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 Objections
Claim 2, 4, 6-7, 9, and 14 objected to because of the following informalities:
In claim 2, recites “configured for interchangeable attachment …” is grammatically incorrect. Suggested correction is “configured to be interchangeably attached …”.
In claim 4 and 14, the abbreviation “EGC” and “EEG” is inconsistent for “electrocardiogram”, suggested correction is “ECG or EKG”.
In claim 6-7 and 9, recites "further comprising” without previously reciting a comprising to begin with (i.e. since claim 1 never recited “comprising” or any other transitional phrase), so it cannot "further" comprise.
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.
Claim 1-4 is/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. These claims do not actually recite any limitations of "the device" other than its intended use, therefore failing to point out what is required by the claim. In other words, the claims are essentially only a preamble, but missing a transitional phrase and body of the claim.
Claim 2-5 and 7-10 is/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. These claims recite "A device according to claim ...", it should be "The device according to claim …". When it states “A device …” it is unclear if it is requiring all of the limitations of claim 1.
Claim 1, 10, and 17 is/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 limitation “wrist fastening means” has been evaluated under the three-prong test set forth in MPEP § 2181, subsection I, but the result is inconclusive. Thus, it is unclear whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the recitation renders the scope of the claim unclear. The specification does disclose “hook-and-loop” for fastening means as corresponding structure but it is unclear whether the claimed wrist fasting means encompasses all such structures. Therefore, the metes and bounds of the claim cannot be determine with reasonable certainty. Applicant may wish to amend the claim to recite the specific structure for clarity. The boundaries of this claim limitation are ambiguous; therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
In response to this rejection, applicant must clarify whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Mere assertion regarding applicant’s intent to invoke or not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph is insufficient. Applicant may:
(a) Amend the claim to clearly invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by reciting “means” or a generic placeholder for means, or by reciting “step.” The “means,” generic placeholder, or “step” must be modified by functional language, and must not be modified by sufficient structure, material, or acts for performing the claimed function;
(b) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, should apply because the claim limitation recites a function to be performed and does not recite sufficient structure, material, or acts to perform that function;
(c) Amend the claim to clearly avoid invoking 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by deleting the function or by reciting sufficient structure, material or acts to perform the recited function; or
(d) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, does not apply because the limitation does not recite a function or does recite a function along with sufficient structure, material or acts to perform that function.
Claim 3-4 and 6 is/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 3 recites the device “performing any of a SpO2 measurement, a Photoplethysmography (PPG), a galvanic skin response (GSR), an electrodermal activity or a combination thereof”. The phrase “any of” renders the scope of the claim unclear because there is a question or doubt as to whether the claim requires one single measurement, all of the measurements, or selected/subset of the measurement.
Regarding claim 4 and 6, claim 4 recites “the device is configured to be removably connected to external electrodes, preferably to electrocardiogram (EGC) electrodes” and claim 6 recites “a printed circuit board, preferably an optoelectronic circuit board”, where the phrase “preferably” is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20220128950 A1 to Trapero Martin (hereinafter “Trapero”).
Regarding Claim 1 and 10, Trapero teaches a device (see Para 51: “an electronic device 100”) for measuring and/or monitoring physiological signals of a user (see Para 05 : “The electronic device further includes one or more sensors provided within the chamber and configured to interface with a user to generate physiological data associated with the user” and Para 117: “the optical sensors 2034 may be used to determine blood oxygen levels, blood pressure, and calibration for glucose level. Blood oxygen saturation (SpO.sub.2) is an important vital sign for assessing a user's physical health”), the device being configured to be attached to a first wearable holder (see Para 77: “a smartwatch configuration 900 of the electronic device 100”, also Para 92 and Fig. 9A-9C) and to a second wearable holder (see Para : “The electronic device 100 can be configured in a smart patch configuration”), each of the first and second wearable holders being configured to be attached to a different part of a body of the user (see Para 77: “smartwatch configuration 900 (wrist)” and Para 107: “a smart patch 1900 on the left chest area of a user”, also Fig 9C and 19), the first wearable holder having a first holding frame (see Para 77: “The smartwatch configuration 900 includes hands or straps 904, 906 that couple with the electronic device 100”, also Para 78) configured to be removably attached to the device (see Para 85: “a method of engaging and disengaging a strap”, also Fig. 11A-11D) and to wrist fastening means (see Para 77: “the electronic device 100 to be wearable on a wrist of the user” and Fig. 9A-9C).
Regarding Claim 2, Trapero further teaches the device above, wherein the device is configured for interchangeable attachment between the first and second wearable holders (see Para 77: “The electronic device 100 can be adorned in multiple manners. For example, straps, bands or adhesive patches can be used with the electronic device 100 to secure the electronic device 100 to a body part of the user” and Para 92: “the electronic device 100 of FIG. 1 in a smartwatch configuration (e.g., the smartwatch configuration 900). The electronic device 100 can be configured in a smart patch configuration” (same electronic device is disclosed changing holders in different configuration)).
Regarding Claim 3, Trapero further teaches the device above, wherein the device is configured for performing any of a SpO2 measurement, a photoplethysmography (PPG) (see Para 117: “Signals extracted from the optical sensors 2034 may be used to determine blood oxygen levels, blood pressure, and calibration for glucose level. Blood oxygen saturation (SpO.sub.2) is an important vital sign for assessing a user's physical health as low blood oxygen levels can indicate hypoxemia, which can compromise organ functions, if it is not properly treated. Blood volume changes in the microvascular bed of tissue of the user's body part in contact with the electronic device 2000 can be calculated through photoplethysmogram (PPG) sensing”), a galvanic skin response (GSR) an electrodermal activity or a combination thereof (see Para 113: “The sensors 2002 can include FDA sensors 2026 for measuring electrical properties of skin. The FDA sensors 2026 can measure galvanic skin response or skin potential, resistance, and/or conductance”).
Regarding Claim 4, Trapero further teaches the device above, wherein the device is configured to be removably connected to external electrodes, preferably to electrocardiogram (EGC) electrodes (see Para 93: “The patch assembly 1200 includes one or more electrodes 1202. The electrodes 1202 can be ECG electrodes …” also Fig 12-14 and Para 109”).
Regarding Claim 5, Trapero further teaches the device above, wherein the device comprises pins for connecting the external electrodes to the device when the device is attached to the second wearable holder (see Para 93: “The patch assembly 1200 includes one or more electrodes 1202 … The electrodes 1202 can be electrically and mechanically coupled to connecting members 1225 that can snap into a corresponding connecting member (e.g., the connecting member 224 of FIG. 3) on the electronic device 100”, also Para 61 and 103 (male/female snap connector)).
Regarding Claim 6, Trapero further teaches the device above, a casing comprising a first portion and a second portion (see Para 51: “The electronic device 100 can include a housing with a top portion 102 and a bottom portion 104”) defining a hollow cavity (see Para 51: The top portion 102 and the bottom portion 104 of the housing, when interfacing with one another, form an enclosed chamber”), the first portion comprising one or more holes extending between two opposite surfaces (see Fig. 2 and Para 93 and 76), and a first electrode (see Para 82: “the side touch track 220 … configured as an ECG electrode); and the second portion comprising an internal side and an external side which are opposite to each other (see Fig. 2-6), one or more holes extending between the external and the internal sides (see Fig. 2-6) and a second electrode attached to the external side (see Para 126: “Electrodes … disposed on the bottom of the electronic device 2000”); and
a printed circuit board (see Para 54: “The electronic device 100 includes at least one printed circuit board (PCB)”), preferably an optoelectronic circuit board, configured to be fitted in the hollow cavity (see Fig. 2 (the first PCB 206 and/or the second PCB 208)), the printed circuit board comprising one or more radiation sources and/or one or more sensors configured to detect one or more signals (see Para 55: “The second PCB 208 can be a sensor PCB for gathering sensor data. The second PCB 208 can include one or more sensors and/or can be connected to one or more electrodes” also Para116).
Regarding Claim 7, Trapero further teaches the device above, further comprising pairs of radiation sources in the form of light emitting diodes (LEDs) wherein the pairs of radiation sources comprises at least one of a pair of green LEDs, a pair of yellow-green LEDs, a pair of red LEDs, the red LEDs being dual red/infrared LEDs configured to emit red and infrared electromagnetic radiation (see Para 116: “The optical sensors 2034 can include non-visible light sensors such as infrared and/or visible light sensors provided with blue, red or green LED” also Para 117).
Regarding Claim 8, Trapero further teaches the device above, wherein the pairs of radiation sources are arranged around a photodiode area of the device (see Para 116-117: “One or more emitters and the one or more photodetectors can be provided on a PCB and used as an optical array measurement system. The photodetectors and/or the emitters can be arranged in a circle around a center …”).
Regarding Claim 9, Trapero further teaches the device above, comprising a casing which can be removably and securely attached to the first wearable holder and to the second wearable holder such that the first and second holders are interchangeable for use with the device (see Para 77 and 93 (device/casing assembly with watch and patch), and Para 98-100 (case body and patch housing arrangement) also Fig. 8-16).
Regarding Claim 11, Trapero further teaches the wearable system above, wherein the first wearable holder is configured to be attached to a wrist of the user's body (see Fig. 9C and Para 77: “The smartwatch configuration 900 allows the electronic device 100 to be wearable on a wrist of the user”; the first holding frame comprises a side which remains closer to the user's skin when the first wearable holder is attached to the user’s wrist (see Fig. 9A-11C, and Para 83-91 (watch strap and device inserted and secured through groove structure)); and the first holding frame is further configured to allow the device to be inserted through the side of the first holding frame (see Fig. 9A-11C, and Para 83-91).
Regarding Claim 12, Trapero further teaches the wearable system above, wherein the first wearable holder is configured to be attached to the user's wrist (see Para 77 and Fig. 9C), and the second wearable holder is configured to be attached to a chest of the user's body (see Para 107 and Fig.19).
Regarding Claim 13, Trapero further teaches the wearable system above, wherein the second wearable holder comprises a patch (see Para 92-93: “smart patch”).
Regarding Claim 14, Trapero further teaches the wearable system above, wherein the patch comprises one or more electrocardiogram (ECG), external electrodes (see Para 93: “The patch assembly 1200 includes one or more electrodes 1202. The electrodes 1202 can be ECG electrodes …”).
Regarding Claim 15, Trapero further teaches the wearable system above, wherein the second wearable holder further comprises an adhesive layer attached to the patch and a second holding frame configured to be removably attached to the device (see Para 100: “The patch assembly 1200c thus includes adhesives on both the first surface 1210 and the second surface…” and Para 108-109).
Regarding Claim 16, Trapero further teaches the wearable system above, wherein the first and second wearable holders comprise one or more snap-in pockets, and the device comprises one or more protrusions , or vice versa (see Para 61: “the connecting member 224 includes a male (or a female) snap connector that can mechanically interface with a female (or a male) counterpart outside the electronic device 100”, also Para 66, 70-71, 93); the protrusions and snap-in pockets being configured to fit each other (see Para 103).
Regarding Claim 17, Trapero further teaches the wearable system above, further comprising the wrist fastening means (see Para 77-78 (straps 904, 906)).
Regarding Claim 18, Trapero further teaches the wearable system above, wherein the first wearable holder further comprises a clamp which is curved, forms a single piece and protrudes from the first holding frame (see Fig. 9A – 11C and Para 77-84), and further comprises a curved rigid element that is hingedly connected to the first holding frame (see Fig. 9A – 11C, and Para 77-84); the curved rigid element being configured to pivot about the first holding frame so that an end of the curved rigid element can go around and be attached to a surface of the clamp (see Fig. 9A – 11C, and Para 77-84); and the curved rigid element, the first holding frame and the clamp form a bracelet when the end of the curved rigid element is attached to the surface of the clamp (see Fig. 9A – 11C, and Para 77-84).
Regarding Claim 19, Trapero further teaches the wearable system above, further comprising hook-and-loop means via which the end of the curved rigid element is attachable to and can be removably fastened to the surface of the clamp (see Fig. 9A – 11C, and Para 77-84).
Regarding Claim 20, Trapero further teaches the wearable system above, wherein the clamp comprises a bent portion at an end of the clamp, the bent portion being disposed on an opposite side of the clamp to which the first holding frame is connected, and the bent portion being curved oppositely compared to the rest of the clamp (see Fig. 9A – 11C, and Para 77-84).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
WO 2021260044 A1 - A wearable device for monitoring physical activity of a user, the wearable device being reversibly attachable to a chest strap and an arm strap.
US 9730591 B2 - A removable wrist device in a continuous physiological monitoring system.
US 20160192716 A1 - Apparatus for selectively attaching physiological sensor pod to different types of wearable apparel.
US 20210241900 A1 - A smart patch to monitor health metrics of a user.
US 10058149 B1 - A watch band can provide both a physical connection and an electrical connection with a watch body of a watch.
WO 2021102050 A1- a portable biometric monitoring device having a central pod, sensor electrodes, and a wearable band.
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/I.J./Examiner, Art Unit 3792
/JOHN R DOWNEY/Primary Examiner, Art Unit 3792
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