DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 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.
Claim(s) 15-20 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to program per se. Therefore, claims 15-20 are not directed to a patent eligible statutory category.
Claim 15 is directed to “A computer program product.” Under the 35 U.S.C 101 analysis, determining statutory category, the claim does not fall within at least one of the four categories of patent eligible subject matter, see MPEP § 2106.03. The claim is directed to a product lacking a physical structure in the form of an organizational structure. The claim is directed to a computer program per se (often referred to as “software per se”). “Computer program product” is construed as program code since no hardware is being claimed. Therefore, the claim is ineligible under 35 U.S.C 101. Applicant may amend the claim to “A non-transitory computer readable storage medium comprising a computer program product…” to ensure that the claim is eligible.
Regarding Claims 16-20, the claims are directed to a computer program product as in Claim 15; the claims are ineligible under U.S.C. 101 for the same reasons, but the claims would be eligible if amended similarly to Claim 15 as suggested above.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3, 6, 8-10, 13, 15-17, and 21-23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gildea et al. (WIPO Pub. No. WO2021/007570 A1), hereinafter Gildea.
Regarding Claim 1, Gildea teaches A method for designing a stent (“FIG. 1 illustrates a system 100 for generating patient-specific stent models in accordance with an aspect of the present invention.”) (e.g., paragraph [0021]).
comprising: providing a user interface configured to display a 3D lumen model (“To this end, the executable instructions include an image segmenter 112 that segments at least one image of a region of interest to provide a three-dimensional airway model representing at least a portion of the airway […] A graphic user interface (GUI) 114 allows a user to select a plurality of locations at within the airway model and a corresponding plurality of diameters for the plurality of locations.”) (e.g., paragraphs [0021] and [0023]).
receiving a user input from the user interface indicating a selection of a point of the 3D lumen model (“A graphic user interface (GUI) 114 allows a user to select a plurality of locations at within the airway model and a corresponding plurality of diameters for the plurality of locations.”) (e.g., paragraph [0023]).
determining a 2D cursor position on the user interface corresponding to the selection; (“A graphic user interface (GUI) 114 allows a user to select a plurality of locations at within the airway model and a corresponding plurality of diameters for the plurality of locations […] The input device 214 can include, for example, one or more of a touchscreen, a mouse, a trackball, a keyboard, a microphone, and a gesture recognition interface.”) (e.g., paragraphs [0023] and [0026]).
translating the 2D cursor position to a 3D lumen model position (“A graphic user interface (GUI) 114 allows a user to select a plurality of locations at within the airway model and a corresponding plurality of diameters for the plurality of locations.”) (e.g., paragraph [0023]).
determining a center point of the 3D lumen model based on a proximity to the 3D lumen model position (“The model can include a calculated centerline for the airway in the three-dimensional model for reference by the user.”) (e.g., paragraph [0023]).
determining a diameter for a volume-defining object based on the center point (“In one implementation, the user is prompted to select four initial locations and corresponding diameters, representing a proximal end of the stent, a primary distal end of the stent, a secondary distal end of the stent, and a join location for first and second branches represented by the primary and secondary distal ends of the stent.”) (e.g., paragraph [0023]).
and positioning a center of the volume-defining object at the center point (“Once the initial locations are selected, a model generator 116 constructs a stent model from the selected locations and diameters […] In one implementation, the cylindrical mesh follows the centerline of the airway, although other algorithms, such as a spline approach, can be applied to a set of points selected on the three-dimensional airway model to generate the centerline and diameter of the cylindrical mesh at each point based on the selected locations and diameters.”) (e.g., paragraphs [0024] and [0031]).
Regarding Claim 2, Gildea teaches The method of claim 1. Gildea further teaches the method comprising: forming a stent surface within the 3D lumen model based on a position of the volume-defining object (“Once the initial locations are selected, a model generator 116 constructs a stent model from the selected locations and diameters. In one example, the model generator 116 represents each selected location and diameter as the base of a cylinder and connects the locations using a cylindrical mesh to provide the initial stent model.”) (e.g., paragraph [0024]).
Regarding Claim 3, Gildea teaches The method of claim 1. Gildea further teaches wherein determining the diameter for the volume- defining object includes determining a diameter of a cross-section of the 3D lumen model through the center point (“In one implementation, the cylindrical mesh follows the centerline of the airway, although other algorithms, such as a spline approach, can be applied to a set of points selected on the three-dimensional airway model to generate the centerline and diameter of the cylindrical mesh at each point based on the selected locations and diameters.”) (e.g., paragraph [0031]).
Regarding Claim 6, Gildea teaches The method of claim 1. Gildea further teaches the method comprising: forming a 3D stent model including a stent surface using a position and diameter of the volume-defining object (“Once the initial locations are selected, a model generator 116 constructs a stent model from the selected locations and diameters […] In one implementation, the cylindrical mesh follows the centerline of the airway, although other algorithms, such as a spline approach, can be applied to a set of points selected on the three-dimensional airway model to generate the centerline and diameter of the cylindrical mesh at each point based on the selected locations and diameters.”) (e.g., paragraphs [0024] and [0031]).
Regarding Claim 8, Gildea teaches A stent design system, comprising: a display configured to output a user interface; a user input device configured to control a 2D cursor position on the user interface; a processing device; and a memory device configured to store a set of instructions which, when executed by the processing device, is configured to (“FIG. 2 illustrates an example of a system 200 that facilitates design of a patient-specific stent for placement within an airway of a patient. The system 200 includes a computing device 210 that includes a processor 212, an input device 214, an output device 216, a network interface 218, and a non-transitory medium 220 […] The input device 214 can include, for example, one or more of a touchscreen, a mouse, a trackball, a keyboard, a microphone, and a gesture recognition interface.”) (e.g., paragraph [0021]).
The remaining limitations of Claim 8 recite substantially similar limitations to Claim 1, and the claim is rejected under U.S.C. 102(a)(1) for the same reasons.
Regarding Claims 9-10 and 13, the claims recite substantially similar limitations to Claims 2-3 and 6, respectively, and the claims are rejected under U.S.C. 102(a)(1) for the same reasons.
Regarding Claim 15, Gildea teaches A computer program product for use on a computer system for designing a stent, the computer program product comprising a tangible, non-transient computer usable medium having computer readable program code thereon (“The system 100 includes a processor 102 and a non-transitory memory 110 storing computer executable instructions for designing a stent for placement within an airway of a patient.”) (e.g., paragraph [0021]).
The remaining limitations of Claim 15 recite substantially similar limitations to Claim 1, and the claim is rejected under U.S.C. 102(a)(1) for the same reasons.
Regarding Claims 16 and 17, the claims recite substantially similar limitations to Claims 2 and 3, and the claims are rejected under U.S.C. 102(a)(1) fort the same reasons.
Regarding Claim 21, Gildea teaches A method for designing an airway stent (“FIG. 1 illustrates a system 100 for generating patient-specific stent models in accordance with an aspect of the present invention. The system 100 includes a processor 102 and a non-transitory memory 110 storing computer executable instructions for designing a stent for placement within an airway of a patient.”) (e.g., paragraph [0021]).
The remaining limitations of Claim 21 recite substantially similar limitations to Claim 1, and the claims are rejected under U.S.C. 102(a)(1) for the same reasons.
Regarding Claims 22 and 23, the claims recite substantially similar limitations to Claims 2 and 3, respectively, and the claims are rejected under U.S.C. 102(a)(1) for the same reasons.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claim(s) 4, 11, 18, and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gildea in view of Kohlmann et al. (U.S. Pub. No. 2010/0135554 A1), hereinafter Kohlmann.
Regarding Claim 4, Gildea teaches The method of claim 1. However, Gildea does not appear to specifically teach wherein translating the 2D cursor position to a 3D lumen model position includes: forming a ray based on a position of a camera view and the 2D cursor position; and determining a point of a lumen surface intersected by the ray.
On the other hand, Kohlmann, which relates similarly as a method for viewing medical images, does teach wherein translating the 2D cursor position to a 3D lumen model position includes: forming a ray based on a position of a camera view and the 2D cursor position (“The apparatus 10 comprises a display 11, e.g. a TFT screen, for displaying a volumetric view 17 and slice views 12 of the image data 18a and a mouse 13 serving as a pointing unit enabling the user, e.g. a physician, to point or to pick at a position on a structure of interest in the displayed volumetric view 17 by moving a pointer 14 to the structure of interest on the displayed volumetric view 17 […] The apparatus 10 further comprises a processing unit 16 for generating a viewing ray profile, in particular an intensity and/or gradient magnitude value profile, of a ray running through a volume intersection of said displayed structure of interest.”) (e.g., paragraphs [0062] and [0065]).
and determining a point of a lumen surface intersected by the ray (“The apparatus 10 further comprises a processing unit 16 for generating a viewing ray profile, in particular an intensity and/or gradient magnitude value profile, of a ray running through a volume intersection of said displayed structure of interest.”) (e.g., paragraph [0065]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the Applicant’s claimed invention to combine Gildea with Kohlman. The claimed invention is considered to be merely combining prior art elements according to known methods, see MPEP § 2143(I)(A). Gildea teaches a method for designing a stent for placement within an airway using a graphic user interface. However, Gildea does not appear to specifically teach translating a 2D cursor position to a 3D lumen model by forming a ray based on a position of a camera view and the cursor position. On the other hand, Kohlman, which relates similarly as a method for viewing medical images, does teach generating a ray running through a structure of interest selected by a user. As both Gildea and Kohlman relate to user interfaces for medical images (e.g., Gildea, paragraph [0003]; Kohlman, paragraph [0010]), one of ordinary skill in the art could have combined the stent design interface of Gildea with the cursor translation of Kohlman, and each element merely performs the same function as it does separately. Furthermore, Gildea already discloses a 3D airway model (e.g., Gildea, paragraph [0022]), which is interacted with using a mouse (e.g., Gildea, paragraph [0026]); Kohman provides a specific implementation for using a 2D input to interact with a 3D model. Thus, one of ordinary skill in the art would have recognized the results of the combination as predictable. Therefore, it would have been obvious to one of ordinary skill in the art to combine Gildea with Kohlman to provide a specific implementation for mapping a cursor position to a 3D lumen model.
Regarding Claims 11, 18, and 24, the claims recite substantially similar limitations to Claim 4, and the claims are rejected under U.S.C. 103 for the same reasons.
Claim(s) 5, 7, 12, 14, 19-20, and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gildea in view of Gopinath et al. (U.S. Pub. No. 2020/0294659 A1), hereinafter Gopinath.
Regarding Claim 5, Gildea teaches The method of claim 1. Gildea further teaches wherein the cross-sectional includes a representation of the center point (“The model can include a calculated centerline for the airway in the three-dimensional model for reference by the user.”) (e.g., paragraph [0023]).
However, Gildea does not appear to specifically teach wherein determining the diameter for the volume- defining object includes: displaying a cross-section of the 3D lumen model […] a representation of the shortest and longest diameters of the cross-section, a representation of a cross-section of a stent, and a representation of a diameter of the stent, wherein the cross-section is configured to receive a stent adjustment from a user.
On the other hand, Gopinath, which relates similarly as a method for designing arterial stents, does teach wherein determining the diameter for the volume- defining object includes: displaying a cross-section of the 3D lumen model (“the method also includes displaying a second panel in the user interface, the second panel comprising a first cross-sectional view of a position along the longitudinal section […] FIG. 3A shows a graphical user interface of a stent sizing workflow. In the upper portion of the interface, there three views in the top portion of the figure that corresponding to frames or particular views or slices of artery at proximal reference 151.”) (e.g., paragraphs [0013] and [0102]).
a representation of the shortest and longest diameters of the cross-section (“In one embodiment, the method also includes displaying a diameter value for the proximal reference and a diameter value for the distal reference […] The view in lower portion of FIG. 3A shows a combined Ca and EEL [(External Elastic Lamina)] in Lumen Profile view. The proximal and distal references 151, 155 shows lumen L with one or more dotted lines passing through lumen L. These values from measuring these lines are applied to measured or detected EEL positions, points, or pixels and are used to generate a measured EEL diameter or an average EEL diameter. Some exemplary EEL diameter measure is shown as about 3.8 mm (proximal) and about 3.4 (distal).”) (e.g., paragraphs [0014] and [0103]).
a representation of a cross-section of a stent, and a representation of a diameter of the stent (“FIG. 5B is a user interface showing a review mode of stent placement relative to an artery representation […] In one embodiment, a stent is visualized as a mesh or graphic object with cross-hatching. The landing zones for the stent, S and T, are shown in various views. The EEL diameter is shown at a frame or segment location 180. The minimum stent expansion 73% is shown. The horizontal line shown in color corresponds to stent expansion. Stent expansion for frame or location 180 is also shown in top right with another view showing 83% stent expansion at the point along the stent and a lumen area of about 9.09 at that location/frame 180.”) (e.g., paragraphs [0107] and [0108]).
wherein the cross-section is configured to receive a stent adjustment from a user (“An example of the measurement of such a diameter is shown in FIGS. 3A-3D as part of the stent sizing workflow in which lumen diameter or another lumen distance and EEL diameter or another EEL distance can be reviewed by end users to size stents based on these arterial measures and candidate landing zones.”) (e.g., paragraph [0083]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the Applicant’s claimed invention to combine Gildea with Gopinath. The claimed invention is considered to be merely combining prior art elements according to known methods, see MPEP § 2143(I)(A). Gildea teaches a method for designing a stent for placement within an airway using a graphic user interface. However, Gildea does not appear to specifically teach generating cross sectional images of a lumen or generating cross sectional images of a stent, wherein the stent cross sections are overlaid on image slices of the lumen. On the other hand, Gopinath, which relates similarly as a method for designing arterial stents, does teach generating cross sectional images of a lumen and generating cross sectional images of a stent, wherein the stent cross sections are overlaid on image slices of the lumen. As both Gildea and Gopinath relate to designing stents (e.g., Gildea, paragraph [0003]; Gopinath, abstract), one of ordinary skill in the art could have combined the stent design interface of Gildea with the lumen and stent slicing of Gopinath. In combination, each element merely performs the same function as it does separately; thus, one of ordinary skill in the art would have recognized the results of the combination as predictable. Therefore, it would have been obvious to one of ordinary skill in the art to combine Gildea with Gopinath in order to provide additional stent an lumen visualizations.
Regarding Claim 7, Gildea teaches The method of claim 6. However, Gildea does not appear to specifically teach the method comprising: translating the 3D stent model into a sliced object; determining an image slice intersecting the 3D stent model; overlaying the sliced object onto the image slice; and displaying the overlayed image slice.
Otoh, Gopinath, which relates similarly as a method for designing arterial stents, does teach translating the 3D stent model into a sliced object (“FIG. 5B is a user interface showing a review mode of stent placement relative to an artery representation […] In one embodiment, a stent is visualized as a mesh or graphic object with cross-hatching.” Figures 5B and 5C further illustrate multiple cross sections of the stent model overlaid on a cross section of an arterial lumen.) (e.g., Figures 5B and 5C; paragraphs [0107] and [0108]).
determining an image slice intersecting the 3D stent model overlaying the sliced object onto the image slice; and displaying the overlayed image slice (“FIG. 5B is a user interface showing a review mode of stent placement relative to an artery representation […] In one embodiment, a stent is visualized as a mesh or graphic object with cross-hatching.” Figures 5B and 5C further illustrate multiple cross sections of the stent model overlaid on a cross section of an arterial lumen.) (e.g., Figures 5B and 5C; paragraphs [0107] and [0108]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the Applicant’s claimed invention to combine Gildea with Gopinath for the same reasons as in Claim 5, above.
Regarding Claims 12, 14, and 19, the claims recite substantially similar limitations to Claims 5, 7, and 5, respectively, and the claims are rejected under U.S.C. 103 for the same reasons.
Regarding Claim 20, the claim recites substantially similar limitations to Claims 6 and 7, and the claim is rejected under U.S.C. 103 for the same reasons.
Regarding Claim 25, the claim recites substantially similar limitations to Claim 5, and the claim is rejected under U.S.C. 103 for the same reasons.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Goel et al. (U.S. Pub. No. 2019/0279367 A1) teaches a method for determining a centerline of a lumen.
Douglas et al. (U.S. Pub. No. 2020/0409480 A1) teaches a method for manipulating 3D medical images.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE HWA-KAI TSENG whose telephone number is (571)272-3731. The examiner can normally be reached M-F 9A-5P PST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rehana Perveen can be reached at (571) 272-3676. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/K.H.T./ Examiner, Art Unit 2189
/REHANA PERVEEN/ Supervisory Patent Examiner, Art Unit 2189
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