DETAILED ACTION
Claims 1-12 are currently presented for examination.
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/2/2026 has been entered.
Response to Arguments
Following Applicants arguments and amendments, and in light of the 2019 Patent Eligibility guidance, the 101 rejection of the Claims is Maintained.
Applicant’s Argument: Applicant’s arguments directed to 101 rejection are based on newly amended subject matter."
Examiner’s Response: All arguments are addressed in the 101 rejection of the claims below.
Applicant’s Argument: The claims do not recite an abstract idea of a mathematical concept.
Examiner’s Response: The Examiner disagrees and notes that Applicant’s argument is explicitly points to the calculating steps, the definition of mathematical functions and physical parameters used in mathematical calculations, which are mathematical concepts. This argument is not persuasive.
Applicant’s Argument: The claims are integrated into a practical medical application.
Examiner’s Response: The Examiner disagrees as this is not expressed through the additional elements of the claim. MPEP 2106.05(a): “It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements...” Additionally, as discussed in 2106.05(a)(II) improvements to technology or technical fields, “an improvement in the abstract idea itself … is not an improvement in technology”.
Applicant’s Argument: The claim amounts to significantly more because it defines a non-conventional, rule based iterative process.
Examiner’s Response: The Examiner disagrees as the abstract idea cannot provide the improvement. MPEP 2106.05(a): “It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements...” Additionally, as discussed in 2106.05(a)(II) improvements to technology or technical fields, “an improvement in the abstract idea itself … is not an improvement in technology”.
Applicant’s Argument: The claim claims are akin to McRO and CardioNet as they produce a concrete and tangible result.
Examiner’s Response: The Examiner disagrees and again notes this is not done through the additional elements of the claim. Here, the end result of the claim is a simulation and a determination of position information. Neither of these are a concrete and tangible result, making Applicant’s case distinguishable from McRO and CardioNet.
Therefore, the 101 rejection of the claims is Maintained.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Regarding claims 1-12, are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e. abstract idea) without anything significantly more.
Step 1: Claims 1-10 and 12 are directed to a method, which is a process, which is a statutory category of invention. Claims 11 is directed to a non-transitory computer readable medium, which is a manufacture, which is a statutory category of invention. Therefore, claims 1-12 are directed to patent eligible categories of invention.
Step 2A, Prong 1: Claims 1 and 11 recite the abstract idea of calculating the ends of an implanted device before it is positioned, constituting an abstract idea based on Mathematical Concepts including mathematical formulas or equations as well as calculations or alternatively Mental Processes based on concepts performed in the human mind, or with the aid of pencil and paper. The limitation of "using the computer to define, based on an input provided by a user, a distal point Pd on the traced central line and a local morphology of a vessel, the distal point Pd being configured to indicate a point where the distal end will start to be deployed;” covers mental processes including making a judgment about points on a line. But for the recitation of “using the computer”, there is nothing in the claim that precludes operation in the human mind. This follows for each additional recitation. Additionally, the limitation of “using the computer to calculate a proximal point Pp by using the defined distal point Pd and the defined local morphology of the vessel, the proximal point Pp the being configured to indicate a point that limits a portion of the central line over the traced central line that will be needed for deploying the proximal section comprising the singularity, or that will be needed for deploying the distal section comprising the singularity,” covers mathematical concepts including a calculation, or alternatively a mental processes including evaluating a labeled dataset. Additionally, the limitation of “if the distal section comprises the singularity, the method further comprises extracting a morphological descriptor md of the vascular structure at the distal point Pd and comparing the morphological descriptor md with a nominal morphological descriptor Mn of the distal section a point Pa being defined as Pa = Pd; if the morphological descriptor md is smaller than the nominal morphological descriptor Mn, the method further comprises: i. making the point Pa equal to a point next to Pa in a proximal direction along the traced central line, ii. calculating a local morphological descriptor ma of a cross section of the vascular structure at the point Pa, iii. calculating a distance ha as ha = Mn • dumping (ma), where dumping(m) is a mathematical function in an interval [0, 1] which considers a variation of ha according to an expansion of the distal section to an expansion diameter corresponding to the local morphological descriptor ma, iv. identifying a point Pam that is located an interval ha away from the distal point Pd and on a plane perpendicular to and intersecting the traced central line at point Pa, v. calculating dd as the distance between the point Pa and the point Pam, and vi. comparing the calculated distance dd with the local morphological descriptor ma, if the distance d is smaller than the local morphological descriptor ma, the method further comprises repeating steps i. to v., if the distance dd is greater than or equal to the local morphological descriptor ma, Pp = Pa is defined as the proximal point that limits a portion of the central line over the traced central line that will be needed for deploying the distal section; or” covers mathematical concepts including a series of calculations, or alternatively a mental processes including evaluating a labeled dataset after making judgements on how to proceed given a set of rules. Additionally, the limitation of “if the morphological descriptor md is greater than or equal to the nominal morphological descriptor Mn, the method comprises selecting the proximal point Pp as the point that is located a distance dmin from the distal point Pd in the proximal direction, where dmin is a minimum height, over the traced central line, defined by the distal section, and corresponding to a height of the distal section being in a configuration corresponding to the nominal morphological descriptor Mn; or if the singularity is at the proximal end, the method further comprises: extracting a morphological descriptor md of the vascular structure at the distal point Pd; calculating a distance hd as hd = Mn • dumping (md), where dumping(m) is a mathematical function in an interval [0, 1] which considers a variation of hd according to an expansion of the proximal section to an expansion diameter corresponding to the morphological descriptor md; and comparing the morphological descriptor md with a nominal morphological descriptor Mn of the proximal section: a point Pa being defined as Pa = Pd; identifying a point Pdm that is located an interval md from the distal point Pd and on a plane perpendicular to and intersecting the traced central line at the distal point Pd, if the morphological descriptor md is smaller than the nominal morphological descriptor Mn, the method further comprises: vii. making the point Pa equal to a point next to Pa in a proximal direction along the traced central line, viii. calculating da as the distance between the point Pa and the point Pdm, and iv. comparing the calculated distance da with the distance hd wherein: if the distance da is smaller than the distance hd, the method further comprises repeating steps vii. to viii., if the distance da is greater than or equal to the distance hd, Pp = Pa is defined as the proximal point that limits a portion of the central line over the traced central line that will be needed for deploying the proximal section; or if the morphological descriptor md is greater than or equal to the nominal morphological descriptor Mn, the method comprises selecting the proximal point Pp as the point that is located a distance dmin from the distal point Pd in the proximal direction, where dmin is a minimum height, over the traced central line, achieved by the proximal section, corresponding to a height of the proximal section being in a configuration corresponding to the morphological descriptor md.” covers mathematical concepts including a series of calculations, or alternatively a mental processes including evaluating a labeled dataset after making judgements on how to proceed given a set of rules. Additionally, the limitation of “simulate, based on the traced central line, distal point Pd, and proximal point Pp, a final arrangement of the interlaced device within the vascular structure, including a configuration of the interlaced device when positioned inside an aneurysm prior to implantation; and” covers mathematical concepts including a series of calculations to determine position, or alternatively a mental processes including evaluating a set of variables to determine a position. Additionally, the limitation of “using the simulated final arrangement to determine deployment position information for positioning the interlaced device within the vascular structure.” covers mathematical concepts including a series of calculations to determine position, or alternatively a mental processes including evaluating a set of variables to determine a position. Thus, the claims recite the abstract idea of a mental process performed in the human mind, or with the aid of pencil and paper.
Dependent claims 2-10 and 12 further narrow the abstract ideas, identified in the independent claims.
Step 2A, Prong 2: The judicial exception is not integrated into a practical application. In Claims 1 and 11, the additional element of “a computer”, and “a three-dimensional image”, merely uses a computer device as a tool to perform the abstract idea. (MPEP 2106.05(f)) The limitation of “using a computer to receive a three-dimensional image of a vascular structure in which a device formed by interlaced threads, also termed interlaced device, will be positioned, and tracing a central line of the vascular structure in the three-dimensional image defining a direction in which the interlaced device is to be deployed, the interlaced device comprising a proximal end disposed at a proximal section thereof, the proximal end comprising a singularity, the singularity comprising a coincidence of a plurality of interlaced threads, or the interlaced device comprising distal section disposed at a distal end thereof, the distal section comprising the singularity” in claims 1 and 11 are mere instructions to implement an abstract idea using a computer in its ordinary capacity, or merely uses the computer as a tool to perform the identified abstract idea. See MPEP (2106.05(f)) Use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a mental process or mathematical concept) does not integrate a judicial exception into a practical application. (MPEP 2106.05(f)(2)) Therefore, the judicial exception is not integrated into a practical application.
Dependent claims 2-10 and 12 further narrow the abstract ideas, identified in the independent claims, and do not introduce further additional elements for consideration beyond those addressed above.
Step 2B: Claims 1 and 11 do not include additional elements that are sufficient to amount to significantly more than the judicial exception. In Claims 1 and 11, the additional element of “a computer”, and “a three-dimensional image”, merely uses a computer device as a tool to perform the abstract idea. (MPEP 2106.05(f)) The limitation of “using a computer to receive a three-dimensional image of a vascular structure in which a device formed by interlaced threads, also termed interlaced device, will be positioned, and tracing a central line of the vascular structure in the three-dimensional image defining a direction in which the interlaced device is to be deployed, the interlaced device comprising a proximal end disposed at a proximal section thereof, the proximal end comprising a singularity, the singularity comprising a coincidence of a plurality of interlaced threads, or the interlaced device comprising distal section disposed at a distal end thereof, the distal section comprising the singularity” in claims 1 and 11 are mere instructions to implement an abstract idea using a computer in its ordinary capacity, or merely uses the computer as a tool to perform the identified abstract idea. See MPEP (2106.05(f)) Use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a mental process or mathematical concept) does not amount to significantly more. (MPEP 2106.05(f)(2)) Therefore, the claim as a whole does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements, when considered alone or in combination, do not amount to significantly more than the judicial exception. As stated in Section I.B. of the December 16, 2014 101 Examination Guidelines, “[t]o be patent-eligible, a claim that is directed to a judicial exception must include additional features to ensure that the claim describes a process or product that applies the exception in a meaningful way, such that it is more than a drafting effort designed to monopolize the exception.”
The dependent claims include the same abstract ideas recited as recited in the independent claims, and merely incorporate additional details that narrow the abstract ideas and fail to add significantly more to the claims.
Dependent claim 2 is directed to further defining where the singularity is, which further narrows the abstract idea identified in the independent claim, which is directed to “Mental Processes”, or alternatively “Mathematical Concepts.”
Dependent claim 3 is directed to further defining additional calculations, which further narrows the abstract idea identified in the independent claim, which is directed to “Mental Processes”, or alternatively “Mathematical Concepts.”
Dependent claim 4 and 12 are directed to further defining the size of the device and performing an additional calculation, which further narrows the abstract idea identified in the independent claim, which is directed to “Mental Processes”, or alternatively “Mathematical Concepts.”
Dependent claim 5 is directed to further defining the morphological descriptor parameter, which further narrows the abstract idea identified in the independent claim, which is directed to “Mental Processes”, or alternatively “Mathematical Concepts.”
Dependent claim 6 is directed to further defining the morphological descriptor parameter, which further narrows the abstract idea identified in the independent claim, which is directed to “Mental Processes”, or alternatively “Mathematical Concepts.”
Dependent claim 7 is directed to further defining the division of a surface and additional calculations, which further narrows the abstract idea identified in the independent claim, which is directed to “Mental Processes”, or alternatively “Mathematical Concepts.”
Dependent claim 8 is directed to further defining the portions, which further narrows the abstract idea identified in the independent claim, which is directed to “Mental Processes”, or alternatively “Mathematical Concepts.”
Dependent claim 9 is directed to further defining the portions, which further narrows the abstract idea identified in the independent claim, which is directed to “Mental Processes”, or alternatively “Mathematical Concepts.”
Dependent claim 10 is directed to further defining the number of portions, which further narrows the abstract idea identified in the independent claim, which is directed to “Mental Processes”, or alternatively “Mathematical Concepts.”
Accordingly, claims 1-12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e. an abstract idea) without anything significantly more.
Examiner’s Note: The Examiner notes that no prior art has been applied to the claims. See allowability section of the Non-Final Office Action mailed 9/25/2025.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Uveges et al. “Three‑dimensional evaluation of the spatial morphology of stented coronary artery segments in relation to restenosis”: Also teaches of the calculation of a position of a stent in a vascular structure based on proximal and distal ends and angles in a 3D vascular structure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL COCCHI whose telephone number is (469)295-9079. The examiner can normally be reached 7:15 am - 5:15 pm CT Monday - Thursday.
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/MICHAEL EDWARD COCCHI/Primary Examiner, Art Unit 2188
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