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 .
Election/Restrictions
Applicant's election with traverse of group I in the reply filed on 13 is acknowledged. The traversal is on the ground(s) that the amendments overcome the restriction requirement. This is not found persuasive because claim 18 still requires one or more electrodes for sensing, while the method claims still do not require the step or a structure for gathering cardiac data. The method could be performed with a database of information previously gathered rather than instantaneous data.
The requirement is still deemed proper and is therefore made FINAL.
Claim Objections
Claim 17 objected to because of the following informalities: claim 17 requires “one or more…medium”. For grammatical purposes, this should read “one or more…media”. Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1- 17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
Claims 1-16 are directed to a computer-implemented method (process). Claim 17 is directed to one or more non-transitory machine-readable medium [sic] (machine) configured to store instructions, which are executable by a processor.
Step 2A, Prong One
Regarding claim 1, the recited steps are directed to a mental process of performing concepts in a human mind or by a human using a pen and paper. See MPEP § 2106.04(a)(2)(Ill). The limitation(s) of “generating a map on a surface of interest and/or performing automated signal processing based on the cardiac electrophysiological signals for heartbeat intervals” is/are a process that, as drafted, covers performance of the limitation by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard interpretation. For example, these limitations are nothing more than drawing a graph on a piece of paper corresponding to previously gathered data points.
Regarding claim 17, the medium/media performs the method of claim 1, and therefore the above analysis is relevant here.
Step 2A, Prong Two
The judicial exception is not integrated into a practical application. In particular, claim 1 recites no structure. Claim 17 also requires a “processor” and a “non-transitory machine-readable medium”. The processor is recited at a high-level of generality and amount to nothing more than parts of a generic computer. Merely including instructions to implement an abstract idea on a computer does not integrate a judicial exception into practical application.
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of a processor amount to nothing more than mere pre-solution activity of data gathering, which does not amount to an inventive concept. The additional elements recited above are well known in the field of data collection and presentation. Moreover, simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, is discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984. See MPEP § 2106.05(d). In this case, elements of general computer are being used to implement the abstract idea of generating a map on a surface of interest and/or performing automated signal processing based on the cardiac electrophysiological signals for heartbeat intervals.
Regarding dependent claims 2-7 and 9-15, the limitations of claim 1 further defines the limitations already indicated as being directed to the abstract idea.
Regarding claim 8, the limitation of “generating notification to instruct the user to move an invasive device…signal parameters” reads on a medical professional providing instruction to another medical professional to perform a surgical step. Here, only the instruction for surgical step is being provided (e.g., via verbal or written communication) and the surgical step is not actually being performed. MPEP 2106.04(a)(2)(II) states that the sub-grouping "managing personal behavior or relationships or interactions between people" include social activities, teaching, and following rules or instructions. As such, this limitation is directed to organizing human activity.
Regarding claim 16, the limitation of “generating report…time interval” is nothing more than a medical professional providing evaluation report associated with cardiac data, which would be considered as organizing human activities. The additional limitation of “storing the report on memory” is nothing more than a generic computer part storing results of performing abstract idea steps.
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 12 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. Claim 12 recites the limitation "performing other automated signal processing" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
Claims 1-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Welsh et al (U.S. 2019/0200886). Welsh discloses (par. 0355) identifying respective heartbeat intervals based on electrophysiological data representative of cardiac electrophysiological signals measured over a time interval (“the recorded biopotential data is analyzed, such as by a processor of console 20 of FIG. 1, to determine the time periods, or segments, representing various phases of the cardiac cycle (e.g. phases of the heart beat).” in par. 0355); analyzing the cardiac electrophysiological signals over at least a portion of the time interval (see previous citation); and generating a map on a surface of interest (par. 0359) and/or performing automated signal processing (par. 0356) based on the cardiac electrophysiological signals for heartbeat intervals, wherein the map is generated (“Functional characteristics, such as displacement or velocity of the wall at each vertex or region (instantaneously over a window of time) can be displayed as a map (e.g. a color map) depicting a representation (e.g. an index) of contractility. The difference and/or change in functional characteristic before and after a clinical event, such as an ablation procedure, can be similarly displayed as a color map depicting regions of altered function arising from the clinical event. Additionally or alternatively, one or more surface dynamics can be measured and/or displayed, such as tissue stress or strain, blood velocity, regional wall contractility or other index/representation of loss of function or stiffness.”) and/or the automated signal processing (“In Step 1930, the recorded anatomic data is aggregated, per the time segments determined in Step 1920. For example, for each common time segment of each recorded cycle, the recorded anatomic data, comprising a set of points representing at least a portion of the cardiac surface during each time segment, is aggregated to form a set of anatomic data comprising points from multiple cycles representing a common time segment (e.g. a common phase of the cardiac cycle).”) is performed automatically responsive to the analysis of the cardiac electrophysiological signals.
Regarding claim 2, Welsh discloses (par. 0359) computing changes in signal features and/or signal parameters over the at least a portion of the time interval (“the difference and/or change in functional characteristic before and after a clinical event, such as an ablation procedure, can be similarly displayed as a color map depicting regions of altered function arising from the clinical event.”).
Regarding claim 3, Welsh discloses (par. 0344) determining a difference between the signal features and/or signal parameters and a respective baseline value (“The method can further include a processing step to reconstruct a representative surface or surface segment comprising one or more of the identified regions of surface points from within, near, and/or comprising a connected structure. In some embodiments, the representative surface is reconstructed from the one or more identified regions of surface points, independent of information from other surface data. In some embodiments, the processing steps for the representative surface incorporate information from the primary surface.”; baseline value corresponds to “primary surface”, and signal features/parameters correspond to “identified regions of surface points”).
Regarding claim 4, Welsh discloses (par. 0344) comparing the signal features and/or signal parameters relative to a threshold (“the reconstruction of the representative surface can utilize an iterative fitting or deformation algorithm, such as an algorithm that begins with a generalized surface shape, modifies one or more regions of the surface shape to the set of points, estimates a cost function such as a distance-error, evaluates the cost function against an ending criteria such as a threshold, and iteratively continues with the determination of a next modification to the surface shape if the end criteria is not met.”).
Regarding claim 5, Welsh discloses (par. 0308-0309) the map is generated responsive to the computed changes in the signal features indicating an instability and/or an arrhythmogenic condition (tracking the catheter position using the 3D map such that “an algorithm of system 10 filters the localization signal to remove the jittering motion while maintaining proper responsiveness of the catheter movement.”).
Regarding claim 6, Welsh discloses (par. 0355) the automated signal processing is performed responsive to the computed changes in the signal features indicating a stable rhythm and/or a non-arrhythmogenic condition (“the recorded biopotential data is analyzed, such as by a processor of console 20 of FIG. 1, to determine the time periods, or segments, representing various phases of the cardiac cycle (e.g. phases of the heart beat). For example, recorded biopotential data of a regular and/or near regular heart rhythm (e.g. sinus rhythm or flutter), can be segmented into a periodic set of time segments, representing phases of the cardiac cycle.”).
Regarding claim 7, Welsh discloses (par. 0385) generating the map on the surface of interest is performed automatically responsive to the computed changes in signal features and/or signal parameters changes (“One or more of the steps to create the improved anatomic model can be performed semi-automatically and/or automatically (“automatically” herein). In some embodiments, an automatic modification by system 100 to the base model can be overridden by the user.”), and the method further comprises: comparing (par. 0305) the generated map with respect to a reference map and identifying regions of interest and/or differences between the automatically generated map and the reference map, the reference map being generated for the surface of interest based on cardiac electrophysiological signals for one or more intervals that do not include the portion of the time interval for which the changes were detected (“each point in the set of points is compared to the calculated centroid, and/or to its neighboring points. In some embodiments, the distance between each point and the centroid is compared to a threshold, such as a threshold equal to two times the expected radius of the shape being modeled. In some embodiments, the distance between each point and its neighbors is compared to the same threshold, or a different threshold. In Step 1640, if the distance comparison exceeds the threshold, the point is determined to be invalid and removed from the set of points (Step 1645a). In some embodiments, a point is determined to be invalid if at least one, at least two, or all of the comparisons made exceed the compared thresholds, or if at least one of the comparisons exceeds the threshold.”).
Regarding claim 8, Welsh discloses (par. 0380) generating a notification to instruct the user to move an invasive device within the patient's body responsive to the computed changes in signal features and/or signal parameters (“system 100 can inform a user (e.g. via a user interface) of an area of low data density (e.g. a sparsely sampled area). The user can collect additional data correlating to that area, such as by directing (e.g. steering) catheter 10 “towards” the area indicated, and recording additional data. The additional data collected can be compiled with the first set of data to generate an improved base anatomic model.”).
Regarding claim 9, Welsh discloses (par. 0242) applying a trained machine learning model to the one or more parameters determined for the portion of the electrophysiological data to ascertain the signal features associated with the cardiac electrophysiological signals for the portion of the time interval (“mathematical processing can include: a fitting method; a series of weighted coefficients; a linear system; machine learning; adaptive fitting and/or filtering methods; principal components; filtering (e.g. low pass and/or high pass filtering); other mathematical methods; and/or combinations of one or more of these.”).
Regarding claim 10, Welsh discloses (par. 0355) the signal features associated with the cardiac electrophysiological signals include a cardiac rhythm for electrophysiological signals at locations on the surface of interest (“In Step 1920, the recorded biopotential data is analyzed, such as by a processor of console 20 of FIG. 1, to determine the time periods, or segments, representing various phases of the cardiac cycle (e.g. phases of the heart beat). For example, recorded biopotential data of a regular and/or near regular heart rhythm (e.g. sinus rhythm or flutter), can be segmented into a periodic set of time segments, representing phases of the cardiac cycle.”).
Regarding claim 11, Welsh discloses (par. 0355) the signal features associated with the cardiac electrophysiological signals include at least cycle length for electrophysiological signals distributed across a surface of interest (see above citation; “time periods, or segments, representing various phases of the cardiac cycle”).
Regarding claim 12, Welsh discloses (par. 0081) at least identifying one or more bad measurement channels (“The algorithmic trigger determination can use subsets of channels, edge detection and/or pulse width detection to determine if pacing of the patient has occurred. Optionally, pace blanking can be applied on all channels or subsets of channels, including channels on which detection did not occur.”).
Regarding claim 13, Welsh discloses (par. 0312) reconstructed electrophysiological signals calculated for the surface of interest by solving an inverse problem based on the electrophysiological data and geometry data, the geometry data representing anatomy of a patient spatially, and locations of electrodes in three-dimensional space, and the electrophysiological data being measured by one or more electrodes adapted to measure the cardiac electrophysiological signals over the time interval (par. 0293).
Regarding claim 14, Welsh discloses (par. 0232-0239) the electrophysiological signals on the surface of interest comprise respective electrophysiological signals measured invasively from the surface of interest (“The inputs can be composed entirely of electrodes internal to the body”).
Regarding claim 15, Welsh discloses (par. 0101) automatically detecting the heartbeat intervals in the cardiac electrophysiological signals, and storing beat data with the electrophysiological data to specify the detected heartbeat intervals for the respective cardiac electrophysiological signals.
Regarding claim 16, Welsh discloses (par. 0378-0379) generating a report summarizing steps performed in the method (“a base anatomic model of the heart is generated (e.g. comprising a set of vertices and polygons defining a 3D surface), based on the first set of recorded data.”), including data describing respective computed signal features and/or changes thereof associated with the cardiac electrophysiological signals over at least a portion of the time interval; and storing the report in memory (“the static anatomic model comprises a model generated using a method of “building” a complex 3D geometry around a set of points while or after they are collected”).
Regarding claim 17, Welsh discloses (par. 0055) one or more non-transitory machine-readable medium configured to store instructions, which are executable by a processor to perform the method.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEBORAH L MALAMUD whose telephone number is (571)272-2106. The examiner can normally be reached Mon - Fri 1:00-9:30 Eastern.
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/DEBORAH L MALAMUD/Primary Examiner, Art Unit 3792