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 .
Response to Amendment
This Office Action is responsive to the amendment filed on 01/02/2026. As directed by the amendment: Claims 1, 7, 10, and 16 have been amended, claims 19-20 have been cancelled, and no claims have been added. No claims were previously withdrawn due to a Restriction Requirement. Thus, claims 1-18 are presently under consideration in this application.
Response to Arguments
Applicant’s arguments, see pages 9-10, filed 01/02/2026, with respect to 35 U.S.C. 112(b) have been fully considered and are persuasive. Applicants arguments and amendments obviate the rejection of record. The rejection of the claims has been withdrawn.
Applicant’s arguments, see pages 11-14, filed 01/02/2026, with respect to 35 U.S.C. 103 have been fully considered and are persuasive. Applicant argues on page 11 that “Claim 1 recites a structured conditional sequence, in which: (i) a determination is made as to whether an alarm should be generated based on photoplethysmogram parameters; and (ii) when the alarm is generated, subsequent steps are expressly performed, including powering on an electrocardiogram measurement circuit and performing electrocardiogram measurements. Accordingly, when the condition precedent is satisfied, the downstream steps are mandatory and form part of the claimed method.” Examiner agrees because the condition has been met and therefore the limitations following the condition are performed.
Applicant then argues on page 12 that “Doerr discloses a fully differential amplifier architecture using electrode pairs and does not disclose or suggest such a single-ended input configuration. Doerr's implantable device architecture is also structurally and operationally distinct from the claimed wearable or portable electrocardiogram system… Mottayan does not disclose or suggest configuring electrode impedances in an analog front- end circuit, nor does it provide any motivation to replace digital post-processing with analog impedance control… Thomson does not disclose or suggest injecting a minute current through electrodes for contact detection, nor does it disclose generating an output by detecting such a current. Thomson instead describes providing user guidance or feedback based on signal acquisition.” Examiner agrees because amendments to the claim obviate the rejections of record.
Applicant further argues on page 13 that “an output is generated at the moment when a defined hand-contact condition is satisfied. Neither Banet nor Thomson teaches or suggests this claimed method logic… The Examiner has not explained how the cited passages teach this conditional triggering behavior, nor why a person of ordinary skill in the art would have modified Banet to incorporate such a method step… the Examiner has not identified any disclosure in Thomson showing that such a detector exists as a structural component, nor has the Examiner explained how the cited references would be modified to arrive at the claimed apparatus.” Examiner agrees. The rejection of the claims has been withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-18 are rejected under 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
Claims 1 and 10 has been amended to include the limitation, " wherein the current detector causes a minute current to flow through the two electrocardiogram electrodes and generates the output by detecting the minute current ". The limitation does not have support in the instant specification nor in the parent application.
The specification provides support for a micro current to flow to the hands for detection ([0095]). However, the specification does not provide support for a minute current flowing the electrodes that generates the output through detection of the minute current. Applicant has not indicated where the disclosure provides adequate written description support for the instant claim limitation, "wherein the current detector causes a minute current to flow through the two electrocardiogram electrodes and generates the output by detecting the minute current”. Therefore, the new claim limitations introduce new matter.
Claims 1-18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The analysis of whether the specification complies with the written description requirement calls for the examiner to compare the scope of the claim with the scope of the description to determine whether applicant has demonstrated that the inventor was in possession of the claimed invention. Such a review is conducted from the standpoint of one of ordinary skill in the art at the time the application was filed (see, e.g., Wang Labs., Inc. v. Toshiba Corp., 993 F.2d 858, 865, 26 USPQ2d 1767, 1774 (Fed. Cir. 1993)) and should include a determination of the field of the invention and the level of skill and knowledge in the art. For some arts, there is an inverse correlation between the level of skill and knowledge in the art and the specificity of disclosure necessary to satisfy the written description requirement. Information which is well known in the art need not be described in detail in the specification. See, e.g., Hybritech, Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1379-80, 231 USPQ 81, 90 (Fed. Cir. 1986). However, sufficient information must be provided to show that the inventor had possession of the invention as claimed. See MPEP 2163 (II)(2).
A "representative number of species" means that the species which are adequately described are representative of the entire genus. See MPEP 2163(III)(a)(ii).
The Federal Circuit has explained that a specification cannot always support expansive claim language and satisfy the requirements of 35 U.S.C. 112 "merely by clearly describing one embodiment of the thing claimed." LizardTech v. Earth Resource Mapping, Inc., 424 F.3d 1336, 1346, 76 USPQ2d 1731, 1733 (Fed. Cir. 2005). The issue is whether a person skilled in the art would understand inventor to have invented, and been in possession of, the invention as broadly claimed. In LizardTech, claims to a generic method of making a seamless discrete wavelet transformation (DWT) were held invalid under 35 U.S.C. 112, first paragraph, because the specification taught only one particular method for making a seamless DWT and there was no evidence that the specification contemplated a more generic method. Id.; see also Tronzo v. Biomet, 156 F.3d at 1159, 47 USPQ2d at 1833 (Fed. Cir. 1998)(holding that the disclosure of a species in a parent application did not provide adequate written description support for claims to a genus in a child application where the specification taught against other species). See MPEP 2163(III)(a)(ii).
Claims 1 and 10 fails to sufficiently describe the invention with the amplifiers used in enough detail for one skilled in the art to have possession of the broadly claimed genus, and sufficient written description support. Although the 2 amplifiers are used is used in the instant specification, the instant specification states that a differential amplifier cannot be used: [0065] “the two amplifiers 411 and 412 used in the present invention are not differential amplifiers but single-ended input amplifiers” and [0082] “the effect of power line interference cannot be eliminated using a differential amplifier whose input is connected to the electrodes 111 and 113 or a differential amplifier whose input is connected to the electrodes 112 and 113.” Although the claim only requires 1 single ended input amplifier, however the instant specification requires 2 single-ended input amplifies, which cannot be differential amplifiers because the invention would function as intended. Similar to Lizardtech, there is no evidence that the specification contemplated a more generic method of any amplifier for the second electrode. The instant specification fails to disclose any other embodiment/species, and therefore does not have a representative number of species to claim the genus, as instantly claimed. Therefore, claims 1-18 do not provide sufficient detail for a person skilled in the art to have been in possession of the invention as broadly claimed.
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 1-18 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.
Regarding claim 1, it is unclear if the “third electrocardiogram electrode” of line 26 is the same or different than the “third electrocardiogram electrode” of lines 14-15.
Regarding claims 1 and 10, it is unclear if a “minute current” is the same or different than the “micro current” defined in [0095] of the instant specification.
Regarding claims 1 and 10, the phrase “impedance looking into the ECG measurement circuit”, is unclear as to how an impedance is “looked into”, and how this “looking into” is measured.
Conclusion
Claims 1-18 overcome the prior art but are still rejected under 35 U.S.C. 112(a) and 112(b).
The following is a statement of reasons for the indication of the claims overcoming the prior art:
Following the generation of alarm based on the PPG parameters, the generation of 2 ECG signals simultaneously from 2 separate electrodes and the use of 3 electrodes in which an output is generated with a current detector when 2 electrodes are contacted by the skin, wherein the current detector causes a minute current to flow through the two electrocardiogram electrodes and generates the output by detecting the minute current, the current detector being continuously supplied with power required for operation amplifying the two electrocardiogram signals inputted to the first and second electrocardiogram electrodes simultaneously by using two amplifiers built in the electrocardiograph, wherein at least one of the two amplifiers is a single-ended input amplifier configured to receive and amplify an electrocardiogram signal: and wherein an impedance looking into the electrocardiogram measurement circuit through a third electrocardiogram electrode among the at least three electrocardiogram electrodes is lower than respective impedances looking into the electrocardiogram measurement circuit through the first and second electrocardiogram electrodes are not conventionally relied upon in removing power line interference from ECG collection and are therefore allowable over the prior art.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Peterson et al. (US 20160029915), Guermandi et al. (“A Driving Right Leg Circuit (DgRL) for Improved Common Mode Rejection in Bio-Potential Acquisition Systems”, IEEE Transactions on Biomedical Circuits and Systems ( Volume: 10, Issue: 2, April 2016)), and Jiang et al. (“Effective Biopotential Signal Acquisition: Comparison of Different Shielded Drive Technologies”, MDPI, Appl. Sci. 2018, 8(2), 276). Examiner notes that these references deviate from the claimed invention as they use differential amplifiers for directing interference through one electrode, via the determination of a common-mode rejection ratio, which the instant specification makes the point that differential amplifiers cannot be used (see [0064]).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOUSSA M HADDAD whose telephone number is (571)272-6341. The examiner can normally be reached M-TH 8:00-6:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at (571) 270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOUSSA HADDAD/Examiner, Art Unit 3796
/REX R HOLMES/Primary Examiner, Art Unit 3796