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 § 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.
Claim 24 is 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.
Claim 24 is confusing because it states that the far field measurements are acquired from a multiple electrode catheter or a body surface ECG signal, while base claim 21 now has been amended to state that the far field measurements are based on a body surface ECG signal alone.
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 15, 17, 19-21 and 23-25 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) the mentally performable steps of (or equivalent processor configured to cause) encoding input intracardiac signals utilizing an intracardiac data set to produce a latent representation; decoding, in real-time, to produce output intracardiac signals that do not include signal artifacts, wherein the decoding comprises decomposing a near field component and a far field component from the intracardiac signals; and detecting a residual near field signal that indicates local activity of the heart. These steps/elements relate to mathematical operations and algorithms, and involve observation, analysis, judgement and opinion.
The newly added reference to decoding the latent representation in real-time fails to remove the task from that which is mentally performable. There are no limitations on the number of intracardiac signals processed, and no limitations on any specific speed of processing. The encoding and decoding of a single intracardiac signal, for example, could be performed in “real-time” during a cardiac procedure, where “real-time” includes the time necessary for a cardiologist to process the data. The applicant discloses that the signals may be in real-time and/or recorded and processed, or recorded and transmitted (par. 0022). Claiming improved speed or efficiency (i.e., the ability to perform the existing process in real-time) of the system inherent with applying the abstract idea on a computer does not integrate the judicial exception into a practical application (MPEP 2106.05(f)(2)).
Regarding the newly added limitation pertaining to the generation and display of an ECG based at the residual near field signal, the examiner considers generation to be mentally performable, or with pen and paper, in that the applicant discloses that a processor performs the task using software (pars. 0037, 0143, 0157). The act of displaying the result, while considered an additional element outside of that which is mentally performable, is considered insignificant data outputting as discussed in detail below.
This judicial exception is not integrated into a practical application because there are no improvements to the functioning of a computer, or to any other technology or technical field, as discussed in MPEP 2106.05(a), as the memory, processor, electrode catheter and implied display, function in their usual capacity; there is no application or use of a judicial exception to effect a particular treatment or prophylaxis for disease or medical condition – see Vanda Memo; there is no application of the judicial exception with, or by use of, a particular machine, as discussed in MPEP 2106.05(b), but only generic components arranged in a conventional combination; there is no transformation or reduction of a particular article to a different state or thing, as discussed in MPEP 2106.05(c), but only data manipulation; and there is no application or use of the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to the particular technological environment of cardiac electrical signal processing using machine/deep learning, such that the claim as a whole is more than a drafting effort designed to monopolize the exception, as discussed in MPEP 2106.05(e) and the Vanda Memo issued in June 2018.
As already noted above, the use of a generic computer to provide the alleged improvements in speed, efficiency and accuracy --inherent with the application of the abstract idea on a computer—are insufficient to show a technological improvement in the context of §101. The computer of the present invention merely acts as a tool upon which the abstract idea is performed. Any claimed improvements lie entirely within the abstract idea itself and not in any additional element beyond the judicial exception.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional steps of receiving intracardiac signals and acquiring far field ventricle measurements based on a body surface ECG, would be required in every implementation of the abstract idea and is thus considered insignificant data gathering. They merely provide the data necessary to perform the abstract idea. Additionally, the step of acquiring far field ventricle measurements is also considered insignificant data gathering activity to provide the necessary data for performance of the abstract idea (it is noted that the phrase “based on” does not require an additional element of body surface electrodes, but merely the data produced from such an arrangement). The display of an ECG (note the comments above regarding the interpretation of this limitation) based at least on a residual near field signal represents insignificant data outputting that would be required in every implementation of the method in order to convey the results of the method in a human-perceivable form. The memory and processor of apparatus claim 21 simply serve as a tool upon which the abstract idea is executed. These conventional elements are generic in nature and would be a necessary combination in any computerized system, as all computerized systems require data input, data processing, and data output (i.e., display) indicating the results of the processing.
The additional elements, alone and in combination, are also WURC in the art of cardiac signal processing. The applicant discloses that the autoencoder may be a processor executable code or software rooted in process operations by, and in processing hardware of, medical device equipment (par. 0021). It merely denotes instructions to be carried out and represents the abstract idea itself. The processor may be any computing device including software and/or hardware such as a general-purpose computer, with the memory being any suitable volatile and/or non-volatile memory (pars. 0051, 0054). The electrode catheter is disclosed as being of the type typically used in medical practice and being of any applicable shape that includes one or more electrodes (pars. 0028, 0042 and 0060). It is further disclosed that the signals may be obtained using catheters or other sensors of various configurations and types (pars. 0057-0060). The generation of ECG signals may be performed and displayed (it is noted that apparatus claim 21 does not even positively recite a display) using a commercially available CARTO 3 3D mapping system (par. 0037). The combination of a generic processor, memory, electrode catheter/body surface ECG and generic display is also WURC in the cardiac monitoring arts given that these elements are the basic and requisite building blocks of any computerized cardiac monitoring system and are in widespread use such as the commercially available CARTO system which comprises a processor, memory, both intracardiac electrode catheters and body surface electrodes (note also the discussion of claim 24 above and the disclosure which indicates that body surface electrodes are optional and thus not critical, in addition to the “based on” interpretation above), as well as a display.
Claims 17, 20, 23 and 25 contain no new additional elements.
Regarding claims 19 and 24, the use of a multiple electrode catheter or a body surface ECG signal is considered insignificant extra-solution activity. The collection of data is necessary for the performance of the abstract idea. Multiple electrode catheters or body surface ECGs are merely the means used to obtain the necessary data and function in their usual capacity. Both are WURC in the ECG art as they are the standard means of obtaining the heart’s electrical signal.
Response to Arguments
Applicant's arguments filed November 7, 2025 have been fully considered but they are not persuasive.
In addressing the §101 rejection, the applicant argues that the present claims are similar to those found eligible in the CardioNet, LLC v. InfoBionic, Inc., decision.
While the present claims and those of Cardionet may be similar in that they both relate to cardiac monitoring, in Cardionet the patent involved monitoring of atrial fibrillation and flutter. It was recognized that the occurrence of ventricular beats is generally unrelated to atrial fibrillation and atrial flutter, whereas it is known to be indicative of ventricular tachycardia. The written description disclosed various technological improvements in the detection of atrial fibrillation and atrial flutter as a result of identifying variability in the beat-to-beat timing of identified ventricular beats, including increased accuracy of atrial fibrillation/flutter detection and the reduction of false positives. Thus, the presence of the additional element of a ventricular beat detector (an element that traditionally is negatively indicative of atrial fibrillation) in combination with the act of identifying a relevance of the variability in the beat-to-beat timing of detected ventricular beats to atrial fibrillation and/or atrial flutter, effectively integrated the abstract idea into a practical application. It was not merely collecting electronic information from a standard arrangement, applying the abstract idea using the information, and displaying the result, where the improvement lies entirely within the performance of the abstract idea, as in the present case. It is noted that the court effectively relied upon what is now Prong Two of Step 2A of the revised guidelines by determining that the claims integrated the additional elements into an improvement. Application of this prong is only done after the analysis under Prong One is concluded (i.e., only after the finding that the claim does indeed recite an abstract idea –which in this case involved mentally performable actions).
The applicant further argues that the Office is improperly generalizing the present claims by failing to account for the specific requirements by applying the “any doctor” argument rejected by the Court. It is concluded that the present invention improves on existing technology.
In CardioNet, however, the Court found that claim 1 was not drawn to an abstract idea because the additional element of the ventricular beat detector integrated the abstract idea (those steps which were mentally performable) into a practical application as discussed above. InfoBionic’s argument that the claims were drawn to automating basic diagnostic processes that doctors have long used was rejected because the written description of the ‘207 patent did not disclose that doctors performed the same techniques using the ventricular beat detector in a device for detecting atrial fibrillation or flutter. The search for an inventive concept, however, should not be confused with a novelty or non-obviousness determination. A new abstract idea is still an abstract idea. MPEP 2106.05, I.:
Although the courts often evaluate considerations such as the conventionality of an additional element in the eligibility analysis, the search for an inventive concept should not be confused with a novelty or non-obviousness determination. See Mayo, 566 U.S. at 91, 101 USPQ2d at 1973 (rejecting "the Government’s invitation to substitute §§ 102, 103, and 112 inquiries for the better established inquiry under § 101 "). As made clear by the courts, the "‘novelty’ of any element or steps in a process, or even of the process itself, is of no relevance in determining whether the subject matter of a claim falls within the § 101 categories of possibly patentable subject matter." Intellectual Ventures I v. Symantec Corp., 838 F.3d 1307, 1315, 120 USPQ2d 1353, 1358 (Fed. Cir. 2016) (quoting Diamond v. Diehr, 450 U.S. at 188–89, 209 USPQ at 9). See also Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1151, 120 USPQ2d 1473, 1483 (Fed. Cir. 2016) ("a claim for a new abstract idea is still an abstract idea. The search for a § 101 inventive concept is thus distinct from demonstrating § 102 novelty."). Although the courts often evaluate considerations such as the conventionality of an additional element in the eligibility analysis, the search for an inventive concept should not be confused with a novelty or non-obviousness determination. See Mayo, 566 U.S. at 91, 101 USPQ2d at 1973 (rejecting "the Government’s invitation to substitute §§ 102, 103, and 112 inquiries for the better established inquiry under § 101 "). As made clear by the courts, the "‘novelty’ of any element or steps in a process, or even of the process itself, is of no relevance in determining whether the subject matter of a claim falls within the § 101 categories of possibly patentable subject matter." Intellectual Ventures I v. Symantec Corp., 838 F.3d 1307, 1315, 120 USPQ2d 1353, 1358 (Fed. Cir. 2016) (quoting Diamond v. Diehr, 450 U.S. at 188–89, 209 USPQ at 9). See also Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1151, 120 USPQ2d 1473, 1483 (Fed. Cir. 2016) ("a claim for a new abstract idea is still an abstract idea. The search for a § 101 inventive concept is thus distinct from demonstrating § 102 novelty.")…
Thus, while claim 1 clearly had mentally performable features (e.g., determining variability in beat-to-beat timing of a collection of beats which involves simple measurement of the time interval between R peaks contained in the data, and thus contained an abstract idea), the analysis proceeded to determine whether the mentally performable features were integrated into a practical application (i.e., the equivalent of Step 2A, Prong Two). As already argued above, any improvements in technology must be reflected in the additional elements (such as the ventricular beat detector of CardioNet) and cannot solely reside within the abstract idea. MPEP 2106.05, I.:
An inventive concept "cannot be furnished by the unpatentable law of nature (or natural phenomenon or abstract idea) itself." Genetic Techs. Ltd. v. Merial LLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016). See also Alice Corp., 573 U.S. at 21-18, 110 USPQ2d at 1981 (citing Mayo, 566 U.S. at 78, 101 USPQ2d at 1968 (after determining that a claim is directed to a judicial exception, "we then ask, ‘[w]hat else is there in the claims before us?") (emphasis added)); RecogniCorp, LLC v. Nintendo Co., 855 F.3d 1322, 1327, 122 USPQ2d 1377 (Fed. Cir. 2017) ("Adding one abstract idea (math) to another abstract idea (encoding and decoding) does not render the claim non-abstract"). Instead, an "inventive concept" is furnished by an element or combination of elements that is recited in the claim in addition to (beyond) the judicial exception, and is sufficient to ensure that the claim as a whole amounts to significantly more than the judicial exception itself. Alice Corp., 573 U.S. at 27-18, 110 USPQ2d at 1981 (citing Mayo, 566 U.S. at 72-73, 101 USPQ2d at 1966).
As stated above, CardioNet explicitly discloses why the presence of a ventricular beat detector in a device for detecting atrial fibrillation and/or atrial flutter is critical to integrating the abstract idea into a practical application. In the present application, however, the applicant has not provided any evidence to show that using a standard catheter to collect cardiac signals and/or information gleaned from a standard body surface ECG provides any integration of the abstract idea to a practical application. The applicant in fact discloses that one may routinely obtain far field signals by using either an intracardiac catheter, a body surface ECG, or a combination (pars. 00126, 00140, 00145). The particular arrangement is not critical. The electrode catheter (which is not even positively recited in apparatus claim 21) is disclosed as being of the type typically used in medical practice and being of any applicable shape that includes one or more electrodes (pars. 0028, 0042 and 0060). It is further disclosed that the signals may be obtained using catheters or other sensors of various configurations, combinations and types (pars. 0057-0060). The generation of ECG signals may be performed using a commercially available CARTO 3 3D mapping system (par. 0037). The step of receiving input cardiac signals of the heart gleaned from conventional cardiac sensors in non-critical and conventional combinations, is therefore not analogous to the ventricular beat detector of CardioNet as suggested by the applicant, as any sensor arrangement capable of obtaining the cardiac data necessary to perform the abstract idea would suffice in the present invention.
Applicant’s new reliance upon the Thales decision is similarly flawed for the same reasons already discussed above. Unlike the Thales invention which used sensors in a non-conventional manner deemed integral to the improvement. The current invention uses conventional arrangements (note the comments above indicating the non-criticality of the source(s) of data as well as the comments concerning claim 24) to simply provide the data required to perform the abstract idea. The improved usage of sensor data alleged by the applicant resides within the performance of the abstract idea (i.e., how the abstract idea uses the data and not the source(s) of the data or arrangement of sensors as in Thales).
The applicant then refers to the non-precedential and non-binding case of Ex Parte Fautz (it is noted that the applicant erroneously refers to the “clear precedent [emphasis added] established in Fautz,” page 16 of the Remarks). The examiner is unpersuaded. In this case, the actual physical properties of the reception coils (an additional element) were used in the analysis to improve the display and were accounted for in the analysis itself. As stated by the applicant on page 15 of the Remarks, first full paragraph:
“[t]he mathematical calculations recited in the independent claims are "a consequence of the arrangement of" the device's coils and how they receive signals during the scan and "the reception coil's physical properties- -i.e., the reception-sensitivity profiles --are used in the analysis" that "results in an improved reconstructed image." (Ex Parte Fautz, Pg. 11).”
In the present case, the data is collected through standard sources using conventional, commercially available equipment, where details about the source(s) of the data is not critical (other than as a tool to provide the requisite data), as various known arrangements and combinations are cited as capable of providing the data necessary to perform the abstract idea. Most importantly, the algorithm of the present invention is not affected by the particular sensor used or any peculiarity of its construction; it merely obtains the required data without regard to the physical properties of the sensor(s). There are no concrete technical problems solved by any additional elements of the invention. The applicant, in fact, admits on page 17 of the Remarks that it is the autoencoder (i.e., the software instructions embodying the abstract idea) that “…enable generation of improved ECGs to physicians.” And unlike in Fautz where the RF coils were positively recited additional elements, apparatus claim 21 doesn’t even positively recite the electrode catheter, the body surface electrodes or the display. The generic memory and the generic processor are the only elements that are positively recited. Even if positive recitation were made, any improvements in the mapping procedure clearly lie entirely within the abstract idea itself. One would be hard-pressed to find an inventor that did not consider their invention to represent an improvement in the field, but for the purposes of §101 eligibility, the alleged improvement must be integrated into the additional elements. As already quoted above, the MPEP specifically states that the search for the inventive concept must be furnished by an additional element or elements that lie beyond the abstract idea.
Next, the applicant argues that the present invention improves the operation of the cardiac sensor to produce an improved ECG.
The examiner is unconvinced by this argument. The operation of the cardiac sensor itself is not improved. It functions in its usual manner unaffected by the performance of the abstract idea. It is only through the abstract idea that the alleged improvement in ECG display occurs.
The examiner is also unpersuaded by the various decisions the applicant references in Section IV on page 19 of the Remarks. In the Trading Technologies International decision, the district court explained that the challenged patents do not simply claim displaying information on a graphical user interface. The claims require a specific, structured graphical user interface paired with a prescribed functionality directly related to the graphical user interface's structure that is addressed to and resolves a specifically identified problem in the prior state of the art. More specifically, the claim in question included a limitation where a single action of a user input device set a plurality of parameters for a trade order relating to the commodity and subsequently electronically sent the trade order to the electronic exchange (an additional element representing integration of the improvement), thus solving the problem of traders placing orders that miss a particular price due to rapid market movement. The court found that these patents are directed to improvements in existing graphical user interface devices that have no “pre-electronic trading analog,” and recite more than setting, displaying, and selecting data or information that is visible on a graphical user interface device. The present invention to the contrary contains no like feature and merely generates visible data for display on an interface, based on execution of the abstract idea.
Finally, and contrary to the applicant’s summation, the present invention does not represent an improvement in technology in the context of §101 eligibility as already elaborated above in detail. It is respectfully asserted that the applicant’s reliance upon the numerous court decisions cited throughout the course of prosecution is flawed as the fact patterns of those cases do not match that of the current invention.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KENNEDY SCHAETZLE whose telephone number is (571)272-4954. The examiner can normally be reached on the 2nd Monday of the biweek and W-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David E. Hamaoui can be reached on 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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/KENNEDY SCHAETZLE/Primary Examiner, Art Unit 3796
KJS
February 18, 2026