interaction for a predetermined time; [0099]).
However, Taub fails to specifically teach a population model configured to operatively communicate with the server and the reader, the population model configured to execute a custom model of a user and to determine a target level of interaction for the user based on the custom model, wherein the custom model comprises machine learning based on contextual information of the user.
In a similar technical field, Memmelaar discloses a population model operatively coupled to the server and the reader, the population model configured to execute a custom model of a user and to determine a target level of interaction for the user based on the custom model, wherein the custom model comprises machine learning based on contextual information of the user (In an illustrative embodiment, IDM history data 142 is data generated and stored during a user's previous interactions with the IDM system 100. This can include previous inquiries submitted by the user; previous responses provided by the user; user-entered preferences; and/or a log indicating the timing of the user's interactions with the IDM system 100, among other things. The IDM system 100 can automatically add IDM history data 142 as the user continues to use and/or interact with the IDM system 100. The IDM history data 142 can be used by a predictive analytics module 136 and a machine learning module 138 of the interactive engine 130 (or other modules of the IDM system 100) to customize future interactions between the IDM system 100 and the user. As a user interacts with the IDM system 100, the IDM history data 142 associated with the user's account in the user database 140 grows, allowing the IDM system 100 to know the user better, provide better content, and create a more engaging experience. In some embodiments, this increases the efficacy of the IDM system 100; [0052]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the machine learning teachings of Memmelaar into those of Taub in order to customize interactions between the system and the user, allowing the system to know the user better, provide better content, and create a more engaging experience (Memmelaar [0052]).
Taub and Memmelaar fail to specifically teach wherein the metabolic parameter is HbA1c or time in target range.
In a similar technical field, Hayter teaches systems, devices, and methods for episode detection and evaluation with visit guides, action plans and/or scheduling interfaces (Abstract), wherein the metabolic parameter is HbA1c or time in target range (Analytes that may be monitored include, but are not limited to, acetyl choline, amylase, bilirubin, cholesterol, chorionic gonadotropin, glycosylated hemoglobin (HbA1c); [0037]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the HbA1c teachings of Hayter into those of Taub and Memmelaar, as HbA1c monitoring is useful for accurately diagnosing diabetes, tracking long-term treatment, and assessing future risk for patients.
Claims 58 and 64 are rejected under 35 U.S.C. 103 as being unpatentable over Taub et al and Memmelaar et al as applied to claim 46 above, and further in view of Hayter et al.
Regarding Claim 58, Taub and Memmelaar fail to disclose wherein the reader is configured to collect data from the analyte sensor in response to a scan or request for data by the reader to a sensor control device of the analyte sensor.
In a similar technical field, Hayter teaches systems, devices, and methods for episode detection and evaluation with visit guides, action plans and/or scheduling interfaces (Abstract), wherein the reader is configured to collect data from the analyte sensor in response to a scan or request for data by the reader to a sensor control device of the analyte sensor (Sensor control device 102 can transfer data to reader device 120 in any manner suitable for the implementation…the patient can obtain glucose level measurements manually, or “on-demand,” with reader device 120 by a patient-initiated request for data (e.g., an NFC scan) from sensor control device 102; [0068]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the data request teachings of Hayter into those of Taub and Memmelaar in order to allow the patient to be able to obtain glucose level measurements manually, or “on-demand” (Hayter [0068]).
Regarding Claim 64, Taub and Memmelaar fail to disclose wherein the metabolic parameter is HbA1c or time in target range.
In a similar technical field, Hayter teaches systems, devices, and methods for episode detection and evaluation with visit guides, action plans and/or scheduling interfaces (Abstract), wherein the metabolic parameter is HbA1c or time in target range (Analytes that may be monitored include, but are not limited to, acetyl choline, amylase, bilirubin, cholesterol, chorionic gonadotropin, glycosylated hemoglobin (HbA1c); [0037]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the HbA1c teachings of Hayter into those of Taub and Memmelaar, as HbA1c monitoring is useful for accurately diagnosing diabetes, tracking long-term treatment, and assessing future risk for patients.
Conclusion
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/CHANEL J YOON/Examiner, Art Unit 3791
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