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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the flow metric map of existing flow with the virtual medical device masked from the flow data must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-42 and 47 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1 is rejected because the specification, as originally filed, fails to support the amended limitation of generating a flow metric map characterizing existing flow within the volume of interest using the masked medical flow data as now claimed. While Applicant asserts support is found in Paragraph [0036] (REMARKS, page 10), however, Paragraph [0036] fails to disclose existing flow. Claim 47 appears to have a similar issue.
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 1-42 and 47 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 is rejected because it is unclear how the computer system generates a flow metric map characterizing existing flow within the volume of interest using the masked medical flow data as now claimed. As best understood, the masked medical flow data would result from virtually inserting the device within the vessel which would not characterize “existing” flow as now claimed. Claim 47 appears to have the same issue(s).
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.
Claim(s) 1-3, 12, 14, 17-19, 24-25, 27-38 and 43-44 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2011/0144658 to Wenderow et al. “Wenderow” in view of U.S. Publication No. 2018/0353241 to Tu et al. “Tu” and NPL “Bicuspid Aortic Valve Is Associated With Altered Wall Shear Stress in the Ascending Aorta” to Barker et al. “Barker” and U.S. Publication No. 2018/0353241 to Tu et al. “Tu”.
As for Claims 1, 12, 17-19, 24-25, 27-33 and 43-44, Wenderow discloses a catheter simulation system and method for generating a flow metric map from medical flow data to provide feedback regarding the efficacy of a virtual catheterization procedure on restoring blood flow through a portion of a coronary artery (Abstract; Paragraphs [0004], [0006] and [0045]). Examiner notes that the portion of the coronary would read on a reference point within a volume of interest in its broadest reasonable interpretation. Wenderow discloses wherein the system obtains patient specific medical flow data (Paragraphs [0025], [0040]-[0041] and [0045]) used for the aforementioned simulation to simulate the effect the virtual catheter has on the blood flow (Paragraphs [0045] and [0047]). Wenderow explains that the virtual catheter is displayed over the medical image data and is changed as the user manipulates the simulation controls (Paragraph [0038]-[0039] and [0041]). Examiner notes that by displaying the virtual catheter “over” the medical image data, Wenderow would read on the steps of defining a virtual medical device representing an invasive medical device having a virtual volume and generating “masked” data using the virtual volume in its broadest reasonable interpretation. Moreover, the simulated effects of blood flow would read on the claimed step of computing at least one flow metric based on the masked data in its broadest reasonable interpretation.
However, the masked blood flow data does not appear to be represented as a subset of the medical flow data as now claimed.
Tu teaches from within a similar field of endeavor with respect to simulating post medical device results on blood flow (Abstract) where segments (e.g. subsets) of the blood vessel are separately represented (Paragraphs [0007], [0042] and [0087]) so that “post stent” segments may replace one of the pre-stent segments (Paragraphs [0010], [0058] and [0077]).
Accordingly, one skilled in the art would have been motivated to have modified the blood flow representations described by Wenderow to be computationally defined and stored as segments as described by Tu in order to replace segments with simulated flow data of post device intervention. Such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
However, while Wenderow discloses “blood flow data” (Paragraph [0045]) it is not clear if the blood flow data is represented as a flow metric map as claimed.
Barker teaches from within a similar field of endeavor with respect to visualizing flow data where a flow metric map is generated from medical flow data (Abstract; Figs. 2A-B and 3A-C and corresponding descriptions) including steps of accessing medical flow data with a computer system The flow metric map includes computing a flow metric (e.g. velocity) (Figs. 2A-2B, 3A-C and corresponding descriptions).
Accordingly, one skilled in the art would have been motivated to have modified the blood flow data as described by Wenderow to use conventional blood flow metric maps described by Barker in order to enhance the visualization of the simulated effects on blood flow during the simulated virtual catheter procedure. Such a modification merely involves combining prior art elements according to known techniques to yield predicable results (MPEP 2143).
As for Claims 2-3, Examiner notes that the simulated catheter’s volume is based on a distance relative to the reference point and would include one or more radii in its broadest reasonable interpretation.
As for Claim 14, Examiner notes that the flow models depicted by Barker (Figs. 2B and 3B) comprise a flow direction at one or more time points and a magnitude of the flow path in its broadest reasonable interpretation.
As for Claim 34, Examiner notes that the 4D flow data for 3D visualization depicted by Barker (Figs. 2B and 3B) is considered to read on a particle image velocimetry data given that velocity is mapped in parts.
Regarding Claims 35-36, Examiner notes that the 4D flow data for 3D visualization depicted by Barker (Figs. 2B and 3B) is considered to be multidimension flow data that includes at least one dimensional data in its broadest reasonable interpretation.
Regarding Claims 37-38, Examiner notes that the 4D flow data for 3D visualization depicted by Barker (Figs. 2B and 3B) is considered to a flow metric map at one or more time points along one or more directions in its broadest reasonable interpretation.
Claim(s) 4-7, 10-11, 13, 20-23, 26, 39, 45 and 48 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wenderow, Tu and Barker as applied to Claims 3, 12, 19, 25 and 43 above and in further view of U.S. Publication No. 2013/0066219 to Jiang et al. “Jiang”.
As for Claims 4-6, 20-23, 26 and 48, Wenderow, Tu and Barker disclose a system and method for generating a flow metric map during a simulated (e.g. virtual) catheterization procedure as described above. However, the art of record does not expressly depict a centerline of the vessel as claimed.
Jiang teaches from within a similar field of endeavor with respect to producing a computational flow dynamic model of a blood vessel (Abstract) where a vessel model is constructed about a known centerline which is calculated (Paragraph [0023]).
Accordingly, one skilled in the art would have been motivated to have modified the simulation system and method described by Wenderow, Tu and Barker to define a vessel centerline as described by Jiang in order to correctly position the virtual catheter. Such a modification merely involves combining prior art elements according to known techniques to yield predicable results (MPEP 2143).
As for Claim 7, Examiner notes that the virtual tubular catheter displayed in the simulation would include a single radius based on the catheter’s size.
As for Claims 10-11, Jiang explains that a region may be defined using a Euclidean distance (Paragraphs [0029]-[0031). Accordingly, one skilled in the art would have been motivated to have utilized the Jiang’s processing technique to render the virtual catheter’s representation in the aforementioned simulation.
With respect to Claims 13, 39 and 45, Barker discloses segmenting the region (Page 458 “Data Analysis”) and Jiang explains that the vessel model is generated by segmenting reconstructed images (Abstract). Examiner notes that the segmenting would be considered thresholding in its broadest reasonable interpretation.
Claim(s) 8-9, 15-16, 40-42 and 46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wenderow, Tu, Barker and Jiang as applied to claims 2, 12, 39 and 45 above, and further in view of U.S. Publication No. 2020/0167930 to Wang et al. “Wang”.
As for Claims 8-9, 15-16, 40-42 and 46, Wenderow, Tu, Barker and Jiang disclose a system and method for generating flow metric map from medical flow data as described above. However, Wenderow, Tu, Barker and Jiang do not expressly disclose measuring a distance as a non-Euclidean distance for the reference point and where the distance is measured based on a geodesic distance as claimed.
Wang teaches from within a similar field of endeavor with respect to medical image processing and particularly with respect to segmenting an input image (Abstract) where geodesic distance transforms may be used to differentiate neighboring pixels (Paragraphs [0072], [0099], [0150], [0163]).
Accordingly, one skilled in the art would have been motivated to have modified the system and method for generating flow metric map from medical flow data as described by Wenderow, Tu, Barker and Jiang to utilize conventional machine learning segmentation algorithms that utilize geodesic or Euclidean distance transforms as described by Wang in order to reduce the burden on the user and enhance segmentation. Such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
With respect to Claim 15-16, Wang discloses wherein a region growing can be used for unsupervised and supervised image specific fine tuning (Paragraphs [0192]-[0193]). Examiner notes that the region growing algorithm would be based on an initial point (e.g. seed).
Claim(s) 47 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wenderow, Tu, Barker and Wang.
As for Claim 47, Wenderow, Tu and Barker disclose a system and method for generating a flow metric map during a simulated (e.g. virtual) catheterization procedure as described above.
However, Wenderow and Barker does not disclose wherein the image is inputted a trained machine learning algorithm as claimed.
As for the trained algorithm, Wang teaches from within a similar field of endeavor with respect to medical image processing and particularly with respect to segmenting an input image (Abstract) where geodesic distance transforms may be used to differentiate neighboring pixels (Paragraphs [0072], [0099], [0150], [0163]).
Accordingly, one skilled in the art would have been motivated to have modified the system and method for generating flow metric map from medical flow data as described by Wenderow, Tu and Barker to utilize conventional machine learning segmentation algorithms that utilize geodesic or Euclidean distance transforms as described by Wang in order to reduce the burden on the user and enhance segmentation during the simulated catheterization. Such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
Response to Arguments
Applicant’s arguments have been considered but they are moot in view of the updated grounds of rejection necessitated by amendment. New 35 U.S.C. 112 rejections also necessitated by amendment.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER L COOK whose telephone number is (571)270-7373. The examiner can normally be reached M-F approximately 8AM-5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Kozak can be reached on 571-270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTOPHER L COOK/Primary Examiner, Art Unit 3797