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 .
Information Disclosure Statement
The IDS filed 2/19/2023 has been considered by the Examiner.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
The specification has a “Patent Literature” section and a “Non-Patent Literature” section both in page 16.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. Priority of a 371 of PCT/IB2020/058396 filed 09/09/2020 is acknowledged.
Claim Status
Claims 2-4, 6-7, 17-19 and 21-22 are cancelled.
Claims 1, 5, 8-16, 20 and 23-30 are examined on the merit.
Claim Objections
Claim 1 is objected to because of the following informalities: claim 1 recites “dimeters” in page 4, 4th step. “Dimeters” should read as “diameters” 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.
Claims 1, 5, 8-16, 20 and 23-30 are 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 1 recites the limitation “the neurovascular device model” in the 5th step (lines 1-2). There is insufficient antecedent basis for this limitation in the claim. “Neurovascular devices” has an antecedent but not “neurovascular device model”
Claim 1 recites the limitation “the boundaries” in the 6th step (line 1). There is insufficient antecedent basis for this limitation in the claim. It is unclear what “the boundaries” is referring to. Is there a second “boundaries”?
Claim 1 recites the limitation “the final post-implantation deformed shape” in the 6th step (lines 2-3). There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation “the stent” in the 6th step (line 3). There is insufficient antecedent basis for this limitation in the claim. It is unclear which “stent” is referred here.
Claim 1 recites the limitation “the neck” in the 7th step (line 2). There is insufficient antecedent basis for this limitation in the claim. It is unclear which “neck” is referred.
Claim 1 recites the limitation “the anatomical structure” in the 8th step. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation “the stent under the neck” in the 9th step (lines 1-2). There is insufficient antecedent basis for this limitation in the claim. It is unclear what “the stent under the neck” is referring to as no anatomical structure with a neck and implanted stent are set forth.
Claim 1 recites the limitation “the plurality of braided strands” in page 4, 2nd step. There is insufficient antecedent basis for this limitation in the claim. “Braided strands” has an antecedent but not “plurality of braided strands”.
The term “several” in claim 1 (page 4, 2nd step, line 1) is a relative term which renders the claim indefinite. The term “several” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the meets and bounds of the term and the scope of the invention. Claim 1 is hence indefinite.
Claim 1 recites the limitation “the plurality of the neurovascular device models” in page 4, 3rd step. There is insufficient antecedent basis for this limitation in the claim. “Plurality of the neurovascular device” has an antecedent but not “plurality of the neurovascular device models”.
Claim 1 recites the limitation “the neurovascular device models” in the 3rd step of page 4 (page 4 line 5). There is insufficient antecedent basis for this limitation in the claim. “Neurovascular device” has an antecedent but not “neurovascular device models”.
Claim 1 recites the limitation “the two-dimensional lines” in page 4, 5th step. There is insufficient antecedent basis for this limitation in the claim. “Two-dimensional bounding box” has an antecedent but not “two-dimensional lines”.
Claim 1 recites the limitation “the virtual placement” in page 4, 8th step, line 2. There is insufficient antecedent basis for this limitation in the claim. This issue can be fixed by deleting “virtual”, as in simulation software “virtual” is default.
Claim 1 recites the limitation “the post-processing parameters” in page 4, 9th step, line 1. There is insufficient antecedent basis for this limitation in the claim. It is unclear which step “post-processing” refers to as there is no “processing” step recited.
Claim 1 recites the limitation “the neurovascular device model performance data” in page 4, 10th step, line 2. There is insufficient antecedent basis for this limitation in the claim. This issue can be fixed by delete “performance data”
Claim 16 recites the limitation “the neurovascular device model” in the 1st step of page 7 (page 7 line 2). There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation “the neurovascular device models” in the 8th step of page 7 (page 7 line 15). There is insufficient antecedent basis for this limitation in the claim.
In the above two cases “neurovascular device” has an antecedent but not the “neurovascular device model(s)”.
Claim 11 recites the limitation "the formula” in the first line. There is insufficient antecedent basis for this limitation in the claim.
Claim 26 recites the limitation "the formula” in the first line. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the lengths of transition zones" in the 2nd line. There is insufficient antecedent basis for this limitation in the claim.
Similarly, claims 11, 25 and 26 recites the limitation "the lengths" in the 2nd line. There is insufficient antecedent basis for this limitation in the claim.
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.
Claims 1, 5, 8-16, 20 and 23-30 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
Step 1: Process, Machine, Manufacture or Composition
Claims 1, 5 and 8-15 are to a system of final deformed deployed shape and configuration of neurovascular devices and their corresponding hemodynamics in anatomical structure models, so a machine or a manufacturer.
Claims 16, 20 and 23-30 are to a method for simulation of final deformed deployed shape and configuration of neurovascular devices and their corresponding hemodynamics in anatomical structure models, so a process.
Step 2A Prong One: Identification of Abstract Ideas
The claims recite:
Selecting a plurality of the neurovascular device characteristics from the database.
This step recites querying a database for the neurovascular device characteristics, which can be achieved in the human mind (aka running the SQL in the human mind). Therefore, this step equates to an abstract idea of mental processes.
Virtually construct an anatomical structure model of the patient.
This step recites virtually construct an anatomical structure model of the patient that can be achieved in the human mind (perhaps with the help of a pen and paper). Therefore, this step equates to an abstract idea of mental processes.
Virtually construct the final post-implantation deformed shape of the neurovascular device model.
This step recites virtually construct the final post-implantation deformed shape of the neurovascular device model that can be achieved in the human mind (aka using the human mental process). Therefore, this step equates to an abstract idea of mental processes.
Firstly, making a two-dimensional bounding box comprising the boundaries of the anatomical structure and the boundaries of the final post-implantation deformed shape of the stent obtained by: calculating at least two transition zones and at least one compaction zone between the distal and proximal tips of the aneurysm(s) under the neck, and, calculating the center of rotation of the anatomical structure, and, calculating the maximum final post-implantation diameter of the stent under the neck, and, calculating the diameters of the deformed stent at the distal and proximal tips of the aneurysm(s).
This first step recites making a two-dimensional bounding box comprising the boundaries of the anatomical structure and the boundaries of the final post-implantation deformed shape of the stent obtained by four explicit mathematical calculations of geometry parameters. Therefore this step equates to an abstract idea of mathematical concepts.
Secondly, by modeling the plurality of braided strands via several two- dimensional clockwise and counterclockwise lines within the bounding box, simulate the placement of the plurality of the neurovascular device models in the anatomical structure model via: modeling a three-dimensional bed regarding the dimeters of the deformed stent at the distal, proximal, and compaction zones and, projection of the two-dimensional lines onto the three-dimensional bed to obtain three-dimensional lines and, assigning the corresponding thickness of strands to the three-dimensional lines in the bounding box.
This second step recites modeling the plurality of braided strands via several two-dimensional clockwise and counterclockwise lines within the bounding box by four explicit steps of modeling, simulation, projection and assigning operations. Simulation and modeling are directed to mathematical operations, because a simulation is an imitative representation with math of a process or system that could exist in the real world. Simulations require the use of models, and models are set of mathematical equations describing the working of procedures or devices. Projection and assigning values are also mathematical operations. Therefore this step equates to an abstract idea of mathematical concepts.
Generating at least one stent volume mesh and at least one blood volume mesh.
This step recites generating at least two numbers (of volume mesh), which, under a broadest reasonable interpretation (BRI), will be generated by mathematical calculations (although not specific on the input but the outputs are explicit). Therefore this step equates to an abstract idea of mathematical concepts.
Simulation of hemodynamics after simulating the virtual placement of the plurality
of the neurovascular device models in the anatomical structure model.
This step recites simulations, which are directed to mathematical operations. Therefore this step equates to an abstract idea of mathematical concepts.
Calculating the post-processing parameters, indices, and principles after the hemodynamics simulation.
This step recites mathematical calculation of parameters explicitly. Therefore this step equates to an abstract idea of mathematical concepts.
Select a device for use in neurovascular device placement procedure based at least in part on one or more of the hemodynamic post-processing data and the neurovascular device model performance data.
This step recites a decision-making process (select a device) based on data observations (one or more of the hemodynamic post-processing data and the neurovascular device model performance data) that can be achieved in the human mind. Therefore this step equates to an abstract idea of mental processes.
Step 2A Prong Two: Consideration of Practical Application
The claims result in a decision-making process based on data observation (select a device for use in neurovascular device placement procedure based at least in part on one or more of the hemodynamic post-processing data and the neurovascular device model performance data). The claims do not recite any additional elements that integrate the abstract idea/judicial exception into a practical application.
This judicial exception is not integrated into a practical application because the claims do not meet any of the following criteria:
An additional element reflects an improvement in the functioning of a computer, or an improvement to other technology or technical field;
an additional element that applies or uses a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition;
an additional element implements a judicial exception with, or uses a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim;
an additional element effects a transformation or reduction of a particular article to a different state or thing; and
an additional element applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than
a drafting effort designed to monopolize the exception.
Step 2B: Consideration of Additional Elements and Significantly More
The claimed method also recites "additional elements" that are not limitations drawn to an abstract idea. The recited additional elements are drawn to:
storing a computer-readable database comprising different neurovascular stents, comprising diameter of the device, length, and the thickness and number of braided strands;
receiving clinical data of a patient;
using one or more processors; and
generate a report comprising one or more of hemodynamics post-processing data regarding the neurovascular device model performance data.
The claims do not include additional elements that are sufficient to amount of significantly more than the judicial exception because it is routine and conventional to perform the acts of:
storing a computer-readable database comprising different neurovascular stents, comprising diameter of the device, length, and the thickness and number of braided strands;
receiving clinical data of a patient; and
generate a report comprising one or more of hemodynamics post-processing data regarding the neurovascular device model performance data.
These are common and conventional data acquiring, outputting and data storage operations pertaining to the clinical industry. Other elements of the method include “by using one or more processors”, which is a recitation of generic computer structure that serves to perform generic computer functions that are well-understood, routine, and conventional activities previously known to the pertinent industry. Viewed as a whole, these additional claim element(s) do not provide meaningful limitation(s) to transform the abstract idea recited in the instantly presented claims into a patent eligible application of the abstract idea such that the claim(s) amounts to significantly more than the abstract idea itself. Therefore, the claim(s) are rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 1, 5, 8-9, 13-16, 20, 23-24 and 28-30 are rejected under 35 U.S.C. 103 as being unpatentable over Larrabide et al.: (“Fast virtual deployment of self-expandable stents: Method and in vitro evaluation for intracranial aneurysmal stenting,” Medical Image Analysis, vol. 16, no. 3, Apr. 2012. Newly cited), and in view of Bouillot et. al.: (“Geometrical deployment for braided stent,” Medical Image Analysis, vol. 30, May 2016. Newly cited).
Claim 1 is interpreted as a system for simulation of final deformed deployed shape and configuration of neurovascular devices and their corresponding hemodynamics in anatomical structure models. Regarding claim 1, Larrabide provides (page 721, section “Abstract/Methodology”) “The Fast Virtual Stenting (FVS) method, which provides an estimation of the configuration of intracranial stents when released in realistic geometries” and (page 721, section “Abstract/Results”) “corresponding Computational Fluid Dynamics (CFD) analyzes were carried out on a digital replica of the phantom with the virtually released stent”, which teaches a virtual intracranial stent deployment and CFD/hemodynamic analysis.
Larrabide provides Table 1 (page 725, col 2) and (page 724, col 2, 3rd para) “closer than half the stent radial thickness to the vessel surface”, which teaches collection of different stents with data of length, diameter, thickness. The exact database field “number of braided strands” is not quoted, but is a routine device-design parameter for braided stent modeling. Storing data collection in a database is obvious and routine in software design.
Larrabide provides (page 721, section “Abstract/Introduction”) “assessing stenting alternatives beforehand is crucial.” User interface is a conventional computational implementation of the clinical planning tool suggested by Larrabide.
Larrabide provides (page 721, section “Abstract/Methodology”) “the Fast Virtual Stenting (FVS) method, which provides an estimation of the configuration
of intracranial stents when released in realistic geometries”, which teaches virtually construct an anatomical model of the patient.
Larrabide provides (page 721, section “Abstract/Methodology”) “estimation of the configuration of intracranial stents when released in realistic geometries”, which suggests virtually construct the final post-implantation deformed shape of the neurovascular device model.
Larrabide does not teach two-dimensional bounding box. Bouillot provides (page 85, section “Abstract”) deployment based on “geometrical properties of braided stents” and prediction of “position of the filaments”, which suggests a 2D bounding box with anatomical boundaries and final stent boundaries because a 2D parameter domain/bounding region is an obvious geometric implementation for mapping braided lines to 3D vessel geometry.
Bouillot predicts (page 85, section “Abstract”) “it is subsequently generalized to patient specific vasculature predicting the position of the filaments along with the length and local porosity of the stent” in patient-specific vasculature, which suggests calculating transition zones and compaction zone between distal/proximal aneurysm tips under neck because local compression/transition regions are supported by braided stent geometry and compression modeling.
Bouillot provides (page 85, section “Abstract”) “a deployment model was developed based on geometrical properties of braided stents. The proposed mathematical description is first applied on idealized toroidal vessels demonstrating the stent shortening in curved vessels”; “predicting the position of the filaments along with the length and local porosity of the stent”; and “stent radius assessment” is important. Bouillot teaches local geometry, shortening, length, and porosity. It does not use exactly “transition zone”, “compaction zone”.
Bouillot provides (page 85, section “Abstract”) “stent radius assessment” is important ”in the accuracy of the deployment prediction.” Bouillot suggests local radius/diameter and geometric reference lines/points. Exact “center of rotation” is not explicitly quoted.
Bouillot provides (page 85, section “Abstract”) “deployment model was developed based on geometrical properties of braided stents” and “predicting the position of the filaments”, which teaches filament-position prediction; the 2D clockwise and counter-clockwise lines to 3D-bed projection is a predictable representation of braided helicity filaments.
Bouillot provides (page 85, section “Abstract”) “geometrical properties of braided stents” and prediction of “position of the filaments along with the length and local porosity”, which suggests assigning corresponding strand thickness to 3D lines. Because strand thickness/porosity are ordinary braided-stent geometry parameters.
Larrabide provides (page 721, section “Abstract/Results”) “Computational Fluid Dynamics (CFD) analyzes were carried out on a digital replica of the phantom with the virtually released stent. Virtual angiographies are used to compare in vitro experiments and CFD analysis. Contrast time–density curves for in vitro and CFD data were generated and used to compare them”, which teaches generating stent volume mesh and blood volume mesh in the CFD workflow.
Larrabide provides (page 721, section “Abstract/Results”) “Computational Fluid Dynamics (CFD) analyzes were carried out on a digital replica of the phantom with the virtually released stent”, which teaches simulating hemodynamics after virtual device placement.
Larrabide provides (page 721, section “Abstract/Results”) “In vitro experiments were performed on the phantom where a contrast injection was performed.
Subsequently, corresponding Computational Fluid Dynamics (CFD) analyzes were carried out on a digital replica of the phantom with the virtually released stent. Virtual angiographies are used to compare in vitro experiments and CFD analysis. Contrast time–density curves for in vitro and CFD data were generated and used to compare them”, which suggests calculating post-processing parameters/indices /principles after hemodynamics simulation.
Larrabide provides (page 721, section “Abstract/Conclusion”) “The use of FVS methodology in the clinical environment could provide additional information to clinicians before the treatment to choose the therapy that best fits the patient”, which teaches generating a report to support clinicians treatment/device choice.
Larrabide provides (page 721, section “Abstract/Conclusion”) “The use of FVS methodology in the clinical environment could provide additional information to clinicians before the treatment to choose the therapy that best fits the patient”, which teaches selection based on simulated performance.
Regarding claim 5, Larrabide provides (page 721, section “Abstract/Introduction”) “vessel and aneurysm geometry, hemodynamic conditions.” Larrabide teaches anatomical structure includes blood vessels/arteries and aneurysms, include velocity magnitude.
Regarding claim 8, Larrabide uses (page 721, section “Abstract/Results”) a “digital replica” with virtual stent for CFD; Taylor creates (claim 1) a “three-dimensional model.” combined Larrabide and Taylor teach device models comprise volume mesh and/or CAD geometry. CAD/mesh implementation is routine for CFD and virtual deployment.
Regarding claim 9, Larrabide provides (page 721, title) “Fast virtual deployment of self-expandable stents: Method and in vitro evaluation for intracranial aneurysmal stenting”, which teaches the stent is any neurovascular self-expanding stent.
Regarding claim 13, Bouillot predicts stent diameters in transition zones assigned by trendline (page 89, Table 1 and Fig. 8; page 91, Table 2 and Fig. 13).
Regarding claim 14, Bouillot provides (page 85, section “Abstract”) “a deployment model was developed based on geometrical properties of braided stents. The proposed mathematical description is first applied on idealized toroidal vessels demonstrating the stent shortening in curved vessels. It is subsequently generalized to patient specific vasculature predicting the position of the filaments along with the length and local porosity of the stent”, which suggests angles of clockwise/counterclockwise lines determined in bounding box. Opposite-helicity strand angles are inherent/obvious in braided-stent geometry.
Regarding claim 15, Larrabide provides (page 721, section “Abstract/Conclusion”) “The use of FVS methodology in the clinical environment could provide additional information to clinicians before the treatment to choose the therapy that best fits the patient”, which suggests the post-processing parameters used to predict treatment outcome.
Claim 16 is the “method” version of the claim 1 system. Regarding claim 16, the art applied to claim 1 also teaches claim 16.
Claim 20 is the “method” version of the claim 5 system. Regarding claim 20, the art applied to claim 5 also teaches claim 20.
Claim 23 is the “method” version of the claim 8 system. Regarding claim 23, the art applied to claim 8 also teaches claim 23.
Claim 24 is the “method” version of the claim 9 system. Regarding claim 24, the art applied to claim 9 also teaches claim 24.
Claim 28 is the “method” version of the claim 13 system. Regarding claim 28, the art applied to claim 13 also teaches claim 28.
Claim 29 is the “method” version of the claim 14 system. Regarding claim 29, the art applied to claim 14 also teaches claim 29.
Claim 30 is the “method” version of the claim 15 system. Regarding claim 30, the art applied to claim 15 also teaches claim 30.
It would have been prima facie obvious to combine Larrabide’s virtual intracranial stent deployment and CFD workflow with Bouillot’s detailed braided-stent geometrical deployment, because Larrabide says (page 721, section “Abstract/Introduction”) pre-treatment assessment of stenting alternatives is crucial and can help choose the therapy that best fits the patient. Bouillot says prediction of FDS implantation is required for hemodynamic simulations and procedural planning.
One would reasonably expect success as Larrabide and Bouillot are both directed to intracranial aneurysm stenting/flow-diverter deployment, virtual stenting, CFD, and treatment planning. Larrabide supplies fast virtual stenting and CFD; Bouillot supplies braided-stent geometry and filament/porosity/length prediction; Larrabide and Bouillot compensate each other without interfering each other.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GUOZHEN LIU whose telephone number is (571)272-0224. The examiner can normally be reached Monday-Friday 8-5.
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/GL/
Patent Examiner
Art Unit 1686
/Anna Skibinsky/
Primary Examiner, AU 1635
Prosecution Insights