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 July 5th, 2024 and November 18th, 2025 is being considered by the examiner.
Priority
The current application claims benefit of provisional application 63/272,902, filed on October 28th, 2021. Examiner acknowledges the applicant’s claim for priority.
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.
Claims 2 and 16 are 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.
The term “near” in claims 2 and 16is a relative term which renders the claim indefinite. The term “near” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The limitation of “near real-time” is rendered in definite by the use of the relative term “near” in claims 2 and 16.
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 a judicial exception without significantly more.
Step 1
The claims recite subject matter within a statutory category as a process, machine, and/or article of manufacture. However, it will be shown in the following steps, that claims 1-20 are nonetheless unpatentable under 35 U.S.C. 101.
Step 2A Prong One
Claim 1 states:
A system for pediatric heartbeat monitoring, comprising:
at least one electrode configured to be applied to a pediatric subject;
at least one processor coupled to the at least one electrode, the at least one processor configured for:
receiving, from the at least one electrode, an input electrocardiogram (ECG) signal;
determining a signal quality index (SQI) associated with input ECG signal;
applying a bandpass filter to the input ECG signal to generate a filtered ECG signal;
determining a derivative of the filtered ECG signal to generate a derived ECG signal;
applying a squaring function to the derived ECG signal to generate a squared ECG signal;
applying an integrator to the derived ECG signal to generate an integrated ECG signal; and
applying one or more decision rules to the integrated ECG signal to output one or more heartbeat parameters associated with the subject.
The broadest reasonable interpretation of these steps includes mathematical concepts and/or mental processes because each bolded component can practically be performed by the human mind or with pen and paper. Other than reciting generic computer terms like an electrode and processor, nothing in the claims precludes the bold-font portions from practically being performed in the mind. For example, bolded limitations above are nothing more than a medical professional observing ECG data/chart to determine ECG signal quality and performing mathematical calculations (applying derivative, squaring function, and integrator) to perform a diagnostic decision. It is further noted that outputting heartbeat parameter is an intended use limitation and not a step being performed. 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” or “Mathematical Concepts” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
These steps of:
“A system for pediatric heartbeat monitoring, comprising:
applying a bandpass filter to the input ECG signal to generate a filtered ECG signal;
determining a derivative of the filtered ECG signal to generate a derived ECG signal;
applying a squaring function to the derived ECG signal to generate a squared ECG signal;
applying an integrator to the derived ECG signal to generate an integrated ECG signal;”
as drafted, under the broadest reasonable interpretation, includes multiple abstract ideas that will be identified as a single abstract idea moving forward.
Independent claim 15 cover similar steps of determining a signal quality index, applying a bandpass filter, determining a derivative of the filtered ECG signal, applying a squaring function to the derived ECG signal, applying an integrator to the derived ECG signal, and applying one or more decision rules to the integrated ECG signal. These claims fall under the same category of an abstract idea and follows the same rationale as claim 1.
Dependent claims recite additional subject matter which further narrows or defines the abstract idea embodied in the claims. Dependent claims 2, 3, 10, 11, 16, and 17 add additional elements to their parent claims which will be further inspected in the following steps for a practical application to their abstract idea.
Step 2A Prong Two
This judicial exception of “Mental Processes” or “Mathematical Concepts” is not integrated into a practical application. Independent claim 1 and 15’s system and method recites additional elements such as electrodes and a processor. The processor will be treated as a generic computer component. The electrode will be further inspected as an additional element for conventionality. In particular, these additional elements do not integrate the abstract idea into a practical application because the additional elements:
amount to mere instructions to apply an exception (such as recitation of “at least one processor coupled to the at least one electrode, the at least one processor configured for” amounts to invoking computers as a tool to perform the abstract idea, see applicant’s specification [0085], see MPEP 2106.05(f))
add insignificant extra-solution activity to the abstract idea (such as recitation of “at least one electrode configured to be applied to a pediatric subject” amounts to mere data gathering, see MPEP 2106.05(g))
Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims. For instance, dependent claims 3 and 11 add additional elements of a hardware circuit filter and an external device to their parent claims. The external device will be treated as generic computer components and the filter will be further analyzed for conventionality as an additional element. Additionally, claim 3 “further comprising a hardware circuit filter coupled between the at least one electrode and the at least one processor”, amount to invoking computers as a tool to perform the abstract idea, claim 3 “wherein the hardware circuit filter receives an ECG signal from the at least one electrode and generates a pre-filtered ECG signal, and the input ECG signal comprises the pre-filtered ECG signal.” add insignificant extra-solution activity to the abstract idea which amounts to mere data gathering, and claim 2 and 16 “wherein the at least one processor is configured to output the one or more heartbeat parameters in real-time, or near real-time” and claim 11 “transmit the one or more encoded output parameters to an external device”, amounts to necessary data outputting, and claim 10 “Wherein the at least one processor is further configured to apply thresholding to the integrated ECG signal and to further convert the signal into a one-bit signal” amounts to insignificant application, see MPEP 2106.05(g). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application.
The remaining dependent claims 4-9, 12-14 and 18-20 do not recite additional elements or activity but further narrow or define the abstract idea embodied in the claims and hence also do not integrate the aforementioned abstract idea into a practical application.
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception, add insignificant extra-solution activity to the abstract idea, and generally link the abstract idea to a particular technological environment or field of use. Additionally, the additional limitations, amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As previously noted, the claim recites an additional element of an electrode. Korzingov et al. (WO0310520) demonstrates that electrodes were conventional long before the priority data of the claimed invention [Figure 3] “an embodiment of an event recorder 22 comprising a differential input amplifier 46, connected to conventional cardiac electrodes 24”. As such, this additional element, individually and in combination with the prior additional element, does not amount to significantly more.
Dependent claims recite additional subject matter which, as discussed above with respect to integration of the abstract idea into a practical application, amount to no more than mere instructions to apply an exception, add insignificant extra-solution activity to the abstract idea, and generally link the abstract idea to a particular technological environment or field of use. Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims.
As previously noted, the claim recites an additional element of a hardware circuit filter. Akiba et al. (US20030234700) in FIG. 2 “depicts a conventional filter circuit 200” and demonstrates that filter circuits were conventional long before the priority data of the claimed invention. As such, this additional element, individually and in combination with the prior additional element, does not amount to significantly more.
To elaborate:
claim 3 “wherein the hardware circuit filter receives an ECG signal from the at least one electrode and generates a pre-filtered ECG signal, and the input ECG signal comprises the pre-filtered ECG signal.”, is equivalently, receiving or transmitting data over a network, Symantec, MPEP 2106.05(d)(II)(i);
claim 2 and 16 “wherein the at least one processor is configured to output the one or more heartbeat parameters in real-time, or near real-time”, is equivalently, receiving or transmitting data over a network, Symantec, MPEP 2106.05(d)(II)(i);
claim 11 “transmit the one or more encoded output parameters to an external device” , is equivalently, receiving or transmitting data over a network, Symantec, MPEP 2106.05(d)(II)(i);
Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-5, 7-10, and 15-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Najarian et al. (US20120123232).
Regarding claim 1, Najarian teaches a system for pediatric heartbeat monitoring, ([0004] “methods … to analyze heart-related electronic signals.” and [0170] “This dynamic capability would also accommodate individual differences in amplitude for different placements of similar devices because of user size or other physical characteristics.”) comprising: at least one electrode configured to be applied to a pediatric subject; ([0165] “Electrodes 2105A and 2105B are held against the skin”) at least one processor coupled to the at least one electrode, ([0029] “The sensors utilized by the apparatus detect, in one aspect, heart-related electronic signals. The apparatus also includes a processor that receives at least a portion of the data indicative of heart-related parameters”) the at least one processor configured for: receiving, from the at least one electrode, an input electrocardiogram (ECG) signal; ([0158] “electrodes to detect the different aspects of the ECG signal.”) determining a signal quality index (SQI) [i.e., signal strength] associated with input ECG signal; ([0187] “FIG. 25E illustrates an embodiment that provides electrode shielding, and the individual pairs of electrodes can be sampled and then summed and/or subtracted during subsequent analysis,… the CPU controls the gain of the first stage amplifier through AGC circuits 2167, enabling the system to adjust for poor electrode placement or subjects with weaker ECG signals. These embodiments permit the selection of the strongest pair or best signal from of a multiplicity of pairs of electrodes for analysis. This can be accomplished according to several methodologies in addition to mere signal strength.”) applying a bandpass filter to the input ECG signal to generate a filtered ECG signal; ([0293-294] “As FIG. 40 shows, the first step in the detection procedure is ECG preprocessing… Since Noise causes different distortion to a signal, a bandpass filter of order 10 and cutoff between 1 Hz and 55 Hz is utilized”) determining a derivative of the filtered ECG signal to generate a derived ECG signal; applying a squaring function to the derived ECG signal to generate a squared ECG signal; applying an integrator to the derived ECG signal to generate an integrated ECG signal; ([0199] “As is well-known in the prior art, the Pan-Tompkins method uses a set of signal processing frequency filters to first pass only the signal that is likely to be generated by heart beats, then proceeds to differentiate, square and perform a moving window integration on the passed signal.”) and applying one or more decision rules [i.e., algorithms] to the integrated ECG signal to output [i.e., display] one or more heartbeat parameters associated with the subject. ([0182] “(ii) it stores a number of raw digital signals to memory and subsequently transmits them, wired or wirelessly, to a remote computer for analysis as described herein and/or display, such as display in real time; (iii) it processes the raw digital signals using algorithms described herein provided on central processing unit 2165 to determine heart related parameters, such as the timing and various sizes of heart beats, heart rate, and/or beat-to-beat variability.”)
Regarding claim 2, Najarian teaches all of the limitations of claim 1. Najarian also teaches the at least one processor is configured to output the one or more heartbeat parameters in real-time, or near real-time. (0182] “stores a number of raw digital signals to memory and subsequently transmits them, wired or wirelessly, to a remote computer for analysis as described herein and/or display, such as display in real time”)
Regarding claim 3, Najarian teaches all of the limitations of claim 1. Najarian also teaches a hardware circuit filter coupled between the at least one electrode and the at least one processor, wherein the hardware circuit filter receives an ECG signal from the at least one electrode and generates a pre-filtered ECG signal, and the input ECG signal comprises the pre-filtered ECG signal. ([0293-294] “As FIG. 40 shows, the first step in the detection procedure is ECG preprocessing… Since Noise causes different distortion to a signal, a bandpass filter of order 10 and cutoff between 1 Hz and 55 Hz is utilized” where the filter occurs after the electrode and before the digital processing)
Regarding claim 4, Najarian teaches all of the limitations of claim 1. Najarian also teaches: the hardware circuit filter is a bandpass filter. ([0294] “FIG. 41 shows the overall frequency response of the bandpass filter.”)
Regarding claims 5 and 19, Najarian teaches all of the limitations of claim 1. Najarian also teaches the bandpass filter having a passband range of 3 to 48 Hz. ([0179] which teaches the range(s) for high and low pass cut off frequencies of 0.1-3 Hz and 30 Hz and [0178] states that “bandpass network preferably including separate low-pass and high-pass filter sections.”)
Regarding claim 7, Najarian teaches all of the limitations of claim 1. Najarian also teaches the one or more output heartbeat parameters comprise one or more of heartrate ([0221] “average heart rate”), heartrate variability ([0221 “heart rate variability”), RR interval and R-peak locations ([0343] “HRV is extracted based on the RR interval”), and an indication of abnormal heartrate. ([0221] “atrial fibrillation, arrhythmia,”)
Regarding claim 8, Najarian teaches all of the limitations of claim 1. Najarian also teaches a histogram,. ([0333] “a histogram analysis is performed over the moving average signals.”)
Regarding claim 9, Najarian teaches all of the limitations of claim 1. Najarian also teaches the input ECG [i.e., raw] signal is a 12-bit ECG signal. ([0182] “Analog to digital converter 2160 may be implemented using a 12 bit analog to digital converter… it processes the raw digital signals using algorithms described herein provided on central processing unit 2165 to determine heart related parameters,”)
Regarding claim 10, Najarian teaches all of the limitations of claim 1. _ also teaches the at least one processor is further configured to apply thresholding to the integrated ECG signal ([0332] “Additional procedures such as averaging subtraction, histogram analysis, and thresholding process are added to the original Tompkins algorithm”) and to further convert the signal into a one-bit signal. ([0214] “Binary true/false detectors can be used”)
Regarding claim 15, Najarian teaches a method for pediatric heartbeat monitoring ([0025] “An additional embodiment involves a method which utilizes an apparatus on the body that continuously monitors certain physiological parameters, such as heart-related electronic activity.” and [0170] “This dynamic capability would also accommodate individual differences in amplitude for different placements of similar devices because of user size or other physical characteristics.”) comprising: receiving, from the at least one electrode, an input electrocardiogram (ECG) signal; ([0158] “In the preferred embodiment of the present invention, pairs of locations on or near the left arm have been identified for placement of electrodes to detect the different aspects of the ECG signal.”) determining a signal quality index (SQI) [i.e., signal strength] associated with input ECG signal; ([0187] “FIG. 25E illustrates an embodiment that provides electrode shielding, and the individual pairs of electrodes can be sampled and then summed and/or subtracted during subsequent analysis, … the CPU controls the gain of the first stage amplifier through AGC circuits 2167, enabling the system to adjust for poor electrode placement or subjects with weaker ECG signals. These embodiments permit the selection of the strongest pair or best signal from of a multiplicity of pairs of electrodes for analysis. This can be accomplished according to several methodologies in addition to mere signal strength.”) applying a bandpass filter to the input ECG signal to generate a filtered ECG signal; ([0293-294] “As FIG. 40 shows, the first step in the detection procedure is ECG preprocessing… Since Noise causes different distortion to a signal, a bandpass filter of order 10 and cutoff between 1 Hz and 55 Hz is utilized”) determining a derivative of the filtered ECG signal to generate a derived ECG signal; applying a squaring function to the derived ECG signal to generate a squared ECG signal; applying an integrator to the derived ECG signal to generate an integrated ECG signal; and ([0199] “As is well-known in the prior art, the Pan-Tompkins method uses a set of signal processing frequency filters to first pass only the signal that is likely to be generated by heart beats, then proceeds to differentiate, square and perform a moving window integration on the passed signal.”) applying one or more decision rules [i.e., algorithms] to the integrated ECG signal to output [i.e., display] one or more heartbeat parameters associated with the subject. ([0182] “(ii) it stores a number of raw digital signals to memory and subsequently transmits them, wired or wirelessly, to a remote computer for analysis as described herein and/or display, such as display in real time; (iii) it processes the raw digital signals using algorithms described herein provided on central processing unit 2165 to determine heart related parameters, such as the timing and various sizes of heart beats, heart rate, and/or beat-to-beat variability.”)
Regarding claim 16, Najarian teaches all of the limitations of claim 15. Najarian also teaches the one or more heartbeat parameters are output in real-time, or near real-time. (0182] “stores a number of raw digital signals to memory and subsequently transmits them, wired or wirelessly, to a remote computer for analysis as described herein and/or display, such as display in real time”)
Regarding claim 17, Najarian teaches all of the limitations of claim 16. Najarian also teaches receiving an ECG signal from the at least one electrode ([0158] “In the preferred embodiment of the present invention, pairs of locations on or near the left arm have been identified for placement of electrodes to detect the different aspects of the ECG signal.”) and generating, via a hardware circuit filter, a pre-filtered ECG signal, and the input ECG signal comprises the pre-filtered ECG signal. ([0293-294] “As FIG. 40 shows, the first step in the detection procedure is ECG preprocessing… Since Noise causes different distortion to a signal, a bandpass filter of order 10 and cutoff between 1 Hz and 55 Hz is utilized” where the filter occurs after the electrode and before the digital processing)
Regarding claim 18, Najarian teaches all of the limitations of claim 17. Najarian also teaches the hardware circuit filter is a bandpass filter. ([0294] “FIG. 41 shows the overall frequency response of the bandpass filter.”)
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 6 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Najarian et al.
Regarding claims 6 and 20, Najarian teaches all of the limitations of claims 5 and 19 by teaching the bandpass filter range of 3 to 30 Hz ([0179] which teaches the range(s) for high and low pass cut off frequencies of 0.1-3 Hz and 30 Hz and [0178] states that “bandpass network preferably including separate low-pass and high-pass filter sections.”).
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists since there is no criticality disclosed for the claimed range.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Najarian et al. in view of Qin et al. (Pat. 12115004).
Regarding claim 11, Najarian teaches all of the limitations of claim 1. Najarian does not explicitly teach, as taught by Qin wherein the at least one processor is further configured to: encode the one or more output heartbeat parameters using a varied Lempel-Ziv encoding algorithm to generate encoded output parameters; and ([page 2, column 1] “Lossless physiological signal compression mainly utilizes general signal compression approaches such as Huffman coding, arithmetic coding, dictionary-based Lempel-Ziv (LZ) coding” and [page 13, column 5] “STEP S101 is obtaining physiological signals. Here, the physiological signals may be signals collected by physical sign sensors, and include but not be limited to ECG signals, BP signals, pulse signals, PPG (photoplethysmogram) signals, etc.) transmit the one or more encoded output parameters to an external device. ([page 16, column 11] “The embodiments of the present disclosure may be implemented as computer software implemented by one or more networked processing apparatuses… The hardware resources may further include an input device, an output device, and a network device in accordance with the type of the apparatus” where the network of devices comprises the external devices for which the information is sent.)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Najarian with the teachings of Qin, with a reasonable expectation of success, by explicitly incorporating the well-known LZ algorithm into their encoding method. This would have reduced the information transmitted through the system. Qin is adaptable to Najarian as both inventions process ECG signaling to determine heart rate parameters for patients. Najarian would have found Qin’s teachings to avoiding excessive data compression as “this type of approach may damage the fidelity of information; that is, the signal fidelity tends to decrease with the increase of the compression ratio”.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Najarian et al. in view of Krachunov et al. (Sensors, 2016, 16, 1635).
Regarding claim 12, Najarian teaches all of the limitations of claim 1 Najarian does not explicitly teach, as taught by Krachunov wherein the at least one electrode comprises a 3D printed dry electrodes printed from conductive polylactic acid (PLA) film. ([page 5, section 3.2] “In parallel to the mechanical design process, each iteration was 3D printed using standard PLA (Polylactic Acid) plastic. The first four versions (1.0–1.3) were trial versions to find suitable dimensions for electrodes and also to understand the 3D printing capabilities”)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Najarian with the teachings of Krachunov, with a reasonable expectation of success, by explicitly printing 3D electrodes with polylactic acid. This would have allowed for custom made electrodes that fit the size needs of a particular patient. Krachunov is adaptable to Najarian as both inventions use electrodes to determine health parameters for a patient. Najarian would have found Krachunov’s teaching that “a conductive gel, which can be uncomfortable to the subject, causes skin irritation, and some gels have poor long-term stability. A solution to this problem is to use dry electrodes, which do not require conductive gel” [abstract] and thus incorporated dry electrodes.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Najarian et al. in view of Krachunov et al. as applied to claim 12 above, and further in view of 3M Healthcare (“ECG Red Dot Electrodes”, 2016).
Regarding claim 13, Najarian-Krachunov as a combination teaches all of the limitations of claim 12. Krachunov also teaches wherein each of the at least one 3D printed dry electrodes has … width dimensions of … 6 millimeters, respectively. ([page 5, section 3.2] “The electrode … length of the prongs is 4 mm, 7 mm,” where the length of prongs comprises the width of the electrodes.) Regarding claim 13, Najarian-Krachunov does not explicitly teach, as taught by 3M Healthcare: wherein each of the at least one 3D printed dry electrodes has length, height … dimensions of 32 millimeters, 18 millimeters ([Page 3] neonatal ECG’s have dimensions including 1.3”/32 mm to .7”/18mm)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Najarian-Krachunov with the teachings of 3M Healthcare, with a reasonable expectation of success, by using explicit measurements for the electrode patches. Using precise measurements for ECG patches would provide consistent conduction ECG patches. 3M Healthcare is adaptable to Najarian-Krachunov as both inventions utilize industry standard ECG electrode patches. Najarian would have found 3M Healthcare’s teaching while searching for industry standard ECG patches to create a compatible diagnostic system with current healthcare settings.
MPEP 2144.05(I) states “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” [In re Wertheim, 541 F.2d 257]. There is no criticality of overlapping ranges and Applicant has not indicated in the specification that different ranges would produce unexpectedly different results than from the prior art range. One of ordinary skill in the art would have recognized the ranges as obvious variants that could be achieved through routine optimization.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Najarian in view of Krachunov et al. and further in view of Abeykoon et al. (Int. J. Lightweight Materials and Manufacture, 2020, Vol. 3, Issue 3, pp284-297).
Regarding claim 14, Najarian teaches all of the limitations of claim 1. Najarian does not explicitly teach, as taught by Abeykoon dry electrodes are manufactured using a nozzle temperature of about 215°C, a heated bed temperature of about 60°C, a print speed of about 25 mm/s and a fill ratio of 100% ([page 288, section 2.5] “The printing conditions were set as: infill speed 20mm/s of, infill density 100%, and the set nozzle temperature 215 C.” and [page 287, section 2.21] “For CFR-PLA, the bed temperature was between 23 and 70 C (a heated bed is not essential for this material)”; see also [page 288, section 2.2.1] “For printing the test samples, five different printings speeds were chosen based on the range of the speeds used by the current industry: 70 mm/s” where the printing ranged from 20-70 mm/s.)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Najarian with the teachings of Abeykoon, with a reasonable expectation of success, by explicitly indicating optimized print settings for the PLA material. This would have reduced the variability in any printed electrodes. Abeykoon is adaptable to Najarian-Krachunov as Krachunov uses a common manufacturing technique of 3D printing for creating polymer components. Najarian would have found Abeykoon’s teaching that “Generally, some of the current key challenges to the polymer 3D printing field are: 3D printing is not yet standardized” [page 287].
MPEP 2144.05(I) states “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” [In re Wertheim, 541 F.2d 257]. There is no criticality of overlapping ranges and Applicant has not indicated in the specification that different ranges would produce unexpectedly different results than from the prior art range. One of ordinary skill in the art would have recognized the ranges as obvious variants that could be achieved through routine optimization.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Firoozabadi et al. (US20180242872) discloses a system of signal quality evaluation that distinguishes muscle contraction and other electrical noise from cardiac signaling. This system uses root-mean-square functions and other equations to filter the received patient signals.
ジャオ ダン (JP-2016506779) discloses a system of determining the occurrence of QRS complex in ECG data using 12 lead ECGs, filtering artifacts with square functions, and more.
Conclusion
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/R.A.S/Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792