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 .
Duty of Disclosure
The application contains NO IDS and the applicant is reminded of the MPEP section 2001 since the search revealed possible relevant information which does not appear in any IDS.
37 CFR 1.56 Duty to disclose information material to patentability.
[Editor Note: Para. (c)(3) below is applicable only to patent applications filed under 35 U.S.C. 111(a) or 363 on or after September 16, 2012.]
(a) A patent by its very nature is affected with a public interest. The public interest is best served, and the most effective patent examination occurs when, at the time an application is being examined, the Office is aware of and evaluates the teachings of all information material to patentability. Each individual associated with the filing and prosecution of a patent application has a duty of candor and good faith in dealing with the Office, which includes a duty to disclose to the Office all information known to that individual to be material to patentability as defined in this section. The duty to disclose information exists with respect to each pending claim until the claim is cancelled or withdrawn from consideration, or the application becomes abandoned. Information material to the patentability of a claim that is cancelled or withdrawn from consideration need not be submitted if the information is not material to the patentability of any claim remaining under consideration in the application. There is no duty to submit information which is not material to the patentability of any existing claim. The duty to disclose all information known to be material to patentability is deemed to be satisfied if all information known to be material to patentability of any claim issued in a patent was cited by the Office or submitted to the Office in the manner prescribed by §§ 1.97(b)-(d) and 1.98. However, no patent will be granted on an application in connection with which fraud on the Office was practiced or attempted or the duty of disclosure was violated through bad faith or intentional misconduct.
Claim Interpretation
Claims 2 and 6 recite the newly amended limitation of “if the VFR is (a) below 0.83” which in an interpretation it may be construed as a conditional limitation where the limitations followed by the conditional limitations may not be given a full weight in light of the below decisions as for considering the other case scenario of “if the VFR is” not being “below 0.83”.
In the recent Ex parte Gopalan decision, the PTAB addressed a claim where all of the features were recited in a conditional manner. A first step of “identifying … an outlier” was performed if “traffic is outside of a prediction interval.” A second step of “identifying” was performed “only when a count of outliers … is greater than or equal to two, and exceeds an anomaly threshold.” These were the only two elements of the independent claim. Thus, if the traffic is never outside Gopalan’s prediction interval, then the steps of the method are never performed.
However, the PTAB distinguished Schulhauser and noted that this construction “would render the entire claim meaningless.” Gopalan at p. 5. The Board went on to state, “Although each of these steps is conditional, they are integrated into one method or path and do not cause the claim to diverge into two methods or paths, as in Schulhauser. Thus, we conclude that the broadest reasonable interpretation of claim 1 requires the performance of both steps…” Id. at p. 6.”
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: a means for displaying in claim 7 and the depending claims thereof.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claims 3-4, 6 and 9-13 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim. See MPEP § 608.01(n). Accordingly, the claims 3-4 and 6 presumed to depend on the independent claim 1 and claims 9-13 presumed to depend on the independent claim 7in an effort to provide compact prosecution.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim 1 and 7 recite “calculating… a virtual flow reserve” and “determining a clinical outcome”.
The limitation of “calculating”, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting “by a [presumed] processor,” (presumption is due to the storing in an electronic memory device) nothing in the claim element precludes the step from practically being performed in the mind. For example, but for the “by a processor” language, “calculating” in the context of this claim encompasses the user manually calculating the amount manually or with a simple pen and paper. Similarly, the limitation of “determining”, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. For example, but for the “by a processor” language, “determining” in the context of this claim encompasses the user thinking of an outcome for a cutoff value. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim only recites one additional element – using a processor to perform the limitation of “calculating… virtual flow reserve” and “determining a clinical outcome”. The processor in both steps is recited at a high-level of generality (i.e., as a generic processor performing a generic computer function of “” such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using a processor to perform “” steps amount to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. The claim is not patent eligible.
The depending claims also recite similar abstract ideas (e.g., determined, etc.) without additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application.
Therefore, the claims are not patent eligible.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claims 1-13 are rejected under 35 U.S.C. 103 as being unpatentable over Sauer (US 20160022371) in view of Morris et al (Virtual Fractional Flow Reserve from Coronary Angiography: Modeling the Significance of Coronary Lesions: Results From the VIRTU-1 (VIRTUal Fractional Flow Reserve from Coronary Angiography) Study, Volume 6, Issue 2, February 2013, Pages 149-157) and Rai et al (The Value of Pre- and Post-Stenting Fractional Flow Reserve for Predicting Mid-Term Stent Restenosis Following Percutaneous Coronary Intervention (PCI), Glob J Health Sci. 2015 Dec 16;8(7):240–244).
Regarding claim 1, Sauer teaches a method of predicting a clinical outcome of one or more treated blood vessels in a patient (“predicted hemodynamic metrics for the set of stenotic lesions resulting from the stenting configuration” abst), the method comprising the steps of:
storing, in an electronic memory device, blood vessel data collected from the treated blood vessel in a patient (“invention may be performed within a computer system using data stored within the computer system” [0013]);
calculating, using a subsystem of a blood vessel data collection system, a virtual flow reserve (VFR) of the treated blood vessel (“anatomical modeling tasks can be performed automatically … the anatomical models to analyze the effects of such changes on the subsequent computation of FFR [hence Virtual FFR]” [0020]; “automatically detected in the medical image data or in the patient-specific anatomical model of the coronary arteries and then a hemodynamic metric, such as FFR, can be computed for each of the detected lesions” [0021]; “the predicted FFR values for each treatment option can be computed by adjusting patient-specific measurements (e.g., radius measurements) for the stented lesion(s) to reflect full or partial opening due to the virtual stenting and then computed FFR values based on the adjusted patient-specific measurements using a machine learning based technique” [0034]);
determining a clinical outcome of the treated blood vessel in the patient using a cutoff for VFR, wherein the cutoff is equal to or greater than 0.83 (“With two lesions “in series” upstream/downstream of each other, the stenting options are (1) stent lesion #1, (2) stent lesion #2, (3) stent both lesions #1 and #2, and (4) don't stent any lesion. Stenting all lesions (option 3) will restore maximal blood flow. Apart from very pathologic cases, this option can be considered to be curative and, in a possible implementation, does not require extra confirmation by simulation. The evaluation of the stenting options to predict FFR values is performed to determine whether stenting only a subset of the serial lesions is sufficient to restore blood flow such that the predicted FFR values are above the threshold. For the case of two lesions, the evaluation in step 110 can automatically determine whether it is sufficient to stent only lesion #1 or only lesion #2, and if stenting sufficient restores the blood flow, whether lesion #1 or lesion #2 is the preferred lesion to stent. In a possible implementation, we have three stenting options (1)-(3), two of which need to be evaluated. Option (4) can be evaluated by assessing the FFR value after the most distal lesion (in this case downstream of lesion #2) without any stenting. If the FFR value is greater than the threshold (e.g., >0.8), then stenting is not needed for either of the lesions.” [0029]); and
displaying an indicator of the clinical outcome, wherein the indicator is text, a number, a symbol, a color, a picture, or any combination thereof (“FIGS. 4-10 illustrate predicted FFR values for a set of serial stenotic lesions (stenosis 1, stenosis 2, and stenosis 3) in the left anterior descending (LAD) artery for different stenting configurations. FIG. 4 illustrates predicted FFR values resulting from a stenting configuration in which only stenosis 1 is stented. FIG. 5 illustrates predicted FFR values resulting a stenting configuration in which only stenosis 2 is stented. FIG. 6 illustrates predicted FFR values resulting from a stenting configuration in which only stenosis 3 is stented. FIG. 7 illustrates predicted FFR values resulting from a stenting configuration in which stenosis 1 and stenosis 2 are stented. FIG. 8 illustrates predicted FFR values resulting from a stenting configuration in which stenosis 1 and stenosis 3 are stented. FIG. 9 illustrates predicted FFR values resulting from a stenting configuration in which stenosis 2 and stenosis 3 are stented. FIG. 10 illustrates predicted FFR values resulting from a stenting configuration in which stenosis 1, stenosis 2, and stenosis 3 are all stented. [0038]”).
As factually seen above, Sauer teaches all the claimed limitations under broadest reasonable interpretation; yet, if one argues in a narrower interpretation that Sauer does not teach (which the office does not concede) virtual flow reserve and the cutoff is equal to or greater than 0.83, the below references are brought in to provide compact prosecution to show the narrow interpretation.
However, in the same field of endeavor, Morris teaches nineteen patients with stable coronary artery disease awaiting elective PCI were studied. They underwent rotational coronary angiography. The FFR was measured, physiologically significant lesions were stented, and angiography and FFR were repeated. Three-dimensional arterial anatomy pre- and post-stenting was reconstructed offline. Generic boundary conditions for computational fluid dynamics analysis were applied. The virtual fractional flow reserve (vFFR) and measured fractional flow reserve (mFFR) values were compared (methods). The vFFR post-implantation was 0.91 (hence cutoff is equal to or greater than 0.83).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with virtual flow reserve and the cutoff is equal to or greater than 0.83 as taught by Morris because model predicts which lesions were physiologically significant (FFR <0.80) and which were not (FFR >0.80) with accuracy, sensitivity, specificity, positive and negative predictive values (see results of Morris).
Further, also in the same field of endeavor, Rai also teaches FFR cut-off values. Measuring fractional flow reserve (FFR) in percutaneous coronary intervention (PCI) has predictive value for PCI outcome. We decided to examine the utility of pre- and post-stenting FFR as a predictor of 6-month stent restenosis as well as MACE (major adverse cardiac events). Pre- and post-stenting FFR values were measured for 60 PCI patients. Within 6 months after stenting, all patients were followed for assessment of cardiac MACE including myocardial infarction, unstable angina, or positive exercise test. Stent restenosis was also assessed. Cut-off values for pre- and post-stenting FFR measurements were considered respectively as 0.65 and 0.92. Stent restenosis was detected in 4 patients (6.6%). All 4 patients (100%) with restenosis had pre-stenting FFR of < 0.65, while only 26 of 56 patients without restenosis (46.4%) had pre-stenting FFR value of < 0.65 (P = 0.039). Mean pre-stenting FFR in patients with restenosis was significantly lower than in those without restenosis (0.25 ± 0.01 vs. 0.53 ± 0.03, P = 0.022). Although stent restenosis was higher in patients with post-stenting FFR of < 0.92 (2 cases, 9.5%) than in those with FFR value of ≥ 0.92 (2 cases, 5.1%), the difference was not statistically (P = 0.510) (Abst).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with setting the FFR cutoff value to equal to or greater than 0.83 as taught by Rai because it leads to the high diagnostic accuracy of FFR in clinical setting (Intro of Rai).
Regarding claim 2, Sauer teaches wherein if the VFR is (a) below 0.83, it is determined that the treated blood vessel more likely than not to experience a poor clinical outcome; or (b) equal to or above 0.83, it is determined that the treated blood vessel is more likely than not, not to experience a poor clinical outcome (“computational approaches such as machine-learning based approaches, and these values can be used to compute hemodynamic quantities, such as fractional flow reserve (FFR), that support an initial clinical decision regarding whether or not therapy in the form of stenting one or more of the lesions is needed” [0014]; “FIGS. 4-10 illustrate predicted FFR values for a set of serial stenotic lesions (stenosis 1, stenosis 2, and stenosis 3) in the left anterior descending (LAD) artery for different stenting configurations. FIG. 4 illustrates predicted FFR values resulting from a stenting configuration in which only stenosis 1 is stented. FIG. 5 illustrates predicted FFR values resulting a stenting configuration in which only stenosis 2 is stented. FIG. 6 illustrates predicted FFR values resulting from a stenting configuration in which only stenosis 3 is stented. FIG. 7 illustrates predicted FFR values resulting from a stenting configuration in which stenosis 1 and stenosis 2 are stented. FIG. 8 illustrates predicted FFR values resulting from a stenting configuration in which stenosis 1 and stenosis 3 are stented. FIG. 9 illustrates predicted FFR values resulting from a stenting configuration in which stenosis 2 and stenosis 3 are stented. FIG. 10 illustrates predicted FFR values resulting from a stenting configuration in which stenosis 1, stenosis 2, and stenosis 3 are all stented.” [0038]).
Regarding claims 3 and 10, Sauer teaches wherein the treated blood vessel is a blood vessel that has previously undergone one or more of angioplasty, stenting, atherectomy, or any combinations thereof (”the plurality of treatment options corresponds to a stenting configuration in which one or more of the stenotic lesions are stented” [0006]).
Regarding claims 4 and 11, Sauer teaches wherein the treated blood vessel has previous received one or more intravascular stents (”the plurality of treatment options corresponds to a stenting configuration in which one or more of the stenotic lesions are stented” [0006]).
Regarding claim 5, Sauer teaches wherein the poor clinical outcome is target vessel failure, target lesion failure, or a combination thereof (“set of stent combinations can include options corresponding stenting each individual lesion and options corresponding to stenting each possible combination of multiple target stenosis regions, up to an option corresponding to stenting all of the target stenosis regions. In a possible embodiment, multiple treatment options corresponding to different stent characteristics (e.g., implant sizes and/or implant typed, etc.) can be generated for each possible stent combination.” [0027]).
Regarding claim 6, Sauer teaches wherein if the VFR is below 0.83, it is determined that treated blood vessel is more likely than not to experience a poor clinical outcome (“computational approaches such as machine-learning based approaches, and these values can be used to compute hemodynamic quantities, such as fractional flow reserve (FFR), that support an initial clinical decision regarding whether or not therapy in the form of stenting one or more of the lesions is needed” [0014]; “FIGS. 4-10 illustrate predicted FFR values for a set of serial stenotic lesions (stenosis 1, stenosis 2, and stenosis 3) in the left anterior descending (LAD) artery for different stenting configurations. FIG. 4 illustrates predicted FFR values resulting from a stenting configuration in which only stenosis 1 is stented. FIG. 5 illustrates predicted FFR values resulting a stenting configuration in which only stenosis 2 is stented. FIG. 6 illustrates predicted FFR values resulting from a stenting configuration in which only stenosis 3 is stented. FIG. 7 illustrates predicted FFR values resulting from a stenting configuration in which stenosis 1 and stenosis 2 are stented. FIG. 8 illustrates predicted FFR values resulting from a stenting configuration in which stenosis 1 and stenosis 3 are stented. FIG. 9 illustrates predicted FFR values resulting from a stenting configuration in which stenosis 2 and stenosis 3 are stented. FIG. 10 illustrates predicted FFR values resulting from a stenting configuration in which stenosis 1, stenosis 2, and stenosis 3 are all stented.” [0038]).
Regarding claim 7, Sauer teaches a system for use in predicting a clinical outcome of one or more treated blood vessels in a patient (“system for automated decision support for treatment planning of arterial stenoses is disclosed” abst; “predicted hemodynamic metrics for the set of stenotic lesions resulting from the stenting configuration” abst), the system comprising:
a diagnostic system to obtain blood vessel data from a treated blood vessel of interest in a patient (“set of stenotic lesions is identified in a patient's coronary arteries from medical image data of the patient. A plurality of treatment options are generated for the set of stenotic lesions, wherein each of the plurality of treatment options corresponds to a stenting configuration in which one or more of the stenotic lesions are stented” abst), the diagnostic system comprising:
an electronic memory device (“invention may be performed within a computer system using data stored within the computer system” [0013]);
a processor in communication with the electronic memory device (Fig. 11), wherein the memory device comprises instructions executable by the processor to cause the processor to (“FIG. 1 may be defined by the computer program instructions stored in the memory 1110 and/or storage 1112 and controlled by the processor 1104 executing the computer program instructions” [0039]):
compute, using the processor, a virtual flow reserve (VFR) of the treated blood vessel, wherein the VFR is generated using blood vessel data collected from a treated blood vessel (“anatomical modeling tasks can be performed automatically … the anatomical models to analyze the effects of such changes on the subsequent computation of FFR [hence Virtual FFR]” [0020]; “automatically detected in the medical image data or in the patient-specific anatomical model of the coronary arteries and then a hemodynamic metric, such as FFR, can be computed for each of the detected lesions” [0021]; “the predicted FFR values for each treatment option can be computed by adjusting patient-specific measurements (e.g., radius measurements) for the stented lesion(s) to reflect full or partial opening due to the virtual stenting and then computed FFR values based on the adjusted patient-specific measurements using a machine learning based technique” [0034]); and
determining a clinical outcome of the treated blood vessel in the patient using a cutoff for VFR, wherein the cutoff is equal to or greater than 0.83 (“With two lesions “in series” upstream/downstream of each other, the stenting options are (1) stent lesion #1, (2) stent lesion #2, (3) stent both lesions #1 and #2, and (4) don't stent any lesion. Stenting all lesions (option 3) will restore maximal blood flow. Apart from very pathologic cases, this option can be considered to be curative and, in a possible implementation, does not require extra confirmation by simulation. The evaluation of the stenting options to predict FFR values is performed to determine whether stenting only a subset of the serial lesions is sufficient to restore blood flow such that the predicted FFR values are above the threshold. For the case of two lesions, the evaluation in step 110 can automatically determine whether it is sufficient to stent only lesion #1 or only lesion #2, and if stenting sufficient restores the blood flow, whether lesion #1 or lesion #2 is the preferred lesion to stent. In a possible implementation, we have three stenting options (1)-(3), two of which need to be evaluated. Option (4) can be evaluated by assessing the FFR value after the most distal lesion (in this case downstream of lesion #2) without any stenting. If the FFR value is greater than the threshold (e.g., >0.8), then stenting is not needed for either of the lesions.” [0029]); and
a means for displaying an indicator of the clinical outcome (“FIGS. 4-10 illustrate predicted FFR values for a set of serial stenotic lesions (stenosis 1, stenosis 2, and stenosis 3) in the left anterior descending (LAD) artery for different stenting configurations. FIG. 4 illustrates predicted FFR values resulting from a stenting configuration in which only stenosis 1 is stented. FIG. 5 illustrates predicted FFR values resulting a stenting configuration in which only stenosis 2 is stented. FIG. 6 illustrates predicted FFR values resulting from a stenting configuration in which only stenosis 3 is stented. FIG. 7 illustrates predicted FFR values resulting from a stenting configuration in which stenosis 1 and stenosis 2 are stented. FIG. 8 illustrates predicted FFR values resulting from a stenting configuration in which stenosis 1 and stenosis 3 are stented. FIG. 9 illustrates predicted FFR values resulting from a stenting configuration in which stenosis 2 and stenosis 3 are stented. FIG. 10 illustrates predicted FFR values resulting from a stenting configuration in which stenosis 1, stenosis 2, and stenosis 3 are all stented. [0038]”).
As factually seen above, Sauer teaches all the claimed limitations under broadest reasonable interpretation; yet, if one argues in a narrower interpretation that Sauer does not teach (which the office does not concede) virtual flow reserve and the cutoff is equal to or greater than 0.83, the below reference are brought in to provide compact prosecution to show the narrow interpretation.
However, in the same field of endeavor, Morris teaches nineteen patients with stable coronary artery disease awaiting elective PCI were studied. They underwent rotational coronary angiography. The FFR was measured, physiologically significant lesions were stented, and angiography and FFR were repeated. Three-dimensional arterial anatomy pre- and post-stenting was reconstructed offline. Generic boundary conditions for computational fluid dynamics analysis were applied. The virtual fractional flow reserve (vFFR) and measured fractional flow reserve (mFFR) values were compared (methods). The vFFR post-implantation was 0.91 (hence cutoff is equal to or greater than 0.83).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with virtual flow reserve and the cutoff is equal to or greater than 0.83 as taught by Morris because model predicts which lesions were physiologically significant (FFR <0.80) and which were not (FFR >0.80) with accuracy, sensitivity, specificity, positive and negative predictive values (see results of Morris).
Further, also in the same field of endeavor, Rai also teaches FFR cut-off values. Measuring fractional flow reserve (FFR) in percutaneous coronary intervention (PCI) has predictive value for PCI outcome. We decided to examine the utility of pre- and post-stenting FFR as a predictor of 6-month stent restenosis as well as MACE (major adverse cardiac events). Pre- and post-stenting FFR values were measured for 60 PCI patients. Within 6 months after stenting, all patients were followed for assessment of cardiac MACE including myocardial infarction, unstable angina, or positive exercise test. Stent restenosis was also assessed. Cut-off values for pre- and post-stenting FFR measurements were considered respectively as 0.65 and 0.92. Stent restenosis was detected in 4 patients (6.6%). All 4 patients (100%) with restenosis had pre-stenting FFR of < 0.65, while only 26 of 56 patients without restenosis (46.4%) had pre-stenting FFR value of < 0.65 (P = 0.039). Mean pre-stenting FFR in patients with restenosis was significantly lower than in those without restenosis (0.25 ± 0.01 vs. 0.53 ± 0.03, P = 0.022). Although stent restenosis was higher in patients with post-stenting FFR of < 0.92 (2 cases, 9.5%) than in those with FFR value of ≥ 0.92 (2 cases, 5.1%), the difference was not statistically (P = 0.510) (Abst).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with setting the FFR cutoff value to equal to or greater than 0.83 as taught by Rai because it leads to the high diagnostic accuracy of FFR in clinical setting (Intro of Rai).
Regarding claim 8, Sauer teaches wherein the means for displaying the indicator of the clinical outcome is a monitor, a tablet, a mobile phone, an e-mail, an electronic document, a printed document, or any combination thereof (“output and displayed, for example on a display screen of the computer system” [0019]).
Regarding claim 9, Sauer teaches wherein the indicator is text, a number, a symbol, a color, a picture, or any combination thereof (“FIGS. 4-10 illustrate predicted FFR values for a set of serial stenotic lesions (stenosis 1, stenosis 2, and stenosis 3) in the left anterior descending (LAD) artery for different stenting configurations. FIG. 4 illustrates predicted FFR values resulting from a stenting configuration in which only stenosis 1 is stented. FIG. 5 illustrates predicted FFR values resulting a stenting configuration in which only stenosis 2 is stented. FIG. 6 illustrates predicted FFR values resulting from a stenting configuration in which only stenosis 3 is stented. FIG. 7 illustrates predicted FFR values resulting from a stenting configuration in which stenosis 1 and stenosis 2 are stented. FIG. 8 illustrates predicted FFR values resulting from a stenting configuration in which stenosis 1 and stenosis 3 are stented. FIG. 9 illustrates predicted FFR values resulting from a stenting configuration in which stenosis 2 and stenosis 3 are stented. FIG. 10 illustrates predicted FFR values resulting from a stenting configuration in which stenosis 1, stenosis 2, and stenosis 3 are all stented. [0038]”).
Regarding claims 12 and 13, Sauer teaches wherein the treated blood is a vessel coronary artery, a carotid artery, a femoral artery, an iliac artery, a renal artery, an abdominal aortic artery, a vein, or any combinations thereof (“treatment planning of arterial stenoses is disclosed. A set of stenotic lesions is identified in a patient's coronary arteries from medical image data of the patient” abst).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SERKAN AKAR whose telephone number is (571)270-5338. The examiner can normally be reached 9am-5pm M-F.
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/SERKAN AKAR/ Primary Examiner, Art Unit 3797