DETAILED ACTION
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 4, 6, 9, 12, 13, 15, 17, 20, 21, 23 and 26-34 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claims 1, 4 and 13, the examiner cannot find support –nor has the applicant indicated where the support can be found – for the recited feature of causing the output device to transmit a second signal to an external device in response to determining the likelihood –the likelihood determined from analyzing both the artifact score and the second data indicative of the ECG. The disclosure appears to only recite transmitting artifact and ECG context scores to a remote destination, with no discussion of transmitting a second signal in response to the determination of the likelihood itself.
Regarding new claims 31, 32 and 34, the examiner cannot find support for --nor has the applicant provided any reference with respect to the present disclosure to indicate support for-- the newly amended material regarding the transmission of a treatment determination through a transmitter to an external device, where the treatment determination is based on the analyzed likelihood. At best, the specification merely suggests that data concerning the therapy attempted can be communicated with other machines (par. 0038). A treatment determination, for example, may include a decision not to treat the patient, and thus includes situations where therapy is not attempted. A treatment determination may also include situations where treatment is recommended but prior to any actual treatment attempt. The examiner thus does not consider the term “treatment determination” to equate to “therapy attempted.” Related comments apply to claims 21 and 23 with regards to the newly added limitations of transmitting treatment determinations as a second signal to the external device.
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, 2, 4-7, 9, 12-15, 17, 20, 21 and 23-34 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 task of receiving first data indicative of the ECG during a first time; determining that the first data is indicative of a physiological condition of the patient; identifying an artifact in the first data; generating an artifact score as a function of a magnitude of the artifact in the first data; in response to determining that the first data is indicative of the physiological condition, receiving second data indicative of the ECG during a second time; determining that the second data is indicative of the physiological condition; and determining, by analyzing the artifact score and the second data, a likelihood that the first shape in the first data accurately indicates the physiological condition. The above actions can be performed by a cardiologist and require observation, analysis, judgement and opinion.
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), because execution of the abstract idea in no way affects the performance of the system or individual components therein; there is no application or use of a judicial exception to effect a particular treatment or prophylaxis for disease or medical condition, but only diagnosis – 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 structure; 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 monitoring, 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.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the detection electrodes configured to contact the skin of a patient, the measurement circuit, the output device comprising a transmitter and the processor function in their usual capacity of gathering data, processing data and outputting data. Gathering and analyzing information using conventional techniques and displaying/transmitting the result to an external device, have been considered insufficient by the courts to establish eligibility (MPEP 2106.05(a); TLI Communications, 823 F.3d at 612-13, 118 USPQ2d at 1747-48). The combination of generic detection electrodes and a generic measurement circuit represents insignificant data gathering necessary in order to perform the abstract idea. All applications of the abstract idea would require such input. The output device which transmits a second signal comprising the likelihood to an external device (note the comments above regarding the rejection under §112), represents insignificant post-solution activity, as it provides an indication of the likelihood determined by the performance of the abstract idea, such that a user can be apprised of the result. There are no limitations regarding the external device. A broadest reasonable interpretation of “an external device” would include simple displays such as a mobile phone/smartwatch carried by a paramedic (it is noted that the output device for transmitting may employ infrared communications (par. 0037) which is well-known to be short-range or line-of-sight), and/or to a device for storing the data. The generic output device with transmitter imposes no meaningful limits on the claim as the mere presentation of data in human perceivable form, such as to the aforementioned display or storage device, is tangential to the invention. The generic processor functions solely as an obvious mechanism for permitting a solution to be achieved more quickly. It is simply a tool upon which the abstract idea is performed. Further, regarding the newly amended material concerning the receipt of first data from a measurement circuit, as stated above, the examiner considers such an action to be mentally performable as a human can receive information from a measurement device, as distinguished from doing the measuring itself. Even if such an action were to be considered an additional element, the receipt of information from a measuring device represents insignificant extra-solution activity in the form of necessary data gathering. All recited uses of the judicial exception would require such data gathering.
The additional elements are further WURC in the art. All cardiac monitoring systems require detection electrodes, a measurement circuit to input data, a processor to process and analyze the data, and an output to transmit the results of any performed analysis. The measurement circuit may take the form of a standard 12-lead ECG (par. 0028) connected to a non-descript measurement circuit 320 (Fig. 3). The processor is generic, and as stated in par. 0030, may be implemented in any number of ways. The output device with transmitter is generic and may take any suitable form including generic components to allow for wireless, wired or infrared communication and so on (par. 0037). Transmission of signals to external devices via transmitters is also WURC in the medical art.
Regarding claim 4, note the comments already made above concerning related limitations in claim 1.
Regarding claim 6, the provision of a screen is insignificant post-solution activity as it represents necessary data outputting and is WURC in the art (e.g., a computer display screen). The likelihood determination via the generic processor does not affect the output of ECG information (i.e., the claim does not restrict the output dependent only on the likelihood that the first data accurately indicates the physiological condition, but merely that an output occurs in response to determining the likelihood –regardless of whether or not the likelihood indicates the physiological condition). The visual output of the ECG in response to determining the likelihood further does not reflect any alleged improvement in technology. Related comments apply to claim 15.
Claims 9, 12, 17, 20, 26, 27, 29, 30 and 34 contain no new additional elements beyond those already discussed above and/or can be performed entirely within the mind. It is noted that claims 29 and 30 relate to a generic external device –a non-element of the invention outside of the claimed medical device or apparatus. It is additionally noted that new claim 34 merely indicates a treatment to be administered at an external location, which can be done within the mind (e.g., verbal indication). It does not involve the use of a transmitter, nor require treatment to be administered. See also the rejection of this claim under §112(a) above.
Regarding method claim 13, note the comments above pertaining to related limitations.
The output of a second signal indicating the treatment determination in claims 21 and 23 fails to add any meaningful limitation to the invention as it is only nominally related to the invention and thus fails to provide any practical application. Note also the comments above related to the output to an external device of the second signal indicating treatment determination.
Regarding claim 28, the storage of data such as the artifact score is considered insignificant extra-solution activity that would be required in any implementation of the abstract idea in order to allow analysis that the first data likely accurately indicates the physiological condition.
Regarding claim 31, note the rejection under §112(a) above. The transmission of a treatment determination is considered insignificant data outputting as it merely indicates the result of the analysis performed by the abstract idea. Furthermore, a treatment determination is not a positive affirmation of therapy.
Response to Arguments
Applicant's arguments filed January 29, 2026 have been fully considered but they are not persuasive.
In light of the amendment, the objection to the specification and the previous rejection under §112(a) have been removed.
Regarding the rejection under §101, the applicant asserts under Step 2A, Prong One, that the invention is directed to devices that may be utilized by individuals that lack training and concludes that the various steps in claim 1 such as “determining by analyzing the artifact score and the second data, a likelihood that the first data accurately indicates the physiological condition,” are not directed to observations or judgements that can be performed in the human mind, and therefore, are not mental processes.
The applicant, however, provides no evidence as to why a human mind would not be able to analyze data and determine a likelihood that a physiological condition is present. The claims do not limit the level of skill of any individual. The applicant states that the defibrillator-monitor is intended to be used by medical professionals (par. 0021). It would be reasonable to assume that a cardiologist or paramedic who routinely makes judgements concerning patient condition based on observations of cardiac data, would be able to analyze the artifact score and the second data to form a diagnosis. The applicant, in fact, states that such decisions are capable of being determined by ED physicians or consulting cardiologists (see par. 0048). The level of skill an individual has would be highly subjective and the claims do not require any specific level of accuracy, nor does the §101 statute put restrictions on the educational background and/or training of individuals practicing the abstract idea.
The applicant then asserts under Step 2A, Prong Two, that claim 1 is directed to a practical application due to the presence of additional elements such as “detection electrodes,” “a measurement circuit,” and “an output device comprising a transmitter,” as well as the “receiving” and “outputting” steps. It is stated that these elements provide a practical application for improving proper diagnosis and reducing wasteful expenditures of time and resources involving STEMI patients. It is argued that the step of outputting a signal to an external device is therefore not insignificant.
The examiner is unconvinced by this argument because, as stated above, the detection electrodes, ECG measurement circuit, processor and the associated ECG receiving steps would all necessarily be required to gather the data needed to perform and execute the abstract idea. Their presence represents insignificant extra-solution activity.
With regards to the output device with transmitter and the step of transmitting a second signal to an external device, the second signal comprising the likelihood (note the comments made above in the rejection under §112), an output device with a transmitter would be necessary in order to convey the results determined by the abstract idea to a human user and provide visual or audio feedback. The applicant states in par. 0038 that the defibrillator can optionally include other components, such as a communications module for communicating with other machines (i.e., an output device with a transmitter for transmitting to external devices). A component that is optional would suggest that it is not necessarily instrumental in providing the asserted practical advantage. Further, even if there is an improvement in technology, as stated in MPEP 2106.04(d)(1):
…if the specification sets forth an improvement in technology, the claim must be evaluated to ensure that the claim itself reflects the disclosed improvement. That is, the claim includes the components or steps of the invention that provide the improvement described in the specification.
The present invention fails to reflect any asserted improvement. Nothing in the claims reflects the desired result of preventing cath lab activation based on false diagnosis. The “external device” is not an element of the invention and is a generic term that could simply relate to external storage for record keeping and/or to an on-site paramedic’s mobile phone for display –neither of which would be sufficient to prevent false cath lab activations.
The applicant then turns to Ex Parte Desjardins and asserts that improvements to computer technology may reside in not only hardware improvements, but software improvements.
This is not found to be convincing, however, because in Desjardins the functionality of the computer itself was improved by the abstract idea. The software associated with the abstract idea resulted in a reduction in “catastrophic forgetting” by improving machine learning, thus allowing for reduced storage, reduced system complexity and streamlining. Here, unlike in Desjardins, the computer/processor merely acts as a tool to contain and run the abstract idea. The processor functions in its usual capacity unaffected by the performance of the abstract idea.
Under Step 2B the applicant argues again that the alleged improvement is integrated into the additional elements –specifically by providing a processor that causes an output device to transmit a second signal comprising the likelihood to an external device. Desjardins, CardioNet and Bascom are relied upon as analogous to the current situation.
Again, as stated above, Desjardins was considered eligible because execution of the abstract idea improved the functionality of the computer itself, unlike in the present invention where computer functionality is not affected –the processor performs in its usual capacity to run the algorithm.
Referring to CardioNet, 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 transmitting the result, where the improvement lies entirely within the performance of the abstract idea, as in the present case.
Turning to Bascom, eligibility under §101 hinged on an ordered combination of additional conventional elements that improved the computer system itself, by allowing versatile filtering that could be adapted to many different users’ preferences, thus making filters less susceptible to hacking and reducing dependency on local hardware and software, or reliance on one-size-fits-all filtering schemes. The claims of the ‘606 patent in question included the use of a conventional remote ISP server in combination with a conventional local client computer which allowed for the generation of network access requests for individual controlled access network accounts, thus enabling versatile filtering and reflecting the improvement. The present invention, however, simply lists conventional additional elements in conventional arrangements to do generic tasks such as receiving ECG information, processing the information, and outputting/transmitting the determined information to a non-descript external device. The claims do not reflect the alleged improvement.
Lacking any practical application and integration of the additional elements into the abstract idea, or any unconventionality in the individual elements and/or their combination, the rejection under §101 is repeated.
Conclusion
Re the informal request for an interview if any issues remain that would prevent allowance, the examiner notes that two interviews have already been granted focusing on the same issue (see the interviews dated September 4, 2024 and January 23, 2026). Given the nature of the issues present and the prosecutorial history, the examiner is unconvinced that additional interviews would be beneficial at this time.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 2nd Monday of the biweek and W-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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 3792
KJS
May 11, 2026
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