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 .
Claims Accounting
Applicant's arguments, filed 02/10/2026, have been fully considered.
The following rejections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 02/10/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1, 7, 14, and 17 have been amended.
Claims 1-20 are the current claims hereby under examination.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 1 follows.
Step 1
Regarding claim 1, the claim recites a series of steps or acts, including determining one or more concentration ranges. Thus, the claim is directed to a process, which is one of the statutory categories of invention.
Step 2A, Prong One
The claim is then analyzed to determine whether it is directed to any judicial exception. The step of determining one or more concentration ranges sets forth a judicial exception. This step describes a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea.
Step 2A, Prong Two
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Claim 1 recites communicating the one or more concentration ranges and changing a hue based on the one or more concentration ranges, which is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The changing of the hue of the adjustable display does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the changed hue, nor does the method use a particular machine to perform the Abstract Idea.
Step 2B
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites determining an analyte concentration, communicating the one or more concentration ranges and changing a hue based on the one or more concentration ranges, wherein the one or more concentration ranges are not stored on the adjustable display. The determining, communicating and changing steps are well-understood, routine and conventional activity for those in the field of medical diagnostics. The adjustable display recited is a generic adjustable display (such as an LCD or LED array), which does not contain a memory, and therefore would not store the one or more concentration ranges. Further, the determining step is recited at a high level of generality such that it amounts to insignificant presolution activity, e.g., mere data gathering step necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering and comparing activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the obtaining and comparing steps do not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
The same rationale applies to claim 7.
Regarding claim 14, the device recited in the claim is a generic device comprising generic components configured to perform the Abstract Idea of determining a hue of the adjustable light display based on the measured analyte reading. The recited adjustable light display sensor is a generic display device, and the controller and one or more processors are general computer components configured to perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application.
The dependent claims also fail to add something more to the abstract independent claims as they generally recite method steps pertaining to the data gathering, the details of the content of the data, the display of data, and the operation of the controller. Claims 2, 4-5, 11, and 17 recite details regarding the content of the data. Claims 10, 12, and 18 recite details regarding data gathering. Claims 3, 6, 8-9, 13, 15-16, and 19 recite details regarding the display of the data. Claim 20 recited details regarding the operation of the controller in conjunction with the adjustable light display. The determining step recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-5, 7-12, 14-18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Publication 2014/0012117 by Mensinger et al. – previously cited, hereinafter “Mensinger”.
Regarding claim 1, Fig. 12 of Mensinger teaches a method comprising: determining an analyte concentration ([0149]; steps B1204-1206, CGM module outputs blood glucose (BG) value to sensor electronics and the sensor electronics processes BG by calculating estimated glucose value (EGV)); determining one or more concentration ranges based on the analyte concentration, the one or more concentration ranges including a low level concentration range, a target level concentration range, and a high level concentration range ([0149]; the sensor electronics also calculates an expected minimum for a next BG value and an expected maximum for a next BG value at block B1208. The concentration from 0 to the expected minimum is the low level concentration range, the range between the expected minimum and expected maximum is the target concentration range, and any concentration above the expected maximum is the high level concentration range).
Fig. 12 of Mensinger does not teach communicating the one or more concentration ranges to an adjustable display; and changing a hue displayed by the adjustable display based on the one or more concentration ranges, wherein the one or more concentration ranges are not stored on the adjustable display.
Mensinger further teaches that the CGM module 208 may change the color of the display 222 (i.e., an adjustable display) to reflect the user’s current blood glucose level (i.e., communicating the one or more concentration ranges to an adjustable display). The text/background may show a first color, such as green, if the user's blood glucose is within a healthy range, and a second color, such as red, if the user's blood glucose is low or high (i.e., changing a hue displayed by the adjustable display based on the one or more concentration ranges) ([0176]). The distinguishing colors for the blood glucose level provide visual information to help monitor the blood glucose level.
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the method of Fig. 12 of Mensinger to include communicating the one or more concentration ranges to an adjustable display; and changing a hue displayed by the adjustable display based on the one or more concentration ranges, as taught by Mensinger ([0176]) to provide visual information to help monitor the blood glucose level. It is noted that the display 222 is only the display of the smartphone. Therefore, the display does not store data itself. Fig. 2 shows a functional block diagram of the system, including smartphone/tablet 202 and display 222, wherein the display 222 does not comprise a memory. A display receives data/signals indicative of the output to be displayed, however, the display does not store this data as a display does not comprise a memory. Therefore the method of modified Mensinger teaches wherein the one or more concentration ranges are not stored on the adjustable display.
Regarding claim 2, modified Mensinger teaches the method of claim 1, wherein the concentration ranges are adjustable ([0150]; The ranges of acceptable BG values are calculated based on the last EGV, and may be calculated differently depending upon time since implant, therefore the concentration ranges are adjustable.).
Regarding claim 3, modified Mensinger teaches the method of claim 1, further comprising flashing the hue displayed by the adjustable display on and off responsive to the analyte concentration being below a predetermined threshold ([0176-0177]; “If the user's blood glucose value continues to become increasingly low or high, the CGM module 208 produces additional outputs, such as increasing the intensity of the color and/or causing the text/background to flash. These additional outputs may be generated in response to the CGM module 208 comparing input EGV's to additional programmed threshold values.”).
Regarding 4, modified Mensinger teaches the method of claim 1, further comprising sending a notification responsive to a second analyte concentration being in either of the low level concentration range or the high level concentration range ([0176-0177]; the text/background changing to be a different color when the user’s blood glucose is outside of the target concentration range (i.e., in either the low level concentration range or the high level concentration range) is considered a notification).
Regarding claim 5, modified Mensinger teaches the method of claim 1, wherein the analyte concentration includes a blood glucose concentration (The method of Fig. 12 is based on blood glucose values (i.e., concentrations); See par. [0057]).
Regarding claim 7, Fig. 12 of Mensinger teaches a method comprising: determining an analyte concentration ([0149]; steps B1204-1206, CGM module outputs blood glucose (BG) value to sensor electronics and the sensor electronics processes BG by calculating estimated glucose value (EGV)), but does not teach communicating the analyte concentration to an adjustable display; and modifying a hue displayed by the adjustable display based on the analyte concentration, wherein the analyte display is not stored on the adjustable display.
Mensinger further teaches that the CGM module 208 may change the color of the display 222 to reflect the user’s current blood glucose level as a number, as a trend graph, a horizontal bar graph, etc. (i.e., communicating the analyte concentration to an adjustable display). The text/background may show a first color, such as green, if the user's blood glucose is within a healthy range, and a second color, such as red, if the user's blood glucose is low or high (i.e., changing a hue displayed by the adjustable display based on the analyte concentration) ([0176]). The distinguishing colors for the blood glucose level provide visual information to help monitor the blood glucose level.
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the method of Fig. 12 of Mensinger to include communicating the analyte concentration to an adjustable display; and changing a hue displayed by the adjustable display based on analyte concentration, as taught by Mensinger ([0176]) to provide visual information to help monitor the blood glucose level. It is noted that the display 222 is only the display of the smartphone. Therefore, the display does not have a memory and does not store data itself. Therefore the method of modified Mensinger teaches wherein the analyte concentration is not stored on the adjustable display.
Regarding claim 8, modified Mensinger teaches the method of claim 7, further comprising flashing the hue displayed by the adjustable display on and off responsive to the analyte concentration being below a predetermined threshold ([0176-0177]; “If the user's blood glucose value continues to become increasingly low or high, the CGM module 208 produces additional outputs, such as increasing the intensity of the color and/or causing the text/background to flash. These additional outputs may be generated in response to the CGM module 208 comparing input EGV's to additional programmed threshold values.”).
Regarding claim 9, modified Mensinger teaches the method of claim 7, further comprising sending a notification responsive to the analyte concentration being below a predetermined threshold (See the rejection of claim 8, the increasing color intensity and flashing display is the analyte concentration becomes increasingly low, below programmed threshold values, are considered notifications).
Regarding claim 10, modified Mensinger teaches the method of claim 7, wherein the analyte concentration is determined at least once every five minutes ([0149]; At block B1214 the CGM module 208 stores the expected minimum and maximum BG values for later comparison (e.g., within the next 5 minutes, or other interval of time, prior to receipt of a next data packet from the sensor electronics.)).
Regarding claim 11, modified Mensinger teaches the method of claim 7, wherein the analyte concentration includes a blood glucose concentration (The method of Fig. 12 is based on blood glucose values (i.e., concentrations); See par. [0057]).
Regarding claim 12, Mensinger teaches the method of claim 7, wherein the analyte concentration is determined by reading an output of a database ([0149] In step B1204, the BG value is stored in temporary storage 210 (i.e., a database)).
Regarding claim 14, Fig. 2 of Mensinger teaches a system (system 200) comprising: an adjustable light display ([0077]; display 222 which can be adjusted) including one or more processors ([0077]; Processor 206 produces outputs to the display. The processor 206 can be considered to be a part of the display as it produces the outputs for the display.); and a controller (sensor electronics) in communication with the adjustable light display ([0077]; the sensor electronics are in communication with the CGM module 208 (communication between the two are show in steps B1204, and B1212 of Fig. 12. It is noted that the system of Fig. 2 can be configured to complete the method of Fig. 12. ([0031, 0070])); wherein the controller is configured to retrieve a measured analyte reading from a database and communicate the measured analyte reading to the one or more processors (CGM module 208 retrieves the BG value from the temporary storage 210 (i.e., a database) and communicates it to the sensor electronics (i.e., controller) to calculate the EGV.).
Figs. 2 and 12 of Mensinger does not teach wherein the one or more processors are configured to determine a hue of the adjustable light display based on the measured analyte reading, the controller is configured to change the hue of the adjustable light display based on the measured analyte reading, wherein the measured analyte reading is not stored on the one or more processors.
Mensinger further teaches that the CGM module 208 may change the color of the display 222 to reflect the user’s current blood glucose level as a number, as a trend graph, a horizontal bar graph, etc.. The text/background may show a first color, such as green, if the user's blood glucose is within a healthy range, and a second color, such as red, if the user's blood glucose is low or high (i.e., determining a hue displayed by the adjustable display based on the analyte concentration) ([0176]). The distinguishing colors for the blood glucose level provide visual information to help monitor the blood glucose level.
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the system of Fig. 2 of Mensinger to include the one or more processors being configured determine a hue of the adjustable light display based on the measured analyte reading, the controller is configured to change the hue of the adjustable light display based on the measured analyte reading, as taught by Mensinger ([0176]) to provide visual information to help monitor the blood glucose level. It is noted that the calculation of the expected minimum and expected maximum values by the sensor electronics (i.e., controller) changes the hue of the adjustable light display based on the measured analyte reading. It is further noted that the processors are in communication with the CGM module and the display, however, the processors do not comprise the memory 204 or the temporary storage 210. The processors are used to generate the output (i.e., data indicative of the measured analyte reading to be displayed on the display), but does not comprise a memory or storage to store data. Therefore, the method of modified Mensinger teaches wherein the measured analyte reading is not stored on the one or more processors.
Regarding claim 15, modified Mensinger teaches the system of claim 14, wherein the controller is configured to flash the hue of the adjustable light display on and off responsive to the measured analyte reading being below a predetermined threshold ([0176-0177]; “If the user's blood glucose value continues to become increasingly low or high, the CGM module 208 produces additional outputs, such as increasing the intensity of the color and/or causing the text/background to flash. These additional outputs may be generated in response to the CGM module 208 comparing input EGV's to additional programmed threshold values.”).
Regarding claim 16, modified Mensinger teaches the system of claim 14, wherein the controller is configured to send a notification responsive to the measured analyte reading being below a predetermined threshold (See the rejection of claim 15, the increasing color intensity and flashing display is the analyte concentration becomes increasingly low, below programmed threshold values, are considered notifications).
Regarding claim 17, modified Mensinger teaches the system of claim 14, wherein the measured analyte reading includes one of a blood glucose concentration (The method of Fig. 12 is based on blood glucose values (i.e., concentrations); See par. [0057]), cholesterol, a lipid count, a red blood cell count, a concentration of vitamins, or a concentration of minerals.
Regarding claim 18, modified Mensinger teaches the system of claim 14, wherein the controller is configured to retrieve the measured analyte reading from the database at least once every 5 minutes ([0149]; At block B1214 the CGM module 208 stores the expected minimum and maximum BG values for later comparison (e.g., within the next 5 minutes, or other interval of time, prior to receipt of a next data packet from the sensor electronics)).
Regarding claim 20, Mensinger teaches the system of claim 14, wherein the controller is configured to sync with the adjustable light display via a unique user code ([0107]; “With regard to pairing of the transmitter to the smartphone, pairing may be accomplished during a channel establishment process between the two devices. Establishing a channel may involve broadcasting a unique ID by one device and a search and acquisition of this ID by the other device.”) It is noted that the transmitter comprises the sensor electronics (i.e., controller) and the smartphone comprises the adjustable light display, therefore the unique ID is used to sync the adjustable display with the controller.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Mensinger, as applied to claims 1, in view of US Patent Publication 2012/0014592 by Abe – previously cited, hereinafter “Abe”.
Modified Mensinger teaches the method of claim 1, but does not teach wherein the hue is measured as degrees on a color spectrum.
Abe teaches a method of measuring a hue based on the hue angle (i.e., degrees) in a hue circle or color wheel (i.e., color spectrum) such as in Fig. 3. ([0068]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the method of modified Mensinger such that the hue is measured as degrees on a color spectrum. This modification would comprise a simple substitution of one known element (measuring the hue based on the degrees of a color spectrum) for another (the method of Mensinger uses identifies color by name (red, yellow, green, etc.) to obtain predictable results. See MPEP 2143.I.B.
Claims 13 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Mensinger, as applied to claims 7 and 14, in view of US Patent Publication 2020/0214621 by Keroles et al. – previously cited, hereinafter “Keroles”.
Regarding claim 13, modified Mensinger teaches the method of claim 7, but does not teach the method further comprising modifying a brightness of the hue displayed by the adjustable display based on a time of day.
Keroles teaches a system comprising a display for communicating physiological information (Figs. 1-2, display 5). Keroles teaches that features such as an ambient light sensor can be added to the system and can be used to adjust the brightness of the display based on the time of day. This adjustment of the brightness can prevent the disturbance of the user ([0068]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the method of modified Mensinger to include using an ambient light sensor and modifying a brightness of the hue displayed by the adjustable display based on a time of day, to prevent the disturbance of the user, as taught by Keroles ([0068]).
Regarding claim 19, modified Mensinger teaches the system of claim 14, but does not teach wherein the controller is configured to modify a brightness of the hue of the adjustable light display based on a time of day.
Keroles teaches a system comprising a display for communicating physiological information (Figs. 1-2, display 5). Keroles teaches that features such as an ambient light sensor can be added to the system and can be used to adjust the brightness of the display based on the time of day. This adjustment of the brightness can prevent the disturbance of the user ([0068]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the system of modified Mensinger to include an ambient light sensor and wherein the controller is configured to modify a brightness of the hue of the adjustable light display based on a time of day, to prevent the disturbance of the user, as taught by Keroles ([0068]).
Response to Arguments
Applicant’s arguments, filed 02/10/2026 have been fully considered.
The amendments to claims 14 overcome the objections of record.
The amendments to the claims overcome the rejections under 35 U.S.C. 112(b) of claim 4.
The amendments to the claims do not overcome the rejection under 35 U.S.C. 101. Applicant argues that the claimed invention constitutes patent eligible subject matter according to Prong 2A of the USPTO guidance and the claims are not directed to an Abstract Idea. Applicant argues that the claims recite an invention that allows the user to quickly identify and manage their condition by quickly accessing their concentration range, and this solves a problem of limited user interaction found in prior art glucose monitoring interfaces while protecting the users information and privacy by not storing the data on the display. This argument is not found persuasive. While the claims contain limitations that are described in the specification related to the solving the identified problems and obscuring user data to protect the privacy of the user, the claims as a whole do not describe systems/methods that read on a system that is differentiated from other systems and methods found in the prior art. For example, broadest reasonable interpretation of “the adjustable display” can be interpreted as any adjustable display (such as an LCD or LED array), including the adjustable display of a smartphone. The adjustable display can simply be the screen of the smartphone, and therefore would not store the concentration ranges, as this interpretation of an adjustable display does not have a memory. The claims, as currently constructed, do not recite limitations that reasonably convey that the system or method, as a whole, that solves the problems as identified by the Applicant.
Applicant’s assertion regarding the rejections of the independent claims under 35 U.S.C. 103 is acknowledged. This assertion is moot as it is based on amendments to the claims not entered at the time of the previous Office action. The newly presented limitations are rejected on new grounds above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/NELSON ALEXANDER GLOVER/ Examiner, Art Unit 3791
/ADAM J EISEMAN/ Primary Examiner, Art Unit 3791
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