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
Receipt is acknowledged of applicant's amendment filed on 4/28/26. Claims 3 and 14 are cancelled. Claims 1-2, 4-13 and 15-22 are currently pending and an action on the merits is as follows.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-2 and 4-11 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). The claims recite that the electrodes are attached to the human body thus also claiming the human body.
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. “an image reconstruction unit” in claim 1. “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” and “an image reconstruction unit” in claim 1; “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 1, 2, 4-13 and 15-22 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 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. 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.
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) 1-2, 5-9, 12-13 and 16-21, are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rahman et al. “Extraction of cardiac and respiration signals in electrical impedance tomography based on independent component analysis”.
Regarding claims 1 and 12, Rahman discloses an apparatus of noninvasively and separately measuring a lung ventilation component and a cardiac blood flow component ([abstract and introduction on pgs. 38-39]), comprising:
a voltage data acquisition unit configured to acquire a time series voltage data from a subject through a plurality of voltage channels formed through a plurality electrodes attached to a chest of a subject by sequentially injecting current to a pair of electrodes among the plurality of electrodes and continuously measuring voltages through other electrode pairs; ([pg. 38, Introduction] the electrodes collect voltage data on multiple channels. EIT data is collected by injecting current and then sensing the voltage with other electrodes);
a voltage data decomposition unit configured to decompose the acquired time series voltage data into voltage data of the lung ventilation component and the cardiac blood flow component by using shape-reference voltage waveforms of the lung ventilation component and the cardiac blood flow component extracted from the acquired time series voltage data; ([pg. 39, column 1][pg. 40, PCS Based Method] ICA or PCA is used to extract the reference waveform components); and
an image reconstruction unit configured to reconstruct the decomposed voltage data of the lung ventilation component and the cardiac blood flow component into images of the lung ventilation component and the cardiac blood flow component using a linearized image reconstruction algorithm based on a sensitivity matrix derived from lead field theory ([pg. 42, column 2] a sensitivity matrix algorithm is used and truncated singular value decomposition is used which is a linearized reconstruction algorithm).
a measurement unit configured to noninvasively, simultaneously and continuously calculate impedance variations in lung ventilation and in cardiac blood flow from the decomposed voltage data of the lung ventilation component and the cardiac blood flow component, the reconstructed images of the lung ventilation component and the cardiac blood flow component or combinations thereof ([pg. 40, Proposed Method Using ICA] the changes in impedance are extract simultaneously and continuously),
wherein the voltage data decomposition unit is configured to perform the decomposition on the time series voltage data prior to image reconstruction such that the decomposed voltage data of the lung ventilation component and the cardiac blood flow component are separately reconstructed into respective images of the lung ventilation component and the cardiac blood flow component ([pg. 40, column 2] the ICA is performed before the image reconstruction).
Regarding claims 2 and 13, Rahman discloses the shape-reference voltage waveforms of the lung ventilation component and cardiac blood flow component are extracted by applying principal component analysis and independent component analysis to 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. 40] PCA is used to extract lung ventilation and cardiac blood flow and ICA can be used specifically for the cardiac component).
Regarding claims 5 and 16, Rahman 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 ([pg. 40] 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 ([pg. 40] PCA and ICA are used to extract the lung ventilation and cardiac blood flow respectively).
Regarding claims 6 and 17, Rahman 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. 41] a weighting matrix is used with the extracted components).
Regarding claims 7 and 18, Rahman 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. 42, column 2] FFT are used on the extracted components. [pg. 43] the highest amplitudes are selected).
Regarding claims 8 and 19, Rahman 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. 41] a weighting matrix is used with the extracted components or the shape-reference. [pg. 40] least mean square method is used).
Regarding claims 9 and 20, Rahman discloses the respiratory volume signal is extracted by summing 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 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. 41, column 2] the respiratory volume signal and the cardiac volume signal are extracted as sums of the values in the ROI).
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) 4, 10, 15 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rahman further in view of Santos et al. US 2021/0027461.
Regarding claims 4 and 15, Rahman discloses does not specifically disclose determine volume measurements. Santos teaches a similar EIT reconstruction system that has a measurement unit further configured to extract a respiratory volume signal and a cardiac volume signal from the reconstructed images of the lung ventilation component and the cardiac blood flow component, or the decomposed voltage data of the lung ventilation component and the cardiac blood flow component, respectively, and noninvasively, simultaneously, and continuously measure tidal volume and stroke volume, thereby measuring impedance variations in the lung ventilation component and the cardiac blood flow component ([¶43,129] the images are reconstructed and tidal volume and stroke volume are determined from the images). 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 Rahman with the volume measurements of Santos in order to provide more diagnostic data.
Regarding claims 10 and 20, Santos teaches determining the tidal volume and stroke volume is measured for each breathing cycle. Santos does not specifically disclose 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 (peak to valley measurements for stroke volume and tidal volume are standard and well-known calculations on a volume signal that one of ordinary skill in the art could easily perform).
Response to Arguments
Applicant’s arguments, see pgs. 10-13 and 19-22, filed 4/28/26, with respect to the 35 USC 101, 102 and 103 rejections have been fully considered and are persuasive. The rejections have been withdrawn.
The affidavit filed under 37 CFR 1.130(a) filed on 4/28/26 is sufficient to overcome the rejection of claims 1-22 based on Jang. The rejection is withdrawn.
Applicant's arguments filed 4/28/26 have been fully considered but they are not persuasive.
Regarding Applicant’s arguments against the 112f interpretation, Examiner respectfully disagrees. The claims do not include structural elements that define the units. The units are merely defined by their functions.
Regarding Applicant’s arguments against the 112b rejection of claims 5 and 16, Examiner respectfully disagrees. The claim language does not clarify that the descending order is specifically in reference to the matrix disclosed in the specification.
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 MICHAEL ANTHONY CATINA whose telephone number is (571)270-5951. The examiner can normally be reached 10-6pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Chen can be reached at 5712723672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL A CATINA/Examiner, Art Unit 3791 /TSE CHEN/Supervisory Patent Examiner, Art Unit 3791
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