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 .
Election/Restrictions
Applicant’s election without traverse of Group 1, drawn to a device for determination of a measure of homogeneity of the lung based on electrical impedance tomography, in the reply filed on 12/19/25 is acknowledged.
Claims 34-44 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/19/25.
Information Disclosure Statement
The accompanying information disclosure statement (IDS) submission(s) is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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:
“a data input unit” in claim 19;
“a calculation and control unit” in claim 19; and
“an output unit” in claim 28.
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 Objections
Claim 19 is objected to because of the following informalities: there appears to be a missing “and” at the end of line 6. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 19-33 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 19 positively recites “a data input unit” and “a calculation and control unit”. Although these terms find verbatim support in the claims as originally filed and in the Specification (Pgs 21-22), the “units” are not described with any correspondence to actual physical structure(s) such that they are a black box. For example, although numerous functions are specifically described that the “units” may accomplish, there is no corresponding structure(s), controller(s), particularly programmed processor(s), and/or computer readable medium linked to the claimed “units”. Thus, in light of the instant Specification, claim 19 lacks adequate written description and possession of the claimed invention has not been established. Further claim 28 positively recites “an output unit” and suffers the same fact pattern, rendering a lack of written description. Depending claims 20-27 and 29-33 inherit and do not remedy the lack of written description.
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 19-33 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 19 positively recites “a data input unit” and “a calculation and control unit”. Although these terms find verbatim support in the claims as originally filed and in the Specification (Pgs 21-22), the “units” are not described with any correspondence to actual physical structure(s) such that they are a black box. For example, although numerous functions are specifically described that the “units” may accomplish, there is no corresponding structure(s), controller(s), particularly programmed processor(s), and/or computer readable medium linked to the claimed “units”. The scope of claim 19 is indeterminate because one of ordinary skill would not be apprised of the metes and bounds of the claimed invention. It is unclear what is explicitly, implicitly, inherently, and/or inferentially required and/or excluded by the recitations of “a data input unit” and “a calculation and control unit”. One of ordinary skill in the art would have an infinite number of possibilities/assumptions of what may or may not constitute the “a data input unit” and the “a calculation and control unit”. Thus, in light of the instant Specification, claim 19 is indefinite. Further, claim 28 positively recites “an output unit” and suffers the same fact pattern, rendering it indefinite. Depending claims 20-27 and 29-33 inherit and do not remedy the indefiniteness.
Claim 19 positively recites the limitation "the homogeneity" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 19 positively recites the limitation "the lung" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 19 positively recites the limitation "the basis" in line 17. There is insufficient antecedent basis for this limitation in the claim.
Claim 21 positively recites the limitation "the basis" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 32 positively recites the limitation "the basis" in line 3. 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 19-33 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more, wherein the abstract idea may reasonably be considered the mental process of receiving data and performing calculations.
For independent claim 19, the claim(s) recite(s) a device that receives impedance tomography data of the lung(s) and calculates impedance related values and amplitudes to generate a control signal. As broadly as claimed these steps may be reasonably considered as the judicial exception of a mental process performable within the human mind, including by observation, evaluation, judgement and opinion forming, or by a human using pen and paper (see MPEP 2106.04(a)(2) subsection III). For example, at least, these limitations are nothing more than a medical professional capturing data, printing it out, and using the data to mentally calculate, extract, classify or learn from data features to ascertain impedance related values and amplitudes and verbally provide an output or control signal based thereon.
This judicial exception is not integrated into a practical application because the device as broadly as claimed and disclosed is not tied to nor required to be performed, executed, or programmed on a special purpose computer. Further, the judicial exception is not even required to be performed on or tied to a mere generic processing device, controller, or the like.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. No additional elements are recited and only the data acquisition and calculation are required, which are considered the abstract idea and not any additional element.
Depending claims 20-33 inherit and do not remedy the non-statutory deficiency noted above, despite further specifying comparing, calculating, performing mathematical operations, and outputting that could be provided verbally and/or by pen and paper, the claims do not integrate the judicial exception into a practical application nor do the claims include additional elements that are sufficient to amount to significantly more.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 19-33 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Holzhacker et al. (US 2019/0246949 A1, hereinafter Holzhacker).
For claim 19, Holzhacker discloses a device for determination of a measure for the homogeneity of the lung based on electrical impedance tomography (EIT) data (Figs 4-15) ([0043-0113]), the device comprising inter alia:
a data input unit (430), receiving the EIT data obtained by an electrical impedance tomography apparatus (404) (Figs 4-15) ([0043-0113]), wherein the data input unit is configured to receive and provide EIT data from at least one region of at least one lung of a living being over an observation period (AT) (Figs 4-15) ([0043-0113]); and
a calculation and control unit (428) connected to the data input unit (Figs 4-15) ([0043-0113]), wherein the calculation and control unit is configured for and/or capable to
- to determine impedance values over the observation period (AT) for each pixel of the at least one region of at least one lung (Figs 4-15) ([0043-0113], especially [0056,0065-0070,0074,0106-0111]);
- to determine an impedance amplitude value (AZ) for each pixel of at least one lung; - to determine an end-expiratory impedance value (EELI) for each pixel of at least one lung (Figs 4-15) ([0043-0113], especially [0056,0065-0070,0074,0106-0111]);
- to associate the impedance amplitude values (AZ) and the end-expiratory impedance values (EELI) individually for each pixel (Figs 4-15) ([0043-0113], especially [0062,0073,0095]);
- to determine data on the basis of the impedance amplitude values (AZ) and the associated end-expiratory impedance values (EELI) (Figs 4-15) ([0043-0113], especially [0062,0073,0095]), and
- to generate a control signal on basis of the data (Figs 4-15) ([0043-0113]).
For claim 20, Holzhacker discloses the device according to claim 19, wherein the calculation and control unit is configured to and/or capable to compare the data with a predetermined criterion (Figs 4-15) ([0043-0113], especially [0089]).
For claim 21, Holzhacker discloses the device according to claim 19, wherein the calculation and control unit is configured to and/or capable to compare the data with a criterion, which criterion has been predetermined on the basis of a control group of patients (Figs 4-15) ([0043-0113], especially [0089]).
For claim 22, Holzhacker discloses the device according to claim 19, wherein the calculation and control unit is configured to and/or capable to perform a function fit of the impedance amplitude values (AZ) in dependency of the end-expiratory impedance values (EELI) for at least one lung to obtain a fitted function (AZideai(EELI)) for at least one lung (Figs 4-15) ([0043-0113], especially [0052-0054]).
For claim 23. , Holzhacker discloses the device according to claim 22, wherein the fitted function (AZideai(EELI)) is inherently capable of being a linear function AZideal = a EELI + 3 (Figs 4-15) ([0043-0113]).
For claim 24, Holzhacker discloses the device according to claim 22, wherein the calculation and control unit is configured to and/or capable to determine for each pixel a deviation value (StrainEIT) representing the deviation of the impedance amplitude value AZ from the fitted value (AZideal) (Figs 4-15) ([0043-0113], especially [0077]).
For claim 25, Holzhacker discloses the device according to claim 24, wherein the deviation value (StrainE) is or is inherently capable of being the ratio (AZ/AZdeaI) between the impedance amplitude value (AZ) and the fitted value (AZideal) at the same end-expiratory impedance value (EELI) (Figs 4-15) ([0043-0113], especially [0077]).
For claim 26. (New) The device according to claim 24, wherein the calculation and control unit is configured to and/or capable to determine a histogram showing the number of pixels with deviation values (StrainEIT) in certain intervals for each of the intervals for all pixels of at least one lung (Figs 4-15) ([0043-0113]).
For claim 27, Holzhacker discloses the device according to claim 24, wherein the calculation and control unit is configured to determine an amount of pixels for which the deviation value (StrainE-T) is larger than a predetermined threshold and/or for which the deviation value (StrainEIT) is outside a predetermined region (Figs 4-15) ([0043-0113]).
For claim 28, Holzhacker discloses the device according to claim 19, wherein the device comprises an output unit (324) and the output unit is configured to use the control signal to provide or output an output signal for displaying a representation of the data (Figs 4-15) ([0043-0113]) (especially Figs 5,6B,15).
For claim 29, Holzhacker discloses the device according to claim 28, wherein the output unit is configured to display at least one of (Figs 4-15) ([0043-0113]) (especially Figs 5,6B,15)
- a graph associating the impedance amplitude values (AZ) and/or fitted amplitude values (AZideai) with the end-expiratory impedance values (EELI) for each pixel,
- a regional distribution of end-expiratory impedance values (EELI), impedance amplitude values (AZ) and/or fitted values (AZideal) over at least one lung,
- a histogram of numbers of pixels being associated with a deviation value (StrainEIr) within a certain interval,
- a histogram of numbers of pixels being associated with a deviation value (StrainEIT) within an interval of ratios of impedance amplitude values (AZ) and fitted amplitude values (AZideal), and
- a diagram showing an amount of pixels (1) for which a deviation value (StrainEIr) is larger than a predetermined threshold and/or for which a deviation value (StrainEIT) is outside a predetermined region.
For claim 30, Holzhacker discloses the device according to claim 19, wherein the calculation and control unit is configured to and/or capable to normalize the impedance amplitude values (AZ) over all pixels for at least one lung and to obtain a normalized amplitude value (AZ) for all pixels of at least one lung and/or to normalize the end-expiratory impedance values (EELI) over all pixels for at least one lung and to obtain a normalized end-expiratory impedance value (EELI) for each pixel of at least one lung (Figs 4-15) ([0043-0113]) (especially Figs 5,6B,15).
For claim 31, Holzhacker discloses the device according to claim 19, which is configured to determine and/or display reference data (Figs 4-15) ([0043-0113]) (especially Figs 5,6B,15).
For claim 32, Holzhacker discloses the device according to claim 31, which is configured to determine and/or display a reference distribution of impedance amplitude values (AZ) and fitted values (AZideal) or a reference histogram on the basis of electrical impedance tomography (EIT) data of reference patients (Figs 4-15) ([0043-0113]) (especially Figs 5,6B,15).
For claim 33, Holzhacker discloses the device according to claim 19, wherein the calculation and control unit is configured to determine data independently for each of the lungs (Figs 4-15) ([0043-0113]) (especially Figs 5,6B,15).
Conclusion
The cited prior art made of record on the accompanying PTO-892 and not relied upon is considered pertinent to applicant's disclosure, relating to means for determining homogeneity of lung based on electrical impedance tomography.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jeffrey G. Hoekstra whose telephone number is (571)272-7232. The examiner can normally be reached Monday through Thursday from 5am-3pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles A. Marmor II can be reached at (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Jeffrey G. Hoekstra
Primary Examiner
Art Unit 3791
/JEFFREY G. HOEKSTRA/ Primary Examiner, Art Unit 3791