DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 3-4, 8-9, and 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cutforth et al. (US 2022/0254032; hereinafter Cutforth) in view of Lee et al. (US 2019/0216338; hereinafter Lee) and Georgescu et al. (US 2016/0228190).
Cutforth shows a method and system for determining hemodynamic biomarkers of a vessel aneurysm ([0034]), the method comprising: obtaining a geometry of the vessel ([0039]); obtaining at least three ultrasound Doppler planes of the vessel ([0034]), wherein: one of the Doppler planes captures the vessel’s main axis (402C; Fig. 4); and the other two Doppler planes capture two different cross sections of the vessel (402A, 402B; Fig. 4); deriving a three dimensional, 3D, velocity field within the vessel and deriving a 3D relative pressure field within the vessel using the at least three ultrasound Doppler planes and the vessel geometry ([0040]).
Cutforth also shows wherein obtaining the aorta geometry comprises obtaining an ultrasound volume of the aorta of the subject and segmenting the geometry of the aorta from the ultrasound volume ([0039]).
Cutforth fails to show that the vessel is the aorta in the abdominal region of the subject; obtaining a reference pressure measurement of the subject; and deriving a 3D absolute pressure field within the aorta based on the relative pressure field and the reference pressure measurement to function as a biomarker for aortic abdominal aneurysms.
Cutforth also fails to show wherein deriving the 3D velocity field and the 3D relative pressure field comprises: performing a computational fluid dynamic, CFD, simulation of the blood flow through the aorta by: using the Doppler planes to generate reference velocity values; and using the aorta geometry to define the computational domain, wherein the CFD simulation is configured to output the 3D velocity field and the 3D relative pressure field.
Lee discloses methods for determining a risk factor related to aortic aneurysm progression. Lee teaches the vessel is the aorta in the abdominal region of the subject ([0017], [0024]); deriving a biomarker for aortic abdominal aneurysms ([0090]-[0091]).
Georgescu discloses three-dimensional quantitative heart hemodynamic imaging techniques. Georgescu teaches obtaining a reference pressure measurement of the subject ([0052], [0065]); and deriving a 3D absolute pressure field within the aorta based on the relative pressure field and the reference pressure measurement to function as a biomarker ([0023], [0072]-[0074], [0078], [0084]). Georgescu also teaches wherein deriving the 3D velocity field and the 3D relative pressure field comprises: performing a computational fluid dynamic, CFD, simulation of the blood flow through the aorta by: using the Doppler planes to generate reference velocity values ([0025]); and using the aorta geometry to define the computational domain, wherein the CFD simulation is configured to output the 3D velocity field and the 3D relative pressure field ([0026], [0052], [0072]-[0075], [0078], [0084]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Cutforth to analyze the aorta in the abdominal region as taught by Lee, as it would be obvious to analyze any particular blood vessel based upon the patient’s condition, and as Lee teaches that aortic aneurysms are of particular diagnostic interest as they are associated with biological changes in the vasculature, features of systemic inflammation and endothelial dysfunction ([0002]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Cutforth and Lee to determine an absolute pressure field as taught by Georgescu, as Georgescu teaches that obtaining an absolute pressure is of particular diagnostic interest and may impact clinical findings and treatment planning, and may aid in assessing disease state and progression ([0004], [0023]).
Claim(s) 2 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cutforth et al. (US 2022/0254032; hereinafter Cutforth) in view of Lee et al. (US 2019/0216338; hereinafter Lee) and Georgescu et al. (US 2016/0228190) as applied to claims 1 and 9 above, and further in view of Falahatpisheh et al. (US 2014/0149055; hereinafter Falahatpisheh).
Cutforth also shows deriving the 3D relative pressure field from the 3D velocity field ([0034], [0040], [0043]-[0045]).
Cutforth fails to show wherein deriving the 3D velocity field and deriving the 3D relative pressure field comprises: deriving two dimensional, 2D, velocity fields relative to the aorta geometry for each of the Doppler planes; reconstructing the 3D velocity field within the aorta by interpolating the velocity between the 2D velocity fields.
Falahatpisheh discloses multi-plane methods for three-dimensional imaging. Falahatpisheh teaches wherein deriving the 3D velocity field and deriving the 3D relative pressure field comprises: deriving two dimensional, 2D, velocity fields relative to the aorta geometry for each of the Doppler planes ([0025]); reconstructing the 3D velocity field within the aorta by interpolating the velocity between the 2D velocity fields ([0030]-[0033]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Cutforth, Lee, and Georgescu to interpolate the velocity as taught by Falahatpisheh, as interpolation is a known mathematical technique which will provide a more accurate final result by providing additional quantified datapoints.
Claim(s) 5 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cutforth et al. (US 2022/0254032; hereinafter Cutforth) in view of Lee et al. (US 2019/0216338; hereinafter Lee) and Georgescu et al. (US 2016/0228190) as applied to claims 1 and 9 above, and further in view of Acharya et al. (US 2022/0370031; hereinafter Acharya).
Cutforth fails to show wherein obtaining the at least three Doppler planes comprises obtaining one or more Doppler cine-loops, wherein at least one frame of the one or more Doppler cine-loops corresponds to the aorta's main axis and at least two frames correspond to different cross sections of the aorta.
Acharya discloses automated systems and methods of monitoring anatomical structures. Acharya teaches wherein obtaining the at least three Doppler planes comprises obtaining one or more Doppler cine-loops, wherein at least one frame of the one or more Doppler cine-loops corresponds to the aorta's main axis and at least two frames correspond to different cross sections of the aorta ([0014]-[0015], [0072], [0124]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Cutforth, Lee, and Georgescu to utilize cine-loops as taught by Acharya, as a video type format provides for an improved visualization technique for the user, and as Acharya teaches that both still and moving images in video/cine format may be obtained by at the discretion of the clinician depending on the medical need as well as storage and/or analytic capacity ([0014]).
Claim(s) 6 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cutforth et al. (US 2022/0254032; hereinafter Cutforth) in view of Lee et al. (US 2019/0216338; hereinafter Lee) and Georgescu et al. (US 2016/0228190) as applied to claims 1 and 9 above, and further in view of Keidar (US 2019/0142363)
Cutforth fails to show generating a risk of clot by identifying regions of the aorta geometry wherein the corresponding region of the 3D velocity field indicates a velocity lower than a velocity threshold.
Keidar discloses methods and devices for assessing heart valve disease. Keidar teaches generating a risk of clot by identifying regions of the aorta geometry wherein the corresponding region of the 3D velocity field indicates a velocity lower than a velocity threshold (risk of stenosis; [0048]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Cutforth, Lee, and Georgescu to generate a risk of a clot as taught by Keidar, in order to provide the clinician with additional diagnostic indicators regarding the status of the patient’s blood vessels, and to obtain a more complete diagnosis of the patient for improved decision making regarding further treatment options.
Claim(s) 7 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cutforth et al. (US 2022/0254032; hereinafter Cutforth) in view of Lee et al. (US 2019/0216338; hereinafter Lee) and Georgescu et al. (US 2016/0228190) as applied to claims 1 and 9 above, and further in view of Alatriste (US 2011/0257537).
Cutforth fails to show generating a risk of rupture by identifying regions of the aorta geometry where the corresponding 3D absolute pressure field indicates a pressure higher than a pressure threshold.
Alatriste discloses blood pressure monitoring systems providing enhanced aneurysm detection. Alatriste teaches generating a risk of rupture by identifying regions of the aorta geometry where the corresponding 3D absolute pressure field indicates a pressure higher than a pressure threshold (generate indication of potential aneurysm based on blood pressure measurements reaching threshold value; [0022]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Cutforth, Lee, and Georgescu to generate a risk of rupture as taught by Alatriste, in order to provide the clinician with additional diagnostic indicators regarding the status of the patient’s blood vessels, and to obtain a more complete diagnosis of the patient for improved decision making regarding further treatment options.
Response to Arguments
Applicant's arguments filed 4/7/26 have been fully considered but they are not persuasive.
In response to applicant’s arguments regarding the claimed Doppler planes, examiner respectfully disagrees. Cutforth teaches obtaining at least three ultrasound Doppler planes of the vessel ([0034]), wherein: one of the Doppler planes captures the vessel’s main axis (402C; Fig. 4); and the other two Doppler planes capture two different cross sections of the vessel (402A, 402B; Fig. 4). The examiner maintains that in the broadest reasonable interpretation of the term “cross section”, each plane which crosses through the blood vessel may be considered a cross section. The examiner notes that the claim does not specify any particular angle of the cross section planes relative to the main axis.
In response to applicant’s arguments that the combination of the prior art references which change the principal operation of Cutforth, examiner respectfully disagrees. Cutforth is directed to the field of medical image analysis for analyzing blood flow. It is noted that Cutforth teaches that the scanner can be configured to generate 2D medical imaging date in the one or more acquisition planes in any imaging modality, including ultrasound ([0018], [0027]). Georgescu is similarly within the field of medical image analysis for analyzing blood flow. It is noted that Georgescu also teaches that the imaging data may be acquired in various modalities, including ultrasound ([0020]). Lee is similarly within the field of medical image analysis for analyzing blood flow. It is noted that Lee also teaches that the imaging data may be acquired in various modalities, including ultrasound ([0025]). It would have been obvious to combine the image analysis techniques for analyzing blood flow, as described in the rejection above: as Lee teaches that aortic aneurysms are of particular diagnostic interest as they are associated with biological changes in the vasculature, features of systemic inflammation and endothelial dysfunction ([0002]); and as Georgescu teaches that obtaining an absolute pressure is of particular diagnostic interest and may impact clinical findings and treatment planning, and may aid in assessing disease state and progression ([0004], [0023]).
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
In response to applicant's argument that Georgescu and Lee are nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992).
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 JONATHAN CWERN whose telephone number is (571)270-1560. The examiner can normally be reached Monday - Friday, 8:00 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Koharski can be reached at (571) 272-7230. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JONATHAN CWERN/Primary Examiner, Art Unit 3797
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