DETAILED ACTION
This action is pursuant to claims filed on 3/2/2026. Claims 1-10 are pending. A final action on the merits of claims 1-10 is as follows.
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 Objections
Claim 1 is objected to because of the following informalities:
Line 4 states the “electrode unit, wherein” which should be corrected to --electrode unit; wherein--. This helps delineate that the following limitations are not part of the control unit but rather are parts and functions of the portable electrocardiographic device as a whole, and not only the control unit.
Line 27 states “the proximal end side of the finger that is less likely move […]” which should be corrected.
Line 27-28 states “the one of the measurement electrode” which should be corrected to --the one of the measurement electrodes--.
Appropriate correction is required.
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 1-10 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.
Claim 1 recites “the distal end side of the finger where force is likely to be applied and movement is likely to occur” and “the proximal end side of the finger that is less likely move pressed onto the one of the measurement electrode” which does not clearly define the portions of the finger. The term “likely” is not a definite term and does not clearly define whether movement occurs at that portion of the finger or not. Furthermore, when a finger moves, the tip and the proximal portion of the finger tend to move together as it is difficult for most people to only move the fingertip. For the purposes of compact prosecution, utilizing the term --fingertip-- to describe the distal end of the finger would be appropriate, and stating --the proximal end side of the finger nearest a palm of the subject-- would be appropriate for describing the portion of the finger which contacts the measurement electrode.
Claims 2-10 are rejected due to their dependence on claim 1.
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.
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 1-10 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).
Claim 1 recites “the distal end side of the finger […] pressed onto the earth electrode” and “the proximal end side of the finger […] pressed onto the one of the measurement electrode” and “the other measurement electrode pressed […] onto a measurement site of the body” which all directly claim body parts of a human organism. The claim directly requires each of the body parts contacting the electrodes as currently written. This should be corrected such that the electrodes are --adapted to-- or --configured to-- contact those portions of the body, rather than the body parts being directly claimed as pressed against the electrodes.
Claims 2-10 are rejected due to their dependence on claim 1.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: should the claim objections, 112b rejection, and 101 rejection be corrected, the application would be in condition for allowance.
Claim 1 would be allowable if corrected because the measurement electrode contacts the base portion of the finger, and the earth electrode contacts the fingertip and contains the fingerprint detection unit. This is opposite of the conventional state of the art. While contact location is typically intended use, the placement of the fingerprint detection unit on the earth electrode provides a structural reason for the distal tip of the finger to contact the earth electrode. Furthermore, the claim requires that when the electrocardiographic waveform is detected, the earth electrode is contacted by the fingertip, the adjacent measurement electrode contacts the base of the finger, and the second measurement electrode contacts another body part. The claim is clear that a single finger contacts both the earth electrode and a measurement electrode during use.
This functionality is opposite of Umeda. As seen in Fig. 9 of Umeda, the fingertip of the user contacts the measurement electrode 121 and the base of the finger contacts the earth electrode 123. In order to place the fingertip in contact with the earth electrode, the device would have to be used upside down which would make it very difficult to read the display and is thus not an obvious use case.
Having a fingertip contact the measurement electrode is a typical configuration for measurement electrodes in the art. Im et al. (WO 2008120950 A1) discloses a similar ECG monitoring device which includes two adjacent electrodes for contact with the fingers of a user as seen in Fig. 1. Much like the device of Umeda, the measurement electrodes contact the fingertips of the user rather than the base portion of the finger. Additionally, the ground electrode of Im et al. contacts the chest rather than a portion of the user’s finger ([55]). Im et al. thus does not disclose, teach, or suggest the claimed electrode configuration.
Zhou et al. (CN 104000577 B) teaches an ECG measurement device with a fingerprint detection unit. As seen in Fig. 7, the device comprises two electrodes 141 and 142 and a fingerprint detection unit 160. Also seen in Fig. 7, the proximal end of the finger touches a measurement electrode 141. However, Zhou does not disclose an earth electrode on the device or that the fingerprint detection unit is utilized to determine a contact state of the fingertip with the earth electrode. While Zhou shows that a proximal side of the finger can contact a measurement electrode to detect ECG, Zhou does not disclose teach or suggest placing an earth electrode adjacent to the measurement electrode to contact the fingertip of the user or to include a fingerprint sensor to determine the contact state with the electrodes.
Additionally, there is no obvious reason to one of ordinary skill in the art to place a fingerprint detection unit on only the earth electrode. While the previous rejection combined Umeda with Kwon to place a fingerprint sensor with both the earth and the adjacent measurement electrode, when operated as the claim now recites, that configuration would no longer be operable because the measurement electrode no longer contacts a fingerprint. Additionally, the screen would be placed upside down when used in this configuration. Therefore, the combination of record does not disclose, teach, or suggest the required orientation and placement of the electrodes and modifying Umeda to meet the claim limitations would render the device inoperable.
Lastly, changing the locations of the electrodes would not be obvious because this would be hindsight reasoning. As stated on page 8 of the Applicant’s remarks, placing the fingertip in contact with the earth electrode while also bringing the proximal end of the finger into contact with the measurement electrode and further providing a fingerprint detection unit for determining the contact state on the earth electrode is critical for stabilizing contact during measurement (See specification paragraphs [0005], [0008], [0010], [0016], [0036], [0048], and [0065]). Thus, the electrode placement and the placement of the fingerprint detection unit are unique and critical to ensuring a stable connection, and moving the electrodes of Umeda and only placing the fingerprint detection unit on the earth electrode would not be obvious to one of ordinary skill in the art.
Therefore, claim 1 would be allowable upon the correction of the claim objections, and the 112b and 101 rejections.
Similarly, claims 2-10 would be allowable upon the corrections to claim 1 as they would then be dependent upon an allowable claim.
Response to Arguments
Applicant’s arguments, filed 3/2/2026, with respect to the 103 rejection of claim 1 have been fully considered and are persuasive in light of the amendment. The 103 rejection of claim 1 has been withdrawn.
The 103 rejections of claims 2-8 have been withdrawn in light of the rejection of claim 1 being withdrawn.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/W.M./Examiner, Art Unit 3794
/EUN HWA KIM/Primary Examiner, Art Unit 3794
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