DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Withdrawal of finality
This is a 2nd non-final Office action superseding the 9/10/2025 final action and withdrawing finality. A shortened statutory period for reply is set to expire THREE MONTHS from the mailing date of this action.
In the 11/19/2024 non-final Office action, in the 103 rejection, the present action corrects the legal statement at the top of the non-final rejection to cite to Tierney 2001 (instead of 2000). Page citations, etc. within the body of the rejection already were and remain to Tierney 2001.
A Form PTO-892 is provided here citing both Tierney references with copies newly provided. Nonetheless, the 103 rejection relies only on Tierney 2001.
Office Action Overview
Claim Status
Canceled:
1-47, 51, 52, 64-68, 76-82
Pending:
48-50, 53-63, 69-75, and 83-91
Withdrawn:
none
Examined:
48-50, 53-63, 69-75, and 83-91
Independent:
48, 56, 69
Amended:
48, 56, 69, 84, 88
New:
89-91
Allowable:
none
Objected to:
none
Rejections applied
Abbreviations
X
112/b Indefiniteness
PHOSITA
"a Person Having Ordinary Skill In The Art before the effective filing date of the claimed invention"
112/b "Means for"
BRI
Broadest Reasonable Interpretation
112/a Enablement,
Written description
CRM
"Computer-Readable Media" and equivalent language
112 Other
IDS
Information Disclosure Statement
X
102, 103
JE
Judicial Exception
101 JE(s)
112/a
35 USC 112(a) and similarly for 112/b, etc.
101 Other
N:N
page:line
X
Double Patenting
MM/DD/YYYY
date format
Priority
As detailed on the 06/20/2024 filing receipt, this application is a continuation of U.S. Application No. 12/231,048, filed 08/27/2008, now abandoned. At this point in examination, all claims have been interpreted as being accorded this priority date.
Specification
Reference to the Specification in this Office Action refers to Pub. No. US 2020/0214566 A1, published 07/09/2020.
Claim Interpretation
The claim 48, 84, and 88 limitation, "positioning structure", is interpreted as a structure which supports a processing device, a light emitting diode, a receiver, a transmitter, (and sensor in claims 84 and 88); is to be worn by a healthcare recipient; and includes an adhesive backing. Examples in the Specification of a "positioning structure" include: a wearable interface [0030]; a wearable display [0032]; an earpiece, gown, or wristband [0042]; a garment [0045]; special purpose eyewear or sensing units [0049]; a local module [0055]; an adhesive patch [0070]; a headset [0079]; or a physiological support [0104].
Withdrawal of Claim Rejection - 35 USC § 112(a)
The rejection of claims 48-51, 53-55, and 84-88 under 35 U.S.C. 112(a), in the Office Action mailed 11/19/2024, is withdrawn in view of the amendment and remarks received 05/19/2025. The term "housing structure" has been deleted from the claim.
Claim Rejections - 35 USC § 112(b)
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 48-50, 53-63, 69-75, and 83-91 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 depending from rejected claims are rejected similarly, unless otherwise noted, and any amendments in response to the following rejections should be applied throughout the claims, as appropriate.
In claims 48, 56, and 69, the relationship is unclear between "a plurality of electrochemical sensors" and "a level of a physiological constituent". It is not clear if the claim requires the electrochemical sensors to measure the level of one physiological constituent; or if the electrochemical sensors measure levels of more than one physiological constituent; or something else. For examination purposes, the claims will be interpreted as electrochemical sensors configured to measure the level of one physiological constituent.
In claim 48, there are two related issues involving the "adhesive backing" (line 3) and "the adhesive" (line 6):
First, in claim 48, regarding "the adhesive" in line 6 of the claim, there is insufficient antecedent basis for this limitation in the claim. The term "adhesive backing" recited in line 3 of claim 48 does not provide antecedent basis for "the adhesive" in line 6.
Second, in claim 48, because the connection is unclear between the "adhesive backing" (line 3) and "the adhesive" (line 6), then it is not clear if it is required that the sensors be supported by the positioning structure that the adhesive backing is attached to. If the "adhesive backing" (line 3) and "the adhesive" (line 6) are referring to the same thing, this should reflected in an amendment. For now, claim 48 is interpreted as not requiring the sensors be supported by the positioning structure which has the adhesive backing.
It is acknowledged that in independent claims 56 and 69, the wearable adhesive patch clearly comprises the electrochemical sensors and positions the sensors on a body of the subject.
Claim 48, 56, and 69 have several similar clarity issues regarding a transmitter, a request (or a wireless radio signal), a notification, and/or a first remote device (or a local module), as follows:
Regarding claims 48 and 56, the structural relationship is unclear between the "transmitter" and the step of "responsive to a request from the first remote device". These are claims to 101 machines or manufactures, and such claims are interpreted strictly according to their claimed physical structure. Here, it is not clear what is the physical structure corresponding to the recited process steps and conditional logic. While it is implicit that a request is received and responded to, it is not clear what structure embodies performance of this conditional. If structure of the "transmitter" or another recited element is configured to perform this conditional, then this may be clarified with support identified. If this conditional is performed according to stored software instructions, then this may be clarified with support identified. Without clear recitation of the related structure, then the process steps and conditional logic are not clearly claimed.
Regarding claim 48, the relationship is unclear between "a request" and "a notification" in the limitation: "a request from the first remote device that is initiated in response to a notification about the physiological constituent provided via the first remote device" (emphasis added). It is unclear if both a request and a notification are provided by the first remote device, and if so, it is further unclear if both the request and notification are provided to the receiver, or if the notification is provided to the first remote device, or some other way. Additionally, the relationship is unclear between these recited process steps and the claimed structure. As above, it must be clear what recited structure embodies the recited process steps.
Regarding claim 69, in the "transmitting" step, the relationships are unclear between the recited "information," "wireless radio signal" and "notification," i.e. in the recitation "wherein the wireless radio signal is initiated in response to the first remote device providing a notification about the physiological constituent, and provide the request, wherein the request is initiated in response to the notification." This is at least because there is a lack of clarity regarding the process steps (e.g. the verbs) affecting the above elements. The recited "receiving" and "transmitting" are clearly required steps of the instant method. However, it is not clear whether, when and by what actor the recited "requesting," "measured," "initiated" and "providing a notification" steps are required as part of the instant method. It may help to recite these similarly to the recitations of "receiving" and "transmitting." Also, the recited "the first remote device" requires but lacks clear antecedent. There was previously recited "a remote device" ("receiving" step) but not a "first remote device." It should be clarified whether these two recitations refer to the same "device."
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 48-50, 53-63, 69-75, and 83-91 are rejected under pre-AIA 35 U.S.C.103(a) as being unpatentable over Magar (U.S. Patent Pub 2009/0054737; as cited on the 07/19/2021 PTO-892) in view of Tierney 2001 (Biosensors and Bioelectronics, vol. 16:9-12, pages 621-629, 2001; as cited on the attached Form PTO-892; as also cited on the 06/17/2024 IDS) and Stafford (U.S. Patent Pub 2008/0119707; as cited on the 09/26/2022 IDS).
Independent claim 48 recites a device comprising a positioning structure with an attached adhesive backing to secure the positioning structure; electrochemical sensors to measure a physiological constituent which are positioned on a subject's body by adhesive; a processing device supported by the positioning structure that receives and processes electrochemical sensor data to determine the level of physiological constituent of the subject; a light emitting diode supported by the positioning structure that provides an output indicating the level of physiological constituent; a receiver supported by the positioning structure to receive wireless signal from a remote device; a transmitter supported by the positioning structure to wirelessly transmit health-related information including the level of the physiological constituent to a first remote device, responsive to the request from the first remote deceive, that is initiated in response to a notification about the physiological constituent provided via the first remote device.
Independent claim 56 recites a system of a wearable adhesive patch comprising: sensors to measure level of a physiological constituent of a subject; a processing device; an LED; a first receiver to receive wireless signals; a first transmitter to transmit, responsive to a request received by the first receiver, health-related information including the level of the physiological constituent; and a local module configured to provide a notification about the physiological constituent and provide the request, wherein the request is initiated in response to the notification.
Independent claim 69 recites a method comprising positioning a wearable adhesive patch comprising a processing device; sensors; an LED; a receiver; and a transmitter for performing the steps of obtaining and processing sensor data to determine physiological constituent levels; providing output by LED; receiving, from a remote device, a wireless signal requesting the physiological constituent level measured by the sensors; transmitting in response to the received wireless signal, the level of physiological constituent; wherein the wireless radio signal is initiated in response to the first remote device providing a notification about the physiological constituent.
Dependent claims 49 and 70 further recite one electrochemical sensor measures blood glucose. Dependent claim 50 further recites there are two or more types of electrochemical sensors. Dependent claim 71 further recites the adhesive patch positions the electrochemical sensors through the skin surface of the subject. Dependent claims 53 and 72 further recite one of the electrochemical sensors is an ion-selective electrode or a glucose sensor. Dependent claim 54 further recites one of the electrochemical sensors is configured to detect a chemical property of body tissue or fluid. Dependent claim 55 further recites the receiver and/or the transmitter comprise one or more antennae.
Dependent claims 57 and 74 further recite the local module is a stationary device, a utility device, a handheld device, a portable device, or a therapeutic delivery system. Dependent claim 58 further recites the second transmitter transmits a radio signal to the first receiver of the wearable patch to synchronize measurements by some of the electrochemical sensors. Similar to claim 58, dependent claim 75 further recites receiving a radio signal by the receiver, from the local module, to synchronize measurements by some of the electrochemical sensors. Dependent claim 59 further recites the local module comprises a user interface device. Dependent claim 60 further recites the user interface device is a touchpad, a touchscreen, or a voice interface. Dependent claim 61 further recites the user interface device presents health information based at least in part on the health-related information. Dependent claim 62 further recites the presented health information includes decisions, notifications, alerts, medication reminders, and/or procedural explanations. Dependent claim 63 further recites the presented health information includes an indication of at least one of blood glucose level, a metabolic process, a chemical component, calcium, sodium, cholesterol, pH, a protein, a protein complex, hemoglobin, insulin, a binding protein, an antibody, red blood cells, white blood cells, bacteria, viruses, and platelets. Dependent claim 73 further recites the remote device is at least one of a local module or a network. Dependent claim 83 further recites a 2nd receiver to health related information transmitter by the 1st transmitter of the patch; and a 2nd transmitter to transmit information to the receiver of the patch, a network, or a remote device.
Dependent claim 84 further recites a sensor to monitor activity, motion, and/or orientation of a patient wearing the device. Dependent claim 85 further recites wirelessly transmitting the indication of activity, motion, and/or orientation. Dependent claim 86 further recites the sensor comprises an accelerometer. Dependent claim 87 further recites to wirelessly transmit the health-related information to the first remote device in response to one or more status updates related to a patient wearing the wearable device. Dependent claim 88 further recites the one or more status updates a physiological parameter, an image, and data from a sensor supported by the positioning structure of the wearable device.
Dependent claim 89, 90, and 91 respectively further recite the notification:
comprises information about a physiological constituent level change; is generated based on the physiological constituent level exceeding a predetermined threshold; and includes comparative information showing a current level relative to a prior level of the physiological constituent.
Magar shows a wearable patch held onto the skin with an adhesive (i.e., a positioning structure) [0110], comprising …sensors for taking physiological measurements [0108] which are positioned on a body [0111] and are incorporated (i.e., integral) with the wearable adhesive patch [0109]; see also [0027, 0035]. Magar shows the patch ("patch-ASIC") receives physiological signals from a sensor and generally includes a processor for processing those signals into sensor data (i.e., processed sensor data) [0004, 0093, 0095]. Magar discloses at [0095] "the patch-ASIC generally has memory for storing physiological data derived from the measured physiological signals. The data stored in memory can be the data as received at the sensor, or the data that has been processed." Magar shows at [0099], "components attached to the circuit board that facilitate the output of signals. The μ-Patch can have a component that is separate from the patch-ASIC chip that performs digital signal processing (DSP). In some cases, the patch-ASIC chip can perform DSP, and the component that performs DSP enhances the DSP capability of the μ-Patch. Magar at [0114] shows: "In some embodiments, the patch-ASIC has built-in sensor-signal processing for physiological signals such as ECG and EEG…", and further in the same paragraph, [0114], "One aspect of the invention is a patch that is capable of measuring ECG, EEG, EMG, SpO2 , tissue impedance, heart rate, accelerometer, blood glucose, PT-INR, respiration rate and airflow volume, UWB radar, pressure, physical movement, body fluid density, patient physical location, and audible body sounds." Magar shows the patch comprises an alert incorporated into the patch; this alert can be used to inform the user of a particular health condition or of a recommended action to take due to the measured physiological signals. The alert can be used to recommend that the patient take a medication and/or to contact medical professionals; a visual alert can be a flashing or constant light such as an LED [0118]. Magar shows the patch-ASIC chip comprises transmitters and receivers [0007, 0008]; and wirelessly transmitting of instructions from a base-ASIC chip (i.e., remote device) to the patch-ASIC chip (i.e., patch receives wireless signals from remote device) [0010, 0041, 0045]. Magar discloses at [0041] "…receiving signals from a sensor at a patch-ASIC chip that is incorporated into a physiological signal monitoring patch, the patch-ASIC chip comprising a sensor interface coupled to the sensor, a processor coupled to the sensor interface, a memory element coupled to the processor, a radio coupled to the memory element. Magar shows the patch has two main parts: sensor circuits, and a radio core for the transmission of sensor data to other devices [0181]. One aspect of the patch-ASIC chip is its ability to be controlled by the base-ASIC chip (i.e., a remote device). The patch-ASIC chip is able to receive and respond to instructions sent by the base device, such as instructions as to when to store sensor data and when to transmit sensor data [0098, 0141] (i.e., the patch transmits physiological data in response to a request received from the remote device) Additionally, Magar shows, reliability of transmission of patient data is enhanced through schemes to make the wireless link reliable; for example by forward error-correction, packet-retransmission (automatic repeat-request or ARQ) and smart-antenna techniques on the receiver side [0152]. The ARQ would come from a request from a remote device, and cause the patch to resubmit health related information. Magar at [0178] shows the medical signal processing system as shown in FIGS. 1A and 1B can include a variety of sensors-either directly integrated in the medical signal processor or µ-Base 104, or linked to the medical signal processor 104 via a wireless link as patches 102 on the body of a user. Magar at [0183-0203] also discusses a trade-off in which by leveraging the information sent by MSP 104 via signal C, patches can dynamically alter the performance of their various functional blocks to choose trade off among high reliability, high security, low power, and low cost for given applications of health monitoring [0183]. At [0184], a wireless patch comprising a μ-Patch and a patch-ASIC is discussed, and that resources of the patch 102 can be controlled by the MSP 104, by a signals received through the antenna. At [0185], the trade off is shown to be possible due to any combination of features listed in [0186-0203], all features are important, but especially noteworthy is [0201], "Means to analyze and display the sensor data". (Showing a positioning structure comprising the wearable adhesive patch/device, sensors, processing device of claims, obtaining sensor data from the plurality of electrochemical sensors, processing, by the processing device, the sensor data to determine the level of the physiological constituent of the subject; a light emitting diode providing output indicating processed sensor data, first receiver and first transmitter to respectively receive wireless signals and transmit health related information to a remote device, responsive to a request from a remote device, of claims 48, 56, and 69; and positioning structure of claims 84 and 88).
Magar shows the base device, which comprises a μ-Base that includes a base-ASIC chip (i.e., including a second receiver and second transmitter), receives sensor data from the patch [0132] (i.e., the second receiver on the local module (base device), receives health related information (sensor data) from the first transmitter of the patch). Magar also shows the base sends periodic commands to instruct the patch to transmit data [0141] (i.e., second transmitter on the local module transmits information to the patch) (showing a local module of claims 56, 57, 59 and 73; a second receiver to receive health related information transmitted from the first receiver of the wearable device, and a second transmitter to transmit information to the first receiver of the wearable device, a network, or a remote device of claim 83).
Magar at [0035] reports the sensor measures SpO2, blood glucose, and other physiological biomarkers (showing a sensor detects a chemical property of body or tissue of claim 54).
Magar shows at [0009], the patch-ASIC chip communicates through a single antenna; and at [0046], each of the μ-Base, μ-Patch, and μ-Gate comprise a printed circuit board and an antenna attached to the printed circuit board for transmitting and receiving radio signals (showing the first receiver and first transmitter having an antenna of claim 55).
Magar shows, at fig.7 and [0150], the μ-Base (i.e., the local module) as being incorporated into a host device in the form of a cellular phone or PDA (showing the local module of claims 57 and 74, and the user interface device of claims 59 and 60).
Magar shows at [0154]: The patches monitor the electrical signals from the patient and transmit the sensor data to a μ-Base that is in a device that is kept on the patient, for example attached to a belt or kept in a pocket and is which is responsible for keeping a log of the heart's electrical activity throughout the recording period. In some embodiments, the μ-Base keeps track of the time intervals and instructs the μ-Patch when to measure signals and store data (i.e., synchronizing measurements). Examples of periodic monitoring by the system of the present invention are blood-pressure or blood-glucose-monitoring. The time period between monitoring intervals for periodic monitoring can be from seconds to days. Generally, the time period between monitoring intervals for periodic monitoring is on the order of minutes to hours (showing the transmitting of a signal by the second transmitter to the first receiver to synchronize measurements of some of the sensors, of claims 58 and 75).
Magar shows process(ing) the sensor data to determine the level of the physiological constituent of the subject" (at Spec. [0114]): "In some embodiments, the patch-ASIC has built-in sensor-signal processing for physiological signals such as ECG and EEG ... ", and further in the same paragraph, [0114], an embodiment in which "sensor signal processing is provided by components within the patch, but not included on the ASIC" (the patch being the part of the patch-ASIC which comprises a sensor), and further at [0114], "One aspect of the invention is a patch that is capable of measuring ECG, EEG, EMG, SpO2, tissue impedance, heart rate, accelerometer, blood glucose, PT-INR, respiration rate and airflow volume, UWB radar, pressure, physical movement, body fluid density, patient physical location, and audible body sounds." At [0118], Magar shows the patch comprises an alert incorporated into the patch; this alert can be used to inform the user of a particular health condition or of a recommended action to take due to the measured physiological signals (i.e., the level of the physiological constituent). The alert can be used to recommend that the patient take a medication and/or to contact medical professionals; a visual alert can be a flashing or constant light such as an LED. The alert can be, for example, audio, visual, or vibration based. In some cases, the alert is at the base or gate device (i.e., local device with display). The audio alert can be, for example, a small speaker that either beeps or chimes to alert the user, or may have more complex audio output including using language to communicate with the user. A visual alert can be, for example, a flashing or constant light such as an LED, or can comprise a display that displays signals to the user, such as a liquid crystal display capable of displaying alpha-numeric characters. (Showing the user interface device presenting health information of claims 61, 62, and 63; and as the alert can be used to inform the user of a particular health condition or can be used to recommended action to take due to measured physiological signals" includes embodiments of an alert (i.e., a notification) about a change in in level (of physiological constituent), including a level exceeding a threshold, or comparing the current and prior levels, and as such, this is considered to show the limitations of claim 89, 90, and 91).
Magar discloses at [0118] an alert which can be incorporated into the patch…the alert can also be used to inform the user of a particular health condition or of a recommended action to take due to the measured physiological signals. For example, the alert (i.e., a notification) can be used to recommend that the patient take a medication and/or to contact medical professionals. The alert can be, for example, audio, visual, or vibration based. In some cases, the alert is at the base or gate device. The audio alert can be, for example, a small speaker that either beeps or chimes to alert the user, or may have more complex audio output including using language to communicate with the user. A visual alert can be, for example, a flashing or constant light such as an LED, or can comprise a display that displays signals to the user, such as a liquid crystal display capable of displaying alpha-numeric characters. It is noted that "recommended action to take due to measured physiological signals includes embodiments of an alert (i.e., a notification) about a change in in level (of physiological constituent), or exceeding a threshold, and may compare the current level to a prior level of physiological constituent of claim 89-91.
Magar at [0177] shows the mobile device could be a cellular telephone, laptop, notebook, a smart phone, a PDA, a custom medical device or any stationary, portable, or mobile device which can communicate with the server over a network (showing the remote device being a local module or a network of claim 73).
Magar discloses at [0100], "The base-ASIC chip of the present invention has the functionality for receiving data from the patch or the gate device, transmitting the data to a host device, and for controlling the functionality of the patch and/or the gate devices over the air. The base-ASIC generally has at least a processor for processing sensor data, memory for storing data relating to the signals, a radio for transmitting instructions to the patch-ASIC chip and to receive sensor data from it, power management circuits for controlling power on the chip, and a host interface allowing the base-ASIC chip to communicate with a host device." (Showing transmitting of physiological constituent levels between devices of claim 48, 56, and 69.)
Magar at [0271] shows patches may include a Holter mechanism and a loop ECG monitor 506 as well as accelerometers for detecting physical activity, and at [0303], shows the business method involves manufacturing both a patch-ASIC chip and a base-ASIC chip that are designed to work together to wirelessly communicate physiological data. Magar at [0098], and [0141], shows the patch-ASIC chip is able to receive and respond to instructions sent by the base device, such as instructions as to when to store sensor data and when to transmit sensor data (i.e., the patch transmits physiological data in response to a request received from the remote device). Magar discloses at [0172] a distributed sensor based mobile/remote monitoring system for the management of various types of diseases. Magar discloses at [0208] means to process and aggregate the sensor data based on an algorithm that can be programmed in MSP 104 to determine a diseases state and/or health state and/or fitness state; at [0209]means to…connect to a mobile device; at [0210], means to generate an alert based on the determination of the state of disease, health or fitness; at [0212], means for transmission of collected raw sensor data or processed data to a remote server either directly or via a mobile device, at [0216], in addition to collecting and processing the data from all of its peripheral patches/sensors, the MSP 104 also has various means to wirelessly monitor and control all of its peripheral patches/sensors through a wireless uplink with them. (Showing monitoring of activity (i.e., a physiological constituent), wirelessly transmitting activity, accelerometer, transmitting health information in response to status updates (i.e., physiological constituent), status updates (i.e., physiological constituent) of claims 83-88.) Note: the limitation "physiological constituent" of claim 48 is being interpreted to include (measurements of) monitoring, and physiological parameters of monitoring, of physical activity of claims 84-88.
Magar at [0180] shows glucose, cholesterol or blood coagulation monitoring. A drop of blood can be placed on a biochemical sensor that is built into the MSP 104 which can be converted to electrical signal by MSP for further processing. The glucose, cholesterol or blood coagulation rate reading will be registered in the sensor database on MSP 104 and/or mobile device 108 and/ or the secure server 108 (Showing wirelessly transmitting the physiological constituent level to a first remote device of claims 48, 56, and 69.)
While Magar does show a plurality of electrical, optical, electromechanical and biochemical sensors (fig.2; [0056]) , Magar does not explicitly state the term "electrochemical" as in the emphasized portion of this limitation: "a plurality of electrochemical sensors", of claims 48, 56 and 69.
Tierney 2001 shows the GlucoWatch biographer, a wrist-watch device which includes a microprocessor to convert the sensor signal into glucose readings (p.622, col.1). Tierney 2001 shows the GlucoWatch biographer displaying the glucose level, attached to a wrist, with an outer housing (p.622, fig.1). (Showing the positioning structure as a wearable device, which also shows (with Magar) processing signals to determine the level of the physiological constituent from the sensor data of claims 48, 56, and 69.)
Stafford shows a wearable patch and method for monitoring body analytes, the patch comprising a plurality of transcutaneous analyte sensors (fig. 1, sensor sites 34) and [0002, 0023]. The sensors are electrochemical sensors (see documents incorporated by reference in paragraph 24) configured to measure a level of lactate, acetyl choline, amylase, bilirubin, cholesterol, chorionic gonadotropin, creatine kinase, creatine, DNA, fructosamine, glucose, glutamine, growth hormones, hematocrit, hemoglobin, hormones, ketones, lactate, oxygen, peroxide, prostate-specific antigen, prothrombin, RNA, thyroid stimulating hormone, and troponin, in samples of body fluid [Abstract, 0001, 0011, 0023, and 0024]; (Figure 1) (showing the patch including electrochemical sensors of claims 48, 56, and 69).
Regarding one of the electrochemical sensors measuring blood glucose or being a glucose sensor of claims 49, 53, 70, and 72, these limitations are shown by Magar [0035, 0039] with Stafford [0006 and 0011].
With respect to there being two or more types of sensors of claim 50, Magar [Magar 0109, 0178, and fig.2], with Stafford et al, shows that the plurality of electrochemical sensor comprises two or more types of sensors (Stafford [0007, 0011]).
Regarding positioning of the sensors through the skin surface of the subject of claim 71, Magar at [0261] shows patches probe the body through micro-needle based skin punctures, while Stafford at [0023] shows their flexible patch may be provided with one or more sensor sites for receiving transcutaneous analyte sensors.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the wearable adhesive patch device system including sensors, transmitters, and receivers, and processing of sensor signal to measure physiological constituents of Magar, with the electrochemical sensors as taught by Stafford, and with the positioning structure comprising wearable device microprocessor used in processing sensor data to determine a physiological constituent of Tierney 2001, to come to a wearable, adhesive patch device with electrochemical sensors in a system for sensor data gathering, processing, determining of physiological constituents, and receiving & transmission of data and signals, as Magar shows their invention supports a variety of sensors for various physiologic parameters (Magar at [0074]), and at discusses [0183-0203] embodiments in which patches can dynamically alter the performance of their various functional blocks to choose trade off among high reliability, high security, low power, and low cost for given applications of health monitoring, in analyzing and displaying sensor data (i.e., processing data), [while Stafford shows that patches for monitoring analytes can be modified to include a plurality of electrochemical sensors (Stafford at [0023] and Figure 1), and Tierney 2001 shows their device provides frequent, non-invasive measurements of glucose with high accuracy and precision (p.628, col.2). Additionally, Stafford discloses the further advantages that the components that may be integrated with the flexible patch include temperature and other sensors, etc. (Stafford at [0007]); and the multiple sensors which can be used simultaneously to acquire redundant analyte readings(Stafford at [0023]). One would have a reasonable expectation of success as Magar, Stafford, and Tierney 2001 are generally drawn to related teaching of wearable physiological sensor devices and systems, and as such, the modification would have been obvious.
Response to Arguments – Claim Rejections under 35 USC § 103
The Applicant's arguments filed 19 May 2025 have been fully and respectfully considered but they are not persuasive.
The Applicant asserts:
• On p.9, that Magar, Tierney 2001, and Stafford, either alone or in combination, fail to teach or suggest a processing device configured to receive sensor data and process the sensor data to determine the level of the physiological constituent of the subject (of claim 48, 56, and 69).
• On p.9-10, that the patch-ASIC of Magar only processes raw sensor signal into data for further processing, that the base-ASIC of Magar carries out more processing, and that Office Action's interpretation ignores the entirety of Magar's disclosure regarding its distributed processing architecture and is counter to its teachings.
The arguments are not yet persuasive because there are embodiments of Magar in which the patch-ASIC (which contains the sensor), performs processing of the sensor data; and in which the sensors are integrated into the base-ASIC. {It should be noted that Magar does not distinguish what constitutes the processing of data by the patch-ASIC or by the base-ASIC, such that the physiological level of a constituent may be processed at the patch-ASIC (as well as at a base-ASIC which has integrated sensors).} These embodiments are disclosed as follows:
• Magar discloses at [0041] "…(a) receiving signals from a sensor at a patch-ASIC chip that is incorporated into a physiological signal monitoring patch, the patch-ASIC chip comprising a sensor interface coupled to the sensor, a processor coupled to the sensor interface, a memory element coupled to the processor, a radio coupled to the memory element;
• Magar discloses at [0095] "the patch-ASIC generally has memory for storing physiological data derived from the measured physiological signals. The data stored in memory can be the data as received at the sensor, or the data that has been processed."
• Magar discloses at [0114] an embodiment in which "sensor signal processing is provided by components within the patch, but not included on the ASIC" (the patch being the part of the patch-ASIC which comprises a sensor), and further at [0114] discloses "One aspect of the invention is a patch that is capable of measuring ECG, EEG, EMG, SpO2 tissue impedance, heart rate, accelerometer, blood glucose, PT-INR, respiration rate and airflow volume, UWB radar, pressure, physical movement, body fluid density, patient physical location, and audible body sounds."
• Magar discloses at [0178] the medical signal processing system as shown in FIGS. 1A and 1B can include a variety of sensors-either directly integrated in the medical signal processor or µ-Base 104, or linked to the medical signal processor 104 via a wireless link as patches 102 on the body of a user.
As such, Magar teaches a processing device configured to receive sensor data and process the sensor data to determine the level of the physiological constituent of the subject of claims 48, 56, and 69.
The Applicant further asserts:
• (on p.11) that Magar, Tierney 2001, and Stafford, alone or in combination, fail to teach or suggest at least: (1) a transmitter configured to wirelessly transmit health-related information including the level of the physiological constituent responsive to a request from the first remote device that is initiated in response to a notification about the physiological constituent provided via the first remote device, as in claim 48, (2) a local module configured to provide a notification about the physiological constituent and provide the request, wherein the request is initiated in response to the notification, as in claim 56, or (3) transmitting, to the remote device from the transmitter and in response to receiving the wireless radio signal, health-related information comprising the level of the physiological constituent, wherein the wireless radio signal is initiated in response to the first remote device providing a notification about the physiological constituent, as in claim 69.
• (on p.11-12) that Magar fails to teach or suggest that these instructions are generated responsive to a request from a remote device in response to a notification about the physiological constituent that is provided via the base device
• (on p.12) that while Magar does discuss alerts in para. [0118], these alerts 1) are limited to notifications provided directly on the patch-ASIC chip; and 2) are not alerts in response to a request that itself was transmitted from the base-ASIC chip in response to a separate notification; and that the communication sequence of the claimed invention is fundamentally different from Magar' s unilateral, periodic commanding of the patch to transmit data.
The further arguments are not persuasive because:
• Magar discloses at [0118] an alert which can be incorporated into the patch…the alert can also be used to inform the user of a particular health condition or of a recommended action to take due to the measured physiological signals. For example, the alert (i.e., a notification) can be used to recommend that the patient take a medication and/or to contact medical professionals. The alert can be, for example, audio, visual, or vibration based. In some cases, the alert is at the base or gate device. The audio alert can be, for example, a small speaker that either beeps or chimes to alert the user, or may have more complex audio output including using language to communicate with the user. A visual alert can be, for example, a flashing or constant light such as an LED, or can comprise a display that displays signals to the user, such as a liquid crystal display capable of displaying alpha-numeric characters. It is noted that "recommended action to take due to measured physiological signals includes embodiments of an alert (i.e., a notification) about a change in in level (of physiological constituent), or exceeding a threshold, and may compare the current level to a prior level of physiological constituent of claim 89-91.
• Magar discloses at [0041] "…a host interface through which the base-ASIC chip communicates with a host device; and (e) sending instructions wirelessly from the base-ASIC chip to the patch-ASIC chip such that the base-ASIC chip coordinates a function of the physiological signal monitoring patch." It would be obvious that these instructions from a host device (i.e., the host device being a stationary, portable or mobile device or a stationary, portable, or mobile medical instrument.
• Magar discloses at [0098] one aspect of the patch-ASIC chip is its ability to be
controlled by the base-ASIC chip. The patch-ASIC chip is able to receive and respond to instructions sent by the base device, such as instructions as to when to store data and when
to transmit.
• Magar discloses at [0100], "The base-ASIC chip of the present invention has the functionality for receiving data from the patch or the gate device, transmitting the data to a host device, and for controlling the functionality of the patch and/or the gate devices over the air. The base-ASIC generally has at least a processor for processing sensor data, memory for storing data relating to the signals, a radio for transmitting instructions to the patch-ASIC chip and to receive sensor data from it, power management circuits for controlling power on the chip, and a host interface allowing the base-ASIC chip to communicate with a host device."
• Magar [0154] discloses the systems of the invention include continuous, periodic, or episodic measurement of a physiological condition; and that the systems of the invention can perform episodic monitoring, in which a particular event is detected, either manually or automatically.
• Magar discloses at [0172] a distributed sensor based mobile/remote monitoring
system for the management of various types of diseases.
• Magar discloses at [0208] means to process and aggregate the sensor data based on an algorithm that can be programmed in MSP 104 to determine a diseases state and/or health state and/or fitness state. [0209] Means to …connect to a mobile device. [0210] Means to generate an alert based on the determination of the state of disease, health or fitness. [0212] Means for transmission of collected raw sensor data or processed data to a remote server either directly or via a mobile device. [0216] In addition to collecting and processing the data
from all of its peripheral patches/sensors, the MSP 104 also has various means to wirelessly monitor and control all of its peripheral patches/sensors through a wireless uplink with them.
As such, Magar teaches transmitting, from the transmitter and in response to receiving a wireless radio signal, health-related information comprising the level of the physiological constituent to the remote device, wherein the wireless radio signal is initiated in response to the first remote device providing a notification about the physiological constituent. as in claims 48, 56, and 69.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the "right to exclude" granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 48, 49, 56, 87 and 88 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 48, 49, 56-58, 60, and 61 of copending Application 18/243,623 in view of Otto (Journal of mobile multimedia, (2006), pages 307-326), Magar (U.S. Patent Pub 2009/0054737; as cited on the 07/19/2021 PTO-892) in view of Tierney 2001 (Biosensors and Bioelectronics, vol. 16:9-12, pages 621-629, 2001; as cited on the attached Form PTO-892; as also cited on the 06/17/2024 IDS) and Stafford (U.S. Patent Pub 2008/0119707; as cited on the 09/26/2022 IDS).
Instant Application
Copending Application 18/243,623
Pending
Claims
Limitation
Copending
Claims
Limitation
Pending 48
A wearable device comprising:
a positioning structure;
Copending 48
A device for presenting health-related information, a positioning structure;
an adhesive backing attached to the positioning structure and configured to secure the positioning structure to a subject;
an adhesive backing attached to the positioning structure and configured to secure the positioning structure to a skin
surface of a subject;
a plurality of electrochemical sensors configured to measure a level of a physiological
constituent of the subject, wherein the adhesive is configured to position the plurality of electrochemical sensors on a body of the subject;
Copending 56
(Plurality of sensors taught by Otto)
an electrochemical
sensor configured to measure the blood glucose level.
a processing device supported by the positioning structure and configured to receive sensor
data from the plurality of electrochemical sensors and process the sensor data to determine the
level of the physiological constituent of the subject;
Copending 48
(Processing device taught by Otto)
Copending 48
a display supported by the positioning structure and configured to present
information based on data received wirelessly from the remote device, wherein the data
comprises the level of the physiological constituent.
the remote device comprises a sensor configured to
measure a level of a physiological constituent in the subject.
at least one light-emitting diode supported by the positioning structure and configured to
provide an output indicating the level of the physiological constituent;
Copending 48
a display supported by positioning structure and configured to present information based on data received wirelessly from the remote device, wherein the data
comprises the level of the physiological constituent.
Copending 49
the display comprises a light-emitting diode.
a receiver supported by the positioning structure and configured to receive wireless signals from one or more remote devices; and
Copending 48
a transceiver supported by the positioning structure and configured to wirelessly communicate with a
remote device comprising a sensor configured to measure a level of a physiological constituent in the subject;
(again: a display supported by the positioning structure and configured to present information based on data received wirelessly from the remote device. wherein the data
comprises the level of the physiological constituent.)
a transmitter supported by the positioning structure and configured to wirelessly transmit to a first remote device of the one or more remote devices, responsive to a request from the first remote device, health-related information including the level of the physiological constituent.
Pending 49
one of the plurality
of electrochemical sensors is configured to measure blood glucose.
Copending 56
the remote device comprises an electrochemical
sensor configured to measure the blood glucose level.
Pending 87
The wearable device of claim 48, wherein the transmitter is further configured to
wirelessly transmit the health-related information to the first remote device in response to one or more status updates related to a patient wearing the wearable device
Copending 57
the data received comprises a status update from the
electrochemical sensor and the device is configured to present, in response to receipt of the
status update, information representative of the status update via the display
Pending 88
wherein the one or more status updates include one
or more of a physiological parameter, an image, and data from a sensor supported by the positioning structure of the wearable device.
Pending 56
A system comprising:
A wearable adhesive patch comprising:
a plurality of electrochemical sensors configured to measure a level of a physiological constituent of a subject, wherein the wearable adhesive patch is configured
to position the plurality of electrochemical sensors on a body of the subject;
Copending claim 58
(Plurality of sensors taught by Otto)
A system for presenting health-related information, the system
comprising:
-a first device configured to be worn on a subject comprising:
-a positioning structure;
-an adhesive backing attached to the positioning structure and configured to secure
the positioning structure to a skin surface of a subject;
-a sensor configured to monitor a level of a physiological component in the
subject; and
-the first device further comprises a first adhesive patch to secure the first device to a skin surface of the subject.
a processing device configured to receive sensor data from the plurality of electrochemical sensors and process the sensor data to determine the level of the physiological constituent of the subject;
Copending claim 58
(Processing device taught by Otto)
Copending claim 58
Copending claim 60
A system for presenting health-related information, the system
comprising:
--a first device configured to be worn on a subject, comprising
a positioning structure;
-an adhesive backing attached to the positioning structure and configured to secure
the positioning structure to a skin surface of a subject;
a sensor supported by the positioning structure and configured to monitor a level of a physiological component in the
subject; and
-the first device further comprises a first adhesive patch to secure the first device to a skin surface of the subject.
-a display configured to present information representative of the level of the physiological component.
-display of the second device comprises a light emitting diode.
at least one light-emitting diode configured to provide an output indicating the level of the physiological constituent;
a first receiver configured to receive wireless signals; and
Copending claim 58
a receiver supported by the positioning structure and configured to receive the wirelessly transmitted data from the first device;
a first transmitter configured to transmit, responsive to a request received by the
first receiver, health-related information including the level of the physiological
constituent; and
Copending claim 58
a transmitter configured to wirelessly transmit data comprising the level of the
physiological component;
a local module configured to provide a notification about the physiological constituent
and provide the request, wherein the request is initiated in response to the notification.
Copending claim 58
a second device configured to be worn on the subject, (the second device comprising a receiver and a display)
The copending application does not teach the pending claims 48 and 56 limitations of a plurality of types of sensors or a processing device.
Regarding the plurality of sensors and the processor of claim 48, Otto presents an overview of wireless body area networks (WBANs), and discusses a WBAN consists of multiple sensor nodes, each capable of sampling, processing, and communicating; typically, these sensors are placed strategically on the human body as tiny patches (p.308, para. 4-5; and throughout entire document). Otto discusses processors used in sensor technology (p.317, under Power Management).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the limitations of copending claims 48-51 and 56 of copending Application No. 18/243,623 for a device presenting health information, with positioning structure, adhesive patch, transceiver, and LED display, with the teachings of Otto, for using a processor and multiple sensors, because Otto provides motivation by teaching multiple sensors allow ubiquitous health monitoring for extended periods (p.308), and long-life, persistent sensor nodes require efficient power management, so that low power consumption was held as a major design goal (p.317). One would have had a reasonable expectation of success in combining, as both Otto and the Copending Application No. 18/243,623 are drawn to related teachings of wearable sensor(s) and devices for wireless communication of health-related information including the level of the physiological constituent(s), and as such, the combination would have been obvious.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is allowed. This Office action is a Non-Final action. A shortened statutory period for reply to this action is set to expire THREE MONTHS from the mailing date of this action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Meredith A Vassell whose telephone number is (571)272-1771. The examiner can normally be reached 8:30 - 4:30. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, KARLHEINZ SKOWRONEK can be reached at (571)272-9047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/M.A.V./Examiner
Art Unit 1687
/G. STEVEN VANNI/Primary patents examiner
Art Unit 1686