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 .
DETAILED ACTION
The amendment filed on June 08, 2026 is acknowledged and entered. Claims 1, 3-7, 10, 14-16 are amended. Claims 21-34 are new. Claims 1-34 are pending and under examination in this Office action.
Response to Amendment
The objections to claims 1 and 3-7 are now withdrawn in view of the claim amendment.
The rejections to claims 15-20 under 35 U.S.C. 112(b) are now withdrawn in view of the claim amendment.
The rejection to claim 10 under 35 U.S.C. 112(d) is now withdrawn in view of the claim amendment.
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:
Claim 1: Claim 1: the claim limitation of “a renal ultrasound system which produces renal ultrasound data”; “an ultrasound measurement system which evaluates the renal ultrasound data”; and “a diagnostic system which performs at least one diagnostic calculation” have been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because they use a generic placeholder “system” coupled with functional language “produces/evaluates/performs” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “system”.
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.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
Claim 1: “a renal ultrasound system” refers to FIG.1, the renal ultrasound system with a probe that is conventionally known to be configured to produce ultrasound data; “an ultrasound measurement system” and “a diagnostic system” refer to the device 30 being a general purpose computer that includes processor 38.
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.
For more information, see MPEP § 2173 et seq. and Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claims 1 and 14 are directed to a “tool” which describes one of the four statutory categories of patentable subject matter, i.e., a machine.
Step 2A of the subject matter eligibility test (see MPEP 2106.04).
Prong One:
Claims 1 and 14 recite (“sets forth” or “describes”) the abstract idea of “mathematical concepts” (MPEP 2106.04(a)(2).I.), and the abstract idea of “a mental process” (MPEP 2106.04(a)(2).III.), substantially as follows: performs at least one diagnostic calculation on the age, the morphological parameter and the hemodynamic parameter to obtain a risk assessment which predict the patient’s risk of developing moderate-to-severe renal fibrosis.
In claims 1 and 14, performing the calculation on the age and the parameters to obtain a risk assessment is a mathematical concept, which is defined as mathematical relationships, mathematical formulas or equations, and mathematical calculations.
Further, this step can be practically performed in the human mind, with the aid of a pen and paper. If a person were to evaluate the patient’s age, the morphological parameter value, and the hemodynamic parameter value, he or she would be able to perform mathematical operations of the values and compare them with a reference value or a lookup table to result in an index being the risk of developing fibrosis of a particular stage. There is nothing recited in the claim to suggest an undue level of complexity in how the calculation may be performed.
Therefore, the at least one diagnostic calculation is categorized as a mathematical concept, and a person would be able to perform the calculation mentally or with a generic computer. The above identified step hence is an abstract idea.
Prong Two: Claims 1 and 14 do not include additional elements that integrate the mental process into a practical application.
This judicial exception is not integrated into a practical application. In particular, the claims recites (1) a renal ultrasound system which produces renal ultrasound data, (2) an ultrasound measurement system or a processor that evaluates the renal ultrasound data to measure morphological and hemodynamic parameters, (3) the processor outputs the risk assessment to a display.
The steps in (1) and (2) represent merely data gathering or pre-solution activities that are necessary for use of the recited judicial exception and are recited at a high level of generality with conventionally used tools (see below Step IIB for further details).
The step in (3) represents merely notification outputting by a processor as a post-solution activity and is recited at a high level of generality.
As a whole, the additional elements merely serve to gather and feed information to the abstract idea and to output a notification based on the abstract idea, while generically implementing it on conventionally used tools. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. No improvement to the technology is evident, and the calculated risk assessment is not outputted in any way such that a practical benefit is realized. Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application.
Step 2B of the subject matter eligibility test (see MPEP 2106.05).
Claims 1 and 14 do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above, the claims recite additional steps of (1) a renal ultrasound system which produces renal ultrasound data, (2) an ultrasound measurement system or a processor that evaluates the renal ultrasound data to measure morphological and hemodynamic parameters, (3) the processor outputs the risk assessment to a display. These steps represents mere data gathering, data outputting or pre/post/extra-solution activities that are necessary for use of the recited judicial exception and are recited at a high level of generality.
A renal ultrasound system is used for acquiring, i.e., producing, renal ultrasound data. B-mode ultrasound image may be analyzed to obtain morphological information such as the dimension of the kidney. Color Doppler ultrasound image may be analyzed to obtain hemodynamic information such as perfusion and flow velocity. An ultrasound system equipped with an output bus and a display is also commonly seen, for the purpose allowing the practitioner to monitor, evaluate, and analyze the image data. The ultrasound data may be analyzed using conventional software package executed by a processor. All these additional limitations merely represent insignificant, conventional pre-solution activities well-understood in the industry of renal ultrasound imaging, as evidenced by Ge et al., “Diagnostic accuracy of ultrasound-based multimodal radiomics modeling for fibrosis detection in chronic kidney disease”. European Radiology (2023) 33:2386-2398. Published Dec 01, 2022, hereinafter Ge, and Syversveen et al., “Non-invasive assessment of renal allograft fibrosis by dynamic sonographic tissue perfusion measurement”. Acta Radiologica 2011; 52: 920-926. Hereinafter Syversveen.
In particular, Ge teaches an ultrasound diagnostic tool for renal fibrosis assessment (p.2388, Col. Left, Ultrasonography procedures: Mindary Resona 7 Ultrasound System and SC5-IU convex array probe to perform 2D ultrasound and STE software) comprising:
a renal ultrasound system which produces renal ultrasound data related to a kidney of a patient having an age (p.2387, Col. Right, Selection of study participants: patients with any contraindications for kidney biopsy, asymmetric bilateral kidney astrophy, abnormal kidney structure, or poor resolution of kidney cortex and medulla on 2D ultrasound) – any patient has an age;
a processor coupled to a memory, a fixed storage system, a renal ultrasound system , and an output bus, wherein the fixed storage system and/or the memory is configured to store a computer code, and the processor is configured to execute the computer code (p.2388, Col. Left, Ultrasonography procedures: Mindary Resona 7 Ultrasound System and SC5-IU convex array probe to perform 2D ultrasound and STE software; Processing flow of radiomics, Image segmentation: images of DICOM format acquired during B-mode and STE examination were imported into ITK-snap software for manual image segmentation; Feature extraction and establishment of radiomics label: the DICOM images and ROIs obtained from ITK-SNAP software were imported into the AK software for extracting radiomics; Col. Right, Model construction and result validation: feature extraction based on B-mode and STE images yielded a radiomics quality score, which was the radiomics label calculated by the weighted summation of selected features by their coefficients...Multivariate logistic regression combining clinical features with the Rad- Score was conducted)
an ultrasound measurement system or the processor which evaluates the renal ultrasound data to measure at least one morphological parameter (p.2392, Table 2: Clinical characteristics of the training and validation cohorts: Renal length (mm)).
Syversveen teaches that the ultrasound measurement system further evaluates the renal ultrasound data to measure at least one hemodynamic parameter (p.921, Col. Left, ¶-1: microvascular loss is associated with progressive IF/TA; ¶-2: a software-based method for dynamic sonographic tissue perfusion measurement (DTPM), using color Doppler sonographic videos has been developed to evaluate perfusion non-invasively; Col. Right, ¶-4: the software calculates color pixel area and flow velocity, encoded by each pixel and displayed as a color scaling bar on the screen, inside a region of interest of a video sequence. DTPM calculates perfusion parameters that describe tissue perfusion numerically…Both the perfusion intensity (PFI) and tissue pulsatility index (TPI) were calculated separately for both the distal and proximal cortex; p.923, Col. Right, Discussion: our study showed that perfusion intensity given by DTPM was significantly lower in the proximal portion of the cortex in renal transplants with grades 2 and 3 fibrosis compared to transplants without fibrosis; p.924, Col. Eight, last paragraph: loss of microvasculature is associate with progressive fibrosis; and p.925, Col. Right, last paragraph: perfusion intensity assessed by dynamic color Doppler measurements is significantly reduced in renal allografts with grade 2 and 3 fibrosis compared to allografts without fibrosis), and
the processor outputting the risk assessment through the output bus to a display and/or a printer and/or a remote device which can display the risk assessment to a health-care professional (FIG.3 illustrates that the analysis results are displayed).
Accordingly, these additional steps amount to no more than insignificant conventional extra-solution activity. Mere insignificant conventional extra-solution activity cannot provide an inventive concept. The claims hence are not patent eligible.
Dependent Claims
The following dependent claims merely further define the abstract idea and are, therefore, directed to an abstract idea for similar reasons:
describing further calculation on age (claims 8, 17) – increase the risk by 6% per additional year;
describing further calculation on the morphological parameter (claims 9-10, 18) – increase the risk by 58% per unit decrease in renal length;
describing further calculation on the hemodynamic parameter (claims 11-12, 19) – increase the risk by 20% per unit decrease in flow velocity.
The following dependent claims merely further describe the extra-solution activities and therefore, do not amount to significantly more than the judicial exception or integrate the abstract idea into a practical application for similar reasons:
describing the condition of the patient’s kidney (claims 2, 13, 20);
describing the morphological parameter (claims 3, 4, 15);
describing the hemodynamic parameter (claims 5-7, 16).
Taken alone and in combination, the additional elements do not integrate the judicial exception into a practical application at least because the abstract idea is not applied, relied on, or used in a meaningful way. They also do not add anything significantly more than the abstract idea. Their collective functions merely provide computer/electronic implementation and processing, and no additional elements beyond those of the abstract idea. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. There is no indication that the combination of elements improves the functioning of a computer, output device, improves technology other than the technical field of the claimed invention, etc. Therefore, the claims are rejected as being directed to non-statutory subject matter.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-4 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Ge et al., “Diagnostic accuracy of ultrasound-based multimodel radiomics modeling for fibrosis detection in chronic kidney disease”. European Radiology (2023) 33:2386-2398. Published Dec 01, 2022, hereinafter Ge, in view of Syversveen et al., “Non-invasive assessment of renal allograft fibrosis by dynamic sonographic tissue perfusion measurement”. Acta Radiologica 2011; 52: 920-926. Hereinafter Syversveen.
Claim 1. Ge teaches an ultrasound diagnostic tool for renal fibrosis assessment (p.2388, Col. Left, Ultrasonography procedures: Mindary Resona 7 Ultrasound System and SC5-IU convex array probe to perform 2D ultrasound and STE software) comprising:
a) a renal ultrasound system which produces renal ultrasound data related to a kidney of a patient having an age (p.2387, Col. Right, Selection of study participants: patients with any contraindications for kidney biopsy, asymmetric bilateral kidney astrophy, abnormal kidney structure, or poor resolution of kidney cortex and medulla on 2D ultrasound) – any patient has an age;
b) an ultrasound measurement system which evaluates the renal ultrasound data to measure at least one morphological parameter (p.2392, Table 2: Clinical characteristics of the training and validation cohorts: Renal length (mm));
c) a diagnostic system which performs at least one diagnostic calculation on the age, the at least one morphological parameter to obtain a risk assessment which predicts the patient's risk of developing moderate-to-severe renal fibrosis (p.2390-91, end of Col. Right, the DCA based on the combined model (clinical and STE) showed greater benefits in the prediction of IFTA severity in the 20-80% threshold probabilities compared to the clinical and STE models, FIG.3; p.2392, Table 2: Clinical characteristics of the training and validation cohorts – Age (years): p value 0.536 and 0.104; and Renal length (mm), p value 0.59 and 0.61; p.2392, Col. Right: Discussion. With renal function further declining, kidneys may become softer due to poor blood perfusion, and the STE measurement results may decrease, whereas the kidney length becomes smaller on 2D ultrasound examination; p.2394, Table 3: Diagnostic performance of different model prediction for the assessment of IFTA in two training and validation groups).
Ge does not teach that the renal ultrasound data is evaluated to measure at least one hemodynamic parameter based on which the at least one diagnostic calculation is performed.
However, in an analogous renal ultrasound-based fibrosis assessment field of endeavor, Syversveen teaches that
the renal ultrasound data is evaluated to measure at least one hemodynamic parameter based on which the at least one diagnostic calculation is performed (p.921, Col. Left, ¶-1: microvascular loss is associated with progressive IF/TA; ¶-2: a software-based method for dynamic sonographic tissue perfusion measurement (DTPM), using color Doppler sonographic videos has been developed to evaluate perfusion non-invasively; Col. Right, ¶-4: the software calculates color pixel area and flow velocity, encoded by each pixel and displayed as a color scaling bar on the screen, inside a region of interest of a video sequence. DTPM calculates perfusion parameters that describe tissue perfusion numerically…Both the perfusion intensity (PFI) and tissue pulsatility index (TPI) were calculated separately for both the distal and proximal cortex; p.923, Col. Right, Discussion: our study showed that perfusion intensity given by DTPM was significantly lower in the proximal portion of the cortex in renal transplants with grades 2 and 3 fibrosis compared to transplants without fibrosis; p.924, Col. Eight, last paragraph: loss of microvasculature is associate with progressive fibrosis; and p.925, Col. Right, last paragraph: perfusion intensity assessed by dynamic color Doppler measurements is significantly reduced in renal allografts with grade 2 and 3 fibrosis compared to allografts without fibrosis).
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the tool of Ge employ such features associated with the renal ultrasound data being evaluated to measure at least one hemodynamic parameter based on which the at least one diagnostic calculation being performed, as taught in Syversveen for the advantage of “using non-invasive dynamic color Doppler sonographic parenchymal perfusion measurements to correlate various degrees of renal transplant fibrosis”, as suggested in Syversveen, p.921, ¶--3.
Claim 14. Ge teaches an ultrasound diagnostic tool for renal fibrosis assessment (p.2388, Col. Left, Ultrasonography procedures: Mindary Resona 7 Ultrasound System and SC5-IU convex array probe to perform 2D ultrasound and STE software), comprising
a processor coupled to a memory, a fixed storage system, a renal ultrasound system , and an output bus, wherein the fixed storage system and/or the memory is configured to store a computer code, and the processor is configured to execute the computer code (p.2388, Col. Left, Ultrasonography procedures: Mindary Resona 7 Ultrasound System and SC5-IU convex array probe to perform 2D ultrasound and STE software; Processing flow of radiomics, Image segmentation: images of DICOM format acquired during B-mode and STE examination were imported into ITK-snap software for manual image segmentation; Feature extraction and establishment of radiomics label: the DICOM images and ROIs obtained from ITK-SNAP software were imported into the AK software for extracting radiomics; Col. Right, Model construction and result validation: feature extraction based on B-mode and STE images yielded a radiomics quality score, which was the radiomics label calculated by the weighted summation of selected features by their coefficients...Multivariate logistic regression combining clinical features with the Rad- Score was conducted) – it is considered that a processor, a memory and a fixed storage system in order to implement the software that is used to perform these data analysis. Further the data displayed as illustrated in FIG.2 indicates that there is an output bus for outputting the data for display, for:
performing a series of renal ultrasound measurements on a patient to obtain a set of renal ultrasound data (p.2388, Col. Left, Ultrasonography procedures: Mindary Resona 7 Ultrasound System and SC5-IU convex array probe to perform 2D ultrasound and STE software; and p.2387, Col. Right, Selection of study participants: patients with any contraindications for kidney biopsy, asymmetric bilateral kidney astrophy, abnormal kidney structure, or poor resolution of kidney cortex and medulla on 2D ultrasound);
evaluating the renal ultrasound data to obtain at least one morphological parameter (p.2392, Table 2: Clinical characteristics of the training and validation cohorts: Renal length (mm); Renal width (mm), Cortical thickness (mm), ROI depth (mm));
performing at least one diagnostic calculation on the at least one morphological parameter to obtain a risk assessment which evaluates the patient's risk of developing moderate-to-severe renal fibrosis (p.2390-91, end of Col. Right, the DCA based on the combined model (clinical and STE) showed greater benefits in the prediction of IFTA severity in the 20-80% threshold probabilities compared to the clinical and STE models, FIG.3; p.2392, Table 2: Clinical characteristics of the training and validation cohorts –Renal length (mm), p value 0.59 and 0.61; Renal width (mm), p value 0.82 and 0.95; Cortical thickness (mm), p value 0.68 and 0.76; and ROI depth (mm), p value 0.042 and 0.46; p.2392, Col. Right: Discussion. With renal function further declining, kidneys may become softer due to poor blood perfusion, and the STE measurement results may decrease, whereas the kidney length becomes smaller on 2D ultrasound examination; p.2394, Table 3: Diagnostic performance of different model prediction for the assessment of IFTA in two training and validation groups);
outputting the risk assessment through the output bus to a display and/or a printer and/or a remote device which can display the risk assessment to a health-care professional (FIG.3 illustrates that the analysis results are displayed).
Ge does not teach that the renal ultrasound data is evaluated to measure at least one hemodynamic parameter based on which the at least one diagnostic calculation is performed.
However, in an analogous renal ultrasound-based fibrosis assessment field of endeavor, Syversveen teaches that
the renal ultrasound data is evaluated to measure at least one hemodynamic parameter based on which the at least one diagnostic calculation is performed (p.921, Col. Left, ¶-1: microvascular loss is associated with progressive IF/TA; ¶-2: a software-based method for dynamic sonographic tissue perfusion measurement (DTPM), using color Doppler sonographic videos has been developed to evaluate perfusion non-invasively; Col. Right, ¶-4: the software calculates color pixel area and flow velocity, encoded by each pixel and displayed as a color scaling bar on the screen, inside a region of interest of a video sequence. DTPM calculates perfusion parameters that describe tissue perfusion numerically…Both the perfusion intensity (PFI) and tissue pulsatility index (TPI) were calculated separately for both the distal and proximal cortex; p.923, Col. Right, Discussion: our study showed that perfusion intensity given by DTPM was significantly lower in the proximal portion of the cortex in renal transplants with grades 2 and 3 fibrosis compared to transplants without fibrosis; p.924, Col. Eight, last paragraph: loss of microvasculature is associate with progressive fibrosis; and p.925, Col. Right, last paragraph: perfusion intensity assessed by dynamic color Doppler measurements is significantly reduced in renal allografts with grade 2 and 3 fibrosis compared to allografts without fibrosis).
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the tool of Ge employ such features associated with the renal ultrasound data being evaluated to measure at least one hemodynamic parameter based on which the at least one diagnostic calculation being performed, as taught in Syversveen for the advantage of “using non-invasive dynamic color Doppler sonographic parenchymal perfusion measurements to correlate various degrees of renal transplant fibrosis”, as suggested in Syversveen, p.921, ¶--3.
Claim 2. Ge further teaches that
the patient is a person diagnosed with chronic kidney disease (p.2391, FIG.3, D-F: a 36 year old female patient with chronic kidney disease, and G-I: a 28 year old male patient with chronic kidney disease).
Syversveen also teaches the same feature in Background: chronic allograft nephropathy characterized by interstitial fibrosis and tubular atrophy is a major cause of renal transplant failure; Purpose: to evaluate whether non-invasive dynamic color Doppler sonographic parenchymal perfusion measurements are different in grafts with various degrees of biopsy proven renal transplant fibrosis.
Claims 3, 4 and 15. Ge further teaches that
the morphological parameter is a renal length of the kidney (p.2392, Table 2: Clinical characteristics of the training and validation cohorts –Renal length (mm), p value 0.59 and 0.61).
Claims 5-7 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Ge et al., “Diagnostic accuracy of ultrasound-based multimodel radiomics modeling for fibrosis detection in chronic kidney disease”. European Radiology (2023) 33:2386-2398. Published Dec 01, 2022, hereinafter Ge, in view of Syversveen et al., “Non-invasive assessment of renal allograft fibrosis by dynamic sonographic tissue perfusion measurement”. Acta Radiologica 2011; 52: 920-926. Hereinafter Syversveen, further in view of Spatola et al., “Doppler ultrasound in kidney diseases: a skey parameter in clinical long-term follow-up”. J Ultrasound (2016) 19:243-250, hereinafter Spatola.
Claims 5-7 and 16. Ge and Syversveen combined teaches all the limitations of claims 1 and 14.
Neither Ge nor Syversveen teaches that the at least one hemodynamic parameter is an end-diastolic velocity of the interlobar renal artery.
However, in an analogous renal ultrasound-based fibrosis assessment field of endeavor, Spatola teaches that
the hemodynamic parameter is an end-diastolic velocity of the interlobar renal artery (Abstract: the Renal Resistive Index (RRI) [(peak systolic velocity – end diastolic velocity)/peak systolic velocity] is a semi-quantitative index derived by Doppler evaluation of renal vascular bed…RRI is an important prognostic marker in chronic kidney diseases (CKD)…it significantly correlated with hemodynamic (ABPM, SBP, DBP, pulse pressure) and histopathological parameters (…interstitial fibrosis); and p.244, Col. Right, ¶-4: the doppler RRI is a semi-quantitative index, derived by the ratio of the difference between peak systolic velocity (PSV) and enddiastolic velocity (EDV) divided by PSV and enddiastolic velocity (EDV) divided by PSV, obtained from the Doppler spectrum of intrarenal segmental and interlobar arteries (FIG.1)).
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the hemodynamic parameter of Ge and Syversveen combined employ such a feature of it being an end-diastolic velocity of the interlobar renal artery, as taught in Spatola for the advantage of providing a parameter in a semi-quantitative evaluation that is significantly correlated with hemodynamic and fibrosis, as suggested in Spatola, Abstract.
Allowable Subject Matter
Claims 8-13 and 17-20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 21-34 are allowed.
The limitation(s) recited in claims 8 and 17 in regard to the features of “the risk assessment uses an increased risk of 6 percent per additional year of the age in predicting the patient's risk of developing moderate-to-severe renal fibrosis", in combination with the other claimed elements, is/are not taught or disclosed in the prior arts.
The limitation(s) recited in claims 9-10 and 18 in regard to the features of “the risk assessment uses an increased risk of 58 percent for every one unit decrease in the renal length in predicting the patient's risk of developing moderate-to-severe renal fibrosis", in combination with the other claimed elements, is/are not taught or disclosed in the prior arts.
The limitation(s) recited in claims 11-12 and 19 in regard to the features of the risk assessment uses an increased risk of 20 percent for every one unit decrease in the end-diastolic velocity in predicting the patient's risk of ng moderate-to-severe renal fibrosis", in combination with the other claimed elements, is/are not taught or disclosed in the prior arts.
Dependent claims 13 and 20 are allowed solely by virtue of their respective dependency upon an allowable claim otherwise Ge and Syversveen teach the claimed feature as considered in the rejection to claim 2.
Response to Arguments
Applicant’s arguments in regard to the rejection to claims 1-20 under 35 U.S.C. 101 has been fully considered but they are not persuasive.
Applicant asserted that “the claims integrate the mathematical calculation into a practical application. The claimed diagnostic tool integrates the mathematical risk calculation with specific, physical ultrasound hardware operating on patient-specific physiological data….The claims require [elements (1)-(4) (Remarks p.8, last paragraph, emphasis added). Examiner respectfully disagrees and notes that, the asserted elements (1)-(4) are identified in Step 2A Prong 2 and Step 2B analysis as additional elements that represent merely data gathering or pre-solution activities that are necessary for use of the recited judicial exception and are recited at a high level of generality with conventionally used tools (elements (1) and (2)), and element (4) represents merely notification outputting by a processor as a post-solution activity and is recited at a high level of generality.
In regard to element (3), the diagnostic system functions to perform the calculation that is identified as the abstract idea. As interpreted under 35 U.S.C. 112(f), the “diagnostic system” refers to the device 30 being a general-purpose computer that includes processor 38. According to MPEP, a claim that requires computer may still recite a mental process. MPEP 2106.04(a)(2).III.C.: “Performing a mental process on a generic computer, in a computer environment, or using a computer as a tool to perform the steps are considered a mental process”.
Therefore, the asserted elements (1)-(4) are considered merely insignificant pre-solution or post-solution activities that do not integrate the abstract idea into a practical application, nor do they amount to significantly more than the abstract idea.
Applicant further asserted that “the claims reflect a specific improvement to the field of medical diagnosis”. Examiner respectfully disagrees and notes that, any improvement that the abstract idea may provide, whether it is intended to integrate the abstract idea into the practical application, or to amount to significantly more than the abstract idea, needs to be additional elements, rather than the abstract idea itself. See MPEP 2106.04.II.A.2 and 2106.05. Current claim language does not recite any additional element that represents an improvement. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. No improvement to the technology is evident, and the calculated risk assessment is not outputted in any way such that a practical benefit is realized.
Applicant further asserted that “the “pen and paper” characterization overstates the abstractness of the claims…The input data, here specifically B-mode ultrasound measurements of renal morphology and Doppler-derived hemodynamic flow velocities cannot be obtained mentally with pen and paper, They require specific ultrasound imaging hardware. The calculation is thus tethered to, and inseparable from, that physical data acquisition”. Examiner respectfully disagrees and notes that, the elements that are identified to be mental process are the calculation limitations. The calculation is performed upon obtaining the data. Since claims 1 and 14 broadly recite that the calculation is based on the age and the at least one morphological parameter and the at least one hemodynamic parameter, and there is no specificity about those parameters, there is nothing recited in the claim to suggest an undue level of complexity in how the calculation may be performed.
Examiner would like to note that, in contrast, claims 21-34 are not rejected under 35 U.S.C. 101. In claims 21 and 22, the morphological parameter is recited to comprise a renal length of the kidney and the hemodynamic parameter is recited to comprise an end-diastolic velocity of the interlobar renal artery. With this, the ultrasound measurement system is no longer considered a conventional tool, and it amounts to significantly more than the abstract idea.
Applicant’s arguments in regard to the rejection under 35 U.S.C. 103 have been fully considered but they are not persuasive. Applicant asserted that “Syversveen is directed to a fundamentally different clinical population”. Examiner respectfully disagrees and notes that claims 1 and 14 merely recite using a renal ultrasound system to produce renal ultrasound data to measure morphological parameter and hemodynamic parameter. Further these parameters are used altogether with the age to assess fibrosis risk. Claims 1 and 14 is not limited to any patient population, i.e., the clinical population is not reflected in the claims. Since both Ge and Syversveen teach fibrosis assessment, relaying on Syversveen for its teaching of considering a hemodynamic parameter when assessing fibrosis risk is considered appropriate. Further claim 2 requires that the patient is diagnosed with chronic kidney disease. Both Ge and Syversveen teach such a feature. The asserted condition of whether the patient has native kidneys or transplanted kidneys is irrelevant. The assertion of the pathophysiology of fibrosis in a transplanted kidney is clinically and mechanistically distinct from fibrosis in native CKD kidneys is also irrelevant. Claims 1 and 14 merely recite a diagnostic calculation being performed based on the age, the hemodynamic parameter and the morphological parameter to obtain a risk assessment, and claim 2 further recites a chronical kidney disease. Applicant is requested to further amend the claims to reflect the clinical population that the claimed invention is intended for as asserted, if those asserted features are critical.
Applicant further asserted that “Syversveen’ s measurement technique is materially different from the claimed hemodynamic parameter”. Examiner respectfully disagrees and notes that claims 1 and 14 do not require any particular type of hemodynamic parameter. Whether it is PFI, TPI or EDV is irrelevant since they are all hemodynamic parameters.
In regard to claims 5 and 16 in which EDV is recited, Applicant asserted that Spatola does not teach using EDV as an independent diagnostic parameter. Examiner respectfully disagrees and notes that, Spatola is relied upon for the teaching of the particular hemodynamic parameter to be an EDV, and claims 1 and 14 merely broadly recite a diagnostic calculation being performed based on the age, the hemodynamic parameter and the morphological parameter to obtain a risk assessment. None of the asserted features in Section B, p.12 of the Remarks is reflected in the claims. Applicant is requested to further amend the claims to reflect those features that the claimed invention is intended for as asserted, if those asserted features are critical.
The newly added claims 21 and 22 incorporates the previously identified allowable subject matters in claims 17-19. These claims along with their dependent claims therefore are not rejection under prior arts.
Based on the above considerations, claims 1-20 remain being rejected under 35 U.S.C. 101. Claims 1-7 and 14-16 remain being rejected under 35 U.S.C. 103. Claims 21-34 are allowed.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/YI-SHAN YANG/Primary Examiner, Art Unit 3798
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