DETAILED ACTION
Applicant' s arguments, filed 11/06/2025 have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 07/17/2025, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1-2, 5, 7-9, 12, 14-15, 18, 20-29 are the current claims hereby under examination.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claims 1, 5, 7-8, 14-15, 20, and 29 are objected to because of the following informalities:
Claim 1 line 23 it appears that “an alert generator that is coupled to the computer program” should read “an alert generator that is in communication with the computer program” because the limitation “coupled to” implies a physical connection and an alert generator cannot be physically connected to a computer program
Claim 5 line 6 it appears that “the alert generator that is configured to” should read “the alert generator is further configured to”
Claim 7 line 3 it appears that “an intensity” should read “the intensity”
Claim 8 lines 1-2 it appears that “a glucose level” should read “a glucose level of an individual” alternatively, the limitation “the glucose level of an individual” should read “a glucose level of an individual”
Claim 14 line 2 it appears that “an intensity” should read “the intensity”
Claim 15 lines 10-11 it appears that “being on of” should read “being one of”
Claim 20 line 3 it appears that “an intensity” should read “the intensity”
Claim 29 lines 6-7 it appears that “the wireless glucose monitor” should read “a wireless glucose monitor”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 8-9, 12, 14-15, 18, 20, and 24-29 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 8 and its dependents are rejected as claims 8 recites “determining a visible indicium instruction …” in lines 11-13 but it is unclear how the determination of the visible indicium instruction relates to the rest of the claimed method. In particular, the following step of generating is based on the “given visual indicium” and thus it would seem that the determined “visible indicium instruction” is not used in the claimed method. It is thus unclear how this step relates to the rest of the claimed method. For the purposes of this examination, the limitation will be interpreted as the “visible indicium instruction” being used in the generating step. This rejection and interpretation are similarly applied to the similar limitations of claim 15 and its dependents
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-2, 5, 8-9, 12, 15, 18, and 21-29 are rejected under 35 U.S.C. 103 as being unpatentable over Veltz US Patent Application publication Number US 20170173262 A1 hereinafter Veltz in view of Fox US Patent Application Publication Number US 20150190100 A1 hereinafter Fox
Regarding claim 1, Veltz teaches a glucose annunciator system (Abstract; Paragraph 0010), comprising:
a computer program executing on an electronic device associated with an individual (Paragraph 0329: the program executed on the smartphone) and that is configured to:
acquire, from a data server associated with a wireless glucose monitor, data indicating a glucose level of the individual (Paragraph 0329: acquiring blood glucose (BG) data from medical system; paragraph 0083: The medical system may include remote servers), wherein the data is (i) generated by a sensor of the wireless glucose monitor that establishes the glucose level of the individual through periodic analysis of interstitial fluid (Paragraphs 0022, 0025, and 0329: receiving blood glucose values from continuous and/or flash glucose monitors), (ii) transmitted by the wireless glucose monitor to a second computer program executing on the electronic device (Paragraphs 0026 and 0329: the glucose measurements may be transmitted wirelessly from the sensors), and (iii) transmitted by the second computer program to the data server (Paragraphs 0329-0331: the smartphone communicates with a second smartphone through the cloud); an alert generator that is coupled to the computer program and that is configured to: acquire, from the computer program (Paragraphs 0329, 0331 and 0386: the smartphone may send alerts and acquire data regarding BG); and Veltz fails to further disclose the system wherein the device is configured to: comparing the data to multiple predetermined ranges, each of which corresponds to a respective one of multiple visual indica to establish a given range in which the glucose level of the individual is located, the given range being one of the multiple predetermined ranges; and determining a visible indicium instruction for a given visual indicium that corresponds to the given range, the given visual indicium being one of the multiple visual indicia; generating, via light generator, a visible light based on the visible indicium instruction, the visible light corresponding to the given visual indicium and visually indicating the given range in which the glucose level of the individual is located, wherein one or more of a wavelength, an intensity, and an intermittence of the visible light is specifically assigned to correspond to the given range of the multiple predetermined ranges in which the glucose level is located, such that the individual is able to distinguish between visual indicia generated for the multiple predetermined ranges
Fox teaches apparatuses and methods for medical monitoring physiological characteristics values such as blood glucose levels for the treatment of diabetes (Abstract). Thus, Fox falls within the same field of endeavor as Applicant’s invention.
Fox teaches a system wherein the device is configured to: comparing the data to multiple predetermined ranges (paragraphs 0074 and 0082: the most recently recorded value is compared to the user’s threshold ranges), each of which corresponds to a respective one of multiple visual indica to establish a given range in which the glucose level of the individual is located, the given range being one of the multiple predetermined ranges (Paragraphs 0082-0083 and 0085-0086: the glucose values is compared to determine which range it falls within, the range is associated with a corresponding alarm indication which may be visual. Each of the threshold ranges are associated with a different alarm indication such as color or flashing of a light and each of the ranges may be configured by the user); and determining a visible indicium instruction for a given visual indicium that corresponds to the given range, the given visual indicium being one of the multiple visual indicia (Paragraphs 0082-0083 and 0085-0086: the determination of which range the glucose values fall within and what the appropriate alarm is); generating, via light generator, a visible light based on the visible indicium instruction, the visible light corresponding to the given visual indicium and visually indicating the given range in which the glucose level of the individual is located, wherein one or more of a wavelength, an intensity, and an intermittence of the visible light is specifically assigned to correspond to the given range of the multiple predetermined ranges in which the glucose level is located, such that the individual is able to distinguish between visual indicia generated for the multiple predetermined ranges (Paragraphs 0082-0083 and 0085-0086: the generation of the appropriate alarm condition including color and/or flashing)
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to combine the variable alarm generation based on glucose threshold level as taught by Fox into the system of Veltz because Fox teaches that such a display allows the system to immediately convey some information to the user which may allow the system to convey how urgent an alarm is before the user even checks their glucose level (Fox: paragraph 0086) this allows the user to appropriate prioritize their actions in response to an alarm and would improve the alarm system of Veltz. Regarding claim 2, Veltz in view of Fox teaches glucose annunciator system according to claim 1. Modified Veltz further teaches the system wherein the computer program executing on an electronic device is configured to acquire the data from the data sever without interfering in an operation of the wireless glucose monitor (Paragraph 0329; Fig. 2 reference 210: the data eavesdropping interface receives the blood glucose measurements).
Regarding claim 8, Veltz teaches a method of announcing of a glucose level, comprising:
acquiring data from a wireless glucose monitor indicating the glucose level of an individual (Abstract; Paragraphs 0010 and 0329: acquiring blood glucose (BG) data from the wireless glucose monitors), wherein the data is generated by a sensor of the wireless glucose monitor that establishes the glucose level of the individual through periodic analysis of interstitial fluid (Paragraphs 0022, 0025, and 0329: receiving blood glucose values from continuous and/or flash glucose monitors); Veltz fails to further disclose the method comprising: comparing the data to multiple preconfigured ranges, each of which corresponds to a respective one of multiple visual indicia, to establish a given range in which the glucose level of the individual is located, the given range being one of the multiple preconfigured ranges; determining a visible indicium instruction for a given visual indicium that corresponds to the given range, the given visual indicium being one of the multiple visual indicia; and generating, based on the given range in which the glucose level is located, a visible light corresponding to the given visual indicium and visually indicating the given range in which the glucose level of the individual is located, wherein a wavelength of the visible light and one or more of (i) an intensity of the visible light or (ii) an intermittence of the visible light are specifically assigned to correspond to the given range of the multiple preconfigured ranges in which the glucose level is located such that the individual is able to distinguish between visual indicia generated for the multiple preconfigured ranges.
Fox teaches a method comprising: comparing the data to multiple preconfigured ranges (paragraphs 0074 and 0082: the most recently recorded value is compared to the user’s threshold ranges), each of which corresponds to a respective one of multiple visual indicia, to establish a given range in which the glucose level of the individual is located, the given range being one of the multiple preconfigured ranges (Paragraphs 0082-0083 and 0085-0086: the glucose values is compared to determine which range it falls within, the range is associated with a corresponding alarm indication which may be visual. Each of the threshold ranges are associated with a different alarm indication such as color or flashing of a light and each of the ranges may be configured by the user); determining a visible indicium instruction for a given visual indicium that corresponds to the given range, the given visual indicium being one of the multiple visual indicia (Paragraphs 0082-0083 and 0085-0086: the determination of which range the glucose values fall within and what the appropriate alarm is); and generating, based on the given range in which the glucose level is located, a visible light corresponding to the given visual indicium and visually indicating the given range in which the glucose level of the individual is located, wherein a wavelength of the visible light and one or more of (i) an intensity of the visible light or (ii) an intermittence of the visible light are specifically assigned to correspond to the given range of the multiple preconfigured ranges in which the glucose level is located such that the individual is able to distinguish between visual indicia generated for the multiple preconfigured ranges (Paragraphs 0082-0083 and 0085-0086: the generation of the appropriate alarm condition including color and/or flashing of the light).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to combine the variable alarm generation based on glucose threshold level as taught by Fox into the method of Veltz because Fox teaches that such a display allows the system to immediately convey some information to the user which may allow the system to convey how urgent an alarm is before the user even checks their glucose level (Fox: paragraph 0086) this allows the user to appropriate prioritize their actions in response to an alarm and would improve the alarm system of Veltz. Regarding claim 9, Veltz in view of Fox teaches the method according to claim 8. Modified Veltz further teaches the method wherein the wireless glucose monitor is configured to transmit data to a smartphone for further processing by a computer program executing thereon, the computer program configured to acquire the data without interfering in an operation of the wireless glucose monitor (Paragraph 0329: wireless glucose monitors gather data and it is transmitted to the smartphone; Fig. 2 reference 210).
Regarding claim 15, Veltz teaches a glucose annunciator device comprising:
a data eavesdropping interface configured to acquire data indicating a glucose level of an individual (Abstract; Paragraphs 0010, 0022, and 0025; receiving the blood glucose measurements; Fig. 2); a microcontroller (Paragraph 0075: the microcontroller); and
a light generator (Paragraphs 00329 and 00331: the smartphones which can raise alarms)
Veltz fails to further disclose the device wherein the microcontroller is configured to: compare the data to multiple preconfigured ranges (paragraphs 0074 and 0082: the most recently recorded value is compared to the user’s threshold ranges), each of which corresponds to a respective one of multiple visual indicia, to establish a given range in which the glucose level of the individual is located, the given range being one of the multiple preconfigured ranges (Paragraphs 0082-0083 and 0085-0086: the glucose values is compared to determine which range it falls within, the range is associated with a corresponding alarm indication which may be visual. Each of the threshold ranges are associated with a different alarm indication such as color or flashing of a light and each of the ranges may be configured by the user); determine a visible indicium instruction for a given visual indicium that corresponds to the given range, the given visual indicium being one of the multiple visual indicia (Paragraphs 0082-0083 and 0085-0086: the determination of which range the glucose values fall within and what the appropriate alarm is); and the light generator configured to generate, based on the given range in which the glucose level of the individual is located, a visible light corresponding to the given visual indicium and visually indicating the given range in which the glucose level of the individual is located, the visible light indicating the given range in which the glucose level of the individual is located based on a wavelength of the visible light and further based on one or more of: an intensity of the visible light; and an intermittence of the visible light (Paragraphs 0082-0083 and 0085-0086: the generation of the appropriate alarm condition including color and/or flashing of the light).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to combine the variable alarm generation based on glucose threshold level as taught by Fox into the device of Veltz because Fox teaches that such a display allows the system to immediately convey some information to the user which may allow the system to convey how urgent an alarm is before the user even checks their glucose level (Fox: paragraph 0086) this allows the user to appropriate prioritize their actions in response to an alarm and would improve the alarm system of Veltz.
Regarding claim 5, 12, and 18, Veltz in view of Fox teaches glucose annunciator system, method, and device of claims 1, 8 and 15 respectively. Modified Veltz further teaches a sound generator (Paragraphs 0010, 0173, and 0329: the smartphone may generate alerts, the alerts may be audible)
Modified Veltz fails to further disclose: the computer program executing on the electronic device that is configured to: determine an audible indicium instruction based on the given range in which the glucose level is located; and the alert generator that is configured to: generate, via a sound generator, an audible sound based on the audible indicium instruction, wherein the audible sound indicates the given range in which the glucose level is located based on one or more of: a pitch of the audible sound; a volume of the audible sound; and an intermittence of the audible sound.
Fox teaches a system, method, and device comprising: the computer program executing on the electronic device that is configured to: determine an audible indicium instruction based on the given range in which the glucose level is located; and the alert generator that is configured to: generate, via a sound generator, an audible sound based on the audible indicium instruction, wherein the audible sound indicates the given range in which the glucose level is located based on one or more of: a pitch of the audible sound; a volume of the audible sound; and an intermittence of the audible sound (Paragraphs 0082-0083 and 0085-0086: the measured glucose value is compared to the predetermined ranges set by the user and an appropriate alert is generated based on which range the value falls within. The alert may be an audible alert and the audible alerts for each threshold range may be distinguishable from each other by changing the pitch, and/or an intermittence or wavering of the volume).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to combine the variable alarm generation based on glucose threshold level as taught by Fox into the device of modified Veltz because Fox teaches that such an alarm generation allows the system to immediately convey some information to the user which may allow the system to convey how urgent an alarm is before the user even checks their glucose level (Fox: paragraph 0086) this allows the user to appropriate prioritize their actions in response to an alarm and would improve the alarm system of Veltz. Regarding claim 21, 24, and 27, Veltz in view of Fox teaches glucose annunciator system, method, and device of claims 1, 8 and 15 respectively. Modified Veltz fails to further teach the multiple predetermined ranges indicate that the glucose level of the individual is located in a safe level, a hyperglycemia level, a hypoglycemia level, a serious hyperglycemia level, or a serious hypoglycemia level.
Fox teaches a system, method, and device wherein the multiple predetermined ranges indicate that the glucose level of the individual is located in a safe level, a hyperglycemia level, a hypoglycemia level, a serious hyperglycemia level, or a serious hypoglycemia level (Paragraphs 0082-0083 and 0085-0086: the establishing of the user ranges for separate high and low glucose levels. The threshold can be set for different degrees of severity; Fig. 4 references 408 and the two differently shaded areas above and below 404 and 406; Paragraphs 0048 and 0073: the device is configured to detect and alarm for hypoglycemia/hyperglycemia events).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to incorporate the differing alarm settings for different levels of severity of the user’s glucose condition as taught by Fox into the system of modified Veltz because Fox teaches that such an alarm generation allows the system to immediately convey some information to the user which may allow the system to convey how urgent an alarm is before the user even checks their glucose level (Fox: paragraph 0086) this allows the user to appropriate prioritize their actions in response to an alarm and would improve the alarm system of Veltz.
Regarding claim 22, 25, and 28, Veltz in view of Fox teaches glucose annunciator system, method, and device of claims 1, 8 and 15 respectively. Modified Veltz fails to further teach the multiple predetermined ranges are determined at least in part by the individual.
Fox teaches a system, method, and device wherein the multiple predetermined ranges are determined at least in part by the individual (Paragraphs 0079-0080, 0082-0083, and 0085-0086: the threshold values may be customized by the user).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to incorporate the user customized threshold values as taught by Fox into the system of modified Fox because such customization allows the system to personalized to the user to best fit their particular needs and “normal” glucose levels thereby reducing the number of unnecessary alarms and improving usability.
Regarding claim 23, 26, and 29, Veltz in view of Fox teaches glucose annunciator system, method, and device of claims 1, 8 and 15 respectively. Modified Veltz further teaches the computer program is further configured to: acquire the data from one or more of: the data server associated with the wireless glucose monitor (Paragraph 0329: the smartphone with the software acquires the data; Fig. 2 reference 210 ); a memory of the electronic device (Paragraph 0253: a memory unit); or a wireless transmission of the data emanating from a transmitter of the wireless glucose monitor (Paragraphs 0004 and 0025: the data transmitter of the glucose monitors)
Claims 7, 14, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Veltz US Patent Application publication Number US 20170173262 A1 hereinafter Veltz in view of Fox US Patent Application Publication Number US 20150190100 A1 hereinafter Fox as applied to claims 1, 8, and 15 above, and further in view of Fifield US Patent Application Publication Number US 20170332980 A1 hereinafter Fifield.
Regarding claim 7, 14, and 20, Veltz in view of Fox teaches glucose annunciator system, method, and device of claims 1, 8 and 15 respectively. Modified Veltz fails to further teach an ambient light sensor configured to provide a signal to the computer program indicating an ambient light level, wherein an intensity of the visible light generated by the light generator is at least partially based on the ambient light level.
Fifield teaches an apparatus to monitor for hypoglycemia in a human (Abstract). Thus Fifield falls within the same field of endeavor as Applicant’s invention.
Fifield teaches an ambient light sensor configured to provide a signal to the computer program indicating an ambient light level, wherein an intensity of the visible light generated by the light
generator is at least partially based on the ambient light level (Paragraphs 0133-0135: the ambient light sensor which is used to change the intensity of the display based on the ambient light).
Response to Arguments
Applicant’s arguments with respect to claims 1-2, 5, 7-9, 12, 14-15, 18, 20-29 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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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/MATTHEW ERIC OGLES/Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791
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