DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Applicant’s election without traverse of invention I (claims 1-7) in the reply filed on 05/12/2026 is acknowledged.
3. Claims 1-3, 6, and 21-36 are presented for examination.
Claim Rejections - 35 USC § 101
4. 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.
4.1 Claims 1-3, 6, and 21-36 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
Is the claim directed to a statutory category?
Yes. The claim is to a method comprising a plurality of steps (claim 1).
Step 2A- Prong One
The claim(s) recite(s) a method (claim 4), a non-transitory medium (claim 5), comprising: The step of: “determining a stent strength profile for the stent based on the patient anatomical lumen model and the target anatomical lumen model”; “determining a stent model based on the stent strength profile”, under the broadest reasonable interpretation fall under a mental process or otherwise a mathematical concept. Therefore, the claims are directed to an abstract idea, by use of generic computer components and thus are clearly directed to an abstract idea, as constructed.
Step 2A Prong Two
This judicial exception is not integrated into a practical application because the additional limitations are all serve to gather and process data and do not add anything more significantly to the judicial exception, but are mere instructions to apply the exception using a generic computer component that are well known, routine, and conventional activities (see specification at page 3 lines 16-19) which the invention may be implemented at least in part in any conventional computer programming language (page 32 lines 23-24) previously known in the industries. Merely adding a programmable computer to perform generic computer functions does not automatically overcome an eligibility rejection. Alice, 573 U.S. at 223-24. Furthermore, the use of a general-purpose computer to apply an otherwise ineligible algorithm does not qualify as a particular machine. See Ultramerciallnc. v. Hulu, LLC, 772F.3d 709, 716-17 (Fed. Cir. 20l4); In re TLI Commc 'ns LLC v. AV Automotive, LLC, 823 F.3d 607, 613 (Fed. Cir. 2016) (mere recitation of concrete or tangible components is not an inventive concept); Eon Corp. IP Holdings LLC v. AT&T Mobility LLC, 785; the step of: “providing a patient anatomical lumen model; providing a target anatomical lumen model”, under the broadest reasonable interpretation, reasonable fall under data gathering and processing activities that are pre-solution activities” and the further step of: “transmitting instructions to an electronic control system effective to construct the stent using the stent” could amount to post-solution activities that are also well-known, routine and conventional activities and are not sufficient to amount to significantly more than the judicial exception (See further MPEP 2106.05(d)(i-iv)-f); thus are not patent eligible under 35 USC 101.
Step 2B
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because, as previously discussed above with reference to the integration of abstract idea into a practical application, the additional elements are all serve to gather and process data and do not add anything more significantly to the judicial exception, but are mere instructions to apply the exception using a generic computer component that are well known, routine, and conventional activities (see specification at page 3 lines 16-19) which the invention may be implemented at least in part in any conventional computer programming language (page 32 lines 23-24) previously known in the industries. Merely adding a programmable computer to perform generic computer functions does not automatically overcome an eligibility rejection. Alice, 573 U.S. at 223-24. Furthermore, the use of a general-purpose computer to apply an otherwise ineligible algorithm does not qualify as a particular machine. See Ultramerciallnc. v. Hulu, LLC, 772F.3d 709, 716-17 (Fed. Cir. 20l4); In re TLI Commc 'ns LLC v. AV Automotive, LLC, 823 F.3d 607, 613 (Fed. Cir. 2016) (mere recitation of concrete or tangible components is not an inventive concept); Eon Corp. IP Holdings LLC v. AT&T Mobility LLC, 785; the step of: “providing a patient anatomical lumen model; providing a target anatomical lumen model”, under the broadest reasonable interpretation, reasonable fall under data gathering and processing activities that are pre-solution activities” and the further step of: “transmitting instructions to an electronic control system effective to construct the stent using the stent” could amount to post-solution activities that are also well-known, routine and conventional activities and are not sufficient to amount to significantly more than the judicial exception (See further MPEP 2106.05(d)(i-iv)-f); thus are not patent eligible under 35 USC 101.
Therefore, using computer components amount to no more than mere instructions to perform the abstract, and thus are not sufficient to amount to significantly more than the recited abstract, as constructed.
4.2 Dependent claims 2-3, 6, 21-36 merely include limitations pertaining to: (claim 2), “wherein the stent model includes a plurality of cross-sections, and wherein the stent strength profile includes a strength parameter having varying values corresponding to each of the plurality of cross-sections” (mental process). (claim 3); “wherein the strength parameter is a radial stiffness parameter or a radial force parameter” (mental process); (claim 6); “constructing the stent in response to transmitting the instructions” (post-solution activities); (claim 21); “wherein the stent strength profile includes an elevated strength section” (mental process); (claim 22) “wherein a location of the elevated strength section of the stent strength profile is a function of a scaffold position relative to an elastomeric body” (mental process or otherwise a mathematical concept); (claim 23) “wherein the stent strength profile includes a first radial stiffness parameter corresponding to an anatomical abnormality cross-section of the stent, and a second radial stiffness parameter corresponding to another cross-section of the stent, wherein the first radial stiffness parameter is at least two times greater than the second radial stiffness parameter” (mental process or otherwise a mathematical concept); (claim 24) “wherein determining the stent model includes determining an elastomeric body model and a scaffold model based on the stent strength profile” (mental process or otherwise a mathematical concept); (claim 25) “wherein determining the elastomeric body model and the scaffold model based on the stent strength profile includes determining a position of the elastomeric body model relative to the scaffold model” (mental process or otherwise a mathematical concept), (claim 26) “wherein determining the elastomeric body model includes determining an elastomeric body model length and determining the scaffold model includes determining a scaffold length” (mental process or otherwise a mathematical concept); (claim 27) “wherein the stent strength profile is a function of the elastomeric body length relative to the scaffold length” (mental process or otherwise a mathematical concept); (claim 28) “wherein determining the stent strength profile includes determining an anatomical abnormality position, and wherein determining the elastomeric body model and the scaffold model based on the stent strength profile includes determining a scaffold model position relative to the elastomeric body model based on the anatomical abnormality position” (mental process); (claim 29)“ wherein the stent model includes a first cross- section formed of the elastomeric body and a second cross-section parallel to the first cross-section, and wherein a radial stiffness of the second cross-section is greater than a radial stiffness of the first cross-section” (mental process); (claim 30) “wherein the stent model includes a varying radial stiffness as a function of a varying thickness of the elastomeric body” (mental process or otherwise a mathematical concept); (claim 31) “wherein the stent model includes a varying radial stiffness as a function of a difference between an elastomeric body length and a scaffold length” (mental process or otherwise a mathematical concept); (claim 32)“ wherein the stent model includes a varying radial stiffness as a function of a varying composition of the elastomeric body or the scaffold” (mental process or otherwise a mathematical concept); (claim 33) “wherein the stent model includes a varying radial stiffness as a function of a varying geometric pattern of the scaffold” (mental process or otherwise a mathematical concept); (claim 34) “wherein the stent model includes a varying radial stiffness as a function of a position of the scaffold relative to the elastomeric body” (mental process or otherwise a mathematical concept); (claim 35) “wherein the scaffold model is based on a metallic scaffold material” (mental process); (claim 36)“ wherein the elastomeric body model is based on a silicone or polyurethane elastomeric body material” (mental process), all of which further amount to further mental process similar to that already recited by the independent claims and already addressed above and thus are further not patent eligible under 35 USC 101.
Claim Rejections - 35 USC § 102
5. 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.
5.0 Claim(s) 1-2, 6, 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Min et al. (USPG_PUB No. 2022/0392065).
5.1 In considering claim 1, Min et al. teaches a method for constructing a stent, comprising:
providing a patient anatomical lumen model (see para [0011], receiving a first set of images of a first arterial bed and a first set of images of a second arterial bed, the second arterial bed being noncontiguous with the first arterial bed, and wherein at least one of the first set of images of the first arterial bed and the first set of images of the second arterial bed are normalized using the normalization device); providing a target anatomical lumen model (see para [0011]-[0012], receiving a second set of images of the first arterial bed and a second set of images of the second arterial bed, the second set of images of the first arterial bed generated subsequent to generating the first set of image of the first arterial bed, and the second set of images of the second arterial bed generated subsequent to generating the first set of image of the second arterial bed; [0015], accessing, by the computer system, a second medical image of the subject, wherein the second medical image of the subject is obtained non-invasively at a second point in time after the subject is treated with a medical treatment, the second point in time being later than the first point in time, wherein the second medical image of the subject comprises the one or more regions of plaque); determining a stent strength profile for the stent based on the patient anatomical lumen model and the target anatomical lumen model (“Patient-Specific Stent Determination”, para [0329], In some embodiments, the systems, methods, and devices described herein can be used to determine and/or generate one or more parameters for a patient-specific stent and/or selection or guidance for implantation thereof. In particular, in some embodiments, the systems disclosed herein can be used to dynamically and automatically determine the necessary stent type, length, diameter, gauge, strength, and/or any other stent parameter for a particular patient based on processing of the medical image data, for example using AI, ML, and/or other algorithms.); determining a stent model based on the stent strength profile (see para [0331], automatically select a stent from a plurality of available stent options. In some embodiments, the selected stent can be configured to prop open the artery area after implantation to the determined proper artery diameter. [0332] FIG. 4B illustrates an overview of an example embodiment(s) of a method for determination of patient-specific stent parameters based on medical image analysis. [0335], one or more of these parameters derived from a medical image, either individually or combined, can be compared to one or more reference values derived or collected from other subjects, including those who had a stent implanted and those who did not. In some embodiments, based on the determined parameters of a patient-specific stent, the system can be configured to determine a selection of a preexisting stent that matches those parameters. [0724], generating, by the computer system, patient-specific stent parameters for the patient when the predicted effectiveness of stent implantation for the patient is above a predetermined threshold, wherein the patient-specific stent parameters are generated based at least in part on the set of quantified plaque parameters, the set of vessel parameters, and the set of normal vessel parameters; and generating, by the computer system, guidance for implantation of a patient-specific stent comprising the patient-specific stent parameters, wherein the guidance for implantation of the patient-specific stent is generated based at least in part on the set of quantified plaque parameters and the set of vessel parameters, wherein the generated guidance for implantation of the patient-specific stent comprises insertion of guidance wires and positioning of the patient-specific stent, ); and transmitting instructions to an electronic control system effective to construct the stent using the stent (see para [0335], In some embodiments, based on the determined parameters of a patient-specific stent, the system can be configured to determine a selection of a preexisting stent that matches those parameters and/or generate manufacturing instructions to manufacture a patient-specific stent with stent parameters derived from a medical image.).
5.2 Regarding claim 2, Min et al. teaches that wherein the stent model includes a plurality of cross-sections (see [0756], generate and display on the user interface a third panel showing a cross-sectional view of the selected coronary vessel, the cross-sectional view generated using one of the set of CT images of the selected coronary vessel, wherein locations along the at least one SMPR view are each associated with one of the CT images in the set of CT images such that a selection of a particular location along the coronary vessel in the at least one SMPR view displays the associated CT image in the cross-sectional view in the third panel; and in response to an input on the third panel indicating a first location along the selected coronary artery in the at least one SMPR view, display a cross-sectional view associated with the selected coronary artery at the first location in the third panel.), and wherein the stent strength profile includes a strength parameter having varying values corresponding to each of the plurality of cross-sections (see [0407], When a location on the vessel in one panel is selected (e.g., the CMPR view), the views in the other panels (e.g., the cross-section, axial, sagittal, and coronal views) can be automatically updated to also show the vessel at that the selected location in the respective views, thus greatly enhancing the information presented to a user and increasing the efficiency of the analysis. [0441], If more than one stenosis has been marked on a segment, the highest value outputs are displayed by default and the user can click into each stenosis bar to view stenosis details and interrogate smaller stenosis (if present) within that segment. The user can also scroll through each cross-section by dragging the grey button in the center of a SMPR view of the vessel, and view the lumen diameter and % diameter stenosis at each cross-section at any selected location, as illustrated in FIG. 9G.).
5.3 With regards to claim 6, Min et al. teaches the step of constructing the stent in response to transmitting the instructions (see para [0335], generate manufacturing instructions to manufacture a patient-specific stent with stent parameters derived from a medical image).
5.4 As per claim 21, Min et al. teaches that wherein the stent strength profile includes an elevated strength section (see Min para [0996], Classification grades: can be done in many ways: [0997] presence/absent [0998] normal, mild, moderate, severe [0999] elevated or reduced).
Claim Rejections - 35 USC § 103
6. 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.
6.0 Claim(s) 3, 22-36 are rejected under 35 U.S.C. 103 as being unpatentable over (USPG_PUB No. 2022/0392065), in view of Anukhin et al. (USPG_PUB No. 2011/0190872).
6.1 As per claim 3, Min et al. teaches most of the instant invention; however, he does not specifically teach that wherein the strength parameter is a radial stiffness parameter or a radial force parameter. Anukhin et al. teaches that wherein the strength parameter is a radial stiffness parameter or a radial force parameter (see para [0007] Radial strength, which is the ability of a stent to resist radial compressive forces, relates to a stent's radial yield strength and radial stiffness around a circumferential direction of the stent. A stent's "radial yield strength" or "radial strength" (for purposes of this application) may be understood as the compressive loading, which if exceeded, creates a yield stress condition resulting in the stent diameter not returning to its unloaded diameter, i.e., there is irrecoverable deformation of the stent. When the radial yield strength is exceeded the stent is expected to yield more severely and only a minimal force is required to cause major deformation. [0113] A combination of these micro-structural controls in combination with a macroscopic design, e.g., scaffold pattern, crimping process, etc. may improve fracture toughness without significant adverse affects on other scaffold material properties, e.g., radial and/or pinching stiffness.).
Min et al. and Anukhin et al. are analogous art because they are from the same field of endeavor and that the model analyzes by Anukhin et al. is similar to that of Min et al. Therefore, it would have been obvious to a person of skilled in the art at the time of filing of the applicant’s invention to combine the method of Anukhin et al. with that of Min et al. because Anukhin et al. teaches the improvement of fatigue properties (see para 0015-0016).
6.2 Regarding claim 22, the combined teachings of Min et al. and Anukhin et al. teaches that wherein a location of the elevated strength section of the stent strength profile is a function of a scaffold position relative to an elastomeric body (see Anukhin et al. para [0114] An alternative to providing elastomeric properties is the use of a multilayered structure having "soft" and "hard" layers, where the soft layer/layers would be made from a low Tg material and the hard layers would have a high Tg material. In a similar way high and low Tg domains can generate typical rubber-toughened morphologies through the use of block copolymers or polymer blends. [0115], A distribution or pattern of cracks or crazes may dictate or inform one of an expected toughness of the scaffold when subjected to a particular loading, e.g., torsion, radial force, tensile etc. Although it is understand that, due to the generally highly non-linear relationship between crack formation and a coupled loading environment, that is, simultaneously applied and time varying bending, torsion and axial loading, such predictive methods may not be applicable to all situations.). Therefore, it would have been obvious to a person of skilled in the art at the time of filing of the applicant’s invention to combine the method of Anukhin et al. with that of Min et al. because Anukhin et al. teaches the improvement of fatigue properties (see para 0015-0016).
6.3 With regards claim 23, the combined teachings of Min et al. and Anukhin et al. teaches that wherein the stent strength profile includes a first radial stiffness parameter corresponding to an anatomical abnormality cross-section of the stent (see Anukhin et al para 0136] In general, a polymer scaffold that is crush-recoverable, possesses a desired radial stiffness and strength, fracture toughness and is capable of being crimped down to a target delivery diameter, e.g., at least about Dmin, balances the three competing design attributes of radial strength/stiffness verses toughness, in-vivo performance verses compactness for delivery to a vessel site, and crush recovery verses radial strength/stiffness.), and a second radial stiffness parameter corresponding to another cross-section of the stent, wherein the first radial stiffness parameter is at least two times greater than the second radial stiffness parameter (see Anukhin et al. para [0145] In the case of a metal stent, the angle .phi. before crimping is less than the angle when the stent is deployed. By forming the stent with the reduced diameter, the stent may be more easily crimped to a small profile. Due to the presence of the inner radius, the angle .phi. is capable of being exceeded at deployment without loss of radial stiffness. If this radius is too small, however, and the strut angle at deployment exceeds .phi., there is a greater chance of yielding or other problems to develop due to stress concentrations at the inner radius. Due to the ductility and resiliency of metal, stents made from metal may also be crimped down further than shown in FIG. 7B. The struts 420, 422 may touch each other, i.e., S is less than 2.times.r.sub.a, and yet the stent can still recover and maintain its radial stiffness despite the over crimped condition.). Therefore, it would have been obvious to a person of skilled in the art at the time of filing of the applicant’s invention to combine the method of Anukhin et al. with that of Min et al. because Anukhin et al. teaches the improvement of fatigue properties (see para 0015-0016).
6.4 As per claim 24, the combined teachings of Min et al. and Anukhin et al. teaches that wherein determining the stent model includes determining an elastomeric body model and a scaffold model based on the stent strength profile (see Min et al. para [0724], generating, by the computer system, patient-specific stent parameters for the patient when the predicted effectiveness of stent implantation for the patient is above a predetermined threshold, wherein the patient-specific stent parameters are generated based at least in part on the set of quantified plaque parameters, the set of vessel parameters, and the set of normal vessel parameters; and generating, by the computer system, guidance for implantation of a patient-specific stent comprising the patient-specific stent parameters, wherein the guidance for implantation of the patient-specific stent is generated based at least in part on the set of quantified plaque parameters and the set of vessel parameters, wherein the generated guidance for implantation of the patient-specific stent comprises insertion of guidance wires and positioning of the patient-specific stent, wherein the computer system comprises a computer processor and an electronic storage medium. Anukhin et al. para [0113], A combination of these micro-structural controls in combination with a macroscopic design, e.g., scaffold pattern, crimping process, etc. may improve fracture toughness without significant adverse affects on other scaffold material properties, e.g., radial and/or pinching stiffness. [0114] An alternative to providing elastomeric properties is the use of a multilayered structure having "soft" and "hard" layers, where the soft layer/layers would be made from a low Tg material and the hard layers would have a high Tg material). Therefore, it would have been obvious to a person of skilled in the art at the time of filing of the applicant’s invention to combine the method of Anukhin et al. with that of Min et al. because Anukhin et al. teaches the improvement of fatigue properties (see para 0015-0016). Therefore, it would have been obvious to a person of skilled in the art at the time of filing of the applicant’s invention to combine the method of Anukhin et al. with that of Min et al. because Anukhin et al. teaches the improvement of fatigue properties (see para 0015-0016).
6.5 Regarding claim 25, the combined teachings of Min et al. and Anukhin et al. teaches wherein determining the elastomeric body model and the scaffold model based on the stent strength profile includes determining a position of the elastomeric body model relative to the scaffold model (see min para [0461], The fiducials 1203 can be configured to facilitate determination of the alignment of the normalization device 1200 in an image of the normalization device such that the position in the image of each of the one or more compartments holding samples of known materials can be determined. Anukhin et al. para [0004], Delivery" refers to introducing and transporting the stent through an anatomical lumen to a desired treatment site, such as a lesion. "Deployment" corresponds to expansion of the stent within the lumen at the treatment region. Delivery and deployment of a stent are accomplished by positioning the stent about one end of a catheter, inserting the end of the catheter through the skin into an anatomical lumen, advancing the catheter in the anatomical lumen to a desired treatment location, expanding the stent at the treatment location, and removing the catheter from the lumen.). Therefore, it would have been obvious to a person of skilled in the art at the time of filing of the applicant’s invention to combine the method of Anukhin et al. with that of Min et al. because Anukhin et al. teaches the improvement of fatigue properties (see para 0015-0016).
6.6 As per claim 26, the combined teachings of Min et al. and Anukhin et al. teaches wherein determining the elastomeric body model includes determining an elastomeric body model length and determining the scaffold model includes determining a scaffold length (see Anukhin et al. para 0090] "Theoretical minimum diameter" means the smallest diameter for a scaffold based on its geometry of strut lengths thickness and widths. A "theoretical minimum diameter" is not defined in terms of a minimum crimped profile for a scaffold or stent that can be later deployed and work properly as a balloon-expanded prosthesis. Rather, it is only a definition defined by the geometry, or minimum volume of space that a device can occupy following a uniform reduction in diameter. To achieve this result, the length of the link 237 may be increased, (L.sub.237=L.sub.1+L.sub.2,) over the length L.sub.1 of the other links 234 that do not have the markers to carry (the length L.sub.2 being about the length needed to accommodate marker structure (depots 502 and the pair of markers 500), without interfering of limiting the folding of struts 230 as necessary to achieve a 300-400% or more diameter reduction. Stents or scaffold that do not have a tight crimped diameter requirement or minimum space between structural elements of a scaffold, by contrast, may have the link connecting rings increased in size beneath the fold struts to hold a marker 500, since there remains available space for marker structure in the crimped configuration.). Therefore, it would have been obvious to a person of skilled in the art at the time of filing of the applicant’s invention to combine the method of Anukhin et al. with that of Min et al. because Anukhin et al. teaches the improvement of fatigue properties (see para 0015-0016).
6.7 With regards to claim 27, the combined teachings of Min et al. and Anukhin et al. teaches that wherein the stent strength profile is a function of the elastomeric body length relative to the scaffold length (see Min et al. para [01342], In some embodiments, using the formula in FIG. 24G, an Rx can then be determined at any position along the plaques length. In some embodiments, this assumes that the “normal” vessel would have tapered in a linear (or other mathematically predictable fashions) manner across its length. As illustrated in FIG. 24G, in some embodiments, the reference diameter can be better estimated continuously along the length of the diseased portion of the vessel as long as the diameter just before the plaque R0 and just after the plaque Rn is known. Anukhin et al. para 0090] "Theoretical minimum diameter" means the smallest diameter for a scaffold based on its geometry of strut lengths thickness and widths. A "theoretical minimum diameter" is not defined in terms of a minimum crimped profile for a scaffold or stent that can be later deployed and work properly as a balloon-expanded prosthesis. Rather, it is only a definition defined by the geometry, or minimum volume of space that a device can occupy following a uniform reduction in diameter. To achieve this result, the length of the link 237 may be increased, (L.sub.237=L.sub.1+L.sub.2,) over the length L.sub.1 of the other links 234 that do not have the markers to carry (the length L.sub.2 being about the length needed to accommodate marker structure (depots 502 and the pair of markers 500), without interfering of limiting the folding of struts 230 as necessary to achieve a 300-400% or more diameter reduction. Stents or scaffold that do not have a tight crimped diameter requirement or minimum space between structural elements of a scaffold, by contrast, may have the link connecting rings increased in size beneath the fold struts to hold a marker 500, since there remains available space for marker structure in the crimped configuration). Therefore, it would have been obvious to a person of skilled in the art at the time of filing of the applicant’s invention to combine the method of Anukhin et al. with that of Min et al. because Anukhin et al. teaches the improvement of fatigue properties (see para 0015-0016).
6.8 As per claim 28, the combined teachings of Min et al. and Anukhin et al. teaches that wherein determining the stent strength profile includes determining an anatomical abnormality position (see Min et al. para [1134], SPECT, PET, CTP and CMR can measure relative myocardial perfusion, in that you compare the most normal appearing portion of the left ventricular myocardium to the abnormal-appearing areas. PET and CTP can have the added capability of measuring absolute myocardial blood flow and using these quantitative measures to assess the normality of blood supply to the left ventricle. In contrast, exercise treadmill ECG testing measures ST-segment depression as an indirect measure of subendocardial ischemia (reduced blood supply to the inner portion of the heart muscle), while stress echocardiography evaluates the heart for stress-induced regional wall motion abnormalities of the left ventricle. Abnormal relative perfusion, absolute myocardial blood flow, ST segment depression and regional wall motion abnormalities occur at different points in the “ischemic pathway), and wherein determining the elastomeric body model and the scaffold model based on the stent strength profile includes determining a scaffold model position relative to the elastomeric body model based on the anatomical abnormality position (Min et al. para [1134], SPECT, PET, CTP and CMR can measure relative myocardial perfusion, in that you compare the most normal appearing portion of the left ventricular myocardium to the abnormal-appearing areas. PET and CTP can have the added capability of measuring absolute myocardial blood flow and using these quantitative measures to assess the normality of blood supply to the left ventricle. In contrast, exercise treadmill ECG testing measures ST-segment depression as an indirect measure of subendocardial ischemia (reduced blood supply to the inner portion of the heart muscle), while stress echocardiography evaluates the heart for stress-induced regional wall motion abnormalities of the left ventricle. Abnormal relative perfusion, absolute myocardial blood flow, ST segment depression and regional wall motion abnormalities occur at different points in the “ischemic pathway. [1403] At block 2510, the system can analyze the images to identify at least one atherosclerotic lesion (e.g., artery abnormalities) within the portion of the cardiovascular system of the patient. Atherosclerotic lesions may develop predominantly at branches, bends, and bifurcations in the arterial tree. Identifying the at least one atherosclerotic lesion within the portion of the cardiovascular system can include determining information on characteristics and parameters of the atherosclerotic lesion using any of the functionality described herein, for example, information on plaque and it characteristics/parameters, lesion size, lesion location, vessel and/or lumen size and shape information, etc.). Therefore, it would have been obvious to a person of skilled in the art at the time of filing of the applicant’s invention to combine the method of Anukhin et al. with that of Min et al. because Anukhin et al. teaches the improvement of fatigue properties (see para 0015-0016).
6.9 Regarding claim 29, the combined teachings of Min et al. and Anukhin et al. teaches that wherein the stent model includes a first cross- section formed of the elastomeric body and a second cross-section parallel to the first cross-section (see Anukhin et al. para 0188] The diagrams drawn in FIGS. 12A, 12B and 12C are offered to assist with explaining a relationship between wall thicknesses and crush recoverability. FIG. 12A shows a cross-section of a scaffold in its un-deformed (unloaded) state and deformed state when subjected to a pinching load (drawn in phantom). The ends of the scaffold designated by "S" and "S'" refer to regions with the highest strain energy, as one can appreciate by the high degree of curvature in these areas when the scaffold is under the pinching load.), and wherein a radial stiffness of the second cross-section is greater than a radial stiffness of the first cross-section (see anukhin et al. para [0187] The pinching stiffness (as opposed to the radial stiffness) is most influenced or most sensitive to changes in the wall thickness of the scaffold. As the wall thickness increases, the pinching stiffness increases. Moreover, the crush recoverability of a scaffold is most affected by the stresses created at the regions that deflect most outward in response to the applied load. As explained below, as the wall thickness is increased, the crush recoverability decreases due to an increased concentration of strain energy at the outwardly deflected ends of the scaffold. A design for a crush recoverable scaffold, therefore, must balance the wall thickness for increased pinching stiffness against the reduction in crush recoverability resulting from an increased pinching stiffness. Similarly, although radial stiffness is less affected by changes in wall thickness (since loads are more predominantly in-plane loading as opposed to out of plane during pinching) when wall thickness is altered to affect crush recoverability the radial stiffness must be taken into consideration. Radial stiffness changes when the wall thickness changes). Therefore, it would have been obvious to a person of skilled in the art at the time of filing of the applicant’s invention to combine the method of Anukhin et al. with that of Min et al. because Anukhin et al. teaches the improvement of fatigue properties (see para 0015-0016).
6.10 As per claim 30, the combined teachings of Min et al. and Anukhin et al. teaches that wherein the stent model includes a varying radial stiffness as a function of a varying thickness of the elastomeric body (see Anukhin et al. para 0230] A well known design requirement for a vessel supporting prosthesis, whether a stent or scaffold, is its ability to maintain a desired lumen diameter due to the inward radial forces of the lumen walls including the expected in vivo radial forces imparted by contractions of the blood vessel. Referring to the examples in FIGS. 6A-6B, the radial stiffness and radial strength of the scaffold is influenced by the width of struts, crown radii and angles, length of ring struts extending between crowns and valleys, the number of crowns and the wall thickness (thickness 235, FIG. 3) of the scaffold. The latter parameter (wall thickness) influences the pinching stiffness, as explained earlier. During the design process, therefore, this parameter was altered to affect pinching stiffness and crush recoverability, although it also has an effect on radial stiffness. In order to affect the radial stiffness, one or more of the foregoing parameters (crown angle, crown radius, ring strut length, crown number, and strut width) may be varied to increase or decrease the radial stiffness. [0232] The relationships between radial stiffness and above mentioned parameters are well known. However, the relationship of these stiffness-altering parameters to crush recoverability of a balloon expandable stent, much less a balloon expandable scaffold is not well known, if known at all in the existing art. Accordingly, the design process required the constant comparison or evaluation among radial stiffness, pinching stiffness and crush recoverability (assuming the changes did not also introduce yield or fracture problems during crimping and deployment) when the stiffness parameters were altered to determine whether these and related scaffold properties could be improved upon without significant adverse effects to crush recoverability.). Therefore, it would have been obvious to a person of skilled in the art at the time of filing of the applicant’s invention to combine the method of Anukhin et al. with that of Min et al. because Anukhin et al. teaches the improvement of fatigue properties (see para 0015-0016).
6.11 With regards to claim 31, the combined teachings of Min et al. and Anukhin et al. teaches that wherein the stent model includes a varying radial stiffness as a function of a difference between an elastomeric body length and a scaffold length (see Anukhin et al. para [0232] The relationships between radial stiffness and above mentioned parameters are well known. However, the relationship of these stiffness-altering parameters to crush recoverability of a balloon expandable stent, much less a balloon expandable scaffold is not well known, if known at all in the existing art. Accordingly, the design process required the constant comparison or evaluation among radial stiffness, pinching stiffness and crush recoverability (assuming the changes did not also introduce yield or fracture problems during crimping and deployment) when the stiffness parameters were altered to determine whether these and related scaffold properties could be improved upon without significant adverse effects to crush recoverability. 0234] Comparisons were made among mean radial strength (N/mm) and radial stiffness (N/mm) values after e-beam sterilization of a V2, V23 and V59 constructed scaffold (having the properties summarized in FIGS. 6A-6B) with the Control stent, Igaki-Tamai stent, and Absolute stent (8.5 mm outer diameter, 36 mm length). Table 5 summarizes the findings.). Therefore, it would have been obvious to a person of skilled in the art at the time of filing of the applicant’s invention to combine the method of Anukhin et al. with that of Min et al. because Anukhin et al. teaches the improvement of fatigue properties (see para 0015-0016).
6.12 Regarding claim 32, the combined teachings of Min et al. and Anukhin et al. teaches that wherein the stent model includes a varying radial stiffness as a function of a varying composition of the elastomeric body or the scaffold (see anukhin et al. para [0230] A well known design requirement for a vessel supporting prosthesis, whether a stent or scaffold, is its ability to maintain a desired lumen diameter due to the inward radial forces of the lumen walls including the expected in vivo radial forces imparted by contractions of the blood vessel. Referring to the examples in FIGS. 6A-6B, the radial stiffness and radial strength of the scaffold is influenced by the width of struts, crown radii and angles, length of ring struts extending between crowns and valleys, the number of crowns and the wall thickness (thickness 235, FIG. 3) of the scaffold. The latter parameter (wall thickness) influences the pinching stiffness, as explained earlier. During the design process, therefore, this parameter was altered to affect pinching stiffness and crush recoverability, although it also has an effect on radial stiffness. In order to affect the radial stiffness, one or more of the foregoing parameters (crown angle, crown radius, ring strut length, crown number, and strut width) may be varied to increase or decrease the radial stiffness. [0237] According to one aspect of the disclosure a crush-recoverable scaffold has a ratios of pinching stiffness to radial stiffness of between about 4 to 1, 3 to 1, or more narrowly about 2 to 1; ratios of pinching stiffness to wall thickness of between about 10 to 70, or more narrowly 20 to 50, or still more narrowly between about 25 and 50; and ratios of scaffold inflated diameter to pinching stiffness of between about 15 and 60 or more narrowly between about 20 to 40.). Therefore, it would have been obvious to a person of skilled in the art at the time of filing of the applicant’s invention to combine the method of Anukhin et al. with that of Min et al. because Anukhin et al. teaches the improvement of fatigue properties (see para 0015-0016).
6.13 As per claim 33, the combined teachings of Min et al. and Anukhin et al. teaches that wherein the stent model includes a varying radial stiffness as a function of a varying geometric pattern of the scaffold (see Anukhin et al. para [0230] A well known design requirement for a vessel supporting prosthesis, whether a stent or scaffold, is its ability to maintain a desired lumen diameter due to the inward radial forces of the lumen walls including the expected in vivo radial forces imparted by contractions of the blood vessel. Referring to the examples in FIGS. 6A-6B, the radial stiffness and radial strength of the scaffold is influenced by the width of struts, crown radii and angles, length of ring struts extending between crowns and valleys, the number of crowns and the wall thickness (thickness 235, FIG. 3) of the scaffold. The latter parameter (wall thickness) influences the pinching stiffness, as explained earlier. During the design process, therefore, this parameter was altered to affect pinching stiffness and crush recoverability, although it also has an effect on radial stiffness. In order to affect the radial stiffness, one or more of the foregoing parameters (crown angle, crown radius, ring strut length, crown number, and strut width) may be varied to increase or decrease the radial stiffness.). Therefore, it would have been obvious to a person of skilled in the art at the time of filing of the applicant’s invention to combine the method of Anukhin et al. with that of Min et al. because Anukhin et al. teaches the improvement of fatigue properties (see para 0015-0016).
6.14 With regards to claim 34, the combined teachings of Min et al. and Anukhin et al. teaches that wherein the stent model includes a varying radial stiffness as a function of a position of the scaffold relative to the elastomeric body (see Anukhin et al. para [0230] A well known design requirement for a vessel supporting prosthesis, whether a stent or scaffold, is its ability to maintain a desired lumen diameter due to the inward radial forces of the lumen walls including the expected in vivo radial forces imparted by contractions of the blood vessel. Referring to the examples in FIGS. 6A-6B, the radial stiffness and radial strength of the scaffold is influenced by the width of struts, crown radii and angles, length of ring struts extending between crowns and valleys, the number of crowns and the wall thickness (thickness 235, FIG. 3) of the scaffold. The latter parameter (wall thickness) influences the pinching stiffness, as explained earlier. During the design process, therefore, this parameter was altered to affect pinching stiffness and crush recoverability, although it also has an effect on radial stiffness. In order to affect the radial stiffness, one or more of the foregoing parameters (crown angle, crown radius, ring strut length, crown number, and strut width) may be varied to increase or decrease the radial stiffness. [0232] The relationships between radial stiffness and above mentioned parameters are well known. However, the relationship of these stiffness-altering parameters to crush recoverability of a balloon expandable stent, much less a balloon expandable scaffold is not well known, if known at all in the existing art. Accordingly, the design process required the constant comparison or evaluation among radial stiffness, pinching stiffness and crush recoverability (assuming the changes did not also introduce yield or fracture problems during crimping and deployment) when the stiffness parameters were altered to determine whether these and related scaffold properties could be improved upon without significant adverse effects to crush recoverability.). Therefore, it would have been obvious to a person of skilled in the art at the time of filing of the applicant’s invention to combine the method of Anukhin et al. with that of Min et al. because Anukhin et al. teaches the improvement of fatigue properties (see para 0015-0016).
6.15 Regarding claim 35, the combined teachings of Min et al. and Anukhin et al. teaches that wherein the scaffold model is based on a metallic scaffold material (see Anukhin et al para [0019] The present inventors recognize, therefore, that, whereas inferences previously accepted in the art for stent validation or feasibility when an isotropic and ductile metallic material was used, those inferences would be inappropriate for a polymeric scaffold. A change in a polymeric scaffold pattern may affect not only the stiffness or lumen coverage of the scaffold in its deployed state supporting a lumen, but also the propensity for fractures to develop when the scaffold is crimped or being deployed. This means that, in comparison to a metallic stent, there is generally no assumption that can be made as to whether a changed scaffold pattern may not produce an adverse outcome, or require a significant change in a processing step (e.g., tube forming, laser cutting, crimping, etc.). Simply put, the highly favorable, inherent properties of a metal (generally invariant stress/strain properties with respect to the rate of deformation or the direction of loading, and the material's ductile nature), which simplify the stent fabrication process, allow for inferences to be more easily drawn between a changed stent pattern and/or a processing step and the ability for the stent to be reliably manufactured with the new pattern and without defects when implanted within a living being.). Therefore, it would have been obvious to a person of skilled in the art at the time of filing of the applicant’s invention to combine the method of Anukhin et al. with that of Min et al. because Anukhin et al. teaches the improvement of fatigue properties (see para 0015-0016).
6.16 As per claim 36, the combined teachings of Min et al. and Anukhin et al. teaches that wherein the elastomeric body model is based on a silicone or polyurethane elastomeric body material (see Anukhin et al para [0020] A change in the pattern of the struts and rings of a polymeric scaffold that is plastically deformed, both when crimped to, and when later deployed by a balloon, unfortunately, is not predictable to the same or similar degree as for a metal stent. Indeed, it is recognized that unexpected problems may arise in polymer scaffold fabrication steps as a result of a changed pattern that would not have necessitated any changes if the pattern was instead formed from a metal tube. In contrast to changes in a metallic stent pattern, a change in polymer scaffold pattern may necessitate other modifications in fabrication steps or post-fabrication processing, such as crimping and sterilization. [0027] According to the invention, crush-recoverable polymer scaffolds possessing a desired radial stiffness and strength, fracture toughness and capability of being crimped down to a target delivery diameter will properly balance three competing design attributes: radial strength/stiffness verses toughness, in-vivo performance verses compactness for delivery to a vessel site, and crush recovery versus radial strength/stiffness.). Therefore, it would have been obvious to a person of skilled in the art at the time of filing of the applicant’s invention to combine the method of Anukhin et al. with that of Min et al. because Anukhin et al. teaches the improvement of fatigue properties (see para 0015-0016).
Conclusion
7. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
7.1 Moriuchi et al. (USPG_PUB No. 2007/0233234) teaches a biological organ dilating stent and method of manufacturing the same.
7.2 Ngo et al. (USPG_PUB No. 2012/0073733) teaches a method for making crused recoverable polymer scaffold.
8. Claims 1-3, 6, and 21-36 are rejected and this action is non-final. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDRE PIERRE-LOUIS whose telephone number is (571)272-8636. The examiner can normally be reached M-F 9:00 AM-5:00 PM.
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/ANDRE PIERRE LOUIS/Primary Patent Examiner, Art Unit 2187 August 24, 2026
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