DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 5/20/2025 has been entered.
Response to Arguments
Applicant's arguments filed 5/20/2025 with respect to the rejection of Claims 1-21 under 35 USC 101 have been fully considered but they are not persuasive. Applicant argues that “claim 1 integrates any purported judicial exception recited in the claims into practical application since it represents an improvement to the technology and technical fields of diagnosis and treatment of cardiac arrhythmias” (Remarks at Pg. 9). Of the improvement, Applicant states “by determining the ‘adjusted start time’ and ‘render[ing], to the display in response to the determined adjusted start time, the renderable propagation of the cardiac activation wave immediately over the user- selected sub-region of the anatomical map beginning at the determined adjusted start time, the physician/user can carefully inspect the rendered propagation of the cardiac activation wave over the sub-region immediately instead of not being able to see the propagation on the selected rendered sub-region of the anatomical map until after some delay….”
Applicant’s arguments characterize both the “determining” and the “rendering” elements as responsible for the improvement. The Examiner respectfully disagrees. The improvement highlighted by Applicant comes from determining the adjusted start time: “rendering” is merely outputting data reflective of the determining. “It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements.” MPEP 2106.05(a). As the improvement highlighted by Applicant is provided by the judicial exception (i.e., the “determining”), Applicant’s arguments are not persuasive.
Applicant’s arguments regarding the rejection of Independent Claim 1 under 35 USC 103 as unpatentable over Kim Yh et al., 2019 APHRS expert consensus statement on three-dimensional mapping systems for tachycardia developed in collaboration with HRS, EHRA, and LAHRS, J. Arrthymia, 2020 ("Kim") in view of Morgan et al., International Patent Publication No. WO 2020/242940 ("Morgan") have been fully considered and are persuasive. The Examiner agrees that the combination of Kim and Morgan does not disclose “and enable the user, as the cardiac activation wave moves over the anatomical map, to zoom into the user-selected sub-region of the anatomical map of the chamber of the patient after the determined adjusted start time when the cardiac activation wave first arrives in the user-selected sub-region and before the cardiac activation wave leaves the user-selected sub-region, thereby enabling the user to inspect the rendered propagation of the cardiac activation wave over the sub-region” as recited by amended Claim 1. Accordingly, the rejection is withdrawn. However, upon further consideration, new grounds of rejection is made in view of US 20170202469 A1.
Applicant’s arguments regarding Independent Claims 11 and 21 are similar to Applicant’s arguments regarding Claim 1. Applicant’s arguments have been fully considered, and are persuasive for the same reasons explained above with respect to Claim 1. Accordingly, the rejection is withdrawn. However, upon further consideration, new grounds of rejection is made in view of US 20170202469 A1.
Applicant’s arguments regarding dependent Claims 2-10 and 12-20 are similar to Applicant’s arguments regarding the Independent Claims from which each respectively depends. Applicant’s arguments have been fully considered, and are persuasive for the same reasons explained above with respect to Claim 1. Accordingly, the rejection is withdrawn. However, upon further consideration, new grounds of rejection is made in view of US 20170202469 A1.
Applicant’s arguments regarding the provisional rejection of Claims 1-21 on the ground of non-statutory obviousness-type double patenting over claims 1-21 of commonly owned and co-pending U.S. Patent Application No. 17/342,871 have been fully considered and are persuasive. As U.S. Patent Application No. 17/342,871 has been abandoned, the provisional rejection is now moot. Accordingly, the provisional rejection of Claims 1-21 on the ground of non-statutory obviousness-type double patenting over claims 1-21 of commonly owned and co-pending U.S. Patent Application No. 17/342,871 is withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 11 and 21, and Claims 2-10 and 12-20 by dependency, are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding Independent Claim 1, Claim 1 recites “render, to the display in response to the determined adjusted start time….” Applicant points to Page 15, Line 10 through Page 16, Line 3 of the Present Specification as supporting this language. However, the Present Specification does not describe – either at Page 15, Line 10 through Page 16, Line 3 or elsewhere – the rendering being done “in response to the determined adjusted start time.” The limitation thus constitutes new matter.
Regarding Independent Claims 11 and 21, Claims 11 and 21 contain a similar limitation to that explained above with respect to Claim 1, and recite new matter for the same reasons.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 11 and 21, and Claims 2-10 and 12-20 by dependency, 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.
Regarding Independent Claim 1, Claim 1 recites “render, to the display in response to the determined adjusted start time….” It is unclear in what sense the rendering is done “in response to” the determined adjusted start time, because it is unclear how an act can be performed responsively to a time.
For purposes of this Office Action, the limitation “render, to the display in response to the determined adjusted start time…” is being interpreted to mean that rendering is done based on the determined adjusted start time, similarly to the manner described in the remainder of the limitation.
Regarding Independent Claims 11 and 21, Claims 11 and 21 contain a similar limitation to that explained above with respect to Claim 1, and are indefinite for the same reasons.
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 1-21 are rejected under 35 U.S.C. § 101 because the claimed invention is directed to a judicial exception (i.e., an abstract idea) without significantly more.
Eligibility Step 1: Claims 1-21 each fall within one of the four categories of statutory subject matter.
Claims 1-10 are drawn to “a system” (i.e., a machine), and thus fall within one of the four statutory categories. Claims 11-20 are drawn to “a method” (i.e., a process), and thus fall within one of the four statutory categories. Claim 21 is drawn to a “product” (i.e., a machine), and thus falls within one of the four statutory categories.
Eligibility Step 2A, Prong One: Claims 1-21 recite abstract ideas, as explained below.
Eligibility Step 2A, Prong Two: Claims 1-21 do not recite additional elements that integrate the judicial exception into a practical application, as explained below.
Eligibility Step 2B: Claims 1-21 do not amount to significantly more than the abstract ideas recited therein, as explained below.
Regarding Independent Claim 1:
Step 2A, Prong One: Independent Claim 1 recites the following judicial exceptions:
“identify local activation times (LATs) from the captured electrical activity” recites a mental process. The human mind could practically identify local activation times in the manner claimed. No particular manner of identifying is recited, nor are any specifics of how the claimed identifying is performed. A human could observe a spreadsheet containing data detailing the captured electrical activity, and exercise judgment to determine (i.e., “identify”) local activations times from that data.
“and associate the local activation times with respective positions on the surface of an anatomical map of the chamber” recites a mental process. The human mind could practically associate the local activations with such respective positions as recited in the manner claimed. No particular manner of associating is recited, nor are any specifics of how the claimed associating is performed. A human could observe a spreadsheet containing data detailing the determined activation times along with data indicating the location of those activation times, and exercise judgment to associate the local the local activation times with respective positions on the surface of an anatomical map of the chamber (e.g., by matching coordinates representing the location of the activation time observed from data with corresponding coordinates on the anatomical map).
“compute a propagation of a cardiac activation wave over the anatomical map of the chamber from a start time in a cardiac cycle to an end time in the cardiac cycle responsively to the captured electrical activity, wherein the computed propagation of the cardiac activation wave is calculated using a sliding window of the local activation times” recites a mathematical calculation. The claimed computing is a mathematical calculation of the recited propagation. The recitation “wherein the propagation … is calculated using a sliding window…” provides additional details of the calculation.
“determine, based upon a time the computed propagation of the cardiac activation wave would first arrive in the user-selected sub-region, an adjusted start time for rendering the computed propagation of the cardiac activation wave in the selected sub-region of the anatomical map, the adjusted start time being the earliest time after the cardiac cycle start time when the computed propagation of the cardiac activation wave would arrive in the user-selected sub-region of the anatomical map;” recites a mental process. The human mind could practically determine such an adjusted start time as recited. No particular manner of determining is recited, nor are any specifics of how the claimed determining is performed. That the claimed “determin[ing] is “based upon a time the computed propagation wave would first arrive in the user-selected sub-region” does not make it any less practically performable in the human mind. A human could observe a spreadsheet containing ordered pairs of location of computed propagation as a function of time, observe the location of the “user selected sub-region,” and exercise judgment to determine a time that the computed propagation would arrive in the user selected sub-region based thereupon.
Such a determination would be consistent with the limitation “the adjusted start time being the earliest time after the cardiac cycle start time when the computed propagation of the cardiac activation wave would arrive in the user-selected sub-region of the anatomical map,” describes what the start time represents.
“generate a renderable propagation of a cardiac wave over the surface of an anatomical map of the chamber” recites a mental process when the term is afforded its broadest reasonable interpretation. The claimed “generat[ing]” is practically performable in the human mind. For example, a human could observe data reflective of the recited propagation, and exercise judgment regarding that data to generate such a renderable propagation.
Step 2A, Prong Two: Independent Claim 1 recites the following additional elements, none of which integrate the above-noted judicial exceptions into a practical application:
“a catheter configured to be inserted into a chamber of a heart of a patient, and including electrodes configured to capture electrical activity of tissue of the chamber over time” amounts to necessary data gathering in conjunction with implementing the abstract idea, and as such is insignificant extra-solution activity insufficient to integrate the judicial exception into a practical application. The catheter and its included electrodes are “configured to capture electrical activity of tissue of the chamber over time.” The electrical activity captured thereby serves as data which is subsequently used to carry out the above-explained judicial exceptions.
“a display” amounts to necessary data outputting in conjunction with implementing the abstract idea, and as such is insignificant extra-solution activity insufficient to integrate the judicial exception into a practical application. The role of the “a display” is to display the results of the above-explained judicial exceptions.
“and processing circuitry configured to” amounts to merely reciting the words “apply it.” The recited processing circuitry is what allows the recited judicial exceptions to be performed by the system. Accordingly, the recited judicial exceptions are applied by processing circuitry. “As the Supreme Court explained in Alice Corp., mere physical or tangible implementation of an exception does not guarantee eligibility. Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. 208, 224, 110 USPQ2d 1976, 1983-84 (2014) (‘The fact that a computer “necessarily exist[s] in the physical, rather than purely conceptual, realm,” is beside the point’).” MPEP 2106.04(d)(I). Thus, the fact that the physical component “processing circuitry” is used to carry out the recited judicial exception is not sufficient to integrate the judicial exception into a practical application.
“render to the display a user-selected sub-region of the anatomical map” amounts to necessary data outputting in conjunction with implementing the abstract idea, and as such is insignificant extra-solution activity insufficient to integrate the judicial exception into a practical application. Contextually, rendering to the display a sub-region of the anatomical map is outputting the results of the recited judicial exceptions.
“render, to the display in response to the determined adjusted start time, the renderable propagation of the cardiac activation wave immediately over the user-selected sub-region of the anatomical map beginning at the determined adjusted start time” amounts to necessary data outputting in conjunction with implementing the abstract idea and as such is insignificant extra-solution activity insufficient to integrate the judicial exception into a practical application for the same reasons as explained above regarding the similar limitation “render to the display a user-selected sub-region of the anatomical map.”
That the “render[ing]” is done “in response to the adjusted start time” limits the timing of the outputting, but does not change that the “render[ing]” is, fundamentally, still data outputting.
“and enable the user, as the cardiac activation wave moves over the anatomical map, to zoom into the user-selected sub-region of the anatomical map of the chamber of the patient after the determined adjusted start time when the cardiac activation wave first arrives in the user-selected sub-region and before the cardiac activation wave leaves the user-selected sub-region, thereby enabling the user to inspect the rendered propagation of the cardiac activation wave over the sub-region” amounts to necessary data outputting in conjunction with implementing the abstract idea and as such is insignificant extra-solution activity insufficient to integrate the judicial exception into a practical application.
The limitation recites “enable the user … to zoom into the user-selected sub-region of the anatomical map … thereby enabling the user to inspect the rendered propagation of the cardiac activation wave over the sub-region.” The recited “zoom[ing] into” is a manner of outputting data (the data that is output being “the rendered propagation of the cardiac activation wave over the sub-region”).
Eligibility Step 2B: Independent Claim 1 recites the following additional elements, none of which (either alone or in combination) cause the claimed invention to amount to significantly more than the abstract ideas recited therein:
“a catheter configured to be inserted into a chamber of a heart of a patient, and including electrodes configured to capture electrical activity of tissue of the chamber over time” does not contribute an inventive concept. The claimed display is described at a high level of generality. Such a device is well-understood, routine and conventional in the art of cardiac mapping. See, e.g., Kim YH et al., 2019 APHRS expert consensus statement on three-dimensional mapping systems for tachycardia developed in collaboration with HRS, EHRA, and LAHRS. J Arrhythm. 2020 Mar 9;36(2):215-270 (“Kim”) at Pg. 216, Left Column, Second Paragraph, “Catheter mapping and ablation are widely performed for various complex tachyarrhythmias that need a better understanding of fundamental technologies of mapping to identify triggers or substrate of arrhythmias;” Pg. 236, Right Column, First Paragraph, “Commonly employed dedicated mapping catheters with the CARTO system include a fivesplined catheter (PentaRay) and linear decapolar catheter (DecaNav);” Pg. 257, Right Column, Third Paragraph, “Three-dimensional mapping is an established method for tracking catheter movement and manipulation, using the capability to recognize the catheter as their primary visual modality, and to construct a 3D structure in real time.”
“a display” does not contribute an inventive concept. The claimed display is described at a high level of generality. Such a device is well-understood, routine and conventional in the art of cardiac mapping. See, e.g., Kim at Pg. 216, Right Column, “Cardiac mapping is the registration of the spatial distribution of cardiac functional characteristics, typically of localized electrical potentials. The development and availability of accurate 3D localization technology has made this an important part of routine clinical cardiac electrophysiologic care, most frequently by permitting the visualization and ready comprehension of intracardiac activation sequences and contact electrogram characteristics;” Pg. 217, Left Column, First Paragraph, “This is typically graphically represented as a static color-coded map of local activation time, or as a video portrayal of a moving wavefront of activation (Figure 2-1);” Pg. 219, Right Column, First Paragraph, “The commonly used 3D mapping systems are the CARTO 3 (Biosense Webster) and EnSite Precision (Abbott);” Pg. 228, Figure 6-1 shows a display from “commonly used 3D mapping system[]” CARTO 3.
“and processing circuitry configured to” amounts to adding the words “apply it” as explained above, and thus does not contribute an inventive concept. See MPEP 2106.05(I)(A).
“render to the display a user-selected sub-region of the anatomical map” does not contribute an inventive concept. The claimed rendering is described at a high level of generality. Such rendering is well-understood, routine and conventional in the art of cardiac mapping. See, e.g., Kim at Pg. 216, Right Column; Pg. 217, Left Column, First Paragraph; Pg. 219, Right Column, First Paragraph; Pg. 228, Figure 6-1.
“render, to the display in response to the determined adjusted start time, the renderable propagation of the cardiac activation wave immediately over the user-selected sub-region of the anatomical map beginning at the determined adjusted start time” does not contribute an inventive concept for the same reasons as explained above regarding the similar limitation “render to the display a sub-region of the anatomical map.”
“and enable the user, as the cardiac activation wave moves over the anatomical map, to zoom into the user-selected sub-region of the anatomical map of the chamber of the patient after the determined adjusted start time when the cardiac activation wave first arrives in the user-selected sub-region and before the cardiac activation wave leaves the user-selected sub-region, thereby enabling the user to inspect the rendered propagation of the cardiac activation wave over the sub-region” does not contribute an inventive concept. The claimed “enabl[ing] the user … to zoom…” is described at a high level of generality. Such “enabl[ing] the user … to zoom…” is well-understood, routine and conventional in the art of cardiac mapping. See, e.g., Steven E Williams, Nick W F Linton, Steven Niederer, Mark D O'Neill, Simultaneous display of multiple three-dimensional electrophysiological datasets (dot mapping), EP Europace, Volume 19, Issue 10, October 2017, Pages 1743–1749 at Pg. 1744, Right Column, Fifth Paragraph, describing such zooming as a “standard” manipulation.
Regarding Claim 2:
Step 2A, Prong One: Claim 2 recites the following judicial exceptions:
“determine an adjusted end time, the adjusted end time being the time before the cardiac cycle end time when the propagation of the cardiac activation wave would leave the selected sub-region of the anatomical map” recited a mental process when afforded its broadest reasonable interpretation for the same reasons as explained above with respect to the similar Claim 1 limitation “determine an adjusted start time….”
Step 2A, Prong Two: Claim 2 does not recite any additional elements.
Step 2B: Claim 2 does not recite any additional elements.
Regarding Claim 3:
Step 2A, Prong One: Claim 3 further limits the judicial exceptions recited in Claim 1, and thus recite a judicial exception for the same reasons as does Claim 1.
Step 2A, Prong Two: Claim 3 recites “automatically repeat rendering of the renderable propagation of the cardiac activation wave on the sub-region of the anatomical map beginning at the determined adjusted start time” which does not integrate the recited judicial exception into a practical application for the same reasons as explained above with respect to the similar limitations of Claim 1.
Step 2B: Claim 3 recites “a automatically repeat rendering of the renderable propagation of the cardiac activation wave on the sub-region of the anatomical map beginning at the determined adjusted start time” which does not contribute an inventive concept for the same reasons as explained above with respect to the similar limitations of Claim 1.
Regarding Claims 4-5:
Step 2A, Prong One: Claims 4-5 further limits the judicial exceptions recited in Claim 1, and thus recite a judicial exception for the same reasons as does Claim 1.
Step 2A, Prong Two: Claims 4-5 do not recite any additional elements.
Step 2B: Claims 4-5 do not recite any additional elements.
Regarding Claim 6:
Step 2A, Prong One: Claim 6 further limits the judicial exceptions recited in Claim 1, and thus recite a judicial exception for the same reasons as does Claim 1.
Step 2A, Prong Two: Claims 6 recites the recites the following additional elements, none of which integrate the above-noted judicial exceptions into a practical application:
“further comprising a user interface to receive user input of a manipulation of a virtual camera to change a rendered view of the anatomical map from within the anatomical map, wherein the processing circuitry is configured to render the sub-region of the anatomical map responsively to the user input” amounts to adding insignificant extra-solution activity to the judicial exception, and as such is insufficient to integrate the judicial exception into a practical application. The user interface receives an input and changes the form of the output based on the input received. As the output is itself insignificant extra-solution activity (i.e., mere data outputting), changing the form of the output does not add any meaningful limitation to the recited identifying local activation times, associating local activation times with respective positions, computing a propagation of a cardiac activation wave, or selecting a time-bounded portion of the propagation.
Step 2B: Claim 6 recites the following additional elements, none of which (either alone or in combination) cause the claimed invention to amount to significantly more than the abstract ideas recited therein:
“further comprising a user interface to receive user input of a manipulation of a virtual camera to change a rendered view of the anatomical map from within the anatomical map, wherein the processing circuitry is configured to render the sub-region of the anatomical map responsively to the user input” does not contribute an inventive concept. The claimed user interface is described at a high level of generality. Such an interface is well-understood, routine and conventional in the art of cardiac mapping. See, e.g., Kim at Pg. 216, Right Column; Pg. 217, Left Column, First Paragraph; Pg. 219, Right Column, First Paragraph; Pg. 228, Figure 6-1, which depicts such an interface.
Regarding Claim 7:
Step 2A, Prong One: Claim 7 further limits the judicial exceptions recited in Claim 1, and thus recite a judicial exception for the same reasons as does Claim 1.
Step 2A, Prong Two: Claim 7 does not recite any additional elements.
Step 2B: Claim 7 does not recite any additional elements.
Regarding Claim 8:
Step 2A, Prong One: Claim 8 further limits the judicial exceptions recited in Claim 1, and thus recite a judicial exception for the same reasons as does Claim 1.
Step 2A, Prong Two: Claim 8 recites the recites the following additional elements, none of which integrate the above-noted judicial exceptions into a practical application:
“further comprising a user interface to receive user input of a selection of the sub-region of the anatomical map, wherein the processing circuitry is configured to render the sub-region of the anatomical map responsively to the user input” does not integrate the judicial exception into a practical application for the same reasons as explained above regarding the user interface of Claim 6.
Step 2B: Claim 8 recites the following additional elements, none of which (either alone or in combination) cause the claimed invention to amount to significantly more than the abstract ideas recited therein:
“further comprising a user interface…” does not contribute an inventive concept for the same reasons as explained above regarding the user interface of Claim 6.
Regarding Claim 9:
Step 2A, Prong One: Claim 9 further limits the judicial exceptions recited in Claim 1, and thus recite a judicial exception for the same reasons as does Claim 1.
Step 2A, Prong Two: Claim 9 recites the recites the following additional elements, none of which integrate the above-noted judicial exceptions into a practical application:
“further comprising a user interface to receive user input of at least one of width or a rendering speed of the renderable propagation of the cardiac activation wave on the selected sub-region of the anatomical map, wherein the plurality of instructions further cause the one or processors to render to the display the renderable propagation of the cardiac activation wave on the sub-region of the anatomical map responsively to the user input of the speed” does not integrate the judicial exception into a practical application for the same reasons as explained above regarding the user interface of Claim 6.
Step 2B: Claim 9 recites the following additional elements, none of which (either alone or in combination) cause the claimed invention to amount to significantly more than the abstract ideas recited therein.:
“further comprising a user interface…” does not contribute an inventive concept for the same reasons as explained above regarding the user interface of Claim 6.
Regarding Claim 10:
Step 2A, Prong One: Claim 10 further limits the judicial exceptions recited in Claim 1, and thus recite a judicial exception for the same reasons as does Claim 1.
Step 2A, Prong Two: Claim 10 recites the recites the following additional elements, none of which integrate the above-noted judicial exceptions into a practical application:
“further comprising a user interface to receive user input of a width of the cardiac activation wave, wherein the processing circuitry is configured to render to the display the renderable propagation of the cardiac activation wave on the sub-region of the anatomical map responsively to the user input of the width of the cardiac activation wave” does not integrate the judicial exception into a practical application for the same reasons as explained above regarding the user interface of Claim 6.
Step 2B: Claim 10 recites the following additional elements, none of which (either alone or in combination) cause the claimed invention to amount to significantly more than the abstract ideas recited therein:
“further comprising a user interface…” does not contribute an inventive concept for the same reasons as explained above regarding the user interface of Claim 6.
Regarding Independent Claim 11:
Step 2A, Prong One: Independent Claim 11 recites the following judicial exceptions:
“identifying local activation times (LATs) from electrical activity of tissue of a chamber of a heart of a patient captured by electrodes of a catheter inserted into the chamber” recites a mental process for the same reasons as explained above regarding the similar Claim 1 limitation.
“and associating the local activation times with respective positions on the surface of an anatomical map of the chamber of the heart” recites a mental process for the same reasons as explained above regarding the similar Claim 1 limitation.
“computing a propagation of a cardiac activation wave over the anatomical map of the chamber of the heart from a start time in a cardiac cycle to an end time in the cardiac cycle responsively to the captured electrical activity, wherein the computer propagation of the cardiac activation wave is calculated using a sliding window of the local activation times” recites a mathematical calculation for the same reasons as explained above regarding the similar Claim 1 limitation.
“determining based upon a time the computed propagation of the cardiac activation wave would first arrive in the user-selected sub-region, an adjusted start time for rendering the computed propagation of the cardiac activation wave in the selected sub-region of the anatomical map, the adjusted start time being the earliest time after the cardiac cycle start time when the computed propagation of the cardiac activation wave would arrive in the user-selected sub-region of the anatomical map” recites a mental process for the same reasons as explained above regarding the similar Claim 1 limitation.
“generating a renderable propagation of a cardiac wave over the surface of an anatomical map of the chamber” recites a mental process for the same reasons as explained above regarding the similar Claim 1 limitation.
Step 2A, Prong Two: Independent Claim 11 recites the following additional elements, none of which integrate the above-noted judicial exceptions into a practical application:
“rendering a user-selected sub-region of the anatomical map to a display” is insufficient to integrate the judicial exception into a practical application for the same reasons as explained above regarding the similar Claim 1 limitation.
“rendering, in response to the determined adjusted start time, the renderable propagation of the cardiac activation wave immediately over the user-selected sub-region of the anatomical map beginning at the determined adjusted start time” is insufficient to integrate the judicial exception into a practical application for the same reasons as explained above regarding the similar Claim 1 limitation.
“and enabling the user, as the cardiac activation wave moves over the anatomical map, to zoom into the user-selected sub-region of the anatomical map of the chamber of the patient after the determined adjusted start time when the cardiac activation wave first arrives in the user- selected sub-region and before the cardiac activation wave leaves the user-selected sub-region, thereby enabling the user to inspect the rendered propagation of the cardiac activation wave over the sub-region” is insufficient to integrate the judicial exception into a practical application for the same reasons as explained above regarding the similar Claim 1 limitation.
Eligibility Step 2B: Independent Claim 11 recites the following additional elements, none of which (either alone or in combination) cause the claimed invention to amount to significantly more than the abstract ideas recited therein:
“rendering a user-selected sub-region of the anatomical map to a display” does not contribute an inventive concept for the same reasons as explained above regarding the similar Claim 1 limitation.
“rendering, in response to the determined adjusted start time, the renderable propagation of the cardiac activation wave immediately over the user-selected sub-region of the anatomical map beginning at the determined adjusted start time” does not contribute an inventive concept for the same reasons as explained above regarding the similar Claim 1 limitation.
“and enabling the user, as the cardiac activation wave moves over the anatomical map, to zoom into the user-selected sub-region of the anatomical map of the chamber of the patient after the determined adjusted start time when the cardiac activation wave first arrives in the user- selected sub-region and before the cardiac activation wave leaves the user-selected sub-region, thereby enabling the user to inspect the rendered propagation of the cardiac activation wave over the sub-region” does not contribute an inventive concept for the same reasons as explained above regarding the similar Claim 1 limitation.
Regarding Claim 12, Claims 12 recites a similar limitation to Claim 2. The same reasoning as explained above with respect to Claim 2 applies to Claim 12.
Regarding Claim 13, Claims 13 recites a similar limitation to Claim 3. The same reasoning as explained above with respect to Claim 3 applies to Claim 13.
Regarding Claims 14-15:
Step 2A, Prong One: Claims 14-15 further limit the judicial exceptions recited in Claim 11, and thus recite a judicial exception for the same reasons as does Claim 11.
Step 2A, Prong Two: Claims 14-15 do not recite any additional elements.
Step 2B: Claims 14-15 do not recite any additional elements.
Regarding Claim 16, Claims 16 recites a similar limitation to Claim 6. The same reasoning as explained above with respect to Claim 6 applies to Claim 16.
Regarding Claim 17, Claims 17 recites a similar limitation to Claim 7. The same reasoning as explained above with respect to Claim 7 applies to Claim 17.
Regarding Claim 18, Claims 18 recites a similar limitation to Claim 8. The same reasoning as explained above with respect to Claim 8 applies to Claim 18.
Regarding Claim 19, Claims 19 recites a similar limitation to Claim 9. The same reasoning as explained above with respect to Claim 9 applies to Claim 19.
Regarding Claim 20, Claims 20 recites a similar limitation to Claim 10. The same reasoning as explained above with respect to Claim 10 applies to Claim 20.
Regarding Independent Claim 21:
Step 2A, Prong One: Independent Claim 21 recites the following judicial exceptions:
“identify local activation times (LATs) from electrical activity of tissue of a chamber of a heart of a patient captured by electrodes of a catheter inserted into the chamber” recites a mental process for the same reasons as explained above regarding the Claim 1 limitation “identify local activation times (LATs) from the captured electrical activity.”
“and associate the LATs with respective positions on the surface of an anatomical map of the chamber of the heart” recites a mental process for the same reasons as explained above regarding the Claim 1 limitation “and associate the local activation times with respective positions on the surface of an anatomical map of the chamber.”
“compute a propagation of a cardiac activation wave over the anatomical map of the chamber of the heart from a start time in a cardiac cycle to an end time in the cardiac cycle responsively to the captured electrical activity, wherein the computed propagation of the cardiac activation wave is calculated using a sliding window of the local activation times” recites a mathematical calculation for the same reasons as explained above regarding the similar Claim 1 limitation.
“determine, based upon a time the computed propagation of the cardiac activation wave would first arrive in the user-selected sub-region, an adjusted start time for rendering the computed propagation of the cardiac activation wave in the selected sub-region of the anatomical map, the adjusted start time being the earliest time after the cardiac cycle start time when the computed propagation of the cardiac activation wave would arrive in the user-selected sub-region of the anatomical map” recites a mental process for the same reasons as explained above regarding the similar Claim 1 limitation.
Step 2A, Prong Two: Independent Claim 21 recites the following additional elements, none of which integrate the above-noted judicial exceptions into a practical application:
“a non-transient computer readable medium in which program instructions are stored” amounts to merely reciting the words “apply it.” The recited computer readable medium is what allows the recited judicial exceptions to be performed by the system. Accordingly, the recited judicial exceptions are applied by computer readable medium. “As the Supreme Court explained in Alice Corp., mere physical or tangible implementation of an exception does not guarantee eligibility. Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. 208, 224, 110 USPQ2d 1976, 1983-84 (2014) (‘The fact that a computer “necessarily exist[s] in the physical, rather than purely conceptual, realm,” is beside the point’).” MPEP 2106.04(d)(I). Thus, the fact that the physical component “a non-transient computer readable medium” is used to carry out the recited judicial exception is not sufficient to integrate the judicial exception into a practical application.
“render a user-selected sub-region of the anatomical map to a display” is insufficient to integrate the judicial exception into a practical application for the same reasons as explained above regarding the similar Claim 1 limitation.
“render, in response to the determined adjusted start time, the renderable propagation of the cardiac activation wave immediately over the user-selected sub-region of the anatomical map beginning at the determined adjusted start time” is insufficient to integrate the judicial exception into a practical application for the same reasons as explained above regarding the similar Claim 1 limitation.
“and enable the user, as the cardiac activation wave moves over the anatomical map, to zoom into the user-selected sub-region of the anatomical map of the chamber of the patient after the determined adjusted start time when the cardiac activation wave first arrives in the user-selected sub-region and before the cardiac activation wave leaves the user-selected sub-region, thereby enabling the user to inspect the rendered propagation of the cardiac activation wave over the sub- region” is insufficient to integrate the judicial exception into a practical application for the same reasons as explained above regarding the similar Claim 1 limitation.
Eligibility Step 2B: Independent Claim 21 recites the following additional elements, none of which (either alone or in combination) cause the claimed invention to amount to significantly more than the abstract ideas recited therein:
“a non-transient computer readable medium in which program instructions are stored” amounts to adding the words “apply it” as explained above, and thus does not contribute an inventive concept. See MPEP 2106.05(I)(A).
“render a user-selected sub-region of the anatomical map to a display” does not contribute an inventive concept for the same reasons as explained above regarding the similar Claim 1 limitation
“render, in response to the determined adjusted start time, the renderable propagation of the cardiac activation wave immediately over the user-selected sub-region of the anatomical map beginning at the determined adjusted start time” does not contribute an inventive concept for the same reasons as explained above regarding the similar Claim 1 limitation.
“and enable the user, as the cardiac activation wave moves over the anatomical map, to zoom into the user-selected sub-region of the anatomical map of the chamber of the patient after the determined adjusted start time when the cardiac activation wave first arrives in the user-selected sub-region and before the cardiac activation wave leaves the user-selected sub-region, thereby enabling the user to inspect the rendered propagation of the cardiac activation wave over the sub- region” does not contribute an inventive concept for the same reasons as explained above regarding the similar Claim 1 limitation.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 2, 7, 8, 11, 12, 17, 18 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over previously cited Kim YH et al., 2019 APHRS expert consensus statement on three-dimensional mapping systems for tachycardia developed in collaboration with HRS, EHRA, and LAHRS. J Arrhythm. 2020 Mar 9;36(2):215-270 (“Kim”) in view of previously cited WO 2020/242940 A1 to Morgan et al. (“Morgan”) and US 20170202469 A1 to Scharf et al. (“Scharf”).
Regarding Independent Claim 1, Kim discloses:
A medical system for wave propagation enhancement, the medical system comprising: (Pg. 216, Left Column, First Paragraph, “This document describes the use of three-dimensional mapping systems and includes recommendations regarding their application in clinical practice based on scientific evidence.”);
a catheter configured to be inserted into a chamber of a heart of a patient, and including electrodes configured to capture electrical activity of tissue of the chamber over time; (Pg. 216, Left Column, Second Paragraph, “Catheter mapping and ablation are widely performed for various complex tachyarrhythmias that need a better understanding of fundamental technologies of mapping to identify triggers or substrate of arrhythmias;” Pg. 236, Right Column, First Paragraph, “Commonly employed dedicated mapping catheters with the CARTO system include a fivesplined catheter (PentaRay) and linear decapolar catheter (DecaNav);” Pg. 257, Right Column, Third Paragraph, “Three-dimensional mapping is an established method for tracking catheter movement and manipulation, using the capability to recognize the catheter as their primary visual modality, and to construct a 3D structure in real time;” Pg. 219, Right Column, Second Paragraph, “Additionally, the CARTO system sends a small current across the catheter electrode and collects the current-based information…” Pg. 223, FIGURE 4-1);
a display; (Pg. 217, Left Column, First Paragraph, “This is typically graphically represented as a static color-coded map of local activation time, or as a video portrayal of a moving wavefront of activation (Figure 2-1);” Pg. 219, Right Column, First Paragraph, “The commonly used 3D mapping systems are the CARTO 3 (Biosense Webster) and EnSite Precision (Abbott);” Pg. 228, Figure 6-1 shows a display from “commonly used 3D mapping system[]”);
and processing circuitry configured to: identify local activation times (LATs) from the captured electrical activity and associate the local activation times with respective positions on the surface of an anatomical map of the chamber; (Pg. 216, Right Column, Third Paragraph, “Electrodes in contact with functioning cardiac tissue can accurately identify local activation and its timing relative to a reference. This concept was exploited initially for surgical therapy for Wolff-Parkinson White syndrome and subsequently for endocardial mapping using catheters and fluoroscopy. The development of nonfluoroscopic catheter localization technology with computerized graphic representation of electrophysiologic phenomena in a spatially accurate geometry led to the advent of catheter mapping and ablation of complex arrhythmias;” Pg. 217, Left Column, First Paragraph);
compute a propagation of a cardiac activation wave over the anatomical map of the chamber from a start time in a cardiac cycle to an end time in the cardiac cycle responsively to the captured electrical activity, (Pg. 217, Left Column, First Paragraph, “Activation mapping can be achieved by combining the known location of a roving mapping catheter with the activation time of tissue with which it is in contact. In a stable cardiac rhythm, this permits the point-by-point construction of a 3D map of propagation of activation across a cardiac surface. This is typically graphically represented as a static color-coded map of local activation time, or as a video portrayal of a moving wavefront of activation (Figure 2-1).”);
wherein the computed propagation of the cardiac activation wave is calculated using a sliding window of the local activation times; (Pg. 222, Left Column, Third Paragraph, “The continuous acquisition of data points is based on a set of user predefined beat acceptance criteria. All three 3D mapping systems have similar categories of the beat acceptance. The criteria include the cycle length stability and/or range, position/distance stability, QRS morphology/electrocardiogram stability, respiratory phase, speed of the catheter motion, etc. These criteria help the system to discern a particular tachycardia or morphology in the presence of multiple arrhythmias or complex ectopy, which allows the system to quickly create an individual 3D map.”);
See Para. [0072] of the Present Specification in support of this interpretation (“The propagation of the cardiac activation wave 60 may then computed based on the LATs using a sliding window of LATs. For example, at time T0 LATs in a range of -200ms to -160ms are rendered on the anatomical map 62, at time T1 LATs in a range -180ms to -140ms are rendered on the anatomical map 62, and at a time T2 LATs in a range -160ms to -120ms are rendered on the anatomical map 62, and so on. The LAT window continues to move until a complete cycle of the cardiac activation wave cardiac activation wave 60 has been rendered over the anatomical map 62. In this way, the cardiac activation wave 60 is seen to move over the surface of the anatomical map 62. The width of the sliding window, i.e., the range of LATs in the sliding window may be configurable.”)
render to the display a user-selected sub-region of the anatomical map; (Pg. 237, Right Column, First Paragraph, “Late potentials or widely split local electrograms have been shown to have high sensitivity for critical sites for reentry. Mapping wind