OA Summary: fix box 5 (withdrawn claims are still pending claims)
DETAILED ACTION
Response to Amendment
The amendment filed 03/05/2026 has been entered. Amendments to claims 30 and 120-121, cancellation of claim 37, and new claim 126 are acknowledged. Claims 30, 36, 38, 41, 116, and 119-126 remain pending in the application.
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 30, 36-38, 41, 116, and 119-126 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 30 recites the limitation "the first pair of electrode pads" in line 12. There is insufficient antecedent basis for this limitation in the claim. It is further unclear if the electrode pads are the same as the first pair of electrodes disclosed earlier in the claim or an additional element.
Claims 36-38, 41, 116, and 119-125 are rejected due to dependency.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 30, 36-38, 41, 116, and 120-126 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaib et al. (US 20210212397 A1), hereinafter Kaib, in view of Su et al. (CN 111373483 A), hereinafter, Su, in view of Amurthur et al. (US 20140288385 A1), hereinafter Amurthur.
Regarding claim 30, Kaib discloses a continuous monitoring device attachable to a patient ([0136]: “capable of continuous, substantially continuous, long-term and/or extended use or wear by, or attachment or connection to a patient”), the monitoring device comprising: an enclosure having a surface that may be adhered to the patient ([0035]: “In some examples, each of the capacitor modules comprises one or more capacitors encapsulated by an enclosure that is integrated into the garment.”, [0008]: “the garment includes at least one of: a vest worn about an upper body of the patient, a wrap-around garment, and shoulder straps. In some examples, the garment includes a one-shoulder garment configured to be worn about one shoulder and wrap around an upper torso of the patient.”); a first pair of electrodes operable to contact the skin of the patient ([0111]: "the wearable medical device 100 includes a plurality of sensing electrodes 112 that can be disposed at various positions about the patient's body."); a plurality of sensors, each of the plurality of sensors configured to output physiological data relating to a respiratory condition, disorder or ailment of the patient ([0011]: “one or more sensors configured to monitor one or more of patient activity, patient motion, heart sounds, lung sounds, tissue fluids, lung fluid, blood oxygen levels, blood pressure”), wherein the sensors include: a respiratory sensor coupled to the first pair of electrode pads, the respiratory sensor operable to sense a voltage between the first pair of electrode pads ([0171]: “the respiration sensor can include ECG sensing electrodes and an associated circuitry that can extract, e.g., a patient's respiration rate based on signal amplitude changes in body surface potential differences between two electrodes disposed on the patient's torso.”); and a heart rate sensor coupled to the first pair of electrode pads ([0167]: “the ECG sensor module may process the raw ECG data to derive heart rate information”), the heart rate sensor operable to sense a voltage between the first pair of electrode pads ([0146]: “include ECG electrodes to monitor an ECG of the patient”, wherein ECG electrodes sense a voltage, [0195]: “may include a multiplexer to control which ECG sensing electrode pairings are being monitored. For example, the sensor interface module 426 and/or the operations module 406 may identify one or more optimal pairings (e.g., the pairings with the best signal quality) and control a state of the multiplexer so as to receive ECG signals from the identified pairing(s).”, wherein the same electrodes may be selected); a signal processor coupled to the respiratory sensor and the heart rate sensor operable to multiplex respiratory signals and heart rate signals received by the respiratory sensor and the heart rate sensor from the first pair of electrode pads ([0215]: " the patient monitoring circuitry of the sensor interface module may include one or more filters, amplifiers, signal analysis units, signal multiplexers or de-multiplexers, etc. that may be included in separate and distinct modules or modular components. "); a memory configured to store the physiological data ([0150]: "memory (e.g., a memory module accessible for read and/or write by any of the plurality of processors or processor cores)"); and a transceiver operable to transmit the physiological data to an external device ([0155]: "The communication systems 314 may include various systems to communicate with external devices including, for example, a central server and/or a remote base station.”).
Kaib fails to disclose multiplexing the respiratory sensor and the heart rate sensor to sense voltage from the first pair of electrode pads, the signal processor reading either respiratory signals from the respiratory sensor or heart rate signals from the heart rate sensor based on the multiplexing.
Su discloses a wearable monitoring device (title) wherein the respiratory sensor and the heart rate sensor to sense voltage from the first pair of electrode pads (Page 7 paras 4-6: “electrocardio sensor electrode … equipped with a switching switch through the electric circuit, wherein the electrocardio-sensor and said bio-impedance sensor connected with the same electrode (hereinafter called common electrode)”, consistent with applicant’s specification para [0098] wherein an impedance sensor is used as a respiratory sensor, and wherein electrocardio sensor electrodes sense voltage), the signal processor reading either respiratory signals from the respiratory sensor or heart rate signals from the heart rate sensor based on multiplexing (Page 8 para 1: “under the condition of electrode multiplexing, bio-impedance sensor and electrocardiogram sensor due to the common electrode, To avoid signal detected occurrence of confusion or error, does not allow bio-impedance sensor and electrocardiogram sensor are in working state”).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the device disclosed by Kaib to use a single pair of electrodes as disclosed by Su to improve costs by reducing the number of electrodes required by the system.
Kaib as modified by Su fails to disclose a patch shaped enclosure having a bottom surface that may be adhered to the patient and a top surface including a battery housing; a circuit board within the enclosure, the circuit board resting within a center section of the bottom surface under the battery housing; a battery held in the battery housing over the circuit board; a first pair of electrodes operable to contact the skin of the patient on an end section of the bottom surface of the enclosure adjacent to the center section of the bottom surface.
Amurthur discloses disclose a patch shaped enclosure (Fig 2A) having a bottom surface that may be adhered to the patient (Fig 2A element 210/210T, [0065]: “to adhesive patch 210”) and a top surface including a battery housing (Fig 2A element 262 and battery housing 260); a circuit board within the enclosure (Fig 2A element 220), the circuit board resting within a center section of the bottom surface under the battery housing (Fig 2A, wherein element 220 is in the center of the patch and beneath 260); a battery held in the battery housing over the circuit board (Fig 2A element 250); a first pair of electrodes operable to contact the skin of the patient (Fig 2A elements 212 A-D, [0061]: “respectively, to provide electrical conductivity between the electrodes and the skin of the patient”) on an end section of the bottom surface of the enclosure adjacent to the center section of the bottom surface (Fig 2A elements 212 A-D, wherein the electrodes are on the base of the bottom surface, thus the end section, and wherein 212A and 212D are adjacent to the center).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the monitoring device disclosed by Kaib and Su to the patch shaped enclosure disclosed by Amurthur in order to make the device less obtrusive (Amurthur [0013]).
Regarding claim 36, Kaib discloses the monitoring device of claim 30, further comprising a second pair of electrode pads to which the respiratory sensor is coupled for injection of low-amplitude, high-frequency current ([0112]: " The wearable medical device 100 also includes a plurality of therapy electrodes 114 that are electrically coupled to the medical device controller 120 through the connection pod 130. The therapy electrodes 114 are configured to deliver one or more therapeutic defibrillating shocks to the body of the patient if it is determined that such treatment is warranted.").
Regarding claim 37, Kaib discloses the monitoring device of claim 30, wherein the enclosure has a form factor that is one of the group consisting of: a patch, a wristband, a necklace, and a vest ([0008]: " a vest worn about an upper body of the patient, a wrap-around garment, and shoulder straps.").
Regarding claim 38, Kaib further discloses the monitoring device of claim 30, wherein the plurality of sensors includes at least one of an audio sensor, an accelerometer, a gyroscope or a pressure sensor ([0116]: "the acoustic sensor circuitry, ").
Regarding claim 41, Kaib further discloses the monitoring device of claim 30, wherein the enclosure is fabricated from a flexible compliant material ([0119]: “such a garment may comprise at least an anterior portion (e.g., a flexible, substantially rigid, or substantially semi-rigid fabric or other material-based element of the garment disposed about the front of the patient”).
Regarding claim 116, Kaib further discloses the monitoring device of claim 30,wherein the respiratory sensor is an impedance plethysmography sensor([0171-0172]: “include ECG sensing electrodes and an associated circuitry …measure motion, volume, or tissue changes (e.g., trans-thoracic impedance techniques, rib inductance plethysmography”).
Regarding claim 120, Kaib further discloses the monitoring device of claim 30, wherein the battery is a rechargeable battery to power the plurality of sensors, memory and transceiver ([0184]: “may removably couple to one or more rechargeable batteries.”).
Regarding claim 121, Amurthur further discloses wherein the circuit board holds the plurality of sensors, memory and transceiver ([0062]: “components 230 comprise circuitry and components to take physiologic measurements, transmit data to remote center and receive commands from remote center. In many embodiments, electronics components 230 may comprise known low power circuitry, for example complementary metal oxide semiconductor (CMOS) circuitry components. Electronics components 230 comprise an activity sensor and activity circuitry, impedance circuitry and electrocardiogram circuitry, for example ECG circuitry.”).
Regarding claim 122, Kaib further discloses the monitoring device of claim 33, further comprising an adhesive accessory including a top layer ([0211]: “An example long term adhesive electrode for such use is described in U.S. Patent Publication No. 2013/0325096 entitled “LONG TERM WEAR MULTIFUNCTION BIOMEDICAL ELECTRODE,” published on Jan. 1, 2015 (hereinafter the “'096 publication”) which is hereby incorporated herein by reference in its entirety”; US 2013/0325096, hereinafter ‘096, Fig 5, para [0060]: “. An adhesive film layer 430”), wherein the surface includes an adhesive layer and a bottom protective layer (‘096 para [0060]: “The lower adhesive surface 432 of the adhesive film layer 430 and the conductive gel layers 425 may be covered with a protective film (not shown) to prevent the adhesive layer from unintentionally adhering to objects prior to use. The protective film may be removed prior to applying the electrode patch 400 to a subject.”), the top layer including a skirt and a cutout in a shape of the surface of the enclosure (‘096 Fig 5), wherein when the cutout is that when removed leaving the skirt in place (‘096 Fig 5 element 470, para [0063]: “A backing 470, which may have a stiffness greater than the adhesive film layer 430 may be secured to the upper surface 434 of the adhesive film layer 430”), exposes the adhesive layer is exposed for adherence to the surface of the enclosure (‘096 [0060]: “covered with a protective film (not shown) to prevent the adhesive layer from unintentionally adhering to objects prior to use. The protective film may be removed prior to applying the electrode patch 400 to a subject.”), and when the bottom protective layer is removed, the adhesive layer is exposed for adherence to the patient (‘096 [0060]).
Regarding claim 123, Kaib further discloses the monitoring device of claim 122, wherein each of electrode pads are connected to the skin of the patient through a hydrogel patch on the adhesive layer ([0211]: "the therapy electrode 114 can be adhesively coupled to the patient's skin and include hydrogel layers to promote conductivity. For example, a long term (e.g., 7 days or more) hydrogel-based electrode may be disposed on the patient's skin on a patient facing side, and coupled to the garment by a Velcro® brand hook-and-loop fastener on a non-patient facing side”).
Regarding claim 124, Kaib further discloses the monitoring device of claim 30, further comprising: a controller coupled to the memory and signal processor ([0139]: “a device controller and/or a connection pod) may be organized into one or more modules or subsystems as illustrated by the schematic block diagram of an example wearable medical device 300”, Fig 3) the controller programmed via a routine stored in the memory to refine physiological data from the plurality of sensors ([0150]: “For example, the processor arrangement 310 may include a digital signal processor (DSP) that receives and analyzes the sensor data to identify medical conditions that require treatment”).
Regarding claim 125, Kaib further discloses the monitoring device of claim 30 wherein the signal processor is coupled to the plurality of sensors and wherein the signal processor is operable to measure ECG and chest impedance ([0171-0172]: “include ECG sensing electrodes and an associated circuitry …measure motion, volume, or tissue changes (e.g., trans-thoracic impedance techniques, rib inductance plethysmography”).
Regarding claim 126, Amurthur discloses wherein the second pair of electrode pads are on an opposite end section of the bottom surface of the enclosure, the opposite end section adjacent to the center section of the bottom surface (Fig 2A elements 212 C and 212 D, wherein the end section may be the second half of the device).
Claims 119 is rejected under 35 U.S.C. 103 as being unpatentable over Kaib in view of Su in view of Amurthur in view of Mazar et al. (US 20160228060 A1), hereinafter, Mazar.
Regarding claim 119, Kaib as modified by Su and Amurthur discloses the device of claim 30 but fails to disclose a GPS receiver.
Mazar discloses a monitoring device (abstract) for monitoring patient vital signs via multiple sensors (abstract) that includes a GPS receiver ([0032]: “include a GPS unit or a radio signal triangulation based location determination device.”).
It would have been obvious to a person of ordinary skill in the art to modify the monitoring device disclosed by Kaib to include the GPS receiver disclosed by Mazar in order to enable tracking of users with mental diseases such as dementia who may become lost (Mazar [0032]).
Response to Arguments
Applicant's arguments filed 03/05/2026 have been fully considered but they are not persuasive. Applicant argues that Amurthur circuit boards positioned over electrodes and therefore does not disclose a circuit board in a center section with electrodes in an end section. However, the claim language does not specify that the circuit boards are adjacent to the electrodes, only that they are located in a center section and that the electrodes are adjacent to the center. Per Fig 2A, the electrodes 212A and 212D are laterally adjacent to a center portion, and the circuit board is located in a center of the patch. If the claim were to interpreted with the circuit boards adjacent to an electrode, the elements share a vertical boundary (note the position of the aperture 280 in direct contact with the circuit board) and are thus “adjacent”. Additionally, as the electrodes are positioned in the base of the enclosure, they are effectively in an “end section”. As such, the claim limitation is disclosed by Amurthur.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Yang (US 20170231520 A1) – discloses a PCB in the center of a monitoring device (Fig 2 element 13) adjacent to an electrode (Fig 2 element 31).
Liu et al. (CN 108209890 A) – discloses a patch based sensor with a circuit board in the center and electrodes adjacent (Fig 5 elements 5 and 6)
THIS ACTION IS MADE FINAL. 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.
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/KAVYA SHOBANA BALAJI/Examiner, Art Unit 3791
/DANIEL L CERIONI/Primary Examiner, Art Unit 3791
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