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 Objections
Claims 1, 8, 14 and 15 are objected to because of the following informalities:
In each of claims 1, 14 and 15, Examiner suggests replacing the word “analyse” and “analysing” with “analyze” and “analyzing”, respectively. Appropriate correction is required;
In claim 8, Examiner suggests removing the reference numerals (140) and (150).
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, 14 and 15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claims 1, 14 and 15 recite a system, method and computer-readable medium, respectively, for identifying deformations of a deployed stent. The limitations of “analyse the X-ray image data…” and “identify one or more longitudinally-deformed portions of the stent…” as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting “one or more processors configured to” (claim 1), “computer-implemented” (claim 14), and “a non-transitory computer-readable storage medium having stored a computer program…executed by one or more processors” (claim 15), nothing in the claim elements precludes these steps from practically being performed in the mind. For example, but for the “one or more processors configured to” (claim 1), “computer-implemented” (claim 14), and “a non-transitory computer-readable storage medium having stored a computer program…executed by one or more processors” (claim 15) language, “analyse”/”analysing” and “identify”/”identifying” in the context of the claims encompasses a trained radiologist mentally assessing and identifying a deformed stent while viewing an x-ray image. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claims only recite the additional elements of “one or more processors configured to” (claim 1), “computer-implemented” (claim 14), and “a non-transitory computer-readable storage medium having stored a computer program…executed by one or more processors” (claim 15). Each of these elements is recited at a high level of generality, such that it amounts to no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of computer/processor implementation of the steps amount to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. The claims recite the additional element of receiving X-ray image data prior to the analysing and identifying steps, which amounts to no more than insignificant extra-solution activity. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Therefore, independent claims 1, 14 and 15 are not patent eligible.
Dependent claims 2-3 and 10-11 are additionally rejected under 35 USC 101 because they recite additional elements which amount to further mental processes without significantly more, and/or mere data gathering or post-processing steps such as displaying, which are insignificant extra-solution activities.
Claim Rejections - 35 USC § 102
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 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.
Claims 1, 2, 11, 14 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by “Stent fracture and longitudinal compression detected on coronary CT angiography in the first- and new-generation drug-eluting stents” (hereinafter “Chung”; applicant-submitted prior art).
Regarding claim 1, Chung discloses a system for identifying deformations of a deployed stent, the system comprising: one or more processors configured to (Chung, Abstract, Fig. 1; “To evaluated prevalence and clinical implication of stent fracture and longitudinal compression in first- and new-generation drug-eluting stents (DES) using coronary computed tomography angiography (CCTA).” The use of computed tomography necessitates one or more processors.):
receive X-ray image data representing one or more X-ray images of a deployed stent within a lumen, the stent including a plurality of stent struts (Chung, “CT imaging and analysis”, p.638-639, Fig. 1e; “CCTA was performed using a first- or second-generation dual source CT scanner” to obtain images of a deployed stent, stent struts being visualized in Fig. 1(e));
analyse the X-ray image data to determine a distribution of the stent struts along an axis of the lumen (Chung, “CT imaging and analysis”, p.638-639, Fig. 1, p.641, Discussion; “Using CCTA, we identified unique findings of longitudinal compression, with uneven distortion or shortening of stent struts in the longitudinal axis and increased strut density in the shortened area.”); and
identify one or more longitudinally-deformed portions of the stent based on a density of the determined distribution of the stent struts along the axis of the lumen (Chung, “CT imaging and analysis”, p.638-639, Fig. 1, Fig. 3d, p.641, Discussion; “Using CCTA, we identified unique findings of longitudinal compression, with uneven distortion or shortening of stent struts in the longitudinal axis and increased strut density in the shortened area.”).
Regarding claim 2, claim 1 is incorporated, and Chung further discloses wherein the one or more processors are configured to identify the one or more longitudinally-deformed portions of the stent by: displaying the one or more X-ray images, and indicating, in the displayed one or more X-ray images, the one or more longitudinally-deformed portions of the stent (Chung, Fig. 1, arrows pointing to points of longitudinal compression on display images).
Regarding claim 11, claim 1 is incorporated, and Chung further discloses wherein the one or more longitudinally-deformed portions comprise one or more longitudinally-compressed portions of the stent and/or one or more longitudinally-extended portions of the stent (Chung, “CT imaging and analysis”, p.638-639, Fig. 1, Fig. 3d, p.641, Discussion; “Using CCTA, we identified unique findings of longitudinal compression, with uneven distortion or shortening of stent struts in the longitudinal axis and increased strut density in the shortened area.”).
Claim 14 recites a method having features which correspond to the elements recited in system claim 1, the rejection of which is applicable here.
Claim 15 recites a computer-readable storage medium storing a computer program having features which correspond to the elements recited in system claim 1, the rejection of which is applicable here.
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.
Claims 3 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Chung, as applied to claim 1 above, in view of US PG Pub. 2019/0365480 (hereinafter “Gopinath”; applicant-submitted prior art).
Regarding claim 3, claim 1 is incorporated, and Chung does not expressly teach the limitations as further claimed, but, in an analogous field of endeavor, Gopinath does as follows.
Gopinath teaches wherein the one or more processors are configured to identify the one or more longitudinally-deformed portions of the stent by: comparing the density of the determined distribution of the stent struts along the axis of the lumen, to one or more threshold density values; and assigning a marker indicative of the one or more threshold density values to one or more corresponding portions of the stent ((Gopinath, ¶0064; “the stent expansion threshold used to identify regions of stent under inflation range from about 80% to about 90%. Thus, if a stent is inflated at a first location along its length to a level of 48% it is tagged or represented with one visual cue or indicia, while if at another region the stent is expanded to a level at or above the threshold it is identified with another visual cue or indicia.”).
Gopinath is considered analogous art because it pertains to stent image analysis. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system taught by Chung to include comparing the stent strut distribution to a threshold and marking identified under-inflated stent regions with a particular visual cue, as taught by Gopinath, in order to enable a physician to easily view regions of the stent which are underinflated (Gopinath, ¶0070-0071).
Regarding claim 10, claim 1 is incorporated, and Chung does not expressly teach the limitations as further claimed, but, in an analogous field of endeavor, Gopinath does as follows.
Gopinath teaches wherein the one or more processors are further configured to:
receive input defining an extent of the one or more X-ray images to be analysed (Gopinath, ¶0099-0115; “When placing a stent, it is advantageous to select landing zones that are normal/healthy tissue, this facilitates the interpolation of simulation of a healthy fully expanded vessel as a baseline comparator for the lumen profile that arises based on how the stent was actually expanded/under expanded. In one embodiment, cursors or other on-screen user interface elements are placed at both ends of a stented region, such as reference points R1 and R2.”); and
analyse the X-ray image data by analysing the X-ray images only within the defined extent (Gopinath, ¶0099-0115; “In one embodiment, the method to determine a target stent profile in response to one or more user selected reference frames is as follows…”).
Gopinath is considered analogous art because it pertains to stent image analysis. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system taught by Chung to include receiving input of reference points within which to perform stent detection and analysis, as taught by Gopinath, in order to reduce computation time and enable a physician to more easily assess stent expansion (Gopinath, ¶0114-0115).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Chung, as applied to claim 1 above, in view of EP 3 466 326 B1 (hereinafter “Kunio”; applicant-submitted prior art).
Regarding claim 4, claim 1 is incorporated, and Chung does not expressly teach the limitations as further claimed, but, in an analogous field of endeavor, Kunio does as follows.
Kunio teaches wherein the one or more processors are further configured to at least one of:
i) compute the density of the determined distribution of the stent struts along the axis of the lumen in relation to an expected density for the stent; and
identify the one or more longitudinally-deformed portions of the stent, by displaying the computed density as a proportion of the expected density; or
ii) compute the density of the determined distribution of the stent struts along the axis of the lumen; determine an actual length of the stent (130) based on the density (“¶0028-0032; “In step S40, a number of OCT image frames in which stent-struts are detected (Group Gs) is determined. Then in step S50, a stent length is calculated based on the number of OCT image frames and an OCT pullback speed”); and
identify the one or more longitudinally-deformed portions of the stent, by displaying the actual length as a proportion of an expected length of the stent (¶0028-0032, 0044-0045, Figs. 13A-B; “In step S60, the calculated stent length is compared to the actual stent length obtained in step S10 from importing stent information to evaluate the difference between the calculated stent length and the actual stent length” and “In both FIGS. 13A and 13B, the difference between the actual stent length and the calculated stent length 184 is shown underneath the longitudinal view 182 of the OCT pullback so that the user is aware of the quality of OCT pullback.”).
Kunio is considered analogous art because it pertains to evaluation of stent expansion in the vessel of a patient. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system taught by Chung to include computing a length of a deployed stent, comparing it to an actual length of the stent, and displaying the proportional difference on a user interface, as taught by Kunio, in order to enable the physician to easily visualize the quality of the stent expansion (Kunio, ¶0007).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Chung, as applied to claim 1 above, in view of US PG Pub. 2012/0075638 A1 (hereinafter “Rollins”).
Regarding claim 8, claim 1 is incorporated, and Chung does not expressly teach the limitations as further claimed, but, in an analogous field of endeavor, Rollins does as follows.
Rollins teaches wherein the one or more processors are configured to analyse the X-ray image data by:
applying a spatial filter to the one or more X-ray images, and estimating a density of the distribution of the stent struts along the axis of the lumen by fitting a stent model to the filtered one or more X-ray images; or
estimating a density of the distribution of the stent struts along the axis of the lumen (140) by applying one of more image templates representing a predetermined distribution of stent struts (150), to the one or more X-ray images; or
inputting the one or more X-ray images into a neural network trained to predict a stent strut density distribution from inputted X-ray images (Rollins, ¶0100-0113; “the BVS stent detection can be performed using a classification method. Features including but not limited to the following may be considered: (1) The shape of the BVS strut, represented as a rectangular frame in OCT images. The shape can appear as deformed rectangles due to the eccentricity of imaging wire or different designs of stent types. A training database may be used to build a template library including all possible shapes for BVS struts. Templates are sorted according to the probability density function drawn from the statistics of the training library and use the sorted templates for future stent detection” wherein “Several quantitative measures can be derived from the detected/segmented stents with reference to the segmented lumen, including but not limited to, number of uncovered and covered stent struts, number of malaposed stent struts 214, stent area, area of coverage computed as (stent area-lumen area) applicable to follow-up cases, coverage thickness for each strut and coverage thickness versus angle.” Rollins teaches multiple techniques for stent detection/segmentation in medical images, which in turn are used for quantification of stent strut measures, including stent area and number of stent struts. The techniques disclosed in Rollins covers at least one of the alternative analysis techniques as required by the claim.).
Rollins is considered analogous art because it pertains to stent detection in medical images. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system taught by Chung to include analyzing the images to detect stent features and use the segmented features to derive quantitative measures of the stent area and number of struts, as taught by Rollins, in order to reduce analysis time and facilitate timely decision making for intervention procedures (Rollins, Abstract).
Allowable Subject Matter
Claims 5-7, 9 and 12-13 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art of record, either alone or in combination, does not expressly teach or render obvious the limitations of at least claims 5, 9 or 12.
With respect to claims 5-7, although Kunio, cited above with respect to claim 4, teaches identifying under-expanded portions of the stent based on a difference between a calculated length of the stent after pull-back and an expected actual length of the stent, it does not expressly teach computing an expected post-deployment length of the un-deployed portion of the stent based on a distribution of the stent struts in the deployed portion, as claimed. Claims 6-7 are considered allowable by virtue of their dependency from claim 5.
Regarding claim 9, while Rollins teaches that a trained database may store templates of various stent types for template matching-based stent detection, he does not expressly disclose or suggest training a neural network to predict a stent strut density based on ground truth data of labeled strut density, and adjusting parameters of the neural network based on a loss function representing a difference between a predicted strut density along an axis of the stent that is predicted by the neural network, and the ground truth data for the stent, as claimed.
Regarding claims 12-13, Gopinath and Kunio cited above both teach imaging an interventional device during deployment of a stent, but neither reference expressly teaches the interventional device comprising fiducial markers from which a scale factor for the X-ray image is determined and subsequently used to determine the density of the distribution of the stent struts along the axis of the lumen, as is claimed.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The additionally cited prior art pertains generally to stent placement and deformation analysis.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMAH A BEG whose telephone number is (571)270-7912. The examiner can normally be reached M-F 9 AM - 5 PM.
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/SAMAH A BEG/Primary Examiner, Art Unit 2676