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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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 1-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to the judicial exception of an abstract idea falling under the category mathematical concepts. Additionally, the claimed invention is not integrated into practical application at Prong Two Step 2A, and without significantly more at Step 2B. The claims recite a method of calculating gradients from CT data.
Step 1:
The claims in question are directed to a method, therefore the claims are directed to one of the statutory categories of invention.
Step 2A, Prong One:
This part of the eligibility analysis evaluates whether the claim recites a judicial exception. As explained in MPEP 2106.04, subsection II, a claim "recites" a judicial exception when the judicial exception is "set forth" or "described" in the claim. Claims 1/2/4/7/recite calculating a gradient. Additionally Claims 2 and 4 recite calculating an average value, Claim 5 recites weighing data so that some portions hold greater weight than others, Claim 6 recites subtracting CT data of two images, 8/9/10 recite generating CT data, 11 recites normalizing a value, and Claim 15 recites determining a value of a flow parameter. Additionally Claim 5/8/12 recite isolating specific data from an image and Claims 2/3/13 recite identifying a region of interest from an image. These claims fall under mental process groupings. The claims/limitations in question are recited at a high level of generality and lack any specifics that preclude e.g. 'identifying' from being interpreted under the mental processes grouping practically performed in the mind (see also MPEP 2106.04(a)(2) identifying how e.g. a use of pen and paper and/or a computer as a tool (to visually analyze/observe acquired images/video) fail to preclude such an interpretation under the mental processes Abstract Idea grouping). Additionally see MPEP 2106.04(a)(2)(C) regarding mathematical concepts.
MPEP 2106.04(a)(2)(C):
A claim that recites a mathematical calculation, when the claim is given its broadest reasonable interpretation in light of the specification, will be considered as falling within the “mathematical concepts” grouping. A mathematical calculation is a mathematical operation (such as multiplication) or an act of calculating using mathematical methods to determine a variable or number, e.g., performing an arithmetic operation such as exponentiation. There is no particular word or set of words that indicates a claim recites a mathematical calculation. That is, a claim does not have to recite the word “calculating” in order to be considered a mathematical calculation. For example, a step of “determining” a variable or number using mathematical methods or “performing” a mathematical operation may also be considered mathematical calculations when the broadest reasonable interpretation of the claim in light of the specification encompasses a mathematical calculation.
Dependent claims are similarly analyzed at Prong One, where claims 1-11 and 14-15 recite calculating some kind of value, therefore they fall under the category of mathematical concepts, and claims 12-13 recite a mental process since they recite isolating an area of an image an determining a region of interest.
Step 2A, Prong Two:
This part of the eligibility analysis evaluates whether the claim as a whole integrates the recited judicial exception into a practical application of the exception. This evaluation is performed by (1) identifying whether there are any 'additional elements' recited in the claim beyond the judicial exception, and (2) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. See MPEP 2106.04(d). Examiner notes for consideration at Prong Two of 2A that MPEP 2106.05(a), (b), (c), and (e) generally concern limitations that are indicative of integration, whereas 2106.05(f), (g), and (h) generally concern limitations that are not indicative of integration. Any ‘receiving'/outputting broadly, and general collection of data (i.e. image acquisition(s)), be they images for further analysis or calculating a value also fail(s) to integrate at least in view of MPEP 2106.05(g), as they are considered extra-solution data gathering or providing an output (E.g. Claim 12 recites outputting a planar planning image). Integration in view of MPEP 2106.05(a) requires an identification of the manner in which the improvement is achieved, to be explicitly and specifically recited in the claims, as 'additional elements' precluded from interpretation under any of the Abstract Idea groupings (since the improvement cannot be
to the exception itself). In view of MPEP 2106.05(f), the improvement cannot be merely/broadly
automating what is otherwise the exception, nor can it be e.g. a 'novel' calculation per se. With
reference to MPEP 2106.05(a):
It is important to note, the judicial exception alone cannot provide the
improvement. The improvement can be provided by one or more additional
elements. See the discussion of Diamond V. Diehr, 450 U.S. 175, 187 and 191-
92, 209 USPQ 1, 10 (1981))
Even when viewed in combination, the 'additional elements' present do not integrate the recited judicial exception into a practical application, and the claims are
directed to the judicial exception.
Step 2B:
This part of the eligibility analysis evaluates whether the claim as a whole
amounts to 'significantly more' than the recited exception, i.e., whether any 'additional element', or combination of additional elements, adds an inventive concept to the claim. The
considerations of Step 2A Prong 2 and Step 2B overlap, but differ in that 2B also requires
considering whether the claims feature any "specific limitation(s) other than what is well-
understood, routine, conventional activity in the field" (WURC) (MPEP 2106.05(d)). Such a
limitation if specifically recited however, must still be excluded from interpretation under any of
the Abstract Idea groupings. Step 2B further requires a re-evaluation of any additional elements
drawn to extra-solution activity in Step 2A (e.g. gathering video/image(s)) - however no
limitations appear directed to any novel collection per se. Limitations not indicative of an
inventive concept/ 'significantly more' include those that are not specifically recited (instead
recited at a high level of generality), those that are established as WURC, and/or those that are
not ‘additional elements' by nature of their analysis at Prong One. The claim(s) in question recite little beyond those limitations recited at a high level of generality and falling under the mental
processes and/or mathematical concepts Abstract Idea grouping(s).
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.
Claim 8, 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.
Claim 8 states that when a predetermined threshold condition is met, “a generation of the spectral CT data” is measured. However, the spectral CT data was previously mentioned as being the data on which the analysis was being performed. Therefore it is unclear how the data would be generated, if it was already present in previous analysis. The same problem arises in claims 9, 10, and 11 therefore making them indefinite.
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.
Claims 1, 2, 4, 5, 7, 14 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US2020237329 (hereafter referred to as Min).
Regarding Claim 1, Min teaches A computer-implemented method of calculating a value of a contrast agent attenuation gradient for a lumen in a vasculature [See paragraph 0104 and 0039 where the gradient is determined In different vascular components, including the lumen],
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the method comprising: receiving spectral computed tomography, representing a distribution of an injected contrast agent along the lumen , the spectral CT data defining X-ray attenuation at a plurality of energy intervals [See paragraph 0206 which teaches that a CT image includes a contrast agent which is injected, and that the energy can be taken at multiple energy levels. See also paragraph 0055 where the attenuation of the lumen is determined];
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analyzing the spectral CT data to isolate, from the spectral CT data, contrast agent attenuation data representing the distribution of the contrast agent along the lumen [See paragraph 0117 where analysis of the CT data includes obtaining the 3D volumetric shape of the lumen along with its attenuation density];
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and calculating, from the contrast agent attenuation data , a value of a gradient of the contrast agent along one or more portions of the lumen; to provide the value of the contrast agent attenuation gradient [see paragraph 0104 above where the gradients are calculated including for the lumen].
Regarding Claim 2, Min teaches The computer-implemented method according to claim 1, wherein the attenuation gradient is a transluminal attenuation gradient [see figure 16 and paragraph 0036 where the attenuation (radiodensity) gradient is calculated for the lumen;
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and wherein the method further comprises: calculating, from the contrast agent attenuation data, an average value of the contrast agent attenuation across the lumen, at a plurality of positions along the lumen; [see paragraph 0148 where the average radiodensity values can be calculated which are equivalent to contrast agent attenuation values. See also paragraph 0157 and 0159 where different positions of the lumen are looked at].
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wherein the calculating a value of a gradient of the contrast agent along one or more portions of the lumen, is performed using the average values of the contrast agent attenuation across the lumen. [see paragraph 0148 above where the radiodensity is used to calculate the gradient, and the radiodensity can be calculated to be an average]
Regarding claim 4, Min teaches the computer-implemented method according to claim 1, further comprising identifying one or more positions across the lumen [see paragraph 39 and fig 16 above where positions across the lumen are identified such as the outer vessel wall]; wherein the calculating a value of a gradient of the contrast agent along one or more portions of the lumens performed at the one or more positions across the lumen [See paragraph 0148 above where the gradient can be calculated for each region, and the regions include the lumen area]; to provide the value of the contrast agent attenuation gradient [see 0148 above where the gradient can be calculated using the contrast agent attenuation data (radiodensity)].
Regarding claim 5, Min teaches the computer-implemented method according to claim 1 wherein the analyzing the spectral CT data further comprises: analyzing the spectral CT data to isolate, from the spectral CT data, artifact attenuation data representing attenuation arising from one or more artifacts [see example 7 of paragraph 0117 above which discusses that calcified plaques which can be interpreted as artifacts are isolated and removed from the data and paragraph 0077 below where the data can be additionally filtered to remove anomalies and other errors.]
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and weighting the isolated contrast agent attenuation data such that an impact of a compartment the artifacts on the isolated contrast agent attenuation data is reduced [See paragraph 0116 where the compartments encompass different sections of the lumen such as fat, lumen, and plaques and other artifacts. Based on the risk associated with the compartment, the weights are changed].
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Regarding claim 7, Min teaches the computer-implemented method according to claim 1, wherein the contrast agent attenuation data comprises projection data or the contrast agent attenuation data comprises reconstructed image data;
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and wherein the calculating a value of a gradient of the contrast agent along one or more portions of the lumen is performed in the projection domain or in the image domain [See paragraph 0127 and fig 10 which demonstrates the gradient in the reconstructed image, additionally since CT data is use, can reasonably be assumed that the calculation of the gradient values uses from the image, as CT data is image data].
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Regarding claim 14, Min teaches the computer-implemented method according to claim 1, wherein the received spectral CT data represents a distribution of an injected contrast agent along the lumen at each of multiple points in time; wherein the analyzing and the calculating, are performed for the data corresponding to each point in time to provide a time- dependent calculated value for the gradient of the contrast agent along the one or more portions of the lumen; and wherein the method further comprises outputting the time- dependent calculated value for the gradient of the contrast agent along the one or more portions of the lumen. [see paragraph 0064 where the patient can be tracked over time and the images are co-registered to analyze the changes, indicating that the multiple images use the same method of injecting a contrast image and calculating the gradient value of the lumen as discussed of paragraph 0104 and 0206 above]
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Regarding Claim 15, Min teaches the computer-implemented method according to claim 1: determining a value of a blood flow parameter for the lumen; using the calculated value of the gradient of the contrast agent along the one or more portions of the lumen [see paragraph 0070 where the information and analysis can be used to determine blood flow in the arteries and connected vessels].
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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.
Claims 3 and 8-11 are rejected under 35 U.S.C. 103 as being unpatentable over Min in view US 20240404057 (hereinafter referred to as Florent).
Regarding Claim 3, Min teaches the computer-implemented method according to claim 1, [See paragraph 0148 and 0157 above].
Min does not teach that the measurements are from a centerline of a lumen.
Florent does teach identifying a centerline of a lumen and using that location to determine the attenuation of the contrast agent [See Fig 6 which shows the centerline of the lumen being identified. Additionally see paragraph 0108 and Fig 7 where an intensity gradient is computed based on the attenuation of the contrast agent along the many positions at the centerline of the lumen]
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Therefore it would have been obvious to one with ordinary skill in the art before the effective filing date to have combined the method of paining the gradient of the lumen on Min with the method of measuring at the centerline of the lumen of Florent as they are in the same field of endeavor of imaging using CT and contrast agents the vascular system of the body. The motivation to combine would be to increase the accuracy of the collected flow data within the Lumen. [See paragraph 0089 of Florent]
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Regarding Claim 8, Min teaches the computer-implemented method according to claim 1, and obtaining
Although Min does mention obtaining a flow rate [paragraph 0152], Min does not teach that the method further comprises receiving spectral CT data representing a flow of the injected contrast agent in the lumen; analyzing the spectral CT data representing the flow of the injected contrast agent in the lumen to isolate, from said data, contrast agent attenuation flow data representing the flow of the injected contrast agent in the lumen; and triggering a generation of the spectral CT data representing the distribution of the injected contrast agent along the lumen, if the injected contrast agent in the lumen represented in the contrast agent attenuation flow data satisfies a predetermined threshold condition.
Florent does teach receiving spectral CT data representing a flow of the injected contrast agent in the lumen [see the abstract of Florent where the flow is determined based on the images of the injected contrast agent obtained from angiographic data, see also paragraph 0024 (below in claim 10 rejection) where the angiographic data can be acquired using spectral CT imaging systems];
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analyzing the spectral CT data representing the flow of the injected contrast agent in the lumen to isolate, from said data, contrast agent attenuation flow data representing the flow of the injected contrast agent in the lumen [see paragraph 100 where the lumen with the flow running thorough it is identified];
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and triggering a generation of the spectral CT data representing the distribution of the injected contrast agent along the lumen, if the injected contrast agent in the lumen represented in the contrast agent attenuation flow data satisfies a predetermined threshold condition [See paragraph 0100 above where the higher contrast image is used to trigger a second sequence of angiographic images, indicating that some threshold has been met. See also 0057 where the additional angiographic images come from an X- ray imaging system, indicating generation of spectral CT data].
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The motivation to combine is the same as Claim 3, where the additional processes used help increase the accuracy of flow data.
Regarding Claim 9, Min and Florent teach the computer-implemented method according claim 8, wherein the triggering a generation of the spectral CT data representing the distribution of the injected contrast agent along the lumen, comprises initiating the generation of the spectral CT representing the distribution of the injected contrast agent along the lumen [See paragraph 0100 and 0057 above]
Additionally, Florent teaches that the image is generated if an intensity of the injected contrast agent represented in the contrast agent attenuation flow data exceeds a predetermined threshold value at a predetermined position in the lumen [see paragraph 0070 which indicates that the initial flow of the contrast agent has to be at a high enough rate that the lumen has proper visibility, indicating that a minimum threshold must be met before moving on to a subsequent image generation].
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Regarding Claim 10, Florent and Min teach the computer-implemented method according to claim 9. Additionally Florent teaches the received spectral CT data representing the flow of the injected contrast agent in the lumen comprises projection data that is generated during a rotation of an X-ray source detector arrangement around the lumen [See paragraph 0024 where the volumetric X ray system, can generate projection data by rotating an x-ray source]:
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Florent additionally teaches reconstructing the projection data into an image slice; wherein the initiating the generation of the spectral CT data comprises analyzing an image intensity within a region of interest in the reconstructed image slice [See paragraph 0024 where the angiographic data can be created from reconstructed slices, and see paragraph 0070 and 0057 where the angiographic data depicts an area of interest (the lumen) with the contrast agent flowing through at an intensity]
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and initiating the generation of the spectral CT data representing the distribution of the injected contrast agent along the lumen, if the image intensity within the region of interest exceeds the predetermined threshold value [See paragraph 0070 and 0057 above].
Regarding Claim 11, Florent and Min teach the computer-implemented method according to claim 9, additionally Florent teaches determining a temporal profile of the intensity of the injected contrast agent within the region of interest [See paragraph 0100 where a temporal velocity profile is obtained of the lumen] and calculating a value of the gradient of the contrast agent along the one or more portions of the lumen; based on an intensity of the injected contrast agent in the temporal profile [see paragraph 0108 where n intensity gradient is calculated based off of the temporal velocity].
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Additionally, Min teaches normalizing radiodensity which is equivalent to the contrast agent attenuation that is used to calculate the gradient; therefore this normalization step can be done as part of any form of calculation. [See paragraph 0016 of Min]
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Claims 6, 12, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Min in view of US 20120039519 (hereinafter referred to as Fei).
Regarding claim 6, Min teaches the computer-implemented method according to claim 5, and that there are multiple energy intervals [see paragraph 0206 above].
Min does not explicitly teach that the energy levels comprise a lower and higher energy level, where the artifacts are present on the higher energy level interval, or that the data is isolated by subtracting the higher energy interval from the lower energy interval.
Fei does teach that the one or more spectral CT data energy intervals comprises a relatively lower energy interval and a relatively higher energy interval [see paragraph 0003 where the dual energy imaging system includes the generation of a high energy image and a low energy image];
wherein the contrast agent attenuation data is isolated from the spectral CT data by subtracting the spectral CT data corresponding to the relatively higher energy interval from the spectral CT data corresponding to the relatively lower energy interval [See paragraph 0003 where there is a subtracted image created from the low and high energy image that contains all of the soft tissue];
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and wherein the artifact attenuation data is provided by the spectral CT data corresponding to the relatively higher energy interval [See paragraph 0003 above where the high energy image is a standard x-ray indicating that a majority of the artifact attenuation data comes from this interval].
Therefore it would have been obvious to one with ordinary skill in the art before the effective filing date to combine the compartmentalization of section of Min with the process of subtracting the images of different energy intervals if Fei in order to isolate the artifacts as they are in the same field of endeavor of imaging the body using radiation technology such as CT to analyze the vascular system in the body. The motivation to combine would be to create a “cost-effective tool for cardiac and lung diseases as discussed in paragraph 0003 above.”
Regarding claim 12 Min teaches the computer-implemented method according to claim 1 wherein the method further comprises: receiving spectral CT data representing a planar image including the lumen and one or more anatomical landmarks [see paragraph 0125 below where the CT data is collected of multiple anatomical landmarks including the heart and coronary artery. Additionally paragraph 0043 discloses that the image can be displayed as a planar (2D) image]
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the anatomical landmarks including [see 0125 where the heart is a tissue landmark] analyzing the spectral CT data representing the planar image, and isolating, from said data, tissue data representing the lumen and the one or more tissue landmarks; [See paragraph 0125 above and figure 8 where the heart and the blood vessels are isolated, and as stated above the CT data can be processed as a two dimensional image]
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and outputting a planar planning image representing the tissue data. [see paragraph 0117 above where "Box 655 may, in some cases, illustrate the general area for analysis" when plaque and other abnormal tissue was identified. This indicates that certain regions of the tissue can be highlighted for further analysis].
Min does not explicitly teach that bone landmarks could be present in the image, however Fei does teach obtaining bone images [See paragraph 0003 above where bone is also present in an image]
Therefore it would have been obvious for one with ordinary skill in the art before the effective filing date that bone information would be received in the generated CT data. Having the bone data would help in getting a full image of the body to properly map out where areas of interest are in comparison to the other body structure.
Regarding Claim 13, Min and Fei teach the computer-implemented method according to claim 12, wherein the method further comprises: identifying the at least one region of interest in the planar planning image; and wherein the identifying the at least one region of interest is performed automatically, or in response to user input received from a user input device [See paragraph 0103 where the portions of interest can either be selected either automatically when a plaque is detected, or with user input].
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Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANUSHA KASHYAPA whose telephone number is (571)272-8766. The examiner can normally be reached Monday-Friday 8am-5pm.
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, Chan Park can be reached at (571) 272-7409. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANUSHA KASHYAPA/Examiner, Art Unit 2669
/IAN L LEMIEUX/Primary Examiner, Art Unit 2669
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