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 response filed 16 December 2025. As per the amendment: claims 11-21 remain withdrawn, claims 1, 5-6, 9-11 have been amended, claims 4 and 7 have been cancelled, and claims 22-23 have been newly added. Thus, claims 1-10 and 22-23 are presently pending and under examination.
Response to Arguments
Response to Arguments Regarding 35 U.S.C. § 112
Applicant’s arguments, see pg. 6 of Remarks, filed 30 March 2026, with respect to 35 U.S.C. § 112(b) have been fully considered and are persuasive. The 112(b) rejection of claims 1 and 5 have been withdrawn.
Applicant’s arguments, see pg. 7-8, filed 30 March 2026, with respect to the rejection(s) of claim(s) 1,2, and 4-10 under 35 U.S.C. 102 in view of Trapero have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Ariyama et al. (US 2019/0209031 A1), hereinafter Ariyama , and in view of Bernstein (US Patent 7,806,860 B2), hereinafter Bernstein.
Applicant has amended independent claim 1 to recite the limitation of “a bioimpedance and electrodermal activity sensor including a plurality of bioimpedance and electrodermal electrodes that are each arranged in spaced apart relation to one another along a line such that each of the plurality of bioimpedance and electrodermal electrodes are aligned with one another, and a photoplethysmography sensor arranged in alignment with the plurality of bioimpedance and electrodermal electrodes along the line; wherein the single-sided electrocardiography sensor is offset from the line” (emphasis added).
Examiner notes that Trapero teaches the bioimpedance and electrodermal electrodes to be aligned as well as the photoplethysmography sensor (as shown in detail below). Additionally, Examiner notes that Trapero’s structure allows for it to be attached along the brachial artery. However, to further expedite prosecution, Bernstein was also used to teach the alignment of bioimpedance and electrodermal electrodes to be placed along the brachial artery. Trapero and Bernstein, alone or in combination, fail to teach the ECG electrodes to be offset from the line.
However, Ariyama teaches the ECG electrodes to be placed across from the brachial artery in a line perpendicular to the artery (as described in detail below).
Thus, Trapero was used to teach the using ECG/BI electrodes for glucose monitoring, Bernstein and Ariyama were used to establish the positions and orientations of the electrodes.
Additionally, Examiner would like to make note that no criticality for the ECG signals to be offset from the bioimpedance electrodes, and thus it would have been obvious to try, by one of ordinary skill in the art before the effective filing date of the claimed invention to pick an ideal position of the ECG sensor and the bioimpedance sensors and incorporate it into the system of Trapero since there are a finite number of identified predictable potential solutions to have the recognized need (signal acquisition) and one of ordinary skill in the art would have pursued the known potential solutions (as shown in Bernstein and Ariyama) with a reasonable expectation of success.
Thus, claims 1-2, 5-6, 8-10, and 23 are rejected as described in detail below.
No specific additional arguments were presented for previous 35 U.S.C. 103 rejection of dependent claim 3 nor specifically with respect to the previously cited reference: Sobel.
Thus, claim 3 remained rejected as described in detail below.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“a fixation element” in claims 1 and 5.
“a communication module” in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
For the limitation “a fixation element” in claims 1 and 5, the specification recites “a fixation element configured to secure a skin-facing side of the at least one sensor housing to exposed skin of a user” ([0015]) such as straps ([0044]) and adhesive patch ([0046]). Therefore, the examiner is interpreting the fixation element to be a strap or an adhesive patch.
For the limitation “a communication module” in claim 1, the specification recites “a communication module configured to receive signals from the plurality of non-invasive sensors and output data from the device”, such as input/output devices, e.g., a keyboard, a printer, and/or display devices ([0097]), computer processor ([0016]), smartphone, and electronic devices ([0043]). Therefore, the examiner is interpreting the communication module to be an input/output device, a processor, smartphone, or electronic device.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 1-2, 5-6, 8-10, and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Trapero et al. (US Patent 11,166,635 B2, previously cited), hereinafter Trapero in view of Ariyama et al. (US 2019/0209031 A1), hereinafter Ariyama , and alternatively in view of Bernstein (US Patent 7,806,860 B2).
Regarding claim 1, Trapero discloses a wearable multi-sensor device (smart patch 100, smart patch 400) for measuring physiological properties (Column 9, line 64 – Column 10, line 3: “The smart patch 100 can include an electronics module 106 coupled to a patch substrate 104. The electronics module 106 can enclose the electronic circuitry and sensors for recording, storing, processing, and/or wirelessly transmitting (e.g., to a user device, such as a smartphone, or server over a communications network) a user's physiological health metrics.”), the device comprising:
at least one sensor housing (user-facing surface 448) comprising a plurality of non-invasive sensors including:
a single-sided electrocardiography sensor (electrodes 438A, 438B, 440A, 440B, Column 13, lines 27-33: “Electrical signals can be transmitted and/or received via any suitable electrode 338A, 338B, 340A, 340B. In some cases, the outer electrode pair 338 can be used for the injection of electrical current into the skin of the user for BI measurement purposes. In some cases, inner electrode pair 340 can be used for measuring electrical signals from the skin of the user to acquire ECG data and BI data.”, Examiner notes that the electrodes 438 and 440 are similar to the electrodes 338 and 340 in Figure 3.),
a bioimpedance (Column 13, lines 27-33) and electrodermal activity sensor (Column 14, lines 10-15: “Sensor window 436 can permit one or more sensors (e.g., non-contact sensors) to access the skin of the user. In some cases, the one or more sensors can include…electrodermal activity (EDA) sensors (e.g., galvanic skin response sensors).”) including a plurality of bioimpedance and electrodermal electrodes that are each arranged in spaced apart relation to one another along a line such that each of the plurality of bioimpedance and electrodermal electrodes are aligned with one another (view Figure 3, , Column 22, lines 17-18: “two pairs of electrodes are provided in a nested, linear array.”), and
a photoplethysmography sensor (Column 14, lines 10-15: “Sensor window 436 can permit one or more sensors (e.g., non-contact sensors) to access the skin of the user. In some cases, the one or more sensors can include…optical sensors (e.g., PPG sensors)…”) arranged in alignment with the plurality of bioimpedance and electrodermal electrodes along the line (view Figure 3);
a fixation element configured to secure a skin-facing side of the at least one sensor housing to exposed skin of a user (Column 13, lines 43-45: “the user-facing surface 348 can be covered with or can include an adhesive layer (e.g., a biocompatible and preferably breathable adhesive layer) and/or a gel layer (e.g., conductive hydrogel layer)”, Column 8, line 64-Column 9, line 1: “The smart patch can be affixed to a user, such as the chest of the user, using adhesive. The smart patch can use its integrated sensors and electrodes to acquire physiological signals from direct contact with the user's skin”); and
a communication module configured to receive signals from the plurality of non-invasive sensors and output data from the device (Column 14, lines 35-37: “The ECG/BI measurement system 502 can be any suitable ECG/BI measurement system incorporated into any suitable device”, Column 14, lines 44-47: “The ECG/BI measurement system 502 can include…a communication module 522…”, Column 16, lines 28-29: “The sensing module 530 can receive signals from the inner electrodes 540 and output one or more data signals”, view Figures 5-7).
Examiner interprets the line in this case to be the line of the brachial artery. Examiner would also like to make note that “[A]pparatus claims cover what a device is, not what a device does”. Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). Therefore, since the limitation “arranged in spaced apart relation to one another along a line” is a functional limitation and Trapero’s device has all the structural limitations (i.e. a fixation element, a sensor housing, bioimpedance and electrodermal activity sensors, PPG sensors, ECG sensor, current and voltage electrodes, etc.), Trapero’s device can thus also be arranged to be placed in a line along a path of the brachial artery location.
Trapero fails to explicitly disclose wherein the single-sided electrocardiography sensor is offset from the line.
However, Ariyama teaches a multi-sensor upper arm cuff ([0002], Figure 1 and 11) wherein the single-sided electrocardiography sensor is offset from the line (view Figures 6 and 11, [0040] “the blood pressure measuring device 100 is stuck over a brachial artery 2 of a left upper arm 1…electrode 101 and the second electrode 102 crossing over an artery”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Trapero to incorporate the teachings of Ariyama to have the single-sided electrocardiography sensor offset from the line, as these prior art references are directed to measuring electrocardiogram signals from the arm region. One would be motivated to do this as the placement of the ECG sensors crossing over the artery allows for a favorable position for measurement and to obtain a signal even if it is weak, as recognized by Ariyama.
Alternatively, Bernstein (US Patent 7,806,860 B2) teaches an apparatus for measuring bioimpedance from a patient’s upper arm (Abstract) wherein a single-sided electrocardiography sensor (EKG electrodes 118, view Figure 1), a plurality of bioimpedance and electrodermal electrodes that are each arranged in spaced apart relation to one another along a line such that each of the plurality of bioimpedance and electrodermal electrodes are aligned with one another (view Figure 1: electrodes 106, 108, 112, 114); wherein the single-sided electrocardiography sensor is offset from the line (Column 6, lines 28-47: “Many different methods of applying the electrodes or electrode arrays to the arm are envisioned, such as spot electrodes, arm band(s) both circumferential and non-circumferential, adhesive strips or other attachment means known in the art. In one embodiment, an 8 spot-electrode array can be implemented. Alternatively, in another embodiment, a 4 spot-electrode array, placed on the inner, or medial aspect of the upper arm, proximate the brachial artery, can be implemented… In another embodiment, EKG 116 may also be measured by placing EKG electrodes 118 on the patient 100. In the figure, a 3-lead EKG is shown and EKG is measured by known means.”, view Figure 1).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Trapero to incorporate the teachings of Bernstein to have the single-sided electrocardiography sensor is offset from the line, as these prior art references are directed to multi-sensor apparatuses. One would be motivated to do this as these are ideal locations to obtain this data.
Additionally, Examiner would also like to note that it would have been obvious to try, by one of ordinary skill in the art before the effective filing date of the claimed invention to pick an ideal position of the ECG sensor and the bioimpedance sensors and incorporate it into the system of Trapero since there are a finite number of identified predictable potential solutions to have the recognized need (signal acquisition) and one of ordinary skill in the art would have pursued the known potential solutions (as shown in Bernstein and Ariyama) with a reasonable expectation of success.
Regarding claim 2, Trapero in view of Ariyama (alternatively in view of Bernstein) teaches the device of claim 1 (as shown above), Trapero further discloses wherein the data is suitable for use in predicting glycemic events in the user (Column 4, lines 46-49: “The acquisition of ECG data and BI data from a single, wearable device can also facilitate analysis, estimation, and prediction about other physiological metrics or medical conditions of an individual.”, Figure 15, Column 29, lines 51-58: “FIG. 15 is a flowchart depicting a process for obtaining a glucose level using PPG, ECG, and bioimpedance measurements from a wearable device, according to certain aspects of the present disclosure. The wearable device can be any suitable wearable device, such as wearable device 12110 of FIG. 12 or smart patch 100 of FIG. 1. The process depicted in FIG. 15 can include similar steps to the process depicted in FIG. 14.”) .
Additionally, Examiner would like to note that “[A]pparatus claims cover what a device is, not what a device does”. Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). Therefore, Trapero’s device is capable of predicting glycemic events in the user.
Regarding claim 5, Trapero in view of Ariyama (alternatively in view of Bernstein) teaches the device of claim 1 (as shown above). Trapero further discloses wherein the exposed skin of the user includes the user’s upper arm, wherein the fixation element and the least one sensor housing are configured to locate the bioimpedance and electrodermal activity sensor proximal to a brachial artery location of the user (Column 26, lines 35-43: “The wearable device 12110 may be a smartwatch, smart ankle bracelet, smart glasses, smart ring, smart patch, band, smart bra, smart clothing, digital stethoscope, or other device that suitably could be retained on the user 12100 and give access to the patient's 12100 skin to various sensors on the wearable device 12110. In some examples, the wearable device 12110 may include adhesive and stick onto a patient's 12100 skin on the neck, chest, arm, leg, torso, back or other suitable locations.”).
Examiner would like to note that “[A]pparatus claims cover what a device is, not what a device does”. Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). Therefore, Trapero’s device with a fixation element and a sensor housing with bioimpedance and electrodermal activity sensors (as shown in Claim 1) can be configured to be located proximal to a brachial artery location of the user.
Regarding claim 6, Trapero in view of Ariyama (alternatively in view of Bernstein) teaches the device of claim 5 (as shown above). Trapero further discloses wherein the plurality of bioimpedance and electrodermal electrodes comprises at least one current-sensing electrode (outer electrodes) and at least one voltage-sensing electrode (inner electrodes, Column 2, lines 25-41: “BI monitoring can be performed on the body generally, and/or for any particular location on the body, such as on the chest (e.g., when the ECG/BI measurement system is incorporated into a smart patch worn on the user's chest). Although two electrodes can be used to inject and measure current, a tetrapolar (4-electrode) configuration can reduce measurement error that may be induced by electrode-tissue impedance (ETI), which can be an issue in bipolar electrode configuration systems. An impedance recording can be obtained using a specific electrode configuration where the electrodes are placed on the surface of the upper torso. Impedance can be measured by passing a small alternating current (AC) between any pair of electrodes connected to the skin. Thus, the measured impedance resulting from the voltage measured between another pair of electrodes reflects the ability of biological tissue to impede electric current.” ,Column 16, lines 6-12: “outer electrodes 538 are used for current injection and inner electrodes 540 are used for sensing, although this need not always be the case. In some cases, the roles of the electrode pairs can be reversed. In some cases, a pair of electrodes can be switched between injecting current and sensing (e.g., sensing ECG). In some cases, only a single pair of electrodes is used.”, Column 22, lines 17-20:” two pairs of electrodes are provided in a nested, linear array. In such an array, the inner electrodes may be shared between measuring impedance voltage”)).
Regarding claim 8, Trapero in view of Ariyama (alternatively in view of Bernstein) teaches the device of claim 1 (as shown above). Trapero further discloses wherein the photoplethysmography sensor comprises a multi-wavelength LED array (Column 12, lines 4-14: “The optical sensor 236 can be used for photoplethysmography (PPG) sensing. In such cases, the optical sensor 236 can include one or more light emitting diodes (LEDs) and one or more photodiodes, with LEDs emitting light and the photodiodes detecting light. Examples of suitable LEDs include green LEDs, red LEDs, infrared (IR) LEDs, blue LEDs, or yellow LEDs, although other LEDs can be used. When more than one light emitter is integrated, the plurality can include emitters with the same or different wavelengths. The optical sensor 236 for PPG measurements may include one or more light emitters and one or more photodetectors.”).
Regarding claim 9, Trapero in view of Ariyama (alternatively in view of Bernstein) teaches the device of claim 1 (as shown above). Trapero further discloses wherein the single-sided electrocardiography sensor comprises a plurality of electrocardiography (ECG) electrodes (Column 13, lines 22-24: “Either of the inner electrode pair 340 or the outer electrode pair 338 can be used as a shared pair of electrodes for both ECG and BI measurement.”, Column 2, lines 19-24: “The use of at least one pair of shared electrodes permits ECG and BI data acquisition with only a single pair of electrodes or two pairs of electrodes. When two pairs of electrodes are used, one or both pairs can be shared between ECG data acquisition and BI data acquisition.”).
Alternatively, Ariyama teaches wherein the single-sided electrocardiography sensor comprises a plurality of electrocardiography (ECG) electrodes ([0035] “The first electrode 101 and the second electrode 102 are electrodes for acquiring an electrocardiogram that is a weak electric signal flowing through an entire body.”)
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Trapero to incorporate the teachings of Ariyama to have the single-sided electrocardiography sensor comprise a plurality of electrocardiography (ECG) electrodes, as these prior art references are directed to wearable multi-sensor devices. One would be motivated to do this as a potential difference can be calculated allowing ECG to be measured even if the signal is weak, as recognized by Ariyama ([0041]).
Regarding claim 10, Trapero in view of Ariyama (alternatively in view of Bernstein) teaches the device of claim 7 (as shown above). Trapero further discloses wherein the at least one sensor housing comprises a plurality of ECG electrode housings each carrying one of the plurality of ECG electrodes, the plurality of ECG electrode housing being spaced apart from each other (Column 32, lines 49-53: “an electrode sitting at position 18404 on an adhesive substrate 18405 can represent an LA terminal for ECG measurements, and an electrode sitting at position 18406 on the adhesive substrate 18405 can represent the RA terminal.”, view Figure 18: the positions 18404 and 18406 are considered to ECG electrode housings which are spaced apart from each other, Figure 3 and 4).
Trapero fails to disclose the ECG electrode housing being spaced apart from each other along a second line that is different than the line.
However, (noting that Examiner interprets Trapero’s device to be placed along a brachial artery), Ariyama teaches the ECG electrode housing being spaced apart from each other along a second line that is different than the line (view Figure 11, electrodes are sandwiching the artery rather than being placed in line with the artery).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Trapero to incorporate the teachings of Ariyama to have the ECG electrode housing being spaced apart from each other along a second line that is different than the line, as these prior art references are directed to wearable multi-sensor devices. One would be motivated to do this as a potential difference can be calculated allowing ECG to be measured even if the signal is weak, as recognized by Ariyama ([0041]).
Regarding claim 23, Trapero in view of Ariyama (alternatively in view of Bernstein) teaches the device of claim 10 (as shown above). Examiner interprets the line in Trapero to be the line of the brachial artery. Examiner would also like to make note that “[A]pparatus claims cover what a device is, not what a device does”. Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). Therefore, since the limitation “arranged in spaced apart relation to one another along a line” is a functional limitation and Trapero’s device has all the structural limitations (i.e. a fixation element, a sensor housing, bioimpedance and electrodermal activity sensors, PPG sensors, ECG sensor, current and voltage electrodes, etc.), Trapero’s device can thus also be arranged to be placed in a line along a path of the brachial artery location.
Trapero fails to explicitly disclose wherein the second line and the line are perpendicular to one another.
However, Ariyama discloses the ECG electrodes sandwiching the brachial artery (view figure 11).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Trapero to incorporate the teachings of Ariyama to have the second line and the line be perpendicular to one another, as these prior art references are directed to wearable sensor devices. One would be motivated to do this as a potential difference can be calculated across the artery allowing ECG to be measured even if the signal is weak, as recognized by Ariyama ([0041]).
Claim(s) 3 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Trapero in view of Ariyama (alternatively in view of Bernstein) as applied to claim 1 above, in view of Sobel SI, Chomentowski PJ, Vyas N, Andre D, Toledo FGS. Accuracy of a Novel Noninvasive Multisensor Technology to Estimate Glucose in Diabetic Subjects During Dynamic Conditions. Journal of Diabetes Science and Technology. 2014;8(1):54-63. doi:10.1177/1932296813516182, hereinafter Sobel.
Regarding claim 3, Trapero in view of Ariyama (alternatively in view of Bernstein) the device of claim 1 (as shown above). Trapero further discloses wherein the plurality of non-invasive sensors further includes one or more of a skin temperature sensor (Column 15, lines 9-13: “the environmental sensor 520 can be positioned adjacent to the skin of the user when the ECG/BI measurement system 502 is being worn by the user, such as to acquire temperature and/or humidity data associated with the skin of the user.”, Column 14, lines 12-13: “the one or more sensors can include environmental sensors (e.g., a temperature and/or humidity sensor)”) and a motion sensor, the motion sensor configured to sense motion of the user wearing the device.
Trapero fails to explicitly disclose a motion sensor, the motion sensor configured to sense motion of the user wearing the device.
However, Sobel teaches a multisensory technology with integrated data analysis for estimate glucose concentrations in diabetes (Abstract) which can be used for glucose prediction systems (pg. 61, Discussion) wherein the technology includes a motion sensor, the motion sensor configured to sense motion of the user wearing the device (pg. 55, Methods, Armband System: “The SWA is worn around the upper arm and produces a plasma glucose estimation every minute, providing sequential glucoses over time. It contains 5 sensors: (1) a 2-axis accelerometer that tracks the movement and position of the upper arm and body…”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Trapero to incorporate the teachings of Sobel to have a motion sensor, the motion sensor configured to sense motion of the user wearing the device, as these prior art references and the instant application are directed to multi-sensor system for determining/predicting glucose levels. One would be motivated to do this as these parameters have been shown to have an impact on glucose concentrations and therefore would be helpful in predicting glucose levels, as recognized by Sobel (pg. 55).
Regarding claim 22, Trapero in view of Ariyama (alternatively in view of Bernstein) teaches the device of claim 3 (as shown above), wherein the skin temperature sensor is arranged in alignment with the plurality of bioimpedance and electrodermal electrodes and the photoplethysmography sensor along the line (Column 15, lines 9-13: “the environmental sensor 520 can be positioned adjacent to the skin of the user when the ECG/BI measurement system 502 is being worn by the user, such as to acquire temperature and/or humidity data associated with the skin of the user.”, Column 14, lines 12-13: “the one or more sensors can include environmental sensors (e.g., a temperature and/or humidity sensor)”, view Figure 4: sensor window is aligned with the BI electrodes 438 , Column 4, lines 10-15: “Sensor window 436 can permit one or more sensors (e.g., non-contact sensors) to access the skin of the user. In some cases, the one or more sensors can include environmental sensors (e.g., a temperature and/or humidity sensor), optical sensors (e.g., PPG sensors), or electrodermal activity (EDA) sensors (e.g., galvanic skin response sensors).”)
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Strasser et al. (US 2025/0281116 A1) teaches a system for detecting an anomalous biological event in a person using a wearable device for monitoring skin surface sites which can include obtaining bioimpedance spectroscopy data ([0017]) and information from brachial vessels ([0139])
Nomvar et al. (US 2023/0085555 A1) teaches current-sensing and voltage-sensing electrodes for glucose blood monitoring ([0029])
Connor et al. (US 2017/0164878 A1) teaches a wearable technology such as an arm band ([0127]) with multiple sensors ([0201])
T. Mahmud et al., "Non-invasive Blood Glucose Estimation Using Multi-sensor Based Portable and Wearable System," 2019 IEEE Global Humanitarian Technology Conference (GHTC), Seattle, WA, USA, 2019, pp. 1-5, doi: 10.1109/GHTC46095.2019.9033119. teaches a multi-sensor blood glucose detection device
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.
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/ATTIYA SAYYADA HUSSAINI/Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
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