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. 365(c) & 119(e) 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 applications, Application Nos. PCT/US2022/038461, 63/336245 & 63/226040 provide 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 date of 7/27/2021.
Specification
The disclosure is objected to because of the following informalities: amend the Related Applications section to include the PCT priority information.
Appropriate correction is required.
The disclosure is objected to because of the following informalities: amend the Related Applications section to include the PGPUB information and/or patent information for cited applications in Pars. [006-010], [012-021] & [024-026].
Appropriate correction is required.
Claim Objections
Claim 71 is objected to because of the following informalities: amend “the one or more devices” to -the one or more energy delivery devices- in ll. 5-6. Appropriate correction is required.
Claim 71 is objected to because of the following informalities: amend “calculated VDS” to -wherein the calculated VDS- in ll. 7. Appropriate correction is required.
Claim 80 is objected to because of the following informalities: amend “in the display” to -on the display- in ll. 2. Appropriate correction is required.
Claim 81 is objected to because of the following informalities: “such an alteration” to -the alteration- in ll. 1. Appropriate correction is required.
Claim 82 is objected to because of the following informalities: amend “metric” to -metrics- in ll. 2. Appropriate correction is required.
Claim 83 is objected to because of the following informalities: amend “target tissue geometry” to -geometry of the target tissue- in ll. 4. Appropriate correction is required.
Claim 84 is objected to because of the following informalities: amend “at least one or a” to -at least one of a- in ll. 5. Appropriate correction is required.
Claim 86 is objected to because of the following informalities: amend “processes” to -process- in ll. 2. Appropriate correction is required.
Claim 86 is objected to because of the following informalities: “processes” to -process- in ll. 2. 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 71-90 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). 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 71 recites “[a]n energy delivery system, comprising one or more energy delivery devices having an energy delivery portion comprising at least one energy element configured to supply energy to target tissue; and a processor configured to execute an algorithm to calculate a volume-distributed score (VDS) for a volume surrounding the energy-delivery portion of the one or more devices, wherein calculated VDS represents an estimation of therapy effectiveness for a future delivery of energy and/or of therapy effectiveness of an energy delivery already performed.”
Step 1:
Claim 71 recites a method and is thus directed to a statutory category of invention.
Step 2A, Prong One:
Claim 71 recites the abstract idea of “a processor configured to execute an algorithm to calculate a volume-distributed score (VDS) for a volume surrounding the energy-delivery portion of the one or more devices, wherein calculated VDS represents an estimation of therapy effectiveness for a future delivery of energy and/or of therapy effectiveness of an energy delivery already performed”. This limitation recites a mathematical concept, and, specifically, a mathematical calculation.
Therefore, claim 71 recites the abstract idea of a mathematical calculation.
Step 2A, Prong Two:
Claim 71 recites the additional element of: “a processor configured to execute an algorithm” which is a recitation of a processor recited at a high level of generality, i.e., as a generic processor performing a generic computer function of processing data. 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 71 recites the additional element of “one or more energy delivery devices having an energy delivery portion comprising at least one energy element configured to supply energy to target tissue” which is a recitation of extra-solution activity that is understood as incidental to the primary product and is merely a nominal or tangential addition to the claim and amounts to merely indicating a field of use or technological environment in which to apply the judicial exception but does not amount to significantly more than the exception itself and is regarded as insignificant extra-solution activity that does not amount to an inventive concept.
Therefore, claim 71 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 71 recites the additional element of: “a processor configured to execute an algorithm” which is a recitation of a processor recited at a high level of generality, i.e., as a generic processor performing a generic computer function of processing data. 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 71 recites the additional element of “one or more energy delivery devices having an energy delivery portion comprising at least one energy element configured to supply energy to target tissue” which does not amount to significantly more than the abstract idea as energy delivery devices are a well-understood, routine, and conventional element. Specifically, Ben-Haim et al. (2020/0060757) teach an energy delivery system comprising: one or more energy delivery devices having an energy delivery portion comprising at least one energy element configured to supply energy to target tissue ([0208]).
Therefore, claim 71 does not amount to significantly more than the abstract idea as there are no additional elements, either alone or in combination, that provide for an inventive concept.
Claim 72 recites the additional element of: “wherein the target tissue comprises tissue selected from the group consisting of: cardiac tissue; nerve tissue; vessel wall tissue; organ tissue; brain tissue; lung tissue; kidney tissue; liver tissue; stomach tissue; muscle tissue; and combinations thereof” which is further defining the functional limitation recited in claim 71 which is a recitation of extra-solution activity that is understood as incidental to the primary product and is merely a nominal or tangential addition to the claim and amounts to merely indicating a field of use or technological environment in which to apply the judicial exception but does not amount to significantly more than the exception itself 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 energy delivery devices to treat claimed tissue are a well-understood, routine, and conventional element.
Dependent claim 72 does not amount to significantly more than the abstract idea as there are no additional elements that provide for an inventive concept.
Claim 73 recites the additional element of: “the processor is further configured to render the VDS in a visual form on a display of a user interface”, Claim 74 recites the additional element of: “the visual form includes the VDS in an elongate form”, Claim 75 recites the additional element of: “the processor is further configured to limit the display of the VDS to include only VDS values that exceed a threshold”, Claim 77 recites the additional element of: the processor is further configured to display the VDS in a visual form in relation to the target tissue”, Claim 78 recites the additional element of: the processor is further configured to display the VDS as at least one projection onto an anatomic model”, Claim 79 recites the additional element of: the volume of space represented by the VDS can extend far enough to encompass regions that are highly probable”, Claim 80 recites the additional element of: the processor is configured to render a spatial distribution of VDS values in the display using color, opacity, intensity, and/or another variable graphical parameter to indicate differentiation”, which are recitations of a processor recited at a high level of generality, i.e., as a generic processor performing a generic computer function of processing data (outputting step). This generic processor limitation is no more than mere instructions to apply the exception using a generic computer component. Further, the additional elements of claims 73-75 & 77-80 are recitations 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, Ben-Haim et al. (2020/0060757) disclose a processor configured to render a score in a visual form on a display ([0246-0247]; Fig. 3D-E, 8A-C & 16), Ben-Haim et al. (2020/0060757) disclose the visual form includes an elongate form ([0247-051], [0508-0510]; Fig. 3D-E, 8A-C & 16), Rodriguez et al. (2020/0022649) disclose a processor configured to limit the display of a score to values that exceed a threshold ([0372-0374]), Ben-Haim et al. (2020/0060757) disclose displaying the score in a visual form in relation to the target tissue ([0247-051], [0508-0510]; Fig. 3D-E, 8A-C & 16), Ben-Haim et al. (2020/0060757) disclose displaying the VDS (1606) as at least one projection onto an anatomic model ([0247-051], [0508-0510]; Fig. 3D-E, 8A-C & 16), Ben-Haim et al. disclose the volume of space represented by the VDS can extend far enough to encompass regions that are highly probable, marginally probably, and/or minimally probable of receiving a therapeutically effective delivery of energy for irreversible electroporation ([0190], [0275], [0253]; Fig. 3D-E, 8A-C & 16), and Ben-Haim et al. (2020/0060757) disclose the rendering a spatial distribution of values in the display using color, opacity, intensity, and/or another variable graphical parameter to indicate differentiation ([0551-0554], [0557-0558]; Fig. 17A-D).
Accordingly, these additional elements do not integrate the judicial exception into a practical application because it does not impose any meaningful limits on practicing the abstract idea and these additional elements do not provide an inventive concept.
Dependent claims 73-75 & 77-80 do not amount to significantly more than the abstract idea as there are no additional elements that provide for an inventive concept.
Claim 76 recites the abstract idea of “the processor is configured to set or change the threshold in response to a user input via the user interface and visually render the variability of scoring differences on the display in different areas of the target tissue” which is a recitation of a processor recited at a high level of generality, i.e., as a generic processor performing a generic computer function of processing data (data input and data output steps). This generic processor limitation is no more than mere instructions to apply the exception using a generic computer component. Further, this limitation recites an additional element that 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, Rodriguez et al. (2020/0022649) disclose the processor configured to set or change the threshold in response to a user input via the user interface ([0536], [0556-0557]; Fig. 17A-D) and Ben-Haim et al. (2020/0060757) disclose a processor configured to visually render a variability of scoring differences on the display in different areas of the target tissue ([0536], [0556-0557]; Fig. 3D-E & 16). Accordingly, these additional elements do not integrate the judicial exception into a practical application because they do not impose any meaningful limits on practicing the abstract idea and these additional elements do not provide an inventive concept.
Dependent claim 76 does not amount to significantly more than the abstract idea as there are no additional elements that provide for an inventive concept.
Claim 81 recites the additional element of: “the therapeutically effective delivery of energy causes an alteration of the target tissue, wherein such an alteration can comprise: an electrical alteration of tissue where cells of the tissue are stunned or killed; a biophysical alteration of tissue where the tissue is thickened, tissue is thinned, and/or edema results; a biochemical alteration of tissue; a material alteration of tissue where tissue is stiffened, softened, made porous, and/or made brittle, and/or combinations of these” which is a recitation of extra-solution activity that is understood as incidental to the primary product and is merely a nominal or tangential addition to the claim and amounts to merely indicating a field of use or technological environment in which to apply the judicial exception but does not amount to significantly more than the exception itself 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 therapeutically effective delivery of energy to cause the claimed alterations are a well-understood, routine, and conventional element. Specifically, Ben-Haim et al. (2020/0060757) disclose the therapeutically effective delivery of energy causes an alteration of the target tissue, wherein such an alteration can comprise: an electrical alteration of tissue where cells of the tissue are stunned or killed; a biophysical alteration of tissue where the tissue is thickened, tissue is thinned, and/or edema results ([0253], [0297]).
Dependent claim 81 does not amount to significantly more than the abstract idea as there are no additional elements that provide for an inventive concept.
Claim 82 further defines the abstract idea by reciting: “the processor is further configured to calculate the VDS based one or more metric, comprising at least one of electrical field strength; area of contact; angle of contact; force of contact; temperature; impedance; one or more tissue properties; blood properties; and/or combinations of these” and Claim 83 further defines the abstract idea by reciting: “the processor is further configured to calculate the VDS by taking into account one or more of: a configuration of the at least one energy delivery element; a configuration of an energy waveform and/or other energy delivery parameter; and/or blood geometry; target tissue geometry; and/or properties relative to the one or more delivery devices”. These limitations recite a mathematical concept, and, specifically, a mathematical calculation. Claim 82 recites the additional imitation of: “the processor…based one or more metric, comprising at least one of electrical field strength; area of contact; angle of contact; force of contact; temperature; impedance; one or more tissue properties; blood properties; and/or combinations of these” and Claim 83 recites the additional imitation of: “the processor…by taking into account one or more of: a configuration of the at least one energy delivery element; a configuration of an energy waveform and/or other energy delivery parameter; and/or blood geometry; target tissue geometry; and/or properties relative to the one or more delivery devices” which are recitations of a processor recited at a high level of generality, i.e., as a generic processor performing a generic computer function of processing data (data input steps). This generic processor limitation is no more than mere instructions to apply the exception using a generic computer component. Further, these limitations recite the additional elements that are recitations of extra-solution activity (data input) 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, Ben-Haim et al. (2020/0060757) disclose the processor configured to calculate the score based one or more metric, comprising at least one of electrical field strength; area of contact; angle of contact; force of contact; temperature; impedance; one or more tissue properties; blood properties; and/or combinations of these ([0291], [0298-0299]; Fig. 4A) and by taking into account one or more of: a configuration of the at least one energy delivery element; a configuration of an energy waveform and/or other energy delivery parameter; and/or blood geometry; target tissue geometry; and/or properties relative to the one or more delivery devices ([0253]). Accordingly, these additional elements do not integrate the judicial exception into a practical application because it do not impose any meaningful limits on practicing the abstract idea and these additional elements do not provide an inventive concept.
Dependent claims 82-83 do not amount to significantly more than the abstract idea as there are no additional elements that provide for an inventive concept.
Claim 84 further defines the abstract idea by reciting: “the algorithm is configured to use a field model that is based on: analytical calculations and/or equations; discrete and/or numerical methods using randomized point sources with modeled boundary conditions; and/or a look-up table and/or estimation and/or optimization algorithm with data fitting based on a priori data including at least one or a simulation, a database, and/or a training dataset”, Claim 85 further defines the abstract idea by reciting: “the algorithm includes an optimization algorithm that includes statistical models, pattern matching, machine learning, artificial intelligence, and/or other data-driven techniques based on historical data to calculate the VDS”, Claim 86 further defines the abstract idea by reciting: “the algorithm includes a vulnerability algorithm that is executable to processes a set of actual VDS values of a region to qualitatively label and/or quantitatively display areas in which delivered energy is below a predetermined effectiveness threshold”, Claim 87 further defines the abstract idea by reciting: “the vulnerability algorithm is executable to process a set of VDS values to identify data features that are deterministically and/or probabilistically ineffective”, Claim 88 further defines the abstract idea by reciting: “the vulnerability algorithm is executable to search for spatial gaps, edges, channels, and/or spatial heterogeneity in the VDS values”, and Claim 89 further defines the abstract idea by reciting: “the vulnerability algorithm is executable to utilize image processing and/or pattern matching techniques to assess vulnerability”. These limitations recite either a mathematical concept (calculation) or a mental process/a concept (evaluation) that can be performed in the human mind. Further, these limitations recite additional elements that are recitations of extra-solution activity (data input) 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, Ben-Haim et al. (2020/0060757) disclose the algorithm is configured to use a field model that is based on: analytical calculations and/or equations; discrete and/or numerical methods using randomized point sources with modeled boundary conditions; and/or a look-up table and/or estimation and/or optimization algorithm with data fitting based on a priori data including at least one of a simulation, a database, and/or a training dataset ([0217], [0245], [0366]; Fig. 3C). Specifically, Ben-Haim et al. (2020/0060757) disclose the algorithm includes a vulnerability algorithm that is executable to process a set of actual VDS values of a region to qualitatively label and/or quantitatively display areas in which delivered energy is below a predetermined effectiveness threshold ([0392-0394]; Fig. 12). Ben-Haim et al. (2020/0060757) disclose the vulnerability algorithm is executable to process a set of VDS values to identify data features that are deterministically and/or probabilistically ineffective (e.g., gap) ([0394]; Fig. 12). Specifically, Ben-Haim et al. (2020/0060757) disclose the vulnerability algorithm is executable to search for spatial gaps, edges, channels, and/or spatial heterogeneity in the VDS values (e.g., gap) ([0392-0394]; Fig. 12). Specifically, Ben-Haim et al. (2020/0060757) disclose the vulnerability algorithm is executable to utilize image processing and/or pattern matching techniques to assess vulnerability ([0223], [0298], [0392-0394]; Fig. 12). Accordingly, these additional elements do not integrate the judicial exception into a practical application because it do not impose any meaningful limits on practicing the abstract idea and these additional elements do not provide an inventive concept.
Dependent claims 84-89 do not amount to significantly more than the abstract idea as there are no additional elements that provide for an inventive concept.
Claim 90 further defines the additional element of: “the at least one energy delivery element includes at least one energy delivery element disposed on an ablation catheter” which is a recitation of extra-solution activity that is understood as incidental to the primary product and is merely a nominal or tangential addition to the claim and amounts to merely indicating a field of use or technological environment in which to apply the judicial exception but does not amount to significantly more than the exception itself 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 energy delivery devices are a well-understood, routine, and conventional element. Specifically, Ben-Haim et al. (2020/0060757) disclose the at least one energy delivery element includes at least one energy delivery element (1114) disposed on an ablation catheter (1116) ([0208]). Accordingly, these additional elements do not integrate the judicial exception into a practical application because it do not impose any meaningful limits on practicing the abstract idea and these additional elements do not provide an inventive concept.
Dependent claim 90 does not amount to significantly more than the abstract idea as there are no additional elements that provide for an inventive concept.
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 71-90 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 Examiner notes that there are numerous 35 USC 112(b)/second paragraph issues in the claims and has attempted to identify each below. Further, claim 72 limits claim 71 since it recites specific tissue structures that are used by the processor/algorithm.
Claim 71 recites the limitations “supply energy”, in ll. 3, “a future delivery of energy” in ll. 7-8 and “an energy delivery already performed” in ll. 3-4. It is unclear if the “energy” recited in each of those limitations is the same or different. It is suggested to amend “therapy effectiveness for a future delivery of energy and/or of therapy effectiveness of an energy delivery already performed” to -therapy effectiveness for a future delivery of the energy and/or of therapy effectiveness of a previous delivery of the energy-. The claim will be interpreted in this manner.
Claims 72-90 depend from claim 71 and are thus also rejected.
Claim 75 recites the limitation "the display of the VDS" in ll. 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 75 recites the limitation “only VDS values” in ll. 2; however, claim 71, upon which claim 75 relies upon, recites the limitation “calculate a volume-distributed score (VDS) in ll. 4-5. There is no recitation that there is more than one “VDS value” calculated and it is unclear if the “VDS values” recited in claim 75 comprise the previously recited “VDS” of claim 71. For purposes of examination, it will be interpreted as only one VDS value being calculated and used as claimed in claim 71.
Claim 79 recites the limitation "the volume of space" in ll. 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 79 recites the limitation “can extend” in ll. 1-2. It is unclear if the claim is positively reciting the volume of space extending, or if the limitation is optional due to the word “can”. For purposes of examination, it will be interpreted as positively claiming the limitation.
Claim 79 recites the limitation “far enough” in ll. 2, which is regarded as an being subjective and thus indefinite. It is suggested to delete this phrase and the claim will be interpreted in this manner.
Claim 79 recites the limitation “a therapeutically effective delivery of energy for irreversible electroporation” in ll. 3-4; however, claim 71, upon which claim 79 depends, recites the limitations “supply energy”, in ll. 3, “a future delivery of energy” in ll. 7-8 and “an energy delivery already performed” in ll. 3-4. It is unclear if the therapeutically effective delivery of energy includes any of the previously recited limitations with respect to “energy”. For purposes of examination, it will be interpreted as the same “energy”.
Claim 80 recites the limitation “only VDS values” in ll. 2; however, claim 71, upon which claim 80 relies upon, recites the limitation “calculate a volume-distributed score (VDS) in ll. 4-5. There is no recitation that there is more than one “VDS value” calculated and it is unclear if the “VDS values” recited in claim 80 comprise the previously recited “VDS” of claim 71. For purposes of examination, it will be interpreted as only one VDS value being calculated and used as claimed in claim 71.
Claim 81 recites the limitation "the therapeutically effective delivery of energy" in ll. 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 81 recites the limitation “the therapeutically effective delivery of energy for irreversible electroporation” in ll. 1; however, claim 71, upon which claim 81 depends, recites the limitations “supply energy”, in ll. 3, “a future delivery of energy” in ll. 7-8 and “an energy delivery already performed” in ll. 3-4. It is unclear if the “therapeutically effective delivery of energy” includes any of the previously recited limitations with respect to “energy”. For purposes of examination, it will be interpreted as the same.
Claim 81 recites the limitation “can comprise” in ll. 2. It is unclear if the claim is positively reciting the alteration comprising the recited limitations, or if the limitation is optional due to the word “can”. For purposes of examination, it will be interpreted as positively reciting the limitation.
Claim 81 recites the limitation “of tissue” in ll. 3, 4 & 5 (twice) and “tissue” in ll. 4; however, claim 71, upon which claim 81 depends, recites the limitation “target tissue”. It is unclear if any of the limitations of “tissue” in claim 81 are the same as or different from the “target tissue” recited in claim 71. For purposes of examination, they will be interpreted as the same.
Claim 83 recites the limitation “blood geometry” in ll. 4. It is unclear what is meant by this term, the specification fails to provide a definition, and it is not known to one of ordinary skill in the art. For purposes of examination, it will be interpreted as vessel geometry which is known to one of ordinary skill in the art, but the Examiner notes that the originally filed disclosure fails to provide support for this interpretation.
Claim 86 recites the limitation “delivered energy” in ll. 3; however, claim 71, upon which claim 86 depends, recites the limitations “supply energy”, in ll. 3, “a future delivery of energy” in ll. 7-8 and “an energy delivery already performed” in ll. 3-4. It is unclear if the “energy” in claim 86 is the same as or different from any of the recitations of “energy” in claim 71. For purposes of examination, it will be interpreted as the same.
Claim 87 recites “process a set of VDS values” in ll. 2; however, claim 71, upon which claim 87 depends, recites the limitation “a volume-distributed score (VDS)” in ll. 4-5. It is unclear if the “VDS values” of claim 87 encompass the previously recited “VDS” in claim 71. For purposes of examination, it will be interpreted as encompassing the previously recited “VDS” in claim 71.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 71-74, 77-79 & 81-90 is/are rejected under 35 U.S.C. 102(a)(1) or 102(a)(2) as being anticipated by Ben-Haim et al. (2020/0060757).
Concerning claim 71, as illustrated in at least Fig. 1B-14B, BEN-HAIM et al. disclose an energy delivery system (system for ablation and/or tracking the position of an intra-body catheter, which may be used with an estimator; [0199), comprising:
one or more energy delivery devices having an energy delivery portion comprising at least one energy element configured to supply energy to target tissue (plurality of physical electrodes 1114 and/or sensors (optionally, the electrodes serve as the sensors) located on a distal end portion of a physical catheter 1116; [0208]); and
a processor configured to execute an algorithm to calculate a volume-distributed score (VDS) for a volume surrounding the energy-delivery portion of the one or more devices (computing unit 1102 comprises estimator embedded in processor 1104 or by a dedicated estimator 1150 that may be learned lesion estimator 1604 (as described in FIG. 1) and/or ablation line estimator 1804 (as described in FIG. 6) and/or ablation segment estimator 2104 (as described in FIG. 14A), where estimator 1604 outputs an estimated lesion effectiveness that may include a binary prediction (e.g., +1 or −1) or a probabilistic output, e.g., between zero and one (e.g., a dynamic score) to produce an estimated lesion effectiveness 1606 which may be expressed in the same terms as used by lesion model 1601 for learning, or, optionally, may also be accompanied by an estimate of the certainty of the prediction, for example, based on statistically determined specificity and/or sensitivity; [0201], [0214], [0272], [0274], [0276]), wherein calculated VDS represents an estimation of therapy effectiveness for a future delivery of energy and/or of therapy effectiveness of an energy delivery already performed (estimators 2010, 2012, 2014 include estimators for pre-procedure, intra-procedure, and post-ablation times and any of the learned lesion estimator 1604, ablation line estimator 1804, and/or ablation segment estimator 2104; [0390-0391]).
Concerning claim 72, Ben-Haim et al. disclose the target tissue comprises tissue selected from the group consisting of: cardiac tissue; nerve tissue; vessel wall tissue; organ tissue; brain tissue; lung tissue; kidney tissue; liver tissue; stomach tissue; muscle tissue; and combinations thereof ([0238], [0406]).
Concerning claim 73, Ben-Haim et al. disclose the processor (1102/1104/1150) is further configured to render the VDS (1606) in a visual form on a display (1132) of a user interface (1124) ([0246-0247], [0250-0251]; Fig. 3D-E, 8A-C & 16).
Concerning claim 74, Ben-Haim et al. disclose the visual form includes the VDS (1606) in an elongate form ([0247-051], [0508-0510]; Fig. 3D-E, 8A-C & 16).
Concerning claim 77, Ben-Haim et al. disclose the processor (1102/1104/1150) is further configured to display the VDS (1606) in a visual form in relation to the target tissue ([0247-051], [0508-0510]; Fig. 3D-E, 8A-C & 16).
Concerning claim 78, Ben-Haim et al. disclose the processor (1102/1104/1150) is further configured to display the VDS (1606) as at least one projection onto an anatomic model ([0247-051], [0508-0510]; Fig. 3D-E, 8A-C & 16).
Concerning claim 79, Ben-Haim et al. disclose the volume of space represented by the VDS (1606) can extend far enough to encompass regions that are highly probable, marginally probably, and/or minimally probable of receiving a therapeutically effective delivery of energy for irreversible electroporation ([0190], [0275], [0253]; Fig. 3D-E, 8A-C & 16).
Concerning claim 81, Ben-Haim et al. disclose the therapeutically effective delivery of energy causes an alteration of the target tissue, wherein such an alteration can comprise: an electrical alteration of tissue where cells of the tissue are stunned or killed; a biophysical alteration of tissue where the tissue is thickened, tissue is thinned, and/or edema results; a biochemical alteration of tissue; a material alteration of tissue where tissue is stiffened, softened, made porous, and/or made brittle, and/or combinations of these ([0253], [0297]).
Concerning claim 82¸Ben-Haim et al. disclose the processor (1102/1104/1150) is further configured to calculate the VDS (1606) based one or more metric, comprising at least one of electrical field strength; area of contact; angle of contact; force of contact; temperature; impedance; one or more tissue properties; blood properties; and/or combinations of these ([0291], [0298-0299]; Fig. 4A).
Concerning claim 83, Ben-Haim et al. disclose the processor (1102/1104/1150) is further configured to calculate the VDS (1606) by taking into account one or more of: a configuration of the at least one energy delivery element; a configuration of an energy waveform and/or other energy delivery parameter; and/or blood geometry; target tissue geometry; and/or properties relative to the one or more delivery devices ([0253]).
Concerning claim 84, Ben-Haim et al. disclose the algorithm is configured to use a field model that is based on: analytical calculations and/or equations; discrete and/or numerical methods using randomized point sources with modeled boundary conditions; and/or a look-up table and/or estimation and/or optimization algorithm with data fitting based on a priori data including at least one of a simulation, a database, and/or a training dataset ([0217], [0245], [0366]; Fig. 3C).
Concerning claim 85, Ben-Haim et al. disclose the algorithm includes an optimization algorithm that includes statistical models, pattern matching, machine learning, artificial intelligence, and/or other data-driven techniques based on historical data to calculate the VDS ([0226], [0257], [0272]).
Concerning claim 86, Ben-Haim et al. disclose the algorithm includes a vulnerability algorithm that is executable to process a set of actual VDS values of a region to qualitatively label and/or quantitatively display areas in which delivered energy is below a predetermined effectiveness threshold ([0392-0394]; Fig. 12).
Concerning claim 87, Ben-Haim et al. disclose the vulnerability algorithm is executable to process a set of VDS values to identify data features that are deterministically and/or probabilistically ineffective (e.g., gap) ([0394]; Fig. 12).
Concerning claim 88, Ben-Haim et al. disclose the vulnerability algorithm is executable to search for spatial gaps, edges, channels, and/or spatial heterogeneity in the VDS values (e.g., gap) ([0392-0394]; Fig. 12).
Concerning claim 89, Ben-Haim et al. disclose the vulnerability algorithm is executable to utilize image processing and/or pattern matching techniques to assess vulnerability ([0223], [0298], [0392-0394]; Fig. 12).
Concerning claim 90, Ben-Haim et al. disclose the at least one energy delivery element includes at least one energy delivery element (1114) disposed on an ablation catheter (1116) ([0208]).
Claim(s) 71, 73 & 75 is/are rejected under 35 U.S.C. 102(a)(1) or 102(a)(2) as being anticipated by Rodriguez et al. (2020/0022649).
Concerning claim 71, as illustrated in at least Fig. 1B-14B, Rodriguez et al. disclose an energy delivery system (system for ablation and/or tracking the position of an intra-body catheter; [0109]), comprising:
one or more energy delivery devices having an energy delivery portion comprising at least one energy element configured to supply energy to target tissue (plurality of physical electrodes 1114 and/or sensors (optionally, the electrodes serve as the sensors) located on a distal end portion of a physical catheter 1116; [0165]); and
a processor configured to execute an algorithm to calculate a volume-distributed score (VDS) for a volume surrounding the energy-delivery portion of the one or more devices (computing unit 1102 comprises estimator embedded in processor 1104 or by a dedicated estimator 1150 that may be learned lesion estimator 1604 (as described in FIG. 1) and/or ablation line estimator 1804 (as described in FIG. 6) and/or ablation segment estimator 2104 (as described in FIG. 14A), where estimator 1604 outputs an estimated lesion effectiveness that may include a binary prediction (e.g., +1 or −1) or a probabilistic output, e.g., between zero and one (e.g., a dynamic score) to produce an estimated lesion effectiveness 1606 which may be expressed in the same terms as used by lesion model 1601 for learning, or, optionally, may also be accompanied by an estimate of the certainty of the prediction, for example, based on statistically determined specificity and/or sensitivity; [0158], [0233], [0327], [0407]), wherein calculated VDS represents an estimation of therapy effectiveness for a future delivery of energy and/or of therapy effectiveness of an energy delivery already performed (estimators 2010, 2012, 2014 include estimators for pre-procedure, intra-procedure, and post-ablation times and any of the learned lesion estimator 1604, ablation line estimator 1804, and/or ablation segment estimator 2104; [0354-0355]).
Concerning claim 73, Rodriguez et al. disclose the processor (1102/1104/1150) is further configured to render the VDS (1606) in a visual form on a display (1132) of a user interface (1124) ([0164], [0208], [0396], [0461]; Fig. 3D-E, 8A-C & 16).
Concerning claim 75, Rodriguez et al. disclose the processor (1102/1104/1150) is further configured to limit the display of the VDS (1606) to include only VDS (1606) values that exceed a threshold ([0372-0374]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 75-76 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ben-Haim et al. (2020/0060757), as applied to claim 71, in further view of Rodriguez et al. (2020/0022649).
Concerning claim 75, Ben-Haim et al. fail to specifically disclose the processor is further configured to limit the display of the VDS to include only VDS values that exceed a threshold. However, Rodriguez et al. disclose an energy delivery system (system for ablation), comprising: one or more energy delivery devices (1116) having an energy delivery portion comprising at least one energy element (1114) configured to supply energy to target tissue; and a processor (1102/1104) configured to execute an algorithm to calculate a volume-distributed score (VDS) (2606) for a volume surrounding the energy-delivery portion (1114) of the one or more devices (1116), wherein the calculated VDS represents an estimation, the processor (1102/1104) is further configured to limit the display of the VDS to include only VDS values (2606) that exceed a threshold. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify Ben-Haim et al. such that the processor is further configured to limit the display of the VDS to include only VDS values that exceed a threshold in order to provide the benefit of allowing the physician to set any desired threshold based on his/her own preferences as taught by Rodriguez et al. ([0109], [0165], [0536]); Fig. 1 & 18).
Concerning claim 76, Ben-Haim et al. disclose the processor (1102/1104) is configured to visually render a variability of scoring differences on the display (1132) in different areas of the target tissue ([0536], [0556-0557]; Fig. 3D-E & 16). Rodriguez et al. further disclose the processor (1102/1104) is configured to set or change the threshold in response to a user input via the user interface (1124) ([0536], [0556-0557]; Fig. 17A-D). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify Ben-Haim et al. such that the processor is configured to set or change the threshold in response to a user input via the user interface in order to provide the benefit of allowing the physician to set any desired threshold based on his/her own preferences as taught by Rodriguez et al. ([0109], [0165], [0536]); Fig. 1 & 18.
Claim(s) 80 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ben-Haim et al. (2020/0060757), as applied to claim 71.
Concerning claim 80, Ben-Haim et al. fail to specifically disclose the processor is configured to render a spatial distribution of VDS values in the display using color, opacity, intensity, and/or another variable graphical parameter to indicate differentiation. However, Ben-Haim et al. disclose the processor (1102/1104) configured to render a spatial distribution of values in the display using color, opacity, intensity, and/or another variable graphical parameter to indicate differentiation for edema estimation. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the lesion and/or ablation line and/or ablation segment estimator embodiment in order to provide the benefit of schematically representing changes such that the user can change parameters to achieve a desired effectiveness (e.g., full ablation) as taught by Ben-Haim et al. ([0551-0554], [0557-0558]; Fig. 17A-D)
Conclusion
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/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794