DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on July 11, 2024; and January 17, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings filed on March 18, 2024 are accepted.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 12-13 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.
Claim 12 recites the limitation “an analysis system”. Claim 1 already recites, “an analysis system” it is unclear if they are the same. It will be interpreted that they are the same and claim 12 is further defining the specific protocol to include the cloud. There is insufficient antecedent basis for this limitation in the claim.
Dependent claims are rejected as depending on a rejected base claim.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 3-9 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Leabman (US 2020/0192428 A1) (“Leabman”) in view of Teyeb et al. (WO 2022/184623 A1) (“Teyeb”).
Regarding claim 1, Leabman discloses A health parameter monitoring system, comprising (Abstract and entire document):
a monitoring device configured for communicative coupling to an analysis system, including (FIG. 1-9 and “wearable health monitoring device” see at least claim 1; and see [0166], [0217] discussing wired and wireless communication with a local/remote analysis system. see also [0269], “monitoring device 6300”):
one or more transmit antennas configured to transmit radio-frequency (RF) analyte detection signals into a user over the space below a skin surface and one or more receive antennas configured to detect RF analyte signals that result from the RF analyte detection signals transmitted into the user (FIG. 1-9 and [0116], “In the embodiment of FIG. 5, the sensor system 510 includes two TX antennas 544 and four RX antennas 546. Although two TX and four RX antennas are used, there could be another number of antennas, e.g., one or more TX antennas and two or more RX antennas. In an embodiment, the antennas are configured to transmit and receive millimeter range radio waves.” Showing the tx and rx on the watch disposed over the wrist see also [0269], “rf sensors 6310”);
an analog-to-digital converter connected to the one or more receive antennas and receiving the RF analyte signals detected by the one or more receive antennas (FIG. 1-5 and [0118], “analog-to-digital converter (ADC) 562” and [0133], “In the example of FIG. 8C, each TX component includes channel-specific circuits (not shown) such as amplifiers, each RX component includes channel-specific circuits (not shown) such as mixers, filters, and LNAs, and the shared circuits include, for example, a voltage control oscillator (VCO), a local oscillator (LO), frequency synthesizers, PLLs, BPFs, divider(s), mixers, ADCs, buffers, digital logic, a DSP, CPU, or some combination thereof that may be utilized in conjunction with the channel-specific TX and RX components.”);
a substrate on which the one or more transmit antennas and the one or more receive antennas are fabricated, the transmit antennas and receive antennas forming one or more antenna arrays (FIG. 1-9 showing an array and FIG> 8A, semiconductor substrate with the tx and rx sensors on the same substrate or part of the same circuit including the adc, see further [0133], “FIG. 8C depicts an example of the physical layout of circuit components on a semiconductor substrate, such as the semiconductor substrate (die) depicted in FIG. 8A. In the embodiment of FIG. 8C, the die 824 includes two TX components 854, four RX components 856, shared circuits 860, and an input/output interface (I/O) 862. In the example of FIG. 8C, each TX component includes channel-specific circuits (not shown) such as amplifiers, each RX component includes channel-specific circuits (not shown) such as mixers, filters, and LNAs, and the shared circuits include, for example, a voltage control oscillator (VCO), a local oscillator (LO), frequency synthesizers, PLLs, BPFs, divider(s), mixers, ADCs, buffers, digital logic, a DSP, CPU, or some combination thereof that may be utilized in conjunction with the channel-specific TX and RX components.” Disclosing the antenna array and ADC connected to the array. see also [0269], “processor 6350”);
Leabman fails to disclose a sensor comprising at least one of: a movement sensor, a body temperature sensor, a body position sensor, and an electrocardiogram sensor, that senses user data during transmission of the RF analyte detection signals by the one or more transmit antennas and during detection of the RF analyte signals by the one or more receive antennas.
However, in the same field of endeavor, Teyeb teaches a sensor comprising at least one of: a movement sensor, a body temperature sensor, a body position sensor, and an electrocardiogram sensor, that senses user data during transmission of the RF analyte detection signals by the one or more transmit antennas and during detection of the RF analyte signals by the one or more receive antennas (FIG. 1 and page 22 disclosing using auxiliary sensors to detect motion, temp, etc.).
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 system as taught by Leabman to include a sensor comprising at least one of: a movement sensor, a body temperature sensor, a body position sensor, and an electrocardiogram sensor, that senses user data during transmission of the RF analyte detection signals by the one or more transmit antennas and during detection of the RF analyte signals by the one or more receive antennas as taught by Teyeb to improve accuracy (Page 22, second from last paragraph).
Regarding claim 3, Leabman as modified discloses The health parameter monitoring system of claim 1, Leabman as modified further discloses wherein the RF analyte detection signals include information related to a blood pressure related analyte (Leabman FIG. 1-9 and associated paragraphs, at least Claim 8 discussing glucose as the analyte).
Regarding claim 4, Leabman as modified discloses The health parameter monitoring system of claim 1, Leabman as modified further discloses wherein the monitoring device is wearable (Leabman FIG. 1-9 wearable device).
Regarding claim 5, Leabman as modified discloses The health parameter monitoring system of claim 4, Leabman as modified further discloses wherein the monitoring device is one of: a cell phone; a smartwatch; a tracker; a wearable monitor; a wristband; and a personal blood monitoring device (Leabman FIG. 1-9, smartwatch).
Regarding claim 6, Leabman as modified discloses The health parameter monitoring system of claim 1, Leabman as modified further discloses wherein the substrate is fabricated with at least two transmit antennas, and at least four receive antennas (Leabman FIG. 1-9 and [0116], “In the embodiment of FIG. 5, the sensor system 510 includes two TX antennas 544 and four RX antennas 546. Although two TX and four RX antennas are used, there could be another number of antennas, e.g., one or more TX antennas and two or more RX antennas.”).
Regarding claim 7, Leabman as modified discloses The health parameter monitoring system of claim 1, Leabman as modified further discloses wherein the substrate has an outer footprint and an inner footprint, wherein the outer footprint corresponds to an integrated circuit device and the inner footprint is a semiconductor substrate with a circuit arrangement (Leabman FIG. 8A, the tx and rx antennas are on the same integrated circuit or the same chip, see [0115], “or example, some combination of components may be fabricated on the same semiconductor substrate and/or included in the same packaged IC device or a combination of packaged IC devices.” See also [0115], “semiconductor substrate”).
Regarding claim 8, Leabman as modified discloses The health parameter monitoring system of claim 1, Leabman as modified further discloses further including a memory connected to the analog-to-digital converter in which digital signals are stored (Leabman FIG. 65 and associated paragraphs, including the sensor system and a memory).
Regarding claim 9, Leabman as modified discloses The health parameter monitoring system of claim 1, Leabman as modified further discloses wherein the sensor provides elevation information related to hand and heart positions of a user (Teyeb FIG. 1 and page 22 disclosing using auxiliary sensors to detect motion, temp, etc.).
Regarding claim 11, Leabman as modified discloses The health parameter monitoring system of claim 1, Leabman as modified further discloses wherein the body position sensor is one of a group of sensors including: an accelerometer, a gyroscope and an inertial movement sensor (Teyeb FIG. 1 and page 22 disclosing using auxiliary sensors to detect motion, temp, etc.).
Regarding claim 14, Leabman discloses A health parameter monitoring method, comprising (Abstract and entire document):
detecting an analyte in a user by transmitting radio-frequency (RF) analyte detection signals into the user over the space below a skin surface from one or more transmit antennas and detecting, using one or more receive antennas, RF analyte signals that result from the RF analyte detection signals transmitted into the user (FIG. 1-9 and [0116], “In the embodiment of FIG. 5, the sensor system 510 includes two TX antennas 544 and four RX antennas 546. Although two TX and four RX antennas are used, there could be another number of antennas, e.g., one or more TX antennas and two or more RX antennas. In an embodiment, the antennas are configured to transmit and receive millimeter range radio waves.” Showing the tx and rx on the watch disposed over the wrist see also [0269], “rf sensors 6310”);
converting the detected RF analyte signals from analog signals to digital signals using an analog-to-digital converter connected to the one or more receive antennas (FIG. 1-5 and [0118], “analog-to-digital converter (ADC) 562” and [0133], “In the example of FIG. 8C, each TX component includes channel-specific circuits (not shown) such as amplifiers, each RX component includes channel-specific circuits (not shown) such as mixers, filters, and LNAs, and the shared circuits include, for example, a voltage control oscillator (VCO), a local oscillator (LO), frequency synthesizers, PLLs, BPFs, divider(s), mixers, ADCs, buffers, digital logic, a DSP, CPU, or some combination thereof that may be utilized in conjunction with the channel-specific TX and RX components.”);
storing the digital signals and parameter data in a memory connected to the analog-to-digital converter (FIG. 65 and associated paragraphs, including the sensor system and a memory).
Leabman fails to disclose sensing parameter data of the user using one of a movement sensor, a body temperature sensor, or a body position sensor, during transmission of the RF analyte detection signals and during detection of the RF analyte signals; and
However, in the same field of endeavor, Teyeb teaches sensing parameter data of the user using one of a movement sensor, a body temperature sensor, or a body position sensor, during transmission of the RF analyte detection signals and during detection of the RF analyte signals (FIG. 1 and page 22 disclosing using auxiliary sensors to detect motion, temp, etc.); and
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 method as taught by Leabman to include sensing parameter data of the user using one of a movement sensor, a body temperature sensor, or a body position sensor, during transmission of the RF analyte detection signals and during detection of the RF analyte signals; and as taught by Teyeb to improve accuracy (Page 22, second from last paragraph).
Regarding claim 15, Leabman as modified discloses The health parameter monitoring method of claim 14, Leabman as modified further discloses further comparing the sensed parameter data of the user to a threshold stored in a memory (Leabman [0183], “At decision point 2806, it is determined whether a correlation between the raw data and the control data is acceptable, e.g., whether the correspondence is within an acceptable threshold. If it is determined that there is an acceptable correspondence, then the process proceeds to block 2808, where the correlation (e.g., a model or algorithm) is saved and then the initial learning process is ended. If at decision point 2806 it is determined that there is not an acceptable correspondence between the raw data and the control data (e.g., the correspondence is not within an acceptable threshold), then the process proceeds to block 2810.”).
Regarding claim 16, Leabman as modified discloses The health parameter monitoring method of claim 15, Leabman as modified further discloses further including modifying the digital signals by filtering using a low band pass filter (Leabman [0117], “low pass filters (LPFs).”).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Leabman in view of Teyeb in further view of Saunamaki et al. (US 2018/0184932 A1) (“Saunamaki”).
Regarding claim 2, Leabman as modified discloses The health parameter monitoring system of claim 1, Leabman as modified fails to disclose further comprising a background noise sensor that senses background noise data during detection of the RF analyte signals by the one or more receive antennas.
However, in the same field of endeavor, Saunamaki teaches further comprising a background noise sensor that senses background noise data during detection of the RF analyte signals by the one or more receive antennas (Claims 1 and 7 discussing a noise sensor during bio signal detection).
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 system as taught by Leabman as modified to include further comprising a background noise sensor that senses background noise data during detection of the RF analyte signals by the one or more receive antennas as taught by Saunamaki to reduce noise (see abstract, [0010], claim 1).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Leabman in view of Teyeb in further view of Koya et al. (US 2022/0218241 A1) (“Koya”).
Regarding claim 10, Leabman as modified discloses The health parameter monitoring system of claim 1 Leabman as modified fails to disclose further including a circadian rhythm sensor that senses one or more of actigraphy, wrist temperature, light exposure, and heart rate during transmission of the RF analyte detection signals and during detection of the RF analyte signals.
However, in the same field of endeavor, Koya teaches further including a circadian rhythm sensor that senses one or more of actigraphy, wrist temperature, light exposure, and heart rate during transmission of the RF analyte detection signals and during detection of the RF analyte signals ([0128] and claim 1, discussing sensors for circadian rhythm).
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 system as taught by Leabman as modified to include further including a circadian rhythm sensor that senses one or more of actigraphy, wrist temperature, light exposure, and heart rate during transmission of the RF analyte detection signals and during detection of the RF analyte signals as taught by Koya to deliver graded therapy (see [0128]).
Claims 12-13 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Leabman in view of Teyeb in further view of Wang et al. (US 2021/0204824 A1) (“Wang”).
Regarding claims 12-13 and 17, Leabman as modified discloses The health parameter monitoring system of claim 1, Leabman as modified fails to disclose further including a communications module providing communication to an analysis system via a cloud network.
However, in the same field of endeavor, Wang teaches further including a communications module providing communication to an analysis system via a cloud network ([0076 – 0077] discussing implementing an analysis system via the cloud).
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 system as taught by Leabman as modified to include further including a communications module providing communication to an analysis system via a cloud network as taught by Wang ([0076 – 0077] discussing implementing an analysis system via the cloud).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH A TOMBERS whose telephone number is (571)272-6851. The examiner can normally be reached on M-TH 7:00-16:00, F 7:00-11:00(Eastern).
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, Robert Chen can be reached on 571-272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see https://ppair-my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JOSEPH A TOMBERS/Examiner, Art Unit 3791