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 .
Comments
The Preliminary Amendments filed on August 29, 2024, and on November 4, 2025 have been entered and made of record.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
Claim 21 lines 8-12, claim 30 lines 10-14, and claim 39 lines 10-14: “determining, for each of the plurality of segments, … a characteristic of a plaque constituent, the characteristic comprising one or more of an arc of the plaque constituent, … and a length of the plaque constituent”
Appropriate correction is required.
Claim Objections
Claims 21, 30, and 39 are objected to because of the following informalities:
Claim 21 lines 15-16: “an anatomy represented by the three-dimensional reconstruction and stiffness of each of the plurality of segments” should read -- an anatomy represented by the three-dimensional reconstruction and the plaque stiffness of each of the plurality of segments --
Claim 30 lines 17-18: “an anatomy represented by the three-dimensional reconstruction and stiffness of each of the plurality of segments” should read -- an anatomy represented by the three-dimensional reconstruction and the plaque stiffness of each of the plurality of segments --
Claim 39 lines 17-18: “an anatomy represented by the three-dimensional reconstruction and stiffness of each of the plurality of segments” should read -- an anatomy represented by the three-dimensional reconstruction and the plaque stiffness of each of the plurality of segments --
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 32 is 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 32 recites the limitation “the stent and vessel morphometric and biomechanical measures” in line 3. There is insufficient antecedent basis for this limitation in the claim. However, claim 32 appears to be dependent upon claim 31 and has been treated as such. Affirmation of this is required by the appropriate amendment.
Appropriate correction is required.
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.
Claims 21, 24-30, and 33-40 are rejected under 35 U.S.C. 103 as being unpatentable over Barratt et al. (“Reconstruction and Quantification of the Cartoid Artery Bifurcation From 3-D Ultrasound Images”, IEEE Transactions on Medical Imaging, Vol. 23, No. 5, May 2004, pp. 567-583) in view of Dzenis et al. (U.S. Pub. No. 2012/0084064).
As to claims 21, 30 and 39, Barratt et al. teaches a computer-implemented method for simulating interventional procedures, the computer-implemented method (i.e., “spline-based method for reconstructing the normal and diseased carotid artery bifurcation from images acquired using a freehand 3-D ultrasound system”, Abstract, p. 567) comprising:
reading a plurality of images of a vessel lumen and of a surface of the vessel lumen (See for example, “Digital image and positional data were captured simultaneously at regular intervals … At the end of each 3-D ultrasound acquisition, image data were downloaded to the host PC”, II. Three-Dimensional Ultrasound Acquisition”, p. 568);
reading a three-dimensional reconstruction of the vessel lumen and of the surface of the vessel lumen (i.e., “The algorithm presented below is suitable for reconstructing vessel surfaces from cross-sectional contours extracted from a series of nonparallel 2-D images … Reconstruction of the lumen for the case of diseased arteries is described in Section IV”, III. Reconstruction of the Vessel Wall, p. 569);
dividing the three-dimensional reconstruction of the surface of the vessel lumen into a plurality of segments (i.e., “Reslicing the reconstructed vessel surfaces in transverse planes”, C. Planar Reslicing, pp. 573-574);
determining, for each of the plurality of segments, a material property based on the plurality of images, the material property comprising one or more of wall thickness, plaque thickness, lumen area, plaque eccentricity (See for example, “Hlumen is some measurement of the lumen and Href is the corresponding reference measurement. These measurements may be either diameter, area or volume”, D. Plaque Quantification, p. 574), and a characteristic of a plaque constituent, the characteristic comprising one or more of an arc of the plaque constituent, a thickness of the plaque constituent, and a length of the plaque constituent (See for example, “The plaque cross- sectional area was computed along the complete length of each 3-D reconstruction, plotted in Fig. 18. These data were used to compute both the extent and volume of plaque, and implicitly quantify the distribution of plaque”, VI. Patient Evaluation, A. Patient Data Sets, pp. 577-578).
However, Barratt et al. does not explicitly disclose assigning, to each of the plurality of segments, a plaque stiffness based on the material property thereof; and determining a recommendation based on an anatomy represented by the three-dimensional reconstruction and stiffness of each of the plurality of segments, the recommendation comprising a lesion preparation strategy, an interventional technique, and interventional device size; a computing node comprising a computer readable storage medium having program instructions embodied therewith, the program instructions executable by a processor of the computing node to cause the processor to perform the method; and a computer program product for providing a clinical recommendation, the computer program product comprising a computer readable storage medium having program instructions embodied therewith, the program instructions executable by a processor to cause the processor to perform the method.
Dzenis et al. teaches assigning, to each of the plurality of segments (i.e., Paragraphs [0075] and [0078]), a plaque stiffness (i.e., “material homogeneity input parameter 106 relates to whether the blood vessel or graft is to be modeled as a homogenous or heterogeneous material. For a heterogeneous material, the mechanical behavior can be approximated by a composite mechanical model that uses the measured behavior of multiple components or constituents … Plaque, in turn, can be considered as a heterogeneous structure consisting of dense, relatively acellular fibrous tissue, calcified tissue, pultaceous debris (i.e., amorphous debris containing cholesterol clefts rich in extracellular lipid), and cellular fibrous tissue”, Paragraph [0080]) based on the material property thereof (i.e., “analyzing the behavior of biological materials and anatomical structures such as blood vessels, plaques”, Paragraph [0079]); and
determining a recommendation (i.e., “proposed solution”, Paragraph [0116]) based on an anatomy represented by the three-dimensional reconstruction and stiffness of each of the plurality of segments, the recommendation comprising a lesion preparation strategy, an interventional technique, and interventional device size (i.e., “the proposed solution generated by the model comprises the determination of a size or shape of a medical device (e.g., a stent) to be used in performing therapy on the patient”, Paragraph [0116]);
a computing node comprising a computer readable storage medium having program instructions embodied therewith, the program instructions executable by a processor of the computing node to cause the processor to perform a model-based method; and a computer program product for providing a clinical recommendation, the computer program product comprising a computer readable storage medium having program instructions embodied therewith, the program instructions executable by a processor to cause the processor to perform a model-based method (See for example, “systems and methods disclosed herein can be implemented in hardware, software, or a combination of both. In some embodiments, the systems and methods can be executed as computer readable instructions on a programmable computer or processor comprising a data storage system with volatile and/or non-volatile memory”, Paragraph [0039]; and Paragraph [0040]).
Barratt et al. and Dzenis et al. are analogous art because they are from the field of digital image processing for medical imaging.
Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify Barratt et al. by incorporating the assigning, to each of the plurality of segments, of a plaque stiffness based on the material property thereof, determining a recommendation based on an anatomy represented by the three-dimensional reconstruction and stiffness of each of the plurality of segments, the recommendation comprising a lesion preparation strategy, an interventional technique, and interventional device size, the computing node comprising a computer readable storage medium having program instructions embodied therewith, the program instructions executable by a processor of the computing node to cause the processor to perform the method, and a computer program product for providing a clinical recommendation, the computer program product comprising a computer readable storage medium having program instructions embodied therewith, the program instructions executable by a processor to cause the processor to perform the method, as taught by Dzenis et al.
The suggestion/motivation for doing so would have been to evaluate, visualize, and optimize mechanical and flow factors such that it could decrease the incidence of neointimal hyperplasia and atherosclerosis by selecting an appropriate medical device or a suitable course of treatment, and for the method to be operable on a personal computer.
Therefore, it would have been obvious to combine Dzenis et al. with Barratt et al. to obtain the invention as specified in claim 21.
As to claims 24, 33 and 40, Dzenis et al. teaches wherein the interventional device size is a size of an interventional device, the interventional device comprising one or more of a stent and a balloon (i.e., “determination of a size or shape of a medical device (e.g., a stent) to be used in performing therapy on the patient”, Paragraph [0116]).
As to claims 25 and 34, Barratt et al. teaches wherein the plurality of images comprise images of a lesion (See for example, “diseased carotid artery bifurcation”, Abstract, p. 567).
As to claims 26 and 35, Barratt et al. teaches wherein the lesion is a bifurcation (i.e., “diseased carotid artery bifurcation”, Abstract, p. 567).
As to claims 27, 28, 36, and 37, Barratt et al. does not explicitly disclose
wherein the plurality of images are angiogram images/angiograms.
Dzenis et al. teaches the plurality of images are angiogram images/angiograms (i.e., “data obtained from an imaging procedure such as Magnetic Resonance Angiography (MRA) or Computerized Tomographic Angiography (CTA)”, Paragraph [0041]).
Therefore, in view of Dzenis et al., it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Barratt et al. by incorporating the plurality of images are angiogram images/angiograms, as taught by Dzenis et al., in order to provide the imaging data from conventional imaging techniques.
As to claims 29 and 38, Barratt et al. does not explicitly disclose wherein the program instructions further cause the processor to: calculating/calculate, for each of the plurality of segments, a hemodynamic flow; and wherein determining the recommendation is further based on the hemodynamic flow of each of the plurality of segments.
Dzenis et al. teaches calculating, for each of the plurality of segments, a hemodynamic flow (See for example, “the restenosis prediction module 76 includes functionality that links parameters such as vessel wall stresses and strains and blood flow characteristics to tissue using a hemorheologic-hemodynamic theory of atherosclerosis”, Paragraph [0058]); and wherein determining the recommendation is further based on the hemodynamic flow of each of the plurality of segments (i.e., “the restenosis prediction module 76 can be used in conjunction with an optimization evaluation module 78 to define various restenosis-related criteria and goals”, Paragraph [0060]; and Paragraphs [0062]-[0063]).
Therefore, in view of Dzenis et al., it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Barratt et al. by incorporating the calculating, for each of the plurality of segments, of a hemodynamic flow, and determining the recommendation is further based on the hemodynamic flow of each of the plurality of segments, as taught by Dzenis et al., in order to predict the likelihood that restenosis will occur within a particular blood vessel.
Claims 22, 23, 31 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Barratt et al. in view of Dzenis et al. as applied to claims 21 and 30 above, and further in view of Whirley et al. (U.S. Pub. No. 2012/0316854). The teachings of Barratt et al. and Dzenis et al. have been discussed above.
As to claims 22 and 31, Barratt et al. and Dzenis et al. do not explicitly disclose wherein the program instructions further cause the processor to: reading/read a three-dimensional model of a stent and a balloon; reading/read at least one material property of the stent and/or the balloon; providing/provide a simulation of the three-dimensional model at a position within the three-dimensional reconstruction of the vessel lumen; expanding/expand, in the simulation, the three-dimensional model within the three-dimensional reconstruction of the vessel lumen based on the at least one material property of the stent and/or the balloon and the material properties assigned to each of the plurality of segments; and determining/determine, in the simulation, stent and vessel morphometric and biomechanical measures.
Whirley et al. teaches reading a three-dimensional model of a stent and a balloon (See for example, “devices can include catheters, balloons, atherectomy devices, guidewires, and the like”, Paragraph [0033]; “The Medical Device Model 140 contains the geometry (geometric shape or geometric model) of the candidate medical device”, Paragraph [0034]; and “The Mesh Generator 130 then generates a finite element model incorporating both the anatomy model, whether idealized or actual, and the medical device model as represented by box 250”, Paragraph [0042]); reading at least one material property of the stent and/or the balloon (i.e., “The Materials Model 170 is the numerical representation of the material characteristics of the medical device, the anatomy, and/or the in vitro model being analyzed. Loads include pressures, displacement, forces, and deformations”, Paragraph [0049]); providing a simulation of the three-dimensional model at a position within the three-dimensional reconstruction of the vessel lumen (i.e., “a 3D volumetric representation of patient anatomy and blood vessel morphology, including complex atherosclerotic plaque distribution within the flow lumen”, Paragraph [0040]; and “Using the mesh 250, the Materials Model 170, and the Load 150, the Stress/Strain/Deformation Analyzer 160 then analyzes and simulates the non-linear stress, strain, and deformation over time such as on a medical device (e.g., a TPEG and the arterial wall)”, Paragraph [0049]); expanding, in the simulation, the three-dimensional model within the three-dimensional reconstruction of the vessel lumen based on the at least one material property of the stent and/or the balloon and the material properties assigned to each of the plurality of segments (i.e., “The command file also tells TRUEGRID that the stent to be modeled is a full 3-segment stent design (line 6 and 22), the model is a full 360 degree model of a stent (lines 6 and 23), to model the stress on the initial expansion of the stent in vivo”, Paragraph [0117]); and determining, in the simulation, stent and vessel morphometric and biomechanical measures (i.e., “Once the Stress/Strain/Deformation Analyzer 160 has analyzed the stresses, strains, and deformations on the medical device, the Visualization module 180 (in FIG. 1) can then receive the output of the Stress/Strain/Deformation Analyzer to visually display the resulting stresses, strains, and deformations 190”, Paragraph [0051]).
Barratt et al., Dzenis et al. and Whirley et al. are analogous art because they are from the field of digital image processing for medical imaging.
Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to further modify Barratt et al. and Dzenis et al. by incorporating the reading of a three-dimensional model of a stent and a balloon, reading at least one material property of the stent and/or the balloon, providing a simulation of the three-dimensional model at a position within the three-dimensional reconstruction of the vessel lumen, expanding, in the simulation, the three-dimensional model within the three-dimensional reconstruction of the vessel lumen based on the at least one material property of the stent and/or the balloon and the material properties assigned to each of the plurality of segments, and determining, in the simulation, stent and vessel morphometric and biomechanical measures, as taught by Whirley et al.
The suggestion/motivation for doing so would have been to allow for the rapid evaluation of stent designs and reduce the cost and time required for development.
Therefore, it would have been obvious to combine Whirley et al. with Barratt et al. and Dzenis et al. to obtain the invention as specified in claims 22 and 30.
As to claim 23 and 32, as best understood, Whirley et al. teaches wherein the program instructions further cause the processor to: providing/provide the stent and vessel morphometric and biomechanical measures to a manufacturer to manufacture one or more of a stent and a balloon (See for example, “A TPEG designer then determines the material properties of the candidate TPEG model and the blood vessel at step 935A”, Paragraph [0130]; and “If it, however, meets the target performance requirements, a “yes” outcome at decision box 955A, a prototype is then fabricated based on the candidate TPEG model and design at step 960A”, Paragraph [0131]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSE M TORRES whose telephone number is (571)270-1356. The examiner can normally be reached Monday thru Friday; 10:00 AM to 6:00 PM EST.
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/JOSE M TORRES/Examiner, Art Unit 2664 08/28/2026
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