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 Arguments
Applicant’s argument on Page 7 regarding the objection to the drawings has been fully considered. The objection to the drawings is withdrawn in view of the amendment.
Applicant’s argument on Page 7 regarding the objection to the specification has been fully considered. While most of the objections were addressed, the term “CIRSTM” remains, which is a trade name or mark used in commerce.
Applicant’s argument on Page 7 regarding the objections to Claims 1, 6, 9-13, and 15 has been fully considered. The objections to Claims 1, 6, and 9-13 are withdrawn in view of the amendments. Claim 15 is considered a substantial duplicate of Claim 14 despite including a “storage medium” because one of ordinary skill in the art would understand that the instructions for executing the computer program product of Claim 14 would be stored on a standard storage medium common in the art. Therefore, the objection to Claim 15 is maintained.
Applicant does not explicitly address the rejection of Claims 1-3 and 5-8 under 35 U.S.C. 112(b). However, the rejection of Claims 1-3 and 5-8 under 35 U.S.C. 112(b) is withdrawn in view of the amendments.
Applicant does not explicitly address the rejection of Claim 4 under 35 U.S.C. 112(d). However, the rejection of Claim 4 under 35 U.S.C. 112(d) is withdrawn in view of the amendments.
Applicant’s argument on Pages 8-10 regarding the rejection of Claim 1 under 35 U.S.C. 102(a)(1) as being anticipated by Andoh has been fully considered but is not persuasive.
On Page 9 Paragraph 2, applicant argues that none of the stiffness assessment involves “determining a stiffness map, as the variation in stiffness from one phantom to another is estimated solely through the comparison of shear velocities.” However, the claims do not require a “determination of a stiffness map.” Additionally, the reconstruction of stiffness maps and production of a final stiffness map is interpreted as acquisition of complex MR data and an output of the mechanical properties, as in 2.2. MRE acquisition, and demonstrated by Fig. 5.
On Page 9 Paragraphs 4-5, applicant argues that the analyzed tissues of Andoh are “considered to behave essentially like liquids,” “in contrast, shear stiffness is described in the present patent application as the magnitude of the imaginary part of the shear modulus G*” and that “the analyzed fabrics are considered to behave essentially like solids.” However, this argument is not embodied in the claims in such a way as to differentiate from Andoh; the claims do not require the tissue to behave like a solid, as Andoh is directed towards application to liver tissue.
On Page 9 Paragraph 6, applicant argues that Andoh is silent with respect to multiresolution resampling. However, it is understood by one of ordinary skill in the art that up and downsampling, as taught by Andoh on Page 4 Paragraph 3, are forms of multiresolution resampling.
On Pages 9-10, applicant argues that Andoh “does not describe the reconstruction of stiffness maps based on the resampling of shear wave displacement at multiple spatial resolutions.” However, the acquired and up/down sampled data is averaged (Page 4 Paragraph 6), and used to create the maps as shown in Fig. 5.
Therefore, the rejection of Claim 1 under 35 U.S.C. 102(a)(1) as being anticipated by Andoh is maintained.
Regarding the rejection of all remaining corresponding claims, applicant’s argument submitted on Page 10 relies on the supposed deficiencies with respect to the rejection of parent Claim 1. Applicant’s argument is moot for the same reasons detailed above.
Therefore, the rejections of Claims 2-4, 6, 8-9, and 14-15 under 35 U.S.C. 102(a)(1) as being anticipated by Andoh, Claim 5 under 35 U.S.C. 103 over Andoh, Claim 7 under 35 U.S.C. 103 over Andoh in view of Wassenaar, Claim 10 under 35 U.S.C. 103 over Andoh in view of Elgeti, Claims 11 and 13 under 35 U.S.C. 103 over Andoh in view of Everson, and Claim 12 under 35 U.S.C. 103 over Andoh in view of Mantzoros are maintained.
Specification
The use of the term CIRSTM, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claim 15 is objected to under 37 CFR 1.75 as being a substantial duplicate of Claim 14. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). The limitations “computer-readable storage medium” and “computer program product comprising instructions” are considered generally common components of a computer known in the art. There is no difference in scope between claims.
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.
Claims 1-4, 6, 8-9, and 14-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Andoh et al. (“Multi-frequency MRE for elasticity quantitation […]”).
Regarding Claims 1 and 14-15, Andoh teaches method for determining mechanical parameters of a tissue of a subject, (1. Introduction “Magnetic Resonance Elastography (MRE) aims at mapping the mechanical properties of biological tissues by recording the displacement fields generated by a mechanical wave travelling through them” and 5. Conclusion “Mechanical properties assessed with MRE may provide critical insights into the tissue pathophysiological state.”), the method being computer-implemented, (2.2. MRE acquisition “MRE acquisitions were carried out on Achieva 1.5 T and Ingenia 3 T MR systems (Philips Healthcare, Eindhoven, The Netherlands). The phantoms were placed at the center of the magnet bore into an 8 channel SENSE knee coil (Philips Healthcare, Eindhoven, The Netherlands) with their axis horizontally aligned with the directing magnetic field (Figure 2).”), and comprising the following steps:
a) receiving at least one image of the tissue, each image being taken by a magnetic resonance elastography technique, (2.2. MRE acquisition “The generation of pressure waves was trigged by the MRI system for synchronization with the MRE acquisition and monitored with an oscilloscope” and 6. Acknowledgements “The MRE experiments were performed on the 1.5 T MRI platform of CEA/SHFJ and the 3 T MRI platform of Beaujon Hospital affiliated to the France Life Imaging network”);
b) reconstructing stiffness maps with resampling of a shear wave displacement at several spatial resolutions, (Fig. 5 and 2.2. MRE acquisition “all the complex MR raw data acquired in non-optimal conditions were resampled before phase unwrapping to retrospectively achieve optimal 𝑠𝑠 conditions before extraction of the displacement fields and computation of the mechanical properties. […] Up and downsampling were performed through a Lanczos kernel.”);
c) estimating a shear wavelength at each pixel of each reconstructed stiffness map, (“how well the propagating shear wave is sampled: the spatial sampling factor (or number of voxels per wavelength), 𝑠 = λ/α […] where λ is the shear wavelength, α the voxel size”);
d) selecting for each pixel, a stiffness value of the reconstructed stiffness map fulfilling a selection criterion, the selection criterion being fulfilled when a ratio of the shear wavelength by a size of the pixel is comprised between 6 and 9, (5. Conclusion “the data should be of high quality and the displacement fields induced in the targeted homogeneous tissue at a single frequency should be sampled with the optimal number of voxels per expected wavelength (6 ≲ 𝑠 ≲ 9).”); and
e) producing a final stiffness map by taking the selected stiffness value for each pixel (Fig. 5).
Furthermore, the cited actions are computer implemented, which necessitate associated computer-readable media, as in Fig. 2 (“Console room” and “Function generator”).
Regarding Claim 2, Andoh teaches all limitations of Claim 1, as discussed above. Furthermore, Andoh teaches wherein the selection criterion is fulfilled when the shear wavelength divided by the size of the pixel is the nearest to a value comprises between 6 and 8 (5. Conclusion “the data should be of high quality and the displacement fields induced in the targeted homogeneous tissue at a single frequency should be sampled with the optimal number of voxels per expected wavelength (6 ≲ 𝑠 ≲ 9).”).
Regarding Claim 3, Andoh teaches all limitations of Claim 2, as discussed above. Furthermore, Andoh teaches where the value is comprises between 6.5 and 7.5 (5. Conclusion “the data should be of high quality and the displacement fields induced in the targeted homogeneous tissue at a single frequency should be sampled with the optimal number of voxels per expected wavelength (6 ≲ 𝑠 ≲ 9).”).
Regarding Claim 4, Andoh teaches all limitations of Claim 1, as discussed above. Furthermore, Andoh teaches wherein during the reconstructing step, the number of spatial resolutions at which the shear wave displacement is resampled is superior to 3 (Table 4 and 4. Discussion “To avoid any loss of spatial mechanical differentiation when small regions are targeted, highly spatially resolved displacement fields should be acquired with accordingly high excitation frequency to achieve optimal MRE in the expectedly stiffest regions such that only piecewise interpolation will remain to be performed in the other softer regions.”).
Regarding Claim 6, Andoh teaches all limitations of Claim 1, as discussed above. Furthermore, Andoh teaches wherein the reconstructing step comprises an unwrapping operation of a phase signal of each image (2.2. MRE acquisition “all the complex MR raw data acquired in non-optimal conditions were resampled before phase unwrapping to retrospectively achieve optimal 𝑠 conditions before extraction of the displacement fields and computation of the mechanical properties.”).
Regarding Claim 8, Andoh teaches all limitations of Claim 1, as discussed above. Furthermore, Andoh teaches wherein the reconstructing step comprises finding the stiffness value by inversion of the Helmholtz wave equation (2.3. MRE reconstruction “The components 𝑞𝑖(r,𝑡) of the curl of 𝐮(r,𝑡) satisfy the Helmholtz equation (2) for shear wave in a locally homogeneous isotropic viscoelastic medium with complex shear modulus 𝐺∗: 𝜌𝜔2𝑞𝑖(𝐫,𝑡) = 𝐺∗∇2𝑞𝑖(𝐫,𝑡) where 𝜔 = 2𝜋f, 𝐪(r,𝑡𝑡) = ∇ × 𝐮(r,𝑡) and 𝑖 = {𝑥, 𝑦, 𝑧} By algebraic inversion, the shear dynamic,
G
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, and loss, ,
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moduli can be deduced along each spatial dimension 𝑖.”).
Regarding Claim 9, Andoh teaches method for predicting that a subject is at risk of suffering from a chronic disease, the method for predicting at least comprising the steps of:
a) determining the mechanical parameters of the subject, to obtain determined parameters, the method for determining being according to claim 1, (as discussed above); and
b) predicting that the subject is at risk of suffering from the chronic disease based on the determined parameters (1. Introduction “Special attention should therefore be paid when performing MRE either using different voxel sizes and different excitation frequencies simply probing tissues at different stages of a disease or mapping mechanically heterogeneous tissues” and 4. Discussion “Yet it is possible to set a broad spectrum of optimal conditions that would cover the expected mechanical range of an organ or a disease by implementing multi-frequency acquisitions.”).
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 5 is rejected under 35 U.S.C. 103 as being unpatentable over Andoh et al. (“Multi-frequency MRE for elasticity quantitation […]”).
Regarding Claim 5, Andoh teaches all limitations of Claim 1, as discussed above. Furthermore, Andoh teaches wherein each resampling of the shear wave displacement is performed with a multiplication factor, (2.2. MRE acquisition “Up and downsampling were performed through a Lanczos kernel. […] Lanczos kernel widths were adapted to each downsampling factor to match expected SNR gain one would obtain with Gaussian noise by mere averaging over downsampled voxels.”), the multiplication factor being comprised between 0.5 and 1.5 (Where one of ordinary skill in the art would understand that adaption of the Lanczos kernel widths would allow the multiplication factor being comprised between 0.5 and 1.5 in order to control and minimize the negative lobes.).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Andoh et al. (“Multi-frequency MRE for elasticity quantitation […]”) in view of Wassenaar et al. (“Measuring Age-Dependent […]”).
Regarding Claim 7, Andoh teaches all limitations of Claim 1, as discussed above. However, Andoh does not explicitly teach wherein the reconstruction step comprises a filtering operation with a Butterworth filter.
In an analogous measuring myocardial stiffness field of endeavor, Wassenaar teaches a method for determining mechanical parameters of a tissue of a subject, (Abstract “To assess reproducibility in measuring left ventricular (LV) myocardial stiffness in volunteers throughout the cardiac cycle using magnetic resonance elastography (MRE) and to determine its correlation with age.”), wherein the reconstruction step comprises a filtering operation with a Butterworth filter (Discussion, 2D vs 3D LFE Shear Stiffness Measurements “we chose instead to apply Butterworth bandpass filter”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify Andoh with Wassenaar by filtering with a Butterworth filter because the filtering removes longitudinal or compressional waves, as taught by Wassenaar in Discussion, which improves signal-to-noise ratio, a desirable outcome in signal outcomes for diagnosis.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Andoh et al. (“Multi-frequency MRE for elasticity quantitation […]”) in view of Elgeti et al. (“Cardiac Magnetic Resonance Elastography […]”).
Regarding Claim 10, Andoh teaches determining the mechanical parameters of the subject, to obtain determined parameters, the method for determining being according to claim 1 (as discussed above).
However, Andoh does not explicitly teach diagnosing a chronic disease based on the determined parameters.
In an analogous cardiac MRE field of endeavor, Elgeti teaches method for predicting that a subject is at risk of suffering from a chronic disease, (Abstract “To assess the potential of cardiac magnetic resonance elastography (MRE) for elasticity-based detection of abnormal left ventricular (LV) relaxation.”), the method for predicting at least comprising the step of: diagnosing a chronic disease based on the determined parameters (Discussion “Because our analysis incorporates neither wave inversion nor time-dependent functional parameters, the proposed average of wave amplitudes is a most robust measure of the underlying mechanical properties of myocardial tissue. […] For this reason, the results presented here should be seen as a first indication of the diagnostic potential of cardiac MRE. […] we conclude that cardiac MRE is a promising imaging-based modality for diagnosis of pathologically altered mechanical properties of the heart.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify Andoh with Elgeti with diagnosing a chronic disease based on the determined parameters because patients with diastolic dysfunction have increased myocardial stiffness, leading to heart failure, which is associated with a significant morbidity, mortality and financial burden to health services, as taught by Elgeti in Introduction.
Claims 11 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Andoh et al. (“Multi-frequency MRE for elasticity quantitation […]”) in view of Everson et al. (US 20210318274).
Regarding Claim 11, Andoh teaches
a) determining mechanical parameters of a first subject, to obtain first determined parameters, the method for determining being according to claim 1, (as discussed above); and
b) determining mechanical parameters of a second subject, to obtain second determined parameters, method for determining being according to claim 1 (as discussed above).
However, Andoh does not explicitly teach the first subject being a subject suffering from the chronic disease, the second subject being a subject not suffering from the chronic disease, and selecting a therapeutic target based on a comparison of the first and second determined parameters.
In an analogous evaluation of liver function field of endeavor, Everson teaches method for identifying a therapeutic target for preventing and/or treating a chronic disease, ([0438] “the DSI value in the patient is used to monitor the need for, or the effectiveness of, a treatment of chronic liver disease in the patient wherein the treatment is selected from the group consisting of antiviral treatment, antifibrotic treatment, antibiotics, immunosuppressive treatments, anti-cancer treatments, ursodeoxycholic acid, insulin sensitizing agents, interventional treatment, liver transplant”), the method comprising:
a) the first subject being a subject suffering from the chronic disease, (Fig. 1 “diseased liver”),
b) the second subject being a subject not suffering from the chronic disease, (Fig. 1 “healthy liver”), and
c) selecting a therapeutic target based on a comparison of the first and second determined parameters ([0072] “the regression coefficients are obtained from a clinical study of a multiplicity of patients having a chronic liver disease, and having a defined rate of clinical events over time. […] the clinical events are selected from the group consisting of Childs-Turcotte-Pugh 2 point score progression (CTP+2), variceal hemorrhage, ascites, encephalopathy, or death.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify Andoh with Everson by selecting a therapeutic target because the modification ensures accuracy of treatment and minimizes risk of further damage to the patient’s health.
Regarding Claim 13, Andoh teaches
a) determining mechanical parameters of a first subject, to obtain first determined parameters, the method for determining being according to claim 1, (as discussed above); and
b) determining mechanical parameters of a second subject, to obtain second determined parameters, method for determining being according to claim 1 (as discussed above).
However, Andoh does not explicitly teach method for screening a compound useful as a probiotic, a prebiotic or a medicine, the compound influencing a known therapeutic target, for preventing and/or treating a chronic disease, wherein the first subject being a subject suffering from the chronic disease, the second subject being a subject not suffering from the chronic disease, and selecting the compound based on a comparison of the first and second determined parameters.
In an analogous evaluation of liver function field of endeavor, Everson teaches method for screening a compound useful as a probiotic, a prebiotic or a medicine, the compound influencing a known therapeutic target, for preventing and/or treating a chronic disease, ([0438] “the DSI value in the patient is used to monitor the need for, or the effectiveness of, a treatment of chronic liver disease in the patient wherein the treatment is selected from the group consisting of antiviral treatment, antifibrotic treatment, antibiotics, immunosuppressive treatments, anti-cancer treatments, ursodeoxycholic acid, insulin sensitizing agents, interventional treatment”), the method comprising:
a) the first subject being a subject suffering from the chronic disease, (Fig. 1, “diseased liver”),
b) the second subject being a subject not suffering from the chronic disease, (Fig. 1 “healthy liver”), and
c) selecting the compound based on a comparison of the first and second determined parameters ([0436]-[0437] “comparing the DSI value within the patient over time is used to monitor the effectiveness of a treatment of chronic liver disease in the patient, wherein a decrease in the DSI value in the patient over time is indicative of treatment effectiveness. […] comparing the DSI value in the patient over time is used to monitor the need for treatment of chronic liver disease in the patient, wherein an increase in the DSI value in the patient over time is indicative of a need for treatment in the patient.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify Andoh with Everson by selecting a compound because the modification helps to alleviate any progression of the chronic disease and help to heal the patient, leading to better quality of life. Additionally, the selection based on a comparison ensures that the most accurate compound is chosen.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Andoh et al. (“Multi-frequency MRE for elasticity quantitation […]”) in view of Mantzoros et al. (WO 2021092265), cited from its respective US Patent Application Publication US 20230064246.
Regarding Claim 12, Andoh teaches
a) determining mechanical parameters of a first subject, to obtain first determined parameters, the method for determining being according to claim 1, (as discussed above); and
b) determining mechanical parameters of a second subject, to obtain second determined parameters, method for determining being according to claim 1 (as discussed above).
However, Andoh does not explicitly teach method for identifying a biomarker, the biomarker being a diagnostic biomarker of a chronic disease, a susceptibility biomarker of a chronic disease, a prognostic biomarker of a chronic disease, or a predictive biomarker in response to a treatment of a chronic disease, the first subject being a subject suffering from the chronic disease, the second subject being a subject not suffering from the chronic disease, and selecting a therapeutic target based on the comparison of the first and second determined parameters.
In an analogous liver fibrosis field of endeavor, Mantzoros teaches method for identifying a biomarker, the biomarker being a diagnostic biomarker of a chronic disease, a susceptibility biomarker of a chronic disease, a prognostic biomarker of a chronic disease, or a predictive biomarker in response to the treatment of a chronic disease, ([0005] “The present invention provides methods for diagnosing NAFLD (e.g., NASH or NAFL) and liver fibrosis by comparing a level of one or more biomarker (e.g., one or more lipid, glycan, fatty acid, and/or hormone) in a biological sample from a subject (e.g., a blood sample, such as a serum or plasma sample) with a reference sample. These methods can also be used to treat, monitor treatment efficacy, or monitor disease progression in subjects having or at risk of developing NAFLD and liver fibrosis.”), wherein
a) the first subject being a subject suffering from the chronic disease, ([0161] “The reference level is used for diagnosis of a subject as healthy or as having NAFL, NASH, or liver fibrosis.”),
b) the second subject being a subject not suffering from the chronic disease, ([0161] “By a “control” is meant any useful reference used to diagnose NASH or liver fibrosis. The control can be any sample, standard, standard curve, or level that is used for comparison purposes. The control may be a negative control (e.g., a sample or level from a subject diagnosed as not having NAFL, NASH, or liver fibrosis, e.g., a healthy subject)”), and
c) selecting the biomarker based on a comparison of the first and second determined parameters ([0216] “The reference level may be generated using a positive or negative control sample, e.g., the level of one or more biomarker in a subject can be compared directly to the level of one or more biomarker in a negative control sample (e.g., a biological sample from a healthy subject not having NAFL, NASH, or liver fibrosis or a biological sample obtained from the subject at an earlier timepoint when the subject was diagnosed as not having NAFL, NASH, or liver fibrosis) or a positive control sample (e.g., a biological sample from a subject clinically diagnosed (e.g., diagnosed using liver biopsy or imaging) with NAFL, NASH, or liver fibrosis).”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify Andoh with Mantzoros by selecting a biomarker because it allows a clinician to reliably and non-invasively diagnose non-alcoholic fatty liver disease in patients at risk of liver fibrosis and non-alcoholic steatohepatitis.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIA CHRISTINA TALTY whose telephone number is (571)272-8022. The examiner can normally be reached M-Th 8:30-5:30 EST.
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/MARIA CHRISTINA TALTY/Examiner, Art Unit 3797
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795
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