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 § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 10, 12-14, 16-21, 23-27, 29, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Kandori (U.S. 2021/0076978, previously cited). Regarding claims 10 and 30, Kandori discloses an electrocardiography (ECG) device configured for use in combination with a magnetic resonance (MR) device, comprising: at least two coil units 103a/103b, each being configured to capture a movement signal representing a movement to which the respective coil unit is subject (“Changes in the impedance accompanying motions of the lungs or the diaphragm in the respiratory activity of the living body 40 are detected by the two coils 103a and 103b, thereby measuring biosignals related to the respiratory activity.”, paragraph [0040]); a movement detector configured to extract a respiratory movement based on at least one of the movement signals (“Changes in the impedance accompanying motions of the lungs or the diaphragm in the respiratory activity of the living body 40 are detected by the two coils 103a and 103b, thereby measuring biosignals related to the respiratory activity.”, paragraph [0040]); at least two electrodes 102a/102b arrangeable on an object 40 under examination (see Figures 4, 9A, and 9B) and configured to capture ECG signals from the object under examination (“As the two electrodes 102a and 102b, electrodes of an electrocardiograph can be used.”, paragraph [0031]); and a receiver 109 including at least two electrode leads that respectively connect the at least two electrodes to the receiver (see Figure 2), at least one of the at least two coil units being arranged on: an electrode of the at least three electrodes, an electrode lead of the at least three electrode leads, and/or the receiver (“The two coils 103a and 103b are placed at vertically symmetric positions with respect to the line linking the two electrodes 102a and 102b.”, paragraph [0035] and “a quadrangular detection coil 60 on which the two coils 103a and 103b are formed integrally… the detection coil 60 includes a connector 63 for connection with the detection circuit 109”, paragraph [0048]); wherein the receiver is configured to: capture ECG data based on the ECG signals; process the ECG data to generate processed ECG data including physiological data of the object under examination; and provide an electronic data signal representing the processed ECG data as an output of the receiver (“As the two electrodes 102a and 102b, electrodes of an electrocardiograph can be used.”, paragraph [0031], paragraph [0036], and “ In addition, on the basis of known relationships between biological substances such as blood and intrapulmonary air, and biometric impedance (e.g. Yukihiro Sawada, and one other person, “Impedance plethysmography revisited,” Japanese Journal of Physiological Psychology and Psychophysiology, vol 11, No. 2, 1993, 47-58), respiration ventilatory volumes and cardiac outputs can be calculated from outputs from the detection circuit 109.”, paragraph [0038]). However, while Kandori recites “at least two electrodes 102a and 102b” in multiple instances (see Abstract and paragraphs [0008] and [0062]), suggesting support for more than two electrodes (i.e. at least three electrodes), Kandori fails to explicitly disclose at least three electrodes and at least three electrode leads. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Kandori to include at least three electrodes and at least three electrode leads, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. MPEP 2144.04. Kandori fails to disclose that at least one of the at least two coil units are arranged on or physically attached to an electrode of the at least three electrodes and/or an electrode lead of the at least three electrode leads, rather disclosing the location on the receiver. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to arrange or physically attach at least one of the at least two coil units of Kandori on an electrode of the at least three electrodes and/or an electrode lead of the at least three electrode leads, as it has been held that rearranging parts of an invention involves only routine skill in the art. MPEP 2144.04
Regarding claim 12, Kandori discloses in a case where the ECG device is arranged on an upper body of the object under examination, the at least two coil units are distributed over a surface of the upper body such that the at least two coil units are configured to capture abdominal breathing and thoracic breathing (see Figures 4, 9A, and 9B and “Thus, by detecting changes in the impedance accompanying motions of the lungs or the diaphragm in the respiratory activity of the living body 40 of the subject while reducing the influence of physical motions of the subject, biosignals related to the respiratory activity can be measured.”, paragraph [0046]).
Regarding claim 13, Kandori discloses that at least one of the at least two coil units is a separate coil unit that is: not in direct contact with an electrode of the at least three electrodes; not in direct contact with an electrode lead of the at least three electrode leads; and/or not in direct contact with the receiver (see Figures 4, 9A, and 9B).
Regarding claim 14, Kandori discloses that the at least two coil units comprise thermal insulation and/or a housing unit (see Figures 6A and 6B, where a housing can be readily seen).
Regarding claim 16, Kandori discloses the invention substantially as clamed, but fails to disclose that at least one of the at least two coil units comprises an electrical coil of circumference between 2 cm and 30 cm and/or a number of turns between 1 and 10. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Kandori such that at least one of the at least two coil units comprises an electrical coil of circumference between 2 cm and 30 cm and/or a number of turns between 1 and 10, as it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. MPEP 2144.05
Regarding claim 17, Kandori discloses that the movement detector comprises: an analog filter, an amplifier 104a/104b (“The voltage detected by the coil 103a is amplified by a preamplifier 104a, and the voltage detected by the coil 103b is amplified by a preamplifier 104b. An adder 105 performs addition or subtraction of signals obtained through the amplification at the preamplifiers 104a and 104b.”, paragraph [0032]), and/or an analog-to-digital converter (ADC) (“adjustment of the amplitude and phase by the adjustment circuit 106 can also be performed through performing AD (analog-digital) conversion on the signal obtained through the addition or subtraction at the adder 105 and performing automatic computation at a CPU, an FPGA or the like”, paragraph [0036]).
Regarding claim 18, Kandori discloses the invention substantially as claimed, including an amplifier 104a/104b (“The voltage detected by the coil 103a is amplified by a preamplifier 104a, and the voltage detected by the coil 103b is amplified by a preamplifier 104b. An adder 105 performs addition or subtraction of signals obtained through the amplification at the preamplifiers 104a and 104b.”, paragraph [0032]), and an analog-to-digital converter (ADC) (“adjustment of the amplitude and phase by the adjustment circuit 106 can also be performed through performing AD (analog-digital) conversion on the signal obtained through the addition or subtraction at the adder 105 and performing automatic computation at a CPU, an FPGA or the like”, paragraph [0036]), but fails to disclose the amplifier having a gain of between 6 and 12, and/or the analog-to-digital converter (ADC) having an operating range between 100 Hz and 300 Hz and/or a resolution of less than 15 pV per least significant bit (pV/LSB). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Kandori such that the amplifier has a gain of between 6 and 12, and/or the analog-to-digital converter (ADC) has an operating range between 100 Hz and 300 Hz and/or a resolution of less than 15 pV per least significant bit (pV/LSB), as it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. MPEP 2144.05
Regarding claim 19, Kandori discloses that the processing of the ECG data comprises filtering the ECG data to generate the processed ECG data, wherein the processed ECG data represents: an identified a heartbeat, a respiratory movement (“Changes in the impedance accompanying motions of the lungs or the diaphragm in the respiratory activity of the living body 40 are detected by the two coils 103a and 103b, thereby measuring biosignals related to the respiratory activity.”, paragraph [0040]), and/or an identified breathing (“to measure only motions near the coils 103a and 103b, to thereby detect breathing or cardiac motions stably.”, paragraph [0033]).
Regarding claim 20, Kandori discloses that the filtering the ECG data comprises: performing a first filtering to identify the heartbeat, performing a second filtering to extract and/or represent the respiratory movement (“Changes in the impedance accompanying motions of the lungs or the diaphragm in the respiratory activity of the living body 40 are detected by the two coils 103a and 103b, thereby measuring biosignals related to the respiratory activity.”, paragraph [0040]), and/or performing a third filtering to identify the breathing (“to measure only motions near the coils 103a and 103b, to thereby detect breathing or cardiac motions stably.”, paragraph [0033]).
Regarding claim 21, it is respectfully submitted that claim 20 from which claim 21 depends does not require all of the filtering, but rather only requires a single one out of the list of filterings that are listed. As such, in order to satisfy claim 21 it is only necessary to disclose a single filter, which would be satisfied by the preamplifier 104, adder 105, cancel circuit 107, and lock-in amplifier 108 of Kandori.
Regarding claim 23, Kandori discloses that the first filter, the second filter, the third filter, and/or the fourth filter comprises a model-based filter and/or a non-linear filter (“ In order to measure the change in the impedance from an output voltage detected at the coil 103, the preamplifier 104, the adder 105, the cancel circuit 107 and the lock-in amplifier 108 constitute at least part of the detection circuit 109.”, paragraph [0037]).
Regarding claim 24, Kandori discloses that the receiver is further configured to: verify a positioning of the at least three electrodes on the object under examination; and determine an optimum position for one or more of the at least three electrodes based on the processed ECG data (“ Preferably, the electrodes 102a and 102b are placed directly above the position where the diaphragm moves up and down accompanying breathing. This is because the path of the current caused to flow by the two electrodes 102a and 102b presumably most noticeably changes due to intrapulmonary air that moves along with breathing.”, paragraph [0041]).
Regarding claim 25, Kandori discloses that the optimum position is determined further based on: an identified breathing in response to the fourth filtering of the ECG data being performed (see paragraph [0051]); an identified heartbeat in response to the second filtering of the ECG data being performed; information relating to the object under examination; a location of the object under examination relative to the magnetic resonance device; and/or system information on the magnetic resonance device.
Regarding claim 26, Kandori discloses that the receiver is further configured to generate an indicator corresponding to the optimum position and project, as a projection, the indicator onto the object under examination (see Figures 4, 9A, and 9B).
Regarding claim 27, Kandori discloses that the optimum position is determined based on a threshold value and/or a range associated with: an amplitude of a respiratory movement of the object under examination (see Figures 7 and 8), and/or an electrical stimulation signal resulting from a heartbeat of the object under examination.
Regarding claim 29, Kandori discloses that the at least two coil units are disconnected from each other (see Figures 4, 9A, and 9B).
Claims 22 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Kandori (U.S. 2021/0076978, cited above) in view of Javed (U.S. 2019/0231257). Kandori discloses the invention substantially as claimed, but fails to disclose that the first filter is a bandpass filter configured for frequencies between 1.0 Hz and 40 Hz; the second filter is a bandpass filter configured for frequencies between 0.1 Hz and 100 Hz; the third filter is a bandpass filter configured for frequencies between 0.01 Hz and 2.0 Hz; and/or the fourth filter is a bandpass filter configured for frequencies between 0.01 Hz and 10.0 Hz, or the processing of the ECG data comprises filtering the ECG data using a high-pass filter. Javed teaches a method and device for measuring ECG signals that includes artefact removal, including bandpass filtering configured for frequencies with a range of 5 to 40 Hz and using a high-pass filter (a bandpass filter is a combination high and low pass filter) (see paragraph [0089]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Kandori to include a bandpass filter for frequencies with a range of 5 to 40 Hz, as taught by Javed, as it has been held that combining prior art elements according to known methods to yield predictable results requires only routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007).
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAMMIE K MARLEN whose telephone number is (571)272-1986. The examiner can normally be reached Monday through Friday from 8 am until 4 pm.
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/TAMMIE K MARLEN/Primary Examiner, Art Unit 3796