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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d) to the effective filing date of 03/28/2024. The certified copy for IN 202441025235 was filed on 10/21/2025 in parent Application No. 19/088329, which was filed on 03/24/2025.
Drawings
The drawings are objected to because Figs. 2A-5, 9B, 10, 12A-15, and 20-23 are low-resolution and not reproducible for publication purposes. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
In [0099], “In case of events such as fluid build-up, increased air-trapping, or a drop in minute ventilation, system 10 may be configured to generae an alert” should read “In case of events such as fluid build-up, increased air-trapping, or a drop in minute ventilation, system 10 may be configured to generate an alert”.
Appropriate correction is required.
Claim Objections
Claims 1, 4, 9, and 17 are objected to because of the following informalities:
In Claim 1, “a patch configured to be disposed non-invasively on skin of a patient” should read “a patch configured to be disposed non-invasively on skin of [[a]] the patient”.
In Claim 4, “The system of claim 1 wherein...” should read “The system of claim 1, wherein...”.
In Claim 9, “wherein the respiration parameters comprising one or more of respiration rate, minute ventilation, tidal volume, rapid shallow breathing index, inspiratory and expiratory time (I and E), I to E ratio and expiratory time constant” should read “wherein the respiration parameters comprise one or more of respiration rate, minute ventilation, tidal volume, rapid shallow breathing index, inspiratory and expiratory (I and E) time ”.
In Claim 17, “computing on the external analysis unit, based on the composite response, the ECG signal, PPG signal, the accelerometer signal, and analysis algorithms personalized for the patient, information reflecting a respiratory, cardiac and/or sleep staging of the patient” should read “computing on the external analysis unit, based on the composite response, the ECG signal, PPG signal, the accelerometer signal, and analysis algorithms personalized for the patient, information reflecting [[a]] the respiratory, cardiac and/or sleep staging of the patient”.
In Claim 17, “reading a SpO2 value” should read “reading an SpO2 value”.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “electronics unit” and “external analysis unit” in Claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim 1 is being interpreted under 35 U.S.C. § 112(f) as it:
Uses the nonce term “unit” for the apparatus performing the specified function
“unit” is linked with the transitional phrase “configured to” and modified by the functional language “apply an electrical stimulus simultaneously at a plurality of frequencies up to and including about 5.0 MHz through respective pairs of the at least four electrodes”
“unit is not modified by sufficient structure, material, or acts for performing the claimed function.
This claim will be interpreted in accordance with the disclosure of the applicant on [0022] and [0084] as a module comprising circuit boards, power and communications circuitry, and equivalents thereof.
Claim 1 is also being interpreted under 35 U.S.C. § 112(f) as it:
Uses the nonce term “unit” for the apparatus performing the specified function
“unit” is linked with the transitional phrase “configured to” and modified by the functional language “receive the composite response via the communications module and to present on the display screen information reflecting the respiratory, cardiac or sleep trends or status of the patient computed by the analysis algorithms based on the composite response”
“unit is not modified by sufficient structure, material, or acts for performing the claimed function.
This claim will be interpreted in accordance with the disclosure of the applicant on Claim 11 and [0024] as a mobile phone, a tablet, a purpose-built device, an external patient monitor, or a component of existing medical equipment and equivalents thereof.
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 1-24 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 1 recites “the external analysis unit configured to receive the composite response via the communications module and to present on the display screen information reflecting the respiratory, cardiac or sleep trends or status of the patient computed by the analysis algorithms based on the composite response”. There is insufficient antecedent basis for this limitation in the claim as there is no previous mention of analysis algorithms. Correspondingly, it is unclear if the analysis algorithms recited in Claim 5 are the same as the analysis algorithms recited in Claim 1, or different analysis algorithms. For the purposes of substantive examination, the examiner is construing this claim limitation as “the external analysis unit configured to receive the composite response via the communications module and to present on the display screen information reflecting the respiratory, cardiac or sleep trends or status of the patient computed by [[the]] analysis algorithms based on the composite response”. In addition, for the purposes of substantive examination, the examiner is construing Claim 5 to recite “wherein the external analysis unit is programmed to execute analysis algorithms...”
The term “about” in Claim 1 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For the purposes of substantive examination, the examiner is construing the term “about 5.0 MHz” as ±1 MHz, i.e. 4-6 MHz.
Claims 2-16 are rejected by virtue of dependence on Claim 1 and Claims 12-13 are rejected by virtue of dependence on Claim 5.
Claim 17 recites “A method of monitoring of respiratory, fluid, cardiac and/or sleep staging of a patient, the method comprising...”. There are two possible interpretations of this clause, one of which is indefinite. It is unclear if the potential parameters to be monitored are 1) respiratory staging, fluid staging, cardiac staging and/or sleep staging, or 2) respiratory, fluid, cardiac, and or sleep staging. If the Applicant intends for the clause to be interpreted the second way, then the phrases “monitoring respiratory”, and “monitoring cardiac”, which recite a verb followed by an adjective, are unclear because they are missing a noun. For the purposes of substantive examination, the examiner is construing this claim limitation as “A method of monitoring of respiratory activity, fluid status, cardiac activity and/or sleep staging of a patient, the method comprising...”.
Claims 18-24 are rejected by virtue of dependence on Claim 17.
Claim 23 recites the limitation " The method of claim 17, wherein the external analysis unit includes an input capability; the method further comprising inputting patient data used by the machine learning algorithms to personalize the equivalent electrical model, wherein the input patient data is selected from the group consisting of: height, weight, sex, age, body fat content, chest circumference, identification of current co-morbidities or relevant medical conditions and historical medical background information". There is insufficient antecedent basis for this limitation in the claim as there is no equivalent electrical model in parent Claim 17. For the purposes of substantive examination, the examiner is construing this claim limitation as “The method of claim [[17]] 18, wherein the external analysis unit includes an input capability; the method further comprising inputting patient data used by the machine learning algorithms to personalize the equivalent electrical model, wherein the input patient data is selected from the group consisting of: height, weight, sex, age, body fat content, chest circumference, identification of current co-morbidities or relevant medical conditions and historical medical background information”.
Claim 24 recites the limitation "wherein the analysis algorithms generate an alert when at least one of the thresholds is breached ". There is insufficient antecedent basis for this limitation in the claim as there is no threshold recited in parent Claim 17 or earlier in Claim 24. For the purposes of substantive examination, the examiner is construing this claim limitation as “wherein the analysis algorithms generate an alert when at least one [[of the]] threshold[[s]] is breached”.
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 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 1-4, 8-11, 14, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Dhillon et al (WO 2020227641 A1, hereinafter Dhillon) in view of Trapero Martin et al (US 11116448 B1, cited by applicant’s IDS, hereinafter Trapero Martin) and Reykhert (US 20210228116 A1, hereinafter Reykhert).
Regarding Claim 1, Dhillon discloses a system for monitoring a patient (See Figs. 1 and 7), comprising:
a patch (Element 10, Fig. 1) configured to be disposed non-invasively on skin of a patient (See Figs. 1 and 7; “A body-worn patch sensor for simultaneously measuring a blood pressure (BP), pulse oximetry (SpO2), and other vital signs and hemodynamic parameters from a patient featuring a sensing portion having a flexible housing that is worn entirely on the patient's chest and encloses a battery, wireless transmitter, and all the sensor's sensing and electronic components”, Abstract),
at least four electrodes disposed on the patch configured to contact the skin (Elements 41-42 and 47-48, Fig. 2) to perform broadband tissue response measurements, wherein two of the at least four electrodes also are configured to sense an ECG signal from the patient (“The electrode leads 41, 42, 47, 48 form two ‘pairs’ of leads, wherein one of the leads 41, 47 in each pair injects electrical current to measure IPG waveforms, and the other leads 42, 48 in each pair sense bio-electrical signals that are then processed by electronics in the central sensing/electronics module 30 to determine the ECG and IPG waveforms”, [0082]);
at least one accelerometer disposed on the patch, the accelerometer configured to be coupled to the skin to measure chest wall motion of the patient (“The patch sensor also includes a motion-detecting accelerometer, from which it can determine motion-related parameters such as posture, degree of motion, activity level, respiratory-induced heaving of the chest, and falls”, [0007]);
an electronics unit disposed on the patch (Element 30, Fig. 2; “electrical circuit”, [0049]-[0050]), the electronics unit having a communications module coupled to the patch (“The patch sensor features a sensing portion having a flexible housing that is worn entirely on the patient’s chest and encloses a battery, wireless transmitter, and all the sensor’s sensing and electronic components”, [0012]), the electronics unit configured to apply an electrical stimulus simultaneously at a plurality of frequencies (“the IPG sensor is configured to inject current at multiple frequencies into the patient’s chest”, [0030]) through respective pairs of the at least four electrodes (“The electrode leads 41, 42, 47, 48 form two ‘pairs’ of leads, wherein one of the leads 41, 47 in each pair injects electrical current to measure IPG waveforms”, [0082]) to generate a composite response corresponding to a plurality of responses simultaneously measured at each of the plurality of frequencies (“the IPG sensor is configured to inject current at multiple frequencies into the patient’s chest, and further configured to measure the current at multiple frequencies to determine the IPG waveform at multiple frequencies”, [0030]); and
an external analysis unit (Element 22, Fig. 1, Fig. 7) having an associated display screen (See Fig. 1), the external analysis unit configured to receive the composite response via the communications module (“As indicated above, in a typical use case, the patch sensor 10 continuously measures numerical and waveform data, and then sends this information wirelessly (as indicated by arrow 77) to a gateway 22, which can be a number of different devices. For example, the gateway 22 can be any device operating a short-range wireless (e.g., Bluetooth®) wireless transmitter, such as a mobile telephone, tablet computer, vital sign monitor, central station (e.g., nursing station in a hospital), hospital bed, ‘smart’ television set, single-board computer, infusion pump, syringe pump, or a simple plug-in unit”, [0096]) and to present on the display screen information reflecting the respiratory, cardiac or sleep trends or status of the patient computed by the analysis algorithms based on the composite response (See Fig. 1).
Dhillion discloses the claimed invention except for expressly disclosing wherein the electronics unit is removably disposed on the patch and configured to apply an electrical stimulus simultaneously at a plurality of frequencies up to and including about 5.0 MHz.
However Trapero Martin, which also discloses a system for monitoring a patient (Abstract), teaches wherein the electronics unit is removably disposed on the patch (“Example 45 is the wearable monitoring device of example(s) 44, further comprising a receptacle for receiving the electronics module, the receptacle being securable to the skin of the user, wherein the electronics module comprises one or more interlocking features that engage one or more corresponding interlocking features of the receptacle to removably secure the electronics module within the receptacle”, 51:17-24). It has been held by the federal courts making an apparatus separable is obvious to one of ordinary skill in the art. See MPEP 2144.04(V)(C). See In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Dhillon by making the electronics unit removably disposed on the patch.
Reykhert, which also discloses a system for monitoring a patient (See Abstract), teaches wherein the electronics unit (Element 200, Fig. 2; [0030]) is configured to apply an electrical stimulus simultaneously at a plurality of frequencies up to and including about 5.0 MHz (“in some examples, the voltage applied will be within the range of 1 MHz-160 MHz”, [0065]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Dhillon with Reykhert, because these frequencies provide additional information about blood glucose values from the ECG signals (See [0064]-[0066] of Reykhert).
Regarding Claim 2, modified Dhillon discloses the system of claim 1, further comprising a photoplethysmography sensor disposed on the patch (“The patch sensor features a sensing portion having a flexible housing that is worn entirely on the patient’s chest and encloses a battery, wireless transmitter, and all the sensor’s sensing and electronic components. The sensor measures ECG, IPG, PPG, and PCG waveforms, and collectively processes these determine BP and Sp02”, [0012]), a photoplethysmography probe configured for placement on an extremity of the patient, or both (As these claim limitation is part of an alternative list, they do not need to be expressly taught by the reference in order for the claim to be anticipated).
Regarding Claim 3, modified Dhillon discloses the system of claim 2, wherein at least one of one of the photoplethysmography sensor or photoplethysmography probe outputs a signal indicative of blood oxygen saturation (“The patch sensor features a sensing portion having a flexible housing that is worn entirely on the patient’s chest and encloses a battery, wireless transmitter, and all the sensor’s sensing and electronic components. The sensor measures ECG, IPG, PPG, and PCG waveforms, and collectively processes these determine BP and Sp02”, [0012]).
Regarding Claim 4, modified Dhillon discloses the system of claim 1, wherein the patch comprises a disposable adhesive portion (See Figs. 6A-6C) and a reusable portion (Element 30, Fig. 2), wherein the at least four electrodes contact the skin via biocompatible gel electrodes (“Disposable electrodes that measure ECG and IPG waveforms are typically worn on the patient’s chest or legs and include: i) a conductive hydrogel that contacts the patient”, [0004]) located on the disposable portion (“Disposable electrodes on a bottom surface of the patch sensor secure it to the patient’s body without requiring bothersome cables. The electrodes measure ECG and IPG waveform”, [0009]) and the accelerometer and electronics unit are located on the reusable portion (See Fig. 2).
Regarding Claim 8, modified Dhillon discloses the system of claim 3, wherein the display screen displays information ([0096])) comprising at least one of a fluid score of the patient (See Fig. 8C; “As described herein, patch sensors are provided that non-invasively measure vital signs such as HR, HRV, RR, Sp02, TEMP, and BP, along with complex hemodynamic parameters such as SV, CO, and FLUIDS”, [0006]), respiration parameters of the patient, ECG parameters or blood oxygen saturation (See Fig. 8B; As described herein, patch sensors are provided that non-invasively measure vital signs such as HR, HRV, RR, Sp02, TEMP, and BP, along with complex hemodynamic parameters such as SV, CO, and FLUIDS”, [0006]).
Regarding Claim 9, modified Dhillon discloses the system of claim 8, wherein the respiration parameters comprising one or more of respiration rate (“As described herein, patch sensors are provided that non-invasively measure vital signs such as HR, HRV, RR, Sp02, TEMP, and BP, along with complex hemodynamic parameters such as SV, CO, and FLUIDS”, [0066]), minute ventilation, tidal volume, rapid shallow breathing index, inspiratory and expiratory time (I and E), I to E ratio and expiratory time constant (As these claim limitation is part of an alternative list, they do not need to be expressly taught by the reference in order for the claim to be anticipated).
Regarding Claim 10, modified Moyer discloses the system of claim 8, wherein the ECG parameters include one or more of heart rate (See Fig. 8A; As described herein, patch sensors are provided that non-invasively measure vital signs such as HR, HRV, RR, Sp02, TEMP, and BP, along with complex hemodynamic parameters such as SV, CO, and FLUIDS”, [0006]), heart rate variability (See Fig. 8A; As described herein, patch sensors are provided that non-invasively measure vital signs such as HR, HRV, RR, Sp02, TEMP, and BP, along with complex hemodynamic parameters such as SV, CO, and FLUIDS”, [0006]), or detection of arrythmia or tachycardia (As this claim limitation is part of an alternative list, it does not need to be expressly taught by the reference in order for the claim to be anticipated).
Regarding Claim 11, modified Dhillon discloses the discloses the system of claim 1, wherein the patch is battery-operated (“The patch sensor measures all of the above-mentioned properties while featuring a comfortable, easy-to-wear form factor. It is lightweight (e.g., about 20 grams) and powered with a rechargeable battery”, [0011]), the external analysis unit (Element 22, Fig. 1) comprises a WiFi or cellular telephony module (“The gateway 22 wirelessly forwards information (as indicated by arrow 87) from the patch sensor 10 to a cloud-based software system 200. Typically, this is done with a wireless cellular radio, or one based on an 802.11a-g protocol”, [0096]), and the external analysis unit is selected from the group consisting of a mobile phone, a tablet, a purpose-built device, an external patient monitor, and a component of existing medical equipment (“the gateway 22 can be any device operating a short-range wireless (e.g., Bluetooth®) wireless transmitter, such as a mobile telephone, tablet computer, vital sign monitor, central station (e.g., nursing station in a hospital), hospital bed, ‘smart’ television set, single-board computer, infusion pump, syringe pump, or a simple plug-in unit”, [0096]).
Regarding Claim 14, modified Dhillon discloses the system of claim 1, wherein the at least four electrodes are split into two pairs with smaller intra-pair spacing than inter-pair spacing (See Fig. 2).
Regarding Claim 16, modified Dhillon discloses the system of claim 1, the analysis algorithms are trained to automatically compute thresholds (“Before a measurement, the buzzer generates an acoustic sound at a known amplitude and frequency. The acoustic sensor measures the sound, and then compares its amplitude (or frequency) to other historical measurements to determine how well the acoustic sensor is coupled to the patient.”, [00115]) and to generate an alert when at least one of the thresholds is breached (“An amplitude that is relatively low, for example, indicates that the sensor is poorly coupled. This scenario may result in an alarm alerting the user that the sensor should be reapplied”, [00115]).
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Dhillon in view of Trapero Martin and Reykhert, and further in view of Dutta et al (US 20220369947 A1, cited in applicant’s IDS, hereinafter Dutta).
Regarding Claim 6, modified Dhillon discloses the system of claim 1. Modified Dhillon discloses the claimed invention except for expressly disclosing wherein the plurality of the responses are corrected for known parasitic effects using calibration parameters determined a priori and are used to continuously monitor a corrected composite response of bodily tissues and contact impedances of each of the at least four electrodes at each of the plurality of frequencies.
However, Dutta, which also discloses a system for monitoring a subject (Abstract), teaches wherein the plurality of the responses are corrected for known parasitic effects using calibration parameters determined a priori (“a method is provided for estimating an impedance matrix of parasitic network disposed between a first network and a second network of a bio-impedance measurement system, the method comprising determining an impedance matrix for the first network (ZMUX) based on an impedance matrix for the second network (ZLOAD) for at least one known load condition”, Abstract; “Measurements are calibrated with respect to RCAL. Measurements are taken on known loads in the factory to estimate the intervening parasitic network. The parasitic network is calibrated and calibration parameters are stored in flash memory. The calibration parameters are later used to de-embed any loads to estimate the load impedance matrix”, [0026]) and are used to monitor a corrected composite response of bodily tissues and contact impedances at each of the plurality of frequencies (“fitting ZMUX values for ZLOAD for the at least one known load condition to estimate parameters of the impedance matrix of the intervening network”, Abstract). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Dhillon with Dutta, such that the plurality of the responses are corrected for known parasitic effects using calibration parameters determined a priori and are used to continuously monitor a corrected composite response of bodily tissues and contact impedances of each of the at least four electrodes at each of the plurality of frequencies, because measuring bio-impedance and the contact impedances means that respiration activity can be obtained even in the presence of motion, and users such as athletes and patients can greatly benefit from such applications (Dutta, [0022]).
Regarding Claim 7, modified Dhillon discloses the system of claim 6. Modified Dhillon discloses the claimed invention except for expressly disclosing wherein the corrected composite response of the bodily tissues at each of the plurality of frequencies is further corrected with obtained values of contact impedances at each of the plurality of frequencies. However, Dutta teaches wherein the corrected composite response of the bodily tissues at each of the plurality of frequencies is further corrected (“By configuring mux 112 and making multiple current measurements, it is possible to derive the (unknown) impedances of the system, including the unknown bio-impedance network Z.sub.BODY (also referred to interchangeably herein as Z.sub.LOAD) and the impedances of the parasitic network, based on a system of equations.”, [0048) with obtained values of contact impedances at each of the plurality of frequencies (“The different signal paths, individually, can include two or more of the unknown impedances of the system: the unknown bio-impedance network Z.sub.BODY, and the contact impedances Z.sub.E1, Z.sub.E2, Z.sub.E3, and Z.sub.E4.”, [0048]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Dhillon with Dutta, such that, because measuring bio-impedance and the contact impedances means that respiration activity can be obtained even in the presence of motion, and users such as athletes and patients can greatly benefit from such applications (Dutta, [0022]).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Dhillon in view of Trapero Marti and Reykhert, and further in view of Stahmann et al (US 20060258952 A1, hereinafter Stahmann).
Regarding Claim 15, modified Dhillon discloses the system of claim 1. Modified Dhillon discloses the claimed invention except for expressly disclosing wherein the system is designed to accept user inputs for thresholds for contact impedances of the at least four electrodes and for fluid score, ECG parameters, PTT, SpO2 and respiration parameters. However, Stahmann, which also discloses a method of monitoring a patient (Abstract), teaches wherein the system is designed to accept user inputs for thresholds for contact impedances of the at least four electrodes (“The user input device 105 provides a means for the subject, caregiver or other user to input data, such as physiologic information about the subject, parameters associated with a pulmonary edema event, a user-programmable thoracic impedance detection level (e.g., threshold)”, [0090]) and for fluid score, ECG parameters, and respiration parameters (“In another example, an indication of breathing difficulty is entered into parameter collection device 150 by the subject at external user interface 104 or 140 based on a sensation of difficult or uncomfortable breathing experienced by the subject…difficulty breathing (which, in one example, is indicated by a low blood oxygen level) may correlate to an indication of pulmonary edema”, [0090]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Dhillon with Stahmann (and to extend the user input thresholds for additional parameters such as PTT and SpO2), because all of the claimed elements were known in the prior art before the effective filing date of the claimed invention, and one with ordinary skill in the art could have combined all the claimed elements by known methods, and the result would have been obvious to one of ordinary skill in the art.
Claims 17, 20, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Dhillon in view of Trapero Martin and Reykhert, and further in view of Kinast et al (US 20170027456 A1, hereinafter Kinast).
Regarding Claim 17, Dhillon discloses a method of monitoring of respiratory, fluid, cardiac and/or sleep staging of a patient, the method comprising:
providing a patch (Element 10, Fig. 1) to be disposed non-invasively on skin of a patient (See Figs. 1 and 7; “A body-worn patch sensor for simultaneously measuring a blood pressure (BP), pulse oximetry (SpO2), and other vital signs and hemodynamic parameters from a patient featuring a sensing portion having a flexible housing that is worn entirely on the patient's chest and encloses a battery, wireless transmitter, and all the sensor's sensing and electronic components”, Abstract), the patch having an electronics unit (Element 30, Fig. 2; “electrical circuit”, [0049]-[0050]) including a communications module (“The patch sensor features a sensing portion having a flexible housing that is worn entirely on the patient’s chest and encloses a battery, wireless transmitter, and all the sensor’s sensing and electronic components”, [0012]), at least four electrodes configured to contact the skin (Elements 41-42 and 47-48, Fig. 2), an accelerometer (“The patch sensor also includes a motion-detecting accelerometer, from which it can determine motion-related parameters such as posture, degree of motion, activity level, respiratory-induced heaving of the chest, and falls”, [0007]) and an external analysis unit (Element 22, Fig. 1, Fig. 7) having an associated display screen (See Fig. 1);
applying the patch to the skin of the patient (See Fig. 1);
activating the electronics unit to apply an electrical stimulus simultaneously at a plurality of frequencies (“the IPG sensor is configured to inject current at multiple frequencies into the patient’s chest”, [0030]) through respective pairs of the at least four electrodes (“The electrode leads 41, 42, 47, 48 form two ‘pairs’ of leads, wherein one of the leads 41, 47 in each pair injects electrical current to measure IPG waveforms”, [0082]);
sensing an ECG using two of the at least four electrodes to generate an ECG signal (“The electrode leads 41, 42, 47, 48 form two ‘pairs’ of leads, wherein one of the leads 41, 47 in each pair injects electrical current to measure IPG waveforms, and the other leads 42, 48 in each pair sense bio-electrical signals that are then processed by electronics in the central sensing/electronics module 30 to determine the ECG and IPG waveforms”, [0082]);
sensing with the accelerometer chest wall motion of the patient to generate an accelerometer signal (“The patch sensor also includes a motion-detecting accelerometer, from which it can determine motion-related parameters such as posture, degree of motion, activity level, respiratory-induced heaving of the chest, and falls”, [0007]);
sensing a PPG signal using a sensor disposed on the patch (“The patch sensor features a sensing portion having a flexible housing that is worn entirely on the patient’s chest and encloses a battery, wireless transmitter, and all the sensor’s sensing and electronic components. The sensor measures ECG, IPG, PPG, and PCG waveforms, and collectively processes these determine BP and Sp02”, [0012]);
generating in the electronics unit a composite response corresponding to a plurality of responses simultaneously measured at each of the plurality of frequencies (“the IPG sensor is configured to inject current at multiple frequencies into the patient’s chest, and further configured to measure the current at multiple frequencies to determine the IPG waveform at multiple frequencies”, [0030]);
sending the composite response, ECG signal, PPG signal, SpO2 value and the accelerometer signal via the communications module to the external analysis unit (“As indicated above, in a typical use case, the patch sensor 10 continuously measures numerical and waveform data, and then sends this information wirelessly (as indicated by arrow 77) to a gateway 22, which can be a number of different devices. For example, the gateway 22 can be any device operating a short-range wireless (e.g., Bluetooth®) wireless transmitter, such as a mobile telephone, tablet computer, vital sign monitor, central station (e.g., nursing station in a hospital), hospital bed, ‘smart’ television set, single-board computer, infusion pump, syringe pump, or a simple plug-in unit”, [0096]);
computing on the external analysis unit, based on the composite response, the ECG signal, PPG signal, the accelerometer signal (“The gateway 22 wirelessly forwards information (as indicated by arrow 87) from the patch sensor 10 to a cloud-based software system 200. Typically, this is done with a wireless cellular radio, or one based on an 802.11a-g protocol. There, it can be consumed and processed by a variety of different software systems, such as an EMR, a third-party software system, or a data-analytics engine”, [0096]), and
analysis algorithms personalized for the patient ([0107]), information reflecting a respiratory, cardiac (“a patient-specific calibration can be determined by measuring reference blood pressure values and corresponding heart sound amplitudes during a calibration measurement, which proceeds an actual measurement. Data from the calibration measurement can then be fit as described above to determine the patient- specific calibration, which is then used going forward to convert heart sounds into blood pressure values”, [0107]) and/or sleep staging of the patient; and displaying on the information on a display screen of the external analysis unit (See the display screen of element 22, Fig. 2).
Dhillon discloses the claimed invention except for expressly disclosing providing an external photoplethysmographic sensor on a probe configured for placement on an extremity of the patient;
activating the electronics unit to apply an electrical stimulus simultaneously at a plurality of frequencies in a range up to and including 5.0 MHz through respective pairs of the at least four electrodes; and
reading a SpO2 value from the external photoplethysmographic sensor.
However, Reykhert, which also discloses a method for monitoring a patient (See Abstract), teaches wherein the electronics unit (Element 200, Fig. 2; [0030]) is configured to apply an electrical stimulus simultaneously at a plurality of frequencies up to and including about 5.0 MHz (“in some examples, the voltage applied will be within the range of 1 MHz-160 MHz”, [0065]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Dhillon with Reykhert, because these frequencies provide additional information about blood glucose values from the ECG signals (See [0064]-[0066] of Reykhert).
Kinast, which also discloses a method for monitoring a patient (See Fig. 4), teaches providing an external photoplethysmographic sensor on a probe (Element 550, Fig. 5) configured for placement on an extremity of the patient (“The optical sensor 102 can include one or more emitters that shine one or more wavelengths of light through tissue of a living person, such as through a finger, toe, or foot”, [0032]); and
reading a SpO2 value (“The optical sensor 102 can use spectrophotometry techniques to measure a variety of blood constituents, including for example, oxygen saturation...”, [0032]) from the external photoplethysmographic sensor (“An optical sensor 552 can also be coupled to the patient 510. The optical sensor 552 can provide any of the plethysmograph waveforms illustrated in FIGS. 2A and 2B and/or the optical sensor data 104 described above in connection with FIG. 1. The illustrated optical sensor 552 can be coupled to oximeter unit 550 via cable 554.”, [0071]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add the external photoplethysmographic sensor of Kinast to the method of modified Dhillon, because all of the claimed elements were known in the prior art before the effective filing date of the claimed invention, and one with ordinary skill in the art could have combined all the claimed elements by known methods, and the result would have been obvious to one of ordinary skill in the art.
Regarding Claim 20, modified Dhillon discloses the method of claim 17, wherein the electronics unit sends the composite response, ECG signal, PPG signal, SpO2 value and accelerometer signal to the external analysis unit using Bluetooth or a near-field transmission technology (“As indicated above, in a typical use case, the patch sensor 10 continuously measures numerical and waveform data, and then sends this information wirelessly (as indicated by arrow 77) to a gateway 22, which can be a number of different devices. For example, the gateway 22 can be any device operating a short-range wireless (e.g., Bluetooth®) wireless transmitter, such as a mobile telephone, tablet computer, vital sign monitor, central station (e.g., nursing station in a hospital), hospital bed, ‘smart’ television set, single-board computer, infusion pump, syringe pump, or a simple plug-in unit”, [0096]).
Regarding Claim 24, modified Dhillon discloses the method of claim 17, wherein the analysis algorithms generate an alert when at least one of the thresholds is breached (“Before a measurement, the buzzer generates an acoustic sound at a known amplitude and frequency. The acoustic sensor measures the sound, and then compares its amplitude (or frequency) to other historical measurements to determine how well the acoustic sensor is coupled to the patient. An amplitude that is relatively low, for example, indicates that the sensor is poorly coupled. This scenario may result in an alarm alerting the user that the sensor should be reapplied”, [00115]; see the rejection of this claim under 35 U.S.C. § 112(b)), the method further comprising manifesting the alert on the external analysis unit (“An amplitude that is relatively low, for example, indicates that the sensor is poorly coupled. This scenario may result in an alarm alerting the user that the sensor should be reapplied”, [00115]; it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to manifest the alert on the external analysis unit).
Claims 19 is rejected under 35 U.S.C. 103 as being unpatentable over Dhillon in view of Trapero Martin, Reykhert and Kinast, and further in view of Dutta.
Regarding Claim 19, modified Dhillon discloses the method of claim 17. Modified Dhillon discloses the claimed invention except for expressly disclosing wherein the equivalent electrical model is adjusted to correct for known parasitic effects of the patch using calibration parameters determined a priori. However, Dutta, which also discloses a method for monitoring a subject (Abstract), teaches wherein the equivalent electrical model (“A proposed method includes a model of a generalized body network (also referred as the load network)”, [0041]) is adjusted to correct for known parasitic effects of the patch using calibration parameters determined a priori (“a method is provided for estimating an impedance matrix of parasitic network disposed between a first network and a second network of a bio-impedance measurement system, the method comprising determining an impedance matrix for the first network (ZMUX) based on an impedance matrix for the second network (ZLOAD) for at least one known load condition”, Abstract; “Measurements are calibrated with respect to RCAL. Measurements are taken on known loads in the factory to estimate the intervening parasitic network. The parasitic network is calibrated and calibration parameters are stored in flash memory. The calibration parameters are later used to de-embed any loads to estimate the load impedance matrix”, [0026]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify further Dhillon with Dutta, because measuring bio-impedance and the contact impedances means that respiration activity can be obtained even in the presence of motion, and users such as athletes and patients can greatly benefit from such applications (Dutta, [0022]).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Dhillon in view of Trapero Martin, Reykhert and Kinast, and further in view of Cory et al (US 20060085049 A1, hereinafter Cory).
Regarding Claim 18, modified Dhillon discloses the method of claim 17, wherein the analysis algorithms are personalized for the patient corresponding to an equivalent electrical model (“By conducting tissue discrimination scans across a range of frequencies, such as from approximately 10 Hz through approximately 10 kHz, the data may be used to estimate resistance R and capacitance C of the RC equivalent circuit element representing tissue”, [0170]) personalized by machine learning algorithms (“Different tissue types are expected to exhibit different R and C values, and therefore the calculated values (e.g., R and C) may be used to identify the type of tissue underlying each electrode, such as in a table look up or filtering algorithm, i.e., neural network or fuzzy logic algorithm”, [0170]) trained on a dataset from a healthy patient population having diverse physiologic characteristics (“By gathering measurement data for a range of tissue types from a range of subjects, characteristic R and C values can be determined, tabulated and stored in memory for use in an automated imaging, diagnostic and tissue discrimination system. Since the RC characteristics of tissues may vary from person to person and even from location to location on a given person, it is expected that the coefficient data may best be used in a filtering algorithm (such as are well known in the computer science art) which can accommodate such variability”, [0170]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Dhillon with Cory (such that the method steps of Cory are responsive to activation of the electronics unit, and are installed on the external analysis unit of Dhillon), because by knowing which tissue types are present, at least fluid status and/or fluid score can be understood with more context.
Claims 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Dhillon in view of Trapero Martin, Reykhert and Kinast, and further in view of Starkov et al (US 20200305833 A1, hereinafter Starkov).
Regarding Claim 21, modified Dhillon discloses the method of claim 17, wherein the external analysis unit communicates with the server via the WiFi or cellular telephony module (“the gateway 22 wirelessly forwards information (as indicated by arrow 87) from the patch sensor 10 to a cloud-based software system 200. Typically, this is done with a wireless cellular radio, or one based on an 802.11a-g protocol. There, it can be consumed and processed by a variety of different software systems, such as an EMR, a third-party software system, or a data-analytics engine”, [0096]). Modified Dhillon discloses the claimed invention except for expressly disclosing wherein personalization of the analysis algorithms is performed by using machine learning algorithms and dataset that reside on a server. However, Starkov, which also discloses a method for monitoring a subject (See Abstract), teaches wherein personalization (“building a supervised database comprising said user-specific database”, [0015]) of the analysis algorithms (See Fig. 6, Box 3; “extracted features from the chest signal 21 are used by the machine-learning classification or regression method for determining the confidence criterion. The machine-learning classification or regression method, comprising hyperparameters, is trained on the supervised database”, [0110]) is performed by using machine learning algorithms and dataset that reside on a server (“Personalizing the step of processing can comprise complementing user-specific data to other users data already available, for example available from a remote server, when building the supervised database and computer software expert model that is fitted to the user”, [0108]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of modified Dhillon with Starkov, because this is a way to ensure the analysis algorithms are reliable accurate for the user’s specific needs.
Regarding Claim 22, modified Dhillon discloses the method of claim 21, wherein the external analysis unit and the server communicate when the patch is applied to a patient and initially activated (“As indicated above, in a typical use case, the patch sensor 10 continuously measures numerical and waveform data, and then sends this information wirelessly (as indicated by arrow 77) to a gateway 22, which can be a number of different devices. For example, the gateway 22 can be any device operating a short-range wireless (e.g., Bluetooth®) wireless transmitter, such as a mobile telephone, tablet computer, vital sign monitor, central station (e.g., nursing station in a hospital), hospital bed, ‘smart’ television set, single-board computer, infusion pump, syringe pump, or a simple plug-in unit. The gateway 22 wirelessly forwards information (as indicated by arrow 87) from the patch sensor 10 to a cloud-based software system 200. Typically, this is done with a wireless cellular radio, or one based on an 802.11a-g protocol. There, it can be consumed and processed by a variety of different software systems, such as an EMR, a third-party software system, or a data-analytics engine”, [0096]; it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to start this procedure as soon as the patch is applied to the patient and initially activated).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Dhillon in view of Trapero Martin, Reykhert and Kinast, and further in view of Stichting (DE 202016104065 U1, hereinafter Stichting).
Regarding Claim 23, Dhillon discloses the method of claim 17, wherein the external analysis unit includes an input capability (“The patch sensor wirelessly transmits information to an external gateway (e.g., tablet, smartphone, or non-mobile, plug-in system) which can integrate with existing hospital infrastructure and notification systems, such as a hospital electronic medical records (EMR) system.”, [0006]; smartphones have input capabilities).
Modified Dhillon discloses the claimed invention except for expressly disclosing wherein the method further comprising inputting patient data used by the machine learning algorithms to personalize the equivalent electrical model, wherein the input patient data is selected from the group consisting of: height, weight, sex, age, body fat content, chest circumference, identification of current co-morbidities or relevant medical conditions and historical medical background information.
However Stichting teaches wherein the method further comprising inputting patient data used by the machine learning algorithms (“An example of how function 30 may be constructed is, for example, the use of multiple regression analysis based on a series of reference measurements on reference persons, such as 500 persons, in a reference group. It is noted that other machine learning techniques, i.e., techniques using a classification algorithm derived by using a reference group as a trial setup, may be applied. The total water content of a body can be measured at each of the reference subjects by using a conventional method, such as by using whole body impedance measurement. Function 30 may therefore be derived from the result obtained by a machine learning technique with input values including measurements at a reference group”, [0068]) to personalize the equivalent electrical model (“Function 30 may include, for example, attempting a Cole-Cole adjustment to estimate the total water content of a body”, [0068]), wherein the input patient data is selected from the group consisting of: height, weight, sex, age, body fat content, chest circumference, identification of current co-morbidities or relevant medical conditions and historical medical background information (“The function 30 has the following input parameters: body impedance 31, user-specific parameter 32, movement and/or posture parameters 33 and body parameters 34”, [0064]; “The user-specific parameter 32 may include one or more user-specific parameters. The user-specific parameter 32 is a parameter specific to the user, in particular for the body of the user. The user-specific parameter may include a parameter that matches a demographic parameter of the user. Non-limiting examples of user-specific parameters are sex, age, height, weight, disease, ethnicity, body mass index, body fat, and the scope of body parts such as a thorax/chest, waist, leg, thigh, and abdomen.”, [0065]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Dhillon with Stichting, because personalizing the equivalent electrical model with specific user patient data would make the model more accurate.
Examiner’s Note
The Examiner notes that the claims have not been rejected under 35 U.S.C. § 101 as the clause “the electronics unit configured to apply an electrical stimulus simultaneously at a plurality of frequencies up to and including about 5.0 MHz through respective pairs of the at least four electrodes to generate a composite response corresponding to a plurality of responses simultaneously measured at each of the plurality of frequencies” is considered to amount to significantly more than the judicial exception for substantially the same reasons as in parent case 19/088329. See the Interview Summary for parent case 19/088329 dated 31 July 2025.
The Examiner notes Claims 5 and 12-13 are not currently rejected under prior art.
Regarding Claim 5, the closest prior art, Cory, teaches a system wherein the external analysis unit is programmed to execute analysis algorithms corresponding to an equivalent electrical model (“By conducting tissue discrimination scans across a range of frequencies, such as from approximately 10 Hz through approximately 10 kHz, the data may be used to estimate resistance R and capacitance C of the RC equivalent circuit element representing tissue”, [0170]) personalized by machine learning algorithms (“Different tissue types are expected to exhibit different R and C values, and therefore the calculated values (e.g., R and C) may be used to identify the type of tissue underlying each electrode, such as in a table look up or filtering algorithm, i.e., neural network or fuzzy logic algorithm”, [0170]) trained on a dataset from a patient population having diverse physiologic characteristics (“By gathering measurement data for a range of tissue types from a range of subjects, characteristic R and C values can be determined, tabulated and stored in memory for use in an automated imaging, diagnostic and tissue discrimination system. Since the RC characteristics of tissues may vary from person to person and even from location to location on a given person, it is expected that the coefficient data may best be used in a filtering algorithm (such as are well known in the computer science art) which can accommodate such variability”, [0170]).
However, there is no prior art reference or obvious combination of references in the same field of invention that discloses wherein parameters of the equivalent electrical model are selected from the group comprising an extravascular resistance and capacitance structure, an intravascular resistance and capacitance structure, and a capacitive membrane separating the extravascular and intravascular regions.
The Examiner notes this limitation is not rejected under prior art for substantially the same reasons as in parent case 19/088329.
The following claims are not rejected under prior art by virtue of dependence on Claim 5:
12. The system of claim 5, wherein the machine learning algorithms and dataset that are used to personalize the equivalent electrical model reside on a server, and the external analysis unit communicates with the server via a WiFi or cellular telephony module.
13. The system of claim 5, wherein the external analysis unit includes an input capability to input patient data used by the machine learning algorithms to personalize the equivalent electrical model, the input patient data selected from the group consisting of: height, weight, sex, age, body fat content, chest circumference, identification of current co-morbidities or relevant medical conditions and historical medical background information.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
See Vosch (US 20070073132 A1)
See Shao (US 12262981 B1).
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/JONATHAN E. COOPER/Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791
