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 .
Amendment Entered
In response to the amendment filed on September 8th, 2025, amended claims 1, 24, 40, 42, and 57-58 are entered. Claims 1, 12-13, 15, 18, 21-22, 24, 27-29, 31, 34, 40-41, and 57-58 are currently under examination. Claims 42 and 48 remain withdrawn.
Response to Arguments
Applicant's remarks and amendments with respect to the claim objections have been fully considered. The objections are withdrawn in view of the amendment.
Applicant's arguments, filed on September 8th, 2025, with respect to the rejections under 35 U.S.C. 101 have been fully considered but they are not persuasive. The rejection is maintained, and further clarified, in view of the amendment.
At Pgs. 13-14 of the Reply, Applicant notes that “the claims now no longer merely require displaying of the indicator. Instead, the claims recite that user input is provided following display of the indicator, with the user input being used to control the system to cause the system to calculate a body state indicator if the user assesses the bioimpedance measurement to be accepted, or repeat the measurement if the user assesses the bioimpedance measurement as not accepted. As such, Applicant respectfully notes that claims are therefore now limited to performing procedures in response to the determination and respectfully submits that the revised claims are patent eligible”. Examiner respectfully disagrees. The newly added limitations fail to overcome the rejections as they recite steps considered as data-outputting. Although the Applicant has added limitations that are no longer merely requiring displaying of the indicator, the addition of requiring user input in order to accept or not accept the bioimpedance measurement is insufficient to integrate this judicial exception into a practical application, as these steps are determined to be a part of extra-solution activity, in the form of data-outputting. Furthermore, mere data-outputting is recognized by the court as insignificant, extra-solution activity. “As explained by the Supreme Court, the addition of insignificant extra-solution activity does not amount to an inventive concept, particularly when the activity is well-understood or conventional. Parker v. Flood, 437 U.S. 584, 588-89, 198 USPQ 193, 196 (1978)” MPEP 2106.05(g).
The data-outputting is done with a generic computer structure (i.e. a display and user interface). The claimed invention is merely using the computer as a tool to implement the process, particularly one that a clinician could do alone. For example, it is certainly possible for a clinician to look at a reading and determine whether the measurement should be accepted or not accepted and repeated to obtain a more accurate result. The additional step of incorporating the acceptance or non-acceptance of data is not being used for doing anything besides either storing the data or completing the previous steps again; therefore, the data is not practically applied. “Integral use of a machine to achieve performance of a method may provide significantly more, in contrast to where the machine is merely an object on which the method operates, which does not provide significantly more.” MPEP 2106.05(b). II. “Use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not provide significantly more.” MPEP 2106.05(b) III. Therefore, the rejections under 35 U.S.C. 101 have been maintained.
Applicant's arguments, filed on September 8th, 2025, with respect to the rejections under 35 U.S.C. 103 have been fully considered but they are not all persuasive. However, there is a new ground of rejection due to the amendments.
At Pgs. 15-16 of the Reply, Applicant argues the combination of Ori and Gray, arguing “the logical combination of Ori and Gray would arguably be to use a separate mechanism when categorizing measurement effectiveness, and not to use the actual bioimpedance measurement on the subject to categorize that measurement”. Examiner respectfully disagrees. Ori already teaches performing an evaluation of a validity of the bioimpedance measurement based on the deviation to categorise the bioimpedance measurement, to thereby generate a measurement categorisation (The errors of the filtered voltage signal, defined as the difference between the predicted and measured digitalized, amplified, and filtered voltage signal from the six measuring points 208, 320, 211, 213, 215 and 325, are used for measurement of quality and to indicate whether a repeat measurement cycle is needed; Column 25 Lines 58-63; to measure quality and reliability of my apparatus' functioning; Column 25 Line 64 – Column 26 Line 6). The Gray reference is being used to teach the display (Display 38 may display the value as a categorical gradation; [0035]) and the specific categorisations of: a) bad; b) questionable; and, c) acceptable (the categorical gradation may include the levels of excellent, good, fair and poor; [0035]). Furthermore, Gray discloses an impedance measurement apparatus for assessment of biomedical electrode interface quality (Abstract). This is considered a similar technical field, as the Applicant’s Specification teaches wherein “evaluation of the impedance measurements can also be performed in accordance with other criteria...negative reactance values typically result from a poor measurement, for example arising due to poor surface contact between the subject and the electrode” ([0118-0119]). Therefore, poor surface contact between the subject and the electrode is a major factor in the evaluation of the impedance measurements and subsequent categorisation.
It is well-settled that the suggestion to combine need not come from the reference itself. “The rationale to modify or combine the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art, established scientific principles, or legal precedent established by prior case law.” MPEP 2144 I.
Claim Objections
Claims 24 and 40 are objected to because of the following informalities:
Claim 24 recites “claim 1, the” in lines 1-4, but should read “claim 1, wherein the”
Claim 40 recites “g) determining” in line 23, but should read “h) determining”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 40-41 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 40 recites the limitation "the display" in line 21. There is insufficient antecedent basis for this limitation in the claim.
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, 12-13, 15, 18, 21-22, 24, 27-29, 31, 34, 40-41, and 57-58 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Independent Claim 1 recites:
a) a signal generator configured to apply alternating signals to at least part of the biological subject at a plurality of different frequencies;
b) a sensor configured to measure response signals from the biological subject;
c) a display; and
d) one or more electronic processing devices that:
i) retrieve the measured response signals:
ii) determine the bioimpedance measurement in the form of impedance values obtained at the plurality of different frequencies using the measured response signals;
iii) calculate an impedance curve using a curve fitting algorithm;
iv) determine a deviation of the impedance curve from the bioimpedance measurement;
v) perform an evaluation of a validity of the bioimpedance measurement based on the deviation to categorise the bioimpedance measurement, to thereby generate a measurement categorisation wherein the bioimpedance measurement is categorised using one or more thresholds as being at least one of:
a) bad;
b) questionable; or,
c) acceptable, and
vi) derive an indicator indicative of the measurement categorization;
vii) display the indicator on the display to allow a user to determine whether to accept or reject the bioimpedance measurement;
viii) determine a user assessment of the impedance measurement in accordance with user input commands provided via a user interface displayed on the display to determine if the bioimpedance measurement should be accepted;
ix) for a bioimpedance measurement that is accepted, use the bioimpedance measurement to calculate a body state indicator relating to the biological subject; and,
x) for a bioimpedance measurement that is not accepted, repeat the bioimpedance measurement.
Independent Claim 40 recites:
a) retrieving response signals measured by a sensor from alternating signals applied to at least part of the biological subject at a plurality of different frequencies;
b) determining the bioimpedance measurement in the form of impedance values obtained from the response signals;
c) calculating an impedance curve using a curve fitting algorithm;
d) determining a deviation of the impedance curve from the bioimpedance measurement; and,
e) performing an evaluation of the bioimpedance measurement based on the deviation to categorise the bioimpedance measurement, to thereby generate a measurement categorisation using one or more thresholds wherein the bioimpedance measurement is categorised as being at least one of:
i) bad;
ii) questionable; or,
iii) acceptable,
f) deriving an indicator indicative of the measurement categorization for display to allow a user to determine whether to accept or reject the bioimpedance measurement;
g) displaying the indicator on the display to allow a user to determine whether to accept or reject the bioimpedance measurement;
g) determining a user assessment of the impedance measurement in accordance with user input commands provided via a user interface displayed on the display to determine if the bioimpedance measurement should be accepted;
i) for a bioimpedance measurement that is accepted, using the bioimpedance measurement to calculate a body state indicator relating to the biological subject; and,
j) for a bioimpedance measurement that is not accepted, repeating the bioimpedance measurement.
Independent Claim 57 recites:
a) a signal generator configured to apply alternating signals to at least part of the biological subject at a plurality of different frequencies;
b) a sensor configured to measure response signals from the biological subject;
c) a display; and
d) one or more electronic processing devices that:
i) retrieve the measured response signals;
ii) determine the bioimpedance measurement in the form of impedance values obtained at the plurality of different frequencies using the measured response signals;
iii) calculate an impedance curve using a curve fitting algorithm;
iv) calculate curve coefficients using the curve fitting algorithm;
v) determine a deviation of the impedance curve from the bioimpedance measurement using the curve coefficients and the bioimpedance measurement;
vi) use the deviation to calculate an estimated error in impedance parameter values, the impedance parameter values being derived from the impedance curve, by propagating the deviation to the impedance parameter values; and,
vii) use the estimated error to perform an evaluation of the bioimpedance measurement to categorise the bioimpedance measurement, thereby generate a measurement categorisation, and derive an indicator indicative of the measurement categorisation
viii) display the indicator on the display to allow a user to determine whether to accept or reject the bioimpedance measurement;
ix) determine a user assessment of the impedance measurement in accordance with user input commands provided via a user interface displayed on the display to determine if the bioimpedance measurement should be accepted;
x) for a bioimpedance measurement that is accepted, use the bioimpedance measurement to calculate a body state indicator relating to the biological subject; and,
xi) for a bioimpedance measurement that is not accepted, repeat the bioimpedance measurement.
Independent Claim 58 recites:
a) retrieving response signals measured by a sensor from alternating signals applied to at least part of the biological subject at a plurality of different frequencies;
b) determining the bioimpedance measurement in the form of impedance values obtained from the response signals;
c) calculating an impedance curve using a curve fitting algorithm;
d) calculating curve coefficients using the curve fitting algorithm;
e) determining a deviation of the impedance curve from the bioimpedance measurement using the curve coefficients and the bioimpedance measurement;
f) calculating an estimated error in impedance parameter values using the deviation, the impedance parameter values derived from the impedance curve, by propagating the deviation to the impedance parameter values; and,
g) performing an evaluation of the bioimpedance measurement using the estimated error to categorise the bioimpedance measurement, and thereby generate a measurement categorization;
h) deriving an indicator indicative of the measurement categorisation for display;
i) displaying the indicator on a display to allow a user to determine whether to accept or reject the bioimpedance measurement;
j) determining a user assessment of the impedance measurement in accordance with user input commands provided via a user interface displayed on the display to determine if the bioimpedance measurement should be accepted;
k) for a bioimpedance measurement that is accepted, using the bioimpedance measurement to calculate a body state indicator relating to the biological subject; and,
l) for a bioimpedance measurement that is no accepted, repeating the bioimpedance measurement.
The above claim limitations constitute an abstract idea that is part of the Mathematical Concepts and/or Mental Processes group identified in the 2019 Revised Patent Subject Matter Eligibility Guidance published in the Federal Register (84 FR 50) on January 7, 2019.
“A mathematical relationship is a relationship between variables or numbers. A mathematical relationship may be expressed in words ….” October 2019 Update: Subject Matter Eligibility, II. A. i. “[T]here are instances where a formula or equation is written in text format that should also be considered as falling within this grouping.” Id. at II. A. ii. “[A] claim does not have to recite the word “calculating” in order to be considered a mathematical calculation.” Id. at II. A. iii. See for example, SAP Am., Inc. v. InvestPic, LLC, 898 F.3d 1161, 1163-65 (Fed. Cir. 2018).
The claimed steps of determining, calculating, and evaluating recite a mathematical concept (i.e., mathematical relationships, mathematical formulas or equations, and mathematical calculations).
The step of “perform[ing] an evaluation of the bioimpedance measurement” in independent Claim 1 is a mathematical relationship to determine error values associated with a number of impedance parameter values. The error calculations can be computed from the equations in Claims 13, 15, and 18.
The claimed steps of determining, calculating, and evaluating can be practically performed in the human mind using mental steps or basic critical thinking, which are types of activities that have been found by the courts to represent abstract ideas.
“[T]he ‘mental processes’ abstract idea grouping is defined as concepts performed in the human mind, and examples of mental processes include observations, evaluations, judgments, and opinions.” MPEP 2106.04(a)(2) III. The pending claims merely recite steps for an evaluation that include observations, evaluations, and judgments.
Examples of ineligible claims that recite mental processes include:
a claim to “collecting information, analyzing it, and displaying certain results of the collection and analysis,” where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind, Electric Power Group, LLC v. Alstom, S.A.;
claims to “comparing BRCA sequences and determining the existence of alterations,” where the claims cover any way of comparing BRCA sequences such that the comparison steps can practically be performed in the human mind, University of Utah Research Foundation v. Ambry Genetics Corp.
a claim to collecting and comparing known information, which are steps that can be practically performed in the human mind, Classen Immunotherapies, Inc. v. Biogen IDEC.
See p. 7-8 of October 2019 Update: Subject Matter Eligibility.
Regarding the dependent claims, the dependent claims are directed to either 1) steps that are also abstract or 2) additional data output that is well-understood, routine and previously known to the industry. Although the dependent claims are further limiting, they do not recite significantly more than the abstract idea. A narrow abstract idea is still an abstract idea and an abstract idea with additional well-known equipment/functions is not significantly more than the abstract idea.
This judicial exception (abstract idea) in Claims 1, 12-13, 15, 18, 21-22, 24, 27-29, 31, 34, 40-41, and 57-58 is not integrated into a practical application because:
The abstract idea amounts to simply implementing the abstract idea on a computer. For example, the recitations regarding the generic computing components for determining, calculating, and evaluating merely invoke a computer as a tool.
The data-gathering step (measuring response signals and retrieving the measured response signals) and data-outputting step (displaying the measurement categorization, determining a user assessment, using the bioimpedance measurement, repeating the bioimpedance measurement) do not add a meaningful limitation to the method as they are categorized as insignificant extra-solution activity.
There is no improvement to a computer or other technology. “The McRO court indicated that it was the incorporation of the particular claimed rules in computer animation that "improved [the] existing technological process", unlike cases such as Alice where a computer was merely used as a tool to perform an existing process.” MPEP 2106.05(a) II. The claims recite a computer that is used as a tool for determining, calculating, and evaluating.
The claims do not apply the abstract idea to effect a particular treatment or prophylaxis for a disease or medical condition. Rather, the abstract idea is utilized to determine a relationship among data to perform an evaluation of the impedance measurements.
The claims do not apply the abstract idea to a particular machine. “Integral use of a machine to achieve performance of a method may provide significantly more, in contrast to where the machine is merely an object on which the method operates, which does not provide significantly more.” MPEP 2106.05(b). II.
“Use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not provide significantly more.” MPEP 2106.05(b) III. The pending claims utilize a computer for determining, calculating, and evaluating. The claims do not apply the obtained prediction to a particular machine. Rather, the data is merely output in a post-solution step.
The additional elements are identified as follows: signal generator, sensor, electronic processing device(s), display, user interface, non-transitory computer-readable medium.
Those in the relevant field of art would recognize the above-identified additional elements as being well-understood, routine, and conventional means for data-gathering and computing, as demonstrated by
Applicant’s specification (e.g. paragraphs [0163-0174]) which discloses that the processor(s) and display comprise generic computer components that are configured to perform the generic computer functions (e.g. determining, calculating, and evaluating) that are well-understood, routine, and conventional activities previously known to the pertinent industry;
Applicant’s Background in the specification; and
The non-patent literature of record in the application.
Thus, the claimed additional elements “are so well-known that they do not need to be described in detail in a patent application to satisfy 35 U.S.C. § 112(a).” Berkheimer Memorandum, III. A. 3.
Furthermore, the court decisions discussed in MPEP § 2106.05(d)(lI) note the well-understood, routine and conventional nature of such additional generic computer components as those claimed. See option III. A. 2. in the Berkheimer memorandum.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the units associated with the steps do not add meaningful limitation to the abstract idea. A computer, processor, memory, or equivalent hardware is merely used as a tool for executing the abstract idea(s). The process claimed does not reflect an improvement in the functioning of the computer.
When considered in combination, the additional elements (i.e. the generic computer functions and conventional equipment/steps) do not amount to significantly more than the abstract idea. Looking at the claim limitations as a whole adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 12, 27-28, 34, and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Ori (U.S. Patent No. 9,949,663; cited by Applicant; previously cited) in view of Gray (U.S. Publication No. 2007/0038257; previously cited) and Gallup et al (U.S. Patent No. 5,372,141).
Regarding Claim 1, Ori discloses an impedance measurement system (Figures 2-4) for performing a bioimpedance measurement on a biological subject (Apparatus for analysis of body composition; Abstract), the system including:
a) a signal generator configured to apply alternating signals to at least part of the biological subject at a plurality of different frequencies (In the second step, I determine the unknown impedance or resistance and reactance of the human subject 105 at a preset frequency…The measurement of resistance and reactance of the human subject at each preset frequency starts with loading a sine function of at least 16 wave lengths to a first in first out memory 401 by a microcontroller unit 412; Column 25 Lines 19-35);
b) a sensor configured to measure response signals from the biological subject (sensory electrodes 210, 212);
d) one or more electronic processing devices (processor 412, 413) that:
i) retrieve the measured response signals (microcontroller unit 412 then sends the signal first to the memory means of the microcontroller unit 412 and upon demand sends the signal to a digital signal processor unit 413; Column 25 Lines 19-51);
ii) determine the bioimpedance measurement in the form of impedance values obtained at the plurality of different frequencies using the measured response signals (In the second step, I determine the unknown impedance or resistance and reactance of the human subject 105 at a preset frequency; Column 25 Lines 19-51);
iii) calculate an impedance curve using a curve fitting algorithm (The digital processor unit 413 performs a non-linear curve fitting algorithm of the Cole circuit model to the measured resistances and reactances of human subject 105; Column 25 Lines 64 - 66);
iv) determine a deviation of the impedance curve from the impedance measurement (the sum of the square of the deviations between Cole circuit model predicted and actually measured impedance values; Column 26 Lines 3-5);
v) perform an evaluation of a validity of the bioimpedance measurement based on the deviation to categorise the bioimpedance measurement, to thereby generate a measurement categorisation (The errors of the filtered voltage signal, defined as the difference between the predicted and measured digitalized, amplified, and filtered voltage signal from the six measuring points 208, 320, 211, 213, 215 and 325, are used for measurement of quality and to indicate whether a repeat measurement cycle is needed; Column 25 Lines 58-63; to measure quality and reliability of my apparatus' functioning; Column 25 Line 64 – Column 26 Line 6), and
vi) derive an indicator indicative of the measurement categorisation (The errors of the filtered voltage signal, defined as the difference between the predicted and measured digitalized, amplified, and filtered voltage signal from the six measuring points 208, 320, 211, 213, 215 and 325, are used for measurement of quality and to indicate whether a repeat measurement cycle is needed; Column 25 Lines 58-63; to measure quality and reliability of my apparatus' functioning; Column 25 Line 64 – Column 26 Line 6).
Ori fails to specifically disclose c) a display; a measurement categorisation wherein the bioimpedance measurement is categorised using one or more thresholds as being at least one of: a) bad; b) questionable; or, c) acceptable; and vii) display the indicator on the display to allow a user to determine whether to accept or reject the bioimpedance measurement.
Gray discloses an impedance measurement apparatus for assessment of biomedical electrode interface quality (Abstract). This is considered a similar technical field, as the Applicant’s Specification teaches wherein “evaluation of the impedance measurements can also be performed in accordance with other criteria...negative reactance values typically result from a poor measurement, for example arising due to poor surface contact between the subject and the electrode” ([0118-0119]). Therefore, poor surface contact between the subject and the electrode is a major factor in the evaluation of the impedance measurements and subsequent categorisation. Gray discloses c) a display (display 38; [0035]); a measurement categorisation wherein the bioimpedance measurement is categorised using one or more thresholds as being at least one of: a) bad; b) questionable; or, c) acceptable (the categorical gradation may include the levels of excellent, good, fair and poor; [0035]); and vii) display the indicator on the display (Display 38 may display the value as a categorical gradation; [0035]) to allow a user to determine whether to accept or reject the bioimpedance measurement (The Examiner notes wherein the limitation “to allow a user to determine whether to accept or reject the bioimpedance measurement” is a recitation of the intended use of the invention. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the indicator display teachings of Gray into the invention of Ori in order to provide a visual indication of the signal quality, to enable the clinician to observe any deterioration of signal quality over time (Gray [0035]).
Gray and Ori both fail to disclose viii) determine a user assessment of the impedance measurement in accordance with user input commands provided via a user interface displayed on the display to determine if the bioimpedance measurement should be accepted; ix) for a bioimpedance measurement that is accepted, use the bioimpedance measurement to calculate a body state indicator relating to the biological subject; and, x) for a bioimpedance measurement that is not accepted, repeat the bioimpedance measurement.
In a similar technical field, Gallup teaches a body composition analyzer provides the resistive and reactive components of a body's measure impedance (Abstract), comprising:
viii) determine a user assessment of the impedance measurement in accordance with user input commands provided via a user interface (keyboard 14) displayed on the display (display 12) to determine if the bioimpedance measurement should be accepted (The microcomputer 34 is coupled to the keyboard 14 to receive inputs therefrom. The microcomputer 34 is also coupled to the display 12 through a display driver 36; Column 6 Lines 1-5);
ix) for a bioimpedance measurement that is accepted, use the bioimpedance measurement to calculate a body state indicator relating to the biological subject (If a send key 26 is actuated, a message is transmitted via an infrared LED to a personal computer or printer capable of receiving such a transmission so that a data record may be stored and/or printed, the record representing the person's entered and measured/calculated data; Column 5 Lines 6-34); and,
x) for a bioimpedance measurement that is not accepted, repeat the bioimpedance measurement (if the enter key is pressed, the unit automatically repeats the various measurements and displays updated information to the user; Column 5 Lines 6-34).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the user interface teachings of Gallup into those of Ori and Gray in order to enable the device to receive user input and enable the user to control the sequence of various measurements (Gallup Column 6 Lines 1-20).
Regarding Claim 12, Ori discloses wherein the one or more processing devices: a) determine the deviation by calculating a co-variance matrix indicative of variances and co-variances associated with the impedance curve and the bioimpedance measurement; b) use the co-variance matrix to estimate an error; and c) used the estimated error to perform the evaluation of the bioimpedance measurement (At process 15, the deviation of the estimated indirectly calculated utilized energy intake vector is evaluated with one of two optional equations, Eq. 103. or Eq. 104. Eq. 103. calculates the deviation of the estimated indirectly calculated utilized energy intake vector from the indirectly measured utilized energy intake vector on day k using the indirectly calculated change of body composition vector of day k and the Measurement Model of the Utilized Energy Intake…The Kalman gain matrix is calculated; Column 29 Line 45 – Column 30 Line 4; Figures 5A-5N).
Regarding Claim 27, Ori discloses wherein the one or more processing devices evaluate the bioimpedance measurement using at least one computational model embodying a relationship between different deviations and measurement validity (The digital processor unit 413 performs a non-linear curve fitting algorithm of the Cole circuit model to the measured resistances and reactances of human subject 105 at preset frequencies and extrapolates the best fitting Cole circuit model curve to zero and infinite frequency to obtain resistance of the human subject at zero and infinite frequency. I use the sum of the square of the deviations between Cole circuit model predicted and actually measured impedance values to measure quality and reliability of my apparatus' functioning; Column 25 Line 64 – Column 26 Line 6).
Regarding Claim 28, Ori discloses wherein the at least one computational model is obtained by applying machine learning to deviations and assessments of measurement validity obtained from one or more reference subjects (reference value generation; Column 32 Lines 14-29).
Regarding Claim 34, Ori discloses wherein the one or more processing devices: a) calculate an impedance parameter value using the impedance values; b) compare the impedance parameter value to a defined frequency impedance value, the defined frequency impedance value being determined from an impedance value obtained from response signals measured at a defined measurement frequency; and, c) use a result of the comparison at b) to perform an evaluation of the bioimpedance measurement (Column 2 Line 61 – Column 3 Line 3).
Regarding Claim 40, Ori discloses a method for use in evaluating a bioimpedance measurement performed on a biological subject (Apparatus for analysis of body composition; Abstract), the method including, in one or more electronic processing devices (processor 412, 413):
a) retrieving response signals measured by a sensor (sensory electrodes 210, 212) from alternating signals applied to at least part of the biological subject at a plurality of different frequencies (microcontroller unit 412 then sends the signal first to the memory means of the microcontroller unit 412 and upon demand sends the signal to a digital signal processor unit 413; Column 25 Lines 19-51);
b) determining the bioimpedance measurement in the form of impedance values obtained from the response signals (In the second step, I determine the unknown impedance or resistance and reactance of the human subject 105 at a preset frequency; Column 25 Lines 19-51);
c) calculating an impedance curve using a curve fitting algorithm (The digital processor unit 413 performs a non-linear curve fitting algorithm of the Cole circuit model to the measured resistances and reactances of human subject 105; Column 25 Lines 64 - 66);
d) determining a deviation of the impedance curve from the bioimpedance measurement (the sum of the square of the deviations between Cole circuit model predicted and actually measured impedance values; Column 26 Lines 3-5); and,
e) performing an evaluation of the bioimpedance measurement based on the deviation to categorise the bioimpedance measurement, to thereby generate a measurement categorisation (The errors of the filtered voltage signal, defined as the difference between the predicted and measured digitalized, amplified, and filtered voltage signal from the six measuring points 208, 320, 211, 213, 215 and 325, are used for measurement of quality and to indicate whether a repeat measurement cycle is needed; Column 25 Lines 58-63; to measure quality and reliability of my apparatus' functioning; Column 25 Line 64 – Column 26 Line 6), and
f) deriving an indicator indicative of the measurement categorisation to allow a user to determine whether to accept or reject the bioimpedance measurement (The errors of the filtered voltage signal, defined as the difference between the predicted and measured digitalized, amplified, and filtered voltage signal from the six measuring points 208, 320, 211, 213, 215 and 325, are used for measurement of quality and to indicate whether a repeat measurement cycle is needed; Column 25 Lines 58-63; to measure quality and reliability of my apparatus' functioning; Column 25 Line 64 – Column 26 Line 6; The Examiner notes wherein the limitation “to allow a user to determine whether to accept or reject the bioimpedance measurement” is a recitation of the intended use of the invention. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations).
Ori fails to specifically disclose a measurement categorisation wherein the bioimpedance measurement is generated using one or more thresholds wherein the bioimpedance measurement is categorised as being at least one of: i) bad; ii) questionable; or, iii) acceptable; and g) displaying the indicator on the display to allow a user to determine whether to accept or reject the bioimpedance measurement.
Gray discloses an impedance measurement apparatus for assessment of biomedical electrode interface quality (Abstract). This is considered a similar technical field, as the Applicant’s Specification teaches wherein “evaluation of the impedance measurements can also be performed in accordance with other criteria...negative reactance values typically result from a poor measurement, for example arising due to poor surface contact between the subject and the electrode” ([0118-0119]). Therefore, poor surface contact between the subject and the electrode is a major factor in the evaluation of the impedance measurements and subsequent categorisation. Gray discloses a measurement categorisation wherein the bioimpedance measurement is generated using one or more thresholds wherein the bioimpedance measurement is categorised as being at least one of: i) bad; ii) questionable; or, iii) acceptable (the categorical gradation may include the levels of excellent, good, fair and poor; [0035]); and g) displaying the indicator on the display (Display 38 may display the value as a categorical gradation; [0035]) to allow a user to determine whether to accept or reject the bioimpedance measurement (The Examiner notes wherein the limitation “to allow a user to determine whether to accept or reject the bioimpedance measurement” is a recitation of the intended use of the invention. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the indicator display teachings of Gray into the invention of Ori in order to provide a visual indication of the signal quality, to enable the clinician to observe any deterioration of signal quality over time (Gray [0035]).
Gray and Ori both fail to disclose g) determining a user assessment of the impedance measurement in accordance with user input commands provided via a user interface displayed on the display to determine if the bioimpedance measurement should be accepted; i) for a bioimpedance measurement that is accepted, using the bioimpedance measurement to calculate a body state indicator relating to the biological subject; and, j) for a bioimpedance measurement that is not accepted, repeating the bioimpedance measurement.
In a similar technical field, Gallup teaches a body composition analyzer provides the resistive and reactive components of a body's measure impedance (Abstract), comprising:
g) determining a user assessment of the impedance measurement in accordance with user input commands provided via a user interface (keyboard 14) displayed on the display (display 12) to determine if the bioimpedance measurement should be accepted (The microcomputer 34 is coupled to the keyboard 14 to receive inputs therefrom. The microcomputer 34 is also coupled to the display 12 through a display driver 36; Column 6 Lines 1-5);
i) for a bioimpedance measurement that is accepted, using the bioimpedance measurement to calculate a body state indicator relating to the biological subject (If a send key 26 is actuated, a message is transmitted via an infrared LED to a personal computer or printer capable of receiving such a transmission so that a data record may be stored and/or printed, the record representing the person's entered and measured/calculated data; Column 5 Lines 6-34); and,
j) for a bioimpedance measurement that is not accepted, repeating the bioimpedance measurement (if the enter key is pressed, the unit automatically repeats the various measurements and displays updated information to the user; Column 5 Lines 6-34).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the user interface teachings of Gallup into those of Ori and Gray in order to enable the device to receive user input and enable the user to control the sequence of various measurements (Gallup Column 6 Lines 1-20).
Claims 21-22, 29, 31, and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Ori, Gray, and Gallup as applied to claims 1 and 40 above, and further in view of Paul et al (U.S. Publication No. 2012/0323237; cited by Applicant; previously cited).
Regarding Claim 21, Ori, Gray, and Gallup fail to disclose wherein the one or more processing devices evaluate the bioimpedance measurement based on a number of negative reactance values.
In a similar technical field, Paul discloses a measurement circuit adapted to measure impedance between the electrode and ground as the electrode approaches a target tissue (Abstract), wherein the one or more processing devices evaluate the bioimpedance measurement based on a number of negative reactance values ([0031], [0101]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the negative reactance teachings of Paul into those of Ori, Gray, and Gallup in order to determine if an insufficient or excessive coupling condition exists (Paul [0031]).
Regarding Claim 22, Ori, Gray, and Gallup fail to disclose, wherein the one or more processing devices evaluate the bioimpedance measurement as being: a) in a first category if at least one of: i) a number of negative reactance measurements exceeds a first category reactance threshold; or ii) at least one parameter value has an error greater than a respective first category threshold; or b) in a second category if at least one of: i) a number of negative reactance measurements exceeds a second category reactance threshold; or ii) at least one parameter value has an error greater than a respective second category threshold; or c) in a third category if the bioimpedance measurement is not in the first or second category.
In a similar technical field, Paul discloses a measurement circuit adapted to measure impedance between the electrode and ground as the electrode approaches a target tissue (Abstract), wherein the one or more processing devices evaluate the bioimpedance measurement as being: a) in a first category if at least one of: i) a number of negative reactance measurements exceeds a first category reactance threshold; or ii) at least one parameter value has an error greater than a respective first category threshold; or b) in a second category if at least one of: i) a number of negative reactance measurements exceeds a second category reactance threshold; or ii) at least one parameter value has an error greater than a respective second category threshold; or c) in a third category if the bioimpedance measurement is not in the first or second category (Table 1 discloses thresholds for parameter values; [0108], [0116]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the negative reactance teachings of Paul into those of Ori, Gray, and Gallup in order to determine if an insufficient or excessive coupling condition exists (Paul [0031]).
Regarding Claim 29, Ori, Gray, and Gallup fail to disclose wherein the one or more processing devices: a) apply a phase correction to impedance values measured at a frequency higher than a set frequency to determine phase corrected impedance values; and, b) calculate the impedance curve using the phase corrected impedance values.
In a similar technical field, Paul discloses a measurement circuit adapted to measure impedance between the electrode and ground as the electrode approaches a target tissue (Abstract), wherein the one or more processing devices: a) apply a phase correction to impedance values measured at a frequency higher than a set frequency to determine phase corrected impedance values; and, b) calculate the impedance curve using the phase corrected impedance values ([0112]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the phase correction teachings of Paul into those of Ori, Gray, and Gallup in order to correct phase lag between the measured current and voltage and compensate for any external factors (Paul [0112]).
Regarding Claim 31, Ori, Gray, and Gallup fail to disclose wherein the one or more processing devices: a) determine a count of impedance values having negative reactance values; b) use the count to perform an evaluation of the bioimpedance measurement.
In a similar technical field, Paul discloses a measurement circuit adapted to measure impedance between the electrode and ground as the electrode approaches a target tissue (Abstract), wherein the one or more processing devices: a) determine a count of impedance values having negative reactance values; b) use the count to perform an evaluation of the bioimpedance measurement ([0031], [0101], [0108], [0116]; Table 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the negative reactance teachings of Paul into those of Ori, Gray, and Gallup in order to determine if an insufficient or excessive coupling condition exists (Paul [0031]).
Regarding Claim 41, Ori, Gray, and Gallup fail to disclose a non-transitory computer-readable medium having stored thereon instructions, which when executed by one or more programmed electronic processing devices, causes the one or more processing devices to perform the method of claim 40.
In a similar technical field, Paul discloses a measurement circuit adapted to measure impedance between the electrode and ground as the electrode approaches a target tissue (Abstract), further comprising a non-transitory computer-readable medium having stored thereon instructions, which when executed by one or more programmed electronic processing devices, causes the one or more processing devices to perform the method of claim 40 ([0127, 0134, 0161, 0165]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the non-transitory computer-readable medium teachings of Paul into those of Ori, Gray, and Gallup in order to store necessary data that may be made readily available to other devices such as phase angle, reactance, and phase comparators (Paul [0127, 0134, 0161]).
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 CHANEL J JHIN whose telephone number is (571) 272-2695. The examiner can normally be reached on Monday-Friday 9:00AM-5:00PM.
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