DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 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.
Claim(s) 25, 27-32, 34-39, and 41-45 are rejected under 35 U.S.C. 103 as being unpatentable over US 2013/0246034 Sharma et al., hereinafter “Sharma”, in view of US 2017/0018081 Taylor et al., hereinafter “Taylor” (both cited previously).
Regarding claim 25, Sharma discloses a non-transitory computer-readable medium storing instructions (Claim 21 and Para 53), which when executed by one or more processors of a system, causes the system to perform a method (Para 53 and Claim 21), comprising: generating a reduced order model of a vessel segment of a vasculature (Para 16 and 21-23; Figure 4 shows the reduced order model), wherein the reduced order model represents flow in the vessel segment in real-time (Para 4 and 51, see Para 21-22 that describe the representation of flow in the reduced order model); generating a vascular system model including the reduced order model of the vessel segment coupled to a 0D model of a remainder of the vasculature (Figure 4 and Para 22 show a reduced order model and shows a lumped parameter model, i.e. the 0D model 422, 424, 426, 428, and 430 which account for the distal vessels); generating simulated flow data based on the vascular system model (Para 21-23); receiving directly measured data representing measurements of flow in the vessel segment taken in real-time by medical imaging equipment (Para 4 and 51; Sharma discloses measuring data in real time and modifying the segmentation based on the measured data during the image acquisition process); modifying the vascular system model directly (Para 4 and 51).
Sharma does not explicitly disclose receiving measured flow data representing measurements of flow in the vessel segment; and modifying the vascular system model based on a comparison of the simulated flow data to the measured flow data, wherein the vascular system model is modified to fit the simulated flow data to the measured flow data.
However, Taylor discloses blood flow models (abstract) and teaches receiving directly measured flow data representing measurements of flow in the vessel segment (Para 27 and 32); and modifying the vascular system model based on a comparison of the simulated flow data to the measured flow data, wherein the vascular system model is modified to fit the simulated flow data to the measured flow data (Para 27; Para 57 discloses directly modifying the model after receiving the image data. Examiner does not agree with the argument against Taylor. The term “directly” under BRI can mean in real-time and it is inherent that blood flow is measured in real-time in both Sharma and Taylor. Taylor specifically states that blood flow can be measured in Para 32, Consider also Figure 2, element 206).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed what the clinician is using to make the adjustment as taught by Taylor, in the invention of Sharma, in order to more closely match the unknown actual blood flow and pressure in the patient (Taylor; Para 27).
Regarding claim 27, Sharma discloses the measurements are taken in real-time by phase contrast magnetic resonance imaging scanner (Para 4 and 17).
Sharma does not disclose the measurements of flow are taken in real-time by phase contrast magnetic resonance imaging scanner.
However, Taylor teaches the measurements of flow are taken by phase contrast magnetic resonance imaging scanner equipment (Para 26-27 and 41).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed measurements of flow by medical imaging as taught by Taylor, in the invention of Sharma, in order to be compared to predicted measurements by the models and reduce computational errors (Taylor; Para 27).
Regarding claim 28, Sharma discloses modifying the vascular system model includes adjusting the 0D model of the remainder of the vasculature (Para 16 and 21-23).
Regarding claim 29, Sharma discloses adjusting the 0D model of the remainder of the vasculature includes determining parameters of the 0D model (Para 16 and 21-23).
Sharma does not disclose to a minimized difference between directly the measured flow data and the simulated flow data.
However, Taylor teaches to a minimized difference between the directly measured flow data and the simulated flow data (Para 27).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed minimizing a difference as taught by Taylor, in the invention of Sharma, in order to more closely match the unknown actual blood flow of the patient (Taylor; Para 27).
Regarding claim 30, Sharma discloses receiving an input to update parameters of the 0D model of the remainder of the vasculature (Para 16) and simulating flow in the vessel segment in near real-time (Para 51) using the vascular system model including the reduced order model of the vessel segment coupled to the 0D model of the remainder of the vasculature having the updated parameters (Para 16 and 51).
Regarding claim 31, Sharma discloses all the limitations of claim 30.
Sharma does not disclose the input includes parameter changes corresponding to one or more of exercise or use of therapeutic substances by a patient.
However, Taylor teaches the input includes parameter changes corresponding to one or more of exercise or use of therapeutic substances by a patient (Para 26-27 and 46-47; contrast).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed the input being a change in therapeutic substance as taught by Taylor, in the invention of Sharma, in order for the predicated distribution to remain accurate (Taylor; Para 27).
Regarding claim 32, Sharma discloses a system (Abstract), comprising: a memory (Para 53) and one or more processors (Para 53 and Claim 21) to generate a reduced order model of the vessel segment of a vasculature (Para 16 and 21-23; Figure 4 shows the reduced order model), wherein the reduced order model represents flow in the vessel segment in real-time (Para 4 and 51, see Para 21-22 that describe the representation of flow in the reduced order model), generate a vascular system model including the reduced order model of the vessel segment coupled to a 0D model of a remainder of the vasculature (Figure 4 and Para 22 show a reduced order model and shows a lumped parameter model, i.e. the 0D model 422, 424, 426, 428, and 430 which account for the distal vessels), generate simulated flow data based on the vascular system model (Para 21-23); receive directly measured data representing measurements of flow in the vessel segment taken in real-time by medical imaging equipment (Para 4 and 51; Sharma discloses measuring data in real time and modifying the segmentation based on the measured data during the image acquisition process); modify the vascular system model directly (Para 4 and 51).
Sharma does not explicitly disclose receive measured flow data representing measurements of flow in the vessel segment; and modify the vascular system model based on a comparison of the simulated flow data to the measured flow data, wherein the vascular system model is modified to fit the simulated flow data to the measured flow data.
However, Taylor discloses blood flow models (abstract) and teaches receive directly measured flow data representing measurements of flow in the vessel segment (Para 27 and 32); and modify the vascular system model based on a comparison of the simulated flow data to the measured flow data, wherein the vascular system model is modified to fit the simulated flow data to the measured flow data (Para 27; Para 57 discloses directly modifying the model after receiving the image data. Examiner does not agree with the argument against Taylor. The term “directly” under BRI can mean in real-time and it is inherent that blood flow is measured in real-time in both Sharma and Taylor. Taylor specifically states that blood flow can be measured in Para 32, Consider also Figure 2, element 206).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed what the clinician is using to make the adjustment as taught by Taylor, in the invention of Sharma, in order to more closely match the unknown actual blood flow and pressure in the patient (Taylor; Para 27).
Regarding claim 34, Sharma discloses the measurements are taken in real-time by phase contrast magnetic resonance imaging scanner (Para 4 and 17).
Sharma does not disclose the measurements of flow are taken in real-time by phase contrast magnetic resonance imaging scanner.
However, Taylor teaches the measurements of flow are taken by phase contrast magnetic resonance imaging scanner (Para 26-27 and 41).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed measurements of flow by medical imaging as taught by Taylor, in the invention of Sharma, in order to be compared to predicted measurements by the models and reduce computational errors (Taylor; Para 27).
Regarding claim 35, Sharma discloses modifying the vascular system model includes adjusting the 0D model of the remainder of the vasculature (Para 16 and 21-23).
Regarding claim 36, Sharma discloses adjusting the 0D model of the remainder of the vasculature includes determining parameters of the 0D model (Para 16 and 21-23).
Sharma does not disclose to a minimized difference between the directly measured flow data and the simulated flow data.
However, Taylor teaches to a minimized difference between the directly measured flow data and the simulated flow data (Para 27).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed minimizing a difference as taught by Taylor, in the invention of Sharma, in order to more closely match the unknown actual blood flow of the patient (Taylor; Para 27).
Regarding claim 37, Sharma discloses the one or more processors are further to receive an input to update parameters of the 0D model of the remainder of the vasculature (Para 16); and simulate flow in the vessel segment in near real-time (Para 51) using the vascular system model including the reduced order model of the vessel segment coupled to the 0D model of the remainder of the vasculature having the updated parameters (Para 16 and 51).
Regarding claim 38, Sharma discloses all the limitations of claim 37.
Sharma does not disclose the input includes parameter changes corresponding to one or more of exercise or use of therapeutic substances by a patient.
However, Taylor teaches the input includes parameter changes corresponding to one or more of exercise or use of therapeutic substances by a patient (Para 26-27 and 46-47; contrast).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed the input being a change in therapeutic substance as taught by Taylor, in the invention of Sharma, in order for the predicated distribution to remain accurate (Taylor; Para 27).
Regarding claim 39, Sharma discloses a computer-implemented method (Abstract and Para 15), comprising: generating a reduced order model of a vessel segment of a vasculature (Para 16 and 21-23; Figure 4 shows the reduced order model), wherein the reduced order model represents flow in the vessel segment in real-time (Para 4 and 51, see Para 21-22 that describe the representation of flow in the reduced order model); generating a vascular system model including the reduced order model of the vessel segment coupled to a 0D model of a remainder of the vasculature (Figure 4 and Para 22 show a reduced order model and shows a lumped parameter model, i.e. the 0D model 422, 424, 426, 428, and 430 which account for the distal vessels); generating simulated flow data based on the vascular system model (Para 21-23); receiving directly measured data representing measurements of flow in the vessel segment taken in real-time by medical imaging equipment (Para 4 and 51; Sharma discloses measuring data in real time and modifying the segmentation based on the measured data during the image acquisition process); modifying the vascular system model directly (Para 4 and 51).
Sharma does not explicitly disclose receiving measured flow data representing measurements of flow in the vessel segment; and modifying the vascular system model based on a comparison of the simulated flow data to the measured flow data, wherein the vascular system model is modified to fit the simulated flow data to the measured flow data.
However, Taylor discloses blood flow models (abstract) and teaches receiving directly measured flow data representing measurements of flow in the vessel segment (Para 27 and 32); and modifying the vascular system model based on a comparison of the simulated flow data to the measured flow data, wherein the vascular system model is modified to fit the simulated flow data to the measured flow data (Para 27; Para 57 discloses directly modifying the model after receiving the image data. Examiner does not agree with the argument against Taylor. The term “directly” under BRI can mean in real-time and it is inherent that blood flow is measured in real-time in both Sharma and Taylor. Taylor specifically states that blood flow can be measured in Para 32, Consider also Figure 2, element 206).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed what the clinician is using to make the adjustment as taught by Taylor, in the invention of Sharma, in order to more closely match the unknown actual blood flow and pressure in the patient (Taylor; Para 27).
Regarding claim 41, Sharma discloses the measurements are taken in real-time by phase contrast magnetic resonance imaging scanner (Para 4 and 17).
Sharma does not disclose the measurements of flow are taken in real-time by phase contrast magnetic resonance imaging scanner.
However, Taylor teaches the measurements of flow are taken by phase contrast magnetic resonance imaging scanner (Para 26-27 and 41).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed measurements of flow by medical imaging as taught by Taylor, in the invention of Sharma, in order to be compared to predicted measurements by the models and reduce computational errors (Taylor; Para 27).
Regarding claim 42, Sharma discloses modifying the vascular system model includes adjusting the 0D model of the remainder of the vasculature (Para 16 and 21-23).
Regarding claim 43, Sharma discloses adjusting the 0D model of the remainder of the vasculature includes determining parameters of the 0D model (Para 16 and 21-23).
Sharma does not disclose to a minimized difference between the measured flow data and the simulated flow data.
However, Taylor teaches to a minimized difference between the measured flow data and the simulated flow data (Para 27).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed minimizing a difference as taught by Taylor, in the invention of Sharma, in order to more closely match the unknown actual blood flow of the patient (Taylor; Para 27).
Regarding claim 44, Sharma discloses receiving an input to update parameters of the 0D model of the remainder of the vasculature (Para 16) and simulating flow in the vessel segment in near real-time (Para 51) using the vascular system model including the reduced order model of the vessel segment coupled to the 0D model of the remainder of the vasculature having the updated parameters (Para 16 and 51).
Regarding claim 45, Sharma discloses all the limitations of claim 44.
Sharma does not disclose the input includes parameter changes corresponding to one or more of exercise or use of therapeutic substances by a patient.
However, Taylor teaches the input includes parameter changes corresponding to one or more of exercise or use of therapeutic substances by a patient (Para 26-27 and 46-47; contrast).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed the input being a change in therapeutic substance as taught by Taylor, in the invention of Sharma, in order for the predicated distribution to remain accurate (Taylor; Para 27).
Allowable Subject Matter
Claims 26, 33, and 40 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Reasons for Allowance
The following is an examiner’s statement of reasons for allowance:
Examiner has found references that discuss reduced order models for vasculature modeling, including the steps of creating a lumped model based on fluid simulations and generating boundary conditions of the vessel segments which is then used to generate the reduced order model. However, examiner has not found a reference that discloses a 0D model with respective inductor and a respective pressure source and wherein values of the pressure sources are taken from a response surface of the static fluid simulations of the vessel segment. For this reason, claims 26, 33, and 40 are objected to allowable.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Response to Arguments
Applicant’s arguments have been fully considered but are moot because the new ground of rejection.
Refer to rejection above for arguments.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AYA ZIAD BAKKAR whose telephone number is (313)446-6659. The examiner can normally be reached on 7:30 am - 5:00 pm M-Th.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carl Layno can be reached on (571) 272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see https://ppair-my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/AYA ZIAD BAKKAR/
Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796