DETAILED ACTION
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 1-20 are deemed to have an effective filing date of December 13, 2021.
Information Disclosure Statement
The information disclosure statement filed June 27, 2024 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. The US Patent documents that have been cited have been considered, but the foreign patent documents and the non-patent literature document referred to therein have not been considered and therefor are crossed-out.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character "101" has been used to designate a mapping engine in a workstation (Fig. 1 and paragraph [0036] of the Originally-Filed Specification (OFS)), a mapping engine directly stored in the catheter (Fig. 2, upper right-hand side in dashed box and paragraphs [0086] of the OFS), and two mapping engines external of the workstation (e.g., paragraph [0087] and Fig. 2, in local computer 206 and remote computer 208).
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference characters not mentioned in the description: 113, 165, 465, 616.
The drawings are objected to under 37 CFR 1.84 (o) because a legend is 5 required for the boxes designated by reference numerals "101", "202", "204", "221", "222", "223", "224", "225" (Fig. 2); "310", "320", "340", "350" (Fig. 3); and "410", "420", "430", "440", "450", "410", "460", "465", and "470" (Fig. 4).
CFR 1.84 (o) Legends. Suitable descriptive legends may be used subject to approval by the Office, or may be required by the examiner where necessary for understanding of the drawing.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: 802 (paragraph [0016], line 4, of the OFS; and 455 (paragraph [0108], line 2, of the OFS).
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). 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:
Paragraph [0086], lines 3 and 5, of the OFS recites “memory 223”. However, reference numeral “224” is used to designate a memory in Fig. 2.
Paragraph [0105], line 1, of the OFS recites “catheter 500”, but Fig. 6 shows a catheter 600.
Paragraph [0105] of the OFS recites “a group of three electrodes 612, 614, 616” . That is, “612” is repeated twice at the end of the group instead of --616--, which is shown in the Figure.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “depth” in independent claims 1 and 11 is a relative term which renders the claim indefinite. The term “depth” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is the Examiner’s position that “a depth within cardiac tissue” can refer to a zero depth on the cardiac surface tissue or any other portion of the cardiac tissue. Consequently, the scope of claims 1-20 are vague and indefinite.
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 1-5, 7-8, 10-15, 17-18 and 20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
Claims 1-10 claim a method (process) and claims 11-20 claim a system (apparatus) that stores a process. Therefore, the claims fall within the statutory categories.
Step 2A, Prong 1:
Claims 1 and 12 recite receiving electrical activity from a plurality of electrodes of a catheter and identifying within the electrical activity an electrical signal originating form a depth within cardiac tissue. Dependent claims 2 and 12 add another identifying step. Dependent claims 3-5, 7, 13-15, and 17 modify the identifying step of claims 1 and 11. The limitations, as drafted, describe a process that, under its broadest reasonable interpretation, includes performance of the limitations in the mind except for the recitation of “a mapping engine” and “memory” and “one or more processors”. That is, other than reciting that a mapping engine and processors, nothing in the claims 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. In this case, aside from the recitation of the “mapping engine” and “processors” , the claims encompass a user observing the clinical data, such as an ECG and making a judgement on which clinical data originates from a depth. It is further noted that limitations concerning calculations and a mathematical model additionally encompass the abstract idea of mathematical concepts.
Step 2A, Prong 2:
Claims recite “a mapping engine”, “memory”, and “processors” to perform abstract idea steps. The specification discloses that a mapping engine is part of computer network (see paragraphs [0006]: methods and systems are implemented by a mapping engine executed by one or more processors; [0010]: memory storing software of a mapping engine; and [0033]: the mapping engine can be implemented as a processor executable code or software). As such, these components 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. With respect to the receiving step limitation recited in claims 8 and 18 and the generating a visual display of claim 10 and 20, these are insignificant extra-solution activities.
Step 2B:
As discussed with respect to Step 2A Prong Two, the additional elements in the claim 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 [0006], [0010] and [0033] does 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 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 by merely thinking). Accordingly, a conclusion that the generic computer functions merely being used to implement an abstract idea is well-understood, routine, conventional activity is supported under Berkheimer Option 2.
Thus, the above-identified claims are directed to the judicial exception and ineligible since there is no inventive concept in the claims.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 6, 8, 10-11, 16, 18, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent Application Publication N0. 2-14/0187991 to Thakur et al. (hereinafter referred to as “Thakur”).
Referring to claim 1, Thakur discloses a method comprising: receiving, by a mapping engine executed by one or more processors, electrical activity from a plurality of electrodes of a catheter (e.g., paragraph [0023]: a catheter system including mapping electrodes for sensing activation signals of intrinsic physiological activity disposed in or near the cardiac chamber and a processing system); and identifying within the electrical activity an electrical signal originating from a depth within cardiac tissue (e.g., paragraph [0023]: processing system identifies the near-field activation signal components in the activation signals and maps the identified near-field activation signal component).
Regarding claim 11, Thakur discloses a system (e.g., paragraph [0002]: present disclosure relates to cardiac mapping systems) comprising: a memory capable of storing software of a mapping engine (e.g., paragraph [0044]: further details on mapping systems are discussed in incorporated by reference USP 6,735,465 – Fig. 1, memory 185 and col. 23, lines 6-9); and one or more processors configured to execute the mapping engine to: receive electrical activity from a plurality of electrodes of a catheter (e.g., paragraph [0023]: a catheter system including mapping electrodes for sensing activation signals of intrinsic physiological activity disposed in or near the cardiac chamber and a processing system), and identify within the electrical activity an electrical signal originating from a depth within cardiac tissue (e.g., paragraph [0023]: processing system identifies the near-field activation signal components in the activation signals and maps the identified near-field activation signal component).
As to claims 6 and 16, Thakur discloses the method of claim 1 and the system of claim 11, wherein identifying an electrical signal originating from a depth within cardiac tissue comprises providing the electrical activity from the plurality of electrodes as inputs to a neural network (e.g., paragraph [0044] of Thakur: incorporating USP 6,735,465 – col. 16, line 60 to col. 17, line 2) and determining, via the neural network, an estimated distance from a corresponding electrode to the nearest activation for at least one of the plurality of electrodes (e.g., paragraph [0044] of Thakur: incorporating USP 6,735,465 – col. 22, line 55 to col. 23, line 62: determining the distance of the proximity electrode/corresponding electrode to the nearest activation or one of the proximity elements on the mapping probe).
With respect to claims 8 and 18, Thakur discloses the method of claim 1 and the system of claim 11, wherein the received electrical activity comprises real-time electrocardiogram (ECG) readings from the plurality of electrodes (e.g., paragraph [0044]: details on mapping systems and methods for processing signal generated by the mapping catheter are discussed in incorporated by reference USP 6,070,094 – col. 7, lines 5-11 and col. 16, lines 64-67).
As to claims 10 and 20, Thakur discloses the method of claim 1 and the system of claim 11, further comprising generating a visual display, by the mapping engine, of the identified electrical signal at a specified depth within the cardiac tissue (e.g., paragraph [0040]: processing system 32 includes an output display device 40 and USP 6,070,094 – col. 7, 5-11 and USP 6,735,465 – col. 23, lines 6-10).
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 2-4 and 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Thakur in view of US Patent Application Publication No. 2014/0067279 to George et al. (hereinafter referred to as “George”).
With respect to claims 2 and 12, Thakur discloses the method of claim 1 and the system of claim 11, but does not expressly teach identifying, within the electrical activity, an electrical signal originating from an endocardial surface of the cardiac tissue. However, George in a related art: signal averaging for electrophysiological signals of the heart (e.g., paragraphs [0002]-[0004]), teaches that a map of a mapping system can represent electrical activity for a plurality of points on a cardiac envelope including an epicardial surface and an endocardial surface (e.g., paragraph [0085]: an inverse method can be performed on the averaged data generated electrophysiological data by combining body surface measurements with patient geometry information to reconstruct a predetermined surface region of the patient’s region of interest (e.g., heart)). Accordingly, one of ordinary skill in the art would have recognized the benefits of further identifying the electrical signal originating from an endocardial surface of the cardiac tissue in view of the teachings of George. Consequently, one of ordinary skill in the art would have modified the method and system of Thakur to further identify an electrical signal originating from an endocardial surface of the cardiac tissue in view of the teachings of George that such was a known protocol in the mapping system art, and because the combination would have yielded a predictable result.
As to claims 3 and 13, Thakur discloses the method of claim 1 and the system of claim 11, further comprising performing, by the mapping engine, a spatial electrode signal analysis of the electrical activity for each electrode of the plurality of electrodes (e.g., paragraph [0037] of Thakur: electrodes 24 are electrically coupled to a processing system 32 where the sensed electrical activity of each electrode is processed by signal processing system 32); but does not expressly disclose that identifying an electrical signal originating from a depth within cardiac tissue comprises calculating a linear combination of signal components within the electrical activity. However, George, in a related art, teaches that principal component analysis (PCA) or signal analysis can include calculating a covariance matrix, performing single value decomposition, forming a feature vector, and then formulating a new data set where the covariance is the measure of the strength of correlation between two or more signals with respect to each other using eigenvectors and eigenvalues – a linear combination of signal components (e.g., paragraphs [0067]-[0068] of George). Accordingly, one of ordinary skill in the art would have recognized the benefits of calculating a linear combination of signal components within the electrical activity in view of the teachings of George. Consequently, one of ordinary skill in the art would have modified the method and system of Thakur to perform spatial electrode signal analysis of the electrical activity by calculating a linear combination of signal components within the electrical activity in view of the teachings of George that such was a known protocol in the mapping system art, and because the combination would have yielded a predictable result.
With respect to claims 4 and 14, Thakur in view of George teaches the method of claim 3 and the system of claim 13, wherein calculating a linear combination of signal components within the electrical activity further comprises multiplying each signal component within the electrical activity by a corresponding weight determined via a trained model (e.g., paragraph [0067] of George: a principal component could be defined as a linear combination of optimally-weighted observed variables). Accordingly, one of ordinary skill in the art would have recognized the benefits of the linear combination including multiplying each signal component within the electrical activity by a corresponding weight in view of the teachings of George. Consequently, one of ordinary skill in the art would have modified the method and system of Thakur to modify the linear combination by multiplying each signal component within the electrical activity by a corresponding weight in view of the teachings of George as such was a known protocol in the mapping art, and because the combination would have yielded a predictable result. With respect to the “weight determined via a trained model”, the weight of George may be determined via a trained model.
Claims 5 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Thakur in view of George as applied to claim 3 above, and further in view of US Patent No. 11,564,591 to Narayan et al. (EFD of 11/29/2021 and hereinafter referred to as “Narayan”).
With respect to claims 5 and 15, Thakur in view of George teaches the method of claim 3 and the system of claim 13, wherein identifying an electrical signal originating from a depth within cardiac tissue but does not expressly disclose calculating a non-linear combination of the signal components within the electrical activity. However, Narayan, in a related art: system and method for diagnosing biological rhythm disorders including a catheter and software for mapping and identification of regions of the biological rhythm disorder (e.g., title and paragraph [0034]), teaches that electrical signal processing can be based on the combination of spectral transformations after different linear or non-linear filtering (e.g., paragraphs [0122]-[0123] of provisional application 63/283,901 of Narayan). Accordingly, one of ordinary skill in the art would have recognized the benefits of calculating a non-linear combination of the signal components within the electrical activity in view of the teachings of Narayan. Consequently, one of ordinary skill in the art would have modified the method and system of Thakur in view of George to calculate a non-linear combination of the signal components within the electrical activity in view of the teachings of Narayan that such was a known protocol in the mapping system art, and because the combination would have yielded a predictable result.
Claims 7, 9, 17, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Thakur in view of Narayan.
With respect to claims 7 and 17, Thakur discloses the method of claim 1 and the system of claim 11, wherein identifying an electrical signal originating from a depth within cardiac tissue but does not expressly disclose, for each of the plurality of electrodes, applying a mathematical model and known electrode positions of the plurality of electrodes to calculate an expected signal at each known electrode position. However, Narayan, in a related art, teaches that the heart can be mapped using electrocardiographic imagining and mathematics on recorded surface potentials to calculate electrical activity at precise location of the heart; and mathematical ‘best estimation’ may be used when not all required data is available (e.g., paragraphs [0048] and [0060] of Narayan US Prov).
Accordingly, one of ordinary skill in the art would have recognized the benefits of using a mathematical model and known electrode positions to calculate electrical activity or an expected signal at each known electrode position in view of the teachings of Narayan. Consequently, one of ordinary skill in the art would have modified the method and system of Thakur to identify an electrical signal originating from a depth within the cardiac tissue by applying a mathematical model and known electrode positions to calculate at expected signal at each of known electrode position in view of the teachings of Narayan that such was a known protocol in the mapping system art, and because the combination would have yielded a predictable result.
As to claims 9 and 19, Thakur discloses the method of claim 1 and the system of claim 11, but does not expressly disclose that the processor is further configured to execute a machine learning model trained on simulated ECG data. However, Narayan, in a related art, teaches that machine learning may refer to analytic methods and algorithms that can learn from and make predictions on data by building a model (e.g., Narayan US Prov. paragraphs [0053]; [0105]-[0106]: machine learning is calibrated to AF patients of similar clinical type and data implies trained on ECG data; and [0120]: learning machine reconstructs tissue physiology from clinical catheter recordings from ECG or electrical signals from within the heart). Accordingly, one of ordinary skill in the art would have recognized the benefits of a processor configured to execute a machine learning model trained on simulated ECG data in view of the teachings of Narayan. Consequently, one of ordinary skill in the art would have modified a processor of the method and system of Thakur to be configured to execute a machine learning model trained on simulated ECG data in view of the teachings of Narayan that such was a known protocol in the mapping system art, and because the combination would have yielded a predictable result.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US Patent Application Publication No. 2018/0296111 to Deno et al. is directed to orientation independent sensing, mapping, interface and analysis systems and methods where unipole signals and associated bipole signals are combined together with various weights to determine electric field components along the catheter x0axis and y-axis (e.g., paragraph [0115]).
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