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 .
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.
Claim 1-19 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.
Regarding Claims 1 and 9, terminology drift renders the claims indefinite. The claims use the terms “continuous glucose monitoring (CGM) device”, “continuous monitoring device” and “continuous glucose monitoring device”. It is unclear if these are all the same CGM type devices. For purposes of examination the indefinite limitations have been deemed to claim the same CGM devices. The rejection may be overcome by picking one defined term and using it consistently.
Regarding Claims 1 and 9, the claims use the terms “a caretaker”, “one or more caretakers” and “the caretaker”. It is unclear if these are all the same caretakers, and it is further unclear how many caretakers there actually are/can be. For purposes of examination the indefinite limitation has been deemed to claim at least one caretaker, all of which are the same caretaker, or one of a potential more than one caretakers.
Regarding Claim 1 and 9, the claim limitation “for each predefined range” renders the claim indefinite, because it is unclear if the claimed “predefined range” is the same as the previously recited “predetermine ranges”. For purposes of examination the indefinite limitation has been deemed to claim “level of alert for each of the one or more predetermined ranges of blood glucose levels”.
Regarding Claims 1, 2, 5, 6, 9, 12, 14 and 15, the various claimed alerts render the claims indefinite. First the claims set forth setting an alert and a level of alert. The claims then set forth determine at least one alert. Is this one alert the same as the alerts that are previously set? The claims then set forth disabling the alert, but it is unclear if the set alerts are disabled or if the determined alert is disabled. The claims then further recite that the alert includes a first, second and third alert, however, it is unclear if these alerts are of the set alerts or the determined alerts. Disabling of the alert is then claimed, however, it is unclear which of the various alerts are to be disable (The set alert? The determined alert? One or more of the first, second and third alerts?). Lastly, the caretaker is enabled to provide one alert to the user, but it is unclear if this is a new alert, or one of the previously recited alerts. Dependent claims 2, 5, 6, 12, 14 and 15 further recite additional alerts, and their metes and bounds are unclear, because it cannot be determined which alerts of Claims 1 and 9 they are related to. For purposes of examination the indefinite limitation has been deemed to claim that all alerts as recited are the same alerts, where there are three potential alerts that can be set, provided and disabled, which include vibration, audio/light, and electric shock.
Regarding Claims 5 and 14, the limitation “the intensity” lacks proper antecedent basis and therefore renders the claim indefinite. For purposes of examination the indefinite limitation has been deemed to claim “an intensity”.
Regarding Claims 5, 6, 14 and 15, the limitation “every predefined time” renders the claim indefinite. It is unclear whether “time” means a point in time or a duration/interval of time. The claim does not identify who defines the time, when they are defined, or how many there are. “Every predefined time” presupposes a set of times previously established, but the Claims 1 and 9 provide no antecedent basis or linage to such times. It is further unclear whether the increase in intensity occurs at the expiration of each interval, at the occurrence of each interval or throughout each interval. Therefore, the phrase “every predefined time” renders the scope of when and how the alert intensity must change. For purposes of examination the indefinite limitation has been deemed to claim that at every alarm instance, the intensity of the alarm increases until the alarm is disabled/turned off.
The term “progressively” in claims 6 and 15 is a relative term which renders the claim indefinite. The term “progressively” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For purposes of examination the indefinite limitation has been deemed to claim any change from the first alert to the third alert.
The term “desired image” in claims 7 and 16 is a relative term which renders the claim indefinite. The term “desired image” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For purposes of examination the indefinite limitation has been deemed to an image selected based on instructions.
Regarding Claims 10 and 19, the limitation “the caregiver” lacks proper antecedent basis and therefore renders the claim indefinite. It is unclear if the “caregiver” in Claim 10 is the same as the “caretaker”. For purposes of examination the indefinite limitation has been deemed to claim “the caretaker” as set forth in Claims 1 and 9.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-6, 10-15 and 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20100265073 A1 to Harper.
Regarding Claims 1 and 11, Harper discloses a system and method for managing blood glucose level (paragraph [0025] “FIG. 1 illustrates an analyte monitoring system 100 of the present disclosure.”), comprising inter alia:
a computing device (remote processor 105) in communication with a continuous glucose monitoring (CGM) device (sensor 101) (paragraph [0025] “…sensor 101 operatively coupled to a transmitter unit 102… in operative communication with a primary receiver 104 via communication path 103… system can further include a secondary receiver 106. In certain embodiments, each of the receivers 104, 106 may be configured to transmit data information to a remote processor 105.”) attached to a user (paragraph [0029] “… sensor 101 is implantable into a subject's body … to contact and monitor an analyte present in a biological fluid), wherein the continuous monitoring device is configured to continuously monitor a blood glucose level of the user (paragraph [0021] “The analyte monitoring system is capable of continuously or intermittently monitoring an analyte in a biological fluid.”) (FIG. 1);
a first user device (receiver 104) associated with a user, wherein the first user device is in communication with the computing device (remote processor 105) via a network (communication path 103) (104 ↔ 105 via 103/upstream) (paragraph [0025] “The transmitter unit is in operative communication with a primary receiver 104 via communication path 103… receivers 104… may be configured to transmit data information to a remote processor 105.”) (FIG. 1);
at least one second user device (receiver 106) associated with a caretaker (“associated with a caregiver” merely requires that the claimed unit be linked to and usable by a caregiver and receiver 106 is configured to receive data transmitted from the transmitter unit 102 and to communicate with the patient’s primary receiver 103 and terminal 105 (paragraph [0025]) and it is further disclosed in caregiver appropriate forms such as a wrist watch, page, mobile phone, PDA (paragraph [0027]) and for night time monitoring via a bedside cradle (paragraph [0027])), wherein the second user device (receiver 106) is in communication with the computing device (remote processor 105) via the network (communication path 103) (106 ↔ 105 via 103/upstream) (FIG. 1), and
a wearable device configured to be worn by the user (transmitter 102) (paragraph [0031] “…the transmitter can be configured to be worn on the skin of a user.”),
wherein the wearable device (transmitter 102) is in communication with the computing device (remote processor 105) via the network (communication path 103) (102 ↔ 104/106 ↔ 105 over 103/upstream) (paragraph [0025] “… the analyte monitoring system can further include a secondary receiver 106. In certain embodiments, each of the receivers 104, 106 may be configured to transmit data information to a remote processor 105.”) (FIG. 1), wherein the computing device (remote processor 105) is configured to:
receive the blood glucose level of the user from the continuous glucose monitoring device (105 receives CGM data forwarded from 104/106 sources from 101) (see paragraph [0025]);
enable the user to set one or more predetermined ranges of blood glucose level (paragraph [0048] “The analyte monitor system may be configured so that the threshold levels for these or any other conditions may be programmable by the patient, care giver or medical professional.”) and set an alert (paragraph [0057] “..auditory alarms have a different tone, note…”) and level of alert (paragraph [0057] “…volume…”) for each predefined range (paragraph [0057] “In some embodiments, auditory alarms have different tone, note, or volume indicating different conditions.”);
determine whether the blood glucose level is within one or more predetermined ranges (paragraph [0047] “… the alarm is configured such that when the data from the sensor 101 reaches or exceeds a threshold value, it outputs an alarm notification. Some non-limiting examples of threshold values for blood glucose levels are about 60, 70, or 80 mg/dL for hypoglycemia, about 70, 80, or 90 mg/dL for impending hypoglycemia, about 130, 150, 175, 200, 225, 250, or 275 mg/dL for impending hyperglycemia, and about 150, 175, 200, 225, 250, 275, or 300 mg/dL for hyperglycemia.”);
determine at least one alert corresponding to the blood glucose level (paragraph [0047] “… the alarm is configured such that when the data from the sensor 101 reaches or exceeds a threshold value, it outputs an alarm notification.) (paragraph [0057] “… auditory alarms have different tone, note, or volume indicating different conditions.”) and enable the wearable device to provide the determined alert until the user disables the alert (paragraph [0058] “… the alarm may be automatically deactivated after a predetermined time period… configured to deactivate when the data no longer indicates that the condition which triggered the alarm exists.”), wherein the alerts include a first alert, a second alert and a third alert, wherein the first comprises vibratory alert, the second comprises an audio and/or a light-based alert and the third alert comprises electric shock (paragraph [0087] “… the alarm is a tri-modal alarm and includes an audible alarm, a visual alarm and a tactile alarm … mild electrical shock when triggered.”);
provide one or more tasks to the user to disable the alert (menu or submenu for disenabling or muting alarms is displayed, paragraph [0063]) (menus for selecting a predetermined period of time for disablement or muting or alarm notification, paragraph [0064]);
broadcast the blood glucose level to one or more caretakers of the user (paragraph [0025] “…each of the receivers 104, 106 may be configured to transmit data information to a remote processor 105.”), and enable the caretaker to control the wearable device to provide at least one alert to the user (paragraph [0021] “… it is contemplated that the "user" could be a care taker for the monitored subject.”) (paragraph [0048] “…the threshold levels for these or any other conditions may be programmable by … care giver or medical professional.) (paragraph [0060] “When depressed by the … another person, the flexible conducting strip is pushed directly toward a metal contact and completes the circuit to shut off the alarm.”).
Regarding Claims 2 and 12, Harper discloses the system of claim 1 and method of claim 11, wherein the wearable device is configured to enable the user to set a range of intensity for the alert and deliver the alert at a predefined range of intensity (paragraph [0040] “… user may select the tone, the length of the tone and the volume of the tone for each auditory notification.”).
Regarding Claims 3, 4 and 13, Harper discloses the system of claim 1 and the method of claim 11, wherein the wearable device comprises at least one detection sensor (the processor of the receiver 104 and respective counting of data packets and determining loss of data packets, paragraph [0043]) to determine whether the wearable device is attached to the user body (paragraph [0024] “Data loss events include … improper insertion or implantation of the sensor … sensor error … System events include … sensor removal.”), wherein the detection sensor an electrical sensor (the processor of the receiver 104 determines loss of data packets, paragraph [0043], which is indicative of improper insertion, implantation, sensor error, and/or sensor removal).
Regarding Claims 5 and 14, Harper discloses the system of claim 1 and method of claim 11, wherein the computing device is configured to enable the wearable device to increase the intensity of the alert for every predefined time until the user disables the alert (paragraph [0040] “… user may select the tone, the length of the tone and the volume of the tone for each auditory notification.”) (paragraph [0044] “… the volume of the alert increase after each time the alert is snoozed or silenced…”).
Regarding Claims 6 and 15, Harper discloses the system of claim 1 and method of claim 11, wherein the computing device is configured to enable the wearable device to change a type of alert progressively from the first alert to the third alert (the muting of audible notification during tri-modal alert while tactile alert continues is a progressive change of alert type, from a tri-modal alert to a dual-modal alert) (paragraph [0010] “… alert can simultaneously include an audible… and tactile notification … receiver can be configured to mute only one or two of the three alarm modes … the audible notification can be muted by the user while the tactile (e.g., vibration) … notifications are not disenabled. “) for every predefined time until the user disables the alert ([0059] “Other embodiments provide that the alarm may be deactivated manually by a user.”).
Regarding Claims 10 and 19, Harper discloses the system of claim 1 and method of claim 19, wherein the blood glucose level is broadcasted to one or more caretakers of the user, if the user shares their data with the caregiver through the CGM device (Harper discloses distributing the patient’s CGM data from transmitter 102 through primary receiver 104 to remote processor 105 and specifically sets forth a separate secondary receiver 106 for remote besides monitoring which are all capable of being reviewed by caretakers, paragraph [0026] “The primary receiver unit 104 may be further configured to transmit data to a data processing terminal 105 for evaluating the data received by the primary receiver unit 104. Moreover, the data processing terminal 105 in one embodiment may be configured to receive data directly from the transmitter unit 102 via a communication link which may optionally be configured for bidirectional communication. “).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 9 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harper in view of US 20080319294 A1 to Taub.
Harper discloses the system of claim 1 and method of claim 11, except for wherein the wearable device further comprises a secure attachment assembly to attach the wearable device to the user. However, Taub teaches at paragraph [0026] a data processing unit that includes an adhesive. One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the wearable device to include the adhesive of Taub, as Taub teaches this would have allowed securement of the device to the body of the user.
Claim(s) 7, 8, 16 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harper in view of both EP 1087602 A2 to Todd and US 8195203 B1 to Tseng.
Harper discloses the system of claim 1 except for discloses wherein the tasks include entering a code by pressing one or more buttons of the wearable device in a predefined sequence, answering a question, and selecting one or more desired images from a plurality of images, and the user is enabled to execute the task using the first user device.
However, Todd teaches entering a code by pressing one or more buttons of the wearable device in a predefined sequence to disable an alarm of a device (paragraph [0004] “a keypad can be used to activate and deactivate the alarm system”), and Tseng teaches answering a question to disable an alarm of a device (col. 2, lines 7-8) and selecting one or more desired puzzle piece images from a plurality of puzzle piece images to solve an puzzle to disable an alarm of a device (col. 2, lines 8-15).
One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the task of Harper to include the code by buttons of Todd, because Todd teaches that such a code would have ensured that only an authorized user of the device would have the ability to deactivate the alarm (paragraph [0028]) and Tseng teaches that this would have helped determine whether or not the user is groggy. A skilled artisan would have employed such codes, questions, and image selection of Todd and Tseng, to prevent accidental alarm disengagement.
Conclusion
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/SEAN P DOUGHERTY/Primary Examiner, Art Unit 3791