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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3/6/2025 was filed after in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 1-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claim 1 is directed to a process and claims 7 and 13 are directed to a process (Step 1 of MPEP 2106). All three claims recite computing and explanation using obtained data. These limitations, as currently drafted, recite a process that covers performance of the limitations in the mind while additionally reciting generic computer components in association with the abstract steps. That is, other than reciting generic computing component language, nothing in the claims preclude the steps from practically being performed in the mind. As a specific example, a doctor is a trained classifier that can receive information, generate models, analyze/process the information, and compute an explanation based on the analysis in his mind. No tangible output, therapy, or change to the operation of the device itself is claimed. That is, the claims do not require actually doing anything as a result of the computation (besides potentially performing further analysis), or even specifically describing specialized circuitry or structures for performing the diagnosis. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea (Step 2A in MPEP 2106).
This judicial exception is not integrated into a practical application. As described above, the claims do not attempt to apply the abstract idea to produce any useful/tangible output to a user, to deliver treatment to a patient or to change operation of the device itself. In particular, the claims merely recites generic “hardware processors.” These additional limitations are recited at a high-level of generality (i.e., as a generic component with no details in the claims). Additionally, the specification goes into no detail of the specific structure of the computing device or processor, instead disclosing in par. 047 that the processors can be any one of a garden variety of generic and off-the-shelf processors. The mere fact that a computing device is recited to perform certain tasks does not make the circuitry "special purpose," based on the Supreme Court's decisions in Alice and Bilski, wherein providing a programmed computer with no further details is insufficient to impart eligibility. The current claims amount to no more than an abstract idea and trying to claim a generic computing device to “apply it." Additionally, data gathering and its generic components have been deemed an “extra-solution activity” that does not amount to an inventive concept when the activity is well-understood and/or conventional (see MPEP 2106.05(g)). Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea (Step 2B of MPEP 2106).
Additionally, invoking computers or other machinery merely as a tool to perform an existing process will generally not amount to significantly more than a judicial exception. See. e.g., Versata Development Group v, SAP America, 793 F.3d 1306, 1335, 115 USPG2d 1681, 1702 (Fed. Cir. 2015) (explaining that in order for a machine to add significantly more, it must “play a significant part in permitting the claimed method to be performed, rather than function solely as an obvious mechanism for permitting a solution to be achieved more quickly"). In this case, as described above, it is possible for the claimed functional language/method steps performed by the “hardware processor” to be carried out mentally and/or manually. The claim is directed to an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using generic structures to perform certain functional language steps and/or to collect data amounts to no more than mere instructions to apply the exception using a generic computer component or to perform extra-solution activity in a conventional way. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. Additionally, a generic computer that has not been claimed with any specificity is considered by the Examiner to be well-understood, routine and conventional in the art and thus cannot be considered significantly more than the judicial exception. The recited “processors”, “memory”, “communication interfaces” and “storage mediums” have not been claimed with any specificity and are considered by the Examiner to be well-understood, routine and conventional in the art and thus cannot be considered significantly more than the judicial exception.
Furthermore, the Examiner takes Official Notice that the “processors”, “memory”, “communication interfaces” and “storage mediums” broadly and generically disclosed and claimed in the current application are well-understood, routine and conventional in the art for receiving and processing cardiac signals.
Therefore, the claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception (Step 2B of MPEP 2106).
Furthermore, the applicant has not shown that the claimed apparatus is necessarily and inextricably rooted in cardiac diagnosis technologies. For example, in DDR Holdings it was found that the claimed subject matter was significantly more because the abstract method was not just applied on/using the internet but it changed how the internet itself worked. In this case, the applicant’s claims do not change the functioning of the recited system. Instead, these generic components are merely being used to apply the abstract idea, as in Alice.
While it seems clear that there is not a particular machine required by the claims, it also appears that there is not a particular transformation, either. It has been held that manipulation or signal processing of data to produce new data is NOT a transformation CyberSource v. Retail Decisions, 654 F.3d 1366, 1372 n.2, 99 USPQ2d 1690, 1695 n.2 (Fed. Cir. 2011) (quoting In re Warmerdam, 33 F.3d 1354, 1355, 1360 (Fed. Cir. 1994)).
Finally claims 1, 7 and 13 are analogous to the case Elec. Power Grp., LLC v. Alstom S.A. (Fed. Cir. 2016) which contains the following analysis: Information as such is an intangible. See Microsoft Corp. v. AT & T Corp., 550 U.S. 437, 451 n.12 (2007). Accordingly, we have treated collecting information, including when limited to particular content (which does not change its character as information), as within the realm of abstract ideas. See, e.g., Internet Patents, 790 F.3d at 1349; OIP Techs., Inc. v. Amazon. com, Inc., 788 F.3d 1359, 1363 (Fed. Cir. 2015). In a similar vein, we have treated analyzing information by steps people go through in their minds, or by mathematical algorithms, without more, as essentially mental processes within the abstract-idea category. See, e.g., TLI Commc’ns, 823 F.3d at 613; Digitech, 758 F.3d at 1351; SmartGene, Inc. v. Advanced Biological Labs., SA, 555 F. App’x 950, 955 (Fed. Cir. 2014); Bancorp Servs., L.L.C. v. Sun Life Assurance Co. of Canada (U.S.), 687 F.3d 1266, 1278 (Fed. Cir. 2012); CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1372 (Fed. Cir. 2011); SiRF Tech., Inc. v. Int’l Trade Comm’n, 601 F.3d 1319, 1333 (Fed. Cir. 2010); see also Mayo, 132 S. Ct. at 1301; Parker v. Flook, 437 U.S. 584, 589–90 (1978); Gottschalk v. Benson, 409 U.S. 63, 67 (1972); Diamond v. Diehr, 450 U.S. 175 (1981). And we have recognized that merely presenting the results of abstract processes of collecting and analyzing information, without more (such as identifying a particular tool for presentation), is abstract as an ancillary part of such collection and analysis. See, e.g., Content Extraction, 776 F.3d at 1347; Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 715 (Fed. Cir. 2014). Here, the claims are clearly focused on the combination of those abstract-idea processes. The advance they purport to make is a process of gathering and analyzing information of a specified content, and not any particular assertedly inventive technology for performing those functions. They are therefore directed to an abstract idea. Applicant should add some sort of active use to the claims, such as applying a SPECIFIC therapy or updating the functioning of the processor based on the determination/comparison.
Additional case law that supports this analysis include Digitech (Organizing and manipulating information through mathematical correlations), and Grams (An algorithm for calculating parameters indicating an abnormal condition).
Therefore, the Examiner must conclude that the independent claims are directed to an abstract idea. Regarding the dependent claims, the recited limitations fall under a mental process using the same rationale as above.
Allowable Subject Matter
Claims 1-18 would be allowable if rewritten or amended to overcome the 101 rejections, set forth in this Office action, without broadening the scope of the claims.
The following is a statement of reasons for the indication of allowable subject matter: in claims 1, 7 and 13, while the general use of XAI in the medical arts in classifying ECG is known (see as examples US 2024/0212857, US 2023/0355119 and US 2022/0346676), specifically generating an explainer model using a trained classifier based on an ECG training dataset, generating, using the explainer model, an explanation comprising a contribution value to each data point present in each lead, obtaining a filtered set of contribution values pertaining to a plurality of data points present in the multi-lead ECG signal based on a comparison of (i) the contribution value of the generated explanation assigned to each data point present in the multi-lead ECG signal, and (ii) a cut-off frequency range, normalizing the filtered set of contribution values pertaining to the multi-lead ECG signal, to obtain a set of normalized contribution values, determining, one or more prominent ECG leads based on a comparison of (i) a mean contribution value computed for each lead present in the multi-lead ECG signal using the set of normalized contribution values and (ii) a threshold contribution value, analyzing a contribution of the one or more prominent ECG leads with respect to a reference lead contributing to a specific disease class amongst the one or more disease classes as classified by the trained classifier, and computing an explanation performance with respect to a ground-truth explanation using the analyzed contribution of the one or more prominent ECG leads, when combined with the rest of the limitations in the claims, has not been taught or suggested by the prior art.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See attached PTO-892, particularly US 2024/0212857, US 2023/0355119 and US 2022/0346676, which all disclose the general use of XAI in the medical arts in classifying ECG.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric D Bertram whose telephone number is (571)272-3446. The examiner can normally be reached Monday-Friday 8am-6pm Central Time.
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/Eric D. Bertram/Primary Examiner, Art Unit 3796
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