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 . Status of Claims
This office action is responsive to the amendment filed on 7/1/2025. As directed by the
Amendment, claims 29 and 30 have been added, claims 1-11, 13-18, 28 have been currently amended, and claims 12 and 26 have been canceled. Thus, claims 1-11, 13-25, and 27-30 remain pending. 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 27-30 rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (US20140214110A1; hereinafter known as “Yang”; previously cited) in view of Goetz et al. (US20030176807A1; hereinafter known as “Goetz”).
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 computing an equivalent impedance, a plurality of impedance elements including at least three impedance elements extending between at least three terminals, a telemetry circuit configured to transmit a status notification signal in response to the generated output; and a display unit configured to generate a display of the detected status condition in response to the transmitted status notification signal.
Goetz teaches an implanted device measuring impedance (See Goetz abstract), and further teaches computing an equivalent impedance (See Goetz Figure 5, impedance values between two electrodes), a plurality of impedance elements including at least three impedance elements extending between at least three terminals (See Goetz [0007][0011], set of electrodes determines the impedance), telemetry circuit configured to transmit a status notification signal in response to the generated output (See Goetz [0028]); and a display unit configured to generate a display of the detected status condition in response to the transmitted status notification signal (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 to compute an equivalent impedance, a plurality of impedance elements including at least three impedance elements extending between at least three terminals, a telemetry circuit configured to transmit a status notification signal in response to the generated output; and a display unit configured to generate a display of the detected status condition in response to the transmitted status notification signal as taught by Goetz to modify Yang’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]). 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. Goetz teaches an implanted device measuring impedance (See Goetz abstract), and further teaches the equivalent impedance (See Goetz Figure 5, impedance values between two electrodes), plurality of at least three impedance elements of the circuit model (See Goetz [0007][0011], set of electrodes determines the impedance). 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 Goetz to modify Yang’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]). 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 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 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 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]). 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]).
Claims 4-7, 11, 18-21, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Yang in view of Goetz in view of Rabinovich et al. (US5749369A; hereinafter known as “Rabinovich”; previously cited) in view of 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 Goetz 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 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 Goetz 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 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 is 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 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 is 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 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 is 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 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 in view of Goetz 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 is 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 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).
Response to Arguments Applicant’s argument with respect to rejection regarding claims 1-28 under 35 U.S.C. 101 have been considered and are persuasive, the rejection has been withdrawn. Applicant’s argument with respect to rejection regarding claims 1-3, 8-9, 11-13, 15-17, 22-23, 25-26 and 28 under 35 U.S.C. 102 specifically regarding “Applicant asserts that Yang does not disclose “computing an equivalent impedance of the circuit model of thoracic impedance measurements” has been fully considered and is persuasive. The rejection has been withdrawn a new grounds of rejection has been made in view of Yang et al. (US20140214110A1; hereinafter known as “Yang”; previously cited) in view of Goetz et al. (US20030176807A1; hereinafter known as “Goetz”). Applicant’s argument with respect to rejection regarding claims 1-3, 8-9, 11-13, 15-17, 22-23, 25-26 and 28 under 35 U.S.C. 102 specifically regarding “Determining if values from multiple vectors cross-correlate is not computing an equivalent impedance of a circuit model of thoracic impedance as in claim 1.The notion that computing an equivalent impedance is cross-correlating multiple impedance measurements is an improper reading of the claim language taken in light of Applicant’s specification and the ordinary meaning of equivalent impedance as would be interpreted and understood by one of ordinary skill in the art” has been fully considered and is persuasive. The rejection has been withdrawn a new grounds of rejection has been made in view of Yang et al. (US20140214110A1; hereinafter known as “Yang”; previously cited) in view of Goetz et al. (US20030176807A1; hereinafter known as “Goetz”). Applicant’s argument with respect to rejection regarding claims 4 under 35 U.S.C. 103 specifically regarding “Rabinovich does not disclose computing an equivalent impedance and does not disclose a wye circuit model and Rabinovich is silent regarding computing an equivalent impedance” has been fully considered and is persuasive. The rejection has been withdrawn a new ground of rejection has been made in view of Yang et al. (US20140214110A1; hereinafter known as “Yang”; previously cited) in view of Goetz et al. (US20030176807A1; hereinafter known as “Goetz”).
ConclusionApplicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/M.R.K./Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791
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