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 .
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.
Status of Claims
In the amendment filed on March 16th, 2026, claim 1 has been amended, no claim has been cancelled and new claims 17 and 18 have been added. Therefore, claims 1-18 are pending for examination.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The applicant amended the independent claim 1, to read as, “A system, comprising: a glucose sensor; a beacon transmitter; and a processing circuit connected to the glucose sensor and the beacon transmitter, the processing circuit being configured to transmit a data packet, the data packet comprising measurement data comprising a measurement value, the measurement value being based on a glucose measurement, wherein the system does not include a receiving data path into the system.”
The applicant suggests support for the added limitation is supported by the specification, in paragraphs 25, 37, and 41.
The sensor circuit 110 may include a probe 120 that is inserted below the skin of a user (e.g., a subject or a patient) for the purpose of sensing a glucose level (e.g., an interstitial glucose level) of the user. The probe 120 may generate a current that is affected by, and that is an indication of, a glucose level of the user. The current may be measured by the sensor circuit 110 and converted to a digital representation, which may be transmitted by the beacon transmitter 115, as part of a data packet. The continuous glucose monitoring circuit 105 may include a controller 125, which may be a processing circuit (discussed in further detail below), and which may control the operations of the continuous glucose monitoring circuit 105. The controller may be a component, of the continuous glucose monitoring circuit 105, which is connected to the sensor circuit 110 and to the beacon transmitter 115, or it may be integrated into one or both of the sensor circuit 110 and the beacon transmitter 115 (e.g., each of the sensor circuit 110 and the beacon transmitter 115[P-25]
4. Sample quality information (or a "measurement quality indicator"). This may be a bitfield that represents confidence in the sample. Examples of quality information may include: whether voltages or currents that were outside of corresponding specified acceptable ranges were detected during a measurement, whether excessively rapid signal changes were detected during a measurement, whether the signal variance within a measurement window exceeded a specified maximum acceptable value, and whether the sensor is present in an incorrect tissue space.[P-37]
8. Device Status. Examples of device status indications include transmitter over- temperature, sensor activation failed, sensor warmup in progress, and sensor warmup complete.[P-41]
None of the cited areas within the specifications, recites specifically “measurement, wherein the system does not include a receiving data path into the system” Outside of the communication components such as the beacon transmitter, there is no mention of the exclusion of a receiving data path into the system anywhere in the specifications. Thereby the claimed limitation above, is inconclusive.
MPEP 2173.05(i)…. The mere absence of a positive recitation is not basis for an exclusion. However, a lack of literal basis in the specification for a negative limitation may not be sufficient to establish a prima facie case for lack of descriptive support. Ex parte Parks, 30 USPQ2d 1234, 1236 (Bd. Pat. App. & Inter. 1993). "Rather, as with positive limitations, the disclosure must only 'reasonably convey[] to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.' ... While silence will not generally suffice to support a negative claim limitation, there may be circumstances in which it can be established that a skilled artisan would understand a negative limitation to necessarily be present in a disclosure." Novartis Pharms. Corp. v. Accord Healthcare, Inc., 38 F.4th 1013, 2022 USPQ2d 569 (Fed. Cir. 2022) (quoting Ariad Pharm. Inc. v. Eli Lilly & Co., 589 F.3d 1336, 1351, 94 USPQ2d 1161, 1172). Any claim containing a negative limitation which does not have basis in the original disclosure should be rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement. See MPEP § 2163 - § 2163.07(b) for a discussion of the written description requirement of 35 U.S.C. 112(a) and pre-AIA 35 U.S.C. 112, first paragraph.
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.
Claim(s) 1, 6, 15 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wiser (US 20170318529 A1) in view of Rusu et al. (WO 2015107042 A1).
In regards to claim 1, Wiser teaches a system, comprising a glucose sensor; a beacon transmitter; and a processing circuit connected to the glucose sensor and the beacon transmitter (Paragraphs 28, 110, 112)
As illustrated in FIG. 2, the BLE device 200 may include a BLE packetizer 202, an oscillator 204, a powertrain 210, and an amplifier 206. These components, as described herein, may be used to transmit a signal 104 from the BLE device 200. However, the BLE device 200 may not be enabled to receive a signal from another device. Thus, in some embodiments, the BLE device 200 may not be able to pair with or receive signals from other Bluetooth devices. Accordingly, the BLE device 200 may operate solely as a transmitter (also referred to herein as a “broadcaster” or as a “beacon”). For instance, in scenario 100, the BLE device may transmit a signal that may be received by the computing devices 106 and 108, without pairing with the computing devices.[P-28]
In some embodiments, Bluetooth device 800 may enter advertisement mode to transmit an advertising packet over the air for one or more applications. In some examples, the application of the Bluetooth device 800 may be predetermined. For instance, the Bluetooth device 800 may be a location beacon. In an example, the Bluetooth beacon 800 may be located inside of a building (e.g., an office building, store, etc.). Further, a computing device 900 may be located in proximity to the Bluetooth beacon 800. When the Bluetooth beacon 800 transmits advertising packets, it may transmit the advertising packet with location data. Depending on the specific embodiment, the location data can take many different forms. For example, the Bluetooth beacon 800 may be configured to provide data related to a location of the respective Bluetooth beacon either via relative position information or geographic coordinate system data. In another example, the Bluetooth beacon 800 may provide the computing device 900 with global location data.[P-110]
In another example, the Bluetooth device 800 may include a sensor 822. As illustrated, the sensor 822 may exchange data with the application manager 802 through the application interface 824. For instance, the Bluetooth device 800 may broadcast advertising packets, which may include data collected by the sensor 822, which the application manager 802 may receive through the application interface 824. For instance, the Bluetooth device 800 may be a body-mountable device configured to be mounted to a skin surface (e.g., to skin of the upper arm or abdomen of a person), with one or more sensors for quantitatively and qualitatively testing an analyte concentration in interstitial fluid (e.g., glucose in interstitial fluid) in situ and in real-time. Those of skill in the art will recognize that the sensing platform described herein may be provided in devices that could be mounted on a variety of portions of the human body to measure concentrations of an analyte in other fluids than interstitial fluid (e.g., to measure an analyte in a tear fluid, blood, saliva, or some other fluid or tissue of the body). Accordingly, the Bluetooth device 800 may be used for monitoring or detecting a user's health state. Further, the Bluetooth device 800 may broadcast, using the BLE device 200, sensor readings to a user's computing device 900.[P-112]
Furthermore, Wiser teaches the processing circuit being configured to transmit a data packet, the data packet comprising measurement data comprising a measurement value, the measurement value being based on a glucose measurement (Paragraph 112)
In another example, the Bluetooth device 800 may include a sensor 822. As illustrated, the sensor 822 may exchange data with the application manager 802 through the application interface 824. For instance, the Bluetooth device 800 may broadcast advertising packets, which may include data collected by the sensor 822, which the application manager 802 may receive through the application interface 824. For instance, the Bluetooth device 800 may be a body-mountable device configured to be mounted to a skin surface (e.g., to skin of the upper arm or abdomen of a person), with one or more sensors for quantitatively and qualitatively testing an analyte concentration in interstitial fluid (e.g., glucose in interstitial fluid) in situ and in real-time. Those of skill in the art will recognize that the sensing platform described herein may be provided in devices that could be mounted on a variety of portions of the human body to measure concentrations of an analyte in other fluids than interstitial fluid (e.g., to measure an analyte in a tear fluid, blood, saliva, or some other fluid or tissue of the body). Accordingly, the Bluetooth device 800 may be used for monitoring or detecting a user's health state. Further, the Bluetooth device 800 may broadcast, using the BLE device 200, sensor readings to a user's computing device 900.[P-112]
Here, a BLE transmitter beacon that is a part of a glucose measuring device, to which measuring data packets representative of glucose level. Though “measurement values” are not mentioned verbatim in Wiser’s disclosure, the examiner takes official notice that using glucose sensors to measure quantitative and qualitative glucose levels is well known in the art, especially regards to measured glucose values. Therefore, it would have been obvious to one of ordinary skill in the art during the filing date of the said invention that the qualitative and quantitative measured data of the glucose in the provide value data pertaining to the concentration of glucose measured in order to more effectively track and analyze the measured substance pertaining to the individual.
Wiser fails to teach the system does not include a receiving data path into the system.
Rusu on the other hand teaches the system does not include a receiving data path into the system (Paragraphs 6, 7, 79, 80)
Present glucose sensors, which are typically used with some type of insulin-delivery system in order to treat diabetics, provide data needed to maintain the concentration of glucose within the patient at an acceptable level. Such glucose sensors must perform properly; otherwise, false data may be provided. Such false data (if acted upon) could result in the administration of an inappropriate amount of insulin, leading to death or serious injury. There is thus a critical need in the art for a sensor which is reliable and which can be monitored for proper function on a regular basis. Likewise, there is a need for a glucose sensor which must work properly within certain specific limits of accuracy. [P-7]
Many implantable sensors require a power source, such as a battery, to power the sensor and transmitter and are therefore useful for only a limited period of time after implantation. After the on-board power source is depleted, an invasive operation, in addition to the initial implantation, will have to be made, if the device is to be removed or replaced [P-8]
A sensor 10 for measuring electrical bio-impedance of a subject 12 is implanted into the subject, for example sub-dermally or sub-cutaneously. The implantable sensor 10 according to the present invention will be described in detail below with reference to Fig. 6. The sensor 10 is powered by an external reader module14 by using inductive coupling, for example, at frequencies around 10 - 15 MHz. The reader module 14 is capable of communicating with a microcontroller 61 of the sensor 10 (see e.g. fig. 6). For example, the reader module 14 may be arranged to perform half-duplex back-scattering serial communication with the sensor 10, which also is known as impedance modulation or load modulation. This technique works by reflecting electromagnetic waves back to the source. The short distance relative to the wavelength means that the reflected wave is received almost instantly. Therefore instead of receiving a pulse back the mutual inductance behaves as a feedback loop and changes the apparent impedance of the inductor. The change in inductance will then change the current that passes through the coil. The changed current will then change the amplitude of the voltage over the coil, and the data can be treated as an amplitude modulated signal. In principle any method that changes the impedance in the secondary resonator can be used to transmit data. For example, amplitude modulation for the downlink (from the reader 14 to the implantable device or sensor 10) by changing the voltage that is available in the sensor 10. The uplink (from the implantable device 10 to the reader 14) uses load shift keying, where the quality factor of the load is changed according to the data being sent. The load is sensed by using a transformer (not shown), which senses the current that passes through the coil used to transmit power. An envelope detector (not shown) followed by a band pass filter (not shown) and comparator (not shown) is used to recover the data.[P-79]
In embodiments of the present invention, the reader module14 and the sensor 10 includes LRC resonant circuits configured for frequencies in a range between 10 - 15 MHz for power transmission and signal reception (at the reader 14). The reader module 14 is configured to communicate with a computing device 15, for example, using wireless communication including infrared, BLUETOOTH® wireless technology, 802.11 a7b/g/n, cellular or other radio frequency communication systems.[P-80]
Here we see Rusu’s glucose monitoring system in communication with a reader, where the only receiving components of the glucose monitoring system are the reception of power from the reader, and no data channels/paths for reception. The only data communication is the transmission of glucose read data to an external device/reader.
Thereby, it would have been obvious during the filing date of the said invention to combine Rusu’s teaching with Wiser’s teaching, in order to enable a more effective and secure method to wirelessly track the operation of a medical sensory system.
In regards to claim 6, Wiser teaches the measurement data is encrypted (Paragraphs 30,90)
Returning to FIG. 2, the BLE packetizer 202 may receive a signal via the HCl. As explained elsewhere herein, the signal may originate from a processor of a device, which may be using the BLE device 200 as a Bluetooth module. Further, the signal that the BLE packetizer 202 may receive may include data, which may be included in the signal transmitted by the BLE device 200. The received signal may also include instructions indicative of the configuration of the BLE device 200, as the BLE device 200 transmits a signal. For example, the signal received may include parameters, such as encryption parameters, modulation parameters, a mode of operation of the BLE device 200, packet type, etc. Further, the parameters may be used to configure the BLE device 200 to generate a specific signal, which may be transmitted by the BLE device 200.[P-30]
At block 702, the method 700 includes generating, based on data, a data signal comprising one or more data packets. The data may include information such as encryption parameters, modulation parameters, mode of operation of the device, packet type, etc. The data may further include certain data that may be included in the data packet. Further, the data packet may be a non-connectable, non-scannable advertising packet. [P-90]
In regards to claim 15, Given the cited passage in the applicant’s specifications i.e.
Referring to FIG. 1, in some embodiments, a continuous glucose monitoring (CGM) circuit 105 includes a sensor circuit 110 and a beacon transmitter 115. The beacon transmitter 115 may be a Bluetooth Low Energy transmitter (e.g., a transmitter configured to transmit data packets that comply with standard 802.15.1 promulgated by the Institute of Electrical and Electronics Engineers), or it may be a different wireless beacon transmitter. Such a data packet may include measurement data, which may include, e.g., (i) a measurement value (e.g., a glucose measurement), (ii) a trend measurement, and other data (discussed in further detail below), such as a sample identifier. As used herein, a "beacon transmitter" is a one-directional transmitter that does not rely on a receiver (e.g., for handshaking or for establishing a connection with another device). In some embodiments, the continuous glucose monitoring circuit 105 lacks a radio receiver, and, in some embodiments, it lacks a receiving data path generally, e.g., there is no data path into the continuous glucose monitoring circuit 105 once manufacturing of the continuous glucose monitoring circuit 105 is complete (e.g., there is no mechanism for data to be received by the continuous glucose monitoring circuit 105). Such an absence of a radio receiver may reduce power consumption, and the absence of a receiving data path may improve the security of the continuous glucose monitoring circuit 105, e.g., it may be an obstacle to malicious actors who may wish to program the continuous glucose monitoring circuit 105 with malicious code [Specifications, Paragraph 25]
By this citation the radio receiver the applicant refers to is an unconventional radio receiver, because the applicant emphasizes an absence of a radio receiver may reduce power consumption, a characteristic that is attributed to a BLE transmitter and receiver. Furthermore, in the passage, the applicant mentions the beacon transmitter being a Bluetooth Low Energy transmitter. From this rationale, the examiner interprets the radio transmitter cited in the claims as either a conventional radio transmitter.
The applicant also states, in some embodiments, the continuous glucose monitoring circuit 105 lacks a radio receiver, such an absence of a radio receiver, and the absence of a receiving data path may improve the security of the continuous glucose monitoring circuit 105, which may also indicate the communication means is no longer a BLE protocol or wireless protocol, and in turn would be a direct communication protocol (wired).
Thereby, Wiser indeed teaches both instances of interpretation of the system not comprising a radio receiver, where Wiser teaches BLE as the means of communication requires an unconventional receiver. (low energy consuming receiver), as well as other communication protocols such as wireline communication (i.e. Ethernet connection) which in turn does not require a radio receiver (Paragraphs 106)
Network interface 906 may take the form of a wireless connection, such as Bluetooth. In particular, network interface 906 may enable one or more Bluetooth standards or protocols, including BLE protocols and related advertising protocols. For example, referring back to FIG. 1, computing device 106 may also include network interface 906 to pair with computing device 108. In addition, network interface 906 may take the form of other wireless connections, such as IEEE 802.11 (Wi-Fi), or a wide-area wireless connection. However, other forms of physical layer connections and other types of standard or proprietary communication protocols may be used over network interface 906. Furthermore, network interface 906 may comprise multiple physical interfaces. Further, network interface 906 may take the form of a wireline connection, such as an Ethernet connection.[P-106]
In regards to claim 16, Wiser teaches the measurement data is encrypted (Paragraphs 30,90)
Returning to FIG. 2, the BLE packetizer 202 may receive a signal via the HCl. As explained elsewhere herein, the signal may originate from a processor of a device, which may be using the BLE device 200 as a Bluetooth module. Further, the signal that the BLE packetizer 202 may receive may include data, which may be included in the signal transmitted by the BLE device 200. The received signal may also include instructions indicative of the configuration of the BLE device 200, as the BLE device 200 transmits a signal. For example, the signal received may include parameters, such as encryption parameters, modulation parameters, a mode of operation of the BLE device 200, packet type, etc. Further, the parameters may be used to configure the BLE device 200 to generate a specific signal, which may be transmitted by the BLE device 200.[P-30]
At block 702, the method 700 includes generating, based on data, a data signal comprising one or more data packets. The data may include information such as encryption parameters, modulation parameters, mode of operation of the device, packet type, etc. The data may further include certain data that may be included in the data packet. Further, the data packet may be a non-connectable, non-scannable advertising packet. [P-90]
Claim(s) 2-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wiser (US 20170318529 A1) in view of Rusu et al. (WO 2015107042 A1), applied above in claim 1, in further view of Ghaziani (US 20200113032 A1).
In regards to claim 2, Wiser modified fails to teach the data packet complies with standard 802.15.1 promulgated by the Institute of Electrical and Electronics Engineers.
Ghaziani on the other hand teaches medical communicative device(s) that transmit data packets, that comply with standard 802.15.1 promulgated by the Institute of Electrical and Electronics Engineers (Paragraphs 24, 26, 30)
In some example embodiments, the transceiver 114 may include one or more receivers and one or more transmitters that can receive wireless signals and transmit, respectively, wireless signals. For example, the transceiver 114 may receive and transmit wireless signals that are compliant with one or more communication standards. To illustrate, the wireless signals received and transmitted by the transceiver 114 may be compliant with an IEEE 802.11 standard, an IEEE 802.15.1 standard, an IEEE 802.15.4 standard, or another standard. For example, the transceiver 114 may receive and transmit wireless signals that are compliant with Wi-Fi, Bluetooth, Bluetooth Low Energy, ZigBee, Thread, and/or a proprietary protocol. In some alternative embodiments, one or more discrete receivers that can receive wireless signals and one or more discrete transmitters that can transmit wireless signals may be used instead of the transceiver 114.[P-24]
In some example embodiments, the physical asset 104 may include a processor 120, the asset tag 122, a transceiver 124, a memory device 126, and a user interface 128. The physical asset 104 may be a piece of equipment that is typically used in hospitals, schools, businesses, etc. For example, the physical asset 104 may be a medical device (e.g., a dialysis machine, an imaging machine, etc.), a laboratory device (e.g., a microscope), a laptop, a printer, etc. To illustrate, the physical asset 104 may include one or more core components 140 that are used to execute the main functions (e.g., dialysis, imaging, printing, etc.) of the physical asset independently or in combinations of other components (e.g., the processor 120) of the physical asset 104. The physical asset 104 may be powered through a power receptacle (e.g., wall or floor power outlet) that may be controlled, for example, by a relay. Alternatively or in addition, the physical asset 104 may be fully or partially powered by a battery.[P-26]
In some example embodiments, the asset tag 122 may be a device that is attached to the physical asset 104 or integrated in the physical asset 104. The asset tag 104 may transmit the beacon signal 134, such as a BLE beacon signal or another beacon signal, that includes identification information. For example, the identification information may be known or determined by the system 100 as being associated with the physical asset 104. The asset tag 122 may be battery powered and may periodically transmit the beacon signal. In some example embodiments, the processor 120 may control the transmission of the beacon signal by the asset tag 12. The beacon signal transmitted by the asset tag 122 may be received, for example, by the sensor 112 of the lighting device 102.[P-30]
Therefore, it would have been to one of ordinary skill in the art to combine Ghaziani’s teaching with Wiser modified’s teaching in order to enable the appropriate compliant communication standards for the different device(s) in communication with the medical device(s).
In regards to claim 3, Wiser modified teaches the data packet comprises a packet payload comprising a header and a payload.(Paragraph 41, Wiser)
In addition, PDU 306 may include header 310 and advertisement payload 312 with 6 to 37 bytes. Further, advertisement payload 312 may include header 314, MAC address 316, and advertisement data 318 with up to 31 bytes. In an example, the 31 byte space may contain sensor data that may be communicated via the advertisement packet. The header 314 may include a type of the PDU 306. The type of PDU 306 may specify the type of the advertisement packet. As explained above, the advertisement packet type may be a non-connectable, non-scannable, and undirected packet type.[P-41]
In regards to claim 4, Wiser modified teaches the header of the packet payload comprises a Protocol Data Unit field having a value of 2 (Paragraph 40, 41, Wiser).
FIG. 3 illustrates an example advertising packet. In particular, an advertising packet 300 may, for example, take the form of any advertising packets described above in relation to the FIG. 1. In some additional embodiments, a Bluetooth tag may communicate the advertisement packet 300. As shown in FIG. 3, advertising packet 300 may include preamble 302, access address 304, payload data unit (PDU) 306 with 2 to 39 bytes, and cyclic redundancy check (CRC) 308.[P-40]
In addition, PDU 306 may include header 310 and advertisement payload 312 with 6 to 37 bytes. Further, advertisement payload 312 may include header 314, MAC address 316, and advertisement data 318 with up to 31 bytes. In an example, the 31 byte space may contain sensor data that may be communicated via the advertisement packet. The header 314 may include a type of the PDU 306. The type of PDU 306 may specify the type of the advertisement packet. As explained above, the advertisement packet type may be a non-connectable, non-scannable, and undirected packet type.[P-41]
Here, Wiser illustrates the Protocol Data Unit field having a value of 2, as a broadcasted advertisement packet (signifying a value of 2).
In regards to claim 5, Wiser modified teaches the payload of the packet payload comprises the measurement data (Paragraphs 40, 112)
FIG. 3 illustrates an example advertising packet. In particular, an advertising packet 300 may, for example, take the form of any advertising packets described above in relation to the FIG. 1. In some additional embodiments, a Bluetooth tag may communicate the advertisement packet 300. As shown in FIG. 3, advertising packet 300 may include preamble 302, access address 304, payload data unit (PDU) 306 with 2 to 39 bytes, and cyclic redundancy check (CRC) 308.[P-40]
In another example, the Bluetooth device 800 may include a sensor 822. As illustrated, the sensor 822 may exchange data with the application manager 802 through the application interface 824. For instance, the Bluetooth device 800 may broadcast advertising packets, which may include data collected by the sensor 822, which the application manager 802 may receive through the application interface 824. For instance, the Bluetooth device 800 may be a body-mountable device configured to be mounted to a skin surface (e.g., to skin of the upper arm or abdomen of a person), with one or more sensors for quantitatively and qualitatively testing an analyte concentration in interstitial fluid (e.g., glucose in interstitial fluid) in situ and in real-time. Those of skill in the art will recognize that the sensing platform described herein may be provided in devices that could be mounted on a variety of portions of the human body to measure concentrations of an analyte in other fluids than interstitial fluid (e.g., to measure an analyte in a tear fluid, blood, saliva, or some other fluid or tissue of the body). Accordingly, the Bluetooth device 800 may be used for monitoring or detecting a user's health state. Further, the Bluetooth device 800 may broadcast, using the BLE device 200, sensor readings to a user's computing device 900.[P-112]
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wiser (US 20170318529 A1) in view of Rusu et al. (WO 2015107042 A1) as applied above in claim 1, in further view of Kwon (US 20220248355 A1).
In regards to claim 7, Wiser modified fails to teach the measurement data further comprises a sample identifier.
Kwon on the other hand teaches the measurement data further comprises a sample identifier (Paragraph 85)
For example, the synchronization marker may be unique data for identifying sample data, sampled at a specific point in time. The sensor data (e.g., the first sensor data 221, the second sensor data 231 and/or the third sensor data 211 of FIG. 2) may be a set of a plurality of sample data continuously sampled according to each specific sampling period, and the synchronization marker may correspond to an identifier for identifying sample data sampled at a specific time point. According to an embodiment, the synchronization marker may include an identification (ID) corresponding to the transmission or reception time of the synchronization signal. According to an embodiment, the processor 340 may generate and transmit a signal that causes the external electronic device (e.g., first external electronic device 220 and/or second external electronic device 230) to generate a marker ID corresponding to the ID of the synchronization signal by including the marker ID in the synchronization marker.[P-85]
It would have been obvious to one of ordinary skill in the art to combine Kwon’s teaching with Wiser modified’s teaching in order to more effectively synchronize sensor data for transmission purpose to another device.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wiser (US 20170318529 A1) in view of Rusu et al. (WO 2015107042 A1), as applied above in claim 1, in further view of Bowman et al. (AU 2021203385 B2).
In regards to claim 8, Wiser modified fails to teach the measurement data further comprises a measurement quality indicator.
Bowman on the other hand teaches the measurement data further comprises a measurement quality indicator (Paragraph 34).
The method may further include determining a level of confidence in the sensor over a period of time, and once the measured level of confidence has reached a predetermined threshold, the method may further include the step of displaying high-resolution data and causing a transition to a therapeutic mode. The determining a level of confidence may include receiving an external blood glucose meter reading. The external blood glucose meter reading may correlate to what the monitoring device estimates the glucose concentration value to be or may be used to calibrate the monitoring device. The method may further include configuring the monitoring device to enter a user-dependent calibration mode of operation. The method may further include receiving an external blood glucose meter reading, developing a level of confidence in the sensor over a period of time, and once the level of confidence has reached a predetermined threshold, causing the monitoring device to enter a user-dependent calibration mode of operation. [P-34]
Here, by Bowman teaching once the measured level of confidence has reached a predetermined threshold, the method may further include the step of displaying high-resolution data and causing a transition to a therapeutic mode. This being an indication that the quality of measurement has surpassed a predetermined threshold.
Therefore, it would have been obvious to one of ordinary skill in the art to combine Bowman’s teaching with Wiser modified’s teaching in order to determine and track the accuracy of the measured physiological data.
Claim(s) 11-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wiser (US 20170318529 A1) in view of Rusu et al. (WO 2015107042 A1), applied above in claim 1, in further view of Miller et al. (US 12023180 B1).
In regards to claim 11, Wiser modified fails to teach the measurement data further comprises a status indicator indicating a status of the system.
Miller teaches the measurement data further comprises a status indicator indicating a status of the system (Column 20, lines 21-39; Column 80, lines 7-31)
In an embodiment, the peripheral measurement device 304 may be configured, i.e. programmed, to select whether to transmit a physiological characteristic measurement to the invasive analyte measurement device 302 and/or the wearable device 100 based on one or more device status characteristics. The device status characteristics may include a remaining battery life, a power output of the device, a strength of a signal between the device and the cloud-based server 306, a strength of a signal between the device and the peripheral measurement device 304, whether the device is networked to the peripheral measurement device 304, and/or a physical proximity of the device to the peripheral measurement device. For example, the peripheral measurement device 304 may select the device which has the greatest remaining battery life, has the greatest power output, has the greatest signal strength with the cloud-based server and/or the peripheral measurement device, is networked to the peripheral measurement device, and/or has a nearest physical proximity to the peripheral measurement device.[Col 20, ln 21-39]
The real-time status indicator 1004 may include a bubble. The bubble may be transparent to allow a background color of the coefficient of variation graph 1000 to show through the bubble, and/or the bubble may be filled with a color. The bubble may hover over the numbers associated with the level indicators 1002a-d to indicate a proximity of the patient's current analyte level to the level indicators 1002a-d. The bubble may be filled in with a color and may include an arrow pointing towards the curve 506. A portion of the color within the bubble may disappear as the bubble hovers over the numbers associated with the level indicators. The color within the bubble may change as the bubble moves relative to the level indicators 1002a-d to provide a secondary indication of the patient's analyte level. The color within the bubble may change continuously along a spectrum ranging from green, through yellow and orange, and ranging to red. The color within the bubble may be green when the patient's analyte level is normal, yellow when the patient's analyte level is half a coefficient of variation from normal, orange when the patient's analyte level is a full coefficient of variation from normal, and red when the patient's analyte level is two coefficients of variation from normal.[Col 80, ln 7-31]
Therefore, it would have been obvious to one of ordinary skill in the art to combine Miller’s teaching with Wiser modified’s teaching in order to enable consistent monitoring of the glucose device and its functional parameters.
In regards to claim 12, Wiser modified fails to teach wherein the measurement data further comprises a trend measurement.
Miller on the other hand teaches the measurement data further comprises a trend measurement (Column 21, lines 15-34)
In an embodiment, the APIs may include a representational state transfer (RESTful) API configuration 306a. The RESTful API 306a may enable data calls to the cloud-based server 306 from a variety of devices and/or applications having different hardware and/or software architectures. The APIs may further include a database abstraction layer 306b. The database applications may include a raw data database 306c and/or a processed data database 306d. The cloud-based server 306 may include a data analytics application 306e. The data analytics application 306e may include, for example, a data pre-processing component, a multi-variant analysis component, and/or a results component. The data analytics application 306e may generate a predictive model, may identify correlations between data, may integrate measurement data from two or more measurement devices, and so forth. In an embodiment, the predictive model may correlate invasive glucose measurements to non-invasive glucose measurements to identify one or more trends in the invasive glucose measurements and/or the non-invasive glucose measurements.[Col 21, ln 15-34]
Therefore, it would have been obvious to one of ordinary skill in the art to combine Miller’s teaching with Wiser modified’s teaching in order to enable effective aggregating and categorizing measurement parameter data
In regards to claim 13, Wiser modified fails to teach the measurement value comprises a raw glucose measurement.
Miller on the other hand teaches the measurement value comprises a raw glucose measurement (Column 35, lines 18-35)
In an embodiment, a method of processing and/or correlating raw measurement data at a cloud-based server 306 may include: taking the first measurement; and receiving, directly from the non-invasive glucometer, the second measurement. The invasive analyte measurement device 302 may aggregate the set of raw data. In an embodiment, a method may include: taking the second measurement; and receiving, directly from the invasive glucometer, the first measurement. The non-invasive glucometer may aggregate the set of raw data. Transmitting the raw data batch may be prompted by: the raw data batch occupying a threshold amount of physical memory; the raw data batch comprising a threshold number of the first measurement or the second measurement; a threshold amount of time passing after the first measurement is taken; a third measurement being taken by the invasive glucometer; and/or receiving a request for the raw data batch.[Col 35, ln 18-35]
Therefore, it would have been obvious to one of ordinary skill in the art to combine Miller’s teaching with Wiser modified’s teaching in order to enable effective aggregating and categorizing measurement parameter data
In regards to claim 14, Wiser modified fails to teach the measurement value comprises a calibrated glucose measurement.
Miller on the other hand teaches the measurement value comprises a calibrated glucose measurement (Column 57, line 50- Column 58, line 19).
The validation and/or reinitialization of the analyte measurements (validation) may be distinguished from a calibration and/or baselining process. Calibration may generally refer to a process by which device settings are tuned to a particular standard. Baselining may generally refer to a process by which measurements are compared to a standard, or baseline, for differences between the measurements and the standard. The validation may include a process by which effects of a physiological element on a set of measurements directed toward an analyte are subtracted to yield a precise indication of the analyte. The validation may include calibration of the non-invasive analyte measurement device using the invasive analyte measurement device. For example, the processor of the non-invasive analyte measurement device may set an initial measurement by the non-invasive analyte measurement device to be equal to a measurement by the invasive analyte measurement device. The validation may include baselining by setting a standard measurement taken by the invasive analyte measurement device against which non-invasive analyte measurement device measurements are compared. The validation may additionally include extraneous validation of non-invasive analyte measurements using periodic invasive analyte measurements. The validation may additionally include resetting the one or more values stored in the non-invasive analyte measurement device to compensate for physiological changes in the patient. The validation may additionally include determining whether an invasive analyte measurement taken to validate the non-invasive analyte measurements is discontinuous with the non-invasive analyte measurements. The validation may additionally include keeping the invasive analyte measurement and validating the non-invasive analyte measurements if there is a discontinuity. The validation may additionally include discarding the invasive analyte measurement and continuing the non-invasive analyte measurements if the invasive analyte measurement is continuous with the non-invasive analyte measurements.[Col 57, ln 50-Col 58, ln 19]
Therefore, it would have been obvious to one of ordinary skill in the art to combine Miller’s teaching with Wiser modified’s teaching in order to enable effectively set the device settings to a desired standard.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wiser (US 20170318529 A1) in view of Rusu et al. (WO 2015107042 A1), applied above in claim 1, in further view of San Vicente et al. (US 20160183799 A1)
In regards to claim 9, Wiser modified fails to teach the measurement data further comprises an indication of a battery voltage of the system.
San Vicente on the other hand teaches the measurement data further comprises an indication of a battery voltage of the system (Paragraph 265)
The maximum number of display devices that can communicate during a transmission window interval can be variable. The variable can be set during manufacturing of sensor electronics module 12, can be user configurable by using display device 14, 16, 18, 20, for example, or can be automatically adjusted by sensor system 8 or display device 14, 16, 18, 20 based on one or more criteria. The criteria can include a monitored battery level of the analyte sensor system 8. For example, if the battery level is below a threshold, the analyte sensor system 8 may be configured to only communicate with one display device 14, 16, 18, 20. The criteria can include: (i) one or more errors detected by sensor system 8 or display device 14, 16, 18, 20, (ii) a currently measured, previously measured and/or predicted glucose concentrations meeting or exceeding a predetermined threshold, (iii) a glucose concentration trend of the host based on currently measured, previously measured and/or predicted glucose concentrations, (iv) a rate of change of glucose concentration of the host based currently measured, previously measured and/or predicted glucose concentrations meeting or exceeding a predetermined threshold, (v) whether the host is determined to be in or near hyperglycemia based on currently measured, previously measured and/or predicted glucose concentrations, (vi) whether the host is determined to be in or near hypoglycemia based on currently measured, previously measured and/or predicted glucose concentrations, (vii) user inputted activity of the host (e.g., exercising or sleeping), (viii) time since a sensor session has started (e.g., when a new sensor 10 is used), and (ix) type of display device.[P-265]
It would have been obvious to one of ordinary skill in the art to combine San Vicente’s teaching with Wiser modified’s teaching in order to determine and track the accuracy of the measured battery level of the BLE device
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wiser (US 20170318529 A1) in view of Rusu et al. (WO 2015107042 A1) as applied above in claim 1, in further view of Kamath et al. (WO 2009055736 A1).
In regards claim 10, Wiser modified fails to teach the glucose measurement is a measurement of a glucose level of a subject, and the measurement data further comprises an indication of a skin temperature of the subject.
Kamath on the other hand teaches the glucose measurement is a measurement of a glucose level of a subject, and the measurement data further comprises an indication of a skin temperature of the subject (Paragraph 487)
In another example of non-glucose reaction rate-limiting phenomena, skin temperature can vary dramatically, which can result in thermally related erosion of the signal (e.g., temperature changes between 32 and 39 degrees Celsius have been measured in humans). In yet another embodiment, wherein the glucose sensor is placed intravenously, increased impedance can result from the sensor resting against wall of the blood vessel, for example, producing this non-glucose reaction rate-limiting noise due to oxygen deficiency[P-487]
Here Kamath teaches the skin temperature taken into account for glucose measurement, and at the same time accounting for noise instances that may yield false glucose readings.
Therefore, it would have been obvious to one of ordinary skill in the art to combine Kamath’s teaching with Wiser modified’s teaching in order to effectively avoid false glucose readings, improving the measuring accuracy.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wiser (US 20170318529 A1) in view of Rusu et al. (WO 2015107042 A1) and Bowman et al. (AU 2021203385 B2), as applied above in claim 8, in further view of Miller et al. (US 12023180 B1) and Svoboda et al. (CN 107003264 A)
In regards to claim 17, Wiser modified fails to teach the measurement quality indicator comprises a quantity selected from the group consisting of: whether voltages or currents that were outside of corresponding specified acceptable ranges were detected during a measurement, whether excessively rapid signal changes were detected during a measurement, whether a signal variance within a measurement window exceeded a specified maximum acceptable value, and whether the glucose sensor is present in an incorrect tissue space.
Miller on the other hand teaches the measurement quality indicator comprises a quantity selected from the group consisting of: whether voltages or currents that were outside of corresponding specified acceptable ranges were detected during a measurement(Column 16, lines 7-35)
The processing component may include various electronics for processing electronic signals generated by the measurement component, the communication component, and/or the user interface. In an embodiment, the processing component may include a processing device and a memory device. The processing device may have non-transitory and/or transitory memory, and the memory device may have non-transitory and/or transitory memory. For example, the processing device may have transitory memory and the memory device may have non-transitory memory. The processing device may generate an output based on an input. For example, the processing device may receive an electronic and/or digital signal from the measurement component. The processing device may send the signal to the memory device, and the memory device may store the signal. The processing device may read the signal and perform one or more tasks with the signal, such as determining an amount of current and/or voltage associated with the signal. The processing device may read from the memory device a quantity of the analyte corresponding with the amount of current and/or voltage. The processing device may transmit a value associated with the quantity of the analyte to the user interface, and the user interface may display the value to the user. In an embodiment, the processing device may transmit data such as the value and/or the amount of the current and/or voltage to the communication component, which may transmit the data to another device.[Col 16, ln 7-35]
Here, We see Miller teaching the measuring of the voltage or current signal and thereafter displaying the value of the measured voltage or current signal. Hence obvious to one of ordinary skill in the art to enable the indication of whether voltages or currents that were outside of corresponding specified acceptable ranges were detected during a measurement
Furthermore, Miller teaches the indication of whether excessively rapid signal changes were detected during a measurement (Column 50, lines 60- Column 51, line 15)
The upper warning line 510b may indicate an amount of analyte in the patient within a threshold of the dangerously high amount of analyte. The threshold may be within a certain percentage of the dangerously high amount of analyte indicated by the upper danger line 510d. The threshold may be within an absolute amount of the dangerously high amount of analyte. The threshold may be within a percentage of the dangerously high amount of analyte. The percentage may be based on a difference between the initial analyte level 504a and the dangerously high amount of analyte. The upper warning line 510b may indicate an amount of analyte in the patient at and/or above which the patient is more likely than not to experience minor adverse symptoms. The minor adverse symptoms may correspond to a condition related to the analyte. For example, the analyte may include blood glucose. The minor adverse symptoms may include increased resting heart rate, increased resting blood pressure, sweating, excessive thirst, and so forth. The upper warning line 510b may indicate the patient is close enough to experiencing hyperglycemia to take mitigating steps to avoid hyperglycemia. The mitigating steps may include taking a shot of insulin. [Col 50, ln 60- Col 51, ln 15]
Miller teaches whether a signal variance within a measurement window exceeded a specified maximum acceptable value (Column 50, lines 60- Column 51, line 15)
The upper warning line 510b may indicate an amount of analyte in the patient within a threshold of the dangerously high amount of analyte. The threshold may be within a certain percentage of the dangerously high amount of analyte indicated by the upper danger line 510d. The threshold may be within an absolute amount of the dangerously high amount of analyte. The threshold may be within a percentage of the dangerously high amount of analyte. The percentage may be based on a difference between the initial analyte level 504a and the dangerously high amount of analyte. The upper warning line 510b may indicate an amount of analyte in the patient at and/or above which the patient is more likely than not to experience minor adverse symptoms. The minor adverse symptoms may correspond to a condition related to the analyte. For example, the analyte may include blood glucose. The minor adverse symptoms may include increased resting heart rate, increased resting blood pressure, sweating, excessive thirst, and so forth. The upper warning line 510b may indicate the patient is close enough to experiencing hyperglycemia to take mitigating steps to avoid hyperglycemia. The mitigating steps may include taking a shot of insulin. [Col 50, ln 60- Col 51, ln 15]
Therefore, it would have been obvious during the time of the filing of the invention to combine Miller’s teaching with Wiser modified in order to enable the a more safe and accurate method to monitor and display the physiological measurements of a user/patient.
Wiser modified then fails to teach whether the glucose sensor is present in an incorrect tissue space.
Svoboda on the other hand teaches whether the glucose sensor is present in an incorrect tissue space(Page 11, Paragraph 2)
conductive structure is a counter electrode in one example, skin penetrating member 110 has 110 can function as the skin penetrating member and contained in the skin penetrating member 110 of the internal lumen of the working electrode in association with work. In one example, the skin piercing member 110 has a bare metal structure. In one example, skin penetrating member comprises stainless steel. skin penetrating member 110 diameter may range from about 28-31 gauge or less, so that the insert can form blood generated when there is no wound or obvious pain or discomfort when inserted in skin tissue of the patient. skin penetrating member 110 may have a length of about 12 mm to 13 mm. In one example, when the carrier slides to the extended position, only the penetrating member 100 of relatively short length extends beyond the base 102. In one example, module 100 is configured to make inserting depth does not exceed 2 mm skin penetrating member 110. In another example, the skin penetrating member 110 for skin insertion depth in the range of about 1.5 mm to 2 mm. The puncture depth such that sensor module vascular plexus of the sensor with the tissue 100 (VP) in the dermis. the depth position, sensor represents cell glucose in capillary blood. [Pg 11, P-2]
Here Svobobda teaches a sensor component within the glucose sensor that detects the depth position of the glucose sensor within the users tissue. Hence by detecting the adequate depth of the glucose sensor, one of ordinary skill in the art to determine whether the glucose sensor is present in an incorrect tissue space.
Therefore, it would have been obvious during the time of the filing date to combine Svoboda’s teaching with Wiser modified’s teaching in order to enable a safe and more reliable way to determine the appropriate position of the sensor within the patients tissue.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wiser (US 20170318529 A1) in view of Rusu et al. (WO 2015107042 A1) and Miller et al. (US 12023180 B1), applied above in claim 11, in further view of Abreu (JP 2011005261 A), Budiman et al. (US 20220296132 A1) and Mensinger et al. (US 20160232322 A1)
In regards to claim 18, Wiser modified fails to teach the status indicator indicates a status selected from the group consisting of transmitter over-temperature, sensor activation failed, sensor warmup in progress, and sensor warmup complete.
Abreu on the other hand teaches the status indicator of a medical implant transmitter, indicating a status of transmitter over-temperature (Page 145, Paragraph 1)
Fig. 6 schematically illustrates a surgical implantation of a transmitter device that overheats adjacent to a brain tumor. [49]FIG. 6 shows a surgical implantation of a transmitter that overheats adjacent to a kidney tumor. FIG. [50]Fig. 2 shows an overheated transmitter and its various components. [51]FIG. 5 shows a surgical implantation of a transmitter device that overheats adjacent to an intraocular tumor. FIG. [52]FIG. 6 schematically illustrates a surgical implantation of a transmitter device that overheats adjacent to a lung tumor. FIG. [53]FIG. 6 schematically illustrates the positioning of a transmitter that overheats adjacent to a breast tumor [Pg 145, P-1]
Here we see Abreu illustrate the indication of the overheating of implanted sensor transmitter.
It would have been obvious to the time of the filing date of the said invention to combine Abreu’s teaching with Wiser modified’s signal indication teaching in order to effectively avoid any tissue damage due to indication.
Wiser modified further fails to teach the indication of sensor activation failed
Budiman on the other hand teaches indication of sensor activation failed (Paragraph 58)
Referring still to the various embodiments of the present disclosure, as discussed above, the analyte monitoring system may automatically perform the calibration of the analyte sensor based on the blood glucose measurement received, and thereafter, notify the user or the patient of the successful calibration of the sensor, or alternatively, provide the patient or the user with the option to confirm the performance of the calibration of the sensor based on the receive blood glucose measurement. Within the scope of the present disclosure, other variations or levels of user or patient interaction may be contemplated, such as, for example, notification (alarms or alerts that are visual, auditory, vibratory or one or more combinations thereof) to the user of calibration associated events such as updating the previously stored calibration schedule based on the calibration performed with the current reference or blood glucose data, notification of the next valid scheduled calibration, the number of calibrations remaining for the sensor prior to sensor replacement, failed calibration attempt, unsuitable calibration conditions, verified valid calibration conditions, and the like.[P-58]
Therefore, it would have been obvious to one of ordinary skill in the art to combine Budiman’s teaching with Wiser modified, in order to keep track and notify the user of the operational functionality of the glucose system.
Wiser modified fails to teach the indicator of the sensor warmup in progress, and sensor warmup complete.
Mensinger on the other hand teaches the indicator of the sensor warmup in progress, and sensor warmup complete (Paragraph 66)
In one embodiment, the data transmitted from the continuous glucose sensor unit 100 also includes other data relating to monitoring a patient's glucose levels. For example, the continuous glucose sensor unit 100 transmits metadata including sensor calibration information, patient information, the type of sensor used to generate the measurements, system diagnostic information, rate of change information, a trend (e.g., glucose values rising, steady, or decreasing, or numerical values representing the rate of change), alarms or alert information, and/or a system status. Examples of a system status include warm-up, which may be an interval after installing a new sensor when the sensor is warming up and calibrating, active, and offline.[P-66]
Therefore, it would have been obvious to one of ordinary skill in the art to combine Mensinger’s teaching with Wiser modified, in order to keep track and notify the user of the operational functionality of the glucose system.
Response to Arguments
The examiner acknowledges applicant’s amendment, and has addressed them above under new grounds of rejection above
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANTHONY D AFRIFA-KYEI whose telephone number is (571)270-7826. The examiner can normally be reached Monday-Friday 10am-7pm.
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/ANTHONY D AFRIFA-KYEI/Examiner, Art Unit 2686
/BRIAN A ZIMMERMAN/Supervisory Patent Examiner, Art Unit 2686
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