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 .
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 1-14 are rejected under 35 U.S.C. 101 because the claimed invention is not directed to patent eligible subject matter. Based upon consideration of all of the relevant factors with respect to the claim as a whole, the claims are determined to be directed to a judicial exception, specifically an abstract idea, without significantly more.
Step 1
The claimed inventions in claims 1-14 are directed to statutory subject matter as the claim(s) recite(s) a method and a device for processing cardiac data.
Step 2A, Prong One
Claims 1 and 9 recite the following steps or instructions for “receive(ing) electrocardiogram data…”, “analyse(ing) the electrocardiogram data”…”, “carry out a wavelet transform…”, “derive(ing)…wavelet transform coefficients..”, “extract(ing)…a QRS…signal and subtracting it…”, “carrying out an inverse wavelet transform…”, and “returning/produce as output the….data…”, which is grouped as a mental process in MPEP 2106.04(a)(2)(III) and the use of mathematical concepts in MPEP 2106.04(a)(2)(I). These limitations concern data collection, data analysis using mathematical concepts of wavelet transformation, and inverse wavelet transformation, and recording the results which could be done mentally or by hand with pen and paper. For example, these limitations are nothing more than a medical professional receiving generic or pre-recorded electrocardiogram and electrogram data, and analyzing it for QRS time points, performing mathematical calculations to carry out a wavelet transfomr, extract the wavelet transform coefficients, store them, then use an inverse wavelet transform to produce resultant electrogram data points. Accordingly, each of the above-identified claims recites an abstract idea as in MPEP 2106.04(a).
In addition, Claim 1 recites additional elements of “a memory”, “a detector”, “an analyser”, “an extractor”, and “a composer”.
Step 2A, Prong Two
The above-identified abstract idea in each of independent Claims 1 and 9 (and their respective dependent Claims 2-8 and 10-14) is not integrated into a practical application under MPEP 2106.04(d) because the additional elements (identified above in independent Claim 1), either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use according to MPEP 2106.05(h) and appear to be extra solution activity where data to be analyzed by the abstract idea is acquired or obtained.
More specifically, the additional elements of: “a memory”, “a detector”, “an analyser”, “an extractor”, “a composer”, as recited in independent claim 1, are generically recited computer elements in independent Claims 1 and 9 (and their respective dependent Claims 2-8 and 10-14) which do not improve the functioning of a computer, or any other technology or technical field according to MPEP 2106.04(d)(1) and 2106.05(a). Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine according to MPEP 2106.05(b), effect a transformation according to MPEP 2106.05(c), provide a particular treatment or prophylaxis according to MPEP 2106.04(d)(2) or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception according to MPEP 2106.04(d)(2) and 2106.05(e). Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer in accordance with MPEP 2106.05(f). For at least these reasons, the abstract idea identified above in independent Claims 1 and 9 (and their respective dependent Claims 2-8 and 10-14) is not integrated into a practical application in accordance with MPEP 2106.04(d).
Moreover, the above-identified abstract idea is not integrated into a practical application in accordance with MPEP 2106.04(d) because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and using mathematical concepts) using rules (e.g., computer instructions) executed by a computer (e.g. “a memory”, “a detector”, “an analyser”, “an extractor”, “a composer” as claimed). In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer according to MPEP 2106.05(f). Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims according to MPEP 2106.05(a). That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent Claims 1 and 9 (and their respective dependent Claims 2-8 and 10-14) is not integrated into a practical application under MPEP 2106.04(d)(I).
Accordingly, independent Claims 1 and 9 (and their respective dependent Claims 2-8 and 10-14) are each directed to an abstract idea according to MPEP 2106.04(d).
Step 2B
Claims 1 and 9 do not include additional elements that are sufficient to amount to significantly more than the abstract idea in accordance with MPEP 2106.05 for at least the following reasons:
Claim 1 requires the additional elements of: “a memory”, “a detector”, “an analyser”, “an extractor”, and “a composer”.
Per Applicant’s specification, “The detector 6, the analyser 8, the extractor 10, and the composer 12 directly or indirectly access the memory 4. They may be made in the form of a suitable computer code executed on one or more processor(s)” (published application ¶¶ 62). The examiner expect that these are simply modules or logic chips or separate programs run on a generic processor, which is a well understood, routine, and convention element used and known in the art.
Accordingly, the claimed terms “a memory”, “a detector”, “an analyser”, “an extractor”, and “a composer” are reasonably construed as a generic computing device. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process. See MPEP 2106.05(f).
In addition, These additional elements are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, MPEP 2106.05(d)(II) along with Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for “a memory”, “a detector”, “an analyser”, “an extractor”, and “a composer”. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see MPEP 2106.05(d)(I)(2) and 2106.07(a)(III)). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications along with MPEP 2106.05(d)(I)).
The recitation of the above-identified additional limitations in Claims 1 and 9 (and their respective dependent Claims 2-8 and 10-14) amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general-purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See MPEP 2106.05(f) along with Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. See MPEP 2106.05(a) along with McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, per MPEP 2106.05(a), the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, device and method of Claims 1 and 9 (and their respective dependent Claims 2-8 and 10-14) are directed to applying an abstract idea as identified above on a general purpose computer without (i) improving the performance of the computer itself or providing a technical solution to a problem in a technical field according to MPEP 2106.05(a), or (ii) providing meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself according to MPEP 2106.04(d)(2) and 2106.05(e).
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in independent Claims 1 and 9 (and their respective dependent Claims 2-8 and 10-14) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment according to MPEP 2106.05(h). When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment according to MPEP 2106.05(h). When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself according to MPEP 2106.04(d)(2) and 2106.05(e). Moreover, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity according to MPEP 2106.05(g). As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application as required by MPEP 2106.05.
Claim Rejections - 35 USC § 103
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 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.
In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
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 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over Brown et al. (US 2004/0111121; hereinafter “Brown”) in view of Pelzek et al. (US 2009/0131762; hereinafter “Pelzek”).
Regarding claim 1, Brown discloses an intracardiac signal processing device, comprising a memory arranged to receive electrogram data (e.g. ¶¶ 46; Fig. 2, #102, etc.), a detector arranged to analyse the electrocardiogram data and to detect therein QRS wave time points (e.g. ¶¶ 14-16, Abstract; 18 – “fiducial point of each successive QRS complex is detected (e.g., a VSENSE) prompting the storage of sampled and digitized waveform amplitude data within a timing window bridging the point in time of fiducial point detection”), an analyser arranged to carry out a wavelet transform of the electrogram data (e.g. ¶¶ 34), an extractor arranged to derive in the wavelet transform coefficients each associated with a QRS wave time point detected by the detector, and to store them in a buffer (e.g. ¶¶ 79-87), and a composer arranged to extract from the buffer a QRS fingerprint signal and subtract it in the wavelet transform at the QRS wave time points (e.g. Fig .5) and to produce as output denoised electrogram data by inverse wavelet transform of the resulting signal (e.g. ¶¶ 94).
Brown fails to expressly disclose receiving electrocardiogram data, synchronizing the data with electrogram data, and using the electrocardiogram data to detect the QRS wave time points. The examiner notes that the synchronizing in time of both electrocardiogram and electrogram data is notoriously common in the art. In the same field of endeavor, Pelzek discloses receiving electrocardiogram data and electrogram data, synchronizing the electrocardiogram data with electrogram data, and using the electrocardiogram data to detect the QRS wave time points, in order to account for differences in time delay by the acquiring electrodes (e.g. ¶¶ 8, 28, etc.). It would have been obvious to one of ordinary skill in the art, prior to the effective filing date, to apply the known technique of acquiring electrocardiogram data in addition to electrogram data, synchronize the data, use the electrocardiogram data to detect the QRS wave time points in the cardiac cycle, as taught by Pelzek, to improve the similar device of Brown, by enabling the analysis and comparison of both the electrocardiogram data and the electrogram data together for any abnormalities discovered during the QRS wave analysis.
Regarding claim 9, Brown teaches a method for processing intracardiac signals comprising: a) receiving electrogram data (e.g. ¶¶ 46; Fig. 2, #102, etc.), b) analysing the electrocardiogram data to detect therein QRS wave time points (e.g. ¶¶ 14-16, Abstract), c) carrying out a wavelet transform of the electrogram data (e.g. ¶¶ 34), d) deriving in the wavelet transform coefficients, each associated with a QRS wave time point detected in the operation (b), and storing them in a buffer (e.g. ¶¶ 79-87), e) extracting from the buffer a QRS fingerprint signal and subtracting it in the wavelet transform of the operation c) at the QRS wave time points (e.g. Fig .5) and f) carrying out an inverse wavelet transform of the signal of the operation e), and returning as output the corresponding denoised electrogram data (e.g. ¶¶ 94).
Brown fails to expressly disclose receiving electrocardiogram data, synchronizing the data with electrogram data, and using the electrocardiogram data to detect the QRS wave time points. The examiner notes that the synchronizing in time of both electrocardiogram and electrogram data is notoriously common in the art. In the same field of endeavor, Pelzek discloses receiving electrocardiogram data and electrogram data, synchronizing the electrocardiogram data with electrogram data, and using the electrocardiogram data to detect the QRS wave time points, in order to account for differences in time delay by the acquiring electrodes (e.g. ¶¶ 8, 28, etc.). It would have been obvious to one of ordinary skill in the art, prior to the effective filing date, to apply the known technique of acquiring electrocardiogram data in addition to electrogram data, synchronize the data, use the electrocardiogram data to detect the QRS wave time points in the cardiac cycle, as taught by Pelzek, to improve the similar device of Brown, by enabling the analysis and comparison of both the electrocardiogram data and the electrogram data together for any abnormalities discovered during the QRS wave analysis.
Regarding claim 2, Brown discloses the memory is arranged to receive electrogram data which correspond to distinct tracks, the detector, the analyser, the extractor and the composer being arranged to independently process the electrogram data associated with distinct tracks (e.g. ¶¶ 57 – “stores VT/VF detection episode data and VF delivery data that can be UT transmitted to the external programmer 40 for review by a physician”).
Regarding claims 3 and 10, Brown discloses the extractor is arranged to derive coefficients such that, for a selected coefficient corresponding to a given time point in a given wavelet transform level, the wavelet signal which corresponds to the given wavelet level and which is centred on the given time point has an overlap with a window extracted from the electrogram data from which the selected coefficient is derived, which window is centred on the QRS wave time point with which each respective coefficient is associated (e.g. ¶¶ 23-24 – “The wavelet transform applied to digitized QRS amplitude sample values will yield a set of wavelet transform coefficient (WTC) data, and a selected sub-set of the WTC data can be employed to accurately represent the QRS complex, and thus will achieve a high degree of information compression”).
Regarding claims 4 and 11, Brown discloses the extractor is arranged to weight the coefficients stored in the buffer according to the temporal overlap between the wavelet signal which corresponds to the wavelet level of each respective coefficient and which is centred on the time point corresponding to each respective coefficient and the window centred on the QRS wave time point with which each respective coefficient is associated (e.g. ¶¶ 23-24 – “wavelet transform of the second derivative of the time series of a fibrillation event is performed on digitized QRS complexes in the EGM to provide spectral functions of the QRS complexes”).
Regarding claims 5 and 12, Brown discloses the composer is arranged to define a QRS fingerprint signal for each wavelet level of the wavelet transform, each based on a function of the coefficients derived by the extractor for a respective wavelet level (e.g. ¶¶ 82-88).
Regarding claims 6 and 13, Brown discloses the composer is arranged to apply a function selected from the group including the geometric median (e.g. ¶¶ 99-101).
Regarding claim 7, Brown discloses the composer is arranged to use a selected number of most recent coefficients in the buffer for each wavelet level (e.g. ¶¶ 23 – “selected sub-set of the WTC data can be employed to accurately represent the QRS complex”).
Regarding claim 8, Brown discloses the extractor is arranged to carry out a SWT-type wavelet transform (e.g. ¶¶ 22 – where Haar wavelet transform is a type of SWT-type).
Regarding claim 14, Brown discloses a non-transitory computer readable medium for storin ga computer program comprising instruction when executed on processing circuitry to cause the processing circuitry to carry out the method is used (e.g. ¶¶ 73 – “under control of software stored in ROM associated with microprocessor”).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael D’Abreu whose telephone number is (571) 270-3816. The examiner can normally be reached on 7AM-4PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL J D'ABREU/Primary Examiner, Art Unit 3796