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 .
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in Japan on 05/31/2024. It is noted, however, that applicant has not filed a certified copy of the JP 2024-088828 application as required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/06/2025 is being considered by the examiner.
Claim Objections
Claims 1, 2, and 3 are objected to because of the following informalities:
Claim 1, line 1 recites “an electrocardiogram data detection device installed on a vehicle” should read – an electrocardiogram data detection device configured to be installed on a vehicle --;
Claim 1, line 7 recites “pair of measurement signals from a corresponding pair the of electrodes” should read -- pair of measurement signals from a corresponding pair of the plurality of electrodes --;
Claim 1, line 18 recites “the first region being closer to the bottom seat than the second region which is located above” should read -- the first region being closer to the bottom than the second region which is located above--;
Claim 2, line 3 recites “number of the first electrodes” should read -- number of the at least three first electrodes--;
Claim 3, line 2 recites “wherein a center of the second region is located to an upper right of a center of the first” should read -- wherein a center of the second region is located relative to an upper right position of a center of the first --;
Claim 3, line 3 recites “region, up-down and left-right relationship being defined based on the body of the person sitting on the vehicle seat” should read -- region, an up-down and left-right relationship being defined based on the body of the person sitting on the vehicle seat --.
Appropriate correction is required.
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.
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 therefore, subject to the conditions and requirements of this title.
Claims 1-4 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 abstract idea of using an electrode detection device to record electrocardiogram data and not using the data for post-solution activity. This judicial exception is not integrated into a practical application because the generically recited processor elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a processor. The detection modules do not add meaningful limitations to the system as they are insignificant extra-solution activity. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the detection ECG electrodes amount to merely data gathering of ECG electrical activity and amount to pre-solution activity well-understood, routine, and conventional in manner.
Regarding claim 1, the limitations “generate a differential signal between a pair of measurement signals from a corresponding pair of two of the plurality of electrodes”, “obtain electrocardiogram data based on the plurality of differential signals”, are processes that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting “a differential signal generation unit” and “electrocardiogram data detection unit”, nothing in the claim element precludes the step from practically being performed in the mind. For example, but for the “an electrocardiogram data detection device” language encompasses the user manually analyzing the multichannel ECG signal and calculating the differential signals between the ECG signals. 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” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim only recites one additional element – using a computer and processor to perform the generating and obtaining steps. The computer and processor in both steps are recited at a high-level of generality (i.e., as a generic processor performing a generic computer function of determining and selecting information based on a determined amount of use) such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
Thus, claim 1 does not amount to significantly more than the abstract idea of measuring and analyzing ECG signals since the recited additional elements, either alone or in combination, do not provide for an inventive concept.
Regarding claim 2, the claim refers to an additional element, “wherein a number of the at least one second electrode is smaller than a number of the first electrodes”. This additional element limitation does not integrate the abstract idea into a practical application. The ECG electrodes do not amount to significantly more than the judicial exception. Therefore, this limitation does not amount to integration of the abstract idea into a practical application under Step 2A, Prong 2 nor does it amount to significantly more than the abstract idea under step 2B.
Regarding claim 3, the claim refers to an additional element, “wherein a center of the second region is located to an upper right of a center of the first region, up-down and left-right relationships being defined based on the body of the person sitting on the vehicle seat”. This additional element limitation does not integrate the abstract idea into a practical application. The location of the center of the second region does not amount to significantly more than the judicial exception. Therefore, this limitation does not amount to integration of the abstract idea into a practical application under Step 2A, Prong 2 nor does it amount to significantly more than the abstract idea under step 2B.
Regarding claim 4, the claim refers to an additional element, “wherein the at least three first electrodes are disposed above a height position corresponding to a height position of an iliac crest of the person sitting on the vehicle seat, and wherein the at least one second electrode is disposed below a height position corresponding to a height position of an inferior angle of a scapula of the person sitting on the vehicle seat”. This additional element limitation does not integrate the abstract idea into a practical application. The location of the electrodes does not amount to significantly more than the judicial exception. Therefore, this limitation does not amount to integration of the abstract idea into a practical application under Step 2A, Prong 2 nor does it amount to significantly more than the abstract idea under step 2B.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-4 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Regarding claim 1 which recites “to face a body of a person sitting on the vehicle seat”. It appears the inventor is claiming a human body as the person is required to be sitting on the vehicle seat. Examiner suggests modifying the claim language to recite “a plurality of electrodes provided in the seat back configured to face a body of a person”.
Regarding claim 3, which recites “based on the body of the person sitting on the vehicle seat”. It appears the inventor is claiming a human body as the person is required to be sitting on the vehicle seat.
Regarding claim 4, which recites “corresponding to a height position of an iliac crest of the person sitting on the vehicle seat” and “corresponding to a height position of an inferior angle of a scapula of the person sitting on the vehicle seat”. It appears the inventor is claiming a human body as the person is required to be sitting on the vehicle seat.
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.
Claim(s) 1-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sugiyama et al. (US 20150133804 A1) herein referred to as “Sugiyama” further in view of Kim (US 20210052180 A1) herein referred to as “Kim”.
Regarding claim 1, Sugiyama discloses an electrocardiogram data detection device installed on a vehicle seat having a seat bottom and a seat back (vehicle seat 10A, Figure 1, wherein the sensors 20A-20C are used to detect potential differences which correspond to the R-waves in an electrocardiogram, Paragraph [0075]), the electrocardiogram data detection device comprising: a plurality of electrodes provided in the seat back so as to face a body of a person sitting on the vehicle seat ( the sensor group 20 is an assembly constituted by the sensors 20A, 20B, and 20C each formed out of a conductive fabric tape, and is provided in the seat back 104 near the front surface of the seat back 104. As shown in FIG. 2, each of the sensors 20A, 20B, and 20C functions to detect a body potential of the seated person 80 by being capacitively coupled to a body 800 of the seated person 80 via the skin 104C and clothes 802. A size of each of the sensors 20A, 20B, and 20C is 25 mm in height, 75 mm in width, and 1 mm in thickness. The sensors 20A, 20B, and 20C are arranged in the seat back 104 so that a longitudinal direction of the sensors 20A, 20B, and 20C is parallel to a width direction of the seat back 104. By so arranging, the seat back 104 can be downsized in a height direction, Paragraph [0052], Figures 3-15), each electrode outputting a measurement signal (The waveform generation unit 702 functions to generate voltage waveform data VAB and VAC with a vertical axis representing the potential difference signal and a horizontal axis representing time based on the potential difference signal between the potential signals output from the sensors 20A and 20B that is stored in the storage unit 700 and the potential difference signal between the potential signals output from the sensors 20A and 20C, Paragraph [0065]); a differential signal generation unit configured to generate a differential signal between a pair of measurement signals from a corresponding pair the of electrodes, so as to generate a plurality of differential signals by selecting a plurality of pairs from among the plurality of electrodes (The waveform generation unit 702 functions to generate voltage waveform data VAB and VAC with a vertical axis representing the potential difference signal and a horizontal axis representing time based on the potential difference signal between the potential signals output from the sensors 20A and 20B that is stored in the storage unit 700 and the potential difference signal between the potential signals output from the sensors 20A and 20C, Paragraph [0065], That is, the arithmetic operation device 70C acquires the potential difference data in the zones 20AB and 20AC (Step S01), Paragraphs [0077]-[0084] and Paragraphs [0093]-[0095], Figures 12A-12C); and an electrocardiogram data detection unit configured to obtain electrocardiogram data based on the plurality of differential signals (The arithmetic operation device 70C includes an arithmetic control CPU (Central Processing Unit) 70CA, a RAM (Random Access Memory) 70CB, and a ROM (Read Only Memory) 70CC. Furthermore, the signal input to the arithmetic operation device 70C is the potential difference signal that is the digital signal obtained by conversion in the A/D converter circuit 62, and a signal output from the arithmetic operation device 70C is an electric signal to be displayed on the display D, Paragraphs [0062]-[0064], That is, the arithmetic operation device 70C acquires the potential difference data in the zones 20AB and 20AC (Step S01), Paragraph [0077], The arithmetic operation device 70C computes a peak interval at which a voltage (R-wave potential) exceeding a set threshold is detected by digitally filtering the electrocardiographic waveform data VH for emphasizing a waveform corresponding to QRS waves. Next, the arithmetic operation device 70C sets an inverse of the peak interval as an instantaneous heart rate (heart rate per second) and further calculates the number of heartbeats detected per minute. That is, the arithmetic operation device 70C calculates the heart rate by arithmetic operation. Next, the arithmetic operation device 70C transmits signals relating to the electrocardiographic waveform data VH and the heart rate to the display D to display the electrocardiographic waveform data VH and the heart rate on the display D (Step S04), Paragraphs [0080]-[0081]), wherein the plurality of electrodes include: at least three first electrodes disposed along a width direction of the seat back in a first region of the seat back (sensors 24A-24B are disposed within a first region of the seat back, in a width direction W1, W3, W4, see modified Figure 13 below);
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and at least one second electrode disposed in a second region of the seat back (at least one second electrode 24D disposed in a second region of the seat back, see modified Figure 13 below),
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the first region being closer to the bottom seat than the second region which is located above the first region (see modified Figure 13 below),
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However Sugiyama does not explicitly disclose wherein the plurality of differential signals includes at least six differential signals obtained from the measurement signals of the at least three first electrodes and the measurement signal of at least one second electrode.
Kim discloses a cardiac monitoring system (Abstract) wherein the plurality of differential signals includes at least six differential signals obtained from the measurement signals of the at least three first electrodes and the measurement signal of at least one second electrode (an ECG monitoring device can use four channels out of six possible differential channels formed from four independent electrodes, Paragraph [0019]).
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 Sugiyama to incorporate the teachings of Kim by including wherein the plurality of differential signals includes at least six differential signals obtained from the measurement signals of the at least three first electrodes and the measurement signal of at least one second electrode. The motivation to do so being to form six different vectors to determine if shock analysis is necessary is one or more of the vectors is noisy or one or more of the ECG leads is not contacting the patient (Kim, Paragraph [0019]).
Regarding claim 2, Sugiyama discloses the electrocardiogram data detection device according to Claim 1, wherein a number of the at least one second electrode is smaller than a number of the first electrodes (24D is the only second electrode which is smaller than the 3 first electrodes 24A-24C, Figure 13).
Regarding claim 3, Sugiyama discloses the electrocardiogram data detection device according to Claim 1, wherein a center of the second region is located to an upper right of a center of the first region (see modified Figure 13 below), up-down and left-right relationships being defined based on the body of the person sitting on the vehicle seat (see key of modified Figure 13 below).
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Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sugiyama in view of Kim further in view of Freeman et al. (US 20120041279 A1) herein referred to as “Freeman”.
Regarding claim 4, Sugiyama in view of Kim discloses the electrocardiogram data detection device according to Claim 1.
However Sugiyama in view of Kim does not explicitly disclose wherein the at least three first electrodes are disposed above a height position corresponding to a height position of an iliac crest of the person sitting on the vehicle seat, and wherein the at least one second electrode is disposed below a height position corresponding to a height position of an inferior angle of a scapula of the person sitting on the vehicle seat.
Freeman discloses a system that can detect an electrocardiogram utilizing electrodes (Paragraph [0032], claim 22 and claim 51) wherein the at least the three first electrodes are disposed above a height position corresponding to a height position of an iliac crest of the person (the second electrode 12 is placed two inches beneath electrode 1, the third 13 electrode is placed two inches beneath electrode 2, and the fourth electrode 14 is placed beneath electrode 3, Paragraph [0130], Figure 3), and wherein the at least one second electrode is disposed below a height position corresponding to a height position of an inferior angle of a scapula of the person sitting on the vehicle seat (the first electrode is placed midway between the midaxillary line and the spine just beneath the scapula, Paragraph [0130], Figure 3).
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 Sugiyama to incorporate the teachings of Freeman by including wherein the at least three first electrodes are disposed above a height position corresponding to a height position of an iliac crest of the person sitting on the vehicle seat, and wherein the at least one second electrode is disposed below a height position corresponding to a height position of an inferior angle of a scapula of the person sitting on the vehicle seat. The motivation to do so being to prevent the movement of the electrodes due to thoracic expansion of the patient (Freeman, Paragraph [0132]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The prior art not relied upon includes: US 20100049068 A1, US 20120330173 A1, US 20140039330 A1, US 20140323838 A1, US 20140361871 A1, US 20150057556 A1, US 20150094603 A1, US 20150099985 A1, US 20150126877 A1, US 20160200220 A1, US 20160354027 A1, US 20170150929 A1, and US 20190038229 A1 which are related to vehicle seats comprising ECG sensors.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Dana Stumpfoll whose telephone number is (703)756-4669. The examiner can normally be reached 9-5 pm (CT), M-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, Joanne Rodden can be reached at (303) 297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D.S./Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
