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 .
Response to Amendment
The amendments filed 05 FEBRUARY 2026 have been entered. Claims 59 – 60, 63 – 64, 66 - 78, and 125 - 127 are pending. Applicant’s amendments to the claims have overcome each and every objection to the specification and the claims previously applied in the office action dated 06 AUGUST 2025. Applicant’s amendments have overcome each and every rejection under 35 U.S.C. 112 previously applied in the office action dated 06 AUGUST 2025.
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 59 – 60, 63 – 64, 66 – 78, and 125 - 127 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.
Regarding Claims 59 and 127, the claims recite an apparatus, which is one of the statutory categories of invention (Step 1). The claim is then analyzed to determine whether it is directed to any judicial exception (Step 2A, Prong 1).
Regarding Claim 125, the claim recites "an act or step, or series of acts or steps" and is therefore a process, which is a statutory category of invention (Step 1). The claims are then analyzed to determine whether it is directed to any judicial exception (Step 2A, Prong 1).
Each of Claims 59 – 60, 63 – 64, 66 – 78, and 125 - 127 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1
Each of Claims 59 – 60, 63 – 64, 66 – 78, and 125 - 127 recites at least one step or instruction for observations, evaluations, judgments, and opinions, which are grouped as a mental process under the 2019 PEG. The claimed invention involves making observations, evaluations, judgments, and opinions, which are concepts performed in the human mind under the 2019 PEG.
Accordingly, each of Claims 59 – 60, 63 – 64, 66 – 78, and 125 - 127 recites an abstract idea.
Specifically, Independent Claims 59, 125, and 127 recite (underlined are observations, judgements, evaluations, or opinions, which are grouped as a mental process under the 2019 PEG) (additional elements bolded, see Step 2A, prong 2);
Claim 59
A system for monitoring meal-related analyte glucose responses in a subject, the system comprising: a reader device, comprising:
wireless communication circuitry configured to receive data indicative of a glucose level of the subject,
one or more processors coupled with a memory, the memory storing a meal monitoring application that, when executed by the one or more processors causes the one or more processors to:
identify a peak glucose level value within a predetermined time period for the received data indicative of the glucose level of the subject,
determine an estimated meal start time and an initial glucose level value based on the peak glucose analyte level value
determine a glucose level variance value
prompt the subject to enter meal information, and
associate the entered meal information with the glucose level variance value.
Claim 125
A method for monitoring meal-related glucose responses in a subject, the method comprising:
receiving, by a reader device, data indicative of a glucose level of the subject from a glucose sensor;
identifying a peak glucose level value within a predetermined time period for the received data indicative of the glucose level of the subject;
determining an estimated meal start time and an initial glucose level value based on the peak glucose level value;
determining a glucose level variance value;
prompting the subject to enter meal information; and
associating the entered meal information with the glucose level variance value.
Claim 127
A non-transitory computer-readable medium storing instructions that, when executed by one or more processors of a reader device, cause the one or more processors to perform a method for monitoring meal-related glucose responses in a subject, the method comprising:
receiving data indicative of a glucose level of the subject from a glucose sensor;
identifying a peak glucose level value within a predetermined time period for the received data indicative of the glucose level of the subject;
determining an estimated meal start time and an initial glucose level value based on the peak glucose level value;
determining a glucose level variance value;
prompting the subject to enter meal information; and
associating the entered meal information with the glucose level variance value.
(observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG);
These underlined limitations describe a mathematical calculation and/or a mental process, as a skilled practitioner is capable of performing the recited limitations and making a mental assessment thereafter. Examiner notes that nothing from the claims suggests that the limitations cannot be practically performed by a human with the aid of a pen and paper, or by using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time. Examiner additionally notes that nothing from the claims suggests and undue level of complexity that the mathematical calculations and/or the mental process steps cannot be practically performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps. For example, in Independent Claims 59, 125, and 127 these limitations include:
Observation and judgment of data indicative of a glucose level of the subject
Observation and judgment of a peak glucose level value within a predetermined time period for the received data indicative of the glucose level of the subject,
Observation and judgment to evaluate an estimated meal start time and an initial glucose level value based on the peak glucose analyte level value
Observation and judgment to evaluate a glucose level variance value
Observation and judgment of an association of the entered meal information with the glucose level variance value.
(observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG);
Instructing the subject to enter meal information
which is a certain method of organizing human activity or mental process to communicate.
Similarly, the dependent claims include the following abstract limitations, in addition the aforementioned limitations in Independent Claims 59, 125, and 127 (underlined observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG):
transmit the data indicative of the glucose level of the subject to the reader device.
Observation and judgment to communicate the data indicative of the glucose level of the subject to the reader device.
receive the data indicative of the glucose level of the subject according to a short-range wireless communication protocol or a Near Field Communication wireless protocol.
Observation and judgment of the data indicative of the glucose level of the subject according to a short-range wireless communication protocol or a Near Field Communication wireless protocol.
the estimated meal start time is determined by counting two, three, or four hours back from a time of the peak analyte level value.
the estimated meal start time is Observed, judged, and evaluated by counting two, three, or four hours back from a time of the peak analyte level value.
the glucose level variance value is determined by subtracting the initial glucose level value from the peak glucose level value.
the glucose level variance value is evaluated by subtracting the initial glucose level value from the peak glucose level value.
counting a predetermined amount of time backward from a time associated with the peak glucose level value.
Observation and judgment to count a predetermined amount of time backward from a time associated with the peak glucose level value.
all of which are grouped as mental processes or mathematical algorithms under the 2019 PEG.
Accordingly, as indicated above, each of the above-identified claims recite an abstract idea.
Step 2A, Prong 2
The above-identified abstract ideas in each of Independent Claims 59, 125, and 127 (and their dependent claims) are not integrated into a practical application under 2019 PEG because the additional elements (identified in Claims 59 – 60, 63 – 64, 66 – 78, and 125 - 127), either alone or in combination, generally link the use of the above-identified abstract ideas to a particular technological environment or field of use. More specifically, the additional elements of:
“reader device”
“wireless communication circuitry”
“one or more processors”
“memory”
“meal monitoring application”
“smart phone”
“trusted computer system”
“cloud-computing platform”
“one or more servers”
“sensor control device”
“glucose sensor”
“non-transitory computer-readable medium”
Additional elements recited include “reader device”, “wireless communication circuitry”, “one or more processors”, “memory”, “meal monitoring application”, “smart phone”, “trusted computer system”, “cloud-computing platform”, “one or more servers”, “sensor control device”, “glucose sensor”, and “non-transitory computer-readable medium” in Independent Claim 59 (and its dependent claims). These components are recited at a high level of generality, i.e., as a generic processor(s) performing a generic function of processing data (the identifying, determining, prompting, and associating); a memory performing a generic function of storing data (the storing). These generic hardware component limitations for “reader device”, “wireless communication circuitry”, “one or more processors”, “memory”, “meal monitoring application”, “smart phone”, “trusted computer system”, “cloud-computing platform”, “one or more servers”, “sensor control device”, “glucose sensor”, and “non-transitory computer-readable medium” are no more than mere instructions to apply the exception using generic computer and hardware components. As such, these additional elements do not impose any meaningful limits on practicing the abstract idea.
Further additional elements from Independent Claims 59, 125, and 127 include pre-solution activity limitations, such as:
A non-transitory computer-readable medium storing instructions that, when executed by one or more processors of a reader device, cause the one or more processors to perform a method for monitoring meal-related glucose responses in a subject,
one or more processors coupled with a memory, the memory storing a meal monitoring application
In addition the aforementioned extra-solution activity limitations in Independent Claims 59, 125, and 127, additional extra-solution activity limitations recited in Dependent Claims 60, 63 – 64, and 66 – 78 include:
the reader device comprises a smart phone
wherein the trusted computer system is a cloud-computing platform comprising one or more servers
further comprising a sensor control device, wherein the sensor control device comprises a glucose sensor, and wherein at least a portion of the glucose sensor is configured to be positioned under a skin layer of the subject and in contact with a bodily fluid of the subject.
wherein the peak glucose level value comprises a highest glucose value over a predetermined glucose level threshold.
wherein the predetermined glucose level threshold is 170 mg/dL, 180 mg/dL, or 190 mg/dL.
wherein the predetermined time period for the received data indicative of the glucose level of the subject comprises a last two, four, or eight hours of glucose data.
the meal monitoring application, when executed by the one or more processors, further causes the one or more processors to store the meal information and associated glucose level variance value in the memory of the reader device
These pre-solution measurement elements are insignificant extra-solution activity, setting up the parameters of the system, and serve as data-gathering for the subsequent steps.
The “reader device”, “wireless communication circuitry”, “one or more processors”, “memory”, “meal monitoring application”, “smart phone”, “trusted computer system”, “cloud-computing platform”, “one or more servers”, “sensor control device”, “glucose sensor”, and “non-transitory computer-readable medium” as recited in Independent Claims 59, 125, and 127 (and their dependent claims) are generically recited computer and hardware elements which do not improve the functioning of a computer, or any other technology or technical field. 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 ideas identified above in Independent Claims 59, 125, and 127 (and their dependent claims) are 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 and certain method of organizing human activity) using rules (e.g., computer instructions) executed by a computer processor 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 Claim 59 (and its Dependent Claims) is not integrated into a practical application under the 2019 PEG.
Accordingly, Independent Claims 59, 125, and 127 (and their dependent claims) are each directed to an abstract idea under 2019 PEG.
Step 2B –
None of Claims 59 – 60, 63 – 64, 66 – 78, and 125 - 127 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 device”, “wireless communication circuitry” to receive data, “one or more processors” to identify, determine, prompt, and associate, “memory” to store, “meal monitoring application”, “smart phone”, “trusted computer system” to transmit, “cloud-computing platform”, “one or more servers”, “sensor control device”, “glucose sensor”, and “non-transitory computer-readable medium” as recited in Independent Claims 59, 125, and 127 (and their dependent claims)
The additional elements of the “reader device”, “wireless communication circuitry”, “one or more processors”, “memory”, “meal monitoring application”, “smart phone”, “trusted computer system”, “cloud-computing platform”, “one or more servers”, “sensor control device”, “glucose sensor”, and “non-transitory computer-readable medium” in Independent Claims 59, 125, and 127 (and their dependent claims), as discussed with respect to Step 2A Prong Two, amounts to no more than mere instructions to apply the exception using generic computer and hardware components. The same analysis applies here in 2B, i.e., mere instructions to apply an exception using a generic computer component cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B.
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. 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.
Per Applicant’s specification, the “reader device” is described generically at [0018] and [0035], as including other generic electronic components such as a touch screen, meal monitoring application, wireless communication circuitry, a memory; at [0072] as being a smart phone; and at [00164] as being a “device that receives sensed analyte data from the sensor control device and processes and/or displays that sensed analyte data, forms, to the user,” in a number of generic electronic forms such as a “reader device”, “reader”, “handheld electronics”, “portable data processing” device or unit. The “reader device” is shown as “reader device” 120 in Fig 1.
Per Applicant’s specification, the “wireless communication circuitry” is described generically at [0094], [00107], and [00113] to “receive data”. A similarly described component is the “local communication path (or link) 140”, described in [00165] as “wired or wireless”. The “local communication path (or link) 140” is shown as a generic arrow from in Figure 1.
Per Applicant’s specification, the “one or more processors” is described generically in [00181] as “processing 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.” The “one or more processors” is shown as generic box element “processing hardware 206” (“Communication Process and Applications Processor”) in Figure 2A.
Per Applicant’s specification, the “memory” is described generically at [00181] and [00184] as “on-board non-transitory memory 223” and “on-board non-transitory memory 225 and that “Memory 230 is non-transitory, and can be volatile (e.g., RAM, etc.) and/or non-volatile memory (e.g., ROM, flash memory, F-RAM, etc.).” The “memory” is shown as generic box element “memory 230” in Figure 2A.
Per Applicant’s specification, the “meal monitoring application” is described in paragraphs such as [0305], [0313], [0321], and [0342]as including a GUI and being used to and alert users. The “meal monitoring application” is shown in GUI representations in Figures 4A-1 to 13C.
Per Applicant’s specification, the “smart phone” is described generically in [00179] as “Examples of smartphones can include, but are not limited to… a WINDOWS® operating system, ANDROID® operating system, IPHONE® operating system, PALM WEBOS®…”. The “smart phone is shown as generic phone-shaped icon “reader device” 120 in Figure 2A.
Per Applicant’s specification, the “trusted computer system” is described generically at [00177] as being implemented “in a more secure fashion” by including well-known security methods like a “password, encryption, firewall…” The “cloud-computing platform” is described generically as part of the “trusted computer system 180] in [00176], and that it includes the “one or more servers”. The “trusted computer system” with the “cloud-computing system” and “one or more servers” is shown as generic box element, “trusted computer system” 180 in Fig 1.
Per Applicant’s specification, the “sensor control device” is described generically at [0075] as including an analyte sensor with at least part of it below the skin of a user, and at [00163] “The sensor control device, and variations thereof, can also be referred to as a "sensor control unit," an "on-body electronics" device or unit, an "on-body" device or unit, or a "sensor data communication" device or unit, to name a few.” It is shown as “sensor control device” 102 in Figure 1.
Per Applicant’s specification, the “glucose sensor” is an analyte sensor and is described generically in [0161] with “In vivo analyte monitoring systems also include "Flash Analyte Monitoring" systems ( or "Flash Glucose Monitoring" systems or simply "Flash" systems”, and as an “analyte sensor” per “sensor control device” above. It is shown as “sensor control device” 102 in Figure 1.
Per Applicant’s specification, the “non-transitory computer readable medium” is generically descried at [00181] as “on-board non-transitory memory 223” as part of “processing hardware 206” and “on-board non-transitory memory 225” as part of “applications processor 224” and [00353] “to the extent that memory, storage, and/or computer readable media are covered by one or more claims, then that memory, storage, and/or computer readable media is only non-transitory.” It is shown as generic box elements “memory 223”, “memory 225”, and “memory 230” in Fig. 2A.
Accordingly, in light of Applicant’s specification, the claimed terms “reader device”, “wireless communication circuitry”, “one or more processors”, “memory”, “meal monitoring application”, “smart phone”, “trusted computer system”, “cloud-computing platform”, “one or more servers”, “sensor control device”, “glucose sensor”, and “non-transitory computer-readable medium” are reasonably construed as a generic computing and hardware devices. 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 “reader device”, “wireless communication circuitry”, “one or more processors”, “memory”, “meal monitoring application”, “smart phone”, “trusted computer system”, “cloud-computing platform”, “one or more servers”, “sensor control device”, “glucose sensor”, and “non-transitory computer-readable medium”. 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 Independent Claims 59, 125, and 127 (and their dependent claims) 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 apparatuses and method of Claims 59 – 60, 63 – 64, 66 – 78, and 125 - 127 is 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 59 – 60, 63 – 64, 66 – 78, and 125 - 127 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 for Step 2A Prong 2 in Independent Claims 59, 125, and 127 (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 instruct the practitioner to 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 59 – 60, 63 – 64, 66 – 78, and 125 - 127 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 59 – 60, 63 – 64, 66 – 78, and 125 - 127 amounts to significantly more than the abstract idea itself. Accordingly, Claims 59 – 60, 63 – 64, 66 – 78, and 125 - 127 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 59 – 60, 63 – 64, 66 - 67, 71 – 77, and 125 - 127 are rejected under 35 U.S.C. 103 as being unpatentable over Hayter et. al., (US 2018/0271418 A1), hereinafter Hayter, in view of Layton (WO 2006/084303 A1), hereinafter Layton.
Regarding 59, Hayter discloses A system for monitoring meal-related analyte glucose responses in a subject ([Abstract]), the system comprising:
a reader device ([Abstract] “system…determining glucose level information and post-prandial glucose level information”; Fig 1A, “mobile phone 110”), comprising:
wireless communication circuitry (Fig 1A, [0033] – [0034] “The communication between mobile phone 110, … glucose monitor 130, monitoring device 160 and data network 140 includes one or more wireless communication”) configured to receive data indicative of a glucose level of the subject (Fig 1A, Arrow from “Glucose monitor 130” to “monitoring device 160” and “data network 140”; [0033] – [0034])
one or more processors coupled with a memory ([0061] “storage unit operatively coupled to the one or more processors”), the memory storing a meal monitoring application ([0061] “instructions…to perform meal start time determination…fasting metrics…glucose level information”; ([0032] “the App is installed in the mobile phone 110 as a downloaded executable file over data network 140 from server 150.”) that, when executed by the one or more processors ([0061] “executed…one or more processors”), causes the one or more processors to:
identify a peak glucose level value (Fig 5B; [0056] – [0058] including “post-meal peak parameter. (the maximum glucose level…”) within a predetermined time period ([0058] “the second time period”) for the received data indicative of the glucose level of the subject ([0058] “glucose level”),
determine an estimated meal start time (Fig 4B “set meal start time”; Process of Fig 4B; [0049] “the potential meal start time is determined from the retrieved glucose data by isolating or identifying the beginning of a sustained glucose level change in direction.”; Can confirm meal start time with either [0040] “retrieved insulin delivery time compared with the potential meal start time” or [0051] compare with a “meal start tag (user initiated)”) and an initial glucose level value ([0058] “pre-meal glucose parameter”; Fig 4B and Fig 5B; [0056]-[0057] “glucose data…first time period relative to the meal start time is retrieved”, “a single glucose level…or a median of the glucose data in the first time period”)(Examiner notes that the peak glucose analyte level value is used to determine the estimated meal start time, then based on that time, the initial glucose level value is found.) based on the peak glucose analyte level value ([0049] “the beginning of a sustained glucose level change in direction”; [0056] – [0058] including “post-meal peak parameter”)(Examiner notes that a “peak” occurs in data at a change in direction. Therefore, the “sustained glucose level change in direction” described above for determining an estimated meal start time is the peak glucose analyte level value, later used at the “post-meal peak parameter”)
determine a glucose level variance value (Fig 5B; [0011] “determining a post-prandial glucose metric from the premeal and post-meal glucose parameters.”; [0058] “post-prandial glucose metric…difference between the post meal peak parameter (the maximum glucose level…) and the pre-meal glucose parameter”)
enter meal information ([0051] “user initiated meal event tag using the user interface 110A of mobile phone 110”), and
associate the entered meal information with the glucose level variance value (Fig 5B; [0051] “meal start tag can be used as the meal start time”).
Hayter does not specifically disclose prompt the subject to enter meal information. Hayter broadly discloses that the user can enter or tag meal timing information, but not specifically that the interface requests it via prompting.
Layton teaches a system for sharing and synchronizing glycemic and health-related data management, including about meal timing and glucose measurements. Specifically for Claim 59, Layton teaches prompt the subject to enter meal information ([Page 9, Lines 22 – 23] “…If a user chooses to record the meal, the healthcare consumer client 120 prompts the user for a date and time…”)
Layton offers a motivation to combine at [Page 11, Lines 8 – 15] citing advantages of recording the date and time of a meal, including being able to “edit an existing entry” or selecting a meal “entered in the diary in a calendar format”. A person having ordinary skill in the art before the effective filing data of the claimed invention would recognize that prompting the user to enter a meal time would permit the user to keep a “diary” of the timing of food entries that can be edited and reviewed as needed. It would have been predictable to use the user prompt for a meal time in combination with Hayter’s disclosure, as Hayter already includes the option for a user to tag mealtimes (and uses this user-entered information to compare the calculated mealtime), simply without disclosing a specific “prompt” for the data entry.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine “user interface 110A of mobile phone 110” and the meal-associated glucose analysis system disclosed in Hayter with the specific prompt to enter meal timing information taught by Layton, creating a single meal-associated glucose tracking system with prompts for user input.
Regarding Claims 125 and 127, Hayter discloses
For Claim 127:
A non-transitory computer-readable medium storing instructions ([0007] “a storage unit…configured to store instructions”) that, when executed by one or more processors of a reader device cause the one or more processors to perform a method for monitoring meal-related glucose responses in a subject ([0007] “embodiments for determining fasting glucose level information….apparatus…executed by the one or more processors”, “…perform meal start time determination…”; Fig 1C and Fig 4A), the method comprising:
For both Claims 125 and 127:
A method for monitoring meal-related glucose responses in a subject ([Abstract]), the method comprising:
receiving, by a reader device ([0007] “embodiments for determining fasting glucose level information….apparatus…executed by the one or more processors”, “…perform meal start time determination…”; Fig 1A, “mobile phone 110”), data indicative of a glucose level of the subject from a glucose sensor (Fig 1A, Arrow from “Glucose monitor 130” to “monitoring device 160” and “data network 140”; [0033] – [0034]);
identifying a peak glucose level value (Fig 5B; [0056] – [0058] including “post-meal peak parameter. (the maximum glucose level…”) within a predetermined time period ([0058] “the second time period”) for the received data indicative of the glucose level of the subject ([0058] “glucose level”),
determining an estimated meal start time (Fig 4B “set meal start time”; Process of Fig 4B; [0049] “the potential meal start time is determined from the retrieved glucose data by isolating or identifying the beginning of a sustained glucose level change in direction.”; Can confirm meal start time with either [0040] “retrieved insulin delivery time compared with the potential meal start time” or [0051] compare with a “meal start tag (user initiated)”) and an initial glucose level value ([0058] “pre-meal glucose parameter”; Fig 4B and Fig 5B; [0056]-[0057] “glucose data…first time period relative to the meal start time is retrieved”, “a single glucose level…or a median of the glucose data in the first time period”)(Examiner notes that the peak glucose analyte level value is used to determine the estimated meal start time, then based on that time, the initial glucose level value is found.) based on the peak glucose analyte level value ([0049] “the beginning of a sustained glucose level change in direction”; [0056] – [0058] including “post-meal peak parameter”)(Examiner notes that a “peak” occurs in data at a change in direction. Therefore, the “sustained glucose level change in direction” described above for determining an estimated meal start time is the peak glucose analyte level value, later used at the “post-meal peak parameter”)
determining a glucose level variance value (Fig 5B; [0011] “determining a post-prandial glucose metric from the premeal and post-meal glucose parameters.”; [0058] “post-prandial glucose metric…difference between the post meal peak parameter (the maximum glucose level…) and the pre-meal glucose parameter”)
subject to enter meal information ([0051] “user initiated meal event tag using the user interface 110A of mobile phone 110”),; and
associating the entered meal information with the glucose level variance value (Fig 5B; Fig 1B; [0051] “meal start tag can be used as the meal start time”; [0066] “the one or more processors may be configured to detect a meal start tag based on a user input to perform the meal start time determination for each one day time period.”; [0035] “one or more of monitored glucose level information, time of day period information, meal start tag/time stamp information…is provided to the analysis module 110B and/or to the data acquisition and report server 150 to perform fasting glucose analysis and/or post-prandial glucose tolerance analysis.”).
Hayter does not specifically disclose prompting the subject. Hayter broadly discloses that the user can enter or tag meal timing information, but not specifically that the interface requests it via prompting.
Layton teaches prompt the subject to enter meal information ([Page 9, Lines 22 – 23] “…If a user chooses to record the meal, the healthcare consumer client 120 prompts the user for a date and time…”)
The motivation to for Claims 125 and 127 to combine Hayter with Layton is the same as that described in more detail in Claim 59. In summary, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine “user interface 110A of mobile phone 110” and the meal-associated glucose analysis system disclosed in Hayter with the specific prompt to enter meal timing information taught by Layton, creating a single meal-associated glucose tracking system with prompts for user input.
Regarding Claim 60, Hayter in view of Layton discloses as described above, The system of claim 59. For the remainder of Claim 60, Hayter discloses wherein the reader device comprises a smart phone (Fig 1, “mobile phone 110”; [0032] “a smart phone”)
Regarding Claim 63, Hayter in view of Layton discloses as described above, The system of claim 59. For the remainder of Claim 63, Hayter discloses further comprising a trusted computer system (Fig 1A including “Data acquisition and report server 150” and “Data network 140”; [0032] “data network 140 includes …suitable data communication that optionally supports data encryption/decryption…“), wherein the trusted computer system is a cloud-computing platform ([0070] “a data server located remotely from the glucose monitor”) comprising one or more servers (Fig 1A; [0032] “Data acquisition and Report Server 150”), wherein the trusted computer system is configured to transmit the data indicative of the glucose level of the subject to the reader device (Fig 1A, communication arrow from “Glucose monitor 130” to “Data network 140” to and from “Data acquisition and report server 150” to “Mobile Phone 110”; [0070] “…data processing device includes a data server…mobile telephone configured to receive the generated glucose measurement data from the glucose monitor”)
Regarding Claim 64, Hayter in view of Layton discloses as described above, The system of claim 59. For the remainder of Claim 64, Hayter discloses further comprising a sensor control device (Fig 1A, “glucose monitor 130”, wherein the sensor control device comprises a glucose sensor (Fig 1A, “glucose monitor 130”; [0034] “glucose sensors”), and wherein at least a portion of the glucose sensor is configured to be positioned under a skin layer of the subject and in contact with a bodily fluid of the subject ([0034] “…each with a portion configured to be in fluid contact with bodily fluid of a user under a skin surface”.)
Regarding Claim 66, Hayter in view of Layton discloses as described above, The system of claim 59. For the remainder of Claim 66, Hayter discloses wherein the wireless communication circuitry of the reader device is configured to receive the data (Fig 1A, communication arrow from “Glucose monitor 130” to “Data network 140” to and from “Data acquisition and report server 150” to “Mobile Phone 110”; [0070] “…data processing device includes a data server…mobile telephone configured to receive the generated glucose measurement data from the glucose monitor”; [0033] “wireless communication…”) indicative of the glucose level of the subject (Fig 1A; [0034] “Glucose monitor 130…communicating the processed glucose signals to…data network 140”) according to a short-range wireless communication protocol or a Near Field Communication wireless protocol ([0033] “…data network 140 includes one or more wireless communication…Bluetooth®…or any other suitable data communication”).
Regarding Claim 67, Hayter in view of Layton discloses as described above, The system of claim 59. For the remainder of Claim 67, Hayter discloses wherein the peak glucose level value comprises a highest glucose value ([0038] “maximum glucose level (203 mg/dL)”) over a predetermined glucose level threshold ([004] “between 140 mg/L and 200 mg/dL…”impaired glucose tolerance””; [0035] “one or more threshold parameters associated with the fasting glucose analysis and/or the-post prandial glucose analysis..”; [0038] “a corresponding diagnosis indication of “impaired glucose tolerance” condition”; (Examiner notes that the threshold is predetermined for testing as the categoric rating of “impaired glucose tolerance”, and 203 mg/dL is greater than the minimum of that level, with an example output shown in Fig 1C.)
Regarding Claims 71, 72, and 73, Hayter in view of Layton discloses as described above, The system of claim 59. For the remainder of Claims 71, 72, and 73, Hayter discloses wherein the predetermined time period for the received data indicative of the glucose level of the subject ([0046] “retrieving glucose data received…for a fasting period”) comprises
For Claim 71, Hayter discloses a last two hours of glucose data ([0046] “by retrieving glucose data received from the glucose monitor 130 (FIG. 1) for a fasting period (FIG. 3)”, “fasting period spans…4 hours and 15 minutes before the meal start time”; “any other suitable time”)(Examiner notes that 4 hours of data have at least a last two hours of glucose data.)
For Claim 72, Hayter discloses a last four hours of glucose data ([0041]; [0046] “by retrieving glucose data received from the glucose monitor 130 (FIG. 1) for a fasting period (FIG. 3)”, “fasting period spans…4 hours and 15 minutes before the meal start time”).
For Claim 73, Hayter discloses a last eight hours of glucose data ([0003] “A fasting glucose test requires the individual to refrain from eating (i.e., fast) for a certain number of hours (e.g., 8 hours) before performing a blood glucose measurement.”; [0041]; [0046] “by retrieving glucose data…fasting period”, “fasting period spans…”, “While 4 hours and 15 minutes are used…these values for the fasting period are non-limiting examples…any other suitable time ranges”)(Examiner notes that since a fasting glucose test requires an 8 hour fast, an 8 hour measuring fast period for data gathering is “any other suitable time range”).
Regarding Claims 74, 75, and 76, Hayter in view of Layton discloses as described above, The system of claim 59.
For the remainder of Claims 74, 75, and 76, Hayter discloses wherein the estimated meal start time is determined (Figure 4B and Figure 5A)
For Claim 74, Hayter discloses by counting two hours back (Fig 4B and 5B; [0057] “second time period”; “glucose data for a second time period relative to the meal start time is retrieved”,“6 hour…or any intervening time period”) from a time of the peak glucose level value ([0049] “Potential meal start time is determined from the retrieved glucose data by isolating or identifying the beginning of a sustained glucose level change in direction”; [0058] “post-meal peak parameter determined by calculating the maximum glucose level from the glucose data in the second time period.”)(Examiner notes that the “maximum glucose level from the glucose data in the second time period” would exhibit a “change in direction” for the data, as a local maximum peak is mathematically the site of a “change in direction”.)
For Claim 75, Hayter discloses by counting three hours back from a time of the peak glucose level value (Fig 4B and 5B; [0057] “…6 hour…or any intervening time period”; [0049] “potential meal start time…from retrieved glucose data…change in direction” ; [0058] “peak parameter…maximum glucose level…”).
For Claim 76, Hayter discloses by counting four hours back from a time of the peak glucose level value (Fig 4B and 5B; [0057] “time period…4 hour…”; [0049] “potential meal start time…from retrieved glucose data…change in direction” ; [0058] “peak parameter…maximum glucose level…”).
Regarding Claim 77, Hayter in view of Layton discloses as described above, The system of claim 59. For the remainder of Claim 77, Hayter discloses wherein the glucose level variance value is determined by subtracting the initial glucose level value from the peak glucose level value ([0058] “…the difference between the post meal peak parameter…and the pre-meal glucose parameter…”)
Regarding Claim 126, Hayter in view of Layton discloses as described above, The method of claim 125. For the remainder of Claim 126 Hayter discloses wherein determining the estimated meal start time (Figure 4B and Figure 5A) comprises counting a predetermined amount of time backward (Fig 4B and 5B; [0057] “second time period”; “glucose data for a second time period relative to the meal start time is retrieved”,“6 hour…or any intervening time period”) from a time associated with the peak glucose level value ([0049] “Potential meal start time is determined from the retrieved glucose data by isolating or identifying the beginning of a sustained glucose level change in direction”; [0058] “post-meal peak parameter determined by calculating the maximum glucose level from the glucose data in the second time period.”)(Examiner notes that the “maximum glucose level from the glucose data in the second time period” would exhibit a “change in direction” for the data, as a local maximum peak is mathematically the site of a “change in direction”.)
Claims 68 - 70 are rejected under 35 U.S.C. 103 as being unpatentable over Hayter in view Layton, further in view of Barulli, “Normal Glucose levels After Eating. What Is Acceptable And What Is Not?”, hereinafter Barulli.
Regarding Claims 68, 69, and 70, Hayter in view of Layton discloses as described above, The system of claim 67, wherein the predetermined glucose level threshold.
For the remainder of Claim 68, Hayter does not disclose the predetermined glucose level threshold is 170 mg/dL. Rather, the nearest threshold range disclosed is [0004] “a second blood glucose measurement between 140 mg/dL and 200 mg/dL is considered to represent impaired glucose tolerance condition”, where the second glucose measurement occurs two hours after eating.
Barulli teaches a chart for determining if glucose levels are “normal” after eating. Specifically for Claim 68, Barulli teaches the predetermined glucose level threshold is 170 mg/dL (Chart, “Normal”, “After meal”, “170 – 200 mg/dL”)(Examiner notes that the time period at which this measurement occurs is immediately after a meal.)
Barulli and Hayter both disclose glucose threshold level ranges to be used to determine categorical levels of blood glucose at measurement times after a meal: Barulli with a chart of thresholds for immediately after a meal (“after meal”) and 2-3 hours after the meal, Hayter with a measurement at 2 hours after a meal [0004] 140 mg/dL – 200 dL. Barulli teaches that multiple time periods of thresholds can be used to investigate glucose levels. Barulli teaches a motivation to combine to use glucose levels less than 1 or 2 hours after a meal with [Page 2, Paragraph 3] “Diabetes studies have even shown that 1- or 2-hour levels during a glucose tolerance test were better predictors of cardiovascular risk (of heart attack or stroke) than either fasting glucose or HbA1c levels.” A person having ordinary skill in the art before the effective filing data of the claimed invention would recognize that using an additional glucose level threshold of specifically 170 mg/dL for the time period immediately after eating would give another data point as a peak threshold for a “normal” glucose level data point that will occur sooner after eating for “normal” blood glucose levels. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the later glucose level threshold of 140 mg/dL – 200 mg/dL 2 hours after eating to deem the value “impaired glucose condition” (Fig 1C) disclosed in Hayter, with Barulli’s teaching of different thresholds for different elapsed times after eating, including a specific threshold of 170 mg/dL immediately after eating as a peak threshold for a “normal” glucose level data point, creating a single glucose device capable of evaluating specific post-meal timed data points useful for making post-prandial glucose level-associated diagnoses for a range of subjects and their associated cardiovascular risk.
For Claim 69, Hayter does not disclose the predetermined glucose level threshold is 180 mg/dL. Again, the nearest threshold range disclosed is [0004] “a second blood glucose measurement between 140 mg/dL and 200 mg/dL is considered to represent impaired glucose tolerance condition”, which includes 180 mg/dL.
For Claim 69, Barulli teaches the predetermined glucose level threshold is 180 mg/dL ([Page 5, Paragraph 4 at bottom of the page] ”A good general goal…maintain a blood sugar level of less than 10 mmol/L (180 mg/dL) in the one to two hours after a meal”).
The motivation for Claim 69 to combine Hayter with Barulli is the similar to that described in Claim 68. Barulli’s threshold of 180 mg/dL is another glucose level threshold, this one a “good general goal” suggestion to maintain a level under 180 mg/dL 1 – 2 hours after a meal for good health. In summary, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the glucose level threshold of 140 mg/dL – 200 mg/dL 2 hours after eating to deem the value “impaired glucose condition” (Fig 1C) disclosed in Hayter, with Barulli’s specific threshold of 180 mg/dL 1 – 2 hours after eating as a threshold for a “normal” glucose level data point, creating a single glucose device with multiple data points useful for making post-prandial glucose level-associated diagnoses.
For Claim 70, Hayter does not disclose the predetermined glucose level threshold is 190 mg/dL. Again, the nearest threshold range disclosed is [0004] “a second blood glucose measurement between 140 mg/dL and 200 mg/dL is considered to represent impaired glucose tolerance condition”, which includes 190 mg/dL.
For Claim 70, Barulli teaches the predetermined glucose level threshold is 190 mg/dL (Chart, “Elevated”, “After meal”, “190 – 230 mg/dL”).
The motivation for Claim 70 to combine Hayter with Barulli is the same as that described in Claims 68. In summary, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the glucose level threshold of 140 mg/dL – 200 mg/dL 2 hours after eating to deem the value “impaired glucose condition” (Fig 1C) disclosed in Hayter, with Barulli’s specific threshold of 190 mg/dL – 230 mg/dL immediately after eating as a threshold for a “elevated” glucose level data point, creating a single glucose device with multiple data points useful for making post-prandial glucose level-associated diagnoses.
Claim 78 is rejected under 35 U.S.C. 103 as being unpatentable over Hayter in view Layton, further in view of Mensinger et. al. (United States Patent Application Publication US 2014/0012117 A1), hereinafter Mensinger.
Regarding Claim 78, Hayter in view of Layton discloses as described above, The system of claim 59. For the remainder of Claim 78, Hayter discloses wherein the meal monitoring application, when executed by the one or more processors ([0061] “one or more processors”), further causes the one or more processors to store the meal information (Fig 4B, 415 “Set meal start time...”)(Examiner notes that “setting” is assigning, or storing the meal start time information.) and associated glucose level variance value (Fig 5A and 5B; “Determine post-prandial metric”; “Generate and output post-prandial glucose information”)
Hayter does not specifically disclose store associated glucose level variance value in the memory of the reader device. Hayter does broadly disclose that the information is displayed (which could technically be stored in the cache of the device), and that it is calculated relative to specific meal information.
Mensinger teaches a smartphone application system with a connected glucose monitor that determines meal-associated glucose information. Specifically for claim 78, Mensinger teaches store associated glucose level variance value ([0022] “output is a value of a difference between blood glucose values at the two points”; [0009] “correlating the information about food consumed with a user's blood glucose level”) in the memory of the reader device ([0009] “the output is data stored for later retrospective viewing…”; [0077] “ data that is stored locally or remotely for retrospective analysis…”)
Both Hayter and Mensinger perform calculations of the difference between glucose measurements at given times relative to food consumption. Mensinger provides a motivation to store the calculated glucose parameter data at [0009] with “…data is stored for later retrospective viewing.” A person having ordinary skill in the art before the effective filing data of the claimed invention would recognize that storing the glucose data (as disclosed by Hayter) as well as storing the associated calculation results from that data (as taught by Mensinger) would be useful for conveniently looking at the data again at a future time. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the determination of glucose-associated meal information for display disclosed in Hayter with the storing the result of glucose calculations taught by Mensinger, creating a single meal-associated glucose measurement apparatus with stored data and resultant calculations for convenient future reference.
Response to Arguments
Applicant's arguments filed 05 FEBRUARY 2026 have been fully considered but they are not persuasive.
Regarding the 35 U.S.C. 101 Rejections:
Applicant argues at [Page 11, 35 U.S.C. 101 Rejections” Section, Paragraph 1 - 3] that the claims are directed to a “concrete technological system” including a reader device with communication circuitry and do not recite mental observations of subjective evaluations or subjective evaluations that could be practically performed by a human without technological assistance.” Using a general processor (or pen and paper), it is within the realm of human capability to observe the outputs of a reader device in a graph or table, observe the peaks in a window of the data (see local high numbers in the data), broadly determine an estimated meal start time and initial glucose level based on the observed peak (look backwards from the peak), determine a glucose level variance value (do subtraction or another statistic operation), ask a subject to describe their meal information, and associate the meal information with a glucose level variance value (mark it on the graph or write down a conclusion). The argument is not persuasive.
Applicant argues at [Page 11, 35 U.S.C. 101 Rejections” Section, Bottom] – [Page 12, Top – 1st Full Paragraph] that the claims as a whole integrate abstract concepts into a practical application, to generate clinically relevant outputs tied to real-world physiological behavior, as an improvement to the functioning of the technological system itself, not an abstract idea implemented on a generic computer. There is nothing particular recited in the claims that uses the output of the abstract ideas for a practical application, or to improve either the “reader device”, the “wireless communication circuitry”, the “one or more processors”, or the “memory”. The receiving-data activity performed by the “reader device” is extra-solution data-gathering activity for subsequent steps. The abstract ideas of identify a peak glucose level…, determine an estimated meal start time…, and determine a glucose level variance value…are not then realized into a practical application of the information that is observed, judged, and/or evaluated. From MPEP 2106.05(a): It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements. See the discussion of Diamond v. Diehr, 450 U.S. 175, 187 and 191-92, 209 USPQ 1, 10 (1981)) in subsection II, below. In addition, the improvement can be provided by the additional element(s) in combination with the recited judicial exception. See MPEP § 2106.04(d) (discussing Finjan, Inc. v. Blue Coat Sys., Inc., 879 F.3d 1299, 1303-04, 125 USPQ2d 1282, 1285-87 (Fed. Cir. 2018)). The argument is not persuasive.
Applicant argues at [Page 12, 2nd Full Paragraph] that the ordered combination of limitations define a specific analytical workflow that is more than conventional, routine, or well-understood in the field of continuous analyte monitoring. The described workflow consists of the identified abstract ideas, including detection of analyte peaks, estimation of physiological event timing, computation of analyte variance values, and association of values with meal information. While characteristics are calculated by using the processor as a tool, the device does not apply this information to a practical action or improvement to the device itself. From MPEP 2106.05(a): It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements. See the discussion of Diamond v. Diehr, 450 U.S. 175, 187 and 191-92, 209 USPQ 1, 10 (1981)) in subsection II, below. In addition, the improvement can be provided by the additional element(s) in combination with the recited judicial exception. See MPEP § 2106.04(d) (discussing Finjan, Inc. v. Blue Coat Sys., Inc., 879 F.3d 1299, 1303-04, 125 USPQ2d 1282, 1285-87 (Fed. Cir. 2018)). The argument is not persuasive.
Applicant argues at [Page 12, 3rd Full Paragraph] that the dependent claims further narrow the scope of the invention by reciting additional technical constraints that tie the claims to concrete sensor behavior and reinforce that the claimed matter is not directed to a disembodied mental process or abstract idea. The “sensor behavior” of the “reader device” to obtain data (extra-solution data gathering for subsequent steps), and perform calculations on a processor (a well-understood, routine, and conventional use of a processor) is not an improvement on the processor itself or the sensing capabilities. The abstract idea mental processes to identify and determine use the data gathered of subject glucose level from the reader device as input to perform observation and judgments. The claims recite a series of limitations that encompass an abstract idea of manipulating variables obtained from electronic components used in a usual way, and that variable manipulation can be accomplished with the aid of time, equations, and paper. The argument is not persuasive.
Regarding the 35 U.S.C. 103 Rejections:
Applicant argues at [Page 13, “35 U.S.C. 103 Rejections” Section] – [Page 14, 2nd Full Paragraph] that Hayter does not disclose identifying a peak glucose value as an operative variable, it does not suggest identifying a maximum glucose value, and it does not use such a peak as a reference point for subsequent processing. As cited in the 35 U.S.C. 103 rejection above, Hayter specifically discloses a peak glucose parameter at [0058] with “a post-meal peak parameter determined by calculating the maximum glucose level from the glucose data in the second time period.” It then uses that peak glucose parameter in subsequent processing to determine the ”post-prandial glucose metric” as described at [0058] “The post-prandial glucose metric is determined from the pre-meal glucose parameter and the post-meal glucose parameters (525).” The argument is not persuasive.
Applicant argues at [Page 14, 3rd Full Paragraph] that Hayter and Layton do not determining an estimated meal start time based on the detected peak glucose value and involves “backward temporal inference from a detected physiological maximum.” As cited in the 35 U.S.C. 103 rejection above, Hayter discloses by counting two hours back (Fig 4B and 5B; [0057] “second time period”; “glucose data for a second time period relative to the meal start time is retrieved”,“6 hour…or any intervening time period”) from a time of the peak glucose level value ([0049] “Potential meal start time is determined from the retrieved glucose data by isolating or identifying the beginning of a sustained glucose level change in direction”; [0058] “post-meal peak parameter determined by calculating the maximum glucose level from the glucose data in the second time period.” Examiner notes that the “maximum glucose level from the glucose data in the second time period” would exhibit a “change in direction” for the data, as a local maximum peak is mathematically the site of a “change in direction”. This discloses performing an inference from the data backward in time from the detected physiological maximum. The argument is not persuasive.
Applicant argues at [Page 14, bottom] – [Page 15, top] that neither Hayter nor Layton disclose or teach prompting a user to enter meal information in response to detected glucose or variance metrics. The claims do not recite that the prompt to the user for meal information is necessarily in response to determining the glucose or variance metrics. The prompt is recited as a general input to the system that is associated…with the glucose level variance value after it has been entered. The argument is not persuasive.
Applicant argues at [Page 15, 1st Full Paragraph] that the independent claims require associating user-entered meal information with a computed glucose variance value derived from the same detected physiological event, such that the combination of Hayter and Layton relies on impermissible hindsight reconstruction. Hayter already discloses that the user can enter or tag meal timing information, which would be associated with a detected peak disclosed at (Fig 1B, [0066] “the one or more processors may be configured to detect a meal start tag based on a user input to perform the meal start time determination for each one day time period.” And [0035] “one or more of monitored glucose level information, time of day period information, meal start tag/time stamp information…is provided to the analysis module 110B and/or to the data acquisition and report server 150 to perform fasting glucose analysis and/or post-prandial glucose tolerance analysis.”). The combination with Layton is for the concept of actively, specifically prompting a user to enter information to encourage diary-type timing of food entries, as opposed to Hayter passively allowing the user to enter information should they desire greater involvement in their glucose data-gathering. The argument is not persuasive.
Applicant argues at [Page 15, 2nd and 3rd Full Paragraphs] that Hayter and Layton do not teach the limitations of independent claim 59, and the dependent claims likewise are not taught due to their dependence. Based on the 35 U.S.C. 103 rejection and discussion above, Hayter and Layton do teach the limitations of independent claim 59 as recited. The argument is not persuasive.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA J MONTGOMERY whose telephone number is (571)272-2305. The examiner can normally be reached Monday - Friday 7:30 - 5:00 ET.
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/MELISSA JO MONTGOMERY/Examiner, Art Unit 3791
/PATRICK FERNANDES/Primary Examiner, Art Unit 3791