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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 August 25, 2025 has been entered.
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.
Claim 71 is 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 phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 88 and 89 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 1, as now amended, already requires a diagnostic catheter with at least one electrode (claim 88) and at least one ultrasound transducer (claim 89). Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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, 71-92, 95 and 96 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) the mentally performable steps of correlating the electrical activity data with locations of the heart, performing a complexity assessment using the electrical activity data to assess the consistency, stability, repeatability, and/or pattern of complexity to differentiate between fixed, substrate-mediated complexity, and functional complexity and to identify substrate- mediated complexity as areas of consistent, stable, repeatable complexity and produce diagnostic results related to a cardiac condition based on the complexity assessment, including identifying areas of consistent, substrate mediated, complexity, wherein the assessment employs one or more of: conduction velocity (CV) algorithm, localized rotational activation (LRA) algorithm, localized irregular activity (LIA) algorithm, focal activation (FA) algorithm, and/or combinations thereof, wherein the complexity assessment indicates variation of one or more characteristics of the heart, including one or more of electrical, mechanical, functional, and/or physiologic characteristics of the heart that vary in time, space, magnitude and/or state, and identify an area of consistent complexity,
The applicant defines “complexity” as including any deviation from the expected or normal behavior of an electrical activity pattern (par. 0142). A trained cardiologist is capable of correlating electrical activity data (i.e., an ECG) with locations of the heart (e.g., correlating P wave activity to the atrium, R wave activity to the ventricles, etc.) and recognizing deviations from normal, forming a diagnosis based on the recognized deviations, and identify an area of consistent complexity. The “…to identify substrate-mediated complexity…” recitation is merely a desired result of the complexity assessment. In any event, such identification includes identifying regions of the heart where abnormalities exist. Again, a cardiologist would be reasonably capable of identifying regions of the heart where abnormalities exist based on a review of the cardiac mapping data (e.g., atrial arrhythmias, ventricular arrhythmias, ischemic regions, etc.). The “wherein” clause is broad enough to read on any variation in a time, space, magnitude and/or physiologic characteristic of the heart. Cardiologists are capable of mentally interpreting cardiac data to determine “variations in a characteristic of the heart” and identifying an area of consistent complexity.
Regarding the newly added material related to identifying areas of consistent, substrate mediated complexity employing one or more algorithms, the algorithms recited are considered capable of being performed within the mind or with pen and paper. Said algorithms comprise defining a neighborhood of vertices, and mathematical operations (see Figs. 4-7), such as for example in the case of a conduction velocity algorithm, determining a polynomial function and calculating derivatives of the function with knowledge of anatomic and electrical activity data, and thus involve observation, evaluation, judgement and opinion.
This judicial exception is not integrated into a practical application because there are no improvements to the functioning of a computer, or to any other technology or technical field, as discussed in MPEP 2106.05(a), as the diagnostic catheter including a plurality of electrodes and ultrasound transducers, processing unit and ablation catheter function in their normal capacity of collecting data and processing data, with the ablation catheter configured to deliver ablation energy in its normal capacity; there is no application to effect a particular treatment or prophylaxis for disease or medical condition –only diagnosis, with reference to ablation therapy being intended use as the therapy is not affirmatively recited (see Vanda Memo; a catheter configured to deliver ablation therapy is not a positive recitation of therapy as the mere presence of an ablation catheter capable of delivering therapy does not inherently invoke therapy); there is no application of the judicial exception with, or by use of, a particular machine (all applications of the algorithm practically require a diagnostic catheter and ablation catheter to obtain the necessary cardiac data for processing, and apply ablation energy; see pars. 0133 and 0168 of the present specification regarding the generic processing circuits and generic ablation treatment elements that may be used), as discussed in MPEP 2106.05(b); there is no transformation or reduction of a particular article to a different state or thing, as discussed in MPEP 2106.05(c), but merely data manipulation; and there is no use of the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to the particular technological environment of cardiac diagnostics, such that the claim as a whole is more than a drafting effort designed to monopolize the exception , as discussed in MPEP 2106.05(e) and the Vanda Memo issued in June 2018.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because, as stated above, the diagnostic catheter structured for insertion into the heart would be required to collect the data necessary to perform the algorithm(s). Data collection is considered an insignificant extra-solution activity to the judicial exception, as discussed in MPEP 2106.05(g). Further, such catheters are WURC in the art as they allow one to access the conductive tissues and pathways of the heart, enabling one to map the electrical activity. The processing unit is also a WURC generic component of the invention that operates in its usual capacity (see par. 0133 of the specification which discloses that the processor may include one or more of a plurality of types of processing circuits such as microprocessors). It is merely a tool upon which the abstract idea is performed. The ablation catheter is also generic (see par. 0168) and represents insignificant extra-solution activity nominally related to the abstract idea. It neither provides any affirmative therapy nor any specific therapy (see MPEP 2106.04(d)(2)). The combination of a data collection catheter, a processing unit to process the data obtained from the catheter, and an ablation catheter configured to deliver ablation energy is also WURC, as it is a necessary arrangement in any computerized medical system attempting to collect intracardiac signals for processing and applying subsequent treatment.
Claims 71-84, 86, 91, 92, 95 and 96 comprise no additional elements beyond that which is mentally performable.
Regarding claim 71, artisans of ordinary skill in the art are considered capable of assessing a variation in complexity over time and space between complex activation patterns as the applicant discloses that complexity includes any deviation from the expected or normal behavior of an electrical activity pattern (par. 0142). A cardiologist would be reasonably expected to recognize deviations from normal when viewing cardiac electrical data. Assessment of a variation in complexity over time and space between patterns relates to the mental process of comparing data to determine changes/trends. Furthermore, the electrical characteristics now being recited include parameters that can be determined from the data within the mind or with pen and paper. It is additionally noted that claim 71 expands upon the optional electrical characteristics portion of base claim 1. As such, it does not limit the claim to any of the electrical characteristics listed or their determination method.
Regarding claim 72 and the material pertaining to determining if a complex activation pattern is part of a macro-level complexity activation pattern, a skilled cardiologist is considered capable of making such determinations. Atrial fibrillation, atrial flutter, etc., have long been recognized as detectable complex macro-level arrhythmias (attention is invited to par. 0010 of the cited Jung et al. ‘960 reference). Cardiologists reviewing the cardiac activity data would reasonably be able to make such judgements since atrial fibrillation, atrial flutter, etc., have long been diagnosed by visual inspection of the cardiac data.
Regarding claim 85’s recitation of a display for displaying diagnostic results relative to an image of the patient’s anatomy, such an element is considered insignificant extra-solution activity necessary to convey the diagnostic information generated by the algorithm(s). The display is further generic and functions in its usual capacity of displaying data. An identical comment applies to the display of claim 87.
Regarding claim 88, at least one electrode would be required in any implementation of the judicial exception to allow the heart’s electrical signals to be detected. Catheters with electrodes for mapping the heart are further WURC in the art.
Regarding claim 89, the provision of an ultrasound transducer is considered insignificant extra-solution activity. The use of ultrasound transducers to image the heart is well known, WURC and poses no meaningful limits on the claim.
Regarding claim 90, the provision of multiple splines on diagnostic catheters is well known in the art, as is the provision of ultrasound transducers. Such an arrangement allows one to place multiple electrodes against cardiac tissue in order to map at a variety of locations.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 71-75, 77, 78, 81, 82 and 84-92 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pulido et al. (Pulido: WO 2017/125794) in view of Willis et al. (Pub. No. 2005/0203375) and Nguyen et al. (Pub. No. 2015/0057522).
Regarding claim 1 (as well as non-limiting claims 88 and 89), Pulido discloses a cardiac diagnostic and treatment system (par. 0001) comprising: a diagnostic catheter including a plurality of electrodes (mapping catheter) structured for insertion into the heart of a patient, the diagnostic catheter configured to record electrical activity data of the patient at multiple recording locations (basket catheter; par. 0028); and at least one processing unit (digital data processor; par. 0035) comprising an algorithm (par. 0028) executable to: correlate the electrical activity data with locations of the heart (mapping); and perform a complexity assessment using the electrical activity data to identify substrate-mediated complexity (determination/interpretation of complex arrhythmias and abnormal cardiac anatomy; pars. 0004, 0024) and produce diagnostic results related to a cardiac condition based on the complexity assessment (electrophysiology study maps (par. 0025), electrogram interpretation (par. 0024); CFAE areas maintaining atrial fibrillation and new areas of interest (pars. 0030-0032, 0034)), wherein the complexity assessment indicates variation of one or more characteristics of the heart, including one or more of electrical, mechanical, functional, and/or physiologic characteristics of the heart that vary in time, space, magnitude and/or state (e.g., any abnormality such as a rotor or a complex fractionated atrial electrograms, CFAE), and identify an area of consistent complexity (pars. 0020-0025, 0047, 0048, 0065-0067), and an ablation catheter (pars. 0005, 0024) for insertion into the heart of the patient, the ablation catheter configured to deliver ablation energy to at least one location on the heart wall (inherent function of an ablation catheter; pars. 0006, 0027, etc.) identified by the system as an area of consistent complexity (par. 0031, areas of complexity that are identified as more stable/constant/consistent; par. 0020, consistent rotor activity).
Pulido does not discuss the use of a diagnostic catheter comprising ultrasound transducers (claims 1 and 89), or the use of a diagnostic catheter comprising multiple splines, each comprising at least one electrode and one ultrasound transducer (claim 90). Willis, in a related system, however, discloses a variety of well-known mapping catheter arrangements including one incorporating multiple splines, each comprising at least one electrode and one ultrasound transducer (Fig. 13; par. 0111), and teaches the advantages of such an arrangement (pars. 0089, 0185). Those of ordinary skill in the art would have recognized that mapping catheters come in a variety of different configurations (see par. 0086), with the exact choice being a matter of obvious design. Any artisan looking to take advantage of the benefits discussed by Willis in a similar system, would have considered it obvious to include the recited catheter in the Pulido system.
Regarding the newly added recitation “to assess the consistency, stability, repeatability and/or pattern of complexity to differentiate…focal activation (FA) algorithm, and/or combinations thereof,” such a recitation is considered a statement of intended use for the act of performing a complexity assessment using the electrical activity data. In any event, Pulido further assesses the consistency, stability, repeatability, and/or pattern of complexity to identify substrate mediated complexity as areas of consistent, stable, repeatable complexity and produce diagnostic results related to a cardiac condition based on the complexity assessment. Pulido, for example, discloses that rotors and CFAEs that are more stable/constant (i.e., consistent, stable, repeatable complexities) are the most important areas to target (pars. 0020, 0021, 0030, 0065, etc.). Pulido explicitly states that an embodiment of the invention may include analysis of the electroanatomical records to provide relevant data enabling accurately defining ablation targets (par. 0050). Analysis of the data in order to define/identify areas of consistent, substrate mediated complexity (i.e., those areas defining ablation targets) by the invention would inherently require the use of an algorithm(s). Given that features such as conduction velocity, localized rotational activation, localized irregular activity and focal activation are all known to be useful in indicating ablative targets, the analysis of such features would have been, in the very least, obvious to those of ordinary skill in the art.
Further, the algorithms are not recited with any specificity –merely reciting a descriptive adjective associated with each algorithm. Any algorithm used to determine a stable/constant rotor or CFAE can be said to include one or more of an undefined CV, LRA, LIA or FA algorithm. Any computerized system capable of detecting rotors, for example, is considered to employ a “localized rotational activation” algorithm. CFAEs are well-known to represent regions of slow conduction. In any event, Nguyen, in a substantially similar invention, teaches that any suitable method may be used to detect rotors (par. 0041). Nguyen, explicitly uses algorithms including conduction velocity algorithms, to identify and classify complexity and determine whether the complexity is substrate mediated or functional (Figs. 1, 2A, 4, pars. 0040-0043). Any artisan attempting to detect CFAEs or AF would thus require a “conduction velocity” algorithm, or in the very least, would find the use of such an algorithm to be obvious given the know properties of CFAEs or AF with respect to conduction velocities.
Regarding claim 71, Pulido teaches to assess the complexity over time and space between complex activation patterns (pars. 0030-0033). Pulido further teaches that cycle length is an electrical characteristic of treatable cardiac complexities (par. 0023). Interval analysis would necessarily be required in order to determine cycle length.
Regarding claim 72, the determination of atrial fibrillation sustaining regions distributed over the heart is considered to represent a “macro-level complexity pattern.”
Regarding claims 73, 75, 78 and 88, the basket catheter of Pulido is described as typically having 64 electrodes contacting the heart wall at multiple locations for providing 64 unipolar electrograms (par. 0013-0017, 0028). Note also par. 0032 of the present disclosure which refers to the use of 64 vertices on the heart wall provided by a substantially similar basket catheter as shown in Fig. 1.
Regarding claim 74, while Pulido does not discuss the surface area of the heart chamber represented by the assessment, such a limitation in an apparatus claim(s) does not limit the structure of the apparatus since the area of assessment may simply depend on the human operating the system or the size of the heart. The systems of the prior art are considered capable of assessing the recited surface areas. Further, one would consider the splined cardiac catheter of Pulido to operate in a similar manner to the conventional splined catheter of the present invention given that they are intended to be placed within the heart with the intent of mapping the electrical activity of the heart wall.
Regarding claim 77, while Pulido does not discuss the surface area of the heart chamber represented by the assessment, such a limitation in an apparatus claim(s) does not limit the structure of the apparatus since the area of assessment may simply depend on the human operating the system or the size of the heart. The systems of the prior art are considered capable of assessing the recited surface areas. Further, one would consider the splined cardiac catheter of Pulido to operate in a similar manner to that of the present invention given that they are intended to be placed within the heart with the intent of mapping the electrical activity of the heart wall. The exact surface area of the heart assessed would clearly depend upon the patient’s particular cardiac condition and the physician’s experience.
Regarding claim 81, see pars. 0028-0030, where multiple activations at each electrode of the multiple electrode catheter are detected over a period of time. As such, those of ordinary skill would have recognized that such an arrangement would result in more than 3 activations being obtained. As to the exact range (i.e., between 3 and 3000), the amount of data necessary to accurately and effectively portray the heart’s activity and determine the regions of interest would have been considered a matter of obvious design dependent upon the condition of the individual under study and the experience of the physician tasked with performing the mapping procedure.
Regarding claim 82, see at least pars. 0024 and 0029.
Regarding claim 84, Pulido does not explicitly refer to the assessment of a single heart wall location. Such a feature, however, would have been considered a matter of design by those of ordinary skill in the art based upon the condition of the patient and the types and locations of abnormalities suspected. If for example a specific location of the heart was of particular interest --such as at a site that had previously been ablated-- those of ordinary skill in the art would have considered assessment at this single location to be obvious in order to better assess the effectiveness of the ablative procedure.
The limitation of claim 85 is clearly and explicitly disclosed by Pulido.
Regarding claim 86 and 87, note at least par. 0025 and Figs. 6 showing an assessment over multiple heart wall locations.
Regarding claims 91 and 92, see at least par. 0001 and 0020-0022.
Claim(s) 76 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pulido et al. (WO 2017/125794), Willis et al. and Nguyen et al. as applied to claims 1, 71-75, 77, 78, 81, 82 and 84-92 above, and further in view of Dubois (Dubois: Pub. No. 2013/0324871).
Regarding claim 76, the number of vertices calculated is clearly dependent on the number of recording locations available and is dependent on the application at hand. Dubois, for instance, teaches in a related system that the number of vertices at which electrical activity is calculated can widely vary (from tens to hundreds or thousands; par. 0085). Clearly in order to produce sufficient data to create a usable electroanatomical map, one of ordinary skill in the art would have recognized the need to record electrical activity data at a multitude of locations and vertices as is standard in the art.
Claim(s) 79 and 80 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pulido, Willis et al. and Nguyen et al. as applied to claims 1, 71-75, 77, 78, 81, 82 and 84-92 above, and further in view of Vignon et al. (Vignon: Pub. No. 2019/0313910).
Regarding claim 79, Pulido does not explicitly discuss the use of a complexity assessment based on calculated surface charge data and/or dipole density data using a second algorithm. Vignon, however, discloses in a substantially related system for identifying ablation sites, that voltages, charges and dipole densities may be determined to assess the state of cardiac tissue (pars. 0029, 0041). The use of an algorithm to control the assessment process would have been considered blatantly obvious to artisans of ordinary skill in the art looking to practically automate control by computer.
Regarding claim 80, while Pulido does not discuss details associated with diagnosis and thus does not discuss the use of an algorithm executable to convert surface charge data and/or dipole density data into surface voltage data for complexity assessment (note the interpretation of the term “complexity assessment” above), Vignon teaches that voltages may be back-propagated to a heart surface to obtain cardiac surface voltages, charges and dipoles (par. 0041). Basing assessment on cardiac surface voltages (and/or charges and/or dipoles) would have been considered a matter of obvious design dependent on the prerogative of the diagnostician.
Claim(s) 83 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pulido et al. (WO 2017/125794), Willis et al. and Nguyen et al. as applied to claims 1, 71-75, 77, 78, 81, 82 and 84-92 above, and further in view of in view of Afonso et al. (Pub. No. 2013/0274582).
Regarding claim 83, the overall time period of electrical activity recording would have been considered a matter of obvious design. Alfonso, for example, discloses that the user may select a timeframe in which to sample multiple activations (EP data; par. 0165). Clearly the amount of data necessary to properly and confidently assess the state of the heart would depend on a host of factors including the patient’s condition, diagnostician experience, quality of the data, noise presence, etc., and thus the exact amount of time dedicated to recording electrical activity data would have been considered a matter of obvious design to those of ordinary skill in the art.
Claim(s) 96 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pulido et al., Willis et al. and Nguyen et al. as applied to claims 1, 71-75, 77, 78, 81, 82 and 84-92 above, and further in view of Bullinga (Pub. No. 2007/0055167).
While Pulido does not discuss the limitations of claim 96, as shown by Bullinga, it is known in the cardiac diagnostic and treatment art that differences in velocity (angle and speed) between cardiac conductions entering and leaving a portion of the heart chamber may indicate a level of complexity, such as a reentrant arrhythmia, that may warrant application of ablation therapy in that portion of the heart. As shown in Fig. 1 and discussed in pars. 0001, 0025 and 0026, an area of slow conduction in, or entering, a region as compared to the average speed of conduction outside of, or leaving, the region, may indicate a reentrant arrhythmia suitable for ablation. In order to determine what is considered a “major conduction velocity variation” as compared to a “minor conduction velocity variation,” one inherently must compare velocities to a threshold/standard (e.g., velocities varying significantly from a reference/threshold velocity would be labeled major variations, while velocities close to the reference velocity would be considered to represent minor variation). The minor variances between regions A, B and C, for example, would set the threshold for determining what is significant and what is minor. Those artisans of ordinary skill in the art looking to identify those areas of tissue critically involved in the mechanism of arrhythmia, would have therefore considered such a feature to be obvious in the system of Pulido, Willis and Nguyen which also attempt to identify regions of the heart suitable for treatment.
Claim(s) 96 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pulido et al., Willis et al. and Nguyen et al. as applied to claims 1, 71-75, 77, 78, 81, 82 and 84-92 above, and further in view of Bokan et al. (Pub. 2015/0216438).
While Pulido does not explicitly discuss the use of a processing circuit to determine whether focal activation has occurred at a vertex, Bokan teaches that such analysis can be used to detect focal points of arrhythmias at a given vertex (pars. 0031, 0032, 0066, 0067, 0074). Clearly since such points represent the origin of arrhythmic activity, one of ordinary skill in the art would obviously use this information to direct targeted therapy such as ablation in order to destroy the aberrant tissue, thus potentially neutralizing the source of cardiac arrhythmias.
Response to Arguments
Applicant's arguments filed August 25, 2025 have been fully considered but they are not persuasive.
Regarding the rejection under §101, the applicant argues that the presently amended claims are self-evidently eligible for patentability by virtue of the newly incorporated limitations associated with the performance of a complexity assessment. It is asserted that said limitations cannot be performed within the mind.
As already argued above, the examiner considers the performance of a complexity assessment to be mentally performable. A cardiologist can identify areas of complexity that are consistent, stable or repeatable, as distinguished from areas that do not exhibit such consistency. The applicant defines “complexity” as including any deviation from the expected or normal behavior of an electrical activity pattern (par. 0142). A cardiologist may further perform any of the algorithms cited as they represent mathematical operations on data such as forming polynomials and taking derivatives in the case of the conduction velocity algorithm. The algorithms further contain no limitations on their execution –merely assigning a name to the algorithm, with no limitations on any of the various steps required to perform the algorithm(s) that would remove the algorithm from the realm of mentally performable processes.
The applicant additionally argues that the various complexity assessments cannot be practically performed within the mind, and points to par. 0021 of the present invention to support the assertion.
Paragraph 0021, however, merely states that clinician review of long durations of AF can be challenging to remember and piece together. The claims do not restrict AF durations or require any specific accuracy that would limit a human from reviewing the data and making as assessment. Further, while it may be easier to use a computer to improve speed and efficiency of an existing process, simply adding a generic computer/processor and insignificant data gathering structure to perform the process has been considered by the courts to be insufficient for eligibility (MPEP 2106.05(f)). Additionally, as argued above, the claimed algorithms contain no limitations on their execution –merely assigning a name to the algorithm, with no limitations on any of the various steps required to perform the algorithm(s) that would remove the algorithm from the realm of mentally performable processes. A “conduction velocity algorithm,” for example, could simply entail receiving timing data from the plurality of electrodes and calculating how fast a conduction wave travels from one electrode to another in any given cycle.
The applicant also argues that the additional elements, including the diagnostic catheter and ablation catheter, integrate the judicial exception into a practical application.
As argued above, the recited diagnostic catheter is considered insignificant as it represents requisite data gathering that all performances of the abstract idea would require. The ablation catheter fails to integrate the judicial exception because it functions in its usual capacity, does not effect a particular treatment, is conventionally found in the art in conjunction with diagnostic catheters and processors, and therefore is not a part of any particular machine, does not effect a transformation of a particular article, and only generally links the exception to the field of mapping and ablation.
Even if one, for the sake of argument, were to consider the ablation catheter to improve technology, the claims do not reflect any asserted improvement as the ablation catheter is merely capable of delivering ablation energy --nothing in the claim actually initiates ablation responsive to the identification of an area of consistent, substrate-mediated complexity. This is similar to the MPEP’s example of a feed dispenser operable/configured to dispense a mineral supplement (MPEP 2106.04(d)(2)), which was not considered an affirmative therapy limitation because it merely indicates how the claimed invention might be used. Here the ablation catheter is operable or configured to dispense ablative energy. As stated in MPEP 2106.04(d)(2), statements of intended use, or field of use limitations, cannot integrate a judicial exception under the “treatment or prophylaxis” consideration.
The additional element of the generic processor acts as a tool upon which the abstract idea is executed. It too functions in its usual capacity. As does the system of the diagnostic catheter, the ablation catheter and the processor. The arrangement is further conventional in the cardiac diagnostic and treatment arts.
It is noted that the various complexity assessment algorithms discussed by the applicant are mentally performable and thus do not constitute additional elements. Furthermore, there are no specific steps recited associated with the various algorithms, so interpretations of what is a “conduction velocity” or a “localized rotational activation” algorithm, etc., is not limited and could simply involve the mental steps a clinician might take to note that conduction is slower in one area of the heart than another, or that a rotor is present, etc..
Under Step 2B analysis the applicant appears to be relying upon the abstract idea itself for eligibility. As stated above, the CV, LRA, LIA or FA algorithms and combinations thereof are considered to be a part of the mentally performable abstract idea and thus are not additional elements. The additional elements of the recited diagnostic catheter, processor and ablation catheter are WURC in the art whether taken alone or in combination, as it is a necessary arrangement in most any computerized medical system attempting to collect intracardiac signals for processing, mapping the signals to the geometry of the heart, and applying subsequent treatment.
Regarding the rejection of claims based on Pulido, the applicant argues that Pulido does not teach or suggest any analysis other than to employ software to produce electroanatomical maps. As a result, it is asserted that Pulido does not teach or suggest identifying areas of consistent, substrate mediated complexity, wherein the assessment employs one or more of a CV, LRA, LIA or FA algorithm.
Pulido, however, explicitly states that an embodiment of the invention may include analysis of the electroanatomical records to provide relevant data enabling accurately defining ablation targets (par. 0050). Analysis of the data in order to identify and define areas of consistent, substrate mediated complexity (i.e., those areas defining ablation targets) by the computerized system would inherently require the use of an algorithm(s). Given that features such as conduction velocity, localized rotational activation, localized irregular activity and focal activation are all known to be useful in indicating ablative targets, the use of algorithms to analyze such features would have been, in the very least, obvious to those of ordinary skill in the art. See also the application of the Nguyen reference to this limitation as discussed above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KENNEDY SCHAETZLE whose telephone number is (571)272-4954. The examiner can normally be reached 2nd Monday of the biweek and W-F.
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/KENNEDY SCHAETZLE/Primary Examiner, Art Unit 3796
KJS
February 4, 2026