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 1-7, 9, 12-13, and 16-23 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) a mental process of deriving a T-wave loop; determining a repolarization measurement representative of the T-wave loop; determining a change in the repolarization measurement from a previously determined repolarization measurement; determining a metric of the determined changes in the repolarization measurements; determining that the metric meets a risk threshold associated with a cardiac event. This judicial exception is not integrated into a practical application because processing circuitry to received up to two cardiac electrical signals; and telemetry circuit are insignificant extra-solution activities of data gathering, and transmitting data in response to the metric meeting the risk threshold. Moreover, the above-identified abstract idea is not integrated into a practical application because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and certain method of organizing human activity) using rules (e.g., computer instructions) executed by a computer (e.g., processing circuitry and telemetry circuit 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. 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. 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 16 (and their respective dependent claims) is not integrated into a practical application.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the above-identified 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, 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.
Per Applicant’s specification, processing circuitry in published paragraphs [0114-0115] and [0178] discloses control circuit comprises subroutines of signal processing and instructions executed by one or more processors, such as one or more digital signal processors (DSPs), general purpose microprocessors, application specific integrated circuits (ASICs), field programmable logic arrays (FPLAs), or other equivalent integrated or discrete logic circuitry; and
Telemetry circuit in published paragraph [0087] discloses using Bluetooth, and Wi-Fi
Accordingly, in light of Applicant’s specification, the claimed term processing circuitry and telemetry circuit is 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.
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the processing circuitry. 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 Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
The recitation of the above-identified additional limitations in Claims 1-7, 9, 12-13, and 16-23amounts 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 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. 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, 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, the apparatus and method of Claims 1-7, 9, 12-13, and 16-23 are directed to applying an abstract idea (e.g., mental process or certain method of organizing human activity) on a general purpose computer without (i) improving the performance of the computer itself (as in McRO, Bascom and Enfish), or (ii) providing a technical solution to a problem in a technical field (as in DDR). In other words, none of Claims 1-7, 9, 12-13, and 16-23 provide 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.
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 16 (and their dependent claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment. That is, 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. 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. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. As such, the above-identified additional elements, when viewed as whole, 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. Thus, Claims 1-7, 9, 12-13, and 16-23 merely apply an abstract idea to a computer and do not (i) improve the performance of the computer itself (as in Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
Therefore, none of the Claims 1-7, 9, 12-13, and 16-23 amounts to significantly more than the abstract idea itself.
Accordingly, Claims 1-7, 9, 12-13, and 16-23 are not patent eligible and rejected under 35 U.S.C. 101 as being directed to abstract ideas implemented on a generic computer in view of the Supreme Court Decision in Alice Corporation Pty. Ltd. v. CLS Bank International, et al.
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.
Claim(s) 1-7, 9, 12-14, and 16-25 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Weng et al (US Publication 2015/0238101).
Referring to Claims 1 and 16, Weng et al teaches a medical device/method, comprising: processing circuitry (e.g. Figure 6, Element 606 and Paragraphs [0004], [0016], [0061], and [0102]) configured to: receive up to two cardiac electrical signals (e.g. Figure 6 and Paragraph [0062] discloses acquiring a VCG signal); for each of a plurality of cardiac cycles of the received cardiac electrical signal(s) consisting of the up to two cardiac electrical signals: derive a T-wave loop in at least two dimensions (e.g. Figures 5 and 10 and Paragraph [0046]); determine a repolarization measurement representative of the T-wave loop (e.g. Figure 5 and Paragraphs [0036-0037]); determine a change in the repolarization measurement from a previously determined repolarization measurement (e.g. Paragraphs [0036] and [0045]); determine a metric of the determined changes in the repolarization measurements (e.g. Paragraph [0073]); determine that the metric meets a risk threshold associated with a cardiac event (e.g. Paragraphs [0036] and [0073]); a telemetry circuit configured to transmit a risk notification in response to the metric meeting the risk threshold (e.g. Paragraphs [0062], [0073] and [0089] discloses transmitting the alarm to a remote device).
Referring to Claims 2 and 17, Weng et al teaches the claimed invention, wherein the processing circuitry is further configured to derive the T-wave loop in at least two dimensions from a first cardiac electrical signal of the up to two cardiac electrical signals by determining a first coordinate in a first dimension and a second coordinate in a second dimension of each point of a plurality of points of the T-wave loop by: determining the first coordinate as a first amplitude of a first sample point of the first cardiac electrical signal (e.g. Figure 5 and Paragraphs [0038] and [0044]); determining the second coordinate as a second amplitude of a second sample point of the first cardiac electrical signal, the second sample point offset by a first time interval from the first sample point (e.g. Figure 5 and Paragraphs [0038] and [0044]).
Referring to Claim 3, Weng et al teaches the medical device of claim 2, wherein the processing circuitry is further configured to derive the T-wave loop in three dimensions from the first cardiac electrical signal by determining a third coordinate in a third dimension of each point of the plurality of points of the T-wave loop as a third amplitude of a third sample point of the first cardiac electrical signal, the third sample point offset by a second time interval from the first sample point (e.g. Figures 5 and 9 and Paragraph [0044]).
Referring to Claim 4, Weng et al teaches the medical device of claim 3, wherein the processing circuitry is further configured to determine the third amplitude of the third sample point offset by the second time interval from the first sample point where the second time interval is different than the first time interval (e.g. Paragraph [0060]).
Referring to Claims 5 and 19, Weng et al teaches the claimed invention, wherein the processing circuitry is further configured to derive the T-wave loop in three dimensions from the first cardiac electrical signal and a second cardiac electrical signal of the up to two cardiac electrical signals by determining a third coordinate in a third dimension of each point of the plurality of points of the T-wave loop as a third amplitude of a third sample point of the second cardiac electrical signal (e.g. Figures 5 and 9 and Paragraph [0044]).
Referring to Claim 6, Weng et al teaches the medical device of claim 5, wherein the processing circuitry is further configured to identify the third sample point of the second cardiac electrical signal at a common sample time as one of the first sample point of the first cardiac electrical signal or the second sample point of the first cardiac electrical signal (e.g. Figures 5 and 9 and Paragraph [0059]).
Referring to Claims 7 and 20, Weng et al teaches the claimed invention, wherein the processing circuit is further configured to derive the T-wave loop in at least two dimensions from a first cardiac electrical signal and a second cardiac electrical signal of the up to two cardiac electrical signals by determining a first coordinate in a first dimension and a second coordinate in a second dimension of each point of a plurality of points of the T-wave loop by: determining the first coordinate as a first amplitude of a first sample point of the first cardiac electrical signal (e.g. Figure 5 and Paragraphs [0038] and [0044]); determining a second coordinate as a second amplitude of a second sample point of the second cardiac electrical signal (e.g. Figure 5 and Paragraphs [0038] and [0044]); determining a third coordinate of each point of the plurality of points of the T-wave loop by determining a third amplitude from a combination of the first amplitude and the second amplitude (e.g. Figure 5 and Paragraphs [0038] and [0044]).
Referring to Claims 9 and 21, Weng et al teaches the claimed invention, wherein the processing circuitry is further configured to: determine the repolarization measurement by determining a T-wave vector in the at least two dimensions from the T-wave loop (e.g. Figure 7 and Paragraphs [0037] and [0067]); determine the change in the repolarization measurement by determining at least an angle between the T-wave vector and a previously determined T-wave vector (e.g. Figure 9 and Paragraphs [0043] and [0071]).
Referring to Claims 12 and 22, Weng et al teaches the claimed invention, wherein the processing circuitry is further configured to determine the repolarization measurement by determining at least one of: an area of the T-wave loop; an area of a two-dimensional projection of the T-wave loop; a distance from a first point of the T-wave loop to a second point of the T-wave loop; a distance from an origin of a coordinate system corresponding to the at least two dimensions of the T-wave loop to a furthest point of the T-wave loop; a centroid of the T-wave loop; or a length of a perimeter of the T-wave loop (e.g. Paragraph [0072] discloses loop centroid area).
Referring to Claims 13 and 23, Weng et al teaches the claimed invention, wherein the processing circuitry is further configured to determine the metric by one or more of a spectral analysis of frequencies of the changes in the repolarization measurements over time or an amplitude analysis of the changes in the repolarization measurement over time (e.g. Figure 9 and Paragraphs [0036-0037]).
Referring to Claims 14 and 24, Weng et al teaches the claimed invention, further comprising a therapy delivery circuit configured to deliver or adjust a cardiac electrical stimulation therapy in response to the metric meeting the risk threshold (e.g. Paragraphs [0012] and [0094]).
Referring to Claim 18, Weng et al teaches the method of claim 17 further comprising deriving the T-wave loop in three dimensions from the first cardiac electrical signal by: determining a third coordinate in a third dimension of each point of the plurality of points of the T-wave loop as a third amplitude of a third sample point of the first cardiac electrical signal, the third sample point offset by a second time interval from the first sample point, the second time interval being different than the first time interval (e.g. Figures 5 and 9 and Paragraphs [0044] and [0060]).
Referring to Claim 25, Weng et al teaches a non-transitory computer-readable medium storing instructions that, when executed by processing circuitry of a medical device, cause the medical device to: receive up to two cardiac electrical signals (e.g. Figure 6 and Paragraph [0062] discloses acquiring a VCG signal); for each of a plurality of cardiac cycles of the received cardiac electrical signal(s) consisting of the up to two cardiac electrical signals: derive a T-wave loop in at least two dimensions (e.g. Figures 5 and 10 and Paragraph [0046]); determine a repolarization measurement representative of the T-wave loop (e.g. Figure 5 and Paragraphs [0036-0037]); determine a change in the repolarization measurement from a previously determined repolarization measurement (e.g. Paragraphs [0036] and [0045]); determine a metric of the determined changes in the repolarization measurements (e.g. Paragraph [0073]); determine that the metric meets a risk threshold associated with a cardiac event (e.g. Paragraphs [0036] and [0073]); in response to the metric meeting the risk threshold: deliver or adjust a cardiac electrical stimulation therapy; or adjust a cardiac electrical stimulation therapy that is being delivered by the medical device (e.g. Paragraphs [0012] and [0094]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Couderc et al (US Publication 2005/0010124) discloses obtaining an ECG signal and obtaining a 3-dimensional representation of successive cardiac cycles illustrating the T-waves and using this to identify a risk of fibrillation.
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/William J Levicky/Primary Examiner, Art Unit 3796
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