DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendments filed 15 DECEMBER 2025 have been entered. Claims 1 – 6, 10 – 17, 19, and 21 - 25 are pending. Applicant’s amendments to the claims have overcome each and every objection to the claims previously applied in the office action dated 16 JUNE 2025.
Claim Objections
Claim 12 is objected to because of the following informalities: the term “the sensing electrodes are disposed” is suggested to be revised to be “the at least two sensing electrodes” for readability. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 – 6, 10 – 17, 19, and 21 – 25 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 and Claim 24 each recite the limitation “fitting the set of the plurality of impedance measurements to a single Cole-Cole model, and, by comparing each impedance measurement in the set to an expected value given by the single Cole-Cole model, excluding impedance measurements that exceed a threshold from the expected value, thereby obtaining a subset of impedance measurements that conform to the single Cole-Cole model”. As noted below, it is unclear if this is intended to recite two separate data processing steps, the first being “fitting the set of the plurality…” and “excluding impedance measurements that exceed a threshold from the expected value”, or if it is a single processing step that includes fitting the set of the impedance measurements to the Cole-Cole model in order to exclude impedance measurements. In the interest of compact prosecution, should the claimed intent be for including a second, separate (for example) filtering step with the “excluding impedance measurements that exceed a threshold from the expected value” that is in addition to the Cole-Cole model, there is not description in the specification for the additional step. Therefore, adequate disclosure is needed.
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 – 6, 10 - 17, 19, and 21 – 25 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 (line 16 – 17) and Claim 24 (line 15 – 16) each recite the term “impedance measurements that exceed a threshold” in lines 15 – 16. It is unclear if the impedance measurements are intended to be the same or different than the “each impedance measurement in the set” previously recited in Claim 1. For the purposes of examination, the term “excluding impedance measurements that exceed a threshold” is deemed to claim “excluding the each impedance measurement in the set that exceeds a threshold”. Claims 2 – 6, 10 – 17, 19, and 21 – 23 are similarly rejected due to their dependence on Claim 1. Claim 25 is similarly rejected due to its dependence on Claim 24.
Claim 1 (lines 14 - 19) and Claim 24 (lines 12 - 17) each recite the term “fitting the set of the plurality of impedance measurements to a single Cole-Cole model, and, by comparing each impedance measurement in the set to an expected value given by the single Cole-Cole model, excluding impedance measurements that exceed a threshold from the expected value, thereby obtaining a subset of impedance measurements that conform to the single Cole-Cole model”. It is unclear if this is intended to recite two separate data processing steps, the first being “fitting the set of the plurality…” and “excluding impedance measurements that exceed a threshold from the expected value”, or if it is a single processing step that includes fitting the set of the impedance measurements to the Cole-Cole model in order to exclude impedance measurements. As recited, it is unclear if the intent is to claim a second, separate (for example) filtering step that is in addition to the Cole-Cole model. The metes and bounds of the claim are unclear. Claims 2 – 6, 10 – 17, 19, and 21 – 23 are similarly rejected due to their dependence of Claim 1. Claim 25 is similarly rejected due to its dependence on Claim 24.
Claim 22 recites the term “validating impedance measurements” in line 2. It is unclear if these impedance measurements are intended to be the same or different than the previously-recited “each impedance measurement” of the set of a plurality of impedance measurements. For the purposes of examination, the term “validating impedance measurements” is deemed to claim “validating the each impedance measurement of the set”.
Claim 22 recites the term “the Cole-Cole Plot” in line 5. There is insufficient antecedent basis for this term in the claim. It is unclear the Cole-Cole Plot is intended to be something other than the Cole-Cole model. For the purposes of examination, the term “the Cole-Cole Plot” is deemed to claim “a Cole-Cole Plot”.
Claim 22 recites the term “shift in the impedance signals” in lines 6 – 7. There is insufficient antecedent basis for this term in the claim. It is unclear if these impedance signals are intended to be the same or different than the previously-recited “each impedance measurement” of the set of a plurality of impedance measurements. For the purposes of examination, the term “shift in the impedance signals” is deemed to claim “shift in a signal of the each impedance measurement of the set”.
Claim 23 recites the term “and the impedance measurement is performed for a duration” in line 3. It is unclear if this impedance measurements are intended to be the same or different than the previously-recited “each impedance measurement” of the set of a plurality of impedance measurements. It appears that it is possibly intended to be correlated with the “measuring an impedance” limitation of Claim 1. For the purposes of examination, the term “and the impedance measurement is performed for a duration” is deemed to claim “the measuring the impedance to acquire the set of the plurality of the impedance measurements is performed for a duration”.
Claim 23 recites the term “a period of testing of one to twenty-four hours” in line 4. It is unclear if this period of testing is intended to be the same or different than the previously-recited period of testing in claim 1. For the purposes of examination, the term “a period of testing” is deemed to claim “the period of testing, consisting of a period of one to twenty-four hours.”
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1 – 6, 10 – 17, 19, and 21 - 25 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Regarding Claim 1, the claim recites "an act or step, or series of acts or steps" and is therefore a process, which is a statutory category of invention (Step 1). The claim is then analyzed to determine whether it is directed to any judicial exception (Step 2A, Prong 1).
Regarding Claim 24, the claim recites an apparatus, which is one of the statutory categories of invention (Step 1). The claim is then analyzed to determine whether it is directed to any judicial exception (Step 2A, Prong 1).
Each of Claims 1 – 6, 10 – 17, 19, and 21 - 25 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1
Each of Claims 1 – 6, 10 – 17, 19, and 21 - 25 recites at least one step or instruction for observations, evaluations, judgments, and opinions, which are grouped as a mental process under the 2019 PEG. The claimed invention involves making observations, evaluations, judgments, and opinions, which are concepts performed in the human mind under the 2019 PEG.
Accordingly, each of Claims 1 – 6, 10 – 17, 19, and 21 - 25 recites an abstract idea.
Specifically, Claims 1 – 6, 10 – 17, 19, and 21 - 25 recite (underlined are observations, judgments, evaluations, or opinions, which are grouped as a mental process under the 2019 PEG) (additional elements bolded, see Step 2A, prong 2);
Claim 1
A method performed by a system including a signal generator, at least two stimulation electrodes, and at least two sensing electrodes to monitor a level of edema of a subject, the method comprising:
generating, by the signal generator, a first signal that causes a current to flow between the at least two stimulation electrodes and measuring an impedance between the at least two sensing electrodes disposed on a skin of the subject at a selected interval of time during a period of testing, thereby acquiring a set of a plurality of impedance measurements;
converting each of the validated sub-set of impedance measurements to an edema index, thereby providing a plurality of edema indices;
fitting the set of the plurality of impedance measurements to a single Cole-Cole model, and, by comparing each impedance measurement in the set to an expected value given by the single Cole-Cole model, excluding impedance measurements that exceed a threshold from the expected value, thereby obtaining a subset of impedance measurements that conform to the single Cole-Cole model;
converting each of the impedance measurements in the subset to an edema index, thereby acquiring a plurality of edema indices;
generating a specific edema index, which is an average, mode, or median of the plurality of edema indices for the period of testing; and
outputting a graph showing a time series transition of the specific edema index during the period of testing
Claim 24
A system for monitoring a level of edema of a subject comprising:
a signal generator;
at least two stimulation electrodes;
at least two sensing electrodes; and
one or more processors configured to:
(a) generate, by the signal generator, a first signal that causes a current to flow between the at least two stimulation electrodes, and measure an impedance between the at least two sensing electrodes disposed on a skin of the subject at a selected interval of time during a period of testing, thereby acquiring a set of a plurality of impedance measurements,
(b) fit the set of the plurality of impedance measurements to a single Cole- Cole model, and, by comparing each impedance measurement in the set to an expected value given by the single Cole-Cole model, exclude impedance measurements that exceed a threshold from the expected value, thereby obtaining a subset of impedance measurements that conform to the single Cole-Cole model,
(c) convert each of the impedance measurements in the subset to an edema index, thereby acquiring a plurality of edema indices,
(d) generate a specific edema index, which is an average, mode, or median of the plurality of edema indices for the period of testing, and
(e) output a graph showing a time series transition of the specific edema index during the period of testing.
(observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG);
These underlined limitations describe a mathematical calculation and/or a mental process, as a skilled practitioner is capable of performing the recited limitations and making a mental assessment thereafter. Examiner notes that nothing from the claims suggests that the limitations cannot be practically performed by a human with the aid of a pen and paper, or by using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time. Examiner additionally notes that nothing from the claims suggests and undue level of complexity that the mathematical calculations and/or the mental process steps cannot be practically performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps. For example, in Independent Claims 1 and 24, these limitations include:
Observation and Judgment to acquire a set of a plurality of impedance measurements,
Observation and Judgment of converting each of the validated sub-set of impedance measurements to an edema index
Observation and Judgment to fit the set of the plurality of impedance measurements to a single Cole-Cole model
Observation and Judgment to compare each impedance measurement in the set to an expected value given by the single Cole-Cole model
Observation and Judgment to exclude impedance measurements that exceed a threshold from the expected value
Observation and Judgment of a subset of impedance measurements that conform to the single Cole-Cole model;
Observation and Judgment to convert each of the impedance measurements in the subset to an edema index
Observation and Judgment of a plurality of edema indices;
Observation and Judgment to evaluate a specific edema index, which is an average, mode, or median of the plurality of edema indices for the period of testing; and
Observation and Judgment to communicate a graph showing a time series transition of the specific edema index during the period of testing
all of which are grouped as mental processes under the 2019 PEG.
Similarly, the dependent claims include the following abstract limitations, in addition the aforementioned limitations in Independent Claims 1 and 24 (underlined observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG):
calculating the calibrated bioelectric impedance based at least in part on voltages between the at least two sensing electrodes when the first and second currents are supplied.
Evaluating the calibrated bioelectric impedance based at least in part on voltages between the at least two sensing electrodes when the first and second currents are supplied.
determining the calibrated bioelectric impedance based at least in part on: a voltage difference between the at least two sensing electrodes when each of the first and second currents is supplied; a ratio of voltages at a first sensing electrode when the first and second currents are supplied; and a current that flows across a current sense resistor when the first current is supplied.
Observation and judgment to determine the calibrated bioelectric impedance based at least in part on: a voltage difference between the at least two sense electrodes when each of the first and second currents is supplied; a ratio of voltages at a first sense electrode when the first and second currents are supplied; and a current that flows across a current sense resistor when the first current is supplied.
measuring the impedance is repeated between once every ten minutes to once every twenty minutes.
Observation and judgment to repeat measuring the impedance between once every ten minutes to once every twenty minutes.
measuring the impedance is performed for 1 second to 4 seconds.
Observation and judgment to measure the impedance for 1 second to 4 seconds.
extending the period of testing to a predetermined duration of time.
Observation and judgment to extend the period of testing to a predetermined duration of time.
Outputting an alert depending on the specific edema index
Observation and judgment to communicate an alert depending on the specific edema index
validating impedance measurements based on at least one quality metric selected from: total error term from the Cole-Cole model, number of frequency points exceeding a threshold deviation from the expected fit, overall shape conformity to the Cole-Cole plot, distance in a metric space defined by Cole- Cole features, temporal metadata, or variance of phase shift in the impedance signals.
Observation and judgment to validate impedance measurements based on at least one quality metric selected from: total error term from the Cole-Cole model, number of frequency points exceeding a threshold deviation from the expected fit, overall shape conformity to the Cole-Cole plot, distance in a metric space defined by Cole- Cole features, temporal metadata, or variance of phase shift in the impedance signals.
all of which are grouped as mental processes under the 2019 PEG.
Accordingly, as indicated above, each of the above-identified claims recite an abstract idea.
Step 2A, Prong 2
The above-identified abstract ideas in each of Independent Claims 1 and 24 (and their respective Dependent Claims) are not integrated into a practical application under 2019 PEG because the additional elements (identified above in Independent Claims 1 and 24), either alone or in combination, generally link the use of the above-identified abstract ideas to a particular technological environment or field of use. More specifically, the additional elements of:
“signal generator”
“At least two stimulation electrodes”, “source electrode”, “sink electrode”
“At least two sensing electrodes”, “dry electrodes”, “first sensing electrode”
“current sense resistor”
“controller”
“band”
“one or more processors”, “first processor”, “second processor”
“wearable device”
Additional elements recited include a “signal generator”, “at least two stimulation electrodes”, “source electrode”, “sink electrode”, “at least two sensing electrodes”, “dry electrodes”, “first sensing electrode”, “current sense resistor”, “controller”, “band”, “one or more processors”, “first processor”, “second processor”, “wearable device” to control, measure, validate, eliminate, convert, average, and generate in the Independent Claims 1 and 24 and their dependent claims. These components are recited at a high level of generality, , i.e., as a controller performing a generic function of controlling a system (the controlling), and a generic signal generator and electrodes performing the generic function of measuring signals (the measuring). These generic hardware component limitations for “signal generator”, “at least two stimulation electrodes”, “source electrode”, “sink electrode”, “at least two sensing electrodes”, “dry electrodes”, “first sensing electrode”, “current sense resistor”, “controller”, “band”, “one or more processors”, “first processor”, “second processor”, “wearable device” are no more than mere instructions to apply the exception using generic computer and hardware components. As such, these additional elements do not impose any meaningful limits on practicing the abstract idea.
Further additional elements from Independent Claims 1 and 24 include extra-solution, pre-solution activity limitations, such as:
generating, by the signal generator, a first signal that causes a current to flow between the at least two stimulation electrodes and measuring an impedance between the at least two sensing electrodes disposed on a skin of the subject at a selected interval of time during a period of testing
including a signal generator, at least two stimulation electrodes, and at least two sensing electrodes to monitor a level of edema of a subject
In addition to the aforementioned extra-solution activity limitations in Independent Claims 1 and 24, additional extra-solution activity limitations recited in the dependent claims include:
wherein the at least two stimulation electrodes include a source electrode and a sink electrode
measuring the impedance includes measuring a calibrated bioelectric impedance by supplying a first current between the source electrode and the sink electrode in a first direction, supplying a second current simultaneously to the source electrode and sink electrode in the first direction and a second direction opposite to the first direction,
wherein the period of testing is a period of 1 hour to 24 hours.
wherein the extended period of time is one month to six months.
wherein the sensing electrodes are disposed on a wrist of the subject.
the specific edema index is the average of the plurality of edema indices for the period of testing
the alert is output when the specific edema index exceeds or falls below a preselected value
wherein the alert is an electronic report to a caregiver.
wherein the alert is an audible or visible report
wherein the subset of impedance measurements comprises at least 40% of the plurality of impedance measurements measured during the period of testing.
securing a band including the at least two sensing electrodes to the skin of the subject
disposing the at least two sensing electrodes at different points on the subject.
wherein the at least two sensing electrodes are dry electrodes disposed at least one centimeter apart on the skin of the subject, and the impedance measurement is performed for a duration of one to four seconds during a period of testing of one to twenty-four hours.
a first processor of a wearable device that is configured to perform (a), and
a second processor of an external device that is configured to perform (b)- (e), and
the signal generator, the at least two stimulation electrodes, and the at least two sensing electrodes are housed in the wearable device.
These pre-solution measurement elements are insignificant extra-solution activity, setting up the parameters of the system, and serve as data-gathering for the subsequent steps.
The “signal generator”, “at least two stimulation electrodes”, “source electrode”, “sink electrode”, “at least two sensing electrodes”, “dry electrodes”, “first sensing electrode”, “current sense resistor”, “controller”, “band”, “one or more processors”, “first processor”, “second processor”, “wearable device” as recited in Independent Claims 1 and 2 and their dependent claims are generically recited computer and hardware elements which do not improve the functioning of a computer, or any other technology or technical field. Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. For at least these reasons, the abstract ideas identified above in Independent Claims 1 and 24 (and their respective dependent claims) is not integrated into a practical application under 2019 PEG.
Moreover, the above-identified abstract idea is not integrated into a practical application under 2019 PEG because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and certain method of organizing human activity) using rules (e.g., computer instructions) executed by a computer processor as claimed. In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in Independent Claims 1 and 20 (and their respective dependent claims) is not integrated into a practical application under the 2019 PEG.
Accordingly, Independent Claims 1 and 24 (and their respective dependent claims) are each directed to an abstract idea under 2019 PEG.
Step 2B –
None of Claims 1 – 6, 10 – 17, 19, and 21 - 25 include additional elements that are sufficient to amount to significantly more than the abstract idea for at least the following reasons.
These claims require the additional elements of: “signal generator”, “at least two stimulation electrodes”, “source electrode”, “sink electrode”, “at least two sensing electrodes”, “dry electrodes”, “first sensing electrode”, “current sense resistor”, “controller”, “band”, “one or more processors”, “first processor”, “second processor”, “wearable device” as recited in Independent Claims 1 and 20 and their dependent claims.
The additional elements of the “signal generator”, “at least two stimulation electrodes”, “source electrode”, “sink electrode”, “at least two sensing electrodes”, “dry electrodes”, “first sensing electrode”, “current sense resistor”, “controller”, “band”, “one or more processors”, “first processor”, “second processor”, “wearable device” in Claims 1 – 6, 10 – 17, 19, and 21 - 25, as discussed with respect to Step 2A Prong Two, amounts to no more than mere instructions to apply the exception using generic computer and hardware components. The same analysis applies here in 2B, i.e., mere instructions to apply an exception using a generic computer component cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B.
The above-identified additional elements are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, Versata Dev. Group, Inc. v. SAP Am., Inc. , 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Per Applicant’s specification, the “signal generator” is described generically in [0042], [0045], and [0047] with “a signal generator 202 for generating test signals” and general statements of the signal generator generating signals. The signal generator is presented as generic box element “signal generator” 202 in Figure 2.
Per Applicant’s specification, the “at least two stimulation electrodes”, “source electrode”, “sink electrode” are described generically in [0016], [0040], [0042], [0061] and [0043] with “current is applied simultaneously to both stimulation electrodes”, “The first electrode 112 and the third electrode 116 are stimulation electrodes.”, “current to flow between the stimulation electrodes 112 and 116 disposed on the skin of an extremity of the subject”, and “the source electrode 112 and the sink electrode 116”. The stimulation electrodes are presented as generic elements “stimulation electrodes” 112 and 116 in Figure 1.
Per Applicant’s specification, the “at least two sensing electrodes” and “first sensing electrode” are described generically in [0039], [0040], [0061], and [0016] with “The wearable device may have any number of driving, sensing, or combined driving/sensing electrodes such that two driving points and two sensing points may be chosen.”; “The second electrode 114 and the fourth electrode 118 are sensing electrodes. The electrodes are all dry contact electrodes and require no skin preparation, gel or other material to optimize the skin-electrode impedance.“; and “…storing voltages from a first sense electrode.” The sensing electrodes are presented as generic elements “sensing electrodes” 114 and 118 in Figure 1.
Per Applicant’s specification, the “dry electrodes” are described generically at [0040] as “The electrodes are all dry contact electrodes and require no skin preparation, gel or other material to optimize the skin-electrode impedance.” Electrodes 112, 114, 116, and 118 are shown in Figure 1.
Per Applicant’s specification, the “current sense resistor” is described generically at [0041] with “current sense resistor 210 for sensing a current.”. It is shown as “current source resistor” in Figure 2.
Per Applicant’s specification, the “controller” is described generically in [0042] with “The controller 200 may include one or more processors and volatile and non- volatile memories. The controller 200 may further include an interface circuit configured to communicate with an external device such as a host computer to output an alert and related data via a wired or wireless network. In some variations, any of these components may be combined or integrated together.” The controller is presented as generic box element “controller” 200 in Figure 2.
Per Applicant’s specification, the “band” is described generically at [0014] “securing one or more bands including at least two electrodes…to the extremity…a wrist…or a leg”. The band is presented as a generic band shape in Figure 1.
Per Applicant’s specification, the “one or more processors”, “first processor”, and ”second processor” is described generically at [0043] as “…lines between the signal processor 204 and the multiplexer 206 to sense a current flowing…The controller 200 may include one or more processor and volatile and non-volatile memories.” The “one or more processors”, “first processor”, and ”second processor” are presented as “signal processor 204” block in Figure 2.
Per Applicant’s specification, the “wearable device” is described generically in [0006] and [0039] “The wearable device is designed to comfortably contact the skin of the monitored individual to obtain an impedance measurement which may be converted to an edema index,” and “…the wearable device is configured to be secured to the wrist of an individual, such that the two electrodes which sense voltage (e.g., convertible to an impedance measurement) are disposed at two different points upon the skin of the individual.” The wearable device is shown as “wearable device 100” in Figure 1.
Accordingly, in light of Applicant’s specification, the claimed terms “signal generator”, “at least two stimulation electrodes”, “source electrode”, “sink electrode”, “at least two sensing electrodes”, “dry electrodes”, “first sensing electrode”, “current sense resistor”, “controller”, “band”, “one or more processors”, “first processor”, “second processor”, “wearable device” are reasonably construed as a generic computing and hardware devices. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process.
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the “signal generator”, “at least two stimulation electrodes”, “source electrode”, “sink electrode”, “at least two sensing electrodes”, “dry electrodes”, “first sensing electrode”, “current sense resistor”, “controller”, “band”, “one or more processors”, “first processor”, “second processor”, “wearable device”. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
The recitation of the above-identified additional limitations in Claims 1 – 6, 10 – 17, 19, and 21 - 25 amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general-purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the apparatus and method of Claims 1 – 6, 10 – 17, 19, and 21 - 25 are directed to applying an abstract idea as identified above on a general-purpose computer without (i) improving the performance of the computer itself, or (ii) providing a technical solution to a problem in a technical field. None of Claims 1 – 6, 10 – 17, 19, and 21 - 25 provides meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements for Step 2A Prong 2 in Independent Claims 1 and 24 (and their dependent claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment. That is, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity. When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. Thus, Claims 1 – 6, 10 – 17, 19, and 21 - 25 merely apply an abstract idea to a computer and do not (i) improve the performance of the computer itself (as in Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
Therefore, none of the Claims 1 – 6, 10 – 17, 19, and 21 - 25 amounts to significantly more than the abstract idea itself. Accordingly, Claims 1 – 6, 10 – 17, 19, and 21 - 25 are not patent eligible and rejected under 35 U.S.C. 101.
Response to Arguments
Applicant's arguments filed 15 DECEMBER 2025 have been fully considered but they are not persuasive.
Regarding 35 U.S.C. 101 Rejections:
Applicant argues at [Page 7, bottom] – [Page 8, 1st Full Paragraph] that the limitations of “fitting the set of the plurality of impedance measurements to a single Cole-Cole model, and, by comparing each impedance measurement in the set to an expected value given by the single Cole-Cole model, excluding impedance measurements that exceed a threshold from the expected value” do not fall within the mental process grouping because the human mind cannot process raw electrical impedance sensor data in real-time. Applicant argues that the USPTO Memo Guidance, Page 2 indicates that a limitation cannot be practically performed in the human mind when the human mind is not equipped to perform the claim limitations. The instant claims recite a series of limitations that encompass an abstract idea of manipulating variables obtained from electronic components used in a usual way, and that variable manipulation can be accomplished with the aid of time, equations, and paper. As an example, a researcher could obtain a graphical or matrix output of impedance measurements by using a signal generator and electrodes in their usual way (measuring impedance). Then, the researcher could apply the equation for a Cole-Cole model from a textbook with the aid of time, equations, and graph paper. Alternatively, the researcher could use a computer including MATLAB® as a calculator tool, in a usual way, to process the matrix mathematical operations to compute a Cole-Cole plot and to visually observe or choose outlying data for removal. There is nothing particular in the claims that recites that the processing steps are performed in a way that is outside the capabilities of a human researcher. The argument is not persuasive.
Applicant argues at [Page 8, 2nd Full Paragraph] that the claimed subject matter should not be grouped into the mathematical concepts subcategory because it involves mathematics but does not particularly recite mathematical formulas or equations using words or mathematical symbols, citing USPTO Memo Guidance, Page 3. Claim 1 recites “fitting the set of the plurality of impedance measurements to a single Cole-Cole model”, which describes in words the mathematical concept of applying a Cole-Cole formula to an output of data to obtain a result modified by the equation that has been “fit”. Additional mathematical formulas recited in words include the “average, mode, or median of the plurality of edema indices”, which invokes the use of well-known statistical formulas to process data. A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that these limitations are referring to mathematical formulas. The argument is not persuasive.
Applicant argues at [Page 9, All] – [Page 10, Top] that the claims are integrated into a practical application by providing a specific technological solution to the technical problems inherent in wearable bioimpedance monitoring systems, by correcting physical signal instabilities caused by dry electrodes and loose physical coupling, as claimed in the “fitting the set…to a single Cole-Cole model” and “excluding impedance measurements that exceed a threshold” limitations. There is nothing particularly recited in the claims that the abstract ideas are improving the functioning of the claimed hardware. The measurements from the hardware elements of the signal generator, two stimulation electrodes, and at least two sensing electrodes are extra-solution activity that serve as data-gathering for the subsequent abstract idea data-processing steps. From MPEP 2106.05(a): It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements. See the discussion of Diamond v. Diehr, 450 U.S. 175, 187 and 191-92, 209 USPQ 1, 10 (1981)) in subsection II, below. In addition, the improvement can be provided by the additional element(s) in combination with the recited judicial exception. See MPEP § 2106.04(d) (discussing Finjan, Inc. v. Blue Coat Sys., Inc., 879 F.3d 1299, 1303-04, 125 USPQ2d 1282, 1285-87 (Fed. Cir. 2018)). MPEP 2106.04(d)(1) “Second, if the specification sets forth an improvement in technology, the claim must be evaluated to ensure that the claim itself reflects the disclosed improvement.” The claims presently do not reflect the alleged improvement.
Further, there is nothing particular in the independent claim that limits the electrodes to “dry electrodes”, or a lack of “hydrogel pads” as described. The “dry electrodes” are only recited in the claims in dependent Claim 23. There is nothing particular recited in Claim 23 that indicates that the functioning of the dry sensing electrodes themselves is improved. The argument is not persuasive.
Applicant summarily argues at [Page 10, 1st Full Paragraph] that the claimed subject matter is integrated into a practical application and eligible under Step 2A, Prong Two. Based on the 35 U.S.C 101 analysis herein and the discussion of arguments above, Claims 1 – 6, 10 – 17, 19, and 21 - 25 do not qualify as eligible subject matter under 35 U.S.C. 101. The argument is not persuasive. The argument is not persuasive.
Regarding 35 U.S.C. 103 Rejections:
Based on Applicant’s arguments and amendments to the claims, and in light of the current 112(b) rejections, no prior art rejection is currently able to be applied to Claims 1 – 6, 10 – 17, 19, and 21 - 25
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA J MONTGOMERY whose telephone number is (571)272-2305. The examiner can normally be reached Monday - Friday 7:30 - 5:00 ET.
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/MELISSA JO MONTGOMERY/Examiner, Art Unit 3791
/PATRICK FERNANDES/Primary Examiner, Art Unit 3791