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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submissions filed on 9/18/2025 and 10/16/2025 have been entered.
Response to Arguments
The previous 112(a), 112(b) and 101 (human organism) rejections have been withdrawn as a result of the amendments.
Applicant's arguments filed 10/16/2025 have been fully considered but they are not persuasive.
Applicant argues the analysis steps are performed in real-time and simultaneously that cannot be practically performed by a human mind, even aided by pen and paper, to yield a timely and medically relevant result. The examiner respectfully disagrees as humans routinely processed large amounts of data by hand before the advent of computers. As the court has explained, “the fact that the required calculations could be performed more efficiently via a computer does not materially alter the patent eligibility of the claimed subject matter.” Bancorp Servs., L.L.C. v. Sun Life Assur. Co. of Can. (U.S.), 687 F.3d 1266, 1278 (Fed. Cir. 2012). The Applicant argues the specific hardware configuration of the electrode unit, including a first electrode provided at a bottom of the portable electrocardiographic device, a second electrode and a third electrode provided at a top of the portable electrographic device is non-conventional. The examiner respectfully disagrees as 2020/0375568 in Figure 7 and Paragraph [0085] discloses a top electrode (front side) and a second electrode (back side) along with other electrodes on the front or back. Baxi (US Patent 9,204,814) discloses a handheld heart monitor 130 with a top electrode 134, a bottom electrode 138 and a third and fourth electrode 136 and 140 as shown in Figure 1 or the heart monitor as illustrated in Figure 3. Bojovic et al (US Patent 7,647,093), Figure 4 illustrates a mobile ECG device with an electrode at the bottom of the device, a second electrode, and a third electrode on the top.
The Applicant argues the claimed invention constitutes a technological improvement in usability and accessibility to allow ordinary users to perform sophisticated ECG diagnostics that previously required expert interpretation. That the computations performed in real-tie and simultaneously, constitute a technical implementation of quantitative waveform computation and probabilistic decision making and cannot simply be substituted for a mental process and thus are patent eligible. The examiner respectfully disagrees as MPEP 2106.05(a) states it is important to note, the judicial exception alone cannot provide the improvement. Upon evaluation of the claim as a whole the electrode unit being claimed is not a technical improvement and the use of mobile portable electrocardiographic devices is well known routine and conventional. In addition, the use of such a device provides for a pre-solution activity of data gathering and does not rise to an improvement in technology.
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 1-20 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 filtering and analyzing ECG waveforms, detecting R-peaks and fiducial points, computing inter-beat intervals and waveform amplitudes and evaluating probabilistic conditions. This judicial exception is not integrated into a practical application because the electrode unit including a first electrode provided at a bottom of the portable electrocardiographic device, a second electrode and a third electrode provided at a top of the portable electrocardiographic device is a pre-solution activity for data gathering. The processor along with a storage unit is a generic computing structure to implement the abstract idea. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because ethe electrode unit including a first electrode provided at a bottom of the portable electrocardiographic device, a second electrode and a third electrode provided at a top of the portable electrocardiographic device is well-known routine and conventional as Pagoulatos et al (US Publication 2020/0375568) in Figure 7 and Paragraph [0085] discloses a top electrode (front side) and a second electrode (back side) along with other electrodes on the front or back. Baxi (US Patent 9,204,814) discloses a handheld heart monitor 130 with a top electrode 134, a bottom electrode 138 and a third and fourth electrode 136 and 140 as shown in Figure 1 or the heart monitor as illustrated in Figure 3. Bojovic et al (US Patent 7,647,093) in Figure 4 illustrates a mobile ECG device with an electrode at the bottom of the device, a second electrode, and a third electrode on the top. The use of generic computing structures such as control unit/processors and ROM or RAM that make up a storage unit is not sufficient to amount to significantly more than the judicial exception.
The examiner notes that dependent claims 2 and 9 add a display unit which includes a liquid crystal display or LEDS and a setting unit comprising LEDS and buttons (claims 4, 11, 18, and 19) comprising LEDS and buttons are also considered part of a generic computing structure and do not add significantly more than the abstract idea itself. The remaining dependent claims further define the abstract idea and do not integrate the abstract idea into a practical application or recite significantly more.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to William J Levicky whose telephone number is (571)270-3983. The examiner can normally be reached Monday-Thursday 8AM-5PM EST.
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/William J Levicky/Primary Examiner, Art Unit 3796