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 information disclosure statement (IDS) filed on 11/8/2024 was considered and placed on the file of record by the examiner. The Other References #23-#25 in the IDS dated 11/8/2024 are missing and therefore not considered. Please provides copies of the documents #23-#25.
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, 2, 9, 10, and 11 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. The dependent claims 2-9 are rejected based on their dependency because the claims do not clarify the indefinite claim 1.
The following highlighted claims 1, 10, and 11 elements are vague and indefinite because the it is not clear whether the FFR value is singular or plural;
“perform a fluid analysis on the image data according to a coronary artery model which represents the coronary artery of the patient rendered the image data, to obtain spatial distribution of FFR value among the coronary artery,
determine a potential stenosis position by analyzing at least one of spatial distribution of shape of the coronary artery or spatial distribution of FFR value, determine a representative position on the coronary artery by using the determined potential stenosis position,
select a representative value at the representative position from among the FFR value in positions,”
The following highlighted claim 2 elements are vague and indefinite because the it is not clear whether the FFR value is singular or plural;
“Claim 2. The apparatus according to claim 1, wherein the processing circuitry is configured to determine the potential stenosis position based on a change amount in the FFR value along an extending direction of the coronary artery.”
The following highlighted claim 9 elements are vague and indefinite because the it is not clear whether the FFR value is singular or plural;
“Claim 9. The apparatus according to claim 1, wherein the processing circuitry is configured to switch the representative value with a marker on the image into a chart indicating the FFR value in the coronary artery, in response to an operation performed by an operator.”
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)(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.
Claims 1, 3-5, 7, 9-11 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Taylor et al. (US 2013/0211728).
Regarding claim 1, Taylor teaches an apparatus for analyzing a coronary artery image, the apparatus comprising: processing circuitry configured to:
obtain image data rendering a coronary artery of a patient (see para. 0198, Taylor discusses computer system displaying images of coronary arteries),
perform a fluid analysis on the image data according to a coronary artery model which represents the coronary artery of the patient rendered the image data, to obtain spatial distribution of FFR value among the coronary artery (see para. 0158, Taylor discusses blood flow characteristic associated with the patient's modeled anatomy, e.g., at the boundaries of the modeled anatomy, and the blood flow characteristics may include blood flow velocity, pressure, flow rate, FFR),
determine a potential stenosis position by analyzing at least one of spatial distribution of shape of the coronary artery or spatial distribution of FFR value, determine a representative position on the coronary artery by using the determined potential stenosis position (see para. 0205, Taylor discusses functionally significant lesions located by finding a narrowing or stenosis located near the location of the cFFR model having the local minimum cFFR value),
select a representative value at the representative position from among the FFR value in positions (see para. 0205, Taylor discusses displaying to the user the portions of the cFFR and FFR model that includes the functionally significant lesion), and
cause a display to display the representative value in a predetermined display region with a marker which represents position of the representative position among the coronary artery on an image which represents the coronary artery (see figure 23, Taylor discusses markers indicating cFFR values along coronary artery; see figure 25 figure 26, para. 0205, Taylor discusses displaying to the user the portions of the cFFR model that includes the functionally significant lesion).
Regarding claim 3, Taylor teaches wherein the processing circuitry is configured to determine the potential stenosis position based on a change amount in a cross-sectional area of the coronary artery along an extending direction of the coronary artery (see para. 0254, Taylor discusses diseased portions and stenoses may be identified, e.g., by measuring the cross-sectional area along the length of the centerline and calculating locally minimum cross-sectional areas).
Regarding claim 4, Taylor teaches wherein the processing circuitry is configured to determine the potential stenosis position based on a size in a coronary artery diameter of the coronary artery along an extending direction of the coronary artery (see para. 0179, 0274, Taylor discusses diseased portions and stenoses may be identified, by measuring the cross-sectional area along the length of the centerline and calculating locally minimum cross-sectional areas).
Regarding claim 5, Taylor teaches wherein the processing circuitry is configured to determine the potential stenosis position based on previously designated position relative to the coronary artery (see figure 21, figure 22, Taylor discusses previously captured image data used as reference to determine a potential stenosis position).
Regarding claim 7, Taylor teaches wherein the processing circuitry is configured to cause the display to display the representative value in the predetermined display region with the marker on a coronary artery image generated by 3D rendering of the coronary artery (see figure 23, figure 25, figure 26,Taylor discusses markers indicating cFFR and FFR values along coronary artery; see para. 0205, Taylor discusses the computer system may indicate or display to the user the portions of the cFFR model that includes the functionally significant lesion).
Regarding claim 9, Taylor teaches wherein the processing circuitry is configured to switch the representative value with a marker on the image into a chart indicating the FFR value in the coronary artery, in response to an operation performed by an operator (see figure 26, Taylor discusses a chart with calculations; see figure 23, figure 25, figure 26, Taylor discusses markers indicating cFFR and FFR values along coronary artery; see para. 0205, Taylor discusses the computer system may indicate or display to the user the portions of the cFFR model that includes the functionally significant lesion; see para. 0119, Taylor discusses display computer system used by such human operator).
Claim 10 is rejected as applied to claim 1 as pertaining to a corresponding system.
Claim 11 is rejected as applied to claim 1 as pertaining to a corresponding method.
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.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Taylor et al. (US 2013/0211728) in view of Takahashi et al. (US 2015/0161790).
Regarding claim 2, Taylor does not expressly disclose wherein the processing circuitry is configured to determine the potential stenosis position based on a change amount in the FFR value along an extending direction of the coronary artery.
However, Takahashi teaches wherein the processing circuitry is configured to determine the potential stenosis position based on a change amount in the FFR value along an extending direction of the coronary artery (see para. 0075, Takahashi discusses presence or absence of the vascular stenosis portion is determined based on evaluation of lowering of the blood flow rate due to the stenosis site. When the value of the FFR is equal to or lower than the reference value, the position is determined to be a stenosis portion).
Motivation to combine may be gleaned from the prior art considered. It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the invention of Taylor with Takahashi to derive at the invention of claim 2. The result would have been expected, routine, and predictable in order to perform blood vessel analysis.
The determination of obviousness is predicated upon the following: One skilled in the art would have been motivated to modify Taylor in this manner in order to improve blood vessel analysis by generating a user operable 3D model displaying flow data that indicates important regions such as stenotic regions. Furthermore, the prior art collectively includes each element claimed (though not all in the same reference), and one of ordinary skill in the art could have combined the elements in this manner explained using known engineering design, interface and/or programming techniques, without changing a fundamental operating principle of Taylor, while the teaching of Takahashi continues to perform the same function as originally taught prior to being combined, in order to produce the repeatable and predictable result of calculating flow values and displaying the values on an user operable model to properly determine locations of serious conditions such as severe aortic stenosis. The Taylor and Takahashi systems perform blood vessel 3D modeling, therefore a person having ordinary skill in the art would have reasonable expectation of success in the combination yielding predictable results. It is for at least the aforementioned reasons that the examiner has reached a conclusion of obviousness with respect to the claim in question.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Taylor et al. (US 2013/0211728) in view of Fonte et al. (US 2014/0114618).
Regarding claim 6, Taylor does not expressly disclose wherein the processing circuitry is configured to determine the representative position at a predetermined distance downstream from the determined potential stenosis position. However, Fonte teaches wherein the processing circuitry is configured to determine the representative position at a predetermined distance downstream from the determined potential stenosis position (see para. 0054, Fonte discusses processing image data from model to identify stenosis that blends into the patient's aorta, or stenosis within some predetermined distance from the ostia).
Motivation to combine may be gleaned from the prior art considered. It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the invention of Taylor with Fonte to derive at the invention of claim 6. The result would have been expected, routine, and predictable in order to perform blood vessel analysis.
The determination of obviousness is predicated upon the following: One skilled in the art would have been motivated to modify Taylor in this manner in order to improve blood vessel analysis by generating a user operable 3D model displaying flow data that indicates important regions such as stenotic regions. Furthermore, the prior art collectively includes each element claimed (though not all in the same reference), and one of ordinary skill in the art could have combined the elements in this manner explained using known engineering design, interface and/or programming techniques, without changing a fundamental operating principle of Taylor, while the teaching of Fonte continues to perform the same function as originally taught prior to being combined, in order to produce the repeatable and predictable result of calculating flow values and displaying the values on an user operable model to properly determine locations of serious conditions such as severe aortic stenosis. The Taylor and Fonte systems perform blood vessel 3D modeling, therefore a person having ordinary skill in the art would have reasonable expectation of success in the combination yielding predictable results. It is for at least the aforementioned reasons that the examiner has reached a conclusion of obviousness with respect to the claim in question.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Taylor et al. (US 2013/0211728) in view of Hart et al. (US 8,548,778).
Regarding claim 8, Taylor does not expressly disclose wherein the processing circuitry is configured to cause the display to display a coronary artery image generated by 3D rendering of the coronary artery, control the display of the coronary artery image in a rotating manner in response to an operation performed by an operator, determine a coronary artery that is displayed in a foreground in the rotated coronary artery image, and cause the display to display the representative value with the marker at the representative position of the coronary artery that is displayed in the foreground.
However, Hart teaches wherein the processing circuitry is configured to cause the display to display a coronary artery image generated by 3D rendering of the coronary artery (see figure 2, col. 55 lines 43-59, col. 10 lines 29-37, Hart discusses a 3D model controlled by a user),
control the display of the coronary artery image in a rotating manner in response to an operation performed by an operator (see figure 2, col. 55 lines 43-59, col. 10 lines 29-37, Hart discusses a 3D model rotated a user),
determine a coronary artery that is displayed in a foreground in the rotated coronary artery image (see figure 2, col. 6 lines 20-37, Hart discusses a 3D model containing coronary arteries), and
cause the display to display the representative value with the marker at the representative position of the coronary artery that is displayed in the foreground (see figure 2, figure 3, figure 5, figure 6, col. 6 lines 20-37, col. 14 lines 59-67, Hart discusses a 3D model displaying FFR values).
Motivation to combine may be gleaned from the prior art considered. It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the invention of Taylor with Hart to derive at the invention of claim 8. The result would have been expected, routine, and predictable in order to perform blood vessel analysis.
The determination of obviousness is predicated upon the following: One skilled in the art would have been motivated to modify Taylor in this manner in order to improve blood vessel analysis by generating a user operable 3D model displaying flow data that indicates important regions such as stenotic regions. Furthermore, the prior art collectively includes each element claimed (though not all in the same reference), and one of ordinary skill in the art could have combined the elements in this manner explained using known engineering design, interface and/or programming techniques, without changing a fundamental operating principle of Taylor, while the teaching of Hart continues to perform the same function as originally taught prior to being combined, in order to produce the repeatable and predictable result of calculating flow values and displaying the values on an user operable model to properly determine locations of serious conditions such as severe aortic stenosis. The Taylor and Hart systems perform blood vessel 3D modeling, therefore a person having ordinary skill in the art would have reasonable expectation of success in the combination yielding predictable results. It is for at least the aforementioned reasons that the examiner has reached a conclusion of obviousness with respect to the claim in question.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Grady et al. (US 2017/0132388) discusses patient-specific vascular and/or anatomical model showing the FFR-CT map and/or CPR images may be displayed on an image screen, such as a computer monitor.
Lavi et al. (US 2014/0200867) discusses calculating a coronary edge by interpolating the coronary vessel segments considered free from illness located proximally and distally to the region of stenosis with the edges of the region of the stenosis.
Kano et al. (US 2017/0071479) discusses identifying the stenosis region by using either the dynamic model.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KENNY A CESE whose telephone number is (571) 270-1896. The examiner can normally be reached on Monday – Friday, 9am – 4pm.
If attempts to reach the primary examiner by telephone are unsuccessful, the examiner’s supervisor, Gregory Morse can be reached on (571) 272-3838. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/Kenny A Cese/
Primary Examiner, Art Unit 2663
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