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.
Claims 1, 17, and 26 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter because the claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea.
The claims are directed to a statutory category (process, machine, manufacture, or composition of matter). The claims employ abstract idea of predicting calcification activity in a vascular vessel in which data is analyzed and a calculation is completed to determine microcalcification activity without reciting significantly more than an abstract idea. The claims lack an inventive concept sufficient to transform the abstract idea into a patent-eligible invention. The claim does not include additional step(s)/element(s) that are sufficient to amount to significantly more than the judicial exception because the recited step(s)/element(s), when considered both individually and as an ordered combination, do not amount to more than the above-identified abstract idea. The additional elements or combination of elements “processor” in the claim taken individually or in combination is not sufficient to amount to significantly more than the judicial exception (abstract idea) itself because the “processor” is recited at a high level of generality as performing generic computer functions routinely used in computer applications. The use of generic computer components does not impose any meaningful limits on the computer implementation of the abstract idea. A claim without significantly additional limitations is not patent eligible.
In the present case, claim 1, 17, and 26 is directed to the abstract idea of predicting calcification activity in a vascular vessel in which data is analyzed and a calculation is completed to determine microcalcification activity without reciting significantly more than an abstract idea. Using the 101 subject matter eligibility test, the claims pass Step 1 since they are directed to a statutory category (process, machine, manufacture, or composition of matter). Analyzing under Step 2A, i.e., part 1- Mayo Test, the claims are directed to abstract idea and therefore must be analyzed at Step 2B. Using Step 2B, viewed as a whole, these additional claim element(s) do not provide meaningful limitation(s) to transform the abstract idea into a patent eligible application of the abstract idea such that the claim(s) amounts to significantly more than the abstract idea itself. Therefore, the claim(s) are rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter. The claimed limitations can be done mentally and by use of a calculation device by a human user. Dependent claim(s) 2-11, 16, 18, and 20-24 when analyzed as a whole are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitation(s) fail(s) to establish that the claim(s) is/are not directed to an abstract idea.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. See claims 6 and 17, “image processing means”.
Claim Rejections - 35 USC § 103
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 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(s) 1-7, 9-11, 16-18, 20, 21, 23-24, and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over D1 [2017/0340393 A1] in view of D2 [2019/0290232 A1] in view of D3 [US 2019/0244348 A1].
Claim 1. A method of predicting microcalcification activity in a vascular vessel comprising either an artery or a vein, comprising the steps of: [D1, [0104]]
(a) measuring patient data comprising one or more of:
(i) the existence of and/or quantity of coronary plaques or visible markers of disease in a vascular tissue sample; [D1, Abstract; Figure 2, 3, 4A-4B; and [0031-0048]] D1 teaches the exemplary method for predicting coronary plaque vulnerability from anatomic image data.
(ii) the existence of and/or quantity of healthy tissue in the vascular tissue sample; [D1, Abstract; Figure 2, 3, 4A-4B; and [0031-0048]] D1 teaches, see [0038], the determination of the positive remodeling, low attenuation plaque, and/or spotty calcification.
(iii) one or more features that define an abnormal hemodynamic environment in a vessel; [D1, Abstract; Figure 2 and 4A-4B; and [0115, 0135-0136]] D1 teaches, see Fig. 2 (208), the extraction of hemodynamic and/or mechanical characteristics. For every point in each patient - specific geometric model , the method may include feature vectors for each point , comprising a numerical description of the geometry and biophysical hemodynamic and biomechanical characteristic at that point and estimate
(iv) one or more geometric features that are associated with vascular remodeling and which influence hemodynamics in a vessel, and/or [D1, Abstract; Figure 2-4A-4B; and [0115, 0135-0136]] D1 teaches, see Fig. 2 (208), the extraction of hemodynamic and/or mechanical characteristics. For every point in each patient - specific geometric model , the method may include feature vectors for each point , comprising a numerical description of the geometry and biophysical hemodynamic and biomechanical characteristic at that point and estimate
(v) one or more material properties that influence vascular hemodynamics; and [D1, Abstract; Figure 4A-4B; and [0115]] D1 teaches the extraction of hemodynamic and/or mechanical characteristics. For every point in each patient - specific geometric model , the method may include feature vectors for each point , comprising a numerical description of the geometry and biophysical hemodynamic and biomechanical characteristic at that point and estimate
(b) calculating the microcalcification activity in the vessel as a function of the measurements taken in Step (a). [D1, Abstract; Figure 2-5, and [0035]] D1 teaches the machine learning algorithms used in determination of the optimal treatment. D2, [Abstract, [0008 and 0085]] D2 teaches the determination is made of sodium fluoride uptake. The combination of D1 in view of D2 teaches the determination of the patient data in order to determine the uptake in sodium fluoride uptake in the patient, however, the combination does not explicitly teach the use of the AI-trained model. D3, however, teaches the structure, design, and execution of various training and learning models and AI in order to model the vascular plaque as shown in, for example, Fig 19-27, 35-38. D3 teaches the ability to include vascular applications, see table 2, in which it would render the use of the AI model to be obvious in determination of the prediction of uptake of sodium fluoride. It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to combine the teachings of D1 with the teachings of D2, wherein D2 teaches the determination of the sodium fluoride uptake thus being a function of the measurements being taken while using the AI model of D3 which has been determined to be of use in vascular applications. Therefore, one skilled in the art would have been motivated to modify D1 in this manner in order to make the determination of sodium fluoride in D2, and using the AI model of D3 to ensure accurate and efficient application in vascular applications. Therefore one of ordinary skill in the art, such as an individual with a basic degree in electrical engineering could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately. It is for at least the aforementioned reasons that the Examiner has reached a conclusion of obviousness with respect to claim 1.
Claim 2. The method of claim 1, wherein the vascular tissue sample comprises a patient's vascular system. [D1, Abstract and [0027]] D1 teaches the image data is from the patient’s vascular system. The supplied tissue from the patient imaging.
Claim 3. A method of claim 1, wherein the measurements of Step (a) are associated with the of the radiotracer .sup.18F-sodium fluoride (NaF). [D2, [0085]] D2 teaches the determination of NaF amounts.
Claim 4. A method of claim 1, wherein the measurements of Step (a) are derived from one or more patient image sources. [D1, [0004]] D1 teaches at least CT.
Claim 5. The method of claim 4 wherein the one or more patient image sources are selected from the group comprising one or more of: computer tomography; optical coherence tomography; intravascular ultrasound; x-ray angiography; PET imaging. [D1, [0004]] D1 teaches at least CT.
Claim 6. The method of claim 4, wherein the measurements are obtained by segmenting and annotating the patient image date using image processing means. [D1, [0034]] D1 teaches segmenting. [D3, Claim 36] D3 teaches semantic segmentation to identify and classify regions of interest in cross-sections of a focal structure in the radiological data to produce an annotated dataset.
Claim 7. The method of claim 6, wherein the measurements of the vessel tissue comprise one or more of: tortuosity of the vessel lumen centerline; the percentage of the vessel lumen surface area that has a wall shear stress value below a predetermined threshold; or the plaque free wall of the vessel tissue. [D1, [0085]] D1 teaches the tortuosity measurement.
Claim 9. The method of claim 1 wherein the measurements of Step (a) include biomechanical measurements selected from the group of one or more of: blood pressure; blood flow rate or localised hemodynamic characteristics; and tissue stresses. [D1, [0027]] D1 teaches the determination of the patients blood pressure.
Claim 10. A method of claim 1, wherein the one or more geometric features correspond with atherosclerotic processes and or microcalcification activity. [D3, [0091 and 0093]] D1 teaches the analysis of the data from atherosclerotic imaging data.
Claim 11. A method of claim 1, wherein the one or more geometric features correspond to image-based diameter measurements in a vessel prone to calcification. [D1, [0040]] D1 teaches the diameter calcification of the vessel.
Claim 16. The method of claim 1, wherein the vessel is one or more of a coronary artery, carotid artery, cerebral artery, aorta, peripheral artery, or vein. [D1, [0028]] D1 teaches the invention described with respect to the coronary artery.
Claim 17. A method of providing information for predicting the uptake of .sup.18F-NAF in vascular tissues of a patient, comprising: using image processing means on patient image data, measuring vascular biomarkers indicative of the existence of and/or quantity of coronary plaques or visible markers of disease in the vascular tissue associated with cardiovascular disease progression; and using a processor, calculating the microcalcification activity in the vascular tissue as a function of the measurements. Claim 17 is rejected for similar reasons as to those described in claim 1.
Claim 18. The method of claim 1, comprising measuring microcalcification activity in a coronary artery, carotid artery, cerebral artery, aorta, peripheral artery, or any vessel of interest, including veins. [D1, [0028]] D1 teaches the invention described with respect to the coronary artery.
Claim 20. The method of claim 1, wherein the patient data comprises biomarker data relating to one or more features of clinical interest selected from the group of: lipid region; superficial calcium; deep calcium; plaque free wall; thrombus; macrophages; microchannels; cholesterol crystals; or thin cap fibro-atheroma in relation to one or more blood vessels of the patient. [D1, [0056]] D1 teaches at least the lipid levels.
Claim 21. The method of claim 1, wherein the patient data comprises one or more of image data selected from the group of: OCT image data; angiography image data; computed tomography (CT) image data; CT angiography image data. [D1, [0004]] D1 teaches at least CT.
Claim 23. The method of claim 1, further comprising determining one or more measures of vessel status selected from the group comprising: endoluminal sheer stress; plaque structural stress; plaque feature analysis; microcalcification activity; virtual stenting; vessel wall feature analysis; thin cap measurement; multimodal imaging; vessel branches; fractional flow reserve; rapid timeframes; and VR virtualisation. [D1, [0046]] Analysis of various stresses.
Claim 24. The method of claim 1, wherein the existence and/or quantity of vascular plaques is measured based on measuring geometric markers of disease from intravascular patient image data, said geometric markers being selected from one or more of lipid; calcium; and macrophages in plaque detected in the vascular vessel. [D1, [0056]] D1 teaches at least the lipid levels.
Claim 26. A computer system comprising: at least one processor; at least one memory device storing patient data relating to: (i) the existence of and/or quantity of coronary plaques or visible markers of disease in a vascular tissue sample; and/or (ii) the existence of and/or quantity of healthy tissue in the vascular tissue sample; and/or (iii) one or more features that define an abnormal hemodynamic environment in a vessel; and/or (iv) one or more geometric features that are associated with vascular remodeling and which influence hemodynamics in a vessel, and/or (v) one or more material properties that influence vascular hemodynamics; and wherein the at least one processor is configured for, using a trained machine learning model, regression model or predictive model, calculating the microcalcification activity in the vessel as a function of the patient data; a prediction processor for accessing an AI-trained model of the patient data and predicting 18F—NaF uptake in vascular tissues of the patient. Claim 26 is rejected for similar reasons as to those described in claim 1, wherein claim 26 is the computer system claim. Claim 26 further details the AI-trained model of the patient data and predicting the uptake of calcification in the vascular tissue of the patient. D2, [Abstract, [0008 and 0085]] D2 teaches the determination is made of sodium fluoride uptake. The combination of D1 in view of D2 teaches the determination of the patient data in order to determine the uptake in sodium fluoride uptake in the patient, however, the combination does not explicitly teach the use of the AI-trained model. D3, however, teaches the structure, design, and execution of various training and learning models and AI in order to model the vascular plaque as shown in, for example, Fig 19-27, 35-38. D3 teaches the ability to include vascular applications, see table 2, in which it would render the use of the AI model to be obvious in determination of the prediction of uptake of sodium fluoride.
Claim(s) 8 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over D1 [2017/0340393 A1] in view of D2 [2019/0290232 A1] in view of D3 [US 2019/0244348 A1] further in view of D4 [US 2019/0209116 A1].
Claim 8. The method of claim 7, wherein the microcalcification activity is measured as the maximum of the tissue-to-background ratio (TBR) in each segment of the vessel tissue. [D4, [0025]] D4 teaches the TBR in the volume, being tissue or bone. It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to combine the teachings of D1 with the teachings of D2 with the teachings of D3, as described in claim 1, wherein D1 in view of D2, in view of D3 makes the determination of macrocalcification activity. The further additional determine made by D4 is a mere change in calculation method in which the measurement is done as maximum of the TBR in the vessel.. Therefore, one skilled in the art would have been motivated to modify D1 in view of D2 in view of D3 in this manner in order to make the calculation of D4, wherein the TBR is determined. Therefore one of ordinary skill in the art, such as an individual with a basic degree in electrical engineering could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately. It is for at least the aforementioned reasons that the Examiner has reached a conclusion of obviousness with respect to claim 8.
Claim 22 is rejected for similar reasons as to those described in claim 8.
Conclusion
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/AMANDEEP SAINI/Supervisory Patent Examiner, Art Unit 2662