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 9-28, specifically independent claims 9, 18 & 27 are directed to an abstract idea without significantly more. Please see the below analysis providing the details as to why the invention is directed towards non-statutory subject matter.
Step 1:
Claim 9 is directed to a method, which is a statutory category of invention.
Claim 18 is directed to an apparatus, which is a product, i.e. a statutory category of invention.
Claim 27 is directed to an apparatus, which is a product, i.e. a statutory category of invention.
Step 2A, Prong 1:
Claim 9 recites the method steps of:
“…receiving, at a circuit: at least one analog body-surface signal…and a plurality of analog unipolar signals…”
“…defining, using a processor: an analog bipolar signal and a digital bipolar signal…”
“…and correcting, using the processor, an identified offset between the analog bipolar signal and the digital bipolar signal.”
Claim 18 recites the method steps of:
“…circuitry, which is configured to receive at least at least one analog body-surface signal…and a plurality of analog unipolar signals…”
“…a processor which is configured to define (i) an analog bipolar signal and a digital bipolar signal…and correct an identified offset between the analog bipolar signal and the digital bipolar signal.”
Claim 27 recites the method steps of:
“…a circuit configured to: to receive at least at least one analog body-surface signal…and a plurality of analog unipolar signals…and produce…a plurality of respective digital unipolar signals…”
“…a processor configured to…define an analog bipolar signal…define a digital bipolar signal…estimate a ground offset and a timing offset between the analog bipolar signal and the digital bipolar signal… apply the ground offset and the timing offset in measuring a new signal sensed by one of the plurality of electrodes…”
These limitations, under their broadest interpretation, fall within the mental processes (i.e. receiving, defining, correcting) and mathematical concept (i.e. estimating) groupings of abstract ideas. It would be practical, but for the recitation “using a processor/a processor configured to” to perform the steps in a human’s mind, or with a pen and paper, to utilize the claimed signals.
Step 2A, Prong 2:
The claims as a whole fails to integrate the abstract idea into a practical application. Claims 9, 18 & 27 recites the following additional elements, which for the reasons set forth below, do not integrate the abstract idea into a practical application.
Claim 9
“…a probe having a plurality of unipolar electrodes… which is directed to data gathering, see MPEP 2106.05(g). “…one or more body-surface electrodes…” which is directed to data gathering, see MPEP 2106.05(g).
“…a legacy signal measurement system…” which is directed to mere instructions to apply an exception, see MPEP 2106.05(f).
“…a plurality of analog unipolar electrodes…” which is directed to data gathering, see MPEP 2106.05(g).
“...a processor…” which is directed to mere instructions to apply an exception, see MPEP 2106.05(f).
Claim 18
“…a probe having a plurality of unipolar electrodes… which is directed to data gathering, see MPEP 2106.05(g). “…one or more body-surface electrodes…” which is directed to data gathering, see MPEP 2106.05(g).
“…a legacy signal measurement system…” which is directed to mere instructions to apply an exception, see MPEP 2106.05(f).
“…circuitry, which is configured to receive…” which is directed to data gathering, see MPEP 2106.05(g).
“…one or more body-surface electrodes…” which is directed to data gathering, see MPEP 2106.05(g).
“…a plurality of unipolar electrodes…” which is directed to data gathering, see MPEP 2106.05(g).
“...a processor…” which is directed to mere instructions to apply an exception, see MPEP 2106.05(f).
Claim 27
“…a probe having a plurality of unipolar electrodes… which is directed to data gathering, see MPEP 2106.05(g). “…one or more body-surface electrodes…” which is directed to data gathering, see MPEP 2106.05(g).
“…a legacy signal measurement system…” which is directed to mere instructions to apply an exception, see MPEP 2106.05(f).
“…a circuit, configured to…” which is directed to data gathering, see MPEP 2106.05(g).
“…at least one analog body-surface electrodes…” which is directed to data gathering, see MPEP 2106.05(g).
“…a plurality of analog unipolar electrodes…” which is directed to data gathering, see MPEP 2106.05(g).
“...a processor…” which is directed to mere instructions to apply an exception, see MPEP 2106.05(f).
Therefore, the claims fail to integrate the abstract idea into a practical application. The examiner also notes that the additional elements recited in claims 9, 18 & 27 apply or use the judicial exception to affect a particular treatment or prophylaxis for a disease or medical condition. The claim is silent to providing any treatment at all to a patient.
Step 2B:
The claims as a whole fails to recite an inventive concept. The additional elements, when considered individually and in combination, do not recite significantly more than the abstract idea for the reasons as set forth above in Step 2A, Prong 2. Upon re-evaluating the limitation that was previously identified as insignificant extra-solution activity in Step 2A, Prong 2, the following evidence to show that the limitation is well-understood, routine and conventional:
real-time discrete data obtained from a medical device/data previously collected from a medical device (i.e. body surface/unipolar electrodes) Presenting offers and gathering statistics, OIP Techs., 788 F.3d at 1362-63, 115 USPQ2d at 1092-93; Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network).
producing at said computer processor a human-readable output (i.e. processor) of the analysis of the gathered data, this is also WURC, as evidenced by Electric Power Group, LLC v. Alstom S.A., 830F.3d 1350, 119 USPQ2d 1739 (Fed.Cir. 2016), which discusses “conventional computer, network, and display technology” and states that “nothing in the patent contains any suggestion that the displays needed for that purpose are anything but readily available. We have repeatedly held that such invocations of computers and networks that are not even arguably inventive are “insufficient to pass the test of an inventive concept in the application” of an abstract idea”.” Similarly, there is nothing in Applicant’s specification that indicates that the device that is “producing at said computer processor a human-readable output indicating” the findings of the analysis is anything but readily available.
Therefore, the claims fail to recite significantly more than the abstract idea and claims 9-28 are rejected under 35 U.S.C 101.
Regarding dependent claims 10-17 & 19-26, the limitations of the dependent claims further define steps of identifying, circuity, and processing signals, which further limit claim limitations already indicated above as being directed to an abstract idea. Therefore, claims 10-17 and 19-26 are directed to patient-ineligible subject matter.
Response to Arguments
Applicant's arguments filed January 27, 2026 have been fully considered but they are not persuasive. The applicant argues the following points in which the examiner provides a reason(s) as to why the arguments are not persuasive:
The applicant argues that the recited analog electrical signals, which are continuous ‘physical phenomena,’ i.e. voltage waveforms generated by electrodes, do not recite mental process that would be practical to perform in a human mind or with a pen and paper, as suggested by the Office.
The Applicant’s argument that the recited analog electrical signals constitute physical phenomena and therefore do not fall within the mental process category is not persuasive. While the signals themselves may represent physical phenomena, the analysis under Step 2A, Prong 1 focuses on the claimed steps performed on the data, not the nature of the input.
The claims recite operations such as receiving, defining, estimating and correcting signals, which constitutes data evaluation and processing steps that fall within the mental process and mathematical concepts groupings of abstract ideas. The mere recitation of physical signals as inputs does not remove the claim from the abstract idea category where the focus of the claim remains on processing and analyzing information.
The applicant argues that the claims, i.e. the current claim amendments, do not recite a judicial except, but rather recite a specific practical application that addresses specific technical problems, i.e. the present claims are argued to ‘overcome’ the lack of common ground and lack of signal synchronization, enabling ‘accurate measurement of multiple unipolar ECG signals using a legacy system,” and therefore the claims are directed to patient-eligible subject matter.
The Applicant’s assertion that the claims address specific technical problems, i.e. lack of common ground and signal synchronization, is not persuasive. Although the Applicant describes an improvement in the specification, the claims do not recite a specific technological solution or improvement to the functioning of the system itself.
Instead, the claims broadly recite defining signals, estimating offsets and correcting signals using a processor, which reflects the application of mathematical relationships and data analysis techniques rather than a specific improvement in signal acquisition or hardware operation. An improvement to data accuracy or result quality, without corresponding improvement to the underlying technology, does not constitute a technological improvement under Step 2A, Prong 2.
The applicant also argues that the claim amendments, which recite connecting “a probe having a plurality of unipolar electrodes to a legacy signal measurement system via an ADC module, and grounding one of the plurality of unipolar electrodes to a ground of the ADC module,” are actions that cannot be performed in the human mind and the claims as a whole define ‘practical applications’ addressing specific technical problems and yield significant technical advancement.
The Applicant’s argument that the claimed steps of connecting a probe, utilizing an ADC module and grounding electrodes cannot be performed in the human mind is not persuasive. While these elements involve physical components, they are recited at a high level of generality and perform routine data acquisition functions, e.g. signal detection and conversion, which are considered insignificant extra-solution activity (see MPEP 2106.05(g)).
These additional elements merely provide a mechanism for obtaining and inputting data to be processed by the abstract idea and do not impose a meaningful limitation on the judicial exception. The claims as a whole remains directed to the abstract processing of signals and the recited hardware does not reflect a specific improvement to the functioning of the method, device and system.
In conclusion, the claims remain directed to a judicial exception and fail to integrate the exception into a practical application. Therefore, the rejection under 35 U.S.C. §101 is maintained.
*The examiner notes that the pending claim 9-28 are not rejected under any prior art rejections, i.e. 35 U.S.C §102 and/or §103. However, the claims are not deemed allowable subject matter due to the outstanding rejection, i.e. 35 U.S.C. §101 judicial exception without significantly more. Please see the above action.
Conclusion
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 NICOLE F JOHNSON whose telephone number is (571)270-5040. The examiner can normally be reached Monday-Friday 8:00am-5:00pm EST.
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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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/NICOLE F JOHNSON/Primary Examiner, Art Unit 3796
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