DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of Claims
This Advisory Action is responsive to the Response After Final Action filed 03DEC2024.
No claims have been amended, added, or cancelled.
Claims 1-13, 15, & 25-26 are presently under consideration.
Response to Arguments
The Applicant's arguments filed in the Response After Final Action mailed 26MAR2026 regarding the 103 rejections (See pages 2-7 of the Remarks) are persuasive. Therefore, the rejections under 103 have been withdrawn
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 1-13, 15, 25, and 26 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.
The term “best fit” in claim 1 is a relative term which renders the claim indefinite. The term “best fit” 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. Although the specification discusses residuals and model fitting, the claim does not define whether the “best fit” is based on a particular statistical threshold, residual minimization technique, polynomial order limitation, correlation criterion, or other objective model-selection rule. Further, it is unclear what objective criterion defines the recited “best fit” and whether the claimed indication causes stopping automatically by the ablation system or instead serves only as information for a practitioner to reference in deciding whether to stop the procedure. It is also unclear what specific threshold or condition corresponds to “when the lesion is formed such that the formed lesion blocks electrical impulses in the tissue.”
Claims 2-13, 15, 25, and 26 are rejected for the same reason set forth above since they depend from claim 1.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1-10, 12-13, 15, & 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Schwartz et al (US Publication No. 20180125575; Previously Cited) in view of Koblish et al (US Patent No. 10888373; Previously Cited) and Merkely et al ("Effects of radiofrequency ablation on monoplasic action potentials," in IEEE Engineering in Medicine and Biology Magazine, vol. 21, no. 1, pp. 69-73, Jan.-Feb. 2002, doi: 10.1109/51.993197.).
Regarding claim 1, Schwartz discloses a method comprising: obtaining a plurality of measurements of a lesion (Schwartz ¶0012 “There is provided, in accordance with some exemplary embodiments, a method of tissue assessment in vivo, comprising: determining at least one dielectric property of a target tissue by analysis of signals sensed at an electrode positioned intra-body; and estimating a tissue state, based on the determined dielectric property.” ¶0013, Abstract), the measurements including measurements of a temperature (Schwartz ¶0120 “In some embodiments, correlations are supplemented by modeling of the effects of one or more physical properties: for example, temperature, and/or time-varying filling with fluid (such as blood) and/or gas (such as air).”; ¶0233 “For example, if the target state Y(t.sub.n) has been reached, ablation stops. In some embodiments, one or more additional criteria are used as stop conditions; for example, a maximal allowed ablation time or a temperature safety threshold. Optionally, the user stops ablation manually. Optionally, the dielectrically measured progress of ablation, and/or one or more parameters of the ablation such as elapsed time and/or temperature are indicated to the user, for example, as one or more displays, tones”; ¶0139; ¶0143) an impedance magnitude (Schwartz ¶0010 “Dielectric properties comprise certain measured and/or inferred electrical properties of a material relating to the material's dielectric permittivity. Such electrical properties optionally include, for example, conductivity, impedance, resistivity, capacitance, inductance, and/or relative permittivity. Optionally, dielectric properties of a material are measured and/or inferred relative to the influence of the material on signals measured from electrical circuits. Optionally, dielectric properties of a material are measured and/or inferred relative to the influence of the material on an applied electric field. Measurements are optionally relative to one or more particular circuits, circuit components, frequencies and/or currents.” Showing the ability for calculation of the impedance magnitude by the properties that are collected; ¶0137; ¶0140), impedance phase (Schwartz ¶0287 “Optionally, a phase difference (e.g., 90 degrees, 45 degrees) between pair(s) of electrodes 103 is varied for ablation different lesion sites, e.g., by obtaining different field patterns”; ¶0087; ¶0096), and an electrical property of tissue of the lesion (Schwartz ¶0107 “The view is similar to that of FIG. 11C. As described, for example, in relation to FIG. 2, measurements of frequency-dependent impedance in the electrical circuit(s) resulting from this configuration reflect electrical properties of tissue through which the electrical field extends (in particular, dielectric properties). The dielectric properties of the tissue in turn are affected, for example, when tissue undergoes lesioning.”; ¶0111); performed during an ablation procedure with an ablation catheter connected to an ablation system (Schwartz ¶0180 “For example, in a feedback-controlled ablation procedure, the state assessed at block 209 is used to determine if ablation (or additional ablation) is to be performed.”; ¶0232); performing a statistical analysis of the obtained plurality of measurements (Schwartz ¶0119 “The linkage is optionally (for example) by statistical correlation (for example, using techniques of computational statistics), by use of equations fit (for example, by mathematical optimization) to correlation data, and/or by use of a machine learning technique. In some embodiments, a machine learning technique used comprises one or more implementations of decision tree learning, association rule learning, an artificial neural network, inductive logic programming, a support vector machine, cluster analysis, Bayesian networks, reinforcement learning, representation learning, similarity and metric learning, and/or another technique taken from the art of machine learning.”; ¶0154;);, wherein the statistical analysis is based on statistical data from a plurality of previously measured lesions (Schwartz ¶0161 “The assessed state can include tissue properties that result from the ablation procedure (e.g., lesion depth, width, volume, and/or type),”; ¶0053 “the estimating is based on statistical correlation between vectors of dielectric parameter values and the at least one parameter of a tissue state, the statistical correlation being described by the data structure.”; ¶0156 “Additionally or alternatively, in some embodiments, state assessment comprises a state being estimated based on previously observed correlations between impedance measurements and that state.”; ¶0121; ¶0092); determining at least one lesion property including at least one of a depth of the lesion (Schwartz ¶0161 “The assessed state can include tissue properties that result from the ablation procedure (e.g., lesion depth, width, volume, and/or type), and/or which indicate a possible adverse event.”; ¶0162; ¶0219; ¶0231), percent transmurality of the lesion (Schwartz ¶0122 “Optionally lesion depth is estimated with respect to a total wall thickness; for example, 70%, 80%, 90%, 100%, or another lesser or intermediate degree of transmurality.”; ¶0139; ¶0162), surface area of the lesion (Schwartz ¶0122 “Optionally, the simulation of the ablation is according to one or more ablation parameters (e.g., voltage, current, power, frequency, and/or ablation electrode surface area dimensions).”; ¶0272) and volume of the lesion (Schwartz ¶0028 “According to some embodiments, the tissue state comprises at least one from a group consisting of: a lesion depth, a lesion volume, a degree of lesion transmurality, a characterization of tissue edema, a characterization of functional inactivation, a classification as to a potential for tissue charring, and a classification as to a potential for steam pop.”; ¶0052; ¶0077) based at least in part on the best fit (Schwartz ¶0208 “In some embodiments, the initial state comprises a thickness, determined by measurement; for example, manually by the user via a user interface, automatically according to previously acquired anatomical data, and/or automatically based on one or more dielectric property measurements. Thickness, in some embodiments, is calculated from one or more anatomical images of the patient (e.g., left atrial wall thickness—LAWT, is calculated from a patient's CT image). Optionally, tissue thickness defines the extent of allowed and/or targeted ablation (fully or partially transmural ablation, for example).”; ¶0220 “Additionally or alternatively, in some embodiments, a simulated ablation is optionally selected (e.g., from a dataset of such simulations) based on the determined initial state. The simulation is calculated, for example, using a model, based on experimental data (such as the calibration dataset), and/or based on thermodynamic equations.”; ¶0053; ¶0118-¶0119); and outputting the at least one lesion property to provide an indication of lesion formation during the ablation procedure, (Schwartz ¶0208 “In some embodiments, the initial state comprises a thickness, determined by measurement; for example, manually by the user via a user interface, automatically according to previously acquired anatomical data, and/or automatically based on one or more dielectric property measurements. Thickness, in some embodiments, is calculated from one or more anatomical images of the patient (e.g., left atrial wall thickness—LAWT, is calculated from a patient's CT image). Optionally, tissue thickness defines the extent of allowed and/or targeted ablation (fully or partially transmural ablation, for example).”; ¶0220 “Additionally or alternatively, in some embodiments, a simulated ablation is optionally selected (e.g., from a dataset of such simulations) based on the determined initial state. The simulation is calculated, for example, using a model, based on experimental data (such as the calibration dataset), and/or based on thermodynamic equations.”; ¶0053; ¶0118-¶0119); wherein the indication is referenced to cause the ablation system to stop the ablation procedure when the lesion is formed such that the formed lesion blocks electrical impulses in the tissue. (Schwartz ¶0217 “Optionally, the adjustment comprises stopping ablation (for example, if X(t.sub.i) is correlated to a finished ablation state, or to a state which indicates a possible existing and/or developing adverse condition).”; ¶0047; ¶0270).
Schwartz does not disclose wherein the best fit is determined based on residuals between predicted values and the statistical data. Koblish in a similar field teaches wherein the best fit is determined based on residuals between predicted values and the statistical data (Koblish Column 146 Lines 25-59 “The impedance measurements may be applied to a model. For example, a frequency response function r(f) may be created and fit to a polynomial or other fitting function. The function may take the form, for example, of: r(ƒ)=a.Math.ƒ.sup.3+b.Math.ƒ.sup.2+c.Math.ƒ+d where a, b, c and d are the terms for the polynomial function that match the response of r(f) to measured data. … In this approach, the R and C values may be determined that best fit the measured data and thresholds may be utilized based on the R and C values to determine whether or not the electrode is in contact with tissue.”). Before the effective filing date, it would have been obvious to a person of ordinary skill in the art to modify system in Schwartz combined with Koblish by integrating the statistical analysis wherein the best fit is determined based on residuals between predicted values and the statistical data of Koblish into Schwartz’s lesion characterization system to provide high order results that can be used to determine the results of lesion formation based on indirect information.
Schwartz in combination with Koblish does not disclose wherein the measurement of the electrical property of the tissue of the lesion is derived from a monophasic action potential (MAP) waveform. Merkely in a similar field of ablation studies teaches wherein the measurement of the electrical property of the tissue of the lesion is derived from a monophasic action potential (MAP) waveform (Merkely Abstract “Reliable MAP (monophasic action potential) measurements were performed during RF delivery with a commercially available ablation system and fractally coated catheters based on an established mechanical design. The obtained results promise an important step forward in online monitoring of the MAP signals during ablation. They may help in the localization of the arrhythmogenic substrate (early and delayed after depolarization) and in the evaluation of RF ablation effect, which have to be investigated in further experimental and clinical studies”; Discussion Lines 11-13 “with growing lesion size, the number of cells contributing to the MAP signal decreases and, therefore, the MAP amplitude is decreased. According to this hypothesis, the MAP amplitude reaching the steady state indicates reaching the final lesion size during RF ablation.”). Before the effective filing date, it would have been obvious to a person of ordinary skill in the art to modify system in Schwartz combined with Koblish by integrating the statistical analysis wherein the measurement of the electrical property of the tissue of the lesion is derived from a monophasic action potential (MAP) waveform of Merkely to create a system that can provide extra information and analysis as to the status of a user’s ablation procedure to improve the outcomes.
Regarding claim 2, claim 1 is obvious over Schwartz, Koblish, and Merkely. Koblish further teaches determining wherein the measurement of the electrical property of the tissue of the lesion is further derived from an electrocardiogram (EGM) waveform (Koblish Column 9 Lines 62-67 “ In some embodiments, the at least one processor of the mapping system is configured to be operatively coupled to at least one separate mapping system, wherein the at least one separate mapping system is configured to obtain and process EGM or other electrical activity data of the targeted anatomical location.”; Column 11 Lines 1-3 “In some embodiments, the electrical activity data comprise EGM activity data, rotor mapping data and/or any other electrical data.”). Before the effective filing date, it would have been obvious to a person of ordinary skill in the art to modify system in Schwartz combined with Koblish and Merkely with items in Koblish by integrating the determined EGM waveforms to create a system that can provide extra information and analysis as to the status of a user’s ablation procedure to improve the outcomes.
Regarding claim 3, claim 1 is obvious over Schwartz, Koblish, and Merkely. Schwartz additionally discloses wherein determining the at least one lesion property includes calculating the depth of the lesion from an equation representing the best fit, (Schwartz ¶0120 “In some embodiments, correlations are supplemented by modeling of the effects of one or more physical properties: for example, temperature, and/or time-varying filling with fluid (such as blood) and/or gas (such as air). In some embodiments, the data structure is compiled by the application of one or more of such linkage methods to previously recorded calibration data. For example, lesions are formed for use in calibration, and separate measurement of dielectric properties and corresponding lesion sizes (and/or other lesion state information, such as lesion type and/or condition) are performed. Optionally, additional data, for example, state data (for example, provided by state inputs 140), is also incorporated into the data structure.”; ¶0139 “For example, a dielectric profile is defined which corresponds with the occurrence of a particular state (e.g., scarring, charring, temperature, or lesion transmurality). Optionally, profile is defined based on observations during calibration indicating that the particular state correlates with one or more impedance measurements occurring within one or more corresponding ranges. These ranges are optionally established as a dielectric profile that serves as an indication of the particular state when it is observed.”; Showing how depth Is calculated from a variety of possible inputs) wherein the equation includes as inputs at least one of: an impedance phase change over a range of impedance phase measurements (Schwartz ¶0096 “Dielectric property measurements are made, for example, based on the frequency response characteristics (for example, characteristics of frequency-dependent impedance, resonances, and/or phase delays) of output signals measured from an electrical circuit comprising a target tissue); a peak to peak impedance magnitude change over a range of impedance magnitude measurements (Schwartz ¶0287 “Optionally, a phase difference (e.g., 90 degrees, 45 degrees) between pair(s) of electrodes 103 is varied for ablation different lesion sites, e.g., by obtaining different field patterns”; where the phase differences are determined through impedance changes, and the magnitude change is representative of a magnitude value that was targeted between to the multiple electrodes in use that are using different impedance ranges); changes in the electrical property of the tissue of the lesion (Schwartz ¶0111 “In some embodiments, a method of correlation is optionally used to relate measured electrical properties (dielectric-related properties in particular) of tissue to lesion results (such a method is explained, for example, in relation to FIG. 3).”; ¶0109 “The view is similar to that of FIG. 11C. As described, for example, in relation to FIG. 2, measurements of frequency-dependent impedance in the electrical circuit(s) resulting from this configuration reflect electrical properties of tissue through which the electrical field extends (in particular, dielectric properties). The dielectric properties of the tissue in turn are affected, for example, when tissue undergoes lesioning.”); and a measurement of the temperature (Schwartz ¶0163 “In some embodiments, another state is assessed. For example, ablation energies potentially produce undesirable effects such as charring, and/or localized boiling (sometimes called “steam pop”). In some embodiments, tissue impedance changes continue to occur past the targeted point of tissue ablation, leading up to conditions (for example, temperatures) where an undesirable event potentially occurs. In some embodiments, impedance changes before reaching targeted ablation condition indicate a danger of such undesirable effects (for example, a change which is too fast potentially indicates that thermal energy is not being adequately dispersed either to achieve good lesion depth, or to prevent steam pop).”).
Regarding claim 4, claims 1 & 3 are obvious over Schwartz, Koblish, and Merkely. Schwartz additionally discloses wherein the equation is determined based at least in part on the statistical data representing a plurality of measurements of the at least one of an impedance magnitude (Schwartz ¶0010 “Dielectric properties comprise certain measured and/or inferred electrical properties of a material relating to the material's dielectric permittivity. Such electrical properties optionally include, for example, conductivity, impedance, resistivity, capacitance, inductance, and/or relative permittivity. Optionally, dielectric properties of a material are measured and/or inferred relative to the influence of the material on signals measured from electrical circuits. Optionally, dielectric properties of a material are measured and/or inferred relative to the influence of the material on an applied electric field. Measurements are optionally relative to one or more particular circuits, circuit components, frequencies and/or currents.” Showing the ability for calculation of the impedance magnitude by the properties that are collected; ¶0137; ¶0140), impedance phase (Schwartz ¶0287 “Optionally, a phase difference (e.g., 90 degrees, 45 degrees) between pair(s) of electrodes 103 is varied for ablation different lesion sites, e.g., by obtaining different field patterns”; ¶0087; ¶0096), a temperature (Schwartz ¶0120 “In some embodiments, correlations are supplemented by modeling of the effects of one or more physical properties: for example, temperature, and/or time-varying filling with fluid (such as blood) and/or gas (such as air).”; ¶0233 “For example, if the target state Y(t.sub.n) has been reached, ablation stops. In some embodiments, one or more additional criteria are used as stop conditions; for example, a maximal allowed ablation time or a temperature safety threshold. Optionally, the user stops ablation manually. Optionally, the dielectrically measured progress of ablation, and/or one or more parameters of the ablation such as elapsed time and/or temperature are indicated to the user, for example, as one or more displays, tones”; ¶0139; ¶0143), and changes in electrical properties of tissue of the previously measured lesion. (Schwartz ¶0111 “In some embodiments, a method of correlation is optionally used to relate measured electrical properties (dielectric-related properties in particular) of tissue to lesion results (such a method is explained, for example, in relation to FIG. 3).”; ¶0109 “The view is similar to that of FIG. 11C. As described, for example, in relation to FIG. 2, measurements of frequency-dependent impedance in the electrical circuit(s) resulting from this configuration reflect electrical properties of tissue through which the electrical field extends (in particular, dielectric properties). The dielectric properties of the tissue in turn are affected, for example, when tissue undergoes lesioning.”).
Regarding claim 5, claim 1 is obvious over Schwartz, Koblish, and Merkely. Schwartz additionally discloses wherein determining the at least one lesion property includes calculating lesion surface area from an equation representing the best fit (Schwartz ¶0120 “For example, lesions are formed for use in calibration, and separate measurement of dielectric properties and corresponding lesion sizes (and/or other lesion state information, such as lesion type and/or condition) are performed. Optionally, additional data, for example, state data (for example, provided by state inputs 140), is also incorporated into the data structure.”; ¶0139 Showing how surface area may be calculated from a variety of possible inputs) wherein the equation includes as inputs at least one of: a percent change in phase of a measured impedance (Schwartz ¶0287 “Optionally, a phase difference (e.g., 90 degrees, 45 degrees) between pair(s) of electrodes 103 is varied for ablation different lesion sites, e.g., by obtaining different field patterns”; ¶0087; ¶0096 “Dielectric property measurements are made, for example, based on the frequency response characteristics (for example, characteristics of frequency-dependent impedance, resonances, and/or phase delays) of output signals measured from an electrical circuit comprising a target tissue ¶0212 Showing how various values may be determined based on the property measurements such as the percent change within the range of data sets collected); an average peak to peak value of post-ablation measured impedance (Schwartz ¶0287 “Optionally, a phase difference (e.g., 90 degrees, 45 degrees) between pair(s) of electrodes 103 is varied for ablation different lesion sites, e.g., by obtaining different field patterns” where the phase differences are determined through impedance changes, and the magnitude change is representative of a magnitude value that was targeted between to the multiple electrodes in use that are using different impedance ranges; ¶0212); a change in the electrical property of the tissue of the lesion (Schwartz ¶0111 “In some embodiments, a method of correlation is optionally used to relate measured electrical properties (dielectric-related properties in particular) of tissue to lesion results (such a method is explained, for example, in relation to FIG. 3).”; ¶0109 “The view is similar to that of FIG. 11C. As described, for example, in relation to FIG. 2, measurements of frequency-dependent impedance in the electrical circuit(s) resulting from this configuration reflect electrical properties of tissue through which the electrical field extends (in particular, dielectric properties). The dielectric properties of the tissue in turn are affected, for example, when tissue undergoes lesioning.”); and a measurement of temperature. (Schwartz ¶0120 “In some embodiments, correlations are supplemented by modeling of the effects of one or more physical properties: for example, temperature, and/or time-varying filling with fluid (such as blood) and/or gas (such as air).”; ¶0233 “For example, if the target state Y(t.sub.n) has been reached, ablation stops. In some embodiments, one or more additional criteria are used as stop conditions; for example, a maximal allowed ablation time or a temperature safety threshold. Optionally, the user stops ablation manually. Optionally, the dielectrically measured progress of ablation, and/or one or more parameters of the ablation such as elapsed time and/or temperature are indicated to the user, for example, as one or more displays, tones”; ¶0139; ¶0143).
Regarding claim 6, claims 1 & 5 are obvious over Schwartz, Koblish, and Merkely. Schwartz additionally discloses wherein the equation is determined based at least in part on the statistical data representing a plurality of measurements (Schwartz ¶0119 “The linkage is optionally (for example) by statistical correlation (for example, using techniques of computational statistics), by use of equations fit (for example, by mathematical optimization) to correlation data, and/or by use of a machine learning technique. In some embodiments, a machine learning technique used comprises one or more implementations of decision tree learning, association rule learning, an artificial neural network, inductive logic programming, a support vector machine, cluster analysis, Bayesian networks, reinforcement learning, representation learning, similarity and metric learning, and/or another technique taken from the art of machine learning.”; ¶0154; ¶0161).) of the at least one of an impedance magnitude (Schwartz ¶0010 “Dielectric properties comprise certain measured and/or inferred electrical properties of a material relating to the material's dielectric permittivity. Such electrical properties optionally include, for example, conductivity, impedance, resistivity, capacitance, inductance, and/or relative permittivity. Optionally, dielectric properties of a material are measured and/or inferred relative to the influence of the material on signals measured from electrical circuits. Optionally, dielectric properties of a material are measured and/or inferred relative to the influence of the material on an applied electric field. Measurements are optionally relative to one or more particular circuits, circuit components, frequencies and/or currents.” Showing the ability for calculation of the impedance magnitude by the properties that are collected; ¶0137; ¶0140), impedance phase (Schwartz ¶0287 “Optionally, a phase difference (e.g., 90 degrees, 45 degrees) between pair(s) of electrodes 103 is varied for ablation different lesion sites, e.g., by obtaining different field patterns”; ¶0087; ¶0096), a temperature (Schwartz ¶0120 “In some embodiments, correlations are supplemented by modeling of the effects of one or more physical properties: for example, temperature, and/or time-varying filling with fluid (such as blood) and/or gas (such as air).”; ¶0233 “For example, if the target state Y(t.sub.n) has been reached, ablation stops. In some embodiments, one or more additional criteria are used as stop conditions; for example, a maximal allowed ablation time or a temperature safety threshold. Optionally, the user stops ablation manually. Optionally, the dielectrically measured progress of ablation, and/or one or more parameters of the ablation such as elapsed time and/or temperature are indicated to the user, for example, as one or more displays, tones”; ¶0139; ¶0143), and changes in electrical properties of tissue of the previously measured lesion. (Schwartz ¶0111 “In some embodiments, a method of correlation is optionally used to relate measured electrical properties (dielectric-related properties in particular) of tissue to lesion results (such a method is explained, for example, in relation to FIG. 3).”; ¶0109 “The view is similar to that of FIG. 11C. As described, for example, in relation to FIG. 2, measurements of frequency-dependent impedance in the electrical circuit(s) resulting from this configuration reflect electrical properties of tissue through which the electrical field extends (in particular, dielectric properties). The dielectric properties of the tissue in turn are affected, for example, when tissue undergoes lesioning.”).
Regarding claim 7, Claim 1 is obvious over Schwartz, Koblish, and Merkely. Schwartz additionally discloses wherein determining the at least one lesion property includes calculating lesion volume from an equation representing the best fit (Schwartz ¶0120 “For example, lesions are formed for use in calibration, and separate measurement of dielectric properties and corresponding lesion sizes (and/or other lesion state information, such as lesion type and/or condition) are performed. Optionally, additional data, for example, state data (for example, provided by state inputs 140), is also incorporated into the data structure.”; ¶0139 Showing how lesion volume may be calculated from a variety of possible inputs) wherein the equationincludes as inputs at least one of: an average of post ablation impedance magnitude measurements (Schwartz ¶0010 “Dielectric properties comprise certain measured and/or inferred electrical properties of a material relating to the material's dielectric permittivity. Such electrical properties optionally include, for example, conductivity, impedance, resistivity, capacitance, inductance, and/or relative permittivity. Optionally, dielectric properties of a material are measured and/or inferred relative to the influence of the material on signals measured from electrical circuits. Optionally, dielectric properties of a material are measured and/or inferred relative to the influence of the material on an applied electric field. Measurements are optionally relative to one or more particular circuits, circuit components, frequencies and/or currents.” Showing the ability for calculation of the impedance magnitude by the properties that are collected; ¶0137; ¶0140; ¶0212 Showing how various values may be determined based on the property measurements such as the average of the range of data sets collected; ¶0098; ¶0100; ¶0196 Showing the ability for calculations based on data collected post ablation); an average of post ablation impedance phase measurements (Schwartz ¶0287 “Optionally, a phase difference (e.g., 90 degrees, 45 degrees) between pair(s) of electrodes 103 is varied for ablation different lesion sites, e.g., by obtaining different field patterns”; ¶0087; ¶0096; ¶0212); an average of changes in peak to peak impedance amplitude measurements (Schwartz ¶0287 “Optionally, a phase difference (e.g., 90 degrees, 45 degrees) between pair(s) of electrodes 103 is varied for ablation different lesion sites, e.g., by obtaining different field patterns” where the phase differences are determined through impedance changes, and the magnitude change is representative of a magnitude value that was targeted between to the multiple electrodes in use that are using different impedance ranges; ¶0212); a change in the electrical property of the tissue of the lesion (Schwartz ¶0111 “In some embodiments, a method of correlation is optionally used to relate measured electrical properties (dielectric-related properties in particular) of tissue to lesion results (such a method is explained, for example, in relation to FIG. 3).”; ¶0109 “The view is similar to that of FIG. 11C. As described, for example, in relation to FIG. 2, measurements of frequency-dependent impedance in the electrical circuit(s) resulting from this configuration reflect electrical properties of tissue through which the electrical field extends (in particular, dielectric properties). The dielectric properties of the tissue in turn are affected, for example, when tissue undergoes lesioning.”); and measurement of the temperature. (Schwartz ¶0120 “In some embodiments, correlations are supplemented by modeling of the effects of one or more physical properties: for example, temperature, and/or time-varying filling with fluid (such as blood) and/or gas (such as air).”; ¶0233 “For example, if the target state Y(t.sub.n) has been reached, ablation stops. In some embodiments, one or more additional criteria are used as stop conditions; for example, a maximal allowed ablation time or a temperature safety threshold. Optionally, the user stops ablation manually. Optionally, the dielectrically measured progress of ablation, and/or one or more parameters of the ablation such as elapsed time and/or temperature are indicated to the user, for example, as one or more displays, tones”; ¶0139; ¶0143).
Regarding claim 8, Claims 1 & 7 are obvious over Schwartz, Koblish, and Merkely. Schwartz additionally discloses wherein the equation is determined based at least in part on the statistical data representing a plurality of measurements (Schwartz ¶0119 “The linkage is optionally (for example) by statistical correlation (for example, using techniques of computational statistics), by use of equations fit (for example, by mathematical optimization) to correlation data, and/or by use of a machine learning technique. In some embodiments, a machine learning technique used comprises one or more implementations of decision tree learning, association rule learning, an artificial neural network, inductive logic programming, a support vector machine, cluster analysis, Bayesian networks, reinforcement learning, representation learning, similarity and metric learning, and/or another technique taken from the art of machine learning.”; ¶0154; ¶0161).) of the at least one of an impedance magnitude (Schwartz ¶0010 “Dielectric properties comprise certain measured and/or inferred electrical properties of a material relating to the material's dielectric permittivity. Such electrical properties optionally include, for example, conductivity, impedance, resistivity, capacitance, inductance, and/or relative permittivity. Optionally, dielectric properties of a material are measured and/or inferred relative to the influence of the material on signals measured from electrical circuits. Optionally, dielectric properties of a material are measured and/or inferred relative to the influence of the material on an applied electric field. Measurements are optionally relative to one or more particular circuits, circuit components, frequencies and/or currents.” Showing the ability for calculation of the impedance magnitude by the properties that are collected; ¶0137; ¶0140), impedance phase (Schwartz ¶0287 “Optionally, a phase difference between pair(s) of electrodes 103 is varied for ablation different lesion sites, e.g., by obtaining different field patterns”; ¶0087; ¶0096), a temperature (Schwartz ¶0120 “In some embodiments, correlations are supplemented by modeling of the effects of one or more physical properties: for example, temperature, and/or time-varying filling with fluid (such as blood) and/or gas (such as air).”; ¶0233 “For example, if the target state Y(t.sub.n) has been reached, ablation stops. In some embodiments, one or more additional criteria are used as stop conditions; for example, a maximal allowed ablation time or a temperature safety threshold. Optionally, the user stops ablation manually. Optionally, the dielectrically measured progress of ablation, and/or one or more parameters of the ablation such as elapsed time and/or temperature are indicated to the user, for example, as one or more displays, tones”; ¶0139; ¶0143), and changes in electrical properties of tissue of the previously measured lesion. (Schwartz ¶0111 “In some embodiments, a method of correlation is optionally used to relate measured electrical properties (dielectric-related properties in particular) of tissue to lesion results (such a method is explained, for example, in relation to FIG. 3).”; ¶0109 “The view is similar to that of FIG. 11C. As described, for example, in relation to FIG. 2, measurements of frequency-dependent impedance in the electrical circuit(s) resulting from this configuration reflect electrical properties of tissue through which the electrical field extends (in particular, dielectric properties). The dielectric properties of the tissue in turn are affected, for example, when tissue undergoes lesioning.”).
Regarding claim 9, Claim 1 is obvious over Schwartz, Koblish, and Merkely. Schwartz additionally discloses wherein determining at least one lesion property includes calculating a transmurality of the lesion from an equation representing the best fit (Schwartz ¶0120 “In some embodiments, correlations are supplemented by modeling of the effects of one or more physical properties: for example, temperature, and/or time-varying filling with fluid (such as blood) and/or gas (such as air). In some embodiments, the data structure is compiled by the application of one or more of such linkage methods to previously recorded calibration data. For example, lesions are formed for use in calibration, and separate measurement of dielectric properties and corresponding lesion sizes (and/or other lesion state information, such as lesion type and/or condition) are performed. Optionally, additional data, for example, state data (for example, provided by state inputs 140), is also incorporated into the data structure.”; ¶0139 “For example, a dielectric profile is defined which corresponds with the occurrence of a particular state (e.g., scarring, charring, temperature, or lesion transmurality). Optionally, profile is defined based on observations during calibration indicating that the particular state correlates with one or more impedance measurements occurring within one or more corresponding ranges. These ranges are optionally established as a dielectric profile that serves as an indication of the particular state when it is observed.”; Showing how transmurality Is calculated from a variety of possible inputs) wherein the equation includes as inputs at least one of: a percent change in impedance magnitude (Schwartz ¶0010 “Dielectric properties comprise certain measured and/or inferred electrical properties of a material relating to the material's dielectric permittivity. Such electrical properties optionally include, for example, conductivity, impedance, resistivity, capacitance, inductance, and/or relative permittivity. Optionally, dielectric properties of a material are measured and/or inferred relative to the influence of the material on signals measured from electrical circuits. Optionally, dielectric properties of a material are measured and/or inferred relative to the influence of the material on an applied electric field. Measurements are optionally relative to one or more particular circuits, circuit components, frequencies and/or currents.” Showing the ability for calculation of the impedance magnitude by the properties that are collected; ¶0137; ¶0140; ¶0212 Showing how various values may be determined based on the property measurements such as the average of the range of data sets collected); a percent change in impedance phase (Schwartz ¶0287 “Optionally, a phase difference (e.g., 90 degrees, 45 degrees) between pair(s) of electrodes 103 is varied for ablation different lesion sites, e.g., by obtaining different field patterns”; ¶0087; ¶0096 “Dielectric property measurements are made, for example, based on the frequency response characteristics (for example, characteristics of frequency-dependent impedance, resonances, and/or phase delays) of output signals measured from an electrical circuit comprising a target tissue; ¶0212); a maximum temperature measurement (Schwartz ¶0120 “In some embodiments, correlations are supplemented by modeling of the effects of one or more physical properties: for example, temperature, and/or time-varying filling with fluid (such as blood) and/or gas (such as air).”; ¶0233 “For example, if the target state Y(t.sub.n) has been reached, ablation stops. In some embodiments, one or more additional criteria are used as stop conditions; for example, a maximal allowed ablation time or a temperature safety threshold. Optionally, the user stops ablation manually. Optionally, the dielectrically measured progress of ablation, and/or one or more parameters of the ablation such as elapsed time and/or temperature are indicated to the user, for example, as one or more displays, tones”; ¶0139; ¶0143; ¶0120 “In some embodiments, correlations are supplemented by modeling of the effects of one or more physical properties: for example, temperature, and/or time-varying filling with fluid (such as blood) and/or gas (such as air). In some embodiments, the data structure is compiled by the application of one or more of such linkage methods to previously recorded calibration data. For example, lesions are formed for use in calibration, and separate measurement of dielectric properties and corresponding lesion sizes (and/or other lesion state information, such as lesion type and/or condition) are performed. Optionally, additional data, for example, state data (for example, provided by state inputs 140), is also incorporated into the data structure.” Implies that varies forms of temperature measurements may be taken into account for calculations such as the maximum or sum); a change in electrical property of the tissue of the lesion (Schwartz ¶0111 “In some embodiments, a method of correlation is optionally used to relate measured electrical properties (dielectric-related properties in particular) of tissue to lesion results (such a method is explained, for example, in relation to FIG. 3).”; ¶0109 “The view is similar to that of FIG. 11C. As described, for example, in relation to FIG. 2, measurements of frequency-dependent impedance in the electrical circuit(s) resulting from this configuration reflect electrical properties of tissue through which the electrical field extends (in particular, dielectric properties). The dielectric properties of the tissue in turn are affected, for example, when tissue undergoes lesioning.”); and a sum of temperature measurements. (Schwartz ¶0120 “; ¶0139; ¶0143; ¶0120 Implies that varies forms of temperature measurements may be taken into account for calculations such as the maximum or sum).
Regarding claim 10, Claims 1 & 9 are obvious over Schwartz, Koblish, and Merkely. Schwartz additionally discloses wherein the equation is determined based at least in part the statistical data representing a plurality of the measurements (Schwartz ¶0119 “The linkage is optionally (for example) by statistical correlation (for example, using techniques of computational statistics), by use of equations fit (for example, by mathematical optimization) to correlation data, and/or by use of a machine learning technique. In some embodiments, a machine learning technique used comprises one or more implementations of decision tree learning, association rule learning, an artificial neural network, inductive logic programming, a support vector machine, cluster analysis, Bayesian networks, reinforcement learning, representation learning, similarity and metric learning, and/or another technique taken from the art of machine learning.”; ¶0154; ¶0161).) of the at least one of an impedance magnitude (Schwartz ¶0010 “Dielectric properties comprise certain measured and/or inferred electrical properties of a material relating to the material's dielectric permittivity. Such electrical properties optionally include, for example, conductivity, impedance, resistivity, capacitance, inductance, and/or relative permittivity. Optionally, dielectric properties of a material are measured and/or inferred relative to the influence of the material on signals measured from electrical circuits. Optionally, dielectric properties of a material are measured and/or inferred relative to the influence of the material on an applied electric field. Measurements are optionally relative to one or more particular circuits, circuit components, frequencies and/or currents.” Showing the ability for calculation of the impedance magnitude by the properties that are collected; ¶0137; ¶0140), impedance phase (Schwartz ¶0287 “Optionally, a phase difference (e.g., 90 degrees, 45 degrees) between pair(s) of electrodes 103 is varied for ablation different lesion sites, e.g., by obtaining different field patterns”; ¶0087; ¶0096), a temperature (Schwartz ¶0120 “In some embodiments, correlations are supplemented by modeling of the effects of one or more physical properties: for example, temperature, and/or time-varying filling with fluid (such as blood) and/or gas (such as air).”; ¶0233 “For example, if the target state Y(t.sub.n) has been reached, ablation stops. In some embodiments, one or more additional criteria are used as stop conditions; for example, a maximal allowed ablation time or a temperature safety threshold. Optionally, the user stops ablation manually. Optionally, the dielectrically measured progress of ablation, and/or one or more parameters of the ablation such as elapsed time and/or temperature are indicated to the user, for example, as one or more displays, tones”; ¶0139; ¶0143), and changes in electrical properties of tissue of the previously measured lesion. (Schwartz ¶0111 “In some embodiments, a method of correlation is optionally used to relate measured electrical properties (dielectric-related properties in particular) of tissue to lesion results (such a method is explained, for example, in relation to FIG. 3).”; ¶0109 “The view is similar to that of FIG. 11C. As described, for example, in relation to FIG. 2, measurements of frequency-dependent impedance in the electrical circuit(s) resulting from this configuration reflect electrical properties of tissue through which the electrical field extends (in particular, dielectric properties). The dielectric properties of the tissue in turn are affected, for example, when tissue undergoes lesioning.”).
Regarding claim 12, claim 1 is obvious over Schwartz, Koblish, and Merkely. Schwartz additionally discloses wherein determining the at least one lesion property is further based on at least one of a tissue thickness, (Schwartz ¶0255 “Optionally, the comparison is facilitated by inclusion in the comparison of anatomical properties such as wall thickness—optionally known or inferred, for example, from separate measurements (e.g., imaging), from the dielectric measurements themselves, and/or with reference to more general anatomical knowledge such as anatomical atlas data.”; ¶0097; ¶0260), and a distance of a probe to the tissue of the lesion, (Schwartz ¶0107 “For measurement, catheter electrodes 103 are optionally placed in a proximity to the target region close enough to select it for sensing. In some embodiment, selection for sensing comprises positioning the electrode where it acts in establishing an electrical field intersecting the target region. Preferably (and particularly if the same electrode is also to be used for ablation) contact is made, but some degree of optional separation is potentially compatible with sufficient proximity to isolate of dielectric properties; for example, up to 1 mm, 2 mm, 3 mm, or another larger, smaller, or intermediate distance from the target region.”; ¶0105; ¶0168).
Regarding claim 13, Claims 1 & 12 are obvious over Schwartz, Koblish, and Merkely. Schwartz additionally discloses wherein at least one of the tissue thicknesses and the distance is determined by at least one of an electro-anatomical mapping system, (Schwartz ¶0242 “In some embodiments, a lesion mapping process is performed, comprises assessment of lesioned and unlesioned regions over an extended tissue area (such as a left atrium wall). Optionally, lesion mapping comprises a procedure separate from lesion formation as such. For example, an operator optionally maps a general region before or after lesioning at one or more specific foci. Before lesioning, this mapping can be, for example, to determine what the general state of tissue is—for example, to assess a baseline dielectric property map, to localize a lesion (e.g., a lesion track) which has been previously created, and/or to map disease-related lesions such as fibrotic heart regions. Additionally or alternatively, lesion mapping is performed after lesion formation, in order to verify the overall structure of the lesions which have been created—for example, to identify potential gaps between lesions, through which pulmonary vein reconnection could potentially occur.”; ¶0078; ¶0247) medical imaging (Schwartz ¶0157 “Optional state assessment at block 211 represents off-line assessment (for example, for determination of tissue state for use in compiling calibration data); for example, histological tissue examination or assessment by in vivo medical imaging.”; ¶0212)and a dielectric method. (Schwartz ¶0212 “For example, dielectric properties of nearby tissues inferred from imaging scans are modeled to assist in isolation of measurement components relating to the tissue to be lesioned. Also for example, initial state determination 302 optionally includes determination of phase of cardiac cycle and/or phase of respiratory cycle. Potentially, this allows dielectric property measurements to be referenced with respect to being of contracted or relaxed tissue, or with respect to a time-varying quality of contact between tissue and probe electrode due to cyclic motions.”; ¶0242).
Regarding claim 15, Claim 1 is obvious over Schwartz, Koblish, and Merkely. Schwartz additionally discloses wherein the obtaining the plurality of measurements, the performing the statistical analysis, the determining the at least one lesion property and the outputting the at least one lesion property occur a plurality of times during an ablation procedure. (Schwartz ¶0095 “Optionally, the parameter of ablation varies iteratively during the ablation. Examples of ablation parameters include duty cycle, total duration, frequency, and/or power level. An aspect of some embodiments of the invention relates to determination of ablation parameters based on dielectric property measurements made pre-ablation.”; ¶0222 “The process of selection, simulation, and forecast is optionally iterated until optimal projected results are obtained.”; ¶0236).
Regarding claim 25, Claim 1 is obvious over Schwartz, Koblish, and Merkely. Koblish additionally teaches wherein the best fit is expressed as a polynomial equation. (Koblish Column 146 Lines 25-59 “The impedance measurements may be applied to a model. For example, a frequency response function r(f) may be created and fit to a polynomial or other fitting function. The function may take the form, for example, of: r(ƒ)=a.Math.ƒ.sup.3+b.Math.ƒ.sup.2+c.Math.ƒ+d where a, b, c and d are the terms for the polynomial function that match the response of r(f) to measured data. … In this approach, the R and C values may be determined that best fit the measured data and thresholds may be utilized based on the R and C values to determine whether or not the electrode is in contact with tissue.”). Before the effective filing date, it would have been obvious to a person of ordinary skill in the art to modify system in Schwartz combined with Koblish and Merkely by integrating the statistical analysis wherein the best fit is determined based on residuals between predicted values and the statistical data of Koblish to provide high order results that can be used to determine the results of lesion formation based on indirect information.
Regarding claim 26, Claims 1 & 25 are obvious over Schwartz, Koblish, and Merkely. Koblish additionally teaches wherein different respective polynomial equations are used to determine different ones of the depth of the lesion, the percent transmurality of the lesion, the surface area of the lesion, and the volume of the lesion (Koblish Column 146 Lines 25-59 “The impedance measurements may be applied to a model. For example, a frequency response function r(f) may be created and fit to a polynomial or other fitting function… In this approach, the R and C values may be determined that best fit the measured data and thresholds may be utilized based on the R and C values to determine whether or not the electrode is in contact with tissue.”; Column 174 Lines 53-67 “…Overlapping may be determined or estimated based on lesion depth, width and volume estimates, as explained herein (e.g., with reference to FIGS. 38 and 39). Various other graphical representations, in addition to or lieu of those depicted herein, can be used to conveniently provide useful information to a physician or other user or viewer of such systems about a particular ablation procedure.” Showing that there may be multiple equations ). Before the effective filing date, it would have been obvious to a person of ordinary skill in the art to modify system in Schwartz combined with Koblish and Merkely by integrating the statistical analysis wherein the best fit is determined based on residuals between predicted values and the statistical data of Koblish into Schwartz’s lesion characterization system to provide high order results that can be used to determine the results of lesion formation based on indirect information.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Schwartz et al. (US Publication No. 20180125575; Previously Cited) in view of Koblish et al (US Patent No. 10888373; Previously Cited), Merkely et al ("Effects of radiofrequency ablation on monoplasic action potentials," in IEEE Engineering in Medicine and Biology Magazine, vol. 21, no. 1, pp. 69-73, Jan.-Feb. 2002, doi: 10.1109/51.993197.) as applied to claim 1 above, and further in view of Drakulic et al. (US Publication No. 20190349310; Previously Cited).
Regarding claim 11, Claim 1 is obvious over Schwartz, Koblish, and Merkely. Neither Schwartz, Koblish, or Merkely disclose wherein determining the at least one lesion property includes applying one of a Fourier transform, a filter and a wavelet matching algorithm to at least one of the obtained measurements. Drakulic in a similar field of ablation teaches wherein determining the at least one lesion property includes applying one of a Fourier transform or a filter (Drakulic ¶0237 “A digital processing function may be implemented using one or more mathematical operations such as a fast Fourier transform. As would be appreciated by a person of ordinary skill in the art, DSP 2904 can apply various types of digital processing functions. For example, DSP 2904 can apply a low-pass filter, a high-pass filter, a band-pass filter, a band-stop filter, a notch filter, a comb filter, an all-pass filter, or various other filters as would be appreciated by a person of ordinary skill in the art.”) and a wavelet matching algorithm to at least one of the obtained measurements. (Drakulic ¶0020 “The disclosed EP system also uses novel optimal biphasic waveforms and signal processing algorithms for signal enhancement during pacing, and novel algorithms for enhanced user visualization.”).
Before the effective filing date, it would have been obvious to a person of ordinary skill in the art to modify system in Schwartz, Koblish, and Merkely with items in Drakulic by integrating the analysis and filtering methods of Drakulic to create a more user-friendly analysis system that can provide extra information and analysis as to the status of a user’s ablation procedure to improve the outcomes of it while additionally removing noise signals for improved readings.
Conclusion
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/MEGAN T FEDORKY/Examiner, Art Unit 3796
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792
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