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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant’s submission filed on 12/3/2025 has been entered.
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.
No claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Warning
The Applicant is advised that should claim 55 be found allowable, claim 68 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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 61-67 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 61 recites “the skin” in line 6 in which there is insufficient antecedent basis for this recitation in the claim.
Claims 62-67 are rejected by virtue of their dependence from claim 61.
Claim 62 recites “the comparative skin capacitance value” in lines 1-2, but it is not clear if this recitation is the same as, related to, or different from “a comparative capacitance value” of claim 61, lines 10-11. If they are the same, consistent terminology should be used. If they are different, it is not clear what relevance this comparative skin capacitance value of claim 62 has with the rest of the limitation of claim 62. Also, if they are different, there is insufficient antecedent basis for “the comparative skin capacitance value” in claim 62.
Claim 62 recites “the skin surface” in line 3 in which there is insufficient antecedent basis for this limitation in the claim. Also, it is not clear what relationship this skin surface has relative to “the skin of the subject” of claim 61, line 6. Clarification is required.
Claim 63 recites “the processor” in lines 1-2 in which there is insufficient antecedent basis for this recitation in the claim. Also, it is not clear what relationship this processor has with the rest of the method of claim 61. Clarification is required.
Claim 63 recites “the comparative skin capacitance value” in line 3, but it is not clear if this recitation is the same as, related to, or different from “a comparative capacitance value” of claim 61, lines 10-11. If they are the same, consistent terminology should be used. If they are different, it is not clear what relevance this comparative skin capacitance value of claim 63 has with the rest of the limitation of claim 63. Also, if they are different, there is insufficient antecedent basis for “the comparative skin capacitance value” in claim 63.
Claim 64 recites “the processor” in line 2 in which there is insufficient antecedent basis for this recitation in the claim. Also, it is not clear what relationship this processor has with the rest of the method of claim 64. Clarification is required.
Claim 66 recites “the comparative skin capacitance value” in lines 1-2, but it is not clear if this recitation is the same as, related to, or different from “a comparative capacitance value” of claim 61, lines 10-11. If they are the same, consistent terminology should be used. If they are different, it is not clear what relevance this comparative skin capacitance value of claim 66 has with the rest of the limitation of claim 66. Also, if they are different, there is insufficient antecedent basis for “the comparative skin capacitance value” in claim 66.
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 18-19, 30, 32, 47, 55, and 68 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2018/085944 (Taylor)(previously cited), in view of U.S. Patent Application Publication No. 2020/0101286 (Windmiller)(previously cited), and further in view of U.S. Patent Application Publication No. 2013/0123587 (Sarrafzadeh)(previously cited), and further in view of U.S. Patent Application Publication No. 2015/0245782 (Morland)(previously cited).
Taylor discloses a method that includes providing a device comprising: (i) an interdigitated portion having two opposing ends and configured for contacting a skin of the subject and measure surface conductivity of the subject’s skin; (ii) a ketosis signal that turns on when the conductivity of the skin is in a high mega ohm range indicative of the subject not burning fat, (iii) a power source, (iv) wherein an intermediate signal turns on when the conductivity of the skin in an intermediate range between the low mega ohm range and the high mega ohm range, thus being indicative of an intermediate state of ketosis, and (v) wherein, when the electric conductivity of the skin is in a low mega ohm range, it is indicative of the subject burning fat (pages 7, 12-14, and 16 of Taylor). Taylor discloses the use of surface conductivity of the subject’s skin as the metric for determining ketosis which is an indication that the subject is burning fat (pages 7, 12-14, and 16 of Taylor). Taylor also teaches that the occurrence of high levels of ketone bodies in the blood during starvation, a low carbohydrate diet, prolonged heavy exercise and uncontrolled type 1 diabetes mellitus is known as ketosis (page 3 of Taylor). Taylor further discloses that the device can be worn on the wrist and an underside is a suitable area of the wrist for examination (page 13, line 19; page 14, lines 1-2; page 18, lines 23-26 of Taylor) (page 13, line 19; page 14, lines 1-2; page 18, lines 23-26 of Taylor).
In the field of monitoring levels of ketone bodies and hence ketosis, Windmiller discloses that a skin-worn capacitive sensor or a skin-worn resistive sensor can be used for continuously determining levels of ketone bodies and hence ketosis (the abstract, paragraphs 0012, 0014, 0016-0017, 0051, 0152 and claims 2, 9-10, and 21 of Windmiller). For example, paragraph 0016 of Windmiller provides, “one of an electrochemical sensor, an optical sensor, a galvanic sensor, a voltammetric sensor, n amperometric sensor, a potentiometric sensor, an impedimetric sensor, a resistive sensor, a capacitive sensor, an ultrasonic sensor, a radio-frequency sensor, and a microwave sensor”. This passage expressly contemplates that each and every sensor can be used in isolation. If each sensor can be used in isolation, they are substitutes for each other. Similarly, paragraph 0017 provides, “The sensor preferably includes at least one of an electrochemical sensor, an optical sensor, a galvanic sensor, a voltammetric sensor, an amperometric sensor, a potentiometric sensor, an impedimetric sensor, a resistive sensor, a capacitive sensor, an ultrasonic sensor, a radio-frequency sensor, and a microwave sensor”. This passage expressly contemplates that one of these sensors may be used which means each and every sensor can be used in isolation. If each sensor can be used in isolation, they are substitutes for each other. Thus, Windmiller discloses a skin-worn capacitive sensor as a suitable substitute for a skin-worn resistance sensor (abstract, paragraph 0012, 0016-0017, 0053, and claims 2, 10, and 21 of Windmiller) for determining levels of ketone bodies and hence ketosis. By implication, Windmiller discloses that the measurement of capacitance is a suitable substitute of resistance when determining levels of ketone bodies and/or ketosis. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use capacitive sensors, capacitance measurements, and capacitance thresholds for the monitoring of ketone bodies and ketosis since it is a simple substitution of one known element for another to obtain predictable results. Additionally, 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 capacitive sensors, the capacitance measurements, and the capacitance thresholds for the monitoring of ketone bodies and ketosis continuously, as suggested by Windmiller, since the ketone bodies and ketosis can be monitored over a long period of time to examine trends.
Sarrafzadeh discloses the use of interdigitated sensors applied to the skin surface for monitoring capacitance (paragraph 0040 and FIG. 2 of Sarrafzadeh). 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 interdigital capacitive sensor of Sarrafzadeh as the capacitance sensor of the combination since (1) a capacitive sensor is required and Sarrafzadeh teaches one such capacitive sensor and/or (2) it is a simple substitution of one known element for another to obtain predictable results.
Morland teaches that capacitance sensors continue to have a capacitance reading (called “an ambient or inactive value”) when the sensors are not coupled to its target material including circumstances when skin contact is lost (paragraphs 0044-0045, 0060, and 0063 and FIG. 5 of Morland). This status of the sensor not being coupled to the target material is known as the sensor “off” condition (abstract, paragraphs 0006, 0027, 0044, 0059, 0063-0065, 0080, and 0096 of Morland). Further, Morland suggests that the ambient or inactive value during the sensor “off” condition is caused by the readings of air since the sensor readings can distinguish between tissue contact and air (paragraph 0025 and 0045 of Morland). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have understood and incorporated the fact that the interdigitated portion of the capacitance sensor measures the capacitance of air when not in contact with the skin including circumstances when skin contact with the sensor is lost since the understanding of such properties provides the user with a better understanding of the operational parameters of the measuring device.
With respect to claim 18, the combination teaches or suggests a method for non-invasive continuous monitoring of fat burning in a subject comprising:
(a) providing a device comprising:
an interdigitated portion configured to non-invasively measure a skin capacitance of a skin surface of the subject (the capacitive sensor of Sarrafzadeh), said interdigitated portion having at least two separate electrical contacts (FIG. 2 of Sarrafzadeh);
a power source (the power source of Taylor; pages 7 and 12-14 of Taylor); and
a processor responsive to one end of the interdigitated portion (the processor is taught in pages 17-18 of Taylor), and configured to activate a ketosis signal when the skin capacitance of the subject increases compared to a comparative skin capacitance value of the subject (outputting a signal when the capacitance is in a ketosis range; pages 7, 12-14, and 16 of Taylor as modified using the capacitive sensors, capacitance measurements, and capacitance thresholds as outlined in the 103 analysis),
(b) placing the device on an underside of a wrist of the subject such that said at least two electrical contacts of said interdigitated portion are adjacent to the skin surface of the underside of the wrist of the subject (placing the capacitive sensor of Sarrafzadeh on the skin; the placement being on the underside of the wrist; page 13, line 19; page 14, lines 1-2; page 18, lines 23-26 of Taylor; pages 7, 12-14, and 16 of Taylor as modified using the capacitive sensors, capacitance measurements, and capacitance thresholds as outlined in the 103 analysis);
(c) the device continuously measuring electrical changes of the skin surface of the underside of the wrist of the subject consisting of measuring the skin capacitance of the skin surface of the underside of the wrist of the subject to detect if the subject is burning fat (measuring the capacitance of the skin; the placement being on the underside of the wrist; page 13, line 19; page 14, lines 1-2; page 18, lines 23-26 of Taylor; the continuous monitoring suggested by Windmiller); and
(d) determining that the subject is burning fat if the processor activates the ketosis signal (outputting a signal when the capacitance is in a ketosis range indicating fat burning; pages 7, 12-14, and 16 of Taylor as modified using the capacitive sensors, capacitance measurements, and capacitance thresholds as outlined in the 103 analysis),
wherein the interdigitated portion measures capacitance of air so that capacitance measurement by the interdigitated portion does not go to zero if a contact force of the interdigitated portion with the skin surface of the underside of the wrist changes or during a loss of contact of the interdigitated portion with the skin surface of the underside of the wrist so that continuity of the continuous monitoring of fat burning of the subject is not lost if the contact force changes or the contact of the interdigitated portion with the skin surface of the underside of the wrist is momentarily lost during the continuous monitoring (the capacitive sensors having readings of the capacitance of air when not attached to the skin thereby providing a continuous capacitance reading even when contact with the skin is lost).
With respect to claim 19, the combination teaches or suggests that the comparative skin capacitance value is a baseline capacitance measurement corresponding to the skin capacitance of the skin surface when the subject is not burning fat (outputting a signal when the capacitance is in a ketosis range means that the range limits are those in which there is no ketosis or fat burning; pages 7, 12-14, and 16 of Taylor as modified using the capacitive sensors, capacitance measurements, and capacitance thresholds as outlined in the 103 analysis).
With respect to claim 30, the combination teaches or suggests that the processor is configured to activate a ketosis exit signal if the skin capacitance is not greater than the comparative skin capacitance value of the subject (outputting a signal when the capacitance is no longer in a ketosis range in which the range limits are those in which there is no ketosis; pages 7, 12-14, and 16 of Taylor as modified using the capacitive sensors, capacitance measurements, and capacitance thresholds as outlined in the 103 analysis; the processor is taught in pages 17-18 of Taylor).
With respect to claim 32, the combination teaches or suggests that the device further comprises a memory module coupled to the processor (pages 17-18 of Taylor).
With respect to claim 47, the combination teaches or suggests outputting a signal when the capacitance is in a ketosis range which means that the range limits are those in which there is no ketosis (pages 7 and 12-14 of Taylor as modified using the capacitive sensors, capacitance measurements, and capacitance thresholds as outlined in the 103 analysis). The limits of the alarm relative to the individual’s baseline can be determined by experimentation and calibration (pages 10-11, 14, and 16 of Taylor) so as to obtain the desired accuracy for a particular user. As such, the alarm limits and baseline values are results-effective variables that would have been optimized through routine experimentation based on the desired accuracy for a particular user. 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 alarm limits and baseline values so as to obtain the desired accuracy for a particular user. Thus, the features of “wherein the comparative skin capacitance value of the subject is a first skin capacitance of the subject and the skin capacitance is a second skin capacitance of the subject taken after an interval” of claim 47 would have been obvious.
With respect to claims and 55 and 68, Sarrafzadeh teaches the use of an ultrathin cover layer 30 of Polyimide (e.g. CA335) to isolate pads the electrodes 14,15 from direct moisture contact and also to provide a uniform contact surface (paragraph 0039 of Sarrafzadeh). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the ultrathin cover layer 30 of Polyimide (e.g. CA335) on the electrodes of Sarrafzadeh so as to isolate them from direct moisture contact and also to provide a uniform contact surface. Thus, the combination teaches or suggests that the at least two separate electrical contacts (the capacitive sensor of Sarrafzadeh) are coated with a plastic skin contact sheet (the ultrathin cover layer 30 of Polyimide).
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Taylor, in view of Windmiller, and further in view of Sarrafzadeh, and further in view of Morland, and further in view of U.S. Patent Application Publication No. 2013/0245388 (Rafferty)(previously cited).
With respect to claim 34, Rafferty discloses that using a digital device may supplement an indicator display so as to give a precise readout of data (paragraphs 0278 and 0135 of Rafferty). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a digital readout, as suggested by Rafferty, so as to provide a precise readout of data.
Claim 53 is rejected under 35 U.S.C. 103 as being unpatentable over Taylor, in view of Windmiller, and further in view of Sarrafzadeh, and further in view of Morland, and further in view of any one of U.S. Patent No. 4,537,203 (Machida)(previously cited), U.S. Patent Application Publication No. 2012/0123232 (Najarian)(previously cited), U.S. Patent No. 5,545,186 (Olson)(previously cited), or U.S. Patent No. 5,741,214 (Ouchi)(previously cited).
The combination teaches or suggests that the ketosis signal is stored in a memory module coupled to a processor (claims 1, 2, 5, and 6 of Taylor). It is known in the art that such storage is performed on digital signals (abstract and col. 5 of Machida; paragraph 0182 of Najarian; col. 5 of Olson; col. 3 of Ouchi). It would have been obvious to convert the ketosis signals to digital since it permits the storage into a memory, suggested by Taylor.
With respect to claim 53, the combination teaches or suggests that the ketosis signal is selected from the group consisting of an electronic signal, a digital signal, a segmented signal, and a progressive signal (the digital ketosis signal of the combination).
Claims 61-64 and 66 are rejected under 35 U.S.C. 103 as being unpatentable over Taylor, in view of Windmiller, and further in view of Sarrafzadeh.
Taylor discloses a method that includes providing a device comprising: (i) an interdigitated portion having two opposing ends and configured for contacting a skin of the subject and measure surface conductivity of the subject’s skin; (ii) a ketosis signal that turns on when the conductivity of the skin is in a high mega ohm range indicative of the subject not burning fat, (iii) a power source, (iv) wherein an intermediate signal turns on when the conductivity of the skin in an intermediate range between the low mega ohm range and the high mega ohm range, thus being indicative of an intermediate state of ketosis, and (v) wherein, when the electric conductivity of the skin is in a low mega ohm range, it is indicative of the subject burning fat (pages 7, 12-14, and 16 of Taylor). Taylor discloses the use of surface conductivity of the subject’s skin as the metric for determining ketosis which is an indication that the subject is burning fat (pages 7, 12-14, and 16 of Taylor). Taylor also teaches that the occurrence of high levels of ketone bodies in the blood during starvation, a low carbohydrate diet, prolonged heavy exercise and uncontrolled type 1 diabetes mellitus is known as ketosis (page 3 of Taylor). Taylor further discloses that the device can be worn on the wrist and an underside is a suitable area of the wrist for examination (page 13, line 19; page 14, lines 1-2; page 18, lines 23-26 of Taylor) (page 13, line 19; page 14, lines 1-2; page 18, lines 23-26 of Taylor).
In the field of monitoring levels of ketone bodies and hence ketosis, Windmiller discloses that a skin-worn capacitive sensor or a skin-worn resistive sensor can be used for continuously determining levels of ketone bodies and hence ketosis (the abstract, paragraphs 0012, 0014, 0016-0017, 0051, 0152 and claims 2, 9-10, and 21 of Windmiller). For example, paragraph 0016 of Windmiller provides, “one of an electrochemical sensor, an optical sensor, a galvanic sensor, a voltammetric sensor, n amperometric sensor, a potentiometric sensor, an impedimetric sensor, a resistive sensor, a capacitive sensor, an ultrasonic sensor, a radio-frequency sensor, and a microwave sensor”. This passage expressly contemplates that each and every sensor can be used in isolation. If each sensor can be used in isolation, they are substitutes for each other. Similarly, paragraph 0017 provides, “The sensor preferably includes at least one of an electrochemical sensor, an optical sensor, a galvanic sensor, a voltammetric sensor, an amperometric sensor, a potentiometric sensor, an impedimetric sensor, a resistive sensor, a capacitive sensor, an ultrasonic sensor, a radio-frequency sensor, and a microwave sensor”. This passage expressly contemplates that one of these sensors may be used which means each and every sensor can be used in isolation. If each sensor can be used in isolation, they are substitutes for each other. Thus, Windmiller discloses a skin-worn capacitive sensor as a suitable substitute for a skin-worn resistance sensor (abstract, paragraph 0012, 0016-0017, 0053, and claims 2, 10, and 21 of Windmiller) for determining levels of ketone bodies and hence ketosis. By implication, Windmiller discloses that the measurement of capacitance is a suitable substitute of resistance when determining levels of ketone bodies and/or ketosis. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use capacitive sensors, capacitance measurements, and capacitance thresholds for the monitoring of ketone bodies and ketosis since it is a simple substitution of one known element for another to obtain predictable results. Additionally, 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 capacitive sensors, the capacitance measurements, and the capacitance thresholds for the monitoring of ketone bodies and ketosis continuously, as suggested by Windmiller, since the ketone bodies and ketosis can be monitored over a long period of time to examine trends.
Sarrafzadeh discloses the use of interdigitated sensors applied to the skin surface for monitoring capacitance (paragraph 0040 and FIG. 2 of Sarrafzadeh). 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 interdigital capacitive sensor of Sarrafzadeh as the capacitance sensor of the combination since (1) a capacitive sensor is required and Sarrafzadeh teaches one such capacitive sensor and/or (2) it is a simple substitution of one known element for another to obtain predictable results.
With respect to claim 61, the combination teaches or suggests a method for non-invasively detecting if a subject is in ketosis comprising:
(a) providing a device comprising an interdigitated portion for measuring skin capacitance of the subject (providing the capacitive sensor of Sarrafzadeh);
(b) placing the device on a body of the subject such that the interdigitated portion is contacting the skin of the subject (placing the capacitive sensor of Sarrafzadeh on the skin; page 13, line 19; page 14, lines 1-2; page 18, lines 23-26 of Taylor);
(c) said device measuring the skin capacitance of the subject (measuring the capacitance of the skin; page 13, line 19; page 14, lines 1-2; page 18, lines 23-26 of Taylor); and
(d) said device activating a ketosis signal when the skin capacitance measurement of the subject increases compared to a comparative capacitance value of the subject (outputting a signal when the capacitance is in a ketosis range; pages 7, 12-14, and 16 of Taylor as modified using the capacitive sensors, capacitance measurements, and capacitance thresholds as outlined in the 103 analysis).
With respect to claim 62, the combination teaches or suggests that the comparative skin capacitance value is a baseline capacitance measurement corresponding to the skin capacitance of the skin surface when the subject is not burning fat (outputting a signal when the capacitance is in a ketosis range means that the range limits are those in which there is no ketosis or fat burning; pages 7, 12-14, and 16 of Taylor as modified using the capacitive sensors, capacitance measurements, and capacitance thresholds as outlined in the 103 analysis).
With respect to claim 63, the combination teaches or suggests that the processor is configured to activate a ketosis exit signal if the skin capacitance is not greater than the comparative skin capacitance value of the subject (outputting a signal when the capacitance is no longer in a ketosis range in which the range limits are those in which there is no ketosis; pages 7, 12-14, and 16 of Taylor as modified using the capacitive sensors, capacitance measurements, and capacitance thresholds as outlined in the 103 analysis; the processor is taught in pages 17-18 of Taylor).
With respect to claim 64, the combination teaches or suggests that the device further comprises a memory module coupled to the processor (pages 17-18 of Taylor).
With respect to claim 66, the combination teaches or suggests outputting a signal when the capacitance is in a ketosis range which means that the range limits are those in which there is no ketosis (pages 7 and 12-14 of Taylor as modified using the capacitive sensors, capacitance measurements, and capacitance thresholds as outlined in the 103 analysis). The limits of the alarm relative to the individual’s baseline can be determined by experimentation and calibration (pages 10-11, 14, and 16 of Taylor) so as to obtain the desired accuracy for a particular user. As such, the alarm limits and baseline values are results-effective variables that would have been optimized through routine experimentation based on the desired accuracy for a particular user. 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 alarm limits and baseline values so as to obtain the desired accuracy for a particular user. Thus, the features of “wherein the comparative skin capacitance value of the subject is a first skin capacitance of the subject and the skin capacitance is a second skin capacitance of the subject taken after an interval” of claim 66 would have been obvious.
Claim 65 is rejected under 35 U.S.C. 103 as being unpatentable over Taylor, in view of Windmiller, and further in view of Sarrafzadeh, and further in view of Rafferty.
With respect to claim 65, Rafferty discloses that using a digital device may supplement an indicator display so as to give a precise readout of data (paragraphs 0278 and 0135 of Rafferty). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a digital readout, as suggested by Rafferty, so as to provide a precise readout of data.
Claim 67 is rejected under 35 U.S.C. 103 as being unpatentable over Taylor, in view of Windmiller, and further in view of Sarrafzadeh, and further in view of any one of Machida, Najarian, Olson, or Ouchi.
The combination teaches or suggests that the ketosis signal is stored in a memory module coupled to a processor (claims 1, 2, 5, and 6 of Taylor). It is known in the art that such storage is performed on digital signals (abstract and col. 5 of Machida; paragraph 0182 of Najarian; col. 5 of Olson; col. 3 of Ouchi). It would have been obvious to convert the ketosis signals to digital since it permits the storage into a memory, suggested by Taylor.
With respect to claim 67, the combination teaches or suggests that the ketosis signal is selected from the group consisting of an electronic signal, a digital signal, a segmented signal, and a progressive signal (the digital ketosis signal of the combination).
Response to Arguments
The Applicant’s arguments filed 12/3/2025 have been fully considered.
Claim warning
There is a new claim warning.
35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph
There are new grounds of claim rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph.
Prior art rejections
On pages 10-11 of the Remarks of the Response filed on 12/3/2025 (hereinafter, “the Remarks), the Applicant provides an individual analysis of each of Taylor, Windmiller, Sarrafzadeh, and Morland and how they each do not teach or suggest the claimed invention. These analyses are not persuasive since it does not directly address the rejection which is based on the combination of Taylor, Windmiller, Sarrafzadeh, and Morland. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
On pages 11-14 of the Remarks, the Applicant asserts that:
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This argument is not persuasive. In response to the Applicant’s argument that the examiner’s conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant’s disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
First, Taylor does NOT explicitly teach that capacitance measurements are unsuitable. That is, Taylor does not directly disparage the use of capacitance measurements. As such, Taylor does not teach away from the use of capacitance measurements.
Second, in the field of monitoring levels of ketone bodies and hence ketosis, Windmiller discloses that a skin-worn capacitive sensor or a skin-worn resistive sensor can be used for determining levels of ketone bodies and hence ketosis (the abstract, paragraphs 0016-0017 and claims 2, 10, and 21 of Windmiller. For example, paragraph 0016 of Windmiller provides, “one of an electrochemical sensor, an optical sensor, a galvanic sensor, a voltammetric sensor, n amperometric sensor, a potentiometric sensor, an impedimetric sensor, a resistive sensor, a capacitive sensor, an ultrasonic sensor, a radio-frequency sensor, and a microwave sensor”. This passage expressly contemplates that each and every sensor can be used in isolation. If each sensor can be used in isolation, they are substitutes for each other. Similarly, paragraph 0017 provides, “The sensor preferably includes at least one of an electrochemical sensor, an optical sensor, a galvanic sensor, a voltammetric sensor, an amperometric sensor, a potentiometric sensor, an impedimetric sensor, a resistive sensor, a capacitive sensor, an ultrasonic sensor, a radio-frequency sensor, and a microwave sensor”. This passage expressly contemplates that one of these sensors may be used which means each and every sensor can be used in isolation. If each sensor can be used in isolation, they are substitutes for each other. Thus, Windmiller discloses a skin-worn capacitive sensor as a suitable substitute for a skin-worn resistance sensor (abstract, paragraph 0012, 0016-0017, 0053, and claims 2, 10, and 21 of Windmiller) for determining levels of ketone bodies and hence ketosis. By implication, Windmiller discloses that the measurement of capacitance is a suitable substitute of resistance when determining levels of ketone bodies and/or ketosis. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use capacitive sensors, capacitance measurements, and capacitance thresholds for the monitoring of ketone bodies and ketosis since it is a simple substitution of one known element for another to obtain predictable results. Windmiller teaches the use of relying solely on capacitance measurements, not Taylor. Thus, weighing the explicit teachings of Windmiller against the Applicant’s own inferences regarding Taylor, the Examiner deems the use of capacitance measurements, as taught by Windmiller, to be reasonable and one of ordinary skill in the art would have a reasonable expectation of success.
On page 13 of the Remarks, the Applicant asserts:
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This argument is not persuasive. Morland teaches that capacitive sensors continue to have readings due to these sensors measuring the capacitance of air when not attached to the patient’s skin. Weighing the explicit teachings of Morland against the Applicant’s inferences regarding Taylor’s problems caused by changes in contact force or by loss of contract, the Examiner deems the non-zero readings from capacitance sensors undergoing a change in contact force or a loss of contact, as taught by Morland, to be reasonable and one of ordinary skill in the art would have a reasonable expectation of success. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
On pages 14-15 of the Remarks, the Applicant focuses on a discussion of an embodiment in Windmiller in the form of a microneedle-based biosensor. However, the disclosure of this embodiment in Windmiller does not negate the teachings of other embodiments disclosed by Windmiller. The Applicant asserts:
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This argument and the arguments on pages 17-18 of the Remarks regarding Windmiller are not persuasive. Paragraph 0016 of Windmiller provides, “one of an electrochemical sensor, an optical sensor, a galvanic sensor, a voltammetric sensor, n amperometric sensor, a potentiometric sensor, an impedimetric sensor, a resistive sensor, a capacitive sensor, an ultrasonic sensor, a radio-frequency sensor, and a microwave sensor”. This passage expressly contemplates that each and every sensor can be used in isolation. If each sensor can be used in isolation, they are substitutes for each other. Similarly, paragraph 0017 provides, “The sensor preferably includes at least one of an electrochemical sensor, an optical sensor, a galvanic sensor, a voltammetric sensor, an amperometric sensor, a potentiometric sensor, an impedimetric sensor, a resistive sensor, a capacitive sensor, an ultrasonic sensor, a radio-frequency sensor, and a microwave sensor”. This passage expressly contemplates that one of these sensors may be used which means each and every sensor can be used in isolation. Therefore, the Applicant’s argument is not persuasive.
Also, paragraph 0053 of Windmiller clearly says “The sensor acquires the sample subcutaneously, percutaneously, transdermally, intradermally, or on the skin surface and employs an electrical or optical stimulus to encourage an electrical, photonic, or chemical change to occur; a voltage, current, charge, resistance, or impedance property is subsequently measured to infer the concentration of a singular ketone body or plurality of ketone bodies circulating in a physiological fluid compartment.”1 The “on the skin surface” language being in contrast to “subcutaneously, percutaneously, transdermally, intradermally” clearly indicates that Windmiller is not only contemplating an invasive, microneedle-based system, but non-invasive systems as well.
On pages 15-16 of the Remarks, the Applicant asserts that the Applicants invention works differently from the embodiment of FIGS. 17-20 of Windmiller. This argument is not persuasive since it is not commensurate with the rejection. The rejection is based on the combination of Taylor, Windmiller, Sarrafzadeh, and Morland. The sensor of Sarrafzadeh is used to measurement capacitance at the skin surfaces, as suggested by Windmiller.
On pages 15-16 of the Remarks, the Applicant asserts that the capacitance sensor of the Applicant’s invention is “the central inventive concept” while use of the capacitive sensor of Windmiller is “a speculative, undeveloped mention in a list”. This argument is not persuasive. Windmiller teaches what is teaches. The Applicant’s characterizations are mere rhetoric that does not negate the actual disclosure of Windmiller. The Examiner cannot find a reason to disbelieve Windmiller’s teachings or why one of ordinary skill in the art would not consider Windmiller’s teachings as correct and pertinent. As to the assertion that Windmiller does not enable the claimed capacitance sensor, this argument is not persuasive since the rejection is based on the combination of Taylor, Windmiller, Sarrafzadeh, and Morland. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). When considering Windmiller in conjunction with Taylor, Sarrafzadeh, and Morland, one of ordinary skill in the art would be enabled to carry out the method of claim 18.
On pages 18-20 of the Remarks regarding the device of Sarrafzadeh being used to measure moisture content for ulcer detection, these arguments are not persuasive. Windmiller discloses a skin-worn capacitive sensor as a suitable substitute for a skin-worn resistance sensor (abstract, paragraph 0012, 0016-0017, 0053, and claims 2, 10, and 21 of Windmiller) for determining levels of ketone bodies and hence ketosis. By implication, Windmiller discloses that the measurement of capacitance is a suitable substitute of resistance when determining levels of ketone bodies and/or ketosis. Sarrafzadeh discloses the use of interdigitated sensors applied to the skin surface for monitoring capacitance (paragraph 0040 and FIG. 2 of Sarrafzadeh). That is, Sarrafzadeh is relied upon for disclosing a skin-surface capacitance sensor, as suggested by Windmiller. Sarrafzadeh processing of the capacitance signals for the determination of moisture content does not negate the use of the capacitance signals for the determination of levels of ketone bodies and hence ketosis. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
On pages 20-23 of the Remarks regarding Morland teaching the use of capacitance for sensor placement verification, these arguments are not persuasive. Morland is relied upon for teaching that capacitance sensors continue to have a capacitance reading (called “an ambient or inactive value”) when the sensors are not coupled to its target material including circumstances when skin contact is lost (paragraphs 0044-0045, 0060, and 0063 and FIG. 5 of Morland). This status of the sensor not being coupled to the target material is known as the sensor “off” condition (abstract, paragraphs 0006, 0027, 0044, 0059, 0063-0065, 0080, and 0096 of Morland). Further, Morland suggests that the ambient or inactive value during the sensor “off” condition is caused by the readings of air since the sensor readings can distinguish between tissue contact and air (paragraph 0025 and 0045 of Morland). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have understood and incorporated the fact that the interdigitated portion of the capacitance sensor measures the capacitance of air when not in contact with the skin including circumstances when skin contact with the sensor is lost since the understanding of such properties provides the user with a better understanding of the operational parameters of the measuring device. It is Morland’s disclosure of the existing/inherent/understood property of unattached capacitance sensors continually providing readings in a general sense that is relevant.
On page 23-24 of the Remarks, the Applicant then constructs their own combination of the references. However, even if the Applicant’s own construction of the references is valid, it does not negate the Examiner’s combination of the references as also being valid. The presence of one combination does not foreclose the existence of a different and just-as-valid combination.
On page 25 of the Remarks, the Applicant asserts:
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This argument is not persuasive since the rejection is based on the combination of Tayler, Windmiller, Sarrafzadeh, and Morland. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). It is not possible to argue against the combination of Taylor and Morland by disregarding the teachings of Windmiller and Sarrafzadeh. The combination must be taken in its entirety. Morland is relied upon for teaching that capacitance sensors continue to have a capacitance reading (called “an ambient or inactive value”) when the sensors are not coupled to its target material including circumstances when skin contact is lost (paragraphs 0044-0045, 0060, and 0063 and FIG. 5 of Morland). Also, the Applicant’s conclusion that Morland teaches that readings are stopped or not recorded does not take into account that Morland teaches other possibilities, such as simply indicating sensor “on” and sensor “off” conditions, providing alerts, turning certain portions of a sensor “off”, changing physiological parameter signal processing techniques based on a detected mode of operation, or waiting a predetermined period of time before providing an alarm to alert the operator (paragraphs 0027 and 0080 of Morland). At the very least, three of these possibilities do not require the readings to be stopped or not recorded. As such, continual operation of the capacitance measurements are not incompatible with Morland.
On pages 26-29 of the Remarks, the Applicant repeats the above arguments. The Examiner has already addressed these argument in the above remarks.
For these reasons, the rejections of claim 18 and its dependent claims are proper.
On pages 30-32 of the Remarks, the Applicant repeats the above arguments as they apply to claims 61-68. The Examiner has already addressed these arguments in the above remarks and the Applicant’s arguments are equally not persuasive with respect to the rejection of claims 61-68 (with the exception of those arguments related to Morland which was not used to reject claims 61-68) .
The Applicant additionally asserts:
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As spelled out above, one of ordinary skill in the art would have combined Taylor and Windmiller so as to use capacitance sensors when determining levels of ketone bodies and/or ketosis. Sarrafzadeh would then have been relevant since Sarrafzadeh discloses the use of interdigitated sensors applied to the skin surface for monitoring capacitance (paragraph 0040 and FIG. 2 of Sarrafzadeh. Morland was not used in the rejection of claims 61-68 so any arguments regarding this reference is not pertinent to the rejection of claims 61-68.
For these reasons, the rejections of claim 61 and its dependent claims are proper.
Conclusion
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/MATTHEW KREMER/Primary Examiner, Art Unit 3791
1 The Applicant replaced the “or on the skin surface” with “…” in their citation of this passage on page 15 of the Remarks of the Response filed on 12/3/2025.