DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claims 1, 11, 12, and 13 are objected to because of the following informalities:
Claim 1 should be amended to recite “a first light emitting unit configured to output a first output light of a first wavelength range…” and “a second light emitting unit configured to output a second output light of a second wavelength range different from the first wavelength range….”
Claim 1 should also be amended to recite “a light receiving unit configured to sense a first reflected light and a second reflected light that are reflected, respectively, from a predetermined object in which the first output light and the second output light are detected within a predetermined distance.”
Claim 11 should be amended to recite “wherein the blind separation technique includes a Principal Component Analysis[[)]] (PCA) method that minimizes cross-correlation of the reflected light data and an Independent Component Analysis[[)]] (ICA) method that minimizes mutual information.”
Claim 12 should be amended to recite “a first light emitting unit configured to output a first output light of a first wavelength range” and “a second light emitting unit configured to output a second output light of a second wavelength range different from the first wavelength range….”
Claim 12 should also be amended to recite “determines that the wearable device is in a wearing state upon determining that the type of the predetermined object is skin….”
Claim 13 should be amended to recite “sensing first reflected light and second reflected light reflected, respectively, from a predetermined object in which the first output light and the second output light are detected within a predetermined distance by a light receiving unit.”
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.
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 limitations are recited in claim 1 and are:
a first light emitting unit configured to output first output light of a first wavelength range;
a second light emitting unit configured to output second output light of a second wavelength range different from the first wavelength range;
a light receiving unit configured to sense first reflected light and second reflected light reflected.
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.
Corresponding structure for light emitting units and light receiving units are described at page 10, lines 3-19 of the specification.
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 2, 10, and 11 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 2 recites “wherein the first output light is red light with a wavelength band of 400nm to 700nm, and the second output light is infrared (IR) light with a wavelength of 850nm to 1050nm.” First, with respect to wavelengths, the color red typically corresponds to 620 nm to about 700 nm. Thus, identifying the first output light as “red light” but then defining it as being within a wavelength band of 400 nm to 700 nm is confusing. Second, the first output light is recited as having “a wavelength band of [range]” whereas the second output light is recited as having “a wavelength of [range]”. This is confusing as it is not clear if “wavelength band of [range]” should have a meaning that differs from “wavelength of [range].”
Based on Applicant’s disclosure and claim 1, Examiner is interpreting the relevant portions of claim 2 as follows: “wherein the first wavelength range of the first output light is within 400nm to 700nm, and the second wavelength range of the second output light is infrared (IR) light within 850nm to 1050nm.”
Claim 10 depends from claim 9 and recites “wherein the controller is configured to filter only the P(t) by removing the M(t) included in the reflected light data based on a blind separation technique, when the reflected light data includes the M(t) comprising a DC component equal to or greater than a predetermined criterion.”
First, it is not clear how P(t) can be filtered by removing M(t). Claim 9 and Applicant’s disclosure make it clear that P(t) and M(t) are separate components of the system: S(t) = E(t) + P(t) + M(t) + N(t). (p.18, lines 10-13). Thus, removing M(t) would not filter only P(t).
Second, it is not clear what is meant by the “M(t) comprising a DC component equal to or greater than a predetermined criterion.” M(t) refers to motion (i.e., noise) whereas DC refers to the baseline of the PPG signal. Moreover, Applicant’s disclosure does not explain how one derives a DC component from M(t). Lastly, it appears that the DC component is a value that is compared to another value. However, claim 10 recites a “predetermined criterion.” It is suggested changing “criterion” to “threshold” or “value.”
For the purpose of a compact prosecution, Examiner is interpreting claim 10 as follows: “wherein the controller is configured to remove the M(t) included in the reflected light data based on a blind separation technique.”
Claim 11 is also rejected for being indefinite as it depends from claim 10.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite:
[a] determine whether the predetermined object is skin based on reflected light data for the first reflected light and the second reflected light sensed in the light receiving unit, as recited in claims 1 and 12;
[b] determine whether the predetermined object is skin in a stationary state based on the first reflected light and the second reflected light, as recited in claim 3;
[c] determine that the object is skin if a ratio of a normalized value of an intensity of the first reflected light and a normalized value of an intensity of the second reflected light falls within a predetermined criterion, as recited in claims 4 and 14;
[d] determine whether the predetermined object is skin in a moving state based on the first reflected light and the second reflected light, as recited in claims 5 and 13;
[e] determine that the object is skin if a ratio of a normalized value of a rate of change of intensity of the first reflected light and a normalized value of a rate of change of intensity of the second reflected light falls within a predetermined criterion, as recited in claims 6 and 15;
[f] detect a predetermined object within a predetermined distance based on the second reflected light for the second output light in the light receiving unit, as recited in claim 7;
[g] wherein the controller is configured to filter only the P(t) by removing the M(t) included in the reflected light data based on a blind separation technique, when the reflected light data includes the M(t) comprising a DC component equal to or greater than a predetermined criterion, as recited in claim 10;
[h] wherein the blind separation technique includes a PCA (Principal Component Analysis) method that minimizes cross-correlation of the reflected light data and an ICA (Independent Component Analysis) method that minimizes mutual information, as recited in claim 11.
Each of claim limitations [a]-[e], as drafted and under its broadest reasonable interpretation, recites a mathematical concept. (MPEP 2106.04(a)(2)). Each of claim limitations [a]-[e] recites a mathematical concept because determining whether the object is skin in a moving or non-moving state requires calculating a ratio between different light intensities, which is an act of calculating using mathematical methods that could be practically performed in the human mind. (MPEP 2106.04(a)(2), I, (C)) (see, e.g., SAP America, Inc. v. InvestPic, LLC, 898 F.3d 1161, 1163, 127 USPQ2d 1597, 1599 (Fed. Cir. 2018) (holding that claims to a “series of mathematical calculations based on selected information” are directed to abstract ideas).
Claim limitation [f], as drafted and under its broadest reasonable interpretation, recites a mathematical concept. (MPEP 2106.04(a)(2)). Determining whether the object is within a predetermined distanced requires (a) determining the distance between the device and the object and (b) determining whether that distance satisfies a threshold. Each of these steps requires a mathematical calculation: (a) calculates the distance using known ranging formulas and (b) compares the result to a threshold number. (see, e.g., Digitech Image Techs., LLC v. Elecs. for Imaging, Inc., 758 F.3d 1344, 1350, 111 USPQ2d 1717, 1721 (Fed. Cir. 2014) (holding that claims to a “process of organizing information through mathematical correlations” are directed to an abstract idea). For example, determining whether a value is less than, equal to, or greater than another value can be considered an act of calculating using mathematical methods that could be practically performed in the human mind. (MPEP 2106.04(a)(2), I, (C)).
Claim limitation [g], as drafted and under its broadest reasonable interpretation, recites a mathematical concept. (MPEP 2106.04(a)(2)). Filtering only the P(t) by removing the M(t) included in the reflected light data based on a blind separation technique requires mathematical calculations, such as decorrelating the reflected-light signals and estimating independent P(t) and M(t). (see, e.g., Digitech Image Techs., LLC v. Elecs. for Imaging, Inc., 758 F.3d 1344, 1350, 111 USPQ2d 1717, 1721 (Fed. Cir. 2014) (holding that claims to a “process of organizing information through mathematical correlations” are directed to an abstract idea).
Claim limitation [h], as drafted and under its broadest reasonable interpretation, recites a mathematical concept. (MPEP 2106.04(a)(2)). The blind separation technique, which includes a PCA (Principal Component Analysis) method that minimizes cross-correlation of the reflected light data and an ICA (Independent Component Analysis) method that minimizes mutual information, requires mathematical calculations, such as decorrelating the reflected-light signals and estimating independent P(t) and M(t).
This judicial exception is not integrated into a practical application. In Prong Two, examiners consider additional elements to evaluate whether the claim as a whole integrates the exception into a practical application of that exception. In this case, the additional elements include: (a) light-emitting units and a light receiving unit, (claims 1 and 12); (b) a controller, (claims 1 and 12); and (c) that the output light is within predetermine wavelength ranges, (claim 2).
Element (a) involves pre-solution activity (i.e., data gathering) that is necessary for performing the judicial exception. It is necessary to collect reflected light signals to determine how the reflected light signals interact with the object. The addition of insignificant extra-solution activity does not amount to an inventive concept, particularly when the activity is well-understood or conventional. (see, e.g., Parker v. Flook, 437 U.S. 584, 588-89, 198 USPQ 193, 196 (1978)). Moreover, elements (a) and (c) only generally link the use of a judicial exception to a particular technological environment (i.e., wearable devices with biometric sensors). Lastly, (b) is merely using a computer as a tool to perform an abstract idea. Accordingly, these additional elements do not meaningfully limit the claim such that the judicial exception is transformed into a patent-eligible application.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above, the additional elements either recite pre-solution activity (i.e., data gathering) that is necessary for performing the judicial exception, generally link the use of a judicial exception to a particular technological environment (i.e., wearable devices with biometric sensors), or use generic computing components to perform the abstract idea.
Accordingly, no claims are patent eligible.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, 12, and 13 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by International Patent Publ. No. WO 2023/180205 A1 (hereinafter “STOJKOVIC”).
With respect to claim 1, STOJKOVIC discloses an optical-based skin detection sensor. STOJKOVIC discloses a proximity sensing system for a wearable or an ear-mountable playback device. (Abstract). “An object to be achieved is to provide a proximity sensing system for an ear-mountable playback device having an optical proximity sensor that is capable of skin detection….” (_). Figure 1 of STOJKOVIC is shown here. The sensor comprising:
a first light emitting unit configured to output first output light of a first wavelength range and a second light emitting unit configured to output second output light of a second wavelength range different from the first wavelength range. “The proximity sensor (10) comprises an emitter structure (11) configured to emit light in a first wavelength range (r1) and in a second wavelength range (r2)….” (Abstract). The wavelength ranges are different. “In contrast, the improved concept realizes a two-point measurement, wherein the proximity sensor is operated at two different wavelengths. Due to different reflection behavior at different wavelength, the two-point measurement typically allows to easily distinguish between whether the wearable or ear-mountable playback device is in contact with the user' s body and whether it is in contact with inanimate objects such as cloth from a pocket or bag, a storage container or a table top, for instance.” (see, e.g., p.5, lines 8-16).
a light receiving unit configured to sense first reflected light and second reflected light reflected, respectively, from a predetermined object in which the first output light and the second output light are detected within a predetermined distance. “The proximity sensor (10) comprises…a detector structure (12) configured to detect light that is emitted by the emitter structure (11) and reflected by an object (3) arranged distant to the optical proximity sensor (10), and to generate a first and second photo signals based on light detected at the first and second
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wavelength ranges (r1, r2).” (Abstract). STOJKOVIC determines whether the object is within a “threshold distance.” (see, e.g., Abstract).
a controller configured to determine whether the predetermined object is skin based on reflected light data for the first reflected light and the second reflected light sensed in the light receiving unit. “The control unit (20) determines based on the first and second photo signals, whether the object (3) is within a threshold distance to the optical proximity sensor (10) and whether the object (3) is a user's body part.” (Abstract). The body part is detected by detecting skin. (see, e.g., p.2, line 16).
With respect to claim 2, STOJKOVIC discloses wherein the first output light is red light with a wavelength band of 400nm to 700nm (“660 nm” at p.18, lines 27-32), and the second output light is infrared (IR) light with a wavelength of 850nm to 1050nm (940 nm or 800-830 nm). NOTE: The claimed “first output light” is taught by an alternative embodiment of STOJKOVIC that includes visible wavelengths for the third wavelength range, and the claimed “second output light” is taught by either a first wavelength range or a second wavelength range in STOJKOVIC. (see, e.g., p.17, line 32 to p.19, line 15). All three wavelength ranges in STOJKOVIC can be used to determine whether the object is within a threshold distance and whether skin is detected. (see, e.g., p.20, lines 4-9).
With respect to claim 12, STOJKOVIC discloses a wearable device. “The present disclosure relates to a proximity sensing system for wearables and ear-mountable playback devices, an ear-mountable playback devices comprising such a system….” (p.1, lines 6-9). The wearable device comprising;
a skin detection sensor (“An object to be achieved is to provide a proximity sensing system for an ear-mountable playback device having an optical proximity sensor that is capable of skin detection,...” (p.2, lines 15-18)) comprising:
a first light emitting unit configured to output first output light of a first wavelength range; a second light emitting unit configured to output second output light of a second wavelength range different from the first wavelength range. “The proximity sensor (10) comprises an emitter structure (11) configured to emit light in a first wavelength range (r1) and in a second wavelength range (r2)….” (Abstract). The wavelength ranges are different. “In contrast, the improved concept realizes a two-point measurement, wherein the proximity sensor is operated at two different wavelengths. Due to different reflection behavior at different wavelength, the two-point measurement typically allows to easily distinguish between whether the wearable or ear-mountable playback device is in contact with the user' s body and whether it is in contact with inanimate objects such as cloth from a pocket or bag, a storage container or a table top, for instance.” (see, e.g., p.5, lines 8-16).
a light receiving unit configured to sense first reflected light and second reflected light reflected, respectively, from a predetermined object in which the first output light and the second output light are detected within a predetermined distance. “The proximity sensor (10) comprises…a detector structure (12) configured to detect light that is emitted by the emitter structure (11) and reflected by an object (3) arranged distant to the optical proximity sensor (10), and to generate a first and second photo signals based on light detected at the first and second wavelength ranges (r1, r2).” (Abstract). STOJKOVIC determines whether the object is within a “threshold distance.” (see, e.g., Abstract).
a controller configured to determine whether the predetermined object is skin based on reflected light data for the first reflected light and the second reflected light sensed in the light receiving unit. “The control unit (20) determines based on the first and second photo signals, whether the object (3) is within a threshold distance to the optical proximity sensor (10) and whether the object (3) is a user's body part.” (Abstract). The body part is detected by detecting skin. (see, e.g., p.2, line 16).
a processor (“control unit 20”, Figure 1) configured to: determines that it is in a wearing state upon determining that the type of the predetermined object is skin, and controls activation of the wearable device based on the determined wearing state. “The control unit is further configured to activate and deactivate and output of the speaker depending on whether the object is in contact with the housing and whether the object is an ear of the user. If the object is determined to be in contact with the housing and if the object is identified to be human skin, the control unit can enable further active circuitry of the earphone device for enabling a sound output of the speaker as well as further optional features such as an active-noise cancellation algorithm.” (p.14, lines 19-28).
With respect to claim 13, STOJKOVIC discloses a method of detecting optical-based skin by at least one processor of a wearable device. “The present disclosure relates to a proximity sensing system for wearables and ear-mountable playback devices, an ear-mountable playback devices comprising such a system, and to a proximity sensing method.” (p.1, lines 6-9). “An object to be achieved is to provide a proximity sensing system for an ear-mountable playback device having an optical proximity sensor that is capable of skin detection,...” (p.2, lines 15-18). The method comprising;
outputting first output light of a first wavelength range based on a first light emitting unit and outputting second output light of a second wavelength range different from the first wavelength range based on a second light emitting unit. “The proximity sensor (10) comprises an emitter structure (11) configured to emit light in a first wavelength range (r1) and in a second wavelength range (r2)….” (Abstract). The wavelength ranges are different. “In contrast, the improved concept realizes a two-point measurement, wherein the proximity sensor is operated at two different wavelengths. Due to different reflection behavior at different wavelength, the two-point measurement typically allows to easily distinguish between whether the wearable or ear-mountable playback device is in contact with the user' s body and whether it is in contact with inanimate objects such as cloth from a pocket or bag, a storage container or a table top, for instance.” (see, e.g., p.5, lines 8-16).t
sensing first reflected light and second reflected light reflected, respectively, from a predetermined object in which the first output light and the second output light are detected within a predetermined distance based on a light receiving unit. “The proximity sensor (10) comprises…a detector structure (12) configured to detect light that is emitted by the emitter structure (11) and reflected by an object (3) arranged distant to the optical proximity sensor (10), and to generate a first and second photo signals based on light detected at the first and second wavelength ranges (r1, r2).” (Abstract). STOJKOVIC determines whether the object is within a “threshold distance.” (see, e.g., Abstract).
determining whether the predetermined object is skin based on reflected light data for the sensed first reflected light and the second reflected light. “The control unit (20) determines based on the first and second photo signals, whether the object (3) is within a threshold distance to the optical proximity sensor (10) and whether the object (3) is a user's body part.” (Abstract). The body part is detected by detecting skin. (see, e.g., p.2, line 16).
determining that it is in a wearing state upon determining that the type of the predetermined object is skin; and controlling activation of the wearable device based on the determined wearing state. “The control unit is further configured to activate and deactivate and output of the speaker depending on whether the object is in contact with the housing and whether the object is an ear of the user. If the object is determined to be in contact with the housing and if the object is identified to be human skin, the control unit can enable further active circuitry of the earphone device for enabling a sound output of the speaker as well as further optional features such as an active-noise cancellation algorithm.” (p.14, lines 19-28).
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 3-6, 14, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over International Patent Publ. No. WO 2023/180205 A1 (hereinafter “STOJKOVIC”) and U.S. Patent Appl. Publ. No. 2017/0215747 A1 (“VAN DITHER”).
Each of claims 3-6, 14, and 15 depend directly or indirectly from claim 1, which is disclosed by STOJKOVIC as discussed above.
With respect to claim 3, STOJKOVIC does not explicitly teach that the controller is configured to determine whether the predetermined object is skin in a stationary state based on the first reflected light and the second reflected light.
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]).
VAN DITHER teaches an “off-skin detection unit” that determines “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.” ([0012]). For one particular embodiment, “[i]f 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
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Figure 5 and [0044] and [0045] explaining the different experimental conditions). “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]). VAN DITHER also teaches an off-skin detection unit that uses AC components. (see, e.g., [0050] and [0051]).
Figure 5 of VAN DITHER is shown here and illustrates how the data may appear depending upon the motion of the device. In Figure 5, “A1” and “A4” represent the surface of a human wrest at rest. VAN DITHER also teaches that the skin detection workflow should only proceed if the level of motion is below a threshold to enable “a more robust and reliable off-skin detection.” ([0052]; see also [0050]).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the STOJKOVIC device to include the skin detection unit of VAN DITHER to determine whether the predetermined object is skin in a stationary state based on the first reflected light and the second reflected light. One of ordinary skill in the art would have been motivated to use the reliable and robust method in VAN DITHER to determine that the skin is in contact with the device so that more reliable data could be obtained using the ratio as taught in VAN DITHER. There would have been a reasonable expectation of success as VAN DITHER teaches that devices similar to STOJKOVIC can implement the skin detection method prior to obtaining physiological data.
With respect to claim 4 (depending from claim 3), STOJKOVIC does not explicitly teach that the controller is configured to determine that the object is skin if a ratio of a normalized value of an intensity of the first reflected light and a normalized value of an intensity of the second reflected light falls within a predetermined criterion.
VAN DITHER teaches that “[o]ptionally, the DC levels of the output signals of the photo detector can be normalized by the power of the light units as well as an ADC gain.” ([0042]) As described above with respect to the rejection of claim 3, the DC levels can determine whether the wearable device is on-skin or off-skin. The predetermined criterion in VAN DITHER is the DC component of the second wavelength is greater than the DC component of the first wavelength, “then the PPG sensor is in contact with the skin.” ([0047]). More specifically, if the ratio DCλ2-normalized/DC λ1-normalized is greater than one, then the PPG sensor is in contact with the skin.
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the STOJKOVIC device to determine that the object is skin if a ratio of a normalized value of an intensity of the first reflected light and a normalized value of an intensity of the second reflected light falls within a predetermined criterion. One of ordinary skill in the art would have been motivated to use normalized values, as suggested in VAN DITHER, to account for the different light sources and different gains for different wavelength channels. There would have been a reasonable expectation of success as VAN DITHER teaches that devices similar to STOJKOVIC can implement the skin detection method prior to obtaining physiological data.
With respect to claim 5, STOJKOVIC does not explicitly teach that wherein the controller is configured to determine whether the predetermined object is skin in a moving state based on the first reflected light and the second reflected light.
Figure 5 of VAN DITHER is shown above and illustrates how the data may appear depending upon the motion of the device. In Figure 5, “A1” and “A4” represent the surface of a human wrist at rest. “A2” and “A3” represent the surface of the human wrist in motion. “It can be seen from FIG. 5 that the DC component at the second wavelength P2 is higher than the DC component at the first wavelength P1 when the sensor is at rest or in motion as long as it is placed against the wrist of a user.” ([0048]).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the STOJKOVIC device to include the skin detection unit of VAN DITHER to determine whether the predetermined object is skin in a moving state based on the first reflected light and the second reflected light. One of ordinary skill in the art would have been motivated to use the reliable and robust method in VAN DITHER to determine that the skin is in contact with the device so that more reliable data could be obtained using the ratio as taught in VAN DITHER. There would have been a reasonable expectation of success as VAN DITHER teaches that devices similar to STOJKOVIC can implement the skin detection method prior to obtaining physiological data.
With respect to claim 6 (depending from claim 5), STOJKOVIC does not explicitly teach that wherein the controller is configured to determine that the object is skin if a ratio of a normalized value of a rate of change of intensity of the first reflected light and a normalized value of a rate of change of intensity of the second reflected light falls within a predetermined criterion.
VAN DITHER teaches another embodiment that compares DC components and then compares AC components after removing the DC components. The AC components represent the changing intensity of the reflected light (i.e., the pulsatile component). “The off-skin detection unit 130 furthermore comprises a DC removal unit 132 for removing the DC component of the output signals of the photo detector 120 at the first and second wavelength P1, P2 such that only the AC components remain. The AC components of the output signal of the photo detector 120 at the first wavelength P1 are stored in a buffer 133 (in particular in a first portion of the buffer) and the AC components of the output signal of the photo detector 120 are stored in the buffer 133 (in particular in a second portion of the buffer). A root mean square unit 134 calculates the root mean square RMS of the AC components in the buffer 133 (in particular in the first and second portion of the buffer) and a second comparing unit 135 compares the results of the AC components in the first buffer portion with the root mean square of the AC components in the second buffer portion multiplied by a constant C3.” ([0050]). Again, VAN DITHER essentially calculates a ratio and decision-making is based on the ratio be less than or greater than 1. “If the root mean square of the AC components in the first buffer portion is smaller than the root mean square of the AC components in the second buffer 134 times the constant C3, then the PPG sensor 100 can be switched off.” ([0050]). In other words, the predetermined criterion in VAN DITHER is the RMS AC component of the first wavelength being greater than the RMS AC component of the second wavelength times a constant. More specifically, if the ratio is greater than one, then the PPG sensor is in contact with the skin.
VAN DITHER also teaches that “[o]ptionally, the DC levels of the output signals of the photo detector can be normalized by the power of the light units as well as an ADC gain.” While this was specifically suggested for DC levels, the same reason for normalizing the DC levels also exist for normalizing the AC values. Both the DC values and AC values can be affected by LED output power, photodiode response, analog gain, ADC gain, etc.
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the STOJKOVIC device to include the skin detection unit of VAN DITHER to determine whether the predetermined object is skin in a moving state based on the first reflected light and the second reflected light. One of ordinary skill in the art would have been motivated to use the reliable and robust alternative method in VAN DITHER (shown in Figure 7) to determine that the skin is in contact with the device so that more reliable data could be obtained using the ratio as taught in VAN DITHER. There would have been a reasonable expectation of success as VAN DITHER teaches that devices similar to STOJKOVIC can implement the skin detection method prior to obtaining physiological data.
It would have also been obvious to determine that the object is skin if a ratio of a normalized value of a rate of change of intensity of the first reflected light and a normalized value of a rate of change of intensity of the second reflected light falls within a predetermined criterion. One of ordinary skill in the art would have been motivated to use normalized values, as suggested in VAN DITHER, to account for the different light sources and different gains for different wavelength channels. There would have been a reasonable expectation of success as VAN DITHER teaches that devices similar to STOJKOVIC can implement the skin detection method prior to obtaining physiological data.
With respect to claim 14, STOJKOVIC does not explicitly teach that determining whether the predetermined object is skin comprises determining whether the predetermined object is skin in a stationary state based on the first reflected light and the second reflected light, and the determining whether the predetermining object is skin in a stationary state comprises determining that the object is skin if a ratio of a normalized value of an intensity of the first reflected light and a normalized value of an intensity of the second reflected light falls within a predetermined criterion.
As discussed above with respect to claims 3 and 4, VAN DITHER teaches an “off-skin detection unit” that determines “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.” ([0012]). VAN DITHER also teaches that the skin detection workflow should only proceed if the level of motion is below a threshold to enable “a more robust and reliable off-skin detection.” ([0052]; see also [0050]). VAN DITHER also teaches that “[o]ptionally, the DC levels of the output signals of the photo detector can be normalized by the power of the light units as well as an ADC gain.” ([0042]).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the STOJKOVIC device to include the skin detection unit of VAN DITHER to determine whether the predetermined object is skin in a stationary state based on the first reflected light and the second reflected light. One of ordinary skill in the art would have been motivated to use the reliable and robust method in VAN DITHER to determine that the skin is in contact with the device so that more reliable data could be obtained using the ratio as taught in VAN DITHER. There would have been a reasonable expectation of success as VAN DITHER teaches that devices similar to STOJKOVIC can implement the skin detection method prior to obtaining physiological data.
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the STOJKOVIC device to determine that the object is skin if a ratio of a normalized value of an intensity of the first reflected light and a normalized value of an intensity of the second reflected light falls within a predetermined criterion. One of ordinary skill in the art would have been motivated to use normalized values, as suggested in VAN DITHER, to account for the different light sources and different gains for different wavelength channels. There would have been a reasonable expectation of success as VAN DITHER teaches that devices similar to STOJKOVIC can implement the skin detection method prior to obtaining physiological data.
With respect to claim 15, STOJKOVIC does not explicitly teach that determining whether the predetermined object is skin comprises determining whether the predetermined object is skin in a moving state based on the first reflected light and the second reflected light, and the determining whether the predetermining object is skin in a moving state comprises determining that the object is skin if a ratio of a normalized value of a rate of change of intensity of the first reflected light and a normalized value of a rate of change of intensity of the second reflected light falls within a predetermined criterion.
As discussed above with respect to claims 5 and 6, VAN DITHER teaches an “off-skin detection unit” that determines “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.” ([0012]). VAN DITHER teaches another embodiment that compares DC components and then compares AC components after removing the DC components. The AC components represent the changing intensity of the reflected light (i.e., the pulsatile component). “The off-skin detection unit 130 furthermore comprises a DC removal unit 132 for removing the DC component of the output signals of the photo detector 120 at the first and second wavelength P1, P2 such that only the AC components remain.” ([0050]).
VAN DITHER also teaches that “[o]ptionally, the DC levels of the output signals of the photo detector can be normalized by the power of the light units as well as an ADC gain.” While this was specifically suggested for DC levels, the same reason for normalizing the DC levels also exist for normalizing the AC values. Both the DC values and AC values can be affected by LED output power, photodiode response, analog gain, ADC gain, etc.
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the STOJKOVIC device to include the skin detection unit of VAN DITHER to determine whether the predetermined object is skin in a moving state based on the first reflected light and the second reflected light. One of ordinary skill in the art would have been motivated to use the reliable and robust alternative method in VAN DITHER (shown in Figure 7) to determine that the skin is in contact with the device so that more reliable data could be obtained using the ratio as taught in VAN DITHER. There would have been a reasonable expectation of success as VAN DITHER teaches that devices similar to STOJKOVIC can implement the skin detection method prior to obtaining physiological data.
It would have also been obvious to determine that the object is skin if a ratio of a normalized value of a rate of change of intensity of the first reflected light and a normalized value of a rate of change of intensity of the second reflected light falls within a predetermined criterion. One of ordinary skill in the art would have been motivated to use normalized values, as suggested in VAN DITHER, to account for the different light sources and different gains for different wavelength channels. There would have been a reasonable expectation of success as VAN DITHER teaches that devices similar to STOJKOVIC can implement the skin detection method prior to obtaining physiological data.
Claims 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over International Patent Publ. No. WO 2023/180205 A1 (hereinafter “STOJKOVIC”) and a translation of International Patent Publ. No. WO 2019/056293 A1 (“GOODIX”).
Each of claims 7 and 8 depend directly or indirectly from claim 1, which is disclosed by STOJKOVIC as discussed above.
With respect to claim 7, STOJKOVIC does not explicitly teach that the controller is configured to: control the second light emitting unit in a non-wearing state to control it to output the second output light at a first output strength; and detect a predetermined object within a predetermined distance based on the second reflected light for the second output light in the light receiving unit. However, STOJKOVIC does contemplate using a single light to determine proximity and then using multiple light signals to identify the type of object. “For further enhancing an energy efficient operation of the respective wearable or ear-mountable playback device particularly in situations, in which it is not worn, the control unit can be configured to merely monitor a proximity to an object arranged in front of the proximity sensor and only enable the object identification via a two- or three-wavelength range measurement described throughout this disclosure if an object is within a certain distance, e.g. only if an object is in contact with a housing of the device.” (p.12, line 29 to p.13, line 5).
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In the same field of endeavor, GOODIX teaches a wearing state detection method for wearable devices. (Abstract). GOODIX teaches that “in order to save power and prolong the use time of the wearable device, and to improve the accuracy of the test data related to the wear, many wearable devices currently have a wear detection function, which can automatically determine the wearable state of the wearable device, and then wear according to the wearable device.” (p.1, lines 23-26).
With this power-saving objective in mind, GOODIX teaches first determining whether the device is in a worn or unworn state by detecting the light intensity reflected by the object. “As an optional implementation manner of the present invention, before the N different wavelengths of light are emitted to the detected object, the method further includes: Transmitting a single wavelength of light to the object to be detected… Determining whether the intensity of the reflected light corresponding to the light of the single wavelength exceeds the light intensity threshold…By emitting a single wavelength of light to the detected object and collecting the acceleration of the wearable device before transmitting the N different wavelengths of light to the detected object, the intensity of the reflected light corresponding to the light of the single wavelength is determined to exceed the light intensity threshold. When the acceleration exceeds the acceleration threshold, N different wavelengths of light are emitted, which can save power and prolong the wearable time of the wearable device. / As an alternative embodiment of the invention, the light of a single wavelength is infrared light. / By using infrared light, you can save power.” (p.3, lines 29-37). In order to have a relevant threshold for the detected light intensity, it would be necessary to have a known output strength for the second output light. Figure 2 shows a relationship between intensity and distance.
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the STOJKOVIC device so that, in a non-wearing state, the device emits a second output light at an output strength and detects, based on light reflected by the second output light, that an object is within a predetermined distance. One of ordinary skill in the art would have been motivated to use GOODIX’s method (i.e., using only one output light to determine when an object is within a threshold distance) in order to conserve power. There would have been a reasonable expectation of success as GOODIX teaches that wearable devices like STOJKOVIC’s can emit one output light to determine whether an object is within a predetermined distance.
With respect to claim 8 (depending from claim 7), STOJKOVIC does not explicitly teach that the controller is configured to control the first light emitting unit to output the first output light, when a predetermined object is detected within the predetermined distance.
According to GOODIX, after determining that the object is within a predetermined distance, other output lights are then emitted to determine more information about the object. “When the acceleration exceeds the acceleration threshold, N different wavelengths of light are emitted, which can save power and prolong the wearable time of the wearable device.” (p.3, lines 31-33).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the STOJKOVIC device so that, after determining that the object is within a threshold distance, the device emits a first output light. One of ordinary skill in the art would have been motivated to use GOODIX’s method (i.e., emitting other output lights after confirming object is within a predetermined distance) in order to determine more information about the user. There would have been a reasonable expectation of success as GOODIX teaches that wearable devices like STOJKOVIC’s can emit one output light to determine whether an object is within a predetermined distance and information about the user (e.g., heart rate).
Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over International Patent Publ. No. WO 2023/180205 A1 (hereinafter “STOJKOVIC”) and U.S. Patent Appl. Publ. No. 2004/0059210 A1 (“STETSON”).
Claim 9 depends from claim 1, which is disclosed by STOJKOVIC as discussed above. STOJKOVIC does not teach the majority of the limitations of claims 9-11. However, STOJKOVIC does teach that the reflected light data includes signal patterns of the first and second reflected light. (see, e.g., P1 and P2 of Figure 5 of STOJKOVIC).
In the same field of endeavor, STETSON teaches a “method and apparatus for the application of Blind Source Separation (BSS), specifically independent Component Analysis (ICA) to mixture signals obtained by a pulse oximeter sensor.” (Abstract). STETSON teaches “the processing of signals obtained from a medical diagnostic apparatus such as a pulse oximeter using a blind source separation technique to separate the obtained data without prior knowledge of its magnitude or frequency into data corresponding to the desired physiological data and the undesired interference sources.” ([0001]). STETSON describes the challenge of pulse oximetry as “analyzing the data to obtain a reliable measure of a physiologic parameter in the presence of large interference sources.” ([0003]).
With respect to claim 9, STETSON teaches that the reflected light data is data which consists of a combination of a signal by blood flow, P(t) and a signal by motion, M(t). “Source components refer to the desired physiologic data including signals corresponding to the plethysmographic signal obtained at multiple wavelengths in addition to undesired interference data, which may be caused by motion, light interference, respiratory artifacts, and other known sources of errors in pulse oximetry.” ([0008]). More specifically, STETSON teaches that the data is a combination of the plethysmographic signal (i.e., the P(t)) and undesired interference data, including motion (i.e., M(t)).
With respect to claim 10 (and in light of the Section 112(b)), STETSON teaches wherein the controller is configured to remove the M(t) included in the reflected light data based on a blind separation technique. The blind source separation technique in STETSON removes the “motion artifact” using a blind separation technique. (Abstract). “[T]he technique provides the advantage of extracting the plethysmographic signal in the presence of large motion interference and especially without requiring prior knowledge of saturation or pulse rate.” ([0013]).
With respect to claim 11, STETSON teaches wherein the blind separation technique includes a PCA (Principal Component Analysis) method that minimizes cross-correlation of the reflected light data (“Furthermore, a comparison of FIGS. 6 and 7 shows that while the original mixture signals are not decorrelated, the principal components are decorrelated…FIG. 7 shows a plot of principal component 2 vs. principal component 1. A review of this figure (FIG. 7) shows that the principal components are decorrelated, since there is no significant linear fit to the data in these coordinates.” ([0045])) and an ICA (Independent Component Analysis) method that minimizes mutual information. (“Having decorrelated the data, the principal components are further processed by ICA processing to determine the independent components describing the photocurrent data (step 230)…In one embodiment, the independent components are determined by decorrelating the data by maximizing the sum of squares of the data set's higher-order cumulants…Furthermore, FIG. 8 shows a plot of independent component 2 vs. independent component 1. As can be seen from this figure (FIG. 8), the plot of independent component 2 vs. independent component 1 lies along the horizontal line at (independent component=0) B-B, showing that the data sets have a minimal amount of mutual information, and thus can be approximated as independent data sets.” ([0045])).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the STOJKOVIC device such that it considers the reflected light data as including a combination of signal by blood flow (P(t)) and a signal by motion (M(t)) and removes M(t) using a blind source separation technique that includes PCA and ICA as recited in claims 9-11. One of ordinary skill in the art would have been motivated to apply the blind source separation analysis of STETSON to obtain “the advantage of extracting the plethysmographic signal in the presence of large motion interference and especially without requiring prior knowledge of saturation or pulse rate” as taught in STETSON. There would have been a reasonable expectation of success as STETSON teaches that blind source separation techniques can be applied to pulse oximetry data.
Prior Art Made of Record
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US-20220225006-A1 (“ALLEC”) teaches wearable electronic devices (e.g., earbud, wristwatch) that also includes a skin sensor. Like STOJKOVIC and VAN DITHER, ALLEC describes differentiating between skin and another object by analyzing the reflected light of two different wavelengths. (see, e.g., [0019]). ALLEC specifically teaches comparing the ratio to a threshold. ([0019]).
Conclusion
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/JASON P GROSS/ Examiner, Art Unit 3797
/SERKAN AKAR/Primary Examiner, Art Unit 3797
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