DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Interpretation
While not necessarily unclear, it is conceivable that the following terms could be interpreted in ways other than the manner in which they are interpreted herein. Accordingly, Examiner seeks correction or confirmation of the following claim interpretations.
Regarding the limitation “a position sensor”, Applicant defines “a position sensor” and “a motion sensor” to be “at least one sensor from the group of an accelerometer, a gyroscope, an inertial movement sensor, or other similar sensor” (instant specification, [0039, 0041]). Although the position sensor and the motion sensor have the same definition, claims 4, 9, and 16 are being interpreted as requiring two sensors (one for measuring motion and one for measuring position) from “the group of an accelerometer, a gyroscope, an inertial movement sensor, or other similar sensors”.
Regarding the limitation “a circadian sensor”, as best understood “a circadian sensor” is being interpreted as any sensor capable of measuring physiological data related that provides insight into a patient’s circadian rhythm. Such examples include but are not limited to a motion sensor, a light sensor, a temperature sensor, or a heart rate sensor.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 5, 10 and 17 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.
In re claim 5, the limitation “The health monitoring system of claim 4, comprising two or more of a)-d); three or more of a)-d) ; or each of a)-d).” raises a clarity concern. Specifically, it is unclear what the limitations “three or more of a)-d); or each of a)-d).” add to the claim since a health monitoring system comprising “three or more of a)-d)” or “each of a)-d)” would still be a heath monitoring system that comprises “two or more of a)-d)”. For examination purposes, the claim will be interpreted as requiring two or more of a)-d).
In re claim 10, see above (In re claim 5).
In re claim 17, see above (In re claim 5).
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.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/608,455 (reference application). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Although the claims at issue are not identical, they are not patentably distinct from each other.
Instant Application
Reference Application (18/608,455)
Claim 1. A health monitoring system, comprising: a monitoring device that includes
Claim 1. A heath parameter monitoring system comprising a monitoring device including:
one or more transmit antennas configured to transmit radio-frequency (RF) analyte detection signals into a user and
one or more transmit antennas configured to transmit radio-frequency (RF) analyte detection signals into a user and
one or more receive antennas configured to detect RF analyte signals that result from the RF analyte detection signals transmitted into the user;
one or more receive antennas configured to detect RF analyte signals that result from the RF analyte detection signals transmitted into the user;
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; and
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; and
a motion sensor that detects motion of the user 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
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.
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.
Claims 1-5, 7-10, 12, 16, 17, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Leabman (US 2020/0187836), in view of Connor (US 2017/0164878).
In re claim 1, Leabman discloses a health monitoring system [0003], comprising:
a monitoring device (FIG. 5: 510) that includes
one or more transmit antennas (544) configured to transmit radio-frequency (RF) analyte detection signals [0091] into a user (abstract) and
one or more receive antennas (546) configured to detect RF analyte signals that result from the RF analyte detection signals transmitted into the user [0091];
an analog-to-digital converter (ADC) (562)
connected to the one or more receive antennas (connected via 556 and 560) and
receiving the RF analyte signals detected by the one or more receive antennas (FIG. 5);
Leabman does not disclose
a motion sensor that detects motion of the user 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.
Connor discloses an analogous monitoring device (Fig. 8), that like Leabman, uses radio frequency energy to measure a patient’s blood glucose levels (abstract, [0160, 0161]). To more accurately measure glucose levels [0181, 0338], Connor discloses including one or more additional sensors (805, 806, 807) in the monitoring device. Examples of additional sensors discussed by Connor include but are not limited to: an accelerometer, a light intensity sensor, an electrocardiographic sensor, a gyroscope, an inertial sensor, a microphone sensor, a motion sensor, a pressure sensor, a neuro sensor, and a body temperature sensor [0201, 0202].
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 monitoring device of Leabman, to include a motion sensor that detects motion, as taught by Connor. One would have been motivated to make this modification to have the ability to detect whether or not the monitoring device is being properly worn, or similar events that would indicate a potentially inaccurate glucose measurement [0338]. Accordingly, such a modification would yield detecting “motion of the user 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”.
In re claim 2, the proposed combination does not yield, further comprising
a body temperature sensor that detects the temperature of the user 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.
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 monitoring device of the proposed combination to include a temperature sensor, as taught by Connor. One would have been motivated to make this modification because doing so would enable the monitoring device to compensate for various factors that influence measurement accuracy, such as excessive sweating which is known to occur when a user experiences an increase in body temperature.
In re claim 3, the proposed combination yields wherein the analog-to-digital converter (Leabman, FIG. 5), the motion sensor (Connor, FIG. 8: 805) and the body temperature sensor (Connor, FIG. 8: 806) are part of the monitoring device.
In re claim 4, the proposed combination yields (all mapping directed to Leabman), further comprising at least one of the following:
a) a body position sensor that senses the user’s body position 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;
b) an electrocardiogram sensor that senses the user’s heartbeat 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;
c) a circadian rhythm sensor that senses circadian data of the user 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;
d) a background noise sensor (FIG. 20: 2064; [0135]) that senses background noise around the user 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 [0115, 0116].
*Examiner notes that under the broadest reasonable interpretation, based on Applicant’s specification [0044] “a background noise sensor” is being interpreted as any component capable of sensing signals that could interfere with the signals received by the receiving (RX) antennas.
In re claim 5, the proposed combination does not yield, comprising
two or more of a)-d);
three or more of a)-d);
each of a)-d);
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 monitoring device of the proposed combination, to comprise **body position sensor, an electrocardiogram sensor, and a **circadian rhythm sensor, as taught by Connor. One would have been motivated to make this modification because doing so would enable the monitoring device to collect more data about various physiological factors that influence blood glucose levels, ultimately improving the accuracy of blood glucose measurements. Moreover, one of ordinary skill in the art would have the ability to choose the number and type of sensors that would best meet their needs.
Accordingly, such a modification would yield a body position sensor “that senses the user’s body position 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”, a electrocardiogram sensor that “senses the user’s heartbeat 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”, and a circadian rhythm sensor that “senses circadian data of the user 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;”.
**Regarding the limitations “a body position sensor” and “a circadian rhythm sensor” see above section Claim Interpretation.
In re claim 7, regarding the following limitations see above (In re claim 1).
A health monitoring system, comprising:
a monitoring device that includes
one or more transmit antennas configured to transmit radio-frequency (RF) analyte detection signals into a user and
one or more receive antennas configured to detect RF analyte signals that result from the RF analyte detection signals transmitted into the user;
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;
Regarding the limitation “and a body temperature sensor that detects the temperature of the user 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.”, for substantially the same reasons described In re claim 2 above, it would have been obvious to modify the monitoring device of Leabman, to include a body temperature sensor that detects the temperature of the user, as taught by Connor. Accordingly, such a modification would yield a body temperature sensor that detects the temperature of the user “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”.
In re claim 8, see above (In re claim 3).
In re claim 9, see above (In re claim 4).
In re claim 10, see above (In re claim 5).
In re claim 12, regarding the following limitations see above (In re claim 1).
Health monitoring comprising:
detecting an analyte in a user by transmitting radio-frequency (RF) analyte detection signals into the user 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;
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; and
at least one of the following:
a) 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, sensing motion of the user using a motion sensor;
Regarding the limitation “b) 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, sensing a body temperature of the user using a body temperature sensor” for substantially the same reasons described In re claim 2 above, it would have been obvious to modify the monitoring device of Leabman, to include a body temperature sensor, as taught by Connor. Accordingly, such a modification would yield a “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, sensing a body temperature of the user” using a body temperature sensor.
The proposed combination also yields: A health monitoring method (Leabman, [0003]).
In re claim 16, see above (In re claim 4).
In re claim 17, see above (In re claim 5).
In re claim 19, the proposed combination yields (all mapping directed to Leabman) further comprising modifying the digital signals by filtering out frequency bands not associated with glucose waveforms [0115, 0116].
Claims 6, 11, 13-15 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Leabman (US 2020/0187836), in view of Connor (US 2017/0164878), in view of Pantelopoulos et al. (US 2017/0209055).
In re claim 6, the proposed combination yields further comprising a memory (Leabman, [0146]).
The proposed combination does not yield further comprising a memory that stores a motion threshold and a body temperature threshold.
Pantelopoulos discloses an analogous monitoring device that like the proposed combination uses electromagnetic energy to non-invasively monitor a user’s heath (abstract, [0007]). Pantelopoulus also discloses equipping the monitoring device with additional sensors to help determine whether or not the user is in a suitable condition for data collection [0117, 0120]. Examples of additional sensors used by Pantelopoulus include but are not limited to accelerometers, gyroscopes, temperature sensors, pressure sensors, and light ambient sensors [0034]. As described in Pantelopoulus, the user is determined to be in a suitable condition for data collection if a parameter of interest (i.e., motion [0117], noise [0120], activity level [0120], a body temperature [0024]) falls below a predefined threshold.
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 monitoring device of the proposed combination, to store a motion threshold and a body temperature threshold, as taught by Pantelopoulous. One would have been motivated to make this modification because doing so would allow the monitoring device to determine whether or not the user is in a suitable condition for data collection [0023, 0024]. Examiner notes that it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to store other parameter threshold values (i.e., not just motion and temperature), as doing so would enable the monitoring device to more accurately determine whether or not the user is in a suitable condition for data collection.
In re claim 11, see above (In re claim 6).
In re claim 13, see above (In re claim 12 and In re claim 6)
In re claim 14, see above (In re claim 12 and In re claim 6)
In re claim 15, see above (In re claim 12 and In re claim 6).
In re claim 18, see above (In re claim 5, and In re claim 6).
Conclusion
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Chase (US 2019/0290161) discloses a monitoring device (FIGS 1-2) that uses radio frequency energy [0011] to determine a patient’s blood glucose level (abstract). Chase further discloses the monitoring device including a pulse rate sensor, a skin galvanic sensor and a skin temperature sensor (FIG. 7; [0038]).
Baheti et al. (US 2019/0216393) discloses radar based vital sign measurement device ([0023]; FIG. 1B, FIG. 2A), that determines a user’s heart rate based on reflected radio frequency signals [0024].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLIVIA WALKER whose telephone number is (571)272-7052. The examiner can normally be reached M-F: 7-4pm CT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571)-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLIVIA WALKER/Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796