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 have been cancelled by preliminary amendment.
Priority
The instant application is a Continuation of US application 15/991,097, filed 29 May 2018, now US Patent 11,605,466 which is a Continuation of US application 15/099,165, filed 14 April 2016, now US Patent 10,007,762 and claiming the benefit of priority to US Provisional Application 62/149,145, filed 17 April 2015. Priority is acknowledged for each of claims 21-40. As such, the instant claims 21-40 are assessed a priority date of the of 17 April 2015.
Information Disclosure Statement
The Information Disclosure Statement filed 14 February 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 submitted 14 February 2023 are accepted.
Specification
All reference to the instant Specification herein pertain to the US PG Publication: US20230197286A1.
Claim Objections
Claims 21-40 are objected to because of the following informalities:
The instant claims have numerous recitations of the word “bloodflow” which is not grammatically correct and should read, instead, “blood flow” (two words). Correction in all instances is requested.
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 Guidance published in the Federal Register notice titled 2019 Revised Patent Subject Matter Eligibility Guidelines (Vol. 84, No. 4, Monday January 7, 2019 at 50) and the October 2019 Updated Subject Matter Eligibility Guidance (hereinafter both referred to as the "Guidance"), 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:
With respect to step (1): yes, the claims are directed to a computer implemented method; a system; and a non-transitory computer-readable medium for assessing tissue function.
With respect to step (2A)(l), 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)(l) 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 mathematical concepts (in particular mathematical relationships and formulas).
The claim steps to abstract ideas are as follows:
Claims 21, 29, and 37: computing a blood flow through the patient-specific vascular model; based on the computed blood flow, identify a vessel of the patient-specific vascular model having a functionally significant compromise of bloodflow; computing, for at least one subsection of the patient-specific tissue model associated with the vessel of the patient-specific vascular model having the functionally significant compromise of bloodflow, a corresponding perfusion value based on the computed blood flow; and generating a treatment recommendation for at least one subsection of the patient-specific tissue model, based on the computed perfusion value for the at least one subsection of the patient-specific tissue model, wherein the steps directed to computing a blood flow are steps that recite mathematical processes whereby, as per the Specification at [0027] disclosing that blood flow may be a rate or velocity or quantity or volume, which are mathematical concepts. Further, blood flow may be computed via perfusion calculations that include solving for blood flow using methods such as fast marching, the diffusion equation, or other equations governing blood flow [0029]. As such, said steps are mathematical processes. The steps directed to identifying a vessel is a mental operation as based on computation and thus recites a mental concept that is an abstract idea. Further, steps to computing a perfusion value is also one that is mathematical in nature, as recited above and disclosed in the Specification per the above. Finally, generating a treatment recommendation is one that is considered a mental operation by which one can assess data and generate a recommendation based on computed data. As such, the claims are directed to abstract ideas.
Claims 22, 30, and 38: identifying, based on the computed perfusion value, a perfusion deficit in the at least one subsection of the patient-specific tissue model, wherein the generating the treatment recommendation is based on the identified perfusion deficit, wherein said operation of identifying based on a computed value is a mental operation whereby one assesses said value and performs a mental step of generating a recommendation based on said value. As such, the claim steps are directed to an abstract idea.
Claims 23, 31, and 39: conducting an assessment of tissue function based on the computed blood flow or the computed perfusion value, wherein the operation of “conducting an assessment” is a mental operation wherein one is informed by a particular set of data, for example, and can make an assessment based on said data. As such, the claim steps are directed to abstract ideas.
Claims 24, 32, and 40: wherein the assessment of the tissue function includes an assessment of a risk to the patient relating to electrical activation, arrhythmia, tachycardia, fibrillation, ejection fraction, stroke volume, aortic pressure, fractional shortening, cardiac index, cardiac output, capacity to perform physical activity, cardiac arrest, pain, claudication, or a combination thereof, wherein the assessment of the tissue function includes an assessment of one or more patient-specific tissue characteristic values including a measure of electrical conductance, muscle contractility, wall motion, or a combination thereof, wherein said operation further defines the type of assessment and thus further limits the abstract ideas as recited in claims 23, 31, and 39 above.
Claims 25 and 33: wherein the assessment of the tissue function includes an assessment of one or more patient-specific tissue characteristic values including a measure of electrical conductance, muscle contractility, wall motion, or a combination thereof, wherein said operation further defines the type of assessment and thus further limits the abstract ideas as recited in claims 23, 31, and 39 above.
Claims 26 and 34: generating a patient-specific electrophysiological and/or biomechanical model of the patient's tissue as a function of the computed blood flow; and calculating a patient-specific tissue characteristic value using the patient-specific electrophysiological and/or biomechanical model of the patient's tissue, wherein the step of generating a model from blood flow computations is a mathematical process, as is calculation of tissue characteristics using said values. The Specification discloses characteristics of tissue as that of a tissue function which may be that of perfusion, for example and can be calculated [0030]. Tissue characteristics may be conductance and can also be a measurement value [0040]. As such, said operation is a mathematical calculation and is an abstract idea.
Claims 27 and 35: determining a vessel outlet of the patient-specific vascular model, wherein the computing the corresponding perfusion value is based on the determined vessel outlet, wherein making a determination is a mental operation. The claim contains no further steps as to what is entailed in determining and thus said step may be a mental observation and is abstract.
Claims 28 and 36: wherein the treatment recommendation includes an evaluation of stent insertion, angioplasty, bypass graft, drugs, increased physical fitness, diet, smoking cessation, recannulation, embolization, valve replacement, and/or ablation therapy, wherein said step further limits the “assessment” step as recited above and thus further limits the abstract idea herein.
The abstract ideas recited above are evaluated under the Broadest Reasonable Interpretation (BRI) and determined herein to each cover performance either in the mind and/or performance by mathematical operation because the steps involve nothing more than instructions for a user to receive data in the form of a model (independent claims) and perform operations such as “computing blood flow”; “dividing” the model into subsections; and “computing” a perfusion value for the subsections. There are no specifics as to the methodology involved in said steps and thus, under the BRI, one could, for example, be provided said model and perform the computations on a piece of paper and further divide said model using pen and paper. Other steps, recited in dependent claims, further include that said techniques are performed using mathematical techniques (e.g., calculating).
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 2106.0S(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 21, 29, and 37: receiving a patient-specific vascular model generated from patient-specific imaging of at least a portion of a vasculature of a patient…receiving a patient-specific tissue model generated from patient-specific imaging
Claims 21, 29, and 37: computer; system; data storage; processor; computer-readable medium with instructions
With respect to the additional elements in the instant claims, those steps directed to data gathering, such as “receiving” 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 2106.0S(g). Further elements to generating a treatment recommendation are those which are extra-solution activity and are recited at a high level of generality that does not provide a practical application to the recited judicial exceptions.
Further steps herein directed to additional non-abstract elements of “processor; computer; storage medium etc...” 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 2106.0S(f)).
None of the recited dependent claims recite additional elements which would integrate a judicial exception into a practical application.
As such, 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 Mansi et al. (US 2013/0197884; IDS document), for example, discloses that using patient-specific models is routine, well-understood and conventional technique in the art. Said portions of the prior art are, for example, (abstract); [0005]. As such, activities such as data gathering do not improve the functioning of a computer, or comprise an improvement to any other technical field; they do not require or set forth a particular machine; they do not effect a transformation of matter; nor do they provide a non-conventional or unconventional step. Rather, the data gathering steps as recited in the instant claims constitute a general link to a technological environment which is insufficient to constitute an inventive concept which would render the claims significantly more than the judicial exception (MPEP2106.05(g)&(h)).
With respect to claims 21-40, the computer-related elements or the general purpose computer do not rise to the level of significantly more than the judicial exception. Further exemplified prior art to, for example, Mansi et al. teaches that computing elements are routine, well-understood and conventional in the art. See, as example, [0005]; [Figures 2, 6, and 19].
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)1-111).
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 Langi, 759 F.2d 887,225 USPQ 645 (Fed. Cir. 1985); In re Van
Ornum, 686F.2d 937,214 USPQ 761 (CCPA 1982); In re Vogel, 422F.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 l.32l(c) or l.32l(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 LB. I. For a reply to a non-final Office action, see 37 CFR 1.11 l(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.
1. Claims 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,178,557.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are directed to: a computer-implemented method of processing medical images, the method comprising: receiving a patient-specific vascular model generated from patient-specific imaging of at least a portion of a vasculature of a patient; computing a blood flow through the patient-specific vascular model; based on the computed blood flow, identify a vessel of the patient-specific vascular model having a functionally significant compromise of bloodflow; receiving a patient-specific tissue model generated from patient-specific imaging; computing, for at least one subsection of the patient-specific tissue model associated with the vessel of the patient-specific vascular model having the functionally significant compromise of bloodflow, a corresponding perfusion value based on the computed blood flow; and generating a treatment recommendation for at least one subsection of the patient-specific tissue model, based on the computed perfusion value for the at least one subsection of the patient-specific tissue model.
Claims of the ‘782 patent are directed to: a computer-implemented method of analyzing patient-specific perfusion, the method comprising: receiving a patient-specific vascular model associated with an individual; receiving or determining a pathology of the patient-specific vascular model; receiving a patient-specific tissue model associated with the individual; identifying one or more perfusion territories within the patient-specific vascular model, using the patient-specific tissue model; parameterizing one or more locations of the pathology within the one or more perfusion territories of the patient-specific vascular model; using forward modeling to generate a patient-specific perfusion model by modeling a blood flow through the identified perfusion territories; prompting a user to provide a severity of the pathology at the one or more locations; and assessing an effect of the pathology on perfusion by modeling perfusion through portions of the one or more perfusion territories corresponding to locations of the pathology for which the user provided a severity of the pathology.
The claims herein are obvious variants ones of the other wherein the recitation in the ‘782 patent to “determining a pathology” is an obvious variant of “identification of functionally significant compromise of blood flow” wherein a pathology may be plaque, for example and said could compromise blood flow as assessed by modeling. Further variants include recitation in the ‘782 patent to “identifying one or more perfusion territories” which is a variant of a “subsection” in the instant application and further recitation of “forward modeling” in the ‘782 patent and computation based on modeling of blood flow in the instant application. Assessment of pathology in the ‘782 patent is further a species to the general recitation of the instant claims including “generating a recommendation based on perfusion herein. As such, said applications contain overlapping matter wherein the claims are obvious variants ones of the other. This is a nonstatutory double patenting rejection.
2. Claims 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,605,466.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are directed to: a computer-implemented method of processing medical images, the method comprising: receiving a patient-specific vascular model generated from patient-specific imaging of at least a portion of a vasculature of a patient; computing a blood flow through the patient-specific vascular model; based on the computed blood flow, identify a vessel of the patient-specific vascular model having a functionally significant compromise of bloodflow; receiving a patient-specific tissue model generated from patient-specific imaging; computing, for at least one subsection of the patient-specific tissue model associated with the vessel of the patient-specific vascular model having the functionally significant compromise of bloodflow, a corresponding perfusion value based on the computed blood flow; and generating a treatment recommendation for at least one subsection of the patient-specific tissue model, based on the computed perfusion value for the at least one subsection of the patient-specific tissue model.
Claims of the ‘466 patent are directed to: a computer-implemented method of assessing tissue function, the method comprising: receiving a patient-specific vascular model generated from patient-specific imaging of at least a portion of a vasculature of a patient; computing a blood flow through the patient-specific vascular model; estimating a functionally significant compromise of blood flow through at least one vessel of the patient-specific vascular model; receiving a patient-specific tissue model generated from patient-specific imaging; dividing the patient-specific tissue model into one or more subsections; determining a relationship between (a) the at least one vessel having a functionally significant compromise of blood flow and (b) at least one subsection of the one or more subsections of the patient-specific tissue model; computing, for the at least one each subsection of the one or more subsections of the patient-specific tissue model, a corresponding perfusion value based on the computed blood flow; simulating a treatment of the at least one subsection of the one or more subsections of the patient-specific tissue model by updating the patient-specific vascular model or the one or more subsections at least one subsection of the patient-specific tissue model based on the estimated functionally significant compromise of blood flow and the determined relationship; computing an updated perfusion value of the at least one subsection of the patient-specific tissue model of the one or more subsections, using the updated patient-specific vascular model or the updated one or more subsections at least one subsection of the patient-specific tissue model; and generating a treatment recommendation for the at least one subsection of the one or more subsections, based on the updated perfusion value of the at least one subsection.
The claims herein are obvious variants ones of the other wherein the recitation in the ‘782 patent of simulating a treatment and making updates to the model in the ‘466 patent is further a species to the general recitation of the instant claims including “generating a recommendation based on perfusion” herein. As such, said applications contain overlapping matter wherein the claims are obvious variants ones of the other. This is a nonstatutory double patenting rejection.
3. Claims 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,007,762.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are directed to: a computer-implemented method of processing medical images, the method comprising: receiving a patient-specific vascular model generated from patient-specific imaging of at least a portion of a vasculature of a patient; computing a blood flow through the patient-specific vascular model; based on the computed blood flow, identify a vessel of the patient-specific vascular model having a functionally significant compromise of bloodflow; receiving a patient-specific tissue model generated from patient-specific imaging; computing, for at least one subsection of the patient-specific tissue model associated with the vessel of the patient-specific vascular model having the functionally significant compromise of bloodflow, a corresponding perfusion value based on the computed blood flow; and generating a treatment recommendation for at least one subsection of the patient-specific tissue model, based on the computed perfusion value for the at least one subsection of the patient-specific tissue model.
Claims of the ‘762 patent are directed to: a computer-implemented method of assessing tissue function, the method comprising: receiving a patient-specific tissue model generated from patient-specific imaging of at least an area or a volume of a patient's tissue; receiving a patient-specific vascular model generated from patient-specific imaging of at least a portion of a patient's vasculature; determining an association between a portion of the patient-specific vascular model and the area or the volume of the patient-specific tissue model; receiving an estimate of blood flow supplied from the portion of the patient-specific vascular model to the area or the volume of the patient-specific tissue model; calculating a value of perfusion to the area or the volume of the patient-specific tissue model using the received estimate of blood flow, one or more vessel outlets of the portion of the patient-specific vascular model, and a measure of the area or a measure of the volume of the patient-specific tissue model; calculating a patient-specific tissue characteristic value using the calculated value of perfusion to the area or the volume of the patient-specific tissue model; and outputting the calculated patient-specific tissue characteristic value.
The claims herein are obvious variants ones of the other wherein the recitation in the ‘762 patent include receiving estimates of blood flow whereas the instant application includes making identifications of blood flow compromise which would be performed by knowing blood flow to begin with for a patient. Further calculations of perfusion to an “area” would be an obvious variant of the recitation of a “subsection” in the instant application. As such, said applications contain overlapping matter wherein the claims are obvious variants ones of the other. This is a nonstatutory double patenting rejection.
4. Claims 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 9,386,933.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are directed to: a computer-implemented method of processing medical images, the method comprising: receiving a patient-specific vascular model generated from patient-specific imaging of at least a portion of a vasculature of a patient; computing a blood flow through the patient-specific vascular model; based on the computed blood flow, identify a vessel of the patient-specific vascular model having a functionally significant compromise of bloodflow; receiving a patient-specific tissue model generated from patient-specific imaging; computing, for at least one subsection of the patient-specific tissue model associated with the vessel of the patient-specific vascular model having the functionally significant compromise of bloodflow, a corresponding perfusion value based on the computed blood flow; and generating a treatment recommendation for at least one subsection of the patient-specific tissue model, based on the computed perfusion value for the at least one subsection of the patient-specific tissue model.
Claims of the ‘933 patent are directed to: a computer-implemented method of evaluating a patient with vascular disease, the method comprising: receiving a tissue model of the patient; receiving a vascular model defining one or more vessel pathologies at a location of vasculature supplying blood to the tissue model; modeling perfusion resulting from a first vessel pathology of the vascular model supplying blood to at least a portion of the tissue model; computing, from the modeled perfusion resulting from the first vessel pathology, a first tissue characteristic value of the tissue model in response to the first vessel pathology, the tissue characteristic including a measure of tissue viability, a tissue capacity to change blood flow, a tissue irregularity, a tissue electrical property, and/or a tissue mechanical property; modeling perfusion resulting from a second vessel pathology of the vascular model supplying blood to at least a portion of the tissue model; computing, from the modeled perfusion resulting from the second vessel pathology, a second tissue characteristic value of the tissue model in response to the second vessel pathology; determining an effect of vessel pathology on the at least one tissue characteristic, from a comparison of the first tissue characteristic to the second tissue characteristic; receiving an observed tissue characteristic value associated with a patient; and estimating, using one or more computer processors, one or more patient pathological characteristics at a location in the patient's anatomy using the observed tissue characteristic value and the determined effect of the vessel pathology on the at least one tissue characteristic.
The claims herein are obvious variants ones of the other wherein the recitation in the ‘933 patent further include modeling that is a comparison between two vessel pathologies as assessed by said method. As such, said applications contain overlapping matter wherein the claims are obvious variants ones of the other and wherein it would be obvious in view of the modeling of one vessel pathology to do it for two and make a comparison using said methods herein. This is a nonstatutory double patenting rejection.
5. Claims 21-40 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/910,583.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are directed to: a computer-implemented method of processing medical images, the method comprising: receiving a patient-specific vascular model generated from patient-specific imaging of at least a portion of a vasculature of a patient; computing a blood flow through the patient-specific vascular model; based on the computed blood flow, identify a vessel of the patient-specific vascular model having a functionally significant compromise of bloodflow; receiving a patient-specific tissue model generated from patient-specific imaging; computing, for at least one subsection of the patient-specific tissue model associated with the vessel of the patient-specific vascular model having the functionally significant compromise of bloodflow, a corresponding perfusion value based on the computed blood flow; and generating a treatment recommendation for at least one subsection of the patient-specific tissue model, based on the computed perfusion value for the at least one subsection of the patient-specific tissue model.
Claims of the ‘583 application are directed to: a computer-implemented method for processing medical images, comprising: receiving a patient-specific vessel model of one or more vessels of a patient and a patient-specific tissue model of a tissue supplied by the one or more vessels, wherein the patient-specific vessel model and the patient-specific tissue model are derived from the medical images of the patient; determining one or more patient-specific values of one or more anatomical or physiological parameters based on the patient-specific vessel model or the patient-specific tissue model; using the patient-specific vessel model or the patient-specific tissue model, determining an estimated supplied blood to the tissue; computing an estimate of a perfusion of blood in the tissue based on the determined patient-specific values of the one or more anatomical or physiological parameters and the determined estimated supplied blood to the tissue; generating a visualization of the computed estimate of the perfusion of blood; and displaying the estimate of the perfusion on an electronic display.
As such, said applications contain overlapping matter wherein the claims are obvious variants ones of the other. This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims are allowed.
With respect to the closest prior art, the prior art to Mansi et al. (2013/0197884-IDS reference) discloses patient anatomic models (claims 1, 9, 17 of Mansi et al) and patient vascular models generated from patient imaging. Mansi et al. disclose assessment of blood flow dynamics [0023]. Mansi et al. include measurements of inflows and outflows as input to a model [0047] and estimations of simulated treatments (claims 8 and 16 of Mansi et al.). However, the prior art fails to teach or fairly suggest the steps whereby both a patient-specific tissue model and a vascular model are employed such that a computation of perfusion is generated using a subsection of a patient-specific tissue model associated with a patient vessel of the vascular model as claimed herein.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Karlheinz Skowronek can be reached on (571) 272-9047.
Any inquiry of a general nature or relating to the status of this application or proceeding should be directed to (571) 272-0547.
Patent applicants with problems or questions regarding electronic images that can be viewed in the Patent Application Information Retrieval system (PAIR) can now contact the USPTO’s Patent Electronic Business Center (Patent EBC) for assistance. Representatives are available to answer your questions daily from 6 am to midnight (EST). The toll free number is (866) 217-9197. When calling please have your application serial or patent number, the type of document you are having an image problem with, the number of pages and the specific nature of the problem. The Patent Electronic Business Center will notify applicants of the resolution of the problem within 5-7 business days. Applicants can also check PAIR to confirm that the problem has been corrected. The USPTO’s Patent Electronic Business Center is a complete service center supporting all patent business on the Internet. The USPTO’s PAIR system provides Internet-based access to patent application status and history information. It also enables applicants to view the scanned images of their own application file folder(s) as well as general patent information available to the public.
/Lori A. Clow/ Primary Examiner, Art Unit 1687
Prosecution Insights