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 .
STATUS OF CLAIMS
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
Claims 12 and 23-28 have been cancelled.
Claims 11, 13-15, 17, 21, 22, 29, and 30 have been amended. Claim 31 is newly added.
Claims 11, 13-22, and 29-31 are pending.
Claim Objections
Claims 11, 17, 19, 30, and 31 are objected to because of the following informalities:
Claim 11 should read:
…
determining, by [[a]] circuitry of the wearable device, that the wearable device is in a near state by determining that an intensity of the first light exceeds a first proximity threshold;
in response to determining that the wearable device is in the near state, detecting, by the receiver module, a second light with the first wavelength;
determining, by the circuitry, that the wearable device is not in a deadzone state by determining that an intensity of the second light does not decrease below the first proximity threshold for a predetermined period of time during which the wearable device is in the near state;
in response to determining that the wearable device is not in the deadzone state, detecting, by the receiver module, a third light with the first wavelength and a fourth light with a second wavelength;
…
Claim 17 should read “wherein the bioinformation measurement comprises a heart rate, a skin moisture, or a blood pressure of a user.”
Claim 19 should read “wherein the first wavelength is within a near-infrared (NIR) wavelength range and the second wavelength is within a short-wave infrared (SWIR) wavelength range.”
Claim 30 should read:
…
a sensor comprising a receiver module and [[a]] circuitry;
…
determine, by the circuitry, that the wearable device is in a near state, comprising by determining that an intensity of the first light exceeds a first proximity threshold;
in response to determining that the wearable device is in the near state, detect, by the receiver module, a second light with the first wavelength;
determine, by the circuitry, that the wearable device is not in a deadzone state, comprising by determining that an intensity of the second light does not decrease below the first proximity threshold for a predetermined period of time of during which the wearable device is in the near state;
in response to determining that the wearable device is not in the deadzone state, detect, by the receiver module, a third light with the first wavelength and a fourth light with the a second wavelength;
…
Appropriate correction is required.
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.
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: receiver module in claims 11, 12, 27 and 30.
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.
The corresponding structure described in the specification as performing the claimed function includes “one or more photodetectors…for three-dimensional (3D) depth sensing (e.g., i-TOF or d-TOF photodetector), proximity sensing, optical spectroscopy, two-dimensional (2D) sensing (e.g., 2D IR imaging), or a combination thereof. Each of the photodetectors can be implemented using a single photodiode or an array of photodetector pixels….” ([0089], see also [0114]-[0115] and Figures 7 and 8).
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 § 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 11, 13-22, and 29-31 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 11 recites “determining…that the wearable device is not in a deadzone state by determining that an intensity of the second light does not decrease below the first proximity threshold for a predetermined period of time during which the wearable device is in the near state.”
Claim 11 recites that the wearable device is “not in a deadzone state” because the light of the same wavelength does not decrease below a threshold. Based on the claim language and after reviewing Applicant’s disclosure, it would not be clear to one having ordinary skill in the art if “a deadzone state” means too close to the skin only or if it means a dual-state in which the wearable device is either (a) too close to the skin or (b) too far away from the skin. According to Applicant’s disclosure, this same standard (i.e., the light of the same wavelength does not decrease below a threshold) also applies to “not in a far state.” In other words, Applicant’s disclosure supports the notion that the deadzone state is a dual-state (i.e., either (a) or (b) above) until an additional condition occurs that confirms that the wearable device is just in the far state.
More specifically, Applicant’s disclosure first defines the deadzone state as “the wearable device [being] extremely close to the object….” ([0098]). However, Applicant’s disclosure then describes an example in which the state switches from “deadzone” to “far” when the measurements of the same wavelength drop below a second threshold. (See the annotated Figure 3 below showing both the deadzone state and the far state). In other words, when the measurement drops below the first threshold TH1(W1), the wearable device is either too close (left side of Figure 3) or moving toward a far state (right side of Figure 3). When the measurement drops below the second threshold TH2(W1), it is now certain that the wearable device is in the far state. According [AltContent: textbox (Applicant’s Fig. 3)]to the disclosure, this is how the deadzone state is distinguished from the far state. “In this way, the wearable device can avoid regarding extremely close distances as far distances.” ([0098]).
Accordingly, for the purpose of a compact prosecution, Examiner is interpreting the claim limitation “not in a deadzone state” as “remaining in the near state.”
Claim 11 also recites “…determining, by the circuitry, the presence of the skin based on a comparison between (i) a first ratio between an intensity of the first light and an intensity of the second light and (ii) a first skin-detection threshold…”
As recited in claim 11, the first light and the second light are measurements of the same wavelength. However, Applicant’s disclosure describes that the “skin detection flow” includes comparing the intensities of two different wavelengths. “The reflectivity of the first light relative to the skin is different from that of the second light, so the wearable device can detect the presence of the skin according to the intensity comparison between the first light and the second light.” ([0099]). Note that the “first light” and the “second light” at [0099] have different wavelengths. “The receiver module 314 of the wearable device can receive a first light with a first wavelength W1 and a second light with a second wavelength W2.” ([0098]). Applicant’s disclosures provides different examples of skin-detection and each involves comparing the ratio of lights of different wavelengths to a threshold. (see [0099]: “As shown in S421, when the wearable device detects the presence of skin and is in the SKIN state, the wearable device is continuously configured to calculate a ratio R of the intensity of first light S(W1) to the intensity of second light S(W2) and compare the ratio R to a second threshold TH2(R) associated with skin detection.”; and see [0100]: “When the wearable device detects the presence of skin and is in the SKIN state, if the ratio R is less than the second threshold TH2(R) associated with skin detection, the wearable device detects the absence of skin and returns to the NEAR state.”; see also original claim 11).
Moreover, as best understood by the Examiner, the entirety of Applicant’s disclosure does not provide any examples in which the ratio is between two measurements of the same wavelength, which is what is presently claimed. Instead, each example has the ratio between two measurements of different wavelengths. (see original claim 11, [0015], [0055], [0067], [0099], [0100]).
Lastly, the first and second lights being of the same wavelength is not consistent with other claim language. Immediately before this claim recitation, claim 11 recites detecting “a third light with the first wavelength and a fourth light with a second wavelength” without ever again referring to the third light or fourth light. Examine believes these were intended to be compared to each other in the subsequent step. Examiner also notes that the subsequent determination of the absence of the skin compares a fifth light and a sixth light having different wavelengths.
Based on the above, Examiner believes the current claim language was inadvertent. As such, for the purpose of a compact prosecution, Examiner is interpreting the relevant portion of claim 11 as follows:
“…determine, by the circuitry, the presence of the skin based on a comparison between (i) a first ratio between an intensity of the third light and an intensity of the fourth light and (ii) a first skin-detection threshold…”
Claim 16 recites “wherein the signal quality associated with the sensor measurement information comprises…a stability of the particular sensor measurement, or a validity of the particular sensor measurement.”
The disclosure does not clearly define, with respect to particular sensor measurements, the meanings of “stability” and “validity,” and Examiner is not aware of the ordinary and customary meanings given to these terms by those of ordinary skill in the art. (see, e.g., MPEP 2173.01, I). Terms like “stability” and “validity” are subjective and the specification does not provide any objective standard for measuring the scope of the term. “When a subjective term is used in the claim, the examiner should determine whether the specification supplies some objective standard for measuring the scope of the term. Some objective standard must be provided in order to allow the public to determine the scope of the claim. A claim term that requires the exercise of subjective judgment without restriction may render the claim indefinite. In re Musgrave, 431 F.2d 882, 893, 167 USPQ 280, 289 (CCPA 1970).” (MPEP 2173.05(b), IV). The disclosure repeats the same phrases as those in claim 16 but does not provide any further depth as to their meanings.
Claim 31 recites “in response to determining that the wearable device is not in the deadzone state, detecting, by the receiver module, a seventh light with the first wavelength; and determining, by the circuitry, that the wearable device is not in a far state by determining that an intensity of the seventh light exceeds a second proximity threshold.”
In the context of proximity, Applicant’s disclosure describes the light of the first wavelength being compared to two thresholds. (see [0098] and Figure 3). As explained above, once the detected light drops below the first threshold, the wearable device may be in a “deadzone” position in which the device is too close to the skin OR the device may be in a “moving toward a far state” position.
Accordingly, claim 31 contradicts itself by first reciting “in response to determining that the wearable device is not in the deadzone state…” If the wearable device is not in the deadzone state then the light intensity is above the first threshold and, if above the first threshold, the light intensity is also above the second threshold. Determining that the device is “not in a deadzone state” simultaneously determines that the device is “not in a far state.”
Applicant can amend claim 31 to positively recite the device being in the far state (e.g., “determining that the wearable device is in a far state in response to the seventh light being less than the second proximity threshold….”).
Claim 30 has similar recitations as those discussed above with respect to claim 11.
Because all claims either depend directly or indirectly from claim 11 or claim 30, claims 11, 13-22, and 29-31 are rejected.
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 11, 13, 21, 22, and 29-31 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Appl. Publication No. 2023/0247341 (hereinafter “SAULSBURY”) and U.S. Patent Appl. Publication No. 2017/0215747 A1 (hereinafter “VAN DITHER”) and/or Röddiger T, Clarke C, Breitling P, Schneegans T, Zhao H, Gellersen H, Beigl M. Sensing with earables: A systematic literature review and taxonomy of phenomena. Proceedings of the ACM on interactive, mobile, wearable and ubiquitous technologies. 2022 Sep 7;6(3):1-57 (hereinafter RODDIGER).
With respect to claim 11 (and in light of the Section 112(b) rejection), SAULSBURY teaches a method for operating a wearable device to detect a presence of skin. (Abstract). SAULSBURY teaches wireless ear buds with proximity sensors. (Title). “To determine the current status of the ear buds and thereby take suitable action in controlling the operation of the electronic device and ear buds, the ear buds may be provided with sensor circuitry. The sensor circuitry may include proximity sensors…The proximity sensors may be light-based sensors that emit light that passes through the housing.” (Abstract). The method includes:
detecting, by a receiver module of the wearable device, a first light with a first wavelength, wherein the receiver module comprises one or more photodetectors. SAULSBURY includes a receiver module having one or more photodetectors (see [0031] and [0032] teaching an ear bud 24 having a light-based proximity sensor 60 having a substrate 62 with light detectors 66 (i.e., photodetectors)). SAULSBURY teaches detecting a first light with a first wavelength. More specifically, the light source 64 emits 70 at a wavelength and the light detector 66 is a “photodetector” and “may be sensitive to the wavelength of light 70.” ([0032).
determining, by circuitry of the wearable device, that the wearable device is in a near state by determining that an intensity of the first light exceeds a first proximity threshold. “Sensors S1, S2, S3, and S4 may use reflected light, capacitance measurements, or other measurements to determine whether an external object is nearby. During operation, a raw sensor signal (e.g., a reflected light signal, capacitance signal, etc.) may be compared to a predetermined threshold. If the raw signal is greater than the threshold, the sensor output will be positive (i.e., an external object is in the vicinity of the sensor). If the raw signal is less than the threshold of the sensor, the sensor output will be negative (i.e., no external object is in the vicinity of the sensor).” ([0028]). As to the “circuitry,” SAULSBURY teaches that “Control circuitry 28 on ear buds 24 and control circuitry 16 of device 10 may be used to run software on ear buds 24 and device 10, respectively. During operation, the software running on control circuitry 28 and/or 16 may be used in gathering sensor data….” ([0022]).
in response to determining that the wearable device is in the near state, detecting, by the receiver module, a second light with the first wavelength. “In response to detecting a positive output from sensors S1 and S2 and a negative output from sensors S3 and S4, it can be tentatively concluded that ear bud 24 has been placed in ear 50 in a configuration of the type shown in FIG. 3 and that the user has released stem 40-2. Operations may therefore transition to state 92 (a state representing the transition of ear bud 24 into ear 50), as indicated by line 110. During state 92, the status of sensors S1, S2, S3, and S4 can be monitored to determine whether the positive state of sensors S1 and S2 and the negative state of sensors S3 and S4 will be sustained for a threshold amount of time (time T2).” ([0046]). In SAULSBURY, after detecting positive outputs from sensors S1 and S2, it is “tentatively concluded” that the ear bud is in the ear (i.e., the wearable device is in a near state).
determining, by the circuitry, that the wearable device is not in a deadzone state by determining that an intensity of the second light does not decrease below the first proximity threshold for a predetermined period of time during which the wearable device is in the near state. NOTE: As discussed above in the Section 112(b) rejection, Examiner is interpreting “is not in a deadzone state” as “remains in the near state.” With respect to SAULSBURY, after “tentatively concluding” that the ear bud is in a near state, SAULSBURY then determines if the positive outputs of sensors S1 and S2 are sustained for a threshold amount of time. In other words, SAULSBURY teaches acquiring additional measurements of light intensity of the same wavelength (i.e., intensity of the second light) for a threshold amount of time (i.e., predetermined period of time) to confirm that the state remains the same (i.e., does not decrease below the first proximity threshold).
While SAULSBURY does not teach performing the specific actions recited in claim 11 in response to determining that the wearable device is not in the deadzone state [i.e., remains in the near state], SAULSBURY clearly describes taking additional actions after confirming that the wearable device has remained in the ear (i.e., remained in the near state). “As an example, control circuitry 28 and 16 may be used in handling audio signals in connection with incoming cellular telephone calls when it is determined that a user has placed one of ear buds 24 in the ear of the user.” ([0022]; see also [0042] describing what happens when the ear bud is in-ear and out of the ear).
SAULSBURY does not teach the remining limitations of claim 11 in which the presence of the skin is detected, a bioinformation measurement is acquired, the presence of the skin is no longer detected.
However, in the same field of endeavor, VAN DITHER teaches an optical vital signs sensor that is configured to determine if the sensor is in contact with a use’s skin. (Abstract). The sensor of VAN DITHER is a photoplethysmography (PPG) sensor. VAN DITHER teaches that “[t]he PPG sensor can be implemented for example in a smart watch and can be placed in direct contact with the skin of the user. If the PPG sensor is, however, not anymore in direct contact with the skin of the user, e.g. if a loss of skin contact has occurred, the output of the photo detector can not be used to detect vital signs of a user.” ([0004]; see also [0020]). To address this issue, VAN DITHER teaches a off-skin detection unit that determines whether the sensor is in sufficient contact with the skin. The off-skin detection unit compares the detected light signal from two different wavelengths. (see, e.g., [0012] and [0017]).
Accordingly, VAN DITHER teaches:
…detecting, by the receiver module, a third light with the first wavelength and a fourth light with a second wavelength. “The optical vital signs sensor comprises an off-skin detection unit configured to detect whether the contact surface is in contact with the skin of the user based on output signals from the photo detector unit at the at least two wavelengths. The off-skin detection unit is configured to compare DC components of the output signal of the photo detector unit at a first wavelength with DC components of the output signal of the photo detector unit at a second wavelength in order to detect whether the contact surface is in contact with the skin of the user. The first wavelength corresponds to green light and the second wavelength corresponds to red light.” ([0012]).
determining, by the circuitry, the presence of the skin based on a comparison between (i) a first ratio between an intensity of the third light and an intensity of the fourth light and (ii) a first skin-detection threshold. “If the DC component of the second wavelength (630 nm, red) is larger than the DC component of the first wavelength (525 nm, green), then the PPG sensor is in contact with the skin” ([0047]; see also Figure 5 and [0044] and [0045] explaining the different experimental conditions). Here, the first ratio is the ratio DC red to DC green. The first skin-detection threshold is essentially one. If DC red is greater than DC green, then the ratio is greater than 1. “Accordingly, a comparison of the DC components at the first and second wavelength P1, P2 can be used in the off set detection unit 13 to detect whether the PPG sensor is placed on a wrist or skin of a user.” ([0046]).
in response to determining the presence of the skin, performing, by the wearable device, a bioinformation measurement. If the device is in direct contact according to VAN DITHER, the device determines a vital sign of the user. (see, e.g., [0004] and [0019] explaining the different bioinformation measurements that can be obtained). Moreover, in the example where motion is detected, the motion “can be used to activate the PPG sensor after it has been deactivated after an off-skin detection. In other words, the output of the motion unit 140 (which can be implemented as an accelerator) can be used to activate the off-skin detection.” ([0038]). In response to determining that the device is in direct contact (i.e., skin is present), then a bioinformation measurement would subsequently be acquired. (see also [0039] explaining step S1 occurs when motion is detected).
detecting, by the receiver module, a fifth light with the first wavelength and a sixth light with the second wavelength. VAN DITHER teaches repeatedly acquiring data to determine whether the device is in sufficient contact with the skin. (see, e.g., [0040]: “If no off-skin condition is detected, the flow continues to step S1.”) “The operation of the PPG sensor 100 can be controlled according to the output signal of the off-skin detection unit 130.” ([0037]). If the device is in sufficient contact, it determines a vital sign measurement. If the device is not in sufficient contact, the device can either ignore the output signals or be placed into a stand-by mode. (see, e.g., [0020]: “According to the embodiment, if an off-skin condition is detected, the output signals of the photo detector can be ignored. Furthermore, optionally, the PPG sensor can be put into a stand-by mode or the light units can be switched off in order to reduce the power consumption.”).
determining, by the circuitry, an absence of the skin based on a comparison between (i) a second ratio between an intensity of the fifth light and an intensity of the sixth light and (ii) a second skin-detection threshold. “If, however, the DC component at the first wavelength P1 (525 nm, green) is larger than the DC component at the second wavelength P2 (630 nm, red), then the PPG sensor 100 is not in contact with the skin and is therefore off-skin.” ([0047]). Here, the second ratio is a ratio of DC green to DC red. To be clear, the second ratio is a ratio of the same wavelengths but the wavelengths are flipped.
It would have been obvious to one having ordinary skill in the art to modify the SAULSBURY device such that the device, after first confirming that the wearable device has remained in the near state (i.e., not in the deadzone state), subsequently confirms the device is in direct contact for detecting vital signs, acquires a bioinformation measurement in response to determine presence of skin, and determines the absence of skin as taught in VAN DITHER. One would have been motivated to acquire vital signs, as taught in VAN DITHER, using the wearable device of SAULSBURY because it is important to monitor one’s vital signs and SAULSBURY’s ear bud is a convenient way of acquiring such signals. Moreover, SAULSBURY does suggest that a variety of sensors could be implemented by the ear bud. (see, e.g., description of various sensors in [0024] of SAULSBURY and also [0022] describing that the control circuitry of the device may be used in “gathering sensor data, user input, and other input and may be used in taking suitable actions in response to detected conditions”). There would have been a reasonable expectation of success as VAN DITHER teaches the off-skin detection unit can be used on wearable devices and SAULSBURY already uses photodetectors.
While Examiner believes the above rationale is sufficient for teaching one having ordinary skill in the art to modify the SAULSBURY ear bud in light of the teachings of VAN DITHER, Examiner also notes that RODDIGER bolsters the rationale that one having ordinary skill in the art would modify SAULSBURY’s ear buds to acquire vital signs. RODDIGER teaches that “earable sensing” can acquire a large variety of biological phenomena. (Figure 2 on page 6). “Earables have emerged as a unique platform for ubiquitous computing by augmenting ear-worn devices with state-of-the-art sensing. This new platform has spurred a wealth of new research exploring what can be detected on a wearable, small form factor. As a sensing platform, the ears are less susceptible to motion artifacts and are located in close proximity to a number of important anatomical structures including the brain, blood vessels, and facial muscles which reveal a wealth of information. They can be easily reached by the hands and the ear canal itself is affected by mouth, face, and head movements.” (Abstract).
It would have also been obvious to one having ordinary skill in the art to modify the SAULSBURY device such that the device uses the same wavelength for proximity detection and for detecting direct contact with skin because the light is already being emitted and detected so using the same wavelength would conserve resources and reduce the complexity of the device.
SAULSBURY and VAN DITHER do not explicitly teach that the second skin-detection threshold is different from the first skin-detection threshold.
However, in the same field of endeavor, HUIJBREGTS teaches a wearable device that determines an amount of sweat accumulated between a lower side of the wearable device and the skin of the user. (Abstract). The wearable device also determines a moment in time for ventilating the lower side of the wearable device based on the measured sweat level. (Id). In one embodiment, an actuator is used to change between a contact state and a ventilation state. ([0043]). If a “sweat level measure” exceeds a first threshold, the actuator changes the wearable device to a ventilation state. (Id). But if the sweat level measure exceeds a second threshold, the actuator changes the wearable device to a contact state. (Id). However, HUIJBREGTS further teaches that the “first and second threshold can be the same or different. Preferably different thresholds are used wherein said second threshold is lower than said first threshold to provide a hysteresis. Thereby frequent changes between the two states can be avoided and an energy efficient implementation is provided to extend the battery life.” (emphasis added) (Id).
It would have been obvious to one skilled in the art to modify the SAULSBURY device to use two different thresholds when determining the presence or absence of the skin. One would have been motivated to use different thresholds to provide a hysteresis, as taught in HUIJBREGTS, thereby avoiding frequent changes by the circuitry and extending battery life. There would have been a reasonable expectation of success because, as taught in HUIJBREGTS, circuitry can use two different thresholds when determining the state of a wearable device.
With respect to claim 13, HUIJBREGTS teaches wherein the first skin-detection threshold is higher than the second skin-detection threshold. As discussed above, HUIJBREGTS teaches using different thresholds to provide a hysteresis. In one example, HUIJBREGTS teaches “[p]referably different thresholds are used wherein said second threshold is lower than said first threshold to provide a hysteresis.” In HUIJBREGTS, the wearable device changes to the ventilation state when the sweat level exceeds the first threshold and changes to the contact state when the sweat level falls below a second threshold.
It would have been obvious to one skilled in the art to modify the SAULSBURY device such that the first threshold is greater than the second threshold when determining the presence or absence of the skin. One would have been motivated to use different thresholds (and to make the first threshold greater than the second threshold) to provide a hysteresis, as taught in HUIJBREGTS, thereby avoiding frequent changes by the circuitry and extending battery life. There would have been a reasonable expectation of success because, as taught in HUIJBREGTS, circuitry can use two different thresholds when determining the state of a wearable device.
With respect to claim 21, the combination of SAULSBURY and VAN DITHER, as described above with respect to claim 11, teach determining the presence of the skin is in response to the first ratio being greater than the first skin-detection threshold. “If the DC component of the second wavelength (630 nm, red) is larger than the DC component of the first wavelength (525 nm, green), then the PPG sensor is in contact with the skin” ([0047]; see also Figure 5 and [0044] and [0045] explaining the different experimental conditions). Here, the first ratio is the ratio DC red to DC green. The threshold is 1. If DC red is greater than DC green, then the ratio is greater than 1.
With respect to claim 22, the combination of SAULSBURY and VAN DITHER, as described above with respect to claim 11, teach determining the absence of the skin is in response to the second ratio being less than the second skin-detection threshold. “If, however, the DC component at the first wavelength P1 (525 nm, green) is larger than the DC component at the second wavelength P2 (630 nm, red), then the PPG sensor 100 is not in contact with the skin and is therefore off-skin.” ([0047]). Here, the second ratio is a ratio of DC green to DC red. To be clear, the second ratio is a ratio of the same wavelengths as the first ratio but the wavelengths have been flipped (DCgreen:DCred instead of DCred:DCgreen). If the second ratio was DC red to DC green, then the first ratio and the second ratio would generate comparable numbers. Consistent with VAN DITHER, the greater the DC green or lesser DC red, the second ratio would decrease. Accordingly, VAN DITHER teaches that the skin is absent when the ratio is less than a threshold. As already discussed above, HUIJBREGTS the thresholds can be different to provide a hysteresis.
It would have been obvious to one having ordinary skill in the art to use the same ratio of measurements (but acquired at different times) to determine the absence of skin and/or the presence of skin. More specifically, instead of using the ratio A:B and then a different ratio B:A, one could use the ratio A:B only and compare that value to a threshold. The results would have been predictable.
With respect to claim 29, the combination of SAULSBURY and VAN DITHER, as described above with respect to claim 11, teach further comprising, in response to determining the absence of the skin, providing, by the circuitry of the wearable device, a control signal to the wearable device to enter into a power-saving mode. “According to the embodiment, if an off-skin condition is detected, the output signals of the photo detector can be ignored. Furthermore, optionally, the PPG sensor can be put into a stand-by mode or the light units can be switched off in order to reduce the power consumption.” ([0020]).
With respect to claim 30, SAULSBURY teaches a wearable device. (Abstract). SAULSBURY teaches wireless ear buds with proximity sensors. (Title). “To determine the current status of the ear buds and thereby take suitable action in controlling the operation of the electronic device and ear buds, the ear buds may be provided with sensor circuitry. The sensor circuitry may include proximity sensors…The proximity sensors may be light-based sensors that emit light that passes through the housing.” (Abstract). The device includes:
a sensor comprising a receiver module and circuitry. See [0031] and [0032] describing an ear bud 24 having a light-based proximity sensor 60 having a substrate 62 with light detectors 66 (i.e., photodetectors) wherein the sensor is configured to:
detect, by the receiver module, a first light with a first wavelength, wherein the receiver module comprises one or more photodetectors. SAULSBURY includes a receiver module having one or more photodetectors (see [0031] and [0032] teaching an ear bud 24 having a light-based proximity sensor 60 having a substrate 62 with light detectors 66 (i.e., photodetectors)). SAULSBURY teaches detecting a first light with a first wavelength. More specifically, the light source 64 emits 70 at a wavelength and the light detector 66 is a “photodetector” and “may be sensitive to the wavelength of light 70.” ([0032).
determine, by the circuitry, that the wearable device is in a near state by determining that an intensity of the first light exceeds a first proximity threshold. “Sensors S1, S2, S3, and S4 may use reflected light, capacitance measurements, or other measurements to determine whether an external object is nearby. During operation, a raw sensor signal (e.g., a reflected light signal, capacitance signal, etc.) may be compared to a predetermined threshold. If the raw signal is greater than the threshold, the sensor output will be positive (i.e., an external object is in the vicinity of the sensor). If the raw signal is less than the threshold of the sensor, the sensor output will be negative (i.e., no external object is in the vicinity of the sensor).” ([0028]). As to the “circuitry,” SAULSBURY teaches that “Control circuitry 28 on ear buds 24 and control circuitry 16 of device 10 may be used to run software on ear buds 24 and device 10, respectively. During operation, the software running on control circuitry 28 and/or 16 may be used in gathering sensor data….” ([0022]).
in response to determining that the wearable device is in the near state, detect, by the receiver module, a second light with the first wavelength. “In response to detecting a positive output from sensors S1 and S2 and a negative output from sensors S3 and S4, it can be tentatively concluded that ear bud 24 has been placed in ear 50 in a configuration of the type shown in FIG. 3 and that the user has released stem 40-2. Operations may therefore transition to state 92 (a state representing the transition of ear bud 24 into ear 50), as indicated by line 110. During state 92, the status of sensors S1, S2, S3, and S4 can be monitored to determine whether the positive state of sensors S1 and S2 and the negative state of sensors S3 and S4 will be sustained for a threshold amount of time (time T2).” ([0046]). In SAULSBURY, after detecting positive outputs from sensors S1 and S2, it is “tentatively concluded” that the ear bud is in the ear (i.e., the wearable device is in a near state).
determine, by the circuitry, that the wearable device is not in a deadzone state by determining that an intensity of the second light does not decrease below the first proximity threshold for a predetermined period of time during which the wearable device is in the near state. NOTE: As discussed above in the Section 112(b) rejection, Examiner is interpreting “is not in a deadzone state” as “remains in the near state.” With respect to SAULSBURY, after “tentatively concluding” that the ear bud is in a near state, SAULSBURY then determines if the positive outputs of sensors S1 and S2 are sustained for a threshold amount of time. In other words, SAULSBURY teaches acquiring additional measurements of light intensity of the same wavelength (i.e., intensity of the second light) for a threshold amount of time (i.e., predetermined period of time) to confirm that the state remains the same (i.e., does not decrease below the first proximity threshold).
While SAULSBURY does not teach performing the specific actions recited in claim 11 in response to determining that the wearable device is not in the deadzone state [i.e., remains in the near state], SAULSBURY clearly describes taking additional actions after confirming that the wearable device has remained in the ear (i.e., remained in the near state). “As an example, control circuitry 28 and 16 may be used in handling audio signals in connection with incoming cellular telephone calls when it is determined that a user has placed one of ear buds 24 in the ear of the user.” ([0022]; see also [0042] describing what happens when the ear bud is in-ear and out of the ear).
SAULSBURY does not teach the remining limitations of claim 11 in which the presence of the skin is detected, a bioinformation measurement is acquired, the presence of the skin is no longer detected.
However, in the same field of endeavor, VAN DITHER teaches an optical vital signs sensor that is configured to determine if the sensor is in contact with a use’s skin. (Abstract). The sensor of VAN DITHER is a photoplethysmography (PPG) sensor. VAN DITHER teaches that “[t]he PPG sensor can be implemented for example in a smart watch and can be placed in direct contact with the skin of the user. If the PPG sensor is, however, not anymore in direct contact with the skin of the user, e.g. if a loss of skin contact has occurred, the output of the photo detector can not be used to detect vital signs of a user.” ([0004]; see also [0020]). To address this issue, VAN DITHER teaches a off-skin detection unit that determines whether the sensor is in sufficient contact with the skin. The off-skin detection unit compares the detected light signal from two different wavelengths. (see, e.g., [0012] and [0017]).
Accordingly, VAN DITHER teaches:
… detect, by the receiver module, a third light with the first wavelength and a fourth light with a second wavelength. “The optical vital signs sensor comprises an off-skin detection unit configured to detect whether the contact surface is in contact with the skin of the user based on output signals from the photo detector unit at the at least two wavelengths. The off-skin detection unit is configured to compare DC components of the output signal of the photo detector unit at a first wavelength with DC components of the output signal of the photo detector unit at a second wavelength in order to detect whether the contact surface is in contact with the skin of the user. The first wavelength corresponds to green light and the second wavelength corresponds to red light.” ([0012]).
determine, by the circuitry, the presence of the skin based on a comparison between (i) a first ratio between an intensity of the third light and an intensity of the fourth light and (ii) a first skin-detection threshold. “If the DC component of the second wavelength (630 nm, red) is larger than the DC component of the first wavelength (525 nm, green), then the PPG sensor is in contact with the skin” ([0047]; see also Figure 5 and [0044] and [0045] explaining the different experimental conditions). Here, the first ratio is the ratio DC red to DC green. The first skin-detection threshold is essentially one. If DC red is greater than DC green, then the ratio is greater than 1. “Accordingly, a comparison of the DC components at the first and second wavelength P1, P2 can be used in the off set detection unit 13 to detect whether the PPG sensor is placed on a wrist or skin of a user.” ([0046]).
in response to determining the presence of the skin, perform a bioinformation measurement. If the device is in direct contact according to VAN DITHER, the device determines a vital sign of the user. (see, e.g., [0004] and [0019] explaining the different bioinformation measurements that can be obtained). Moreover, in the example where motion is detected, the motion “can be used to activate the PPG sensor after it has been deactivated after an off-skin detection. In other words, the output of the motion unit 140 (which can be implemented as an accelerator) can be used to activate the off-skin detection.” ([0038]). In response to determining that the device is in direct contact (i.e., skin is present), then a bioinformation measurement would subsequently be acquired. (see also [0039] explaining step S1 occurs when motion is detected).
detect, by the receiver module, a fifth light with the first wavelength and a sixth light with the second wavelength. VAN DITHER teaches repeatedly acquiring data to determine whether the device is in sufficient contact with the skin. (see, e.g., [0040]: “If no off-skin condition is detected, the flow continues to step S1.”) “The operation of the PPG sensor 100 can be controlled according to the output signal of the off-skin detection unit 130.” ([0037]). If the device is in sufficient contact, it determines a vital sign measurement. If the device is not in sufficient contact, the device can either ignore the output signals or be placed into a stand-by mode. (see, e.g., [0020]: “According to the embodiment, if an off-skin condition is detected, the output signals of the photo detector can be ignored. Furthermore, optionally, the PPG sensor can be put into a stand-by mode or the light units can be switched off in order to reduce the power consumption.”).
determine, by the circuitry, an absence of the skin based on a comparison between (i) a second ratio between an intensity of the fifth light and an intensity of the sixth light and (ii) a second skin-detection threshold. “If, however, the DC component at the first wavelength P1 (525 nm, green) is larger than the DC component at the second wavelength P2 (630 nm, red), then the PPG sensor 100 is not in contact with the skin and is therefore off-skin.” ([0047]). Here, the second ratio is a ratio of DC green to DC red. To be clear, the second ratio is a ratio of the same wavelengths but the wavelengths are flipped.
It would have been obvious to one having ordinary skill in the art to modify the SAULSBURY device such that the device, after first confirming that the wearable device has remained in the near state (i.e., not in the deadzone state), subsequently confirms the device is in direct contact for detecting vital signs. One would have been motivated to acquire vital signs, as taught in VAN DITHER, using the wearable device of SAULSBURY because it is important to monitor one’s vital signs and SAULSBURY’s ear bud is a convenient way of acquiring such signals. Moreover, SAULSBURY does suggest that a variety of sensors could be implemented by the ear bud. (see, e.g., description of various sensors in [0024] of SAULSBURY and also [0022] describing that the control circuitry of the device may be used in “gathering sensor data, user input, and other input and may be used in taking suitable actions in response to detected conditions”). There would have been a reasonable expectation of success as VAN DITHER teaches the off-skin detection unit can be used on wearable devices and SAULSBURY already uses photodetectors.
While Examiner believes the above rationale is sufficient for teaching one having ordinary skill in the art to modify the SAULSBURY ear bud in light of the teachings of VAN DITHER, Examiner also notes that RODDIGER bolsters the rationale that one having ordinary skill in the art would modify SAULSBURY’s ear buds to acquire vital signs. RODDIGER teaches that “earable sensing” can acquire a large variety of biological phenomena. (Figure 2 on page 6). “Earables have emerged as a unique platform for ubiquitous computing by augmenting ear-worn devices with state-of-the-art sensing. This new platform has spurred a wealth of new research exploring what can be detected on a wearable, small form factor. As a sensing platform, the ears are less susceptible to motion artifacts and are located in close proximity to a number of important anatomical structures including the brain, blood vessels, and facial muscles which reveal a wealth of information. They can be easily reached by the hands and the ear canal itself is affected by mouth, face, and head movements.” (Abstract).
SAULSBURY and VAN DITHER do not explicitly teach that the second skin-detection threshold is different from the first skin-detection threshold.
However, in the same field of endeavor, HUIJBREGTS teaches a wearable device that determines an amount of sweat accumulated between a lower side of the wearable device and the skin of the user. (Abstract). The wearable device also determines a moment in time for ventilating the lower side of the wearable device based on the measured sweat level. (Id). In one embodiment, an actuator is used to change between a contact state and a ventilation state. ([0043]). If a “sweat level measure” exceeds a first threshold, the actuator changes the wearable device to a ventilation state. (Id). But if the sweat level measure exceeds a second threshold, the actuator changes the wearable device to a contact state. (Id). However, HUIJBREGTS further teaches that the “first and second threshold can be the same or different. Preferably different thresholds are used wherein said second threshold is lower than said first threshold to provide a hysteresis. Thereby frequent changes between the two states can be avoided and an energy efficient implementation is provided to extend the battery life.” (emphasis added) (Id).
It would have been obvious to one skilled in the art to modify the SAULSBURY device to use two different thresholds when determining the presence or absence of the skin. One would have been motivated to use different thresholds to provide a hysteresis, as taught in HUIJBREGTS, thereby avoiding frequent changes by the circuitry and extending battery life. There would have been a reasonable expectation of success because, as taught in HUIJBREGTS, circuitry can use two different thresholds when determining the state of a wearable device.
With respect to claim 31, the combination of SAULSBURY and VAN DITHER, as discussed above with respect to claim 11, teach detecting, by the receiver module, a seventh light with the first wavelength and determining, by the circuitry, that the wearable device is not in a far state by determining that an intensity of the seventh light exceeds a second proximity threshold. “In response to detecting a positive output from sensors S1 and S2 and a negative output from sensors S3 and S4, it can be tentatively concluded that ear bud 24 has been placed in ear 50 in a configuration of the type shown in FIG. 3 and that the user has released stem 40-2. Operations may therefore transition to state 92 (a state representing the transition of ear bud 24 into ear 50), as indicated by line 110. During state 92, the status of sensors S1, S2, S3, and S4 can be monitored to determine whether the positive state of sensors S1 and S2 and the negative state of sensors S3 and S4 will be sustained for a threshold amount of time (time T2).” ([0046]). In SAULSBURY, after detecting positive outputs from sensors S1 and S2, it is “tentatively concluded” that the ear bud is in the ear (i.e., the wearable device is in a near state).
NOTE: As discussed above in the Section 112(b) rejection, Examiner is interpreting “is not in a far state” as “remains in the near state.” With respect to SAULSBURY, after “tentatively concluding” that the ear bud is in a near state, SAULSBURY then determines if the positive outputs of sensors S1 and S2 are sustained for a threshold amount of time. In other words, SAULSBURY teaches acquiring additional measurements of light intensity of the same wavelength (i.e., intensity of the second light) for a threshold amount of time (i.e., predetermined period of time) to confirm that the state remains the same (i.e., does not decrease below the first proximity threshold).
Claims 14-18 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Appl. Publication No. 2023/0247341 (hereinafter “SAULSBURY”) and U.S. Patent Appl. Publication No. 2017/0215747 A1 (hereinafter “VAN DITHER”) and/or Röddiger T, Clarke C, Breitling P, Schneegans T, Zhao H, Gellersen H, Beigl M. Sensing with earables: A systematic literature review and taxonomy of phenomena. Proceedings of the ACM on interactive, mobile, wearable and ubiquitous technologies. 2022 Sep 7;6(3):1-57 (hereinafter RODDIGER) as applied to claim 11 above, and further in view of U.S. Patent Appl. Publication No. 2022/0273207 A1 (hereinafter “MOHAMMADI”).
With respect to claims 14-18, SAULSBURY and VAN DITHER do not teach determining a signal quality or performing a bioinformation measurement based on the signal quality.
In the same field of endeavor, MOHAMMADI teaches a system and method for robust estimations of a user's physiological signals by filtering or classifying samples. (Title and Abstract). A signal classifier/filter can be used to classify samples from two wavelengths based on a sample from a third wavelength. ([0047]). The classification can be binary in which “valid” samples are used for subsequent processing and “invalid” samples can be rejected from subsequent processing. (Id). The classification can also provide a confidence measure for the samples. (Id).
One exemplary process for “processing physiological signals” includes measuring signals at multiple wavelengths to assess the quality of the signals. ([0058]-[0059]). “The measurements can be filtered to reject or deemphasize measurements for channels that fail to meet criteria and to process or emphasize measurements for channels that meet the criteria.” ([0059]). “When the correlation between the signals is above a threshold and/or the SNR of the signals at each of wavelengths λ1 and λ2 are above a threshold, the sample can be accepted or assigned a higher confidence value. When the correlation between the signals is below a threshold and/or the SNR of the signals at each of wavelengths λ1 and λ2 are below a threshold, the sample can be rejected or assigned a lower confidence value.” (Id).
MOHAMMADI also teaches rejecting measurements from two or more wavelengths based on the measurement of a third wavelength. ([0061]). One reason for rejecting the measurements is a poor “contact condition.” (Id). “In some examples, the samples can be weighted based on the filtering and thus samples corresponding to poor signal quality metrics or poor contact (or other conditions, such as unexpected orientation of the physiological sensor relative to the tissue or a transient or permanent tissue anomaly, that may result in inaccurate measurements of the physiological signal characteristic) can be deemphasized.” ([0063]). “Additionally, in some examples, the estimate of the physiological characteristic at 620 and the report/display of the physiological characteristic can be skipped when the poor contact condition is determined (e.g., at 615).” ([0066]).
Accordingly, and with respect to claim 14, MOHAMMADI teaches calculating, by the circuitry of the wearable device, a signal quality associated with a sensor measurement information, and determining to perform the bioinformation measurement based on a comparison between the signal quality associated with the sensor measurement information and a first signal-quality threshold. “When the correlation between the signals is above a threshold and/or the SNR of the signals at each of wavelengths λ1 and λ2 are above a threshold, the sample can be accepted or assigned a higher confidence value.” ([0059]).
It would have been obvious to one skilled in the art at the time of filing to modify the SAULSBURY device or method to include calculating a signal quality and determining to perform a bioinformation measurement based on a comparison between the signal quality and a first threshold. One would have been motivated to include calculating signal quality because one skilled in the art knows that measurements can only be used to estimate physiological characteristics when the measurements have reduced noise (i.e., are suitable for their intended purpose) and the sensor is in contact with the skin. There would have been a reasonable expectation of success because MOHAMMADI demonstrates that signal quality can be measured by wearable devices.
With respect to claim 15, MOHAMMADI also teaches determining to stop the bioinformation measurement based on a comparison between the signal quality associated with the sensor measurement information and a second signal-quality threshold. “When the correlation between the signals is below a threshold and/or the SNR of the signals at each of wavelengths λ1 and λ2 are below a threshold, the sample can be rejected or assigned a lower confidence value.” ([0059]). See also Figure 6 and [0065] teaching that the estimate operation at 620 is skipped (i.e., bioinformation measurement is stopped) if there is poor contact.
It would have been obvious to one skilled in the art at the time of filing to modify the SAULSBURY method to include stopping the acquisition of bioinformation measurements when the signal quality is poor based on a comparison with a second threshold. One would have been motivated to include stopping the bioinformation measurements because one skilled in the art knows that measurements with poor signal quality are less reliable and, to save power, the measurements should be stopped until a later time. There would have been a reasonable expectation of success because MOHAMMADI demonstrates that signal quality can be measured by wearable devices.
With respect to claim 16, MOHAMMADI also teaches wherein the signal quality associated with the sensor measurement information comprises a weighted calculation of one or more of an AC signal amplitude of a particular sensor measurement, a signal-to-noise ratio of the particular sensor measurement, a DC drift variation of the particular sensor measurement, a stability of the particular sensor measurement, or a validity of the particular sensor measurement. Specifically, MOHAMMADI teaches that the signal quality includes a weighted calculation of a SNR. “When the correlation between the signals is below a threshold and/or the SNR of the signals at each of wavelengths λ1 and λ2 are below a threshold, the sample can be rejected or assigned a lower confidence value.” (emphasis added) ([0059]). “In some examples, samples meeting some confidence value threshold can be used and those failing to meet the confidence value threshold can be rejected. In some examples, the samples can all be weighted and used (though some may be weighted to zero and thereby effectively be rejected).” ([0054]).
It would have been obvious to one skilled in the art at the time of filing to modify the SAULSBURY method to include using a weighted calculation for the signal quality. One would have been motivated to include using a weighted calculation because using a weighted calculation based on multiple factors can provide more confidence as to the reliability of the measurements. There would have been a reasonable expectation of success because MOHAMMADI demonstrates that signal quality can be calculated using weighted calculations.
With respect to claim 17, MOHAMMADI also teaches wherein the bioinformation comprises a heart rate, a skin moisture, or a blood pressure of a user. “Measured raw data…can be transferred to processor 310…[for] the signal processing described herein to estimate a characteristic (e.g., oxygen saturation, heart rate, etc.) of the user from the physiological signals.” (emphasis added) ([0031]).
It would have been obvious to one skilled in the art at the time of filing to modify the SAULSBURY method to include measuring the heart rate of an individual. One would have been motivated to include measuring the heart rate because wearable devices are often used to calculate physiological measurements, as taught in MOHAMMADI. There would have been a reasonable expectation of success because MOHAMMADI demonstrates that signal quality can be calculated using weighted calculations.
With respect to claim 18, MOHAMMADI also teaches wherein calculating, by the circuitry of the wearable device, the signal quality further comprises calculating the signal quality after determining that the skin is present. In [0026], MOHAMMADI teaches monitoring skin contact can be a separate function with respect to “extracting information/characteristics from the physiological signals.” As illustrated in Figure 6, step 610 occurs prior to step 615. Step 610 includes determining signal quality metrics using wavelengths λ1 and λ2. (see, e.g., [0059]). At Step 615, characteristics of measurements at wavelength λ3 can be used to classify the measurements at wavelengths λ1 and λ2. ([0061]). “In some examples, the characteristic of the measurements at the third wavelength can predict a condition that may result in inaccurate measurements of the physiological signal characteristic. For example, the condition may be contact condition between the physiological sensor(s) and the user's skin.” (emphasis added) ([0061]). However, MOHAMMADI teaches that step 615 can occur prior to step 610 (i.e., the signal quality is calculated after determining that the skin is present). “For example, filtering at 610 and 615 can be done in series (in the illustrated or reverse order), in parallel, or otherwise combined.” (emphasis added) ([0066]).
It would have been obvious to one skilled in the art at the time of filing to modify the SAULSBURY method to include calculating the signal quality after determining that the skin is present. One would have been motivated to reject/filter measurements that are acquired during poor contact prior to calculating signal quality metrics because, as taught in MOHAMMADI, “poor contact between a physiological sensor and the user's skin can result in measurements at the first and second wavelengths that may meet signal quality metrics.” There would have been a reasonable expectation of success because MOHAMMADI demonstrates that measurements can be rejected/filtered prior to calculating the signal quality.
Claims 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Appl. Publication No. 2023/0247341 (hereinafter “SAULSBURY”) and U.S. Patent Appl. Publication No. 2017/0215747 A1 (hereinafter “VAN DITHER”) and/or Röddiger T, Clarke C, Breitling P, Schneegans T, Zhao H, Gellersen H, Beigl M. Sensing with earables: A systematic literature review and taxonomy of phenomena. Proceedings of the ACM on interactive, mobile, wearable and ubiquitous technologies. 2022 Sep 7;6(3):1-57 (hereinafter RODDIGER) as applied to claim 11 above, and further in view of U.S. Patent Appl. Publication No. 2022/0225006 A1 (hereinafter “ALLEC ‘006”).
With respect to claim 19, ALLEC ‘006 teaches “[a] wearable electronic device such as an earbud, wristwatch, or other device may be provided with a skin sensor.” (Abstract). The wearable electronic device is configured to perform a method for operating a wearable device to detect a presence of skin. “The skin sensor may use optical measurements to detect the presence of skin adjacent to the electronic device.” (Abstract). “To help avoid false positives, the skin sensors may use a multi-wavelength design that helps to distinguish between scenarios in which the sensors are located adjacent to skin and scenarios in which the sensors are located next to other materials (e.g., fabric in a user's pocket).” ([0018]).
ALLEC ‘006 also teaches that “[t]he spectral response of human skin is characterized by peaks and valleys. for example, the reflectivity of human skin is relatively high (e.g., about 50-60%) at a wavelength of 1065 nm and is relatively low (e.g., about 5-10%) at a wavelength of 1465 nm. As a result, the presence of skin can be monitored by a sensor that emits light at 1065 nm and 1465 and that measures the amount of light reflected from a target object at these wavelengths. With an illustrative arrangement, the ratio R of reflected light at 1065 nm to reflected light at 1465 nm can be monitored and compared to a threshold TH (e.g., 2.0 or other suitable value). When the ratio R is less than TH, it can be concluded that the target object is not skin. When the ratio R is greater than TH, it can be concluded that skin is present.” ([0019]). “Because skin has an identifiable reflection spectrum, optical measurements with a skin sensor can differentiate between the presence of skin and other (non-skin) target objects.” ([0024]). While the specific wavelengths of 1065 nm and 1465 nm are described in ALLE ‘006, it notes that embodiments may use “infrared light (e.g., near infrared light at wavelengths between 900 nm and 2000 nm, as an example).” ([0033]). One advantage to infrared light is that it “is invisible to users and is therefore not distracting.” ([0033]).
Accordingly, LLEC ‘006 teaches that the first wavelength is within an NIR wavelength range and the second wavelength is within a SWIR wavelength range. NOTE: Applicant’s disclosure teaches that the NIR range includes 780 nm to 1000 nm and the SWIR range includes 1000 nm to 3000 nm. (see, e.g., [0004]). While the most frequently described embodiment in ALLEC ‘006 uses 1065 nm and 1465 nm, ALLEC ‘006 does suggest that the light may be as low as 900 nm. Accordingly, ALLEC ‘006 teaches both NIR (900 nm) and SWIR (1465 nm or up to 2000 nm).
It would have been obvious to one having ordinary skill in the art at the time of filing to further modify the SAULSBURY-VAN DITHER device so that the wavelengths included a wavelength that is within an NIR wavelength range and a wavelength that is within a SWIR wavelength range. One of ordinary skill in the art would have replaced the red and green wavelengths of VAN DITHER to instead use an NIR wavelength range and a SWIR wavelength because using these wavelengths can help “avoid false positives” ([0018]-[0019]) and are invisible and therefore less distracting to users. ([0033]). There would have been a reasonable expectation of success as ALLEC ‘006 teaches that they can be used for on-skin detection.
With respect to claim 20, ALLEC ‘006 teaches wherein the first wavelength and the second wavelength are within a SWIR wavelength range. NOTE: Applicant’s disclosure teaches that the SWIR range includes 1000 nm to 3000 nm. (see, e.g., [0004]). The most frequently described embodiment in ALLEC ‘006 uses 1065 nm and 1465 nm. Accordingly, ALLEC ‘006 teaches both wavelengths being within the SWIR range.
It would have been obvious to one having ordinary skill in the art at the time of filing to further modify the SAULSBURY-VAN DITHER device so that the wavelengths were both in a SWIR wavelength range. One of ordinary skill in the art would have replaced the red and green wavelengths of VAN DITHER to instead use SWIR wavelengths because using these wavelengths can help “avoid false positives” ([0018]-[0019]) and are invisible and therefore less distracting to users. ([0033]). There would have been a reasonable expectation of success as ALLEC ‘006 teaches that they can be used for on-skin detection.
RESPONSE TO APPLICANT’S ARGUMENTS:
Applicant’s arguments with respect to claims 11 and 30 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. More specifically, the Section 103 rejections of claims 11 and 30 relies upon SAULSBURY for teaching that the wearable device is “not in a deadzone state.”
While SAULSBURY was used in the prior Office Action, it was not relied upon for teaching “not in a deadzone state.” In fact, determining that the wearable device was “not in a deadzone state” was not claimed in the prior claim set.
Prior Art Made of Record
Prior art made of record but not relied upon in this Office Action include: US20240090784A1 determines the “wearing status” of the user, which may include the device being comfortably-worn, loosely worn, or not worn. Physiological data can be detected after determining the wearing status.
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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/JASON P GROSS/Examiner, Art Unit 3797
/SERKAN AKAR/Primary Examiner, Art Unit 3797
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