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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 2, 2026 has been entered.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 07/13/22 and 06/06/22 have been considered by the examiner.
Amendment Entered
In response to the amendment filed on March 2, 2026, amended claims 1-3, 10 and 13-15 have been entered.
Response to Arguments
Upon further consideration, Examiner has rejected the claims under 35 U.S.C. 101. Please see correct heading below for further detail.
Applicant’s arguments filed with respect to the prior art rejections raised in the previous office action were fully considered, but are moot in view of the current combination of references that were necessitated by amendment. Please see prior art section below for more detail, updated citations (Gopinathan, Sanghera, Park, Ghosh and Condie references), and updated obviousness rationale.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-11, 13-25 and 27-34 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 1 follows.
Regarding claim 1, the claim recites a medical device system comprising: an impedance measurement circuit configured to, for each of a plurality of impedance measurement electrode vectors, obtain an impedance measurement. Thus, the claim is directed to a machine, which is one of the statutory categories of invention
The claim is then analyzed to determine whether it is directed to any judicial exception. The following limitations set forth a judicial exception:
for each of a plurality of impedance measurement electrode vectors, obtain an impedance measurement
determine a thoracic impedance estimate by computing an equivalent impedance of a circuit model of thoracic impedance from the impedance measurements obtained for each of the plurality of impedance measurement electrode vectors
determine that the thoracic impedance estimate meets fluid status condition criteria;
detect a fluid status condition in response to the thoracic impedance estimate meeting the fluid status condition criteria;
generate an output in response to detecting the fluid status condition
These limitations set forth a judicial exception. These steps describe a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea.
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Claim 1 recites transmit a fluid status notification signal in response to the generated output and generate a display of the detected fluid status condition in response to the transmitted fluid status notification signal, which is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The transmitting and displaying of a fluid status notification does not provide an improvement to the technological field, the system does not effect a particular treatment or effect a particular change based on the model, nor does the method use a particular machine to perform the Abstract Idea.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites additional steps of:
a memory configured to store data relating to the thoracic impedance estimate in response to the generated output;
a telemetry circuit
a display unit
Additionally, claims 6 and 20 recite the additional limitation
a housing enclosing the impedance measurement circuit and the control circuit
a first electrode and a second electrode when the first and second electrodes are coupled to the impedance measurement circuit
The providing and recording steps are well-understood, routine and conventional activities for those in the field of medical diagnostics. Further, the providing and recording steps are each recited at a high level of generality such that it amounts to insignificant presolution activity, e.g., mere data gathering step necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering and comparing activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the obtaining and comparing steps do not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
Independent claims 15 and 28 are rejected for substantially similar reasons
Dependent claims 2-5, 7-11, 13, 14, 16-19, 21-25, 27 and 29-34 also fail to add something more to the abstract independent claims as they merely further limit the abstract idea. 1, 6, 15, 20, 28
Therefore, claims 1-11, 13-25 and 27-34 are not patent eligible under 35 USC 101.
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 1-3, 8-10, 13-17, 22-24, and 27, 28 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (US20140214110A1; hereinafter known as “Yang”; previously cited) in view of Gopinathan et al. (US20200054238A1; hereinafter known as “Gopinathan”).
Regarding claim 1, 15, and 28 Yang teaches a medical device system (See Yang Figure 3 part 300) comprising:
an impedance measurement circuit configured to obtain an impedance measurement between each of a plurality of impedance measurement electrode vectors (See Yang [0130], impedance measuring circuit coupled to switch which uses any desire electrode, single or multi-vector impedance measurements);
a control circuit (See Yang [0112][0130], microcontroller 421) configured to: determine a thoracic impedance estimate by computing an impedance of a circuit model of thoracic impedance using the impedance measurements (See Yang [0176], senses an electrical result at each of the different frequencies to determine an impedance of each vector from the electrical result sensed at the frequency associated with that vector), wherein the circuit model of thoracic impedance comprises a plurality of impedance elements extending between at least three terminals (See Yang Figure 12); determine that the thoracic impedance estimate meets fluid status condition criteria (See Yang [0012][0203]); detect a fluid status condition in response to the thoracic impedance estimate meeting the fluid status condition criteria (See Yang [0203], detects trending impedance and determines whether edema has started); generate an output in response to detecting the fluid status condition (See Yang [0166], receives an evaluation and makes a diagnosis); and a memory configured to store data relating to the thoracic impedance estimate in response to the generated output (See Yang [0121-0123], stores the impedance measurements for being processed later).
Yang is silent with respect to determine a thoracic impedance estimate by computing an equivalent impedance of a circuit model of thoracic impedance from the impedance measurements obtained for each of the plurality of impedance measurement electrode vectors, wherein the circuit model of thoracic impedance comprises a plurality of impedance elements including at least three impedance elements extending between at least three terminals.
Gopinathan teaches determine a thoracic impedance estimate by computing an equivalent impedance of a circuit model of thoracic impedance from the impedance measurements obtained for each of the plurality of impedance measurement electrode vectors, wherein the circuit model of thoracic impedance comprises a plurality of impedance elements including at least three impedance elements extending between at least three terminals [par. 39-43]
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to modify Yang to determine a thoracic impedance estimate by computing an equivalent impedance of a circuit model of thoracic impedance from the impedance measurements obtained for each of the plurality of impedance measurement electrode vectors, wherein the circuit model of thoracic impedance comprises a plurality of impedance elements including at least three impedance elements extending between at least three terminals as taught by Gopinathan to modify Yang’s system for determining fluid location (See Gopinathan [0042]). Regarding claim 2 and 16, Yang teaches that the control circuit (See Yang [0112][0130], microcontroller 421) is further configured to determine the thoracic impedance estimate by computing an impedance of the plurality of impedance elements of the circuit model (See Yang [0076], Multiple impedance vectors can be evaluated and/or weighted according to various schemata in order to cross-correlate the vectors). Yang is silent with respect to equivalent impedance, and plurality of at least three impedance elements of the circuit model. Gopinathan teaches an implanted device measuring impedance, and further teaches the equivalent impedance plurality of at least three impedance elements of the circuit model (See Gopinathan [0039-0043]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to modify Yang to have an equivalent impedance and plurality of at least three impedance elements of the circuit model as taught by Gopinathan to modify Yang’s system for determining fluid location (See Gopinathan [0042]). Regarding claim 3 and 17, Yang teaches that the impedance measurement circuit (See Yang [0130], impedance measuring circuit coupled to switch which uses any desire electrode, single or multi-vector impedance measurements)) is further configured to obtain each of the impedance of the measurements by measuring an impedance that includes a combination of at least two of the impedance elements of the circuit model (See Yang Figure 12 [0075][0083], impedance can be cross correlated).
Regarding claim 8 and 22, Yang teaches that the control circuit (See Yang [0112][0130], microcontroller 421) is further configured to determine the thoracic impedance estimate by determining an impedance of a single impedance element of the circuit model of thoracic impedance using the impedance measurements (See Yang [0076], Multiple impedance vectors can be evaluated and/or weighted according to various schemata in order to cross-correlate the vectors).
Regarding claim 9 and 23, Yang teaches that the control circuit is further configured to determine that the thoracic impedance estimate meets the fluid status criteria (See Yang [0012][0084], several impedance vectors can be used to detect fluid build-up) by: determining that the thoracic impedance estimate is outside a normal impedance range; and detecting a fluid status condition in response to the thoracic impedance estimate being outside the normal impedance range (See Yang [0087][0200][0203][0236], can detect and monitor impedance outside of normal ranges and relate it to a condition). Regarding claim 10 and 24, Yang teaches that the control circuit (See Yang [0112][0130], microcontroller 421) is further configured to determine that the thoracic impedance estimate meets the fluid status criteria (See Yang [0012][0203], system can determine swelling) by: establishing a baseline thoracic impedance; determining a fluid status index by determining a cumulative sum of differences between a plurality of consecutively determined thoracic impedance estimates and the baseline thoracic impedance (See Yang [0198] [0200], impedance difference between two states, also measures impedance across vectors, baseline value is 50-80 range); determining that the fluid status index crosses a threshold; and determining that the fluid status criteria are met in response to the fluid status index crossing the threshold (See Yang [0213], therapy module 640 can then use such a table to establish thresholds between a normal state and a fluid overload state.). Regarding claim 13, Yang teaches that the impedance measurement circuit is configured to obtain the impedance measurements from a plurality of impedance measurement electrode vectors comprising at least two electrodes carried by an extra- cardiac, implantable lead (See Yang [0070-0071], measuring impedance itself does not need to be from the same set of leads). Regarding claim 14, Yang teaches a telemetry circuit (See Yang [0124], telemetry circuit 464), that the control circuit is configured to: receive a user selection signal via the telemetry circuit (See Yang Figure 4 telemetry circuit), the user selection signal indicating at least one of a selectable impedance measurement electrode included in the plurality of the impedance measurement electrode vectors (See Yang [0069]), the circuit model of thoracic impedance, or one of the plurality of impedance elements of the circuit model; and determine the thoracic impedance estimate by computing the impedance of the circuit model of thoracic impedance according to the user selection signal (See Yang [0176], senses an electrical result at each of the different frequencies to determine an impedance of each vector from the electrical result sensed at the frequency associated with that vector). Regarding claim 27, Yang teaches receiving a user selection signal indicating at least one of a selectable impedance measurement electrode included in the plurality of the impedance measurement electrode vectors, the circuit model if thoracic impedance, or one of the plurality of impedance elements of the circuit model (See Yang [0069]); and determining the thoracic impedance estimate by computing the impedance of the circuit model of thoracic impedance according to the user selection signal (See Yang [0176], senses an electrical result at each of the different frequencies to determine an impedance of each vector from the electrical result sensed at the frequency associated with that vector).
Regarding claim 30, Yang teaches a therapy delivery circuit configured to: deliver a therapy; and adjust the therapy in response to the output generated by the control circuit (See Yang abstract and [0073]).
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Yang and Gopinathan in view of Goetz et al. (US20030176807A1; hereinafter known as “Goetz”). Regarding claim 29, Yang teaches the impedance measurement circuit is further configured to obtain the impedance measurement between each of a plurality of impedance measurement electrode vectors (See Yang [0004][0007]) by delivering a drive signal having a subthreshold amplitude that is less than a capture threshold of cardiac tissue (See Yang [0075]). Yang is silent to computing the equivalent impedance of the circuit model of thoracic impedance, determine the thoracic impedance estimate correlated to a high voltage impedance measurement without requiring the impedance measurement circuit to obtain a high voltage impedance measurement that requires a drive signal having an amplitude that is greater than the capture threshold of cardiac tissue; and the display unit being configured to display the fluid status condition detected based on the determined thoracic impedance estimate that is correlated to a high voltage impedance measurement without requiring a high voltage impedance measurement. Goetz teaches the control circuit is further configured to, compute the equivalent impedance of the circuit model of thoracic impedance (See Goetz Figure 5, impedance values between two electrodes), determine the thoracic impedance estimate correlated to a high voltage impedance measurement without requiring the impedance measurement circuit to obtain a high voltage impedance measurement that requires a drive signal having an amplitude that is greater than the capture threshold of cardiac tissue (See Goetz [0011] and claim 28); and display the fluid status condition detected based on the determined thoracic impedance estimate that is correlated to a high voltage impedance measurement without requiring a high voltage impedance measurement (See Goetz [0034][0037]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to modify Yang and Gopinathan to compute the equivalent impedance of the circuit model of thoracic impedance, determine the thoracic impedance estimate correlated to a high voltage impedance measurement without requiring the impedance measurement circuit to obtain a high voltage impedance measurement that requires a drive signal having an amplitude that is greater than the capture threshold of cardiac tissue; and the display unit being configured to display the fluid status condition detected based on the determined thoracic impedance estimate that is correlated to a high voltage impedance measurement without requiring a high voltage impedance measurement as taught by Goetz to modify Yang’s and Gopinathan’s system to provide information regarding the placement of the device with respect to the tissue and the integrity of the device itself (See Goetz [0008]).
Claims 4-7, 11, 18-21, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Yang and Gopinathan in view of Rabinovich et al. (US5749369A; hereinafter known as “Rabinovich”; previously cited) and Grimnes (“Impedance measurement of individual skin surface electrodes”; hereinafter known as “Grimnes”). Regarding claim 4 and 18, Yang teaches the control circuit (See Yang [0112][0130], microcontroller 421). Yang in view of Gopinathan is silent to computing the equivalent impedance of the circuit model from the impedance measurements by computing an equivalent impedance of a wye circuit model comprising three impedance elements of the plurality of impedance elements, wherein at least one of the impedance measurements corresponds to a series combination of at least two of the three impedance elements of the wye circuit model. Rabinovich teaches a device for measuring impedance (See Rabinovich abstract) and further teaches computing the equivalent impedance of the circuit model from the impedance measurements by computing an equivalent impedance of a circuit model comprising three impedance elements (See Rabinovich Col. 3 lines 25-34, three electrodes which are used to measure impedance), wherein at least one of the impedance measurements corresponds to a series combination of at least two of the three impedance elements of the circuit model (See Rabinovich Col. 3 lines 25-34, reference electrical circuit including the first electrode, the third electrode, and a second impedance measurement means for measuring a second electrical impedance). It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to provide Yang and Gopinathan with compute the equivalent impedance of the wye circuit model from the impedance measurements by computing an equivalent impedance of a circuit model comprising three impedance elements, wherein at least one of the impedance measurements corresponds to a series combination of at least two of the three impedance elements of the circuit model as taught by Rabinovich to monitor impedance of a biological object over an extended period from various electrodes (See Rabinovich Col. 3 lines 34-44, claim 5 and 8 also see Figure 5 there are three impedance elements Z7, Z8, Z10). Yang in view of Gopinathan in view of Rabinovich is silent with respect to a wye circuit model. Grimnes teaches a three electrode medical measurement system (See Grimnes 2.1, three electrodes) and further teaches a wye circuit model (See Grimnes 2.1). It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to modify Yang, Gopinathan and Rabinovich with a wye circuit model as taught by Grimnes to provide a mathematically consistent and accurate representation of distributed impedance in tissue (See Grimnes page 754 col. 2 last paragraph under table 3, page 752).
Regarding claim 5 and 19, Yang teaches the impedance measurement circuit (See Yang [0130], impedance measuring circuit coupled to switch which uses any desire electrode, single or multi-vector impedance measurements). Yang and Gopinathan are silent to obtaining at least one of the impedance measurements corresponding to a first impedance element of the three impedance elements of the wye circuit model in series with a parallel combination of a second impedance element and a third impedance elements of the wye circuit model. Rabinovich teaches obtaining at least one of the impedance measurements corresponding to a first impedance element of the three impedance elements of the wye circuit model (See Rabinovich Figure 5 and Z7, first impedance element) in series with a parallel combination of a second impedance element and a third impedance elements of the wye circuit model (See Rabinovich Figure 5 Z8, the second impedance element and Z10). It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to provide Yang and Gopinathan with a configuration to obtain at least one of the impedance measurements corresponding to a first impedance element of the three impedance elements of the wye circuit model in series with a parallel combination of a second impedance element and a third impedance elements of the wye circuit model as taught by Rabinovich to calculate impedance values of various electrodes to carry out long term monitoring of the electrical impedance of a biological object which can indicate a buildup of electrically conductive fluid in the body (See Rabinovich Col. 4 lines 17-20). Regarding claim 6 and 20, Yang teaches a housing enclosing the impedance measurement circuit and the control circuit (See Yang [0098], the device which includes the circuit is in a case 400 which can be a housing), wherein: the impedance measurement circuit is further configured to obtain the impedance measurements by determining at least: a first impedance measurement from a first impedance measurement electrode vector of the plurality of impedance measurement electrode vectors, and a second impedance measurement from a second impedance measurement electrode vector of the plurality of impedance measurement electrode vectors, (See Yang [0011], Multiple impedances measured over different vectors of such a multi-vector network are submitted to multi-vector data processing. This processing can take the form of cross-correlation or application of a cross co-variance function. In one instance, cross-correlation aims to find a similarity (or dissimilarity) of the multiple signals, for example, to find a value or feature in an unknown or deviant impedance signal by comparing it to one or more known signals), the control circuit is further configured to determine the thoracic impedance estimate by determining an equivalent impedance of a three terminal circuit model using the impedance measurements (See Yang [0176], senses an electrical result at each of the different frequencies to determine an impedance of each vector from the electrical result sensed at the frequency associated with that vector). Yang and Gopinathan are silent with respect to the first impedance measurement electrode vector being between a first electrode and a second electrode when the first and second electrodes are coupled to the impedance measurement circuit, the second impedance measurement electrode vector being between the first electrode and the housing; wherein the first impedance measurement corresponds to a series combination of a first impedance element and a second impedance element of the three terminal circuit model and the second impedance measurement corresponds to a series combination of the first impedance element and a third impedance element of the three terminal circuit model. Rabinovich teaches the first impedance measurement electrode vector being between a first electrode and a second electrode when the first and second electrodes are coupled to the impedance measurement circuit (See Rabinovich Figure 5, 100 and 103 electrodes and impedance measurement Z7), the second impedance measurement electrode vector being between the first electrode and the housing (See Rabinovich Figure 5, impedance takes the internal environment into account in relation to the reference circuit); wherein the first impedance measurement corresponds to a series combination of a first impedance element and a second impedance element of the three terminal circuit model and the second impedance measurement corresponds to a series combination of the first impedance element and a third impedance element of the three terminal circuit model (See Rabinovich Figure 5, the first impedance element Z7 and second impedance element Z8).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to provide Yang and Gopinathan with the first impedance measurement electrode vector being between a first electrode and a second electrode when the first and second electrodes are coupled to the impedance measurement circuit, the second impedance measurement electrode vector being between the first electrode and the housing; wherein the first impedance measurement corresponds to a series combination of a first impedance element and a second impedance element of the three terminal circuit model and the second impedance measurement corresponds to a series combination of the first impedance element and a third impedance element of the three terminal circuit model as taught by Rabinovich to calculate impedance values of various electrodes to carry out long term monitoring of the electrical impedance of a biological object which can indicate a buildup of electrically conductive fluid in the body (See Rabinovich Col. 4 lines 17-20). Regarding claim 7 and 21, Yang teaches the impedance measurement circuit is further configured to obtain the impedance measurements (See Yang [0130], impedance measuring circuit coupled to switch which uses any desire electrode, single or multi-vector impedance measurements) by obtaining a third impedance measurement from a third impedance measurement electrode vector of the plurality of impedance measurement electrode vectors (See Yang [0011], Multiple impedances measured over different vectors of such a multi-vector network are submitted to multi-vector data processing. This processing can take the form of cross-correlation or application of a cross co-variance function. In one instance, cross-correlation aims to find a similarity (or dissimilarity) of the multiple signals, for example, to find a value or feature in an unknown or deviant impedance signal by comparing it to one or more known signals). Yang and Gopinathan are silent with respect to the third impedance measurement electrode vector being between the first electrode and a combination of the second electrode and the housing. Rabinovich teaches the third impedance measurement electrode vector being between the first electrode and a combination of the second electrode and the housing (See Rabinovich Figure 5 part Zin). It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to provide Yang and Gopinathan with a third impedance measurement electrode vector being between the first electrode and a combination of the second electrode and the housing as taught by Rabinovich to calculate impedance values of various electrodes to carry out long term monitoring of the electrical impedance of a biological object and using a reference electrode to indicate any drift (See Rabinovich Col. 4 lines 17-20). Claims 11 and 25 rejected under 35 U.S.C. 103 as being unpatentable over Yang and Gopinathan in view of Rabinovich.
Regarding claim 11 and 25, Yang teaches the control circuit (See Yang [0112]) is further configured to determine the thoracic impedance estimate (See Yang [0130], measuring thoracic impedance). Yang and Gopinathan are silent to determine the impedance estimate by computing an impedance of one of a star circuit model of the plurality of impedance elements. Rabinovich teaches a device for measuring impedance (See Rabinovich abstract) and further determine the impedance estimate by computing an impedance of one of a star circuit model of the plurality of impedance elements (See Rabinovich Col. 3 lines 25-34, three electrodes which are used to measure impedance). It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to provide Yang and Gopinathan with determining the impedance estimate by computing an impedance of one of a star circuit model of the plurality of impedance elements by Rabinovich to monitor impedance of a biological object over an extended period from various electrodes (See Rabinovich Col. 3 lines 34-44, claim 5 and 8 also see Figure 5 there are three impedance elements Z7, Z8, Z10).
Claims 31 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Yang and Gopinathan in view of Sanghera (US20190299010A1; hereinafter known as “Sanghera”) and Park (US20100204593A1; hereinafter known as “Park”)
Regarding claim 31, Yang teaches the control circuit (See Yang [0112]) is further configured to determine the thoracic impedance estimate (See Yang [0130], measuring thoracic impedance). Yang and Gopinathan are silent to wherein: the therapy delivery circuit is further configured to deliver a high voltage cardioversion defibrillation shock between a plurality of extra-cardiac defibrillation electrodes and a housing; the impedance measurement circuit is further configured to: measure a high voltage impedance during the high voltage cardioversion defibrillation shock delivery; and the control circuit is further configured to: determine a baseline impedance based on the high voltage impedance; and determine that the thoracic impedance estimate meets the fluid status condition criteria by comparing the thoracic impedance estimate to the baseline impedance
Sanghera teaches the therapy delivery circuit is further configured to deliver a high voltage cardioversion defibrillation shock between a plurality of extra-cardiac defibrillation electrodes and a housing [par. 61]; the impedance measurement circuit is further configured to: measure a high voltage impedance during the high voltage cardioversion defibrillation shock delivery [par. 212, 213]; and the control circuit is further configured to: determine a baseline impedance based on the high voltage impedance [par. 212, 213]
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to provide Yang with the therapy delivery circuit is further configured to deliver a high voltage cardioversion defibrillation shock between a plurality of extra-cardiac defibrillation electrodes and a housing; the impedance measurement circuit is further configured to: measure a high voltage impedance during the high voltage cardioversion defibrillation shock delivery; and the control circuit is further configured to: determine a baseline impedance based on the high voltage impedance by Sanghera for recognizing a signal as defibrillation shock (See Sanghera [par. 212]).
Park teaches determine that the thoracic impedance estimate meets the fluid status condition criteria by comparing the thoracic impedance estimate to the baseline impedance [par. 28, 45]
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to provide Yang with the determining that the thoracic impedance estimate meets the fluid status condition criteria by comparing the thoracic impedance estimate to the baseline impedance by Park to identify a potential cause of pulmonary edema as being of cardiac or non-cardiac origin (See Park par. 28).
Regarding claim 33, Park further teaches the control circuit is further configured to: update the baseline impedance using the thoracic impedance estimate; determine a subsequent thoracic impedance estimate; and compare the subsequent thoracic impedance estimate to the updated baseline impedance [par. 45-48]
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to provide Yang with the control circuit is further configured to: update the baseline impedance using the thoracic impedance estimate; determine a subsequent thoracic impedance estimate; and compare the subsequent thoracic impedance estimate to the updated baseline impedance by Park to identify a potential cause of pulmonary edema as being of cardiac or non-cardiac origin (See Park par. 28).
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Yang, Gopinathan, Sanghera and Park in view of Ghosh (US20200094061A1; hereinafter known as “Ghosh”)
Regarding claim 32, Yang teaches the control circuit (See Yang [0112]) is further configured to determine the thoracic impedance estimate (See Yang [0130], measuring thoracic impedance). Yang, Gopinathan, Sanghera and Park are silent to the therapy delivery circuit is further configured to deliver a subthreshold drive signal that is less than a cardiac capture threshold; the impedance measurement circuit is further configured to, for each of the plurality of impedance measurement electrode vectors, obtain the impedance measurement in response to the subthreshold drive signal, wherein each of the plurality of measurement electrode vectors is an extra-cardiac electrode vector comprising at least two extra-cardiac electrodes selected from among the housing and/or the plurality of extra-cardiac defibrillation electrodes
Ghosh teaches the therapy delivery circuit is further configured to deliver a subthreshold drive signal that is less than a cardiac capture threshold [par. 122]; the impedance measurement circuit is further configured to, for each of the plurality of impedance measurement electrode vectors, obtain the impedance measurement in response to the subthreshold drive signal, wherein each of the plurality of measurement electrode vectors is an extra-cardiac electrode vector comprising at least two extra-cardiac electrodes selected from among the housing and/or the plurality of extra-cardiac defibrillation electrodes [par. 122]
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to provide Yang, Gopinathan, Sanghera and Park with the therapy delivery circuit is further configured to deliver a subthreshold drive signal that is less than a cardiac capture threshold; the impedance measurement circuit is further configured to, for each of the plurality of impedance measurement electrode vectors, obtain the impedance measurement in response to the subthreshold drive signal, wherein each of the plurality of measurement electrode vectors is an extra-cardiac electrode vector comprising at least two extra-cardiac electrodes selected from among the housing and/or the plurality of extra-cardiac defibrillation electrodes by Ghosh for encompassing a particular anatomical area of interest (See Ghosh par. 122).
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Yang, Gopinathan, Sanghera and Park in view of Condie (US20160287136 A1; hereinafter known as “Condie”)
Regarding claim 32, Yang teaches the control circuit (See Yang [0112]) is further configured to determine the thoracic impedance estimate (See Yang [0130], measuring thoracic impedance). Yang, Gopinathan, Sanghera and Park are silent to the control circuit is further configured to: obtain the impedance measurements for each of the plurality of impedance measurement electrode vectors by obtaining a specified number of impedance measurements that is equal to or greater than a number of impedance elements in the plurality of impedance elements in the circuit model of thoracic impedance; solve for an unknown impedance of each of the plurality of impedance elements in the circuit model using the impedance measurements; and compute the equivalent impedance of the circuit model of thoracic impedance from the solved for unknown impedances of each of the plurality of impedance elements
Condie teaches the control circuit is further configured to: obtain the impedance measurements for each of the plurality of impedance measurement electrode vectors by obtaining a specified number of impedance measurements that is equal to or greater than a number of impedance elements in the plurality of impedance elements in the circuit model of thoracic impedance [par. 73]; solve for an unknown impedance of each of the plurality of impedance elements in the circuit model using the impedance measurements [par. 73, 74]; and compute the equivalent impedance of the circuit model of thoracic impedance from the solved for unknown impedances of each of the plurality of impedance elements [par. 73, 74]
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to provide Yang, Gopinathan, Sanghera and Park with the control circuit is further configured to: obtain the impedance measurements for each of the plurality of impedance measurement electrode vectors by obtaining a specified number of impedance measurements that is equal to or greater than a number of impedance elements in the plurality of impedance elements in the circuit model of thoracic impedance; solve for an unknown impedance of each of the plurality of impedance elements in the circuit model using the impedance measurements; and compute the equivalent impedance of the circuit model of thoracic impedance from the solved for unknown impedances of each of the plurality of impedance elements by Condie as each of the N simultaneously measured electrodes 24 may be supported by a circuit to generate and measure the excitation current, so it may be desirable to limit N to less than the total number of electrodes by multiplexing the generation and measurement circuitry to multiple electrodes (See Condie par. 81).
Conclusion
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/GRACE L ROZANSKI/Examiner, Art Unit 3791
/ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
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