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 .
Information Disclosure Statement
The information disclosure statement (IDS) filed 5/1/2024 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. The foreign patent documents and non-patent literature documents that have been struck-through on the IDS filed on 5/1/2024 are those references in which no copy has been filed with the PTO in this present application or in any IDS in any of the parent applications. The foreign patent documents and non-patent literature documents that have been struck-through on the IDS filed on 5/1/2024 have has not been considered.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Although the claim limitation “at least one of a head band, an arm band, a foot band, an ankle band, and a ring” in claim 13, line 2 is self-supporting, there is no support in the written specification for the recitation “at least one” (suggesting a plurality is contemplated) of a head band, an arm band, a foot band, an ankle band, and a ring for the apparatus. 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 limitation(s) is/are:
(1) “a processing module electrically coupled to the first electrode and the second electrode and operable to (a) bias the first electrode at a first voltage V+ and the second electrode at a second voltage V-, (b) measure a current flowing between the first electrode and the second electrode, the current corresponding to the conductance of the stratum corneum, (c) subtract a compensation current from the measured current, (d) measure a resulting current and produce an amplified output voltage, (e) measure a conductance of the stratum corneum, and (f) adjust at least one of the first voltage, the second voltage, and the compensation current to desaturate the output voltage” in claim 1, lines 5-12;
(2) “a processing module …the processing module operable to (a) bias the first electrode at a first voltage V+ and the second electrode at a second voltage V- (b) measure a current flowing between the first electrode and the second electrode, the current corresponding to the conductance of the stratum corneum, (c) subtract a compensation current from the measured current, (d) measure a resulting current and produce an amplified output voltage, (e) measure a conductance of the stratum corneum, and (f) adjust at least one of the first voltage, the second voltage, and the compensation current to desaturate the output voltage” in claim 9, lines 9-16; and
(3) a communications module…configured to at least one of a display an electrodermal activity of the user, and communicate electrodermal activity data from the processing module to an external device” of claim 9, lines 17-20.
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.
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.
No other claim limitation has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claims 1, 6, and 9 are objected to because of the following informalities:
in claim 1, line 8: “the conductance” should be “a conductance”;
in claim 6, line 2: “person’s skin” should be “a person’s skin”;
in claim 9, line 11: a comma should be inserted after “V-”;
in claim 9, lines 12-13: “the conductance” should be “a conductance”; and
in claim 9, line 18: “a” before “display” should be deleted.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 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 1 recites “measuring electrodermal activity” in line 1, but it is not clear which, if any, of the variables subsequently mentioned in the claim (the measured current, the resulting current, the amplified output voltage, the measured conductance) are supposed to be the electrodermal activity that is being measured. If none of the subsequently measured variables are the measured electrodermal activity, it is not clear how electrodermal activity is measured. If one or more of the subsequently measured variables are the measured electrodermal activity, the claim should be clear as to which ones those are.
Claim 1 recites “(d) measure a resulting current and produce an amplified output voltage” in lines 9-10, but it is not clear if this recitation is a result of or related to “(c) subtract a compensation current from the measured current” in lines 8-9. If they are related, their relationship should be made clear. If they are not related, it is not clear where “a resulting current” comes from, how it is measured, or how it is produced.
Claim 1 recites “a conductance of the stratum corneum” in line 10, but it is not clear if this conductance is the same as or different from “the conductance of the stratum corneum” of claim 1, line 8. The similarity of terminology suggests that they are the same but the use of the indefinite article in line 10 suggests that they might be different. If they are different, their relationship should be made clear, the should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements), and any subsequent recitation of “the conductance” should make it clear which recitation is being referred to.
Claims 2-8 are rejected by virtue of their dependence from claim 1.
Claim 2 recites “too low” in line 2, which is a relative term which renders the claim indefinite. The term “too low” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For example, it is not clear what value constitutes the difference between “low” relative to “too low”.
Claim 3 recites “a compensated value of conductance” in line 2 and “a tonic level conductance” in line 2, but it is not clear what relationship these conductance values have relative to the “conductance” in item (b) of claim 1 and the “conductance” in item (e) of claim 1. For example, is the recitation “wherein the processing module is further configured to measure a compensated value of conductance from which a tonic level conductance is removed” the same as, related to, or different from item (e) of claim 1? Clarification is required.
Claim 4 recites “the polarity of at least one of the first electrode and the second electrode” in line 2 in which there is insufficient antecedent basis for this limitation in the claim.
Claim 4 recites “substantially reduce electrolysis” in line 3, which is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For example, it is not clear what value constitutes the difference between simply “reduc[ing] electrolysis” relative to “substantially reduc[ing] electrolysis”.
Claim 5 recites “wherein the processing module is configured to allow a tuning of the compensation current that is subtracted from the current between the first electrode and the second electrode prior to amplification” in lines 1-3, but it is not clear if this tuning function is the same as, related to, or different from item (f) in claim 1. If they are the same, consistent terminology should be used. If they are different or related, their relationship should be made clear so that one of ordinary skill in the art would understand the difference between the two.
Claim 5 recites “prior to amplification” in line 3, but it is not clear what this amplification is. Claim 1 mentions “an amplified output voltage” in lines 9-10, but claim 5 does not mention the output voltage explicitly so it is not clear if it is the amplification of the output voltage that is intended by this recitation.
Claim 7 recites “wherein the apparatus is configured to measure a tonic level conductance of the stratum corneum in the range of about 0.05 µS to about 50 µS” in lines 1-2, but it is not clear if this recitation is the same as, related to, or different from item (e) of claim 1. Tonic level conductance is a conductance so they could be the same, but claim 7 seems to present its recitation as separate and distinct from item (e) of claim 1. Clarification is required.
Claim 7 recites “about 0.05 µS to about 50 µS” in line 2. The specification defines “about” in paragraph 0036:
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However, the above definition uses the expression “generally mean”, which connotes that the term “about” is not defined as stated above in all instances. As a result, there is an ambiguity as to the meaning of “about”. Thus, the term “about” in this claim is a relative term which renders the claim indefinite because (1) the term “about” is not defined by the claim, (2) the specification does not provide a standard for ascertaining the requisite degree because of the ambiguity previously mentioned, and (3) one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 9 recites “measuring electrodermal activity” in line 1, but it is not clear which, if any, of the variables subsequently mentioned in the claim (the measured current, the resulting current, the amplified output voltage, the measured conductance) are supposed to be the electrodermal activity that is being measured. If none of the subsequently measured variables are the measured electrodermal activity, it is not clear how electrodermal activity is measured. If one or more of the subsequently measured variables are the measured electrodermal activity, the claim should be clear as to which ones those are.
Related, it is not clear if “an electrodermal activity of the user” of claim 9, lines 18-19 is the same as, related to, or different from “electrodermal activity” in claim 9, line 1. Further, it is not clear if any of the variables previously mentioned in the claim (the measured current, the resulting current, the amplified output voltage, the measured conductance) are supposed to be this electrodermal activity of claim 9, lines 18-19. Clarification is required.
Claim 9 recites “(d) measure a resulting current and produce an amplified output voltage” in line 14, but it is not clear if this recitation is a result of or related to “(c) subtract a compensation current from the measured current” in lines 13-14. If they are related, their relationship should be made clear. If they are not related, it is not clear where “a resulting current” comes from, how it is measured, or how it is produced.
Claim 9 recites “a conductance of the stratum corneum” in lines 14-15, but it is not clear if this conductance is the same as or different from “the conductance of the stratum corneum” of claim 9, lines 12-13. The similarity of terminology suggests they are the same but the use of the indefinite article in lines 14-15 suggests that they might be different. If they are different, their relationship should be made clear, the should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements), and any subsequent recitation of “the conductance” should make it clear which recitation is being referred to.
Claims 10-18 are rejected by virtue of their dependence from claim 9.
Claim 10 recites “too low” in lines 2-3, which is a relative term which renders the claim indefinite. The term “too low” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For example, it is not clear what value constitutes the difference between “low” relative to “too low”.
Claims 11-12 are rejected by virtue of their dependence from claim 10.
Claim 11 recites “wherein the wearable device is a wrist band” in lines 1-2 but it is not clear what relationship this band has with the other elements of the claim. That is, claim 9 recites that the wearable device comprises a housing, a first electrode, a second electrode, a processing module, a communications module, and a power source while claim 11 appears to connote that the wearable device is a wrist band (as opposed to merely comprising a wrist band). What, if any, relationship do the housing, the first electrode, the second electrode, the processing module, the communications module, and the power source have with the wrist band. Are the housing, the first electrode, the second electrode, the processing module, the communications module, and the power source still part of the claimed device? Clarification is required.
Claim 12 is rejected by virtue of their dependence from claim 11.
Claim 12 recites “wherein the processing module is configured to measure a tonic level conductance of the stratum corneum of the wrist of the user in the range of about 0.05 µS to about 50 µS” in lines 1-3, but it is not clear if this recitation is the same as, related to, or different from item (e) of claim 9. Tonic level conductance is a conductance so they could be the same, but claim 12 seems to present its recitation as separate and distinct from item (e) of claim 9. Clarification is required.
Claim 13 recites “wherein the wearable device is at least one of a head band, an arm band, a foot band, an ankle band, and a ring” in lines 1-2 but it is not clear what relationship these structures have with the other elements of the claim. That is, claim 9 recites that the wearable device comprises a housing, a first electrode, a second electrode, a processing module, a communications module, and a power source while claim 11 appears to connote that the wearable device is at least one of a head band, an arm band, a foot band, an ankle band, and a ring (as opposed to merely comprising at least one of a head band, an arm band, a foot band, an ankle band, and a ring). What, if any, relationship do the housing, the first electrode, the second electrode, the processing module, the communications module, and the power source have with the at least one of a head band, an arm band, a foot band, an ankle band, and a ring. Are the housing, the first electrode, the second electrode, the processing module, the communications module, and the power source still part of the claimed device? Clarification is required.
Claim 14 recites “the polarity of at least one of the first electrode and the second electrode” in line 2 in which there is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites “substantially reduce electrolysis” in line 3, which is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For example, it is not clear what value constitutes the difference between simply “reduc[ing] electrolysis” relative to “substantially reduc[ing] electrolysis”.
Claim 18 recites “the communication module” in line 1, but it is not clear if this recitation is the same as, related to, or different from “a communications module” of claim 9, line 17. If they are the same, “the communication module” in claim 18 should be “the communications module”. If they are different, their relationship should be made clear.
Claim 18 recites “BLUETOOTH®” twice in line 3, which is a trademark that appears to be used to identify a product. Such a use of a trademark in the claim does not comply with 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph (see MPEP 2173.05(u)).
Claim 19 recites “measuring electrodermal activity” in line 1, but it is not clear which, if any, of the variables subsequently mentioned in the claim (the measured current, the amplified output voltage, the measured conductance) are supposed to be the electrodermal activity that is being measured. If none of the subsequently measured variables are the measured electrodermal activity, it is not clear how electrodermal activity is measured. If one or more of the subsequently measured variables are the measured electrodermal activity, the claim should be clear as to which ones those are.
Claim 20 is rejected by virtue of its dependence from claim 19.
Claim 20 recites “too low” in line 2 and in line 3, which is a relative term which renders the claim indefinite. The term “too low” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For example, it is not clear what value constitutes the difference between “low” relative to “too low”.
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.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-8 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 1 recites “a first electrode in contact with a first portion of a stratum corneum of skin” in line 2, which improperly includes a human being as part of the claimed invention.
Claim 2 recites “a second electrode in contact with a second portion of the stratum corneum and in electronic communication with the first electrode through the stratum corneum” in lines 3-4, which improperly includes a human being as part of the claimed invention.
Claims 2-8 are rejected by virtue of their dependence from claim 1.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-3, 5-8 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2008/0208016 (Hughes).
Hughes teaches an apparatus for measuring electrodermal activity, comprising: first and second electrodes in contact with the stratum corneum of skin (the skin electrodes of FIGS. 6-7 of Hughes), and a processing module (FIGS. 6-7 of Hughes) electrically coupled to the first electrode and the second electrode and operable to (a) bias the first electrode at a first voltage V+ and the second electrode at a second voltage V- (applying voltage to the electrodes; paragraphs 0057 and 0068-0072 of Hughes), (b) measure a current flowing between the first electrode and the second electrode, the current corresponding to the conductance of the stratum corneum (the measured EDA from the electrodes; paragraphs 0057 and 0068-0072 of Hughes), (c) subtract a compensation current from the measured current (subtracting a proportional amount of the excitation voltage (and its corresponding current) from the measured EDA signal; paragraphs 0057 and 0068-0072 of Hughes), (d) measure a resulting current and produce an amplified output voltage (the EDA signal after subtracting a proportional amount of the excitation voltage (and its corresponding current); paragraphs 0057 and 0068-0072 of Hughes), (e) measure a conductance of the stratum corneum (the final EDA reading; paragraphs 0068-0072 of Hughes).
Hughes teaches that, by varying the DAC 21 output voltage (and hence the excitation voltage 27), the overall gain can be lowered to prevent saturation of the output in the case of a large electrodermal signal, or increased in the case of a weak electrodermal signal, in order to improve the signal to noise ratio (paragraphs 0071-0072 of Hughes). As a result, a feedback loop 19 is formed, which continuously adapts to the user’s changing electrodermal activity, in order to minimize the tonic level in the signal passed to the amplifier and thus maximize the resolution of the measurement of the phasic component (paragraph 0072 of Hughes). From these teachings, Hughes is suggesting that a final EDA reading is desired that is small enough to prevent saturation and large enough to prevent the reading from being lost in the noise. Further, Hughes is suggesting that varying the DAC 21 output voltage, which also varies the excitation voltage 27, will allow these effects to take place. Therefore, Hughes contemplates using the final EDA reading as a metric to vary the DAC 21 output voltage, which also varies the excitation voltage 27, so as to achieve a final EDA reading that is small enough to prevent saturation and large enough to prevent the reading from being lost in the noise. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to adjust at least one of the first voltage, the second voltage, and the compensation current to desaturate the output voltage since Hughes contemplates using the final EDA reading as a metric to vary the DAC 21 output voltage, which also varies the excitation voltage 27, so as to achieve a final EDA reading that is small enough to prevent saturation and large enough to prevent the reading from being lost in the noise.
With respect to claim 1, Hughes teaches or suggests an apparatus for measuring electrodermal activity, comprising:
a first electrode (the skin electrodes of FIGS. 6-7 of Hughes) in contact with a first portion of a stratum corneum of skin;
a second electrode (the skin electrodes of FIGS. 6-7 of Hughes) in contact with a second portion of the stratum corneum and in electronic communication with the first electrode through the stratum corneum; and
a processing module (FIGS. 6-7 of Hughes) electrically coupled to the first electrode and the second electrode and operable to (a) bias the first electrode at a first voltage V+ and the second electrode at a second voltage V- (applying voltage to the electrodes; paragraphs 0057 and 0068-0072 of Hughes), (b) measure a current flowing between the first electrode and the second electrode, the current corresponding to the conductance of the stratum corneum (the measured EDA from the electrodes; paragraphs 0057 and 0068-0072 of Hughes), (c) subtract a compensation current from the measured current (subtracting a proportional amount of the excitation voltage (and its corresponding current) from the measured EDA signal; paragraphs 0057 and 0068-0072 of Hughes), (d) measure a resulting current and produce an amplified output voltage (the EDA signal after subtracting a proportional amount of the excitation voltage (and its corresponding current); paragraphs 0057 and 0068-0072 of Hughes), (e) measure a conductance of the stratum corneum (the final EDA reading; paragraphs 0068-0072 of Hughes), and (f) adjust at least one of the first voltage, the second voltage, and the compensation current to desaturate the output voltage (the above 103 analysis; paragraphs 0071-0072 of Hughes).
With respect to claim 2, Hughes teaches or suggests that the processing module is further configured to adjust the compensation current if the conductance of the stratum corneum is too low (the above 103 analysis in which the excitation voltage (and its corresponding current) is varied which also relates to the subsequent subtraction of the proportional amount of the excitation voltage (and its corresponding current) from the measured EDA signal; paragraphs 0057 and 0068-0072 of Hughes).
With respect to claim 3, Hughes teaches or suggests that the processing module is further configured to measure a compensated value of conductance from which a tonic level conductance is removed (paragraphs 0057 and 0068-0072 of Hughes).
With respect to claim 5, Hughes teaches that the processing module is configured to allow a tuning of the compensation current that is subtracted from the current between the first electrode and the second electrode prior to amplification (the above 103 analysis in which the excitation voltage (and its corresponding current) is varied which also varies the subsequent subtraction of the proportional amount of the excitation voltage (and its corresponding current) from the measured EDA signal; paragraphs 0057 and 0068-0072 of Hughes).
With respect to claim 6, Hughes teaches that the stratum corneum is a stratum corneum of any portion of person's skin (paragraphs 0057 and 0068-0072 of Hughes).
With respect to claims 7-8, Hughes teaches that, by varying the DAC 21 output voltage (and hence the excitation voltage 27), the overall gain can be lowered to prevent saturation of the output in the case of a large electrodermal signal, or increased in the case of a weak electrodermal signal, in order to improve the signal to noise ratio (paragraphs 0071-0072 of Hughes). As a result, a feedback loop 19 is formed, which continuously adapts to the user’s changing electrodermal activity, in order to minimize the tonic level in the signal passed to the amplifier and thus maximize the resolution of the measurement of the phasic component (paragraph 0072 of Hughes). From these teachings, Hughes is suggesting that a final EDA reading is desired that is small enough to prevent saturation and large enough to prevent the reading from being lost in the noise. Further, Hughes is suggesting that varying the DAC 21 output voltage, which also varies the excitation voltage 27, will allow these effects to take place. From these teachings, Hughes is suggesting that the resolution and the measurement range of the various conductances is subject to change which can be optimize through the feedback loop. As such, the resolution and the measurement range of the various conductances are results-effective variables that would have been optimized through routine experimentation based on the factors of saturation prevention and the desired signal to noise ratio. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the resolution and the measurement range of the various conductances so as to obtain the desired saturation prevention and signal to noise ratio. In view of the above, the features of “wherein the apparatus is configured to measure a tonic level conductance of the stratum corneum in the range of about 0.05 µS to about 50 µS” (claim 7) and “wherein the apparatus is configured to measure the conductance of the stratum corneum with a resolution of 0.0001 µS” (claim 8) would have been obvious.
With respect to claim 19, Hughes teaches or suggests a method for measuring electrodermal activity, comprising:
disposing a first electrode and a second electrode on a stratum corneum of a user (disposing the skin electrodes of FIGS. 6-7 of Hughes; paragraph 0057 of Hughes);
biasing the first electrode at a first voltage and a second electrode at a second voltage (using the skin electrodes of FIGS. 6-7 of Hughes);
measuring a current flowing between the first electrode and the second electrode (the measured EDA from the electrodes; paragraphs 0057 and 0068-0072 of Hughes);
subtracting a compensation current from the current flowing between the first electrode and the second electrode to get an input current (subtracting a proportional amount of the excitation voltage (and its corresponding current) from the measured EDA signal; paragraphs 0057 and 0068-0072 of Hughes);
transforming the input current into an amplified output voltage; measuring an output voltage (the EDA signal after subtracting a proportional amount of the excitation voltage (and its corresponding current); paragraphs 0057 and 0068-0072 of Hughes);
measuring a conductance of the stratum corneum (the final EDA reading; paragraphs 0068-0072 of Hughes); and
determining if the output voltage is saturated; and increasing the compensation current to change the output voltage such that the output voltage is not saturated (the above 103 analysis; paragraphs 0071-0072 of Hughes).
With respect to claim 20, Hughes teaches or suggests determining if the conductance of the stratum corneum is too low; and decreasing the compensation current if the conductance is too low (the above 103 analysis in which the excitation voltage (and its corresponding current) is varied which also varies the subsequent subtraction of the proportional amount of the excitation voltage (and its corresponding current) from the measured EDA signal; paragraphs 0057 and 0068-0072 of Hughes).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Hughes, in view of U.S. Patent No. 3,784,908 (Anderson).
Anderson teaches that it is known to reverse the polarity of the first and second electrodes so that no net charge enters the sample through the contacting electrodes, measurement errors due to contact potentials at the interface between the sample and the electrodes are minimized, and/or the effect of electrode polarization is minimized (col. 2, lines 6-27, col. 2, line 41-col. 3, line 5; and claim 4 of Anderson). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the processing module configured to reverse the polarity of at least one of the first electrode and the second electrode after a predetermined period of time so that no net charge enters the sample through the contacting electrodes, measurement errors due to contact potentials at the interface between the sample and the contraction electrodes are minimized, and/or the effect of electrode polarization is minimized.
With respect to claim 4, the combination teaches or suggests that the processing module is configured to reverse the polarity of at least one of the first electrode and the second electrode after a predetermined period of time to substantially reduce electrolysis (col. 2, lines 6-27, col. 2, line 41-col. 3, line 5; and claim 4 of Anderson; the reversal of the polarity would result in the reduction of electrolysis as a side-effect).
Claims 9-13 and 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over Hughes, in view of one of U.S. Patent Application Publication No. 2008/0214903 (Orbach), U.S. Patent Application Publication No. 2011/0092780 (Zhang), or U.S. Patent Application Publication No. 2012/0296175 (Poh).
Hughes teaches an apparatus for measuring electrodermal activity, comprising: first and second electrodes in contact with the stratum corneum of skin (the skin electrodes of FIGS. 6-7 of Hughes), and a processing module (FIGS. 6-7 of Hughes) electrically coupled to the first electrode and the second electrode and operable to (a) bias the first electrode at a first voltage V+ and the second electrode at a second voltage V- (applying voltage to the electrodes; paragraphs 0057 and 0068-0072 of Hughes), (b) measure a current flowing between the first electrode and the second electrode, the current corresponding to the conductance of the stratum corneum (the measured EDA from the electrodes; paragraphs 0057 and 0068-0072 of Hughes), (c) subtract a compensation current from the measured current (subtracting a proportional amount of the excitation voltage (and its corresponding current) from the measured EDA signal; paragraphs 0057 and 0068-0072 of Hughes), (d) measure a resulting current and produce an amplified output voltage (the EDA signal after subtracting a proportional amount of the excitation voltage (and its corresponding current); paragraphs 0057 and 0068-0072 of Hughes), (e) measure a conductance of the stratum corneum (the final EDA reading; paragraphs 0068-0072 of Hughes).
Hughes teaches that, by varying the DAC 21 output voltage (and hence the excitation voltage 27), the overall gain can be lowered to prevent saturation of the output in the case of a large electrodermal signal, or increased in the case of a weak electrodermal signal, in order to improve the signal to noise ratio (paragraphs 0071-0072 of Hughes). As a result, a feedback loop 19 is formed, which continuously adapts to the user’s changing electrodermal activity, in order to minimize the tonic level in the signal passed to the amplifier and thus maximize the resolution of the measurement of the phasic component (paragraph 0072 of Hughes). From these teachings, Hughes is suggesting that a final EDA reading is desired that is small enough to prevent saturation and large enough to prevent the reading from being lost in the noise. Further, Hughes is suggesting that varying the DAC 21 output voltage, which also varies the excitation voltage 27, will allow these effects to take place. Therefore, Hughes contemplates using the final EDA reading as a metric to vary the DAC 21 output voltage, which also varies the excitation voltage 27, so as to achieve a final EDA reading that is small enough to prevent saturation and large enough to prevent the reading from being lost in the noise. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to adjust at least one of the first voltage, the second voltage, and the compensation current to desaturate the output voltage since Hughes contemplates using the final EDA reading as a metric to vary the DAC 21 output voltage, which also varies the excitation voltage 27, so as to achieve a final EDA reading that is small enough to prevent saturation and large enough to prevent the reading from being lost in the noise.
The prior art teaches the use of mounting EDA sensors on a band at locations including the palm, fingers, wrist, or ear lobe (paragraph 0159-0161 of Orbach) or the wrist, hand, or some other body part (paragraph 0045 of Zhang) or the wrist (paragraph 0036 of Poh). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the band of Orbach, Zhang, or Poh in the system of Hughes since Orbach, Zhang, or Poh teaches one or more suitable locations in which EDA sensors may be mounted and it is a simple substitution of one known element for another to obtain predictable results.
With respect to claim 9, the combination teaches or suggests a wearable device for measuring electrodermal activity, comprising:
a housing (paragraph 0159-0161 of Orbach; paragraph 0045 of Zhang; paragraph 0036 of Poh) configured to be removably associated with a user;
a first electrode (the skin electrodes of FIGS. 6-7 of Hughes), at least a portion of the first electrode disposed outside the housing and configured to contact a first portion of a stratum corneum of skin when the housing is associated with the user;
a second electrode (the skin electrodes of FIGS. 6-7 of Hughes), at least a portion of the first electrode disposed outside the housing and configured to contact a second portion of the stratum corneum of the skin when the housing is associated with the user;
a processing module (FIGS. 6-7 of Hughes) disposed in the housing and electrically coupled to the first electrode and the second electrode, the processing module operable to (a) bias the first electrode at a first voltage V+ and the second electrode at a second voltage V- (applying voltage to the electrodes; paragraphs 0057 and 0068-0072 of Hughes), (b) measure a current flowing between the first electrode and the second electrode, the current corresponding to the conductance of the stratum corneum (the measured EDA from the electrodes; paragraphs 0057 and 0068-0072 of Hughes), (c) subtract a compensation current from the measured current (subtracting a proportional amount of the excitation voltage (and its corresponding current), (d) measure a resulting current and produce an amplified output voltage (the EDA signal after subtracting a proportional amount of the excitation voltage (and its corresponding current); paragraphs 0057 and 0068-0072 of Hughes), (e) measure a conductance of the stratum corneum (the EDA signal after subtracting a proportional amount of the excitation voltage (and its corresponding current); paragraphs 0057 and 0068-0072 of Hughes), and (f) adjust at least one of the first voltage, the second voltage, and the compensation current to desaturate the output voltage (the above 103 analysis; paragraphs 0071-0072 of Hughes);
a communications module (the wireless link controller 23 of Hughes; paragraphs 0026, 0060, 0066, 0074, and 0078 of Hughes) disposed in the housing, the communications module coupled to the processing module and configured to at least one of a display an electrodermal activity of the user, and communicate electrodermal activity data from the processing module to an external device; and
a power source (the battery of Hughes; paragraphs 0060 and 0063 of Hughes) disposed in the housing and configured to provide electrical power to the processing module and the communications module.
With respect to claim 10, the combination teaches or suggests that the processing module is further configured to decrease the compensation current if the conductance of the stratum corneum is too low (the above 103 analysis in which the excitation voltage (and its corresponding current) is varied which also relates to the subsequent subtraction of the proportional amount of the excitation voltage (and its corresponding current) from the measured EDA signal; paragraphs 0057 and 0068-0072 of Hughes).
With respect to claim 11, the combination teaches or suggests a wrist band (paragraph 0159-0160 of Orbach; paragraph 0045 of Zhang; paragraph 0036 of Poh).
With respect to claim 12, Hughes teaches that, by varying the DAC 21 output voltage (and hence the excitation voltage 27), the overall gain can be lowered to prevent saturation of the output in the case of a large electrodermal signal, or increased in the case of a weak electrodermal signal, in order to improve the signal to noise ratio (paragraphs 0071-0072 of Hughes). As a result, a feedback loop 19 is formed, which continuously adapts to the user’s changing electrodermal activity, in order to minimize the tonic level in the signal passed to the amplifier and thus maximize the resolution of the measurement of the phasic component (paragraph 0072 of Hughes). From these teachings, Hughes is suggesting that a final EDA reading is desired that is small enough to prevent saturation and large enough to prevent the reading from being lost in the noise. Further, Hughes is suggesting that varying the DAC 21 output voltage, which also varies the excitation voltage 27, will allow these effects to take place. From these teachings, Hughes is suggesting that the resolution and the measurement range of the various conductances is subject to change which can be optimize through the feedback loop. As such, the resolution and the measurement range of the various conductances are results-effective variables that would have been optimized through routine experimentation based on the factors of saturation prevention and the desired signal to noise ratio. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the resolution and the measurement range of the various conductances so as to obtain the desired saturation prevention and signal to noise ratio. In view of the above, the features of “wherein the processing module is configured to measure a tonic level conductance of the stratum corneum of the wrist of the user in the range of about 0.05 µS to about 50 µS” (claim 12) would have been obvious.
With respect to claim 13, the combination teaches or suggests that the wearable device is at least one of a head band, an arm band, a foot band, an ankle band, and a ring (the band of the combination is capable of being placed at the head, arm, foot, or ankle; paragraph 0159-0160 of Orbach; paragraph 0045 of Zhang; paragraph 0036 of Poh).
With respect to claim 15, the combination teaches or suggests a heart beat sensor (paragraph 0094 of Hughes).
With respect to claim 16, the combination teaches or suggests at least one of an accelerometer, a temperature sensor, a blood oxygen sensor, and a glucose sensor (abstract and paragraphs 0020, 0026, 0030, 0056, 0058-0059, and 0094 of Hughes).
With respect to claim 17, the combination teaches or suggests that the communications module is configured to communicate at least one of heart beat data, an accelerometer data, a temperature data, a blood oxygen data, and a glucose data to the external device (abstract and paragraphs 0011, 0020, 0026, 0030, 0056, 0058-0060, 0066, 0074, and 0094-0095 of Hughes).
With respect to claim 18, the combination teaches or suggests that the communication module is configured to communicate with the external device via at least one of a USB, USB 2.0, IEEE 1394, BLUETOOTH®, low powered BLUETOOTH®, and Wi-Fi (paragraphs 0074, 0078, 0090, 0101, 0103-0104, and 0129 of Hughes).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Hughes, in view of one of Orbach, Zhang, or Poh, and further in view of Anderson.
Anderson teaches that it is known to reverse the polarity of the first and second electrodes so that no net charge enters the sample through the contacting electrodes, measurement errors due to contact potentials at the interface between the sample and the electrodes are minimized, and/or the effect of electrode polarization is minimized (col. 2, lines 6-27, col. 2, line 41-col. 3, line 5; and claim 4 of Anderson). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the processing module configured to reverse the polarity of at least one of the first electrode and the second electrode after a predetermined period of time so that no net charge enters the sample through the contacting electrodes, measurement errors due to contact potentials at the interface between the sample and the contraction electrodes are minimized, and/or the effect of electrode polarization is minimized.
With respect to claim 14, the combination teaches or suggests that the processing module is further configured to reverse the polarity of at least one of the first electrode and the second electrode after a predetermined period of time to substantially reduce electrolysis (col. 2, lines 6-27, col. 2, line 41-col. 3, line 5; and claim 4 of Anderson; the reversal of the polarity would result in the reduction of electrolysis as a side-effect).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claim