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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-3, and 5-7 in the reply filed on 4/30/26 is acknowledged.
Examiner’s notes/Claim Interpretation
The following notes on claim construction under the broadest reasonable interpretation for Claims 1-3, 5-7, are reiterated:
a) The “continuous ECG unit” of the preamble does not require any type of controller, processor, or circuit that is configured to detect and produce a continuous ECG.
b) The “wrist-worn device” is not positively recited by the claims. It is only recited as part of the intended use of “couplable to a wrist-worn device” of the preamble. The wrist-worn device has not been introduced in the body of the claim as a part of the “unit”. Given this, the “first and second ECG sensing surfaces”, the “peripheral member”, and all other details of the wrist-worn device, are also not positively recited by the claim.
c) The “connecting element” is not positively recited by the claims. It is only recited as part of the intended use of “connectable by a connecting element to…the wrist-worn device”. Given this, the “electronic pad(s)”, the “peripheral member”, and all other details of the connecting element, including the “is attached to the inner side of the peripheral wall” are also not positively recited by the claim.
It is also noted here that the “connecting element” does not invoke 112f, because it is defined by the “electronic pad”.
d) The “electronics pad(s)” are interpreted as electrode/conductive pads in light of the use of this term in the art (e.g. US 20090240297 by Shavit, ¶¶ 30-34; US 20140222095 by Einy, ¶ 39; US 20140099618 by Yang, ¶ 14). In other words, they do not require circuit boards or associated circuitry etc.
e) The “extended ECG electrode” includes all types of extension, including the electrode extending (ie. from point A to point B) on a surface of the unit or other part. In other words, “extended” does not necessarily require being an extension of the unit.
f) The claims do not require any type of removability for any element.
g) A “sensing surface” is interpreted as any surface capable of being used for sensing. For example, an “ECG sensing surface” is simply a surface that is conductive. A “pulse oximetry sensing surface” is simply a surface that permits pulse oximetry to be performed (e.g. a light transmitting surface for optical oximetry). A “temperature sensor sensing surface” is a surface that permits temperature sensing (e.g. a heat conductive surface, or a heat radiation transmitting surface). None of these surfaces require actual sensors.
h) All intended uses, or fields of use claimed, including those involving the aforementioned non-required elements, would be met, so long as the device is capable of the intended uses or usable in the fields of use.
i) The only structural elements positively recited in Claim 1, remain two: i) the “extended electrode”, and ii) the “casing”.
If Applicant wishes to positively recite a structural element as part of the claimed device, they should first introduce the structural element, such as in the following format:
1. A device comprising:
a main body;
a sensor unit in the main body;
a cable;
an electrode, wherein the electrode is connected to the main body via the cable.
Claim Interpretation
Claims 1-3, 5-7 are objected to because of the following informalities: 1) In Claim 1, line 10, “configured to” should include a colon (ie., “configured to:”), since it is following by multiple intended uses, 2) In Claim 1, “maintaining” should be “maintain”. 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 1-3, 5-7 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.
1) Regarding Claim 1, “tightly” is subjective and relevant, making the scope of the claims unclear.
2) Regarding Claim 1, it is not clear whether the “a peripheral member” of line 10 is the same or different than the “a peripheral member” of line 5. This also creates antecedence issues for the subsequent “the peripheral member” in line 13. Which of the two recitations of “a peripheral member”, does “the peripheral member” refer to?
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.
Claims 1-3, and 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over US 20180035943 by Shemesh in view of US 20200233381 by Yang.
Regarding 1, Shemesh teaches an ECG unit (e.g. ¶ 17: ECG) capable for use in continuous ECG (e.g. ¶ 21: continuous ECG) and capable of being coupled to a wrist-worn device that comprises a first and second ECG sensing surfaces (e.g. ¶ 15, 19: watch/wristband with multiple sensors; As noted in the claim interpretation notes above, the “wrist-worn device” is only recited as part of an intended use or field of use), the continuous ECG unit comprising:
an extended ECG electrode (e.g. ¶¶ 20-21,104, Fig. 7: removable external ECG pads) capable of being electronically connected by a connecting element to a first ECG sensing element of an ECG electrode that is formed on a peripheral member of the wrist-worn device, the connecting element comprising a first electronic pad configured for electronically coupling with the first ECG sensing surface (e.g. ¶¶ 20-21,104, Fig. 7 and claim interpretation notes above: the external ECG pads are clearly capable of being connected by a cable connecting element. The connecting element and the details thereof are not positively recited, and the external ECG pads would be capable of being connected by a hypothetical connecting element having a conductive pad as claimed);
a casing comprising a peripheral wall having an inner side and an external side (e.g. the casing of the watch as clearly shown in Fig. 1, Fig. 2C, Fig. 2G, Fig. 2F, Fig. 3B), wherein a part of the connecting element is attached to the inner side of the peripheral wall (as noted above, the connecting element is not positively recited and the device of Shemesh would be capable of being connected with the hypothetical connecting element as claimed), the casing being configured to (i) tightly fit over a peripheral member of the wrist-worn device that comprises said first ECG sensing surface (again, the wrist-worn device is not positively recited, and the casing of Shemesh would be capable of fitting over the hypothetical wrist worn device claimed), (ii) accommodate at least a part of the connecting element such that at least portions of the connecting element are disposed between the peripheral member and the casing, when being fitted over the peripheral member so as to maintain a constant contact of the first electronic pad with the first ECG sensing surface (again, the connecting element is not positively recited, and the casing of Shemesh would be capable of accommodating a hypothetical connecting element as claimed), and (iii) maintaining a bottom face of the wrist-worn device medical watch that comprises the second ECG surface exposed (again, the wrist-worn device is not positively recited, and the casing of Shemesh would be capable of maintaining a hypothetical bottom face of a hypothetical wrist-worn device as claimed). Thus, apart from the explicit teachings of the casing already being integrated to a wristwatch with multiple sensing surfaces on the top, bottom and sides of the watch (e.g. ¶¶ 17-21, 103-104, Fig. 1, 2F-2G), there is nothing in Shemesh preventing the casing from being docked onto a hypothetical wrist worn device as claimed, including the hypothetical connecting element as claimed, which alone is sufficient to meet the intended uses of the claim. Also see claim interpretation notes, and MPEP 2112.V.
Shemesh does not explicitly disclose that the casing is made of an insulating material.
However, Yang teaches an analogous ECG device which includes a wrist-worn device having multiple sensing surface, including electrode extensions, wherein the housing of the wrist-worn device is insulated from the electrode surfaces and made of plastic (e.g. ¶¶ 13, 78, Fig. 1, Fig. 3, Fig. 4: housing 161 is insulated from electrodes 12 and 13). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate insulating material, such as plastic, to the casing of a device according to the teachings of Shemesh, as taught by Yang, as: a) the selection of a known material based upon its suitability for the intended use is a design consideration within the skill of the art (In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960)), and b) this would predictably prevent short circuits, interference, noise, and faulty measurements.
Regarding Claim 2, Shemesh as modified in Claim 1 teaches the continuous ECG unit of claim 1, wherein the connecting element is further couplable to a ground connection formed in the wrist-worn device (as noted above, the connecting element is not positively recited, and the external ECG pads of Shemesh would be capable of being connected to a hypothetical connecting element capable of being coupled to a hypothetical ground).
Regarding Claim 3, Shemesh as modified in Claim 1 teaches the continuous ECG unit of claim 1, wherein at least part of the connecting element is a flexible PCB ((as noted above, the connecting element is not positively recited, and the external ECG pads of Shemesh would be capable of being connected to a hypothetical connecting element that is a flexible PCB).
Regarding Claim 5, Shemesh as modified in claim 1, teaches the continuous ECG unit of claim 1, wherein the casing is designed to allow access for additional one sensing elements of wrist-worn device (e.g. Fig. 1: temperature sensor at the top, ECG/PPG at the sides; Fig. 2C: two ECG electrodes and a PPG sensor at the bottom).
Regarding Claim 6, Shemesh as modified in claim 1, teaches the continuous ECG unit of claim 5, wherein the casing comprises apertures allowing accessibility to said additional sensing element (e.g. Fig. 1: temperature sensor at the top, ECG/PPG at the sides; Fig. 2C: two ECG electrode and a PPG sensor with two photodiodes at the bottom, all involving apertures or windows for contact, e.g. ¶92, PPG apertures).
Regarding Claim 7, Shemesh as modified in claim 1, teaches the continuous ECG unit of claim 5, wherein said additional sensing element comprises a pulse oximetry sensing surface and/or a temperature sensor sensing surface (e.g. Fig. 1: temperature sensor at the top, PPG at the sides; Fig. 2C: a PPG sensor with two photodiodes at the bottom, all involving apertures or windows for contact, e.g. ¶92, PPG apertures).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MANOLIS Y PAHAKIS whose telephone number is (571)272-7179. The examiner can normally be reached M-F 9-5, EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CARL LAYNO can be reached at (571)272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MANOLIS PAHAKIS/Examiner, Art Unit 3796
Prosecution Insights