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 21-40 are currently pending and under exam herein.
Claims 1-20 are cancelled by preliminary amendment.
Restriction Requirement Withdrawn
After further consideration of the Restriction of Species requirement mailed 30 April 2026, the Restriction is hereby withdrawn and each of claims 21-40 are examined in full herein.
Priority
The instant Application is a Continuation of U.S. Application No. 15/673,637, filed August 10, 2017, now US Patent 11,423,805, which claims priority to U.S. Provisional Application No. 62/373,012, filed August 10, 2016. Priority is acknowledged for each of claims 21-40 to the EFD of 10 August 2016.
Information Disclosure Statement
The Information Disclosure Statement filed 5 July 2022 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 5 July 2022 are accepted.
Specification
Note: All references to the Specification herein pertain to the PG publication: US2022/0335859.
Claim Rejections - 35 USC § 112(b)-Indefiniteness
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.
Claims 21-40 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claims 21, 35, and 39 recite, “identifying one or more lesions in the patient-specific anatomical model suspected of affecting blood flow to at least a part of a gastrointestinal system of the patient”, wherein the claim is unclear with respect to the criteria the would indicate that a lesion is “suspected” of affecting blood flow, as there are no parameters set forth that define what would lead to a “suspicion” of such in the claim nor is there a definition of a particular type of “lesion”, for example, a “stenotic area” or a region of “plaque”. As such, the claim is indefinite. Clarification is requested through clearer claim language. Dependent claims fail to remedy the above and are also rejected for the same reasons.
Claims 21, 35, and 39 recite, “determining a healthy diameter of a blood vessel lumen at a location of each of the one or more lesions”, wherein the claim is unclear with respect to the definition of what would establish a “healthy diameter” of a blood vessel, as what is “healthy for one person or subject is not necessarily so for another. As such, the term is relative herein. It is noted that claim 32 does define that the determination is established by determining a diameter at vessel locations that are proximal to or distal to the one or more lesions. However, the assessment of the proximal or distal vessels does not clearly include what those “determinations” mean in terms of establishing “healthy”. It is suggested that the claims are amended to include that there is a comparison between a lesion area and one of proximal or distal vessels for comparison or the like. Clarification is requested.
Claims 21, 35, and 39 recite, “generating an anatomical model of a treatment of the one or more lesions using the determined healthy diameter”, wherein the claim step is unclear with respect to using a healthy diameter to generate a model of a treatment for the lesion as there are no parameters in the claim that establish what feature or features of a healthy diameter would lead to the generation of a model for treatment. Further, it is not clear as to what “treatment” is intended in the claim. Clarification is requested through clearer claim language.
Claims 21, 35, and 39 recite, “determining and outputting an indicia of an energy available in the patient, based on the treatment of the one or more lesions”, wherein the claim step is unclear with respect to the parameters that determine an indicia of energy as based on some treatment of a lesion. “energy” is a relative term as there is no definition in the claim of any particular kind of “energy”. Clarification is requested through clearer claim language.
Claims 22, 36, and 40 recite, “identifying and outputting at least one of the one or more lesions for which treatment yields a maximum net energy available in the patient”, wherein the claim step is unclear with respect to the recitation of “maximum net energy” as there are no parameters established for “energy” in the claim. See rejection above. Clarification is requested to establish to what the maximum net energy pertains.
It is noted that claims 23 and 37 appear to address the above concerns with respect to “energy” as the patient information is “related to a food intake” and thus is it interpreted that “energy” pertains to “caloric energy”.
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 21-40 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 computer-implemented method, a system and a non-transitory computer-readable medium to plan treatment of a lesion.
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) and in conjunction with mathematical concepts (in particular mathematical relationships and formulas).
Note: The claim steps are recited below and indicate abstract ideas by italics and additional elements by underline.
Independent Claim 21:
A computer-implemented method for processing electronic images to plan treatment of a lesion, the method comprising:
receiving, in an electronic storage medium, a patient-specific anatomical model of at least a portion of a visceral vascular system of a patient;
identifying one or more lesions in the patient-specific anatomical model suspected of affecting blood flow to at least a part of a gastrointestinal system of the patient;
determining a healthy diameter of a blood vessel lumen at a location of each of the one or more lesions;
generating an anatomical model of a treatment of the one or more lesions using the determined healthy diameter; and
determining and outputting an indicia of an energy available in the patient, based on the treatment of the one or more lesions.
Independent Claim 35:
A system for processing electronic images to plan treatment of a lesion, the system comprising:
a data storage device storing instructions for planning treatment of a lesion; and
a processor configured to execute the instructions to perform a method comprising:
receiving, in an electronic storage medium, a patient-specific anatomical model of at least a portion of a visceral vascular system of a patient;
identifying one or more lesions in the patient-specific anatomical model suspected of affecting blood flow to at least a part of a gastrointestinal system of the patient;
determining a healthy diameter of a blood vessel lumen at a location of each of the one or more lesions;
generating an anatomical model of a treatment of the one or more lesions using the determined healthy diameter; and
determining and outputting an indicia of an energy available in the patient, based on the treatment of the one or more lesions.
Independent Claim 39:
A non-transitory computer readable medium for use on a computer system containing computer-executable programming instructions for a method of processing electronic images to plan treatment of a lesion, the method comprising:
receiving, in an electronic storage medium, a patient-specific anatomical model of at least a portion of a visceral vascular system of a patient;
identifying one or more lesions in the patient-specific anatomical model suspected of affecting blood flow to at least a part of al gastrointestinal system of the patient;
determining a healthy diameter of a blood vessel lumen at a location of each of the one or more lesions;
generating an anatomical model of a treatment of the one or more lesions using the determined healthy diameter; and
determining and outputting an indicia of an energy available in the patient, based on the treatment of the one or more lesions.
The limitations to abstract ideas recited in the claims are explained as follows:
identifying one or more lesions in the patient-specific anatomical model suspected of affecting blood flow to at least a part of a gastrointestinal system of the patient, wherein said step is directed to mental operations where one can, under the Broadest Reasonable Interpretation (BRI) of the claim step herein, make an identification by looking at an assessing a model as provided. For example, a physician, when receiving a model may assess the model and determine a lesion area.
determining a healthy diameter of a blood vessel lumen at a location of each of the one or more lesions, wherein said step is directed to mental operations where one can, under the Broadest Reasonable Interpretation (BRI) of the claim step herein can mentally assess the diameter of a lesion by visual observation and measurement, for example with a computer cursor or with pen and paper.
generating an anatomical model of a treatment of the one or more lesions using the determined healthy diameter, wherein said step is directed to mental operations where one can, under the Broadest Reasonable Interpretation (BRI) of the claim step herein can establish an anatomical model using pen and paper or with the aid of a computer to represent a model of treatment.
determining and outputting an indicia of an energy available in the patient, based on the treatment of the one or more lesions, wherein said step is directed to mental operations where one can, under the Broadest Reasonable Interpretation (BRI) of the claim step herein determine an indicia of energy by pen and paper operation.
There are no other steps in the claims as recite beyond said interpretation that would preclude mental activity. Hence, the claims explicitly recite numerous elements that, individually and in combination, constitute abstract ideas.
Dependent claims include the following abstract ideas:
Claims 22, 36, and 40: identifying and outputting at least one of the one or more lesions for which treatment yields a maximum net energy available in the patient-directed to mentally making an identification as discussed above.
Claims 23 and 37:
determining the indicia of the energy available in the patient comprises:
receiving, in the electronic storage medium, patient-specific information related to a food intake of the patient;
generating a patient-specific model of blood flow in the anatomical model that represents the treatment of the one or more lesions;
generating a patient-specific model of nutrient transport from at least a part of a gastrointestinal system of the patient to the visceral vascular system of the patient based on the patient-specific information related to the food intake of the patient; and
determining the indicia of the energy available in the patient based on the patient-specific model of nutrient transport-wherein steps directed to generating and determining are mental operations as describe above.
Claim 24:
simulating blood flow through hepatic and portal blood vessels of the patient based on the patient-specific model of nutrient transport, wherein the blood flow through the hepatic and portal blood vessels transports nutrients, and wherein determining the indicia of the energy available in the patient is based on the simulated blood flow and the patient-specific model of nutrient transport-wherein steps directed to simulating a blood flow can be performed mentally absent any steps by which said “simulation” occurs. One could simply use pen and paper or the aid of a computer armed with appropriate modeling criteria to represent blood flow as fluid or impeded based on vessel diameters, for example.
Claim 25:
receiving an indicia of a liver function of the patient, wherein determining an indicia of the energy available in the patient is based on the indicia of the liver function of the patient and the patient-specific model of nutrient transport, further limiting the above determination of energy, which is an abstract mental operation.
Claim 26:
generating the patient-specific model of blood flow in the anatomical model comprises: truncating the anatomical model at locations; applying boundary conditions at the locations to determine blood flow characteristics in the truncated anatomical model; and generating a patient-specific model of blood flow based on the determined blood flow characteristics in the truncated anatomical model, which further limits the steps of “generating” as described above and is an abstract mental process or alternatively, a mathematical process of boundary condition calculations.
Claim 27:
wherein the indicia of energy available includes one or more of: a net energy available in a systemic circulation, a net nutrient available in the systemic circulation, or a net sugar level in the systemic circulation, which further limits the indicia as described above and is abstract.
Claim 28:
patient- specific information related to the food intake of the patient includes on one or more of: a density, an amount, a volume, a mass, a nutritional content, or an acidity of the food intake of the patient; and temporal and/or environmental information of the food intake by the patient.
Claim 29:
receiving gastrointestinal health information of the patient; generating the patient-specific model of nutrient transport from the at least the part of the gastrointestinal system of the patient to the visceral vascular system of the patient based on the patient-specific information related to the food intake of the patient and the gastrointestinal health information of the patient; and determining the indicia of the energy available in the patient based on the patient-specific model of nutrient transport and the gastrointestinal health information of the patient, which is further directed to steps that are abstract that include further “generation” steps and determination steps that are mental processes as describe above.
Claim 30:
wherein the gastrointestinal health information includes one or more of: an indicia of a peristaltic function of a gastrointestinal tract of the patient; an estimated membrane channel permeability of the patient; or an indicia of mesenteric ischemia of the patient
Claim 31:
wherein generating the patient-specific model of nutrient transport from the at least the part of the gastrointestinal system of the patient to the visceral vascular system of the patient includes one or more of: modeling a mesenteric flow rate based on one or more of the patient-specific information related to the food intake of the patient and gastrointestinal health information of the patient; modeling a membrane channel permeability of a vessel; or modeling a concentration gradient of nutrients between the at least the part of the gastrointestinal system of the patient and a visceral vessels based on one or more of the mesenteric flow rate and the membrane channel permeability, which further limits the judicial exception as describe above and directed to “generating” and doing so by “modeling” which may be executed using pen and paper.
Claim 32:
determining a healthy diameter of a blood vessel lumen at a location of each of the one or more lesions comprises: determining a diameter at vessel locations that are proximal to or distal to the one or more lesions of the identified one or more lesions, wherein said step is a mental operations as described above or alternatively one that is a mathematical measurement operation.
Claim 33:
determining a change in a weight or mass of the patient based on the treatment of the identified one or more lesions, whose treatment yields the maximum net energy available in a systemic circulation of the patient, which is a step directed to abstract mental observation of determinations as described above. One could mentally observe a change in weight of a patient, for example.
Claim 34:
wherein the change in the weight or mass of the patient is further based on one or more of: a metabolic rate and/or metabolic demand of the patient; and an indicia of insulin resistance of the patient, wherein said operation is an abstract mental operation further limiting claim 33.
The abstract ideas recited in the claims are evaluated under the Broadest Reasonable Interpretation (BRI) and determined herein to each cover performance either in the mind (by hand or pen and paper) and performance by mathematical operation (indicia, for example). There are no specifics as to the methodology involved in “identifying” or in “determining and generating” 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 calculations. 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 additional elements as indicated above:
Further with respect to the additional elements in the instant claims, those steps directed to “receiving…a patient-specific anatomical model” are data gathering perform functions of collecting the data needed to carry out the abstract idea. The same holds for those steps to “receiving…patient-specific information related to a food intake of the patient”, “indicia”, “liver function” etc.
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 with respect to those claim elements that include a computer, system and processor and memory with instructions executable by a processor, said elements are part of a general purpose computer system and there are no details herein wherein of how the specific computer structures are used to implement the judicial exceptions beyond generic computing operations, i.e., the computer elements of the claims do not provide improvements to the functioning of the computer itself (see: DDR Holdings, LLC v. Hotels.com LP); they do not provide improvements to any other technology or technical field (see: Diamond v. Diehr); nor do they utilize a particular machine (see: Eibel Process Co. v. Minn. & Ont. Paper Co.). Hence, these are mere instructions to apply the judicial exception using a computer, and therefore the claim does not provide integration into a practical application of 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 review prior art discloses that computer modeling data was routine, well-known and conventional at the time of the invention including patient-specific anatomical modeling as disclosed, for example, Liao et al. (World Journal of Gastroenterology (2009) Vol. 15(2):169-176), disclosing GI tract mathematical and computational modeling (abstract) in encompass steps that are routine, well-understood and conventional in the art.
With respect to the claims to the system and processor, memory and instruction, the computer-related elements or the general purpose computer do not rise to the level of significantly more than the judicial exception. The specification discloses that computer processors and systems, as example, are generic computing systems [0008]; [0026]. 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.
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.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 21-40 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,423,805. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘805 patent are directed to:
A computer-implemented method (and system and non-transitory computer-readable medium) of modeling nutrient transport within a patient, the method comprising:
generating a three-dimensional patient-specific anatomical model of at least a portion of a visceral vascular system of the patient based at least on a velocity of blood or a pressure of blood flowing through the visceral vascular system;
receiving, in an electronic storage medium, patient-specific information related to a patient's food intake;
determining a boundary condition information of the patient-specific anatomical model of at least a portion of the visceral vascular system;
generating a patient-specific feature vector using the boundary condition information;
determining, using a trained machine learning system, the velocity of blood or the pressure of blood flowing through the visceral vascular system using the patient-specific feature vector;
determining an amount of nutrients in the visceral vascular system using the patient-specific information related to the patient's food intake;
generating a patient-specific model of blood flow in the patient-specific anatomical model of the portion of the visceral vascular system of the patient using at least (1) the determined velocity of blood or the pressure of blood flowing through the visceral vascular system, and (2) the patient-specific information related to the patient's food intake, wherein the patient-specific model of blood flow includes the amount of nutrients in the visceral vascular system;
generating a patient-specific model of nutrient transport from at least a part of a gastrointestinal system of the patient to the portion of the visceral vascular system of the patient based on the patient-specific information related to the patient's food intake; and
determining an indicia of energy available in the patient based on the patient-specific model of nutrient transport and the patient-specific model of blood flow, the indicia of energy indicating a normal or an abnormal function of a liver of the patient.
The instant claims are directed to:
A computer-implemented method (system and computer-readable medium) for processing electronic images to plan treatment of a lesion, the method comprising:
receiving, in an electronic storage medium, a patient-specific anatomical model of at least a portion of a visceral vascular system of a patient;
identifying one or more lesions in the patient-specific anatomical model suspected of affecting blood flow to at least a part of a gastrointestinal system of the patient;
determining a healthy diameter of a blood vessel lumen at a location of each of the one or more lesions;
generating an anatomical model of a treatment of the one or more lesions using the determined healthy diameter; and
determining and outputting an indicia of an energy available in the patient, based on the treatment of the one or more lesions.
Further the dependent claims include that the model of blood flow (which can fairly include assessment of velocity and pressure) includes information related to food intake and nutrient transport (claim 23). Blood flow is assessed in the hepatic and portal blood vessels (claim 24) and further includes determining an indicia of energy available based on indicia of liver function (claim 25).
As such, the instant claims are obvious variants of those as in patent ‘805 wherein the inclusion of machine learning modeling is prima facie obvious in light of the definition in the instant Specification that includes that “modeling” is in a machine learning environment at least at [0021]; Figure 6; [0025]; [0041]; [0043].
Prior Art Made of Record
The closest prior art herein is discussed below with respect to the following:
1. Liao et al. (World Gastroenterology (2009) Vol. 15(2):169-176).
2. Jeays et al. (J Biomech 2007; 40: 1916-1926).
3. Jeays et al. (Jeays 2) (World J Gastroenterol 2007 March 7; 13(9): 1393-1398).
4. Mabotuwana et al. (Proceedings of the 28th IEEE EMBS Annual International Conference New York City, USA, Aug 30-Sept 3, 2006:1810-1813).
The prior art to Liao et al. discloses: a computer-implemented method for processing electronic images to plan treatment of a lesion, the method comprising: receiving, in an electronic storage medium, a patient-specific anatomical model of at least a portion of a visceral vascular system of a patient-Liao et al. disclose, “anatomically based models have now been used to investigate normal and pathological electrical activity of the stomach and small intestine[71-74], the muscle functions on the gastroesophageal junction during swallowing[75] and the blood flow in the mesenteric arterial system of the human intestine[69,70]” (p. 5); Liao et al. further include, “GI modelling studies are focused on patient-specific computational modelling and simulation for prediction of disease or early diagnosis by integrating patient specific knowledge and predispositions obtained in biomedical imaging” (p. 6).
identifying one or more lesions in the patient-specific anatomical model suspected of affecting blood flow to at least a part of a gastrointestinal system of the patient-Liao et al. (with reference to Jeays et al.) disclose, “The simplified GI tract models have existed for describing the muscle function[53,68,76], food transportation[77,78,80,81] and blood flow[65] in the GI tract in healthy and diseased situations”, wherein Jeays et al. disclose identification of atheroma by presence of low or oscillating fluid shear stress at the vessel wall (p.1923)
determining a healthy diameter of a blood vessel lumen at a location of each of the one or more lesions, Jeays et al. further disclose time-average wall shear stress over the model including accounting for global norms and maximums thus indicating taking into account healthy blood vessel (geometry)(p.1924-1925).
However, neither Jeays et al. nor Liao et al. disclose the generation of an anatomical model for treatment of one or more lesions and determination of an indicia of energy available in the patient as instantly claimed.
The prior art to Jeays et al. (“Jeays 2” herein) discloses the energy of foodstuffs (p. 1394, col. 2). Jeays 2 further includes that, “Due to the absence of quantitative human data in many areas, the model framework is designed to work logically within the limits of physiologically realistic values for the various inputs and to capture the key understood processes without recourse to the detailed underlying biology. For example, no caloric input, along with expected systolic pressure, will ensure that vessel stiffness and diameter remain at their basal levels, while saturation elements within the model reflect the fact that there are limits on the range of effect of the myogenic and calorie dependent response” (p. 1936, col. 1). However, Jeays 2 fails to disclose generation of treatment of lesions using the determined healthy diameter and output of an indicia of energy based on treatment, as indicated.
The prior art to Mabotuwana et al. discloses modeling blood flow in the gastrointestinal system. Mabotuwana et al. disclose model of the mesenteric arterial system of the human intestine to be used to simulate normal and compromised blood flows (abstract) wherein initial diameters of the abdominal aorta, superior mesenteric artery (SMA) and inferior mesenteric artery (IMA) were considered (p. 1811, col. 1). However, the prior art fails to teach or suggest steps directed to identification of lesions and using healthy diameters to generate a model to treat lesions and determine an indicia of energy available to the patient as claimed herein.
Conclusion
No claims are allowed.
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