DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim 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 1-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim recites the steps of decomposing the voltage data into lung ventilation and cardiac blood flow components and measuring variations in the lung ventilation and cardiac blood flow
The limitation of decomposing the voltage data and measuring the lung ventilation and blood flow components, are processes that, under their broadest reasonable interpretation, cover performance of the limitations in the mind but for the recitation of generic computer components. That is, other than reciting “a measurement unit”, the claims are direct to concepts relating to organizing information in a way that can be performed mentally or analogous to human mental work and nothing in the claim element precludes the steps from practically being performed in the mind. For example, but for the processor, communications interface and output language, “decomposing” and “measuring” in the context of this claim encompasses the user manually calculating the signal components and observing variations. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim recites the additional elements of an acquisition unit to acquire voltage data. The acquisition unit involves mere data gathering and amount to insignificant extra-solutional activity, specifically pre-solutional activity. Additionally, the measurement unit is recited at a high-level of generality such that it amounts no more than mere instructions to apply the exception using generic computer components. Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. Similarly the dependent claims do not include additional elements that amount to significantly more but include more steps for calculating and decomposing the signals. Similarly, the image reconstruction limitations under a broadest reasonable interpretation could be as simple as plotting a waveform. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept and well-understood, routine and conventional activity is not sufficient to amount to significantly more than the abstract idea itself. The claim is not patent eligible.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “voltage data acquisition unit”, “voltage data decomposition unit” and “measurement unit” in claim 1. The data acquisition unit are electrodes, see ¶66. “a shape extraction unit” in claim 2. “an image reconstruction unit” in claim 3. “a lung ventilation shape-reference voltage waveform extraction unit” and “a cardiac blood flow shape-reference voltage waveform extraction unit” in claim 5. “a weight computing unit” in claim 6.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim limitation “voltage data decomposition unit” and “measurement unit” in claim 1; “a shape extraction unit” in claim 2; “an image reconstruction unit” in claim 3; “a lung ventilation shape-reference voltage waveform extraction unit” and “a cardiac blood flow shape-reference voltage waveform extraction unit” in claim 5; “a weight computing unit” in claim 6 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. It is unclear if the units are code modules or processors or something else. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claims 2, 5-8, 13 and 16-19 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. The claims recite that the voltage data is composed of a linear weighted sum of the variations. It is unclear what a “shape-reference” waveform is. It is presumed that this is just the waveform component specific to either the ventilation signal component or cardiac signal component in the overall collected impedance signal.
Claims 5, 16 and their dependent claims 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. The claims recite that the voltage data is composed of a linear weighted sum of the variations. It is unclear what is meant by the choosing a principal component in descending order of singular values. It is presumed this means in descending numerical order for N values, possibly the voltage channels, in a matrix or similar but that is not clear from the claim language or the specification.
Claims 6, 17 and their dependent claims 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. The claims recites “wherein the voltage data of the lung ventilation and cardiac blood flow from the voltage data are computed for each voltage channel by using the weights associated with lung ventilation and cardiac blood flow computed for each voltage channel” but the weights are calculated from the decomposed voltages data of lung ventilation and cardiac blood flow so how is the voltage data of the ventilation and blood flow then further calculated from the weights that were just determined from decomposed data. Are these separate voltage data from those determined in claim 2?
Claims 7, 18 and their dependent claims 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. “biggest” is a relative term. It is presumed that the claims refers to a maximum energy in the fundamental frequency range of the frequency spectrum.
Claims 8, 19 and their dependent claims 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. It is unclear if the weighted sum is across voltage channels or just the some of the components in a specific voltage channel.
Claims 9, 20 and their dependent claims 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. It is unclear what or how a preset region of interest is determined for decomposed voltage data specifically.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 3, 4, 6, 8, 12, 14, 15, 17 and 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Deibele et al. “Dynamic separation of pulmonary and cardiac changes in electrical impedance tomography”.
Regarding claims 1 and 12, Deibele discloses an apparatus of noninvasively and separately measuring a lung ventilation component and a cardiac blood flow component, is configured to comprise:
a voltage data acquisition unit configured to acquire a time series voltage data from a subject through a plurality of voltage channels ([pg. S1-S2] the electrodes collect voltage data on multiple channels);
a voltage data decomposition unit configured to decompose the acquired time series voltage data into voltage data of lung ventilation and cardiac blood flow, which are respectively the lung ventilation component and the cardiac blood flow component ([pg. S4] PCA is used to extract lung ventilation and cardiac blood flow); and
a measurement unit configured to measure variations in lung ventilation and in cardiac blood flow from the decomposed voltage data ([pgs. S5-S6] the variations of the ventilation and stroke volume are determined from the template matrix),
wherein the time series voltage data are composed of a linear weighted sum of impedance variations caused by a plurality of physiological activities comprising lung ventilation and cardiac blood flow ([pg. S3] each voltage channel is approximated as a weight sum of template functions, i.e. lung ventilation and blood flow).
Regarding claims 3 and 14, Deibele discloses an image reconstruction unit configured to reconstruct the decomposed voltage data for lung ventilation and cardiac blood flow into images of lung ventilation and cardiac blood flow, respectively, wherein the variations in lung ventilation and cardiac blood flow are noninvasively, simultaneously, and continuously measured from the reconstructed images of lung ventilation and cardiac blood flow ([pg. S6, S8] the images are reconstructed and the ventilation and cardiac flow are determined from the images).
Regarding claims 4 and 15, Deibele discloses the measurement unit further configured to extract a respiratory volume signal and a cardiac volume signal from the reconstructed images of lung ventilation and cardiac blood flow, or the decomposed voltage data of lung ventilation and cardiac blood flow, respectively, and noninvasively, simultaneously, and continuously measure tidal volume and stroke volume, thereby measuring the variations in lung ventilation and cardiac blood flow ([pg. S6, S8] the images are reconstructed and the ventilation and cardiac flow are determined from the images).
Regarding claims 6 and 17, Deibele discloses the voltage data decomposition unit further configured to comprise:
a weight computing unit configured to compute weights comprising scale factors and offsets for lung ventilation and cardiac blood flow for each voltage channel associated with the acquired time series voltage data by using the extracted shape-reference voltage waveforms of lung ventilation and cardiac blood flow,
wherein the voltage data of lung ventilation and cardiac blood flow from the voltage data are computed for each voltage channel by using the weights associated with lung ventilation and cardiac blood flow computed for each voltage channel, so that the acquired time series voltage data are decomposed into the voltage data of lung ventilation and cardiac blood flow ([pg. S3, S6] the least squares method is used to determine the weighting or scale factors for each channel).
Regarding claims 8 and 19, Deibele discloses the weight computing unit further configured to represent the voltage data for each voltage channel of the acquired time series voltage data as a weighted sum of the extracted lung ventilation shape-reference voltage waveform and the cardiac blood flow shape-reference voltage waveform, and compute weights of lung ventilation and cardiac blood flow by applying a least square method for each voltage channel from the represented weighted sum ([pg. S3, S9] the least squares method is used to determine the weighting or scale factors for each channel).
Claim(s) 1-22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jang et al. (NPL ref 3 on IDs dated 7/31/23)
Regarding claims 1 and 12, Jang discloses an apparatus of noninvasively and separately measuring a lung ventilation component and a cardiac blood flow component, is configured to comprise:
a voltage data acquisition unit configured to acquire a time series voltage data from a subject through a plurality of voltage channels ([pg. 2] the electrodes collect voltage data on multiple channels);
a voltage data decomposition unit configured to decompose the acquired time series voltage data into voltage data of lung ventilation and cardiac blood flow, which are respectively the lung ventilation component and the cardiac blood flow component ([pg. 2-3] PCA with single value decomposition is used to extract lung ventilation and cardiac blood flow); and
a measurement unit configured to measure variations in lung ventilation and in cardiac blood flow from the decomposed voltage data ([pgs. 5-6] the variations of the ventilation and stroke volume are determined),
wherein the time series voltage data are composed of a linear weighted sum of impedance variations caused by a plurality of physiological activities comprising lung ventilation and cardiac blood flow ([pg. 3] each voltage channel is approximated as a weight sum of shape-reference-voltage waveforms of the individual sources, i.e. lung ventilation and blood flow).
Regarding claims 2 and 13, Jang discloses the voltage data decomposition unit further configured to comprise:
a shape-reference voltage waveform extraction unit configured to extract shape-reference voltage waveforms associated with lung ventilation and cardiac blood flow through principal component analysis (PCA) and independent component analysis (ICA) from the time series voltage data acquired from the subject ([pg. 7] shape-reference waveforms are extracted using PCA and ICA),
wherein the lung ventilation component and the cardiac blood flow component are decomposed for each voltage channel by using the extracted shape-reference voltage waveforms, and thereby the acquired time series voltage data is decomposed into the voltage data for lung ventilation and cardiac blood flow, respectively ([pg. 7][FIG. 5] the shape-reference waveforms are used to extract components from each channel).
Regarding claims 3 and 14, Jang discloses an image reconstruction unit configured to reconstruct the decomposed voltage data for lung ventilation and cardiac blood flow into images of lung ventilation and cardiac blood flow, respectively, wherein the variations in lung ventilation and cardiac blood flow are noninvasively, simultaneously, and continuously measured from the reconstructed images of lung ventilation and cardiac blood flow ([pg. 4] a fidelity-embedded regularization algorithm is used to reconstruct the images).
Regarding claims 4 and 15, Jang discloses the measurement unit further configured to extract a respiratory volume signal and a cardiac volume signal from the reconstructed images of lung ventilation and cardiac blood flow, or the decomposed voltage data of lung ventilation and cardiac blood flow, respectively, and noninvasively, simultaneously, and continuously measure tidal volume and stroke volume, thereby measuring the variations in lung ventilation and cardiac blood flow ([pgs. 2, 6] the device allows for extraction of the components simultaneously and continuously).
Regarding claims 5 and 16, Jang discloses the shape-reference voltage waveform extraction unit further configured to comprise:
a lung ventilation shape-reference voltage waveform extraction unit configured to choose a principal component in descending order of singular values as results of applying principal component analysis on the acquired time series voltage data, and extract the chosen principal component as a shape-reference voltage waveform associated with lung ventilation ([FIG. 1][pg. 3, 5] PCA and ICA are used to extract the lung ventilation and cardiac blood flow respectively); and
a cardiac blood flow shape-reference voltage waveform extraction unit configured to extract a plurality of independent components by applying independent component analysis on a plurality of principal components excluding the chosen principal component, and extract independent components associated with heartbeats among the plurality of the extracted independent components as a shape-reference voltage waveforms associated with cardiac blood flow ([FIG. 1][pg. 3, 5] PCA and ICA are used to extract the lung ventilation and cardiac blood flow respectively).
Regarding claims 6 and 17, Jang discloses the voltage data decomposition unit further configured to comprise:
a weight computing unit configured to compute weights comprising scale factors and offsets for lung ventilation and cardiac blood flow for each voltage channel associated with the acquired time series voltage data by using the extracted shape-reference voltage waveforms of lung ventilation and cardiac blood flow,
wherein the voltage data of lung ventilation and cardiac blood flow from the voltage data are computed for each voltage channel by using the weights associated with lung ventilation and cardiac blood flow computed for each voltage channel, so that the acquired time series voltage data are decomposed into the voltage data of lung ventilation and cardiac blood flow ([pg. 4] the least squares method is used to determine the weighting or scale factors for each channel).
Regarding claims 7 and 18, Jang discloses the cardiac blood flow shape-reference waveform extraction unit further configured to apply a Fast Fourier Transform (FFT) on each of the plurality of the extracted independent components, and obtain a frequency spectrum for each extracted independent component, and choose the independent component for the frequency spectrum having the biggest energy within the fundamental frequency range of the heartbeat rate, so that the cardiac blood flow shape-reference voltage waveform is extracted ([pg. 3] an FFT is used to determine the shape-reference waveforms and the largest energy at the fundamental frequency is used).
Regarding claims 8 and 19, Jang discloses the weight computing unit further configured to represent the voltage data for each voltage channel of the acquired time series voltage data as a weighted sum of the extracted lung ventilation shape-reference voltage waveform and the cardiac blood flow shape-reference voltage waveform, and compute weights of lung ventilation and cardiac blood flow by applying a least square method for each voltage channel from the represented weighted sum ([pg. 4] the least squares method is used to determine the weighting or scale factors for each channel).
Regarding claims 9 and 20, Jang discloses the respiratory volume signal is extracted by summing all the voltage data for region of interests preset in a lung region in the decomposed voltage data of lung ventilation or pixel values for region of interests preset in a lung region in the reconstructed image of lung ventilation, respectively, and wherein the cardiac volume signal is extracted by summing all the voltage data for region of interests preset in a heart region in the decomposed voltage data of cardiac blood flow or pixel values for region of interests preset in the heart region in the reconstructed image of cardiac blood flow, respectively ([pg. 4] the respiratory volume signal and the cardiac volume signal are extracted as sums of the values in the ROI).
Regarding claims 10 and 20, Jang discloses the tidal volume is measured for each breathing cycle by computing a valley-to-peak value of each breathing cycle detected from the extracted respiratory volume signal, wherein the stroke volume is measured for each heartbeat cycle by computing a valley-to-peak value of each heartbeat cycle detected from the extracted cardiac volume signal, and wherein the breathing cycle and the heartbeat cycle are extracted by detecting continuous occurrence of valley-peak-valley in the extracted each respiratory volume signal and cardiac volume signal ([pg. 6] the valley to peak values are used to determine tidal volume and stroke volume).
Regarding claims 11 and 22, Jang discloses the measurement unit further configured to comprise mutually overlapping the extracted respiratory volume signal and cardiac volume signal over time and measuring a change in the stroke volumes according to a plurality of preset breathing cycles, by using a maximum value and a minimum value of the measured stroke volumes in the plurality of preset breathing cycles ([PG. 6][FIG. 13] the SVV is determined from the min and max of the aligned signals).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 2 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Deibele in view of Rahman et al. “Extraction of cardiac and respiration signals in electrical impedance tomography based on independent component analysis”.
Regarding claims 2 and 13, Diebele discloses the voltage data decomposition unit further configured to comprise:
a shape-reference voltage waveform extraction unit configured to extract shape-reference voltage waveforms associated with lung ventilation and cardiac blood flow through principal component analysis (PCA) from the time series voltage data acquired from the subject,
wherein the lung ventilation component and the cardiac blood flow component are decomposed for each voltage channel by using the extracted shape-reference voltage waveforms, and thereby the acquired time series voltage data is decomposed into the voltage data for lung ventilation and cardiac blood flow, respectively (([pg. S4] PCA is used to extract lung ventilation and cardiac blood flow).
Diebele does not specifically disclose using ICA for extracting the cardiac component. Rahman teaches a similar EIT device that uses ICA to determine the cardiac components ([pg. 40]). Therefore, it would have been obvious to one of ordinary skill in the art prior to the time of filing to combine the device of Diebele with the teachings of Rahman in order to better extract the components as ICA provides a prominent respiration signal ([pg. 40]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL ANTHONY CATINA whose telephone number is (571)270-5951. The examiner can normally be reached 10-6pm.
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/MICHAEL A CATINA/Examiner, Art Unit 3791 /TSE W CHEN/Supervisory Patent Examiner, Art Unit 3791