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 .
Priority
Claims 1-27 are deemed to have an effective filing date of December 15, 2022.
Drawings
The drawings are objected to under 37 CFR 1.84 (p) (3) because “numbers, letters, and reference characters must measure at least .32 cm (1/8 inch) in height”. Figs. 7A-7C, 8A, and 11B have letters and/or reference characters that are too small.
The drawings are objected to under 37 CFR 1.84 (l) because "every line, number and letter must be durable, clean, black, sufficiently dense and dark, and uniformly thick and well defined". Figs. 7A-7C, 8A (legend has disconnected letters/numbers), and 8C have lines that are too light and/or disconnected.
Figures 1A and 6A-6B should be designated by a legend such as --Prior Art-- because only that which is old is illustrated. See MPEP § 608.02(g). Corrected drawings in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities: Since the instant application has black and white drawings, the recitation of the Figures having “red” or “green” is inconsistent with what is shown in the Figures. Paragraphs [0093] (page 20, lines 27-28), [00129] (page 32, line 29; page 33, line 8) and [00150] (page 38, lines 20 and 26) of the originally-filed specification.
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 1-6, 9, 12, and 15-20, 23, and 27 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract idea without significantly more. The independent claims (1 and 15) recite obtaining bipolar EGM data, determining at least one compound electrogram (e.g., QRS, ST) from the bipolar EGM data, and determining at least one repolarization value from the compound electrogram.
With respect to the dependent claims: Claims 4 and 18 add differential amplification that is nothing more than amplifying acquired data (differential signal); claims 5 and 19 add a Laplacian operation (mathematical calculation); claim 6 and 20 add subtracting data (mathematical calculation); and claims 2-3, 9, 16-17, 23, and 27 are directed to mental processes.
Step 1:
Claims 1-6, 9, 12 and 27 recite a device, and therefore is a product, and claims 15-20 and 23 recite a system with circuitry for using that device/processor. Therefore, the claims fall within the statutory categories.
Step 2A, Prong 1:
Claims 1 and 15 recite the limitations described above. The limitations, as drafted, describe a process that, under its broadest reasonable interpretation, includes performance of the limitation in the mind except for the recitation of "an electrode array". Claim 15 also adds "an instrumentation unit/circuitry", "memory", and "at least one processor", which can be a computer processor. See paragraph [0086] of the originally-filed specification. That is, other than reciting that a system is performing these tasks, nothing in the claim precludes the steps from practically being performed in the human mind. MPEP 2106.04(a)(2)(III) states that the courts consider a mental process (thinking) that "can be performed in the human mind, or by a human using a pen and paper" to be an abstract idea. The claims, as a whole, are directed to a judicial exception/mental process.
Step 2A Prong 2:
The claims recite “an electrode array" to perform the abstract steps. The “electrode array” is an insignificant extra-solution activity (data gathering) to the judicial exception. The additional structure of claim 15: circuitry and a processor read on a computer implemented system and are recited at a high level of generality, i.e., as a generic processor, performing a generic computer function of processing data. This generic processor limitation is no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional limitation does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
Step 2B:
As discussed with respect to Step 2A Prong Two, the additional elements in the claims amount to no more than mere instructions to apply the exception using a generic computer component. The same analysis applies here in 2B, i.e., mere instructions to apply an exception on a generic computer cannot integrate a judicial except into a practical application at Step 2A or provide an inventive concept in Step 2B. Under 2019 PEG, a conclusion that an additional element is insignificant extra-solution activity in Step 2A should be re-evaluated in Step 2B to determine if it is more than what is well- understood, routine, conventional activity in the field. The specification in paragraph [0085] states that at least one of the embodiments may be stored on a storage device or device that is readable by a general or special purpose programmable device, but the claims do not provide any indication that the computer is anything other than a generic, off-the-shelf computer component. Court decisions cited in MPEP 2106.05(d)(II) indicate that computer- implemented processes are not to be significantly more than an abstract idea (and thus ineligible) where the claim, as a whole, amounts to nothing more than generic computer functions merely used to implement an abstract idea, such as an idea that could be done by a human analog (i.e., by hand or merely thinking). Accordingly, a conclusion that the generic computer functions merely being used to implement an abstract idea are well-understood, routine, conventional activities is supported under Berkheimer Option 2.
For the additional limitations of “electrode array” and “instrumentation unit”, these are nothing more than conventional parts of well-known ECG system (see Fig. 4.1 on p34 “ECG Based Analysis of the Ventricular Repolarization in the Human Heart”, KIT Scientific Publishing, 2012). This judicial exception is not integrated into a practical application because the claims are directed to collecting/gathering information (data/signals), selecting the compound electrogram from the gathered signals, and determining the repolarization value by enlarging the signal to visually determine a repolarization value. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the selecting and determining steps can be practically performed in the human mind with the use of a physical aid (e.g., pen and paper) and the gathering steps do not add a meaningful limitation to the method as they are insignificant extra-solution activity.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 12-17, and 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication No. 2020/0196893 to McLeod et al. (hereinafter referred to as “McLeod”) in view of US 2018/0125385 to Chauhan et al. (hereinafter referred to as “Chauhan”).
Referring to claim 1, McLeod discloses a method for determining at least one repolarization value from Electrogram (EGM) data obtained from a heart using an electrode array (e.g., Abstract and paragraphs [0002] and [0007]), wherein the method is performed by at least one processor and/or circuitry (e.g., paragraph [0012]: a processor configured to execute instructions to create a repolarization map of the heart) wherein the method comprises: obtaining bipolar EGM data from the EGM data obtained from the heart (e.g., paragraph [0031]: electrodes 108 can record bipolar electrograms from the heart); and determining the at least one repolarization value from the electrogram (e.g., paragraph [0033]: optimizing repolarization times and creating a repolarization map would necessarily require determining a repolarization value from the electrogram). McLeod differs from the claimed invention in that it does not expressly disclose determining at least one compound electrogram from the bipolar EGM data; and determining the at least one repolarization value from the at least one compound value. However, Chauhan, in a related art: method and system for assessing QRS components, teaches that bipolar and unipolar intracardiac electrograms can be obtained, pre-processed, and analyzed to determine repolarization parameters including ST timing intervals (e.g., Tables 7, 9 and 13: QT interval in milliseconds). Accordingly, one of ordinary would have recognized that at least one repolarization value can be determined from a compound electrogram, such as the QT interval, in view of the teachings of Chauhan. Consequently, one of ordinary skill in the art would have modified the method of McLeod so that a compound electrogram is selected and a determination of the selected compound electrogram’s repolarization value is made in view of the teachings of Chauhan that repolarization values can be determined for compound signals (QT interval), and because the combination would have yielded a predictable result.
With respect to claim 2, McLeod in view of Chauhan teaches the method according to claim 1, wherein the method further comprises filtering the EGM data (e.g., paragraph [0007] of McLeod: the method can include filtering the repolarized signal from a first electrode where the repolarized signal is bipolar EGM data from the heart) by performing high pass filtering using a cutoff frequency of about 0.02 Hz or about 0.05 Hz (e.g., paragraph [0081] of Chauhan: cardiac electrical data is analog filtered to have a pass band of 0.05 Hz). Thus, one of ordinary skill in the art would have recognized the benefits of filtering the obtain EGM data from the heart with a cutoff frequency of 0.05 Hz in view of the teachings of Chauhan. Consequently, one of ordinary skill in the art would have modified the filtering of McLeod in view of Chauhan to have a cutoff frequency of 0.05 Hz in view of the teachings of Chauhan that such was a well-known engineering protocol in the cardiac electrical signal art, and because the combination would have yielded a predictable result.
As to claim 3, McLeod in view of Chauhan teaches the method according to claim 1, wherein the method comprises preprocessing the obtained EGM data by performing baseline correction and/or noise reduction (e.g., paragraph [0007] of McLeod: filtering the repolarization signal can include reducing noise from the repolarization signal).
With respect to claim 12, McLeod in view of Chauhan teaches the method according to claim 1, wherein the method comprises obtaining a plurality of repolarization values corresponding to various locations on an electrode grid defined by the electrode array (e.g., paragraph [0041] of McLeod: creating a repolarization map can create a three-dimensional image necessarily implies obtaining a plurality of repolarization values corresponding to various locations on an electrode grid).
As to claim 13, McLeod in view of Chauhan teaches the method according to claim 12, wherein the method further comprises determining a plurality of repolarization values for generating a repolarization map that is displayed on a display, stored in a data store, transmitted to another computing device or any combination thereof (e.g., paragraph [0041] of McLeod: three-dimensional transmural repolarization map can be displayed).
With respect to claim 14, McLeod in view of Chauhan teaches the method according to claim 13, wherein the repolarization map is used to guide a cardiac procedure including catheter ablation and/or tissue debulking (e.g., e.g., Abstract: method for mapping and modulating repolarization to target atrial and ventricular arrhythmias to deliver electrical stimulation pacing, ablation and/or electroporation and paragraph [0007]: mapping catheter is inserted in a heart of patient, receives repolarization signals from its electrodes, delivers stimulation, and creates a repolarization map).
As to claim 15, McLeod in view of Chauhan teaches a system for determining at least one repolarization value from Electrogram (EGM) data obtained from a heart (e.g., Abstract and paragraphs [0002] and [0007]), wherein the system comprises: an electrode array for obtaining EGM data from the heart (e.g., McLeod paragraphs [0007] and [0027]: mapping catheter 100 includes an array of electrodes 108, see Fig. 1); an instrumentation unit that is coupled to the electrode array and comprises circuitry that is configured to receive and preprocess the obtained EGM data (e.g., paragraph [0028] of McLeod: an external monitoring system coupled to the electrode array provides filtering, signal processing, monitoring, catheter location, and ablation capabilities); memory for storing program instructions (e.g.., paragraph [0012] of McLeod: memory that is capable of storing computer executable instructions); and at least one processor that is coupled to the memory and the instrumentation unit (e.g., paragraph [0012]: processor is configured to execute instructions stored in memory where the instructions cause the processor to receive a repolarization signal form a first electrode, filter the received repolarization signal, deliver stimulation and create a repolarization map), wherein when the at least one processor executes the program instructions, the at least one processor is configured to perform a method that is defined according to claim 1 (see rejection of claim 1 above).
With respect to claim 16, McLeod in view of Chauhan teaches the system according to claim 15, wherein the instrumental unit comprises at least one filter for filtering the EGM data (e.g., paragraph [0007] of McLeod: the method can include filtering the repolarized signal from a first electrode where the repolarized signal is bipolar EGM data from the heart implies the use of a filter) by performing high pass filtering using a cutoff frequency of about 0.02 Hz or about 0.05 Hz (e.g., paragraph [0081] of Chauhan: cardiac electrical data is analog filtered to have a passband of 0.05 Hz). Thus, one of ordinary skill in the art would have recognized the benefits of filtering the obtain EGM data from the heart with a cutoff frequency of 0.05 Hz in view of the teachings of Chauhan. Consequently, one of ordinary skill in the art would have modified the instrumentation unit of McLeod in view of Chauhan to have a filter with a cutoff frequency of 0.05 Hz in view of the teachings of Chauhan that such was a well-known engineering protocol in the cardiac electrical signal art, and because the combination would have yielded a predictable result.
As to claim 17, McLeod in view of Chauhan teaches the system according to claim 1, wherein the circuitry of the instrumentation unit and/or the at least one processor is configured to (a) preprocess the obtained EGM data by performing baseline correction and/or (b) preprocess the obtained EGM data by performing noise reduction (e.g., paragraph [0007] of McLeod: filtering the repolarization signal can include reducing noise from the repolarization signal).
With respect to claim 26, McLeod in view of Chauhan teaches the system of claim 15, wherein the at least one processor is configured to: (a) obtain a plurality of repolarization values corresponding to various locations on an electrode grid defined by the electrode array; and/or (b) determine a plurality of repolarization values for generating a repolarization map that is displayed on a display, stored in a data store, transmitted to another computing device or any combination thereof (e.g., paragraph [0041] of McLeod: three-dimensional transmural repolarization map can be displayed).
27. A non-transitory computer readable medium storing program instructions that when executed by a processor cause the processor to perform a method for determining at least one repolarization value (e.g., paragraph [0012] of McLeod) where the method is defined according to claim 1 (see rejection of claim 1 above).
Claims 4 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over McLeod in view of Chauhan as applied to claims 1 and 15 above, and further in view of US Patent Application Publication No. 2019/0274568 to Shahdoostfard et al. (hereinafter referred to as “Shahdoostfard”).
McLeod in view of Chauhan teaches the method according to claim 1 and the system of claim 15, but does not expressly teach that the method comprises obtaining the bipolar EGM data by applying differential amplification when obtaining the EGM data from the heart, and that the at least one instrumentation unit comprises at least one differential amplifier for obtaining the bipolar ECM data by applying differential application when obtaining the EGM data from the heart. However, Shahdoostfard, in a related art: channel integrity detection and reconstruction of electrophysiological signals, Shahdoostfard teaches a measurement system for obtaining electrophysiological signals from a patient’s body using electrograms and a system to generate a repolarization map of the heart (e.g., paragraph [0089] and Fig. 16 of Shahdoostfard) where the measurement system includes a plurality of input channels to receive respective electrical signals form a set of electrodes, an amplifier stage including a plurality of differential amplifiers and channel detection logic (e.g., paragraph [0003] and [0027]-[0029], Fig. 1 ). Accordingly, one of ordinary skill in the art would have recognized the benefits of a differential amplifier when obtaining EGM data in view of the teachings of Shahdoostfard. Consequently, one of ordinary skill in the art would have modified the method and system of McLeod in view of Chauhan so that the method comprising obtaining the bipolar EBM data by applying differential amplification when obtaining the data from the heart and so that the instrumentation unit includes a differential amplifier in view of the teachings of Shahdoostfard that such was a well-known engineering expedient in the electrogram signals forming repolarization map art, and because the combination would have yielded a predictable result.
Claims 5 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over McLeod in view of Chauhan as applied to claims 1 and 15 above, and further in view of US Patent Application Publication No. 2004/002870 to Rudy et al. (hereinafter referred to as “Rudy”).
McLeod in view of Chauhan teaches the method according to claim 1 and the system of claim 15, but does not expressly teach that the method comprises (and the processor is configured to) obtaining the bipolar EGM data from a principal component referenced unipole or is an EGM derived from a Laplacian operation. However, Rudy, in a related art: system and method for determining a surface geometry of a heart, teaches that epicardial (surface) potentials can be determined based on the stored body surface potentials and that electrograms and other data representations can be generated based on epicardial surface potentials (e.g., paragraph [0067] of Rudy) where one of ordinary skill will recognized that computing torso potentials based on measured epicardial potentials includes solving Laplace’s equation which entails the discretion of Laplace’s equation in the volume between the epicardial surface and the body surface (e.g., paragraph [0068] of Rudy). Thus, Rudy teaches that the EGM data is derived from a Laplacian operation. Consequently, one of ordinary skill in the art would have modified the method and system of McLeod in view of Chauhan so that the EGM data is derived from a Laplacian operation in view of the teachings of Rudy that such was a well-known mathematical protocol used in obtaining EGM data, and because the combination would have yielded a predictable result.
Claims 6 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over McLeod in view of Chauhan as applied to claims 1 and 15 above, and further in view of the article entitled “Theoretical Assessment of a Repolarization Time Marker Based on Intracardiac Bipolar Electrogram” by Orini et al. (cited by Applicant and hereinafter referred to as the “Orini article”).
McLeod in view of Chauhan teaches the method according to claim 1 and the system of claim 15, but does not expressly teach that the method comprises obtaining the bipolar EGM data by subtracting EGM data for a first electrode from EGM data for a second electrode where the first and second electrodes are adjacent to one another in the electrode array, and that the circuitry of the instrumentation unit and/or the at least one processor is configured to obtain by subtracting EGM data for a first electrode from EGM data for a second electrode where the first and second electrodes are adjacent to one another in the electrode array. However, the Orini article teaches that a bipolar electrogram is defined as the potential difference between two adjacent extracellular cardiac sites, and that bipolar electrograms are obtained as the difference between EGM data from pairs of adjacent electrodes (e.g., page 2, column 1, lines 11-13, and page 3, column 1, lines 5-7 of the Orini article). Accordingly, one of ordinary skill in the art would have recognized the benefits of obtaining the bipolar EGM data by taking the difference of (subtracting) EGM data from a first electrode (pole) and a second electrode (pole) where the first electrode is adjacent to the second electrode in view of the teachings of the Orini article. Consequently, one of ordinary skill in the art would have modified the method and system of McLeod in view of Chauhan so that the method comprises and the processor is configured to obtain the bipolar EBM data by subtracting EGM data for a first electrode from EGM data for a second electrode where the first and second electrodes are adjacent to one another in the electrode array in view of the teachings of Orini article that such was a well-known engineering protocol in the electrogram signals and repolarization art, and because the combination would have yielded a predictable result.
Allowable Subject Matter
Claims 7-11 and 21-25 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: As of the date of this Office Action, the Examiner has not located any reference that can be used singularly or in combination with another reference including McLeod, Chauhan, Shahdoostfard, Rudy, and the Orini article to render the invention set forth in those claims anticipated or obvious to one of ordinary skill in the art.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US Patent Application No. 6,154,672 to Pendekanti et al. is directed to method and apparatus for improving the probability of defibrillation shocks and teaches that it was known in the art to collect cardiac signals with an electrode array (e.g., Fig. 2) and to filter the signals with a 0.5 Hz high-pass filter.
US Patent Application Publication No. 2022/0160307 to Zeng et al. is directed to noise filtering for electrophysiological signals where the analysis system can compute other electrical characteristics from the reconstructed electrograms including a repolarization map (e.g., paragraphs [0068]-[0070]).
US Patent Application Publication No. 2007/0265508 to Sheikhzadeh-Nadjar et al. is directed to method and system for managing physiological system where active noise cancellation can be used to obtain bipolar EGM data from an EGM derived from a Laplacian operation (e.g., paragraph [0191]).
US 2007/0208265 to Couderc et al. is directed to method and system for assessing repolarization abnormalities.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERINE M VOORHEES whose telephone number is (571)270-3846. The examiner can normally be reached Monday-Friday 8:30 AM to 4:30 PM.
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/CATHERINE M VOORHEES/Primary Examiner, Art Unit 3792