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 Status
Claims 30-49 are currently pending and under exam herein.
Claims 1-29 have been cancelled by preliminary amendment.
Priority
This application is a Continuation of 17/713,467, filed 04/05/2022, now US Patent 11,861,831, which is a Continuation of 16/122,328, filed 09/05/2018, now US Patent 11,663,715 which is a Continuation of 15/186,962, filed 06/20/2016, now US Patent 10,096,104, which is a Continuation of 14/011,151, filed 08/27/2013, now US Patent 9,805,463. The Effective Filing Data (EFD) of the instant application for each of claims 30-49 is 27 August 2013.
Information Disclosure Statement
The Information Disclosure Statement filed 30 May 2023 is in compliance with the provisions of 37 CFR 1.97 and has therefore been considered. A signed copy of the IDS is included with this Office Action.
Drawings
The Drawings filed 30 May 2023 have been accepted.
Specification
Note: All references to the Specification herein pertain to the PG publication: US20230306596.
Claim Interpretation
With respect to the recitation in the claims of “creating a signal describing a predetermined attribute” and other recitations pertaining to “signal” herein, said claim element is interpreted as only “data” as acquired by or achieved as a result of computation in a computing environment, such as by receiving cardiac image data or patient data [0024]; and simulation data of blood flow [0025]. The Specification does not disclose the literal word “signal” other than in the context of a processor that includes a “digital signal processor (DSP)” at [0082].
With respect to the recitation of an “estimator” in the instant claims, said “estimator” is interpreted as a computer component or computational process or a process that include pen and paper calculation only, as there is no disclosure of a hardware element that is an “estimator” in the instant Specification.
Claim Rejections - 35 USC § 112(b)
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 38-39 and 43-44 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 38 recites, “wherein the temporal feature includes a calculation of a combination of attribute values determined from at least some of the plurality of images”, wherein the claim is unclear with respect to a “feature” that can include a “calculation”. Claim 34, from which said claim depends recites that the temporal feature is extracted and a value of the functional measurement based on the temporal feature is determined. It is suggested that the claim be amended to clarify by recitation of, “wherein the value of the functional measurement based on the temporal feature is further performed by calculation of a combination of attribute values determined from at least some of the plurality of images” or the like. This further applies to similar recitations in claims 43-44 and said claims should also be amended herein for clarification.
Claim 39 recites, “wherein the operations further include: assigning a weight to each attribute determined from the plurality of images, to obtain weighted attribute values; and calculating a combination of the weighted attribute values to create the signal”, wherein there is insufficient antecedent basis in the claim for the recitation of “the operations further include” as no “operations” are recited in claim 38 from which claim 39 depends. Clarification is requested through clearer claim language such as, “wherein calculation of attribute values further includes assigning a weight to each attribute…” or the like.
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 30-49 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
The instant rejection reflects the framework as outlined in the MPEP at 2106.04:
Framework with which to Evaluate Subject Matter Eligibility:
(1) Are the claims directed to a process, machine, manufacture or composition of matter;
(2A) Prong One: Do the claims recite a judicially recognized exception, i.e. a law of nature, a natural phenomenon, or an abstract idea;
Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application (Prong Two); and
(2B) If the claims do not integrate the judicial exception, do the claims provide an inventive concept.
Framework Analysis as Pertains to the Instant Claims:
Step 1 Analysis: Are claims directed to process, machine, manufacture/composition of matter
With respect to step (1): yes, the claims are directed to a system for analysis of a vessel, a method, and a non-transitory computer-readable storage medium for determining a Fractional Flow Reserve (FFR) value for a pathology in a vessel.
Step 2A, Prong 1 Analysis: Do claims recite abstract idea
With respect to step (2A)(1), the claims recite abstract ideas. The MPEP at 2106.04(a)(2) further explains that abstract ideas are defined as:
mathematical concepts, (mathematical formulas or equations, mathematical relationships and mathematical calculations);
certain methods of organizing human activity (fundamental economic practices or principles, managing personal behavior or relationships or interactions between people); and/or
mental processes (procedures for observing, evaluating, analyzing/ judging and organizing information).
With respect to the instant claims, under the (2A)(1) evaluation, the claims are found herein to recite abstract ideas that fall into the grouping of mental processes (in particular procedures for observing, analyzing and organizing information).
The claim steps to abstract ideas are as follows:
Independent Claim 30:
determining a location of a pathology in the vessel, in at least some of the plurality of images; creating a signal describing a predetermined attribute at the location of the pathology, over time; determining a value of a functional measurement for the pathology, based on the signal, wherein steps directed to determining a location, creating a signal and determining a value based on received data are steps directed to mental activity by which one could merely visually assess image data and determine a location based on observations. Further one could assign a “signal” (data) that describes a predetermined attribute wherein said attribute is a value that represents the location in the image and further determine visually or mathematically a functional measurement for pathology using said values (feature vectors representative of patient data [0041]; [0065]). Save for processor implementation (computer as a tool) no steps are provided and, thus under the Broadest Reasonable Interpretation (BRI) of the claims herein, said steps are directed to abstract mental processes.
wherein said claim limitation further limits the “prognosis risk” as particular types of risk thus further limiting the judicial exception in claim 30 above.
Claim 31:
determining the location of the pathology based on structural features of the vessel in at least one image from the plurality of image, wherein said step is directed to determining a location is directed to mental operation that one could simply perform visually to make a determination of a location in an image and therefore is abstract.
Claim 32:
determining the location of the pathology in a first image from the plurality of images; tracking the pathology in subsequent images from the plurality of images to determine the location of the pathology in the subsequent images; and determining a value of the predetermined attribute at each location in each of the subsequent images, to create the signal, wherein said step is directed to determining a location is directed to mental operation that one could simply perform visually to make a determination of a location in an image and therefore is abstract. Further steps directed to “tracking” that pathology in subsequent images is also a step that may be performed by visually assessing the image change from one image to the next and is akin to a mental operation. The step directed to determining a value of the attribute (of interest) in each location may be performed mentally using pen and paper, given the known attribute of interest and is therefore abstract.
Claim 34:
extracting a temporal feature from the signal and determining the value of the functional measurement based on the temporal feature, wherein extracting a time dependent feature from the data and determining a value of a functional measurement based on time is a mental operation whereby one can assess data over time and perform operations such that “functional” parameters may be determined mentally using pen and paper, for example calculations of FFR such as in the Specification at [0071].
Claim 35:
inputting the temporal feature to an estimator to determine the value of the functional measurement, wherein input to an “estimator” is akin to input to a computer or to a mathematical formula on pen and paper for the intended result to determine some value. As such, said operation is an abstract mental process.
Claim 36:
inputting a structural feature of the pathology to the estimator to determine the value of the functional measurement, wherein input to an “estimator” is akin to input to a computer or to a mathematical formula on pen and paper for the intended result to determine some value. As such, said operation is an abstract mental process.
Claim 37:
the estimator includes a regressor, wherein said step further limits the input to a computer to perform operations that are limited to regression and are therefore abstract.
Claim 38:
wherein the temporal feature includes a calculation of a combination of attribute values determined from at least some of the plurality of images, which further limits the abstract recitation of claim 34 and is therefore also directed to a judicial exception.
Claim 39:
assigning a weight to each attribute determined from the plurality of images, to obtain weighted attribute values; and calculating a combination of the weighted attribute values to create the signal, wherein assigning weights and calculating combinations of weighted values are mathematical operations that can be performed in a mental fashion using pen and paper and are therefore abstract.
Claim 40:
wherein the predetermined attribute includes pixel intensity, which is a characteristic of the attribute and thus further limits the type of “data” for said attribute and is further limiting to the judicial exception in claim 30 as above.
Independent Claim 41:
extracting, from a location of the pathology in a plurality images of the vessel, values of a predetermined attribute; calculating a temporal feature based on the values of the predetermined attribute; inputting the temporal feature to an estimator; and obtaining, from an output of the estimator, an FFR value for the pathology, wherein are steps directed to mental activity by which one could merely visually assess image data and determine a location based on observations. Further one could calculate by estimations the values of Fractional Flow Reserve (FFRct-a known calculation) based on said values, such as described at [0071]. No further steps are provided and, thus under the Broadest Reasonable Interpretation (BRI) of the claims herein, said steps are directed to abstract mental processes.
Claim 42:
inputting a structural feature of the pathology to the estimator to obtain the FFR value based on the temporal feature and the structural feature, wherein obtaining FFR is an abstract mental process based on calculated data and limits further the judicial exception as in claim 41 above.
Claim 43:
tracking the location of the pathology throughout the plurality of images of the vessel; and extracting a value of the predetermined attribute from the location of the pathology in at least some of the plurality of images, wherein the temporal feature includes a calculation of the values of the predetermined attributes extracted from the plurality of images, wherein said step is “tracking” that pathology in images which is also a step that may be performed by visually assessing the image change from one image to the next and is akin to a mental operation. The step directed to extracting a value of the attribute (of interest) in each location may be performed mentally using pen and paper, as can calculations of values given the known attribute of interest and is therefore abstract.
Claim 44:
the temporal feature includes a calculation of weighted attributes, which is further limiting to the abstract ideas recited in claim 43 as above.
Claim 45:
assigning a weight to each of the predetermined attributes extracted from the plurality of images, based on a probability of pathology detection in each image of the plurality of images, wherein assigning weights is a mathematical operation that can be performed in a mental fashion using pen and paper and is therefore abstract.
Claim 46:
extracting a first value of the predetermined attribute from the location of the pathology in a first image; extracting a second value of the predetermined attribute from the location of the pathology in a second image; and combining the first and second values of attribute to obtain the FFR value for the pathology, wherein getting values of known attributes from multiple images and combing said values for FFR calculation is an abstract mental/mathematical operation that can be performed using pen and paper, as no other steps are provided that would provide for more beyond said BRI of the instant claims and said operations are therefore abstract.
Claim 47:
combining the first and second values of FFR to obtain the FFR value for the pathology, is directed to merely adding values 1 and 2 to achieve a value, which is a mental procedure performed by mathematical operations and can be done using pen and paper upon data receipt (obtain values).
Independent Claim 49:
extracting, from a location of the pathology in a plurality images of the vessel, values of a predetermined attribute; calculating a temporal feature based on the values of the predetermined attribute; inputting the temporal feature to an estimator; and obtaining, from an output of the estimator, an FFR value for the pathology, wherein are steps directed to mental activity by which one could merely visually assess image data and determine a location based on observations. Further one could calculate by estimations the values of Fractional Flow Reserve (FFRct-a known calculation) based on said values, such as described at [0071]. No further steps are provided, save for computer implementation through executable instructions and, thus under the Broadest Reasonable Interpretation (BRI) of the claims herein, said steps are directed to abstract mental processes that use a computer as a tool by which to perform said abstract functions.
Hence, the claims explicitly recite numerous elements that, individually and in combination, constitute abstract ideas.
The abstract ideas recited in the claims are evaluated under the Broadest Reasonable Interpretation (BRI) and determined herein to each cover performance in the mind (determine location in an image; data attributes; and value of functional measurement). There are no specifics as to the methodology involved in said steps and thus, under the BRI, one could simply, for example, perform said operation with pen and paper, or, alternatively with the aid of a generic computer as a tool to perform said observations in the claims limited to using a computer (claims 30-40 and 49). These recitations are similar to the concepts of collecting information, analyzing it and providing certain results from the collection and analysis (Electric Power Group, LLC, v. Alstom (830 F.3d 1350, 119 USPQ2d 1739 (Fed. Cir. 2016)), organizing and manipulating information through mathematical correlations (Digitech Image Techs., LLC v Electronics for Imaging, Inc. (758 F.3d 1344, 111 U.S.P.Q.2d 1717 (Fed. Cir. 2014)) and comparing information regarding a sample or test to a control or target data in (Univ. of Utah Research Found. v. Ambry Genetics Corp. (774 F.3d 755, 113 U.S.P.Q.2d 1241 (Fed. Cir. 2014) and Association for Molecular Pathology v. USPTO (689 F.3d 1303, 103 U.S.P.Q.2d 1681 (Fed. Cir. 2012)) that the courts have identified as concepts that can be practically performed in the human mind with pen and paper, and can include mathematical concepts.
Further, see MPEP § 2106.04(a)(2), subsection III. The courts do not distinguish between mental processes that are performed entirely in the human mind and mental processes that require a human to use a physical aid (e.g., pen and paper or a slide rule) to perform the claim limitation (see, e.g., Benson, 409 U.S. at 67, 65, 175 USPQ at 674-75, 674: noting that the claimed "conversion of [binary-coded decimal] numerals to pure binary numerals can be done mentally," i.e., "as a person would do it by head and hand."); Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1139, 120 USPQ2d 1473, 1474 (Fed. Cir. 2016): holding that claims to a mental process of "translating a functional description of a logic circuit into a hardware component description of the logic circuit" are directed to an abstract idea, because the claims "read on an individual performing the claimed steps mentally or with pencil and paper"). Nor do the courts distinguish between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer. As the Federal Circuit has explained, "[c]ourts have examined claims that required the use of a computer and still found that the underlying, patent-ineligible invention could be performed via pen and paper or in a person’s mind" (see Versata Dev. Group v. SAP Am., Inc., 793 F.3d 1306, 1335, 115 USPQ2d 1681, 1702 (Fed. Cir. 2015); Mortgage Grader, Inc. v. First Choice Loan Servs. Inc., 811 F.3d 1314, 1324, 117 USPQ2d 1693, 1699 (Fed. Cir. 2016): holding that computer-implemented method for "anonymous loan shopping" was an abstract idea because it could be "performed by humans without a computer").
Step 2A, Prong 2 Analysis: Integration to a Practical Application
Because the claims do recite judicial exceptions, direction under (2A)(2) provides that the claims must be examined further to determine whether they integrate the abstract ideas into a practical application (MPEP 2106.04(d). A claim can be said to integrate a judicial exception into a practical application when it applies, relies on, or uses the judicial exception in a manner that imposes a meaningful limit on the judicial exception. This is performed by analyzing the additional elements of the claim to determine if the abstract idea is integrated into a practical application (MPEP 2106.04(d).I.; MPEP 2106.05(a-h)). If the claim contains no additional elements beyond the abstract idea, the claim is said to fail to integrate the abstract idea into a practical application (MPEP 2106.04(d).III).
With respect to the instant recitations, the claims recite the following additional elements:
Claims 30:
“receiving a plurality of images” and “displaying the value on a user interface device”, wherein said operations are directed to “getting data” (data gathering) and extra-solution output (displaying). With respect to the additional elements in the instant claims, those steps directed to data gathering perform functions of collecting the data needed to carry out the abstract idea. Data gathering does not impose any meaningful limitation on the abstract idea, or on how the abstract idea is performed. Data gathering steps are not sufficient to integrate an abstract idea into a practical application. (MPEP 2106.05(g).
Further to “output” said step is directed to extra-solution activity that are incidental to the process of prediction and generation and do not amount to a limitation that imposes a meaningful limit on the claim. See for example, See Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 715-16, 112 USPQ2d 1750, 1755 (Fed. Cir. 2014) (restricting public access to media was found to be insignificant extra-solution activity); Apple, Inc. v. Ameranth, Inc., 842 F.3d 1229, 1242, 120 USPQ2d 1844, 1855 (Fed. Cir. 2016) (in patents regarding electronic menus, features related to types of ordering were found to be insignificant extra-solution activity). This is considered in Step 2A Prong Two and Step 2B.
Claims 30 and 49
“system; memory; processor” (claim 30); and “computer-readable medium with instructions for” (claim 49), wherein recitation herein of said “computer” components are those that are directed to generic computing components and not to a “specific machine” and wherein said recitations do not describe any specific computational steps by which the “computer parts” perform or carry out the abstract idea, nor do they provide any details of how specific structures of the computer, such as the computer-readable recording media, are used to implement these functions. The claims state nothing more than a generic computer which performs the functions that constitute the abstract idea. Hence, these are mere instructions to apply the abstract idea using a computer, and therefore the claim does not integrate that abstract idea into a practical application. The courts have weighed in and consistently maintained that when, for example, a memory, display, processor, machine, etc… are recited so generically (i.e., no details are provided) that they represent no more than mere instructions to apply the judicial exception on a computer, and these limitations may be viewed as nothing more than generally linking the use of the judicial exception to the technological environment of a computer. (see MPEP 2106.05(f)).
Dependent claims contain further limitations to data and output of results (claims 33, 47, and 48) and are subject to further limiting the additional elements as described above without adding integration or improvement as a whole to any judicial exception.
Step 2B Analysis: Do Claims Provide an Inventive Concept
The claims are lastly evaluated using the (2B) analysis, wherein it is determined that because the claims recite abstract ideas, and do not integrate that abstract ideas into a practical application, the claims also lack a specific inventive concept. Applicant is reminded that the judicial exception alone cannot provide the inventive concept or the practical application and that the identification of whether the additional elements amount to such an inventive concept requires considering the additional elements individually and in combination to determine if they provide significantly more than the judicial exception. (MPEP 2106.05.A i-vi).
With respect to the instant claims, the additional elements of data gathering described above do not rise to the level of significantly more than the judicial exception. As directed in the Berkheimer memorandum of 19 April 2018 and set forth in the MPEP, determinations of whether or not additional elements (or a combination of additional elements) may provide significantly more and/or an inventive concept rests in whether or not the additional elements (or combination of elements) represents well-understood, routine, conventional activity. Said assessment is made by a factual determination stemming from a conclusion that an element (or combination of elements) is widely prevalent or in common use in the relevant industry, which is determined by either a citation to an express statement in the specification or to a statement made by an applicant during prosecution that demonstrates a well-understood, routine or conventional nature of the additional element(s); a citation to one or more of the court decisions as discussed in MPEP 2106(d)(II) as noting the well-understood, routine, conventional nature of the additional element(s); a citation to a publication that demonstrates the well-understood, routine, conventional nature of the additional element(s); and/or a statement that the examiner is taking official notice with respect to the well-understood, routine, conventional nature of the additional element(s).
With respect to the instant claims, the prior art to, for example, Stone et al. (Circulation (2012) Vol. 126:172-181) disclose steps that include getting image data for use in coronary modeling (p. 173, col. 2). Further prior art to, for example, Ricotta et al. (Med Biol Eng Comput (2008) 46:1059–1068) diagnostic testing that includes physiological and anatomical measurements from image analysis (p. 1059-abstract; p. 1060, col. 1; entire reference) and provide that getting such data encompasses steps that are routine, well-understood and conventional in the art. With respect to outputting or providing data, said operations are akin to computer provision of said data and further wherein the computer-related elements or the general purpose computer do not rise to the level of significantly more than the judicial exception. The instant specification provides evidence that computer processors and systems, as example, are generic in nature (see, for example [0082]-[0083]). The additional elements are set forth at such a high level of generality that they can be met by a general purpose computer. Therefore, the computer components constitute no more than a general link to a technological environment, which is insufficient to constitute an inventive concept that would render the claims significantly more than an abstract idea (see MPEP 2106.05(b)I-III).
The dependent claims have been analyzed with respect to step 2B and none of these claims provide a specific inventive concept, as they all fail to rise to the level of significantly more than the identified judicial exception as they are directed to further definition of the “data” herein, and output.
For these reasons, the claims, when the limitations are considered individually and as a whole, are rejected under 35 USC § 101 as being directed to non-statutory subject matter.
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)(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.
1. Claims 30-44 and 46-49 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Tolkowsky et al. (2014/0121513-EFD at least 26 June 2013).
Claim 30 is directed to:
A system for analysis of a vessel, the system comprising:
at least one memory storing instructions; and at least one processor operatively connected to the at least one memory and configured to execute the instructions to perform operations, including (Tolkowsky et al. disclose a processor and apparatus at [0043]:
receiving a plurality of images of a patient's vessel (Tolkowsky et al. disclose getting angiographic images at [0035]);
determining a location of a pathology in the vessel, in at least some of the plurality of images (Tolkowsky et al. disclose, “the given location includes a location in a vicinity of a stenosis within the lumen” [0055]);
creating a signal describing a predetermined attribute at the location of the pathology, over time (Tolkowsky et al. disclose, “the index-determination functionality is configured to determine the value of the luminal-flow-related index of the subject at the location, by determining the value of the luminal-flow-related index in the vicinity of the stenosis” at [0055] and doing so over time [0058]-[0059]);
determining a value of a functional measurement for the pathology, based on the signal (Tolkowsky et al. disclose, “the index-determination functionality is configured to determine the value of the luminal-flow-related index of the subject at the location, by determining a value of functional flow reserve of the subject at the location” [0056]; and
displaying the value on a user interface device (Tolkowsky et al. disclose, output to a display at [0062]).
With respect to claim 31, Tolkowsky et al. disclose, “based upon the geometry of the lumen and the blood velocity, the value of a current flow-related parameter of the lumen at the given location is determined” [0035].
With respect to claim 32, Tolkowsky et al. disclose, “based upon the geometry of the lumen and the blood velocity, the value of a current flow-related parameter of the lumen at the given location is determined. For example, the current flow, blood pressure, and/or blood velocity may be determined. An indication of a value of a second flow-related parameter of the subject is received. For example, an indication of blood pressure at an upstream location (e.g., aortic pressure) may be received” [0035].
With respect to claim 33, Tolkowsky et al. disclose, angiographic images as taken with contrast agents [0043].
With respect to claim 34, Tolkowsky et al. disclose, “determine a value of a current flow related parameter at the location based upon the determined blood velocity and the geometry of the lumen in the vicinity of the location; flow-related-parameter-receiving functionality configured to receive an indication of a value of a second flow-related parameter of the subject; index-determination functionality configured to determine a value of a luminal-flow-related index of the subject at the location, by determining a relationship between the value of the current flow-related parameter and the value of the second flow-related parameter” [0043].
With respect to claim 35, Tolkowsky et al. disclose, estimating FFR by calculations at [0029]-[0033]; [0310]; [0344].
With respect to claim 36, Tolkowsky et al. disclose index-determinations that include input from other features such as geometry in addition to BP, velocity in [0344].
With respect to claim 37, Tolkowsky et al. disclose, “regression analysis” in a machine learning context for FFR calculation [0444].
With respect to claim 38, Tolkowsky et al. disclose, combinations of values at least at [0344]; [0444]; [0447].
With respect to claim 39, Tolkowsky et al. disclose, weight assignment for image attributes and calculation of weighted values by inherent disclosure of machine learning classifiers that include Support Vector Machine and Neural networks [0444].
With respect to claim 40, Tolkowsky et al. disclose image intensity measurement values at [0327]; [0365].
Claim 41 is directed to:
A method for determining a Fractional Flow Reserve (FFR) value for a pathology in a vessel, the method comprising (Tolkowsky et al. estimating FFR by calculations at [0029]-[0033]; [0310]; [0344]):
extracting, from a location of the pathology in a plurality images of the vessel, values of a predetermined attribute (Tolkowsky et al. disclose, “the index-determination functionality is configured to determine the value of the luminal-flow-related index of the subject at the location, by determining the value of the luminal-flow-related index in the vicinity of the stenosis” at [0055]);
calculating a temporal feature based on the values of the predetermined attribute; inputting the temporal feature to an estimator (Tolkowsky et al. disclose the above and doing so in a time-dependent manner [0344]; [0382]; and
obtaining, from an output of the estimator, an FFR value for the pathology (Tolkowsky et al. estimating FFR by calculations at [0029]-[0033]; [0310]; [0344]).
With respect to claim 42, Tolkowsky et al. disclose, “based upon the geometry of the lumen and the blood velocity, the value of a current flow-related parameter of the lumen at the given location is determined” [0035].
With respect to claim 43, Tolkowsky et al. disclose, “based upon the geometry of the lumen and the blood velocity, the value of a current flow-related parameter of the lumen at the given location is determined. For example, the current flow, blood pressure, and/or blood velocity may be determined. An indication of a value of a second flow-related parameter of the subject is received. For example, an indication of blood pressure at an upstream location (e.g., aortic pressure) may be received” [0035]; [0382]..
With respect to claim 44, Tolkowsky et al. disclose weight assignment for image attributes and calculation of weighted values by inherent disclosure of machine learning classifiers that include Support Vector Machine and Neural networks [0444].
With respect to claim 46, Tolkowsky et al. disclose, combinations of values at least at [0344]; [0444]; [0447].
With respect to claim 47, Tolkowsky et al. disclose combinations of values at least at [0344]; [0444]; [0447] and further discloses calculation at multiple locations [0358]; [0359].
With respect to claim 48, Tolkowsky et al. disclose display to a user [0062].
Claim 49 is directed to:
A non-transitory computer-readable medium comprising instructions for determining a Fractional Flow Reserve (FFR) value for a pathology in a vessel, in instructions executable by at least one processor to perform operations, including:
extracting, from a location of the pathology in a plurality images of the vessel, values of a predetermined attribute;
calculating a temporal feature based on the values of the predetermined attribute; inputting the temporal feature to an estimator; and
obtaining, from an output of the estimator, an FFR value for the pathology. Tolkowsky et al. teach the embodiments as the claim elements discussed with respect to claim 41 above. Tolkowsky et al. further disclose processors and apparatus structure for doing so at least at [0043]; [0062]; [0113]; [0277]; [0321].
As such, the prior art to Tolkowsky et al. anticipate each of claims 30-44 and 46-49 as discussed above.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
1. Claims 39, 44 and 45 are rejected under 35 U.S.C. 103 as being unpatentable over by Tolkowsky et al. (2014/0121513-EFD at least 26 June 2013), as applied to claims 30, 41, and 43 above and in view of Sollich (Advances in Neural Information Processing Systems 12 (NIPS 1999): “Probabilistic Methods for Support Vector Machines”; pp. 349-355).
The rejection over claims 39 and 44 herein is alternatively cited with respect to Support Vector Machines (SVMs) including “weights” as discussed above.
The prior art to Tolkowsky et al. disclose the limitations as pertain to claims 30, 41, and 43 above. However, Tolkowsky does not explicitly disclose that “weights” are assigned as in claims 39, 44, and 45 herein. However, the prior art to Sollich discloses frameworks for SVMs to assign optimal value parameters (p. 349, abstract). Further Sollich discloses assessment of vector weights and assignments based on probabilities as detailed at least at page 350-353 therein.
As such, it would have been obvious to one of skill in the art before the effective filing date of the claimed invention to look to the discussion in Sollich for details pertaining to Support Vector Machine implementation of the techniques as disclosed by Tolkowsky et al. One would have been motivated to do so because Sollich disclose details pertaining to weight vector assignments and probabilities thereof and the prior art to Tolkowsky specifically discloses using machine learning that include SVMs. As such, there would have been a reasonable expectation of success in doing so and the claims are thus prima facie obvious.
Conclusion
No claims are allowed.
Assessment of related applications and patents has been made. Upon claim amendment, such will be reevaluated for any double patenting issues.
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/Lori A. Clow/ Primary Examiner, Art Unit 1687
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