DETAILED ACTION
The following is a First Action, Non-Final Office Action on the merits.
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 .
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 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.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 16/726312 provides adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
Accordingly, the claims are given the priority benefit date of 12/24/2019.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “60” has been used to designate both “three-dimensional representation 60” and “RMS valued theoretical field lines 60”.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities: amend the first paragraph to include the appropriate patent number for the priority application.
Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informalities: amend “the instantaneous measured” to -the measured instantaneous- in ll. 16. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: amend “the progress” to -progress- in ll. 24. Appropriate correction is required.
Claim 2 is objected to because of the following informalities: amend “IRE pulses” to -the IRE pulses- in ll. 2. Appropriate correction is required.
Claim 3 is objected to because of the following informalities: amend “IRE pulses” to -the IRE pulses- in ll. 2. Appropriate correction is required.
Claim 4 is objected to because of the following informalities: amend “a user” to -to a user- in ll. 3-4. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: amend “to the be applied” to -to be applied- in ll. 13. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: amend “the instantaneous measured” to -the measured instantaneous- in ll. 20. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: amend “the progress” to -progress- in ll. 28. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: amend “a user” to -to a user- in ll. 3-4. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: amend “the instantaneous measured” to -the measured instantaneous- in ll. 18. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: amend “the progress” to -progress- in ll. 26. Appropriate correction is required.
Claim 16 is objected to because of the following informalities: amend “a user” to -to a user- in ll. 4-5. Appropriate correction is required.
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, 4-7, 10-13 & 16-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) an abstract idea without significantly more. The claim(s) recite(s) a mathematical concept (mathematical calculation) and a mental process (evaluation). This judicial exception is not integrated into a practical application because the combination of additional elements fails to integrate the judicial exception into a practical application. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements, when considered separately and in combination, do not add significantly more (also known as an “inventive concept”) to the exception.
Claim 1 recites: “A method of applying irreversible electroporation pulses (IRE) to tissue to form a lesion, the method comprising: receiving a prespecified target IRE index value, wherein the prespecified target IRE index value is not a size of the lesion but a repeatable predictor of the size of the lesion, the size of the lesion comprising a volume, a depth and a diameter of the lesion; causing the IRE pulses to be applied to the tissue over a time period to form the lesion; causing instantaneous contact forces and instantaneous power levels of the IRE pulses applied to the tissue to be measured over the time period; calculating, on a recurring basis, estimated IRE index values using an integral over the time period of a product of the instantaneous measured contact forces, respectively, raised to a first calibrated non-unity exponent and the measured instantaneous power levels of the IRE pulses, respectively, raised to a second calibrated non-unity exponent, the calculated estimated IRE index values corresponding respectively to an estimated volume, an estimated depth and an estimated diameter of the lesion; causing the progress of the application of the IRE pulses to the tissue over the time period to be displayed as a graphic and/or alphanumeric data while the estimated IRE index values are being calculated; and determining whether a value of the calculated estimated IRE index values has reached the prespecified target IRE index value.”
Step 1:
Claim 1 recites a method and is thus directed to a statutory category of invention.
Step 2A, Prong One:
Claim 1 recites the abstract idea of “calculating, on a recurring basis, estimated IRE index values using an integral over the time period of a product of the instantaneous measured contact forces, respectively, raised to a first calibrated non-unity exponent and the measured instantaneous power levels of the IRE pulses, respectively, raised to a second calibrated non-unity exponent, the calculated estimated IRE index values corresponding respectively to an estimated volume, an estimated depth and an estimated diameter of the lesion”. This limitation recites a mathematical concept, and, specifically, a mathematical calculation.
Claim 1 recites the abstract idea of “determining whether a value of the calculated estimated IRE index values has reached the prespecified target IRE index value”. This limitation recites a mental process, and specifically, a concept (evaluation) that can be performed in the human mind.
Therefore, claim 1 recites the abstract ideas of a mathematical calculation and a mental process.
Step 2A, Prong Two:
Claim 1 recites the additional element of: “receiving a prespecified target IRE index value” which is a recitation of extra-solution activity (pre-solution activity) that is understood as incidental to the primary product and is merely a nominal or tangential addition to the claim and is regarded as insignificant extra-solution activity that does not amount to an inventive concept. Accordingly, this additional element does not integrate the judicial exception into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
Claim 1 recites the additional element of: “causing the IRE pulses to be applied to the tissue over a time period to form the lesion” which is a recitation of extra-solution activity (pre-solution activity) that is understood as incidental to the primary product and is merely a nominal or tangential addition to the claim and is regarded as insignificant extra-solution activity that does not amount to an inventive concept. Accordingly, this additional element does not integrate the judicial exception into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
Claim 1 recites the additional element of: “causing instantaneous contact forces and instantaneous power levels of the IRE pulses applied to the tissue to be measured over the time period” which is a recitation of extra-solution activity (data gathering) that is understood as incidental to the primary product and is merely a nominal or tangential addition to the claim and is regarded as insignificant extra-solution activity that does not amount to an inventive concept. Accordingly, this additional element does not integrate the judicial exception into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
Claim 1 recites the additional element of: “causing the progress of the application of the IRE pulses to the tissue over the time period to be displayed as a graphic and/or alphanumeric data while the estimated IRE index values are being calculated” which is a recitation of extra-solution activity (data outputting) that is understood as incidental to the primary product and is merely a nominal or tangential addition to the claim and is regarded as insignificant extra-solution activity that does not amount to an inventive concept. Accordingly, this additional element does not integrate the judicial exception into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
Claim 1 fails to recite additional elements, or a combination of elements that apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that it is more than a drafting effort designed to monopolize the exception.
Step 2B:
Claim 1 recites the additional element of: “receiving a prespecified target IRE index value” which does not amount to significantly more than the abstract idea as inputting data is regarded as is a well-understood, routine, conventional activity specified at a high level of generality, to the abstract idea. Specifically, Bar Tal (2017/0014181) disclose inputting a desired value which is compared with a calculated value determined from measurements ([0082]). Accordingly, this additional element does not provide an inventive concept.
Claim 1 recites the additional element of: “causing the IRE pulses to be applied to the tissue over a time period to form the lesion” which does not amount to significantly more than the abstract idea as applying energy is a well-understood, routine, conventional activity specified at a high level of generality, to the abstract idea. Specifically, Pearson et al. (2010/0250209) disclose estimating a treatment region of a device where the method application of energy can be the application of electroporation pulsed energy or RF ablation energy ([0008], [0224]). Accordingly, this additional element does not provide an inventive concept.
Claim 1 recites the additional element of: “causing instantaneous contact forces and instantaneous power levels of the IRE pulses applied to the tissue to be measured over the time period” which does not amount to significantly more than the abstract idea as measuring forces and power levels can be categorized as data gathering which is a well-understood, routine, conventional activity specified at a high level of generality, to the abstract idea. Specifically, Bar Tal (2017/0014181) disclose measuring instantaneous contact force and power levels of the energy applied to the tissue over the time period to then calculate estimated values of an IRE index ([0081], [0085]). Accordingly, this additional element does not provide an inventive concept.
Claim 1 recites the additional element of: “causing the progress of the application of the IRE pulses to the tissue over the time period to be displayed as a graphic and/or alphanumeric data while the estimated IRE index values are being calculated” which does not amount to significantly more than the abstract idea as displaying data can be categorized as outputting data which is a well-understood, routine, conventional activity specified at a high level of generality, to the abstract idea. Specifically, Bar Tal (2017/0014181) discloses measuring instantaneous contact force and power levels of the energy applied to the tissue over the time period to then calculate estimated values of an IRE index ([0081], [0085]). Accordingly, this additional element does not provide an inventive concept.
Therefore, claim 1 does not amount to significantly more than the abstract idea as there are no additional elements that provide for an inventive concept.
Claim 4 recites the additional element of “further comprising causing the calculated estimated IRE index values and the prespecified target IRE index value to be presented a user” which is a recitation of extra-solution activity (data outputting) that is understood as incidental to the primary product and is merely a nominal or tangential addition to the claim and is regarded as insignificant extra-solution activity that does not amount to an inventive concept and does not amount to significantly more than the abstract idea as displaying data can be categorized as outputting data which is a well-understood, routine, conventional activity specified at a high level of generality, to the abstract idea. Specifically, Bar Tal (2017/0014181) discloses measuring instantaneous contact force and power levels of the energy applied to the tissue over the time period to then calculate estimated values of an IRE index ([0081], [0085]). Accordingly, this additional element does not integrate the judicial exception into a practical application because it does not impose any meaningful limits on practicing the abstract idea and this additional element does not provide an inventive concept.
Dependent claim 4 does not amount to significantly more than the abstract idea as there are no additional elements that provide for an inventive concept.
Claim 5 recites the additional element of “further comprising causing the instantaneous power levels to be measured by measuring a peak voltage of the IRE pulses” which is a recitation of extra-solution activity (data gathering) that is understood as incidental to the primary product and is merely a nominal or tangential addition to the claim and is regarded as insignificant extra-solution activity that does not amount to an inventive concept and which does not amount to significantly more than the abstract idea as measuring forces and power levels can be categorized as data gathering which is a well-understood, routine, conventional activity specified at a high level of generality, to the abstract idea. Specifically, Bar Tal (2017/0014181) disclose measuring instantaneous contact force and power levels of the energy applied to the tissue over the time period to then calculate estimated values of an IRE index ([0081], [0085]). Accordingly, this additional element does not integrate the judicial exception into a practical application because it does not impose any meaningful limits on practicing the abstract idea and this additional element does not provide an inventive concept.
Dependent claim 5 does not amount to significantly more than the abstract idea as there are no additional elements that provide for an inventive concept.
Claim 6 recites the limitation of “further comprising causing an electric field produced by the IRE pulses to be simulated”. This limitation recites a mathematical concept, and, specifically, a mathematical calculation. Claim 6 fails to recite additional elements, or a combination of elements that apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that it is more than a drafting effort designed to monopolize the exception.
Dependent claim 6 does not amount to significantly more than the abstract idea as there are no additional elements that provide for an inventive concept.
Claim 7 recites: “A system for applying irreversible electroporation pulses (IRE) to tissue to form a lesion, the system comprising: one or more processors; and a non-transitory computer readable medium storing a plurality of instructions, which when executed, cause the one or more processors to: receive a prespecified target IRE index value, wherein the prespecified target IRE index value is not a size of the lesion but a repeatable predictor of the size of the lesion, the size of the lesion comprising a volume, a depth and a diameter of the lesion; cause the IRE pulses to the be applied to the tissue over a time period to form the lesion; cause instantaneous contact forces and instantaneous power levels of the IRE pulses applied to the tissue to be measured over the time period; calculate, on a recurring basis, estimated IRE index values using an integral over the time period of a product of the instantaneous measured contact forces, respectively, raised to a first calibrated non-unity exponent and the measured instantaneous power levels of the IRE pulses, respectively, raised to a second calibrated non-unity exponent, the calculated estimated IRE index values corresponding respectively to an estimated volume, an estimated depth and an estimated diameter of the lesion; cause the progress of the application of the IRE pulses to the tissue over the time period to be displayed as a graphic and/or alphanumeric data while the estimated IRE index values are being calculated; and determine whether a value of the calculated estimated IRE index values has reached the prespecified target IRE index value.”
Step 1:
Claim 7 recites a product and is thus directed to a statutory category of invention.
Step 2A, Prong One:
Claim 7 recites the abstract idea of “one or more processors; and a non-transitory computer readable medium storing a plurality of instructions, which when executed, cause the one or more processors to: … calculate, on a recurring basis, estimated IRE index values using an integral over the time period of a product of the instantaneous measured contact forces, respectively, raised to a first calibrated non-unity exponent and the measured instantaneous power levels of the IRE pulses, respectively, raised to a second calibrated non-unity exponent, the calculated estimated IRE index values corresponding respectively to an estimated volume, an estimated depth and an estimated diameter of the lesion”. This limitation recites a mathematical concept, and, specifically, a mathematical calculation. Under broadest reasonable interpretation, this step covers a mathematical calculation of the limitation but for the recitation of generic computer components. That is, other than reciting “one or more processors; and a non-transitory computer readable medium storing a plurality of instructions, which when executed, cause the one or more processors to”, nothing in the claim element precludes the step from practically being performed in the human mind or with a pen and paper. Additionally, the mere nominal recitation of a generic processor does not take the claim limitation out of the mental processes grouping.
Claim 7 recites the abstract idea of “one or more processors; and a non-transitory computer readable medium storing a plurality of instructions, which when executed, cause the one or more processors to:…determine whether a value of the calculated estimated IRE index values has reached the prespecified target IRE index value”. This limitation recites a mental process, and specifically, a concept (evaluation) that can be performed in the human mind. Under broadest reasonable interpretation, this step covers a mathematical calculation of the limitation but for the recitation of generic computer components. That is, other than reciting “one or more processors; and a non-transitory computer readable medium storing a plurality of instructions, which when executed, cause the one or more processors to”, nothing in the claim element precludes the step from practically being performed in the human mind or with a pen and paper. Additionally, the mere nominal recitation of a generic processor does not take the claim limitation out of the mental processes grouping.
Therefore, claim 1 recites the abstract ideas of a mathematical calculation and a mental process.
Step 2A, Prong Two:
Claim 7 recites the additional element of: “one or more processors; and a non-transitory computer readable medium storing a plurality of instructions, which when executed, cause the one or more processors to:” which is a recitation of a processor, and corresponding non-transitory computer readable medium, recited at a high level of generality, i.e., as a generic processor performing a generic computer function of processing data (calculating and determining steps). This generic processor limitation is no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the judicial exception into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
Claim 7 recites the additional element of: “receive a prespecified target IRE index value, wherein the prespecified target IRE index value is not a size of the lesion but a repeatable predictor of the size of the lesion, the size of the lesion comprising a volume, a depth and a diameter of the lesion” which is a recitation of extra-solution activity (pre-solution activity) that is understood as incidental to the primary product and is merely a nominal or tangential addition to the claim and is regarded as insignificant extra-solution activity that does not amount to an inventive concept. Accordingly, this additional element does not integrate the judicial exception into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
Claim 7 recites the additional element of: “cause the IRE pulses to the be applied to the tissue over a time period to form the lesion” which is a recitation of extra-solution activity (pre-solution activity) that is understood as incidental to the primary product and is merely a nominal or tangential addition to the claim and is regarded as insignificant extra-solution activity that does not amount to an inventive concept. Accordingly, this additional element does not integrate the judicial exception into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
Claim 7 recites the additional element of: “cause instantaneous contact forces and instantaneous power levels of the IRE pulses applied to the tissue to be measured over the time period” which is a recitation of extra-solution activity (data gathering) that is understood as incidental to the primary product and is merely a nominal or tangential addition to the claim and is regarded as insignificant extra-solution activity that does not amount to an inventive concept. Accordingly, this additional element does not integrate the judicial exception into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
Claim 7 recites the additional element of: “cause the progress of the application of the IRE pulses to the tissue over the time period to be displayed as a graphic and/or alphanumeric data while the estimated IRE index values are being calculated” which is a recitation of extra-solution activity (data outputting) that is understood as incidental to the primary product and is merely a nominal or tangential addition to the claim and is regarded as insignificant extra-solution activity that does not amount to an inventive concept. Accordingly, this additional element does not integrate the judicial exception into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
Therefore, claim 7 fails to recite additional elements, or a combination of elements that apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that it is more than a drafting effort designed to monopolize the exception.
Step 2B:
Claim 7 recites the additional element of: “one or more processors; and a non-transitory computer readable medium storing a plurality of instructions, which when executed, cause the one or more processors to:” which is a recitation of a processor, and corresponding non-transitory computer readable medium, recited at a high level of generality, i.e., as a generic processor performing a generic computer function of processing data (calculating and determining steps). This generic processor limitation is no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not provide an inventive concept.
Claim 7 recites the additional element of: “receive a prespecified target IRE index value, wherein the prespecified target IRE index value is not a size of the lesion but a repeatable predictor of the size of the lesion, the size of the lesion comprising a volume, a depth and a diameter of the lesion” which does not amount to significantly more than the abstract idea as inputting data is regarded as is a well-understood, routine, conventional activity specified at a high level of generality, to the abstract idea. Specifically, Bar Tal (2017/0014181) disclose inputting a desired value which is compared with a calculated value determined from measurements ([0082]). Accordingly, this additional element does not provide an inventive concept.
Claim 7 recites the additional element of: “cause the IRE pulses to the be applied to the tissue over a time period to form the lesion” which does not amount to significantly more than the abstract idea as applying energy is a well-understood, routine, conventional activity specified at a high level of generality, to the abstract idea. Specifically, Pearson et al. (2010/0250209) disclose estimating a treatment region of a device where the method application of energy can be the application of electroporation pulsed energy or RF ablation energy ([0008], [0224]). Accordingly, this additional element does not provide an inventive concept.
Claim 7 recites the additional element of: “cause instantaneous contact forces and instantaneous power levels of the IRE pulses applied to the tissue to be measured over the time period” which does not amount to significantly more than the abstract idea as measuring forces and power levels can be categorized as data gathering which is a well-understood, routine, conventional activity specified at a high level of generality, to the abstract idea. Specifically, Bar Tal (2017/0014181) disclose measuring instantaneous contact force and power levels of the energy applied to the tissue over the time period to then calculate estimated values of an IRE index ([0081], [0085]). Accordingly, this additional element does not provide an inventive concept.
Claim 7 recites the additional element of: “cause the progress of the application of the IRE pulses to the tissue over the time period to be displayed as a graphic and/or alphanumeric data while the estimated IRE index values are being calculated” which does not amount to significantly more than the abstract idea as displaying data can be categorized as outputting data which is a well-understood, routine, conventional activity specified at a high level of generality, to the abstract idea. Specifically, Bar Tal (2017/0014181) discloses measuring instantaneous contact force and power levels of the energy applied to the tissue over the time period to then calculate estimated values of an IRE index ([0081], [0085]). Accordingly, this additional element does not provide an inventive concept.
Therefore, claim 7 does not amount to significantly more than the abstract idea as there are no additional elements that provide for an inventive concept.
Claim 10 recites the additional element of “further comprising causing the calculated estimated IRE index values and the prespecified target IRE index value to be presented a user” which is a recitation of extra-solution activity (data outputting) that is understood as incidental to the primary product and is merely a nominal or tangential addition to the claim and is regarded as insignificant extra-solution activity that does not amount to an inventive concept and does not amount to significantly more than the abstract idea as displaying data can be categorized as outputting data which is a well-understood, routine, conventional activity specified at a high level of generality, to the abstract idea. Specifically, Bar Tal (2017/0014181) discloses measuring instantaneous contact force and power levels of the energy applied to the tissue over the time period to then calculate estimated values of an IRE index ([0081], [0085]). Accordingly, this additional element does not integrate the judicial exception into a practical application because it does not impose any meaningful limits on practicing the abstract idea and this additional element does not provide an inventive concept.
Dependent claim 10 does not amount to significantly more than the abstract idea as there are no additional elements that provide for an inventive concept.
Claim 11 recites the additional element of “further comprising causing the instantaneous power levels to be measured by measuring a peak voltage of the IRE pulses” which is a recitation of extra-solution activity (data gathering) that is understood as incidental to the primary product and is merely a nominal or tangential addition to the claim and is regarded as insignificant extra-solution activity that does not amount to an inventive concept and which does not amount to significantly more than the abstract idea as measuring forces and power levels can be categorized as data gathering which is a well-understood, routine, conventional activity specified at a high level of generality, to the abstract idea. Specifically, Bar Tal (2017/0014181) disclose measuring instantaneous contact force and power levels of the energy applied to the tissue over the time period to then calculate estimated values of an IRE index ([0081], [0085]). Accordingly, this additional element does not integrate the judicial exception into a practical application because it does not impose any meaningful limits on practicing the abstract idea and this additional element does not provide an inventive concept.
Dependent claim 11 does not amount to significantly more than the abstract idea as there are no additional elements that provide for an inventive concept.
Claim 12 recites the limitation of “further comprising causing an electric field produced by the IRE pulses to be simulated”. This limitation recites a mathematical concept, and, specifically, a mathematical calculation. Claim 6 fails to recite additional elements, or a combination of elements that apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that it is more than a drafting effort designed to monopolize the exception.
Dependent claim 12 does not amount to significantly more than the abstract idea as there are no additional elements that provide for an inventive concept.
Claim 13 recites: “A computer program product, comprising a non-transitory computer-readable medium having computer-readable program code embodied therein to be executed by one or more processors, the program code including instructions to: receive a prespecified target IRE index value, wherein the prespecified target IRE index value is not a size of the lesion but a repeatable predictor of the size of the lesion, the size of the lesion comprising a volume, a depth and a diameter of the lesion; cause the IRE pulses to be applied to the tissue over a time period to form the lesion; cause instantaneous contact forces and instantaneous power levels of the IRE pulses applied to the tissue to be measured over the time period; calculate, on a recurring basis, estimated IRE index values using an integral over the time period of a product of the instantaneous measured contact forces, respectively, raised to a first calibrated non-unity exponent and the measured instantaneous power levels of the IRE pulses, respectively, raised to a second calibrated non-unity exponent, the calculated estimated IRE index values corresponding respectively to an estimated volume, an estimated depth and an estimated diameter of the lesion; cause the progress of the application of the IRE pulses to the tissue over the time period to be displayed as a graphic and/or alphanumeric data while the estimated IRE index values are being calculated; and determine whether a value of the calculated estimated IRE index values has reached the prespecified target IRE index value.”
Step 1:
Claim 13 recites a product and is thus directed to a statutory category of invention.
Step 2A, Prong One:
Claim 13 recites the abstract idea of “a non-transitory computer-readable medium having computer-readable program code embodied therein to be executed by one or more processors, the program code including instructions to: … calculate, on a recurring basis, estimated IRE index values using an integral over the time period of a product of the instantaneous measured contact forces, respectively, raised to a first calibrated non-unity exponent and the measured instantaneous power levels of the IRE pulses, respectively, raised to a second calibrated non-unity exponent, the calculated estimated IRE index values corresponding respectively to an estimated volume, an estimated depth and an estimated diameter of the lesion”. This limitation recites a mathematical concept, and, specifically, a mathematical calculation. Under broadest reasonable interpretation, this step covers a mathematical calculation of the limitation but for the recitation of generic computer components. That is, other than reciting “one or more processors; and a non-transitory computer readable medium storing a plurality of instructions, which when executed, cause the one or more processors to”, nothing in the claim element precludes the step from practically being performed in the human mind or with a pen and paper. Additionally, the mere nominal recitation of a generic processor does not take the claim limitation out of the mental processes grouping.
Claim 13 recites the abstract idea of “a non-transitory computer-readable medium having computer-readable program code embodied therein to be executed by one or more processors, the program code including instructions to: … determine whether a value of the calculated estimated IRE index values has reached the prespecified target IRE index value”. This limitation recites a mental process, and specifically, a concept (evaluation) that can be performed in the human mind. Under broadest reasonable interpretation, this step covers a mathematical calculation of the limitation but for the recitation of generic computer components. That is, other than reciting “one or more processors; and a non-transitory computer readable medium storing a plurality of instructions, which when executed, cause the one or more processors to”, nothing in the claim element precludes the step from practically being performed in the human mind or with a pen and paper. Additionally, the mere nominal recitation of a generic processor does not take the claim limitation out of the mental processes grouping.
Therefore, claim 13 recites the abstract ideas of a mathematical calculation and a mental process.
Step 2A, Prong Two:
Claim 13 recites the additional element of: “a non-transitory computer-readable medium having computer-readable program code embodied therein to be executed by one or more processors, the program code including instructions to:” which is a recitation of a processor, and corresponding non-transitory computer readable medium, recited at a high level of generality, i.e., as a generic processor performing a generic computer function of processing data (calculating and determining steps). This generic processor limitation is no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the judicial exception into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
Claim 13 recites the additional element of: “receive a prespecified target IRE index value, wherein the prespecified target IRE index value is not a size of the lesion but a repeatable predictor of the size of the lesion, the size of the lesion comprising a volume, a depth and a diameter of the lesion” which is a recitation of extra-solution activity (pre-solution activity) that is understood as incidental to the primary product and is merely a nominal or tangential addition to the claim and is regarded as insignificant extra-solution activity that does not amount to an inventive concept. Accordingly, this additional element does not integrate the judicial exception into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
Claim 13 recites the additional element of: “cause the IRE pulses to the be applied to the tissue over a time period to form the lesion” which is a recitation of extra-solution activity (pre-solution activity) that is understood as incidental to the primary product and is merely a nominal or tangential addition to the claim and is regarded as insignificant extra-solution activity that does not amount to an inventive concept. Accordingly, this additional element does not integrate the judicial exception into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
Claim 13 recites the additional element of: “cause instantaneous contact forces and instantaneous power levels of the IRE pulses applied to the tissue to be measured over the time period” which is a recitation of extra-solution activity (data gathering) that is understood as incidental to the primary product and is merely a nominal or tangential addition to the claim and is regarded as insignificant extra-solution activity that does not amount to an inventive concept. Accordingly, this additional element does not integrate the judicial exception into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
Claim 13 recites the additional element of: “cause the progress of the application of the IRE pulses to the tissue over the time period to be displayed as a graphic and/or alphanumeric data while the estimated IRE index values are being calculated” which is a recitation of extra-solution activity (data outputting) that is understood as incidental to the primary product and is merely a nominal or tangential addition to the claim and is regarded as insignificant extra-solution activity that does not amount to an inventive concept. Accordingly, this additional element does not integrate the judicial exception into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
Therefore, claim 13 fails to recite additional elements, or a combination of elements that apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that it is more than a drafting effort designed to monopolize the exception.
Step 2B:
Claim 13 recites the additional element of: “a non-transitory computer-readable medium having computer-readable program code embodied therein to be executed by one or more processors, the program code including instructions to:” which is a recitation of a processor, and corresponding non-transitory computer readable medium, recited at a high level of generality, i.e., as a generic processor performing a generic computer function of processing data (calculating and determining steps). This generic processor limitation is no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not provide an inventive concept.
Claim 13 recites the additional element of: “receive a prespecified target IRE index value, wherein the prespecified target IRE index value is not a size of the lesion but a repeatable predictor of the size of the lesion, the size of the lesion comprising a volume, a depth and a diameter of the lesion” which does not amount to significantly more than the abstract idea as inputting data is regarded as is a well-understood, routine, conventional activity specified at a high level of generality, to the abstract idea. Specifically, Bar Tal (2017/0014181) disclose inputting a desired value which is compared with a calculated value determined from measurements ([0082]). Accordingly, this additional element does not provide an inventive concept.
Claim 13 recites the additional element of: “cause the IRE pulses to the be applied to the tissue over a time period to form the lesion” which does not amount to significantly more than the abstract idea as applying energy is a well-understood, routine, conventional activity specified at a high level of generality, to the abstract idea. Specifically, Pearson et al. (2010/0250209) disclose estimating a treatment region of a device where the method application of energy can be the application of electroporation pulsed energy or RF ablation energy ([0008], [0224]). Accordingly, this additional element does not provide an inventive concept.
Claim 13 recites the additional element of: “cause instantaneous contact forces and instantaneous power levels of the IRE pulses applied to the tissue to be measured over the time period” which does not amount to significantly more than the abstract idea as measuring forces and power levels can be categorized as data gathering which is a well-understood, routine, conventional activity specified at a high level of generality, to the abstract idea. Specifically, Bar Tal (2017/0014181) disclose measuring instantaneous contact force and power levels of the energy applied to the tissue over the time period to then calculate estimated values of an IRE index ([0081], [0085]). Accordingly, this additional element does not provide an inventive concept.
Claim 13 recites the additional element of: “cause the progress of the application of the IRE pulses to the tissue over the time period to be displayed as a graphic and/or alphanumeric data while the estimated IRE index values are being calculated” which does not amount to significantly more than the abstract idea as displaying data can be categorized as outputting data which is a well-understood, routine, conventional activity specified at a high level of generality, to the abstract idea. Specifically, Bar Tal (2017/0014181) discloses measuring instantaneous contact force and power levels of the energy applied to the tissue over the time period to then calculate estimated values of an IRE index ([0081], [0085]). Accordingly, this additional element does not provide an inventive concept.
Therefore, claim 13 does not amount to significantly more than the abstract idea as there are no additional elements that provide for an inventive concept.
Claim 16 recites the additional element of “further comprising causing the calculated estimated IRE index values and the prespecified target IRE index value to be presented a user” which is a recitation of extra-solution activity (data outputting) that is understood as incidental to the primary product and is merely a nominal or tangential addition to the claim and is regarded as insignificant extra-solution activity that does not amount to an inventive concept and does not amount to significantly more than the abstract idea as displaying data can be categorized as outputting data which is a well-understood, routine, conventional activity specified at a high level of generality, to the abstract idea. Specifically, Bar Tal (2017/0014181) discloses measuring instantaneous contact force and power levels of the energy applied to the tissue over the time period to then calculate estimated values of an IRE index ([0081], [0085]). Accordingly, this additional element does not integrate the judicial exception into a practical application because it does not impose any meaningful limits on practicing the abstract idea and this additional element does not provide an inventive concept.
Dependent claim 16 does not amount to significantly more than the abstract idea as there are no additional elements that provide for an inventive concept.
Claim 17 recites the additional element of “further comprising causing the instantaneous power levels to be measured by measuring a peak voltage of the IRE pulses” which is a recitation of extra-solution activity (data gathering) that is understood as incidental to the primary product and is merely a nominal or tangential addition to the claim and is regarded as insignificant extra-solution activity that does not amount to an inventive concept and which does not amount to significantly more than the abstract idea as measuring forces and power levels can be categorized as data gathering which is a well-understood, routine, conventional activity specified at a high level of generality, to the abstract idea. Specifically, Bar Tal (2017/0014181) disclose measuring instantaneous contact force and power levels of the energy applied to the tissue over the time period to then calculate estimated values of an IRE index ([0081], [0085]). Accordingly, this additional element does not integrate the judicial exception into a practical application because it does not impose any meaningful limits on practicing the abstract idea and this additional element does not provide an inventive concept.
Dependent claim 17 does not amount to significantly more than the abstract idea as there are no additional elements that provide for an inventive concept.
Claim 18 recites the limitation of “further comprising causing an electric field produced by the IRE pulses to be simulated”. This limitation recites a mathematical concept, and, specifically, a mathematical calculation. Claim 6 fails to recite additional elements, or a combination of elements that apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that it is more than a drafting effort designed to monopolize the exception.
Dependent claim 18 does not amount to significantly more than the abstract idea as there are no additional elements that provide for an inventive concept.
Therefore, claims 1, 4-7, 10-13 & 16-18 are not patent eligible under 35 USC 101.
The Examiner notes that claims 2-3, 8-9 & 14-15 recite limitations adding significantly more to the abstract idea as the claims, as a whole, integrate the abstract idea into a practical application by either (1) causing application of the IRE pulses to continue; or (2) causing the application of IRE pulses to cease.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1, 3, 7 & 9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2 & 6 of U.S. Patent No. 11,707,320. Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite: a method of applying irreversible electroporation pulses (IRE) to tissue to form a lesion, the method comprising: (“A method of applying irreversible electroporation pulses (IRE) to tissue to form a lesion, the method comprising:”) receiving a prespecified target IRE index value, wherein the prespecified target IRE index value is not a size of the lesion but a repeatable predictor of the size of the lesion, the size of the lesion comprising a volume, a depth and a diameter of the lesion (“selecting a prespecified target IRE index value, wherein the prespecified target IRE index value is not a size of the lesion but a repeatable predictor of the size of the lesion, the size of the lesion comprising a volume, a depth and a diameter of the lesion”); causing the IRE pulses to be applied to the tissue over a time period to form the lesion (“using a probe, applying the IRE pulses to the tissue over a time period to form the lesion); causing instantaneous contact forces and instantaneous power levels of the IRE pulses applied to the tissue to be measured over the time period (“measuring instantaneous contact forces and instantaneous power levels of the IRE pulses applied to the tissue by the probe over the time period”; calculating, on a recurring basis, estimated IRE index values using an integral over the time period of a product of the instantaneous measured contact forces, respectively, raised to a first calibrated non-unity exponent and the measured instantaneous power levels of the IRE pulses, respectively, raised to a second calibrated non-unity exponent, the calculated estimated IRE index values corresponding respectively to an estimated volume, an estimated depth and an estimated diameter of the lesion (“calculating, on a recurring basis, estimated IRE index values index using an integral over the time period of a product of the instantaneous measured contact forces, respectively, raised to a first calibrated non-unity exponent and the measured instantaneous power levels of the IRE pulses, respectively, raised to a second calibrated non-unity exponent, the calculated estimated IRE index values corresponding respectively to an estimated volume, an estimated depth and an estimated diameter of the lesion”); causing the progress of the application of the IRE pulses to the tissue over the time period to be displayed as a graphic and/or alphanumeric data while the estimated IRE index values are being calculated (“comprising presenting the calculated estimated IRE index values and the prespecified target IRE index value to a user”); and determining whether a value of the calculated estimated IRE index values has reached the prespecified target IRE index value (“ceasing application of the IRE pulses to the tissue in response to a value of the calculated estimated IRE index values reaching the prespecified target IRE index value”). Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite: a system for applying irreversible electroporation pulses (IRE) to tissue to form a lesion, the system comprising: (“system for applying IRE pulses to tissue to form a lesion, the system comprising:”) one or more processors; and a non-transitory computer readable medium storing a plurality of instructions, which when executed, cause the one or more processors to (“a processor configured to”): receive a prespecified target IRE index value, wherein the prespecified target IRE index value is not a size of the lesion but a repeatable predictor of the size of the lesion, the size of the lesion comprising a volume, a depth and a diameter of the lesion (“receive a selection of a prespecified target IRE index value, wherein the prespecified target IRE index value is not a size of the lesion but a repeatable predictor of the size of the lesion, the size of the lesion comprising a volume, a depth and a diameter of the lesion”); cause the IRE pulses to the be applied to the tissue over a time period to form the lesion (“IRE pulses applied to the tissue by the probe over the time period”); cause instantaneous contact forces and instantaneous power levels of the IRE pulses applied to the tissue to be measured over the time period (“measure instantaneous contact forces and instantaneous power levels of the IRE pulses applied to the tissue by the probe over the time period”); calculate, on a recurring basis, estimated IRE index values using an integral over the time period of a product of the instantaneous measured contact forces, respectively, raised to a first calibrated non-unity exponent and the measured instantaneous power levels of the IRE pulses, respectively, raised to a second calibrated non-unity exponent, the calculated estimated IRE index values corresponding respectively to an estimated volume, an estimated depth and an estimated diameter of the lesion (“calculate, on a recurring basis, estimated IRE index values using an integral over the time period of a product of the instantaneous measured contact forces respectively, raised to a first calibrated non-unity exponent and the measured instantaneous power levels of the IRE pulses, respectively, raised to a second calibrated non-unity exponent, the calculated estimated IRE index values corresponding respectively to an estimated volume, an estimated depth and an estimated diameter of the lesion”); cause the progress of the application of the IRE pulses to the tissue over the time period to be displayed as a graphic and/or alphanumeric data while the estimated IRE index values are being calculated (“the processor is further configured to present the calculated estimated IRE index values and the prespecified target IRE index value to a user”); and determine whether a value of the calculated estimated IRE index values has reached the prespecified target IRE index value (“cease application of the IRE pulses to the tissue in response to a value of the calculated estimated IRE index values reaching the prespecified target IRE index value”). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent anticipate the claims of the application. Accordingly, the application claims are not patentably distinct from the patent claims. Here, the more specific patent claims encompass the broader application claims. Following the rationale in In re Goodman cited in the preceding paragraph, where applicant has once been granted a patent containing a claim for the specific narrow invention, applicant may not obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Claims 13 & 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2 & 6 of U.S. Patent No. 11,707,320 in view of Bar-Tal et al. (2017/0014181). Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite: “a computer program product, comprising a non-transitory computer-readable medium having computer-readable program code embodied therein (the patent fails to disclose a computer program product comprising a non-transitory computer-readable medium having computer-readable program code embodied therein. However, Bar-Tal et al. disclose a computer program product comprising a non-transitory computer-readable medium having computer-readable program code embodied (modules of memory 50 may comprise software elements on non-transitory tangible media) therein to be executed by one or more processors (processor 46). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of the patent to comprise a computer program product, comprising a non-transitory computer-readable medium having computer-readable program code embodied therein (the patent fails to disclose a computer program product comprising a non-transitory computer-readable medium having computer-readable program code embodied therein in order to provide the benefit of providing software to the processor to execute the method as taught by Bar-Tal et al. ([0079-0081].) to be executed by one or more processors (“a processor configured to:”), the program code including instructions to: receive a prespecified target IRE index value, wherein the prespecified target IRE index value is not a size of the lesion but a repeatable predictor of the size of the lesion, the size of the lesion comprising a volume, a depth and a diameter of the lesion (“receive a selection of a prespecified target IRE index value, wherein the prespecified target IRE index value is not a size of the lesion but a repeatable predictor of the size of the lesion, the size of the lesion comprising a volume, a depth and a diameter of the lesion”); cause the IRE pulses to be applied to the tissue over a time period to form the lesion (“IRE pulses applied to the tissue by the probe over the time period”); cause instantaneous contact forces and instantaneous power levels of the IRE pulses applied to the tissue to be measured over the time period; (“measure instantaneous contact forces and instantaneous power levels of the IRE pulses applied to the tissue by the probe over the time period”) calculate, on a recurring basis, estimated IRE index values using an integral over the time period of a product of the instantaneous measured contact forces, respectively, raised to a first calibrated non-unity exponent and the measured instantaneous power levels of the IRE pulses, respectively, raised to a second calibrated non-unity exponent, the calculated estimated IRE index values corresponding respectively to an estimated volume, an estimated depth and an estimated diameter of the lesion (“calculate, on a recurring basis, estimated IRE index values using an integral over the time period of a product of the instantaneous measured contact forces respectively, raised to a first calibrated non-unity exponent and the measured instantaneous power levels of the IRE pulses, respectively, raised to a second calibrated non-unity exponent, the calculated estimated IRE index values corresponding respectively to an estimated volume, an estimated depth and an estimated diameter of the lesion”); cause the progress of the application of the IRE pulses to the tissue over the time period to be displayed as a graphic and/or alphanumeric data while the estimated IRE index values are being calculated (“the processor is further configured to present the calculated estimated IRE index values and the prespecified target IRE index value to a user”); and determine whether a value of the calculated estimated IRE index values has reached the prespecified target IRE index value (“cease application of the IRE pulses to the tissue in response to a value of the calculated estimated IRE index values reaching the prespecified target IRE index value”).
Allowable Subject Matter
Claims 2, 8 & 14 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is an examiner’s statement of reasons for allowance: As for claims 2, 8 & 14, the prior art of record, taken alone or in combination, fails to disclose or render obvious a method/system/computer program product comprising a non-transitory computer-readable medium having computer-readable program code embodied therein to be executed by one or more processors and applying IRE pulses to tissue comprising selecting a prespecified target IRE index value that is not a size of a lesion but a reasonable predictor of a lesion, applying IRE pulses to tissue, measuring instantaneous power levels and contact forces, calculating estimated IRE index values using an integral with the instantaneous power levels and contact forces, comparing the calculated estimated IRE index values with the prespecified target IRE index value and either causing application of the IRE pulses to continue pulses when a value of the calculated estimated IRE index values has not reached the prespecified target IRE index value or ceasing application of the IRE pulses when a value of the calculated estimated IRE index values reaches the prespecified target IRE index value.
The closest prior art is regarded as: Bar Tal (2017/0014181) teaches selecting a prespecified/desired lesion size that comprises a volume, a depth, or a diameter of the lesion, applying energy over a time period to form a lesion, measuring instantaneous contact force and power levels of the energy applied to the tissue over the time period, calculating estimated values of an ablation index using an integral over the time period of a product of the instantaneous measured contact forces, respectively, raised to a first calibrated non-unity exponent and on the measured instantaneous power levels of the energy, respectively, raised to a second calibrated non-unity exponent, calculating an estimated lesion size (volume, depth, or diameter) using a value of the estimated ablation index values, and comparing the estimated lesion size to the prespecified lesion size. Bar Tal fails to teach that the prespecified/target lesion size and the estimated lesion size using the ablation index value comprises a volume, depth, and a diameter and the comparison is done with the ablation index value instead of just one specific size parameter. The present application achieves a finer precision level of ceasing the ablation energy by using the value of the estimated IRE index that is a reasonable predictor of the lesion size comprising volume, depth, and diameter than Bar-Tal since Bar-Tal uses the value of just one size parameter (i.e., with Bar-Tal, if depth is the size predictor, ablation ceases when depth reaches the prespecified/target depth value versus with the present application, if the ablation index is the size predictor, where the size of the lesion encompasses a lesion volume that is exceeded but a lesion depth that is not exceeded, ablation still ceases based on the value of the ablation index even though depth is not exceeded). Leo et al. (2016/0213282) teach ablating by choosing a contact force applied between an ablation electrode and a target tissue, a power level, and a time, and then predicting the lesion size (volume, area, and/or depth of lesions) via a force-time-energization integral which is then compared to a desired lesion size ([0018], [0091]). Leo fails to teach the calculated values to be estimated IRE index values that are then compared to a prespecified target IRE index value that is not a size of the lesion, but a repeatable predictor of the size of the lesion comprising a volume, a depth, and a diameter of the lesion and fails to disclose the calculated value to be calculated as an integral over the time period of a product of the instantaneous measured contact forces, respectively, raised to a first calibrated non-unity exponent and the measured instantaneous power levels of the IRE pulses, respectively, raised to a second calibrated non-unity exponent. Lambert et al. (2012/0209260) teach predicting a lesion size using a lesion size index (LSI) that can be used to evaluate the lesion size during an ablation in real time and include a "lesion width index" (LWI) for estimating the maximum width or diameter of a lesion, a "lesion depth index" (LDI) for estimating the maximum and/or effective depth of the lesion, and the "lesion volume index" (LVI) for estimating the total volume of the lesion, where the LSI is derived from a mathematical expression that incorporates a contact force F between the ablation head and the target tissue, an energization parameter E applied to target the tissue (e.g., power, current or voltage), and a duration time t of the energization. Lambert et al. fail to disclose the LSI calculated as an integral over the time period of a product of the instantaneous measured contact forces, respectively, raised to a first calibrated non-unity exponent and the measured instantaneous power levels of the IRE pulses, respectively, raised to a second calibrated non-unity exponent.
Conclusion
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/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794