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 .
This Office action is responsive to the Response to Non-Final Office Action filed May 2, 2025. The Examiner acknowledges the amendments to claims 1, 5 and 7; the cancellation of claim 9; and the addition of New claim 14. Claims 1, 2, 5-8 and 10-14 are currently pending.
Response to Arguments
Applicant's arguments filed May 2, 2025 regarding the rejection of the claims under 35 U.S.C. 101 have been fully considered but they are not persuasive. Regarding Applicant’s arguments that the rejection of the claims under 35 USC 101 should be withdrawn because the use of pressure transducer measurements within an artery for use in numerical simulations is not known or conventional, and therefore provides improvements over existing health monitoring technology, the Examiner respectfully disagrees. The prior art demonstrates that it is known and conventional to use invasive pressure measurements obtained from a pressure transducer in a patient-specific numerical simulation (see 35 U.S.C. 103 rejections below). Moreover, Applicant states that as claim 14 recites a medical or surgical intervention is performed on the artery based upon the computed absolute volumetric flow rate, the claim represents a practical application of any alleged abstract idea. The Examiner respectfully disagrees. The mere assertion of an improvement to the technological field without sufficient evidence is unpersuasive. As a result, the claims still lack a practical application in that the computed absolute volumetric flow rate is not used to effect a particular treatment or change based upon the computed volumetric flow rate (i.e., the mere statement that a medical or surgical intervention is performed on the artery based upon the computed absolute volumetric flow rate, as in claim 14, does not effect a particular treatment or change [emphasis added]). Therefore applicant has not overcome the rejection of the claims under 35 U.S.C 101. See 35 U.S.C. 101 rejection below.
Applicant’s arguments, see remarks, filed May 02, 2025, with respect to the rejection(s) of claim(s) 1-2 & 5-13 under 35 U.S.C. 102(a)(1) as being anticipated by US Patent Application Publication 20120041318, referenced as "Itu" have been fully considered and are persuasive. Therefore, the rejection has been withdrawn in view of the amendments to the claims. However, upon further consideration, a new ground(s) of rejection is made in view of applicant's amendments to the claims and applicant's arguments regarding the . See 35 U.S.C. 103 rejection below.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-2, 5-8 & 10-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1 recites "A computer-implemented method of determining data indicating
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-2, 5-8 & 10-14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “A computer-implemented method of determining data indicating absolute volumetric flow rate within an artery" [emphasis added]. It is unclear what is meant by “absolute” volumetric flow rate, as the specification of the instant application does not describe any “absolute” volumetric flow rate. For examination purposes, this limitation will be interpreted as the volume of fluid that passes a point per unit of time under the real temperature and pressure conditions of the flow (i.e., an actual volume flow rate of a coronary artery in a patient). Claim 5 is similarly rejected and interpreted.
Claim 1 further recites “directly computing an absolute volumetric flow rate within the artery” [emphasis added]. It is unclear what is meant by “directly” computing the absolute volumetric flow rate within the artery. The examiner respectfully requests clarification of this claim limitation. For examination purposes, it will be interpreted that directly computing an absolute volumetric flow rate within an artery comprises using absolute values of flow speed and/or volumetric flow rate within an artery.
Claim 13 recites “an apparatus for determining data indicating volumetric flow rate with an artery”. It is unclear whether the apparatus determines an absolute volumetric flow rate or merely a volumetric flow rate. The examiner respectfully requests clarification. For examination purposes, it will be interpreted that the apparatus determines data indicating an absolute volumetric flow rate.
Dependent claims are similarly rejected as their base claim.
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 1-2, 5-8 & 10-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 1 follows.
Regarding claim 1, the claim recites a series of steps or acts, including directly computing an absolute volumetric flow rate within an artery, wherein computing comprises performing a numerical simulation of blood flow through the artery based upon three-dimensional geometric model data. Thus, the claim is directed to a process, which is one of the statutory categories of invention.
The claim is then analyzed to determine whether it is directed to any judicial exception. The step of directly computing an absolute volumetric flow rate within an artery sets forth a judicial exception. This step describes a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea.
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Claim 1 recites providing, as output, the computed absolute volumetric flow rate, which is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The output of the computed absolute volumetric flow rate does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the outputted computed absolute volumetric flow rate, nor does the method use a particular machine to perform the Abstract Idea.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites additional steps of receiving data indicating a proximal pressure measurement relative to a direction of blood flow, receiving data indicating a distal pressure measurement relative to the direction of blood flow, and receiving three-dimensional geometric model data representing an artery, wherein the geometric model data is generated based upon image data indicative of the artery, the image data based upon a coronary angiogram, further wherein the proximal pressure measurement and the distal pressure measurement are obtained in the same procedure as the coronary angiogram using at least one pressure transducer within the artery. The receiving steps are each recited at a high level of generality such that it amounts to insignificant presolution activity, e.g., mere data gathering step necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering and comparing activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the obtaining and comparing steps do not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
Regarding claims 11-13, the devices recited in each claim are generic devices comprising generic components configured to perform the abstract idea. The recited pressure transducer of claim 13 is a generic sensor configured to perform pre-solutional data gathering activity, and the memory and processor of claim 11 along with the computer readable medium of claims 12 & 13 are configured to perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application.
The dependent claims also fail to add something more to the abstract independent claims as they generally recite method steps pertaining to data gathering and data processing. The receiving steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
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 factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-2, 5-8 & 10-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication 20170032097 --as previously cited--, hereinafter referenced as "Itu", in view of US Patent Application Publication 20120190967, hereinafter referenced as "Nahm".
With respect to claim 1, Itu teaches a computer-implemented method (see Itu, par 0020) of determining data indicating volumetric flow rate within an artery (i.e., blood flow or blood flow rate, as flow is inherently volumetric) (see Itu, abstract, par 0020-0023, fig. 1) comprising:
receiving data indicating a proximal pressure measurement relative to a direction of blood flow (see Itu, par 0029, 0052-0060, figs. 5 & 6, wherein invasive pressure measurements are acquired at a first location to measure a proximal pressure and at a second location to measure a distal pressure that is distal to a first stenosis);
receiving data indicating a distal pressure measurement relative to the direction of blood flow (see Itu, par 0029, 0052-0060, figs. 5 & 6, wherein invasive pressure measurements are acquired at a first location to measure a proximal pressure and at a second location to measure a distal pressure that is distal to a first stenosis);
receiving three-dimensional (i.e., 3D medical image data) (see Itu, par 0024-0026) geometric model data representing the artery (see Itu, par 0024-0026), wherein the geometric model data is generated based upon image data indicative of the artery, the image data based upon a coronary angiogram (i.e., a geometric surface model is generated for a patient based upon segmented data from medical imaging data of the patient’s coronary arteries, wherein the medical imaging data are derived from coronary CT angiography) (see Itu, par 0024-0026);
wherein the proximal pressure measurement and the distal pressure measurement are obtained in the same procedure as the coronary angiogram using at least one pressure transducer within the artery (i.e., the pressure measurements are obtained invasively using a pressure wire that is inserted into the patient’s vessel and/or through invasive medical imaging data using a probe, such as angiography) (see Itu, par 0029, 0054-0060, fig. 6);
and computing a volumetric flow rate (i.e., blood flow or blood flow rate) within the artery (see Itu, par 0030, 0040, 0054-0060, fig. 4), wherein computing comprises performing a numerical simulation of blood flow (i.e., computing the flow rate using a computational blood flow model) (see Itu, abstract, par 0024-0026, 0030, 0040, 0054-0060) through the artery based upon the three-dimensional geometric model data (i.e., geometric surface model), the data indicating a proximal pressure measurement and the data indicating a distal pressure measurement (i.e., the computational blood flow model is personalized for a patient based on the invasive physiological measurements, such as the proximal and distal pressure measurements, and non-invasive patient data, such as the geometric surface model generated from medical images) (see Itu, par 0024-0026, 0030, 0040, 0054-0060),
wherein the numerical simulation is made patient-specific by setting an inlet pressure boundary condition of the numerical simulation to the proximal pressure measurement obtained using the at least one pressure transducer within the artery and setting an outlet pressure boundary condition of the numerical simulation to the distal pressure measurement obtained using the at least one pressure transducer within the artery (i.e., invasive pressure measurements are acquired at a first location to measure a proximal pressure and at a second location to measure a distal pressure that is distal to a first stenosis and are used as inlet and outlet boundary conditions for the computational blood flow model) (see Itu, par 0054-0060, fig. 6);
and providing, as output, the computed volumetric flow rate (i.e., outputting blood flow, pressure computations, and hemodynamic quantities of interest) (see Itu, par 0033, 0040, 0061).
Itu fails to teach neither the computed volumetric flow rate is an absolute volumetric flow rate, nor that the absolute volumetric flow rate is directly computed.
Nahm teaches an arrangement and method for quantitively determining the blood flow within blood vessels wherein computed tomography angiography (CTA) or magnetic resonance angiography (MRI angiography) is used to image blood vessels and calculate absolute values of the volumetric flow rate at every point in the vessel system (see Nahm, par 0008-0010, 0014-0020, 0025-0033, 0050, 0057-0058). The use of angiography for determining absolute volume flow rate values can be used intraoperatively and to provide real-time information regarding the current volumetric flow rate of the blood of a patient (see Nahm, par 0014).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Itu such that the computed volumetric flow rate is an absolute volumetric flow rate, and that the absolute volumetric flow rate is directly computed because absolute volume flow rate values can be used intraoperatively to provide real-time information regarding the current volumetric flow rate of the blood of a patient (see Nahm, par 0014).
With respect to claim 2, Itu as modified by Nahm further teaches that the numerical simulation is a computational fluid dynamics simulation (i.e., computational fluid dynamics or CFD) (see Itu, par 0021, 0030).
With respect to claim 5, Itu as modified by Nahm further teaches that the method further comprises:
determining one or more physiological parameters associated with the artery based upon the computed absolute volumetric flow rate (i.e., hemodynamic quantities of interest other than blood flow are estimated using the blood flow computations, such as fractional flow reserve, index of microvascular resistance, or coronary flow reserve) (see Itu, par 0020-0023, 0033-0034).
With respect to claim 6, Itu as modified by Nahm further teaches that the one or more physiological parameters comprises one or more of the following:
stenosis resistance, distal microvascular resistance, coronary microvascular resistance and coronary flow reserve (see Itu, par 0020-0023, 0033-0034).
With respect to claim 7, Itu as modified by Nahm teaches the method further comprises:
receiving image data representing the artery (see Itu, par 0023-0027, fig. 2);
generating a three dimensional model representing the artery based upon the image data (see Itu, par 0023-0027, fig. 2);
discretizing the three dimensional model (see Itu, par 0023-0027, fig. 2);
and generating the three-dimensional geometric model data representing the artery based upon the discretized three dimensional model (see Itu, par 0023-0027, fig. 2).
With respect to claim 8, Itu as modified by Nahm further teaches that in the method, the artery is a coronary artery (see Itu, par 0025-0026).
With respect to claim 10, Itu as modified by Nahm further teaches that the at least one pressure transducer comprises a catheter and/or pressure wire (see Itu, par 0054).
With respect to claim 11, Itu as modified by Nahm teaches a computer 1002 for determining data indicating volumetric flow rate within an artery (i.e., blood flow or blood flow rate) (see Itu, abstract, par 0020-0023, figs. 1 & 10) comprising:
a memory 1010 storing processor readable instructions (see Itu, par 0020, 0083, fig. 10);
a processor 1004 arranged to read and execute instructions stored in said memory (see Itu, par 0083, fig. 10);
wherein said processor readable instructions comprise instructions arranged to control the computer to carry out a method according to claim 1 (see Itu, par 0083, fig. 10).
With respect to claim 12, Itu as modified by Nahm teaches a computer readable medium carrying computer readable instructions configured to cause a computer to carry out a method according to claim 1 (see Itu, par 0083, fig. 10).
With respect to claim 13, Itu as modified by Nahm teaches an apparatus for determining data indicating volumetric flow rate (i.e., blood flow or blood flow rate) within an artery (see Itu, par 0020-0023, 0083, figs. 1 & 10) comprising:
a computer readable medium carrying computer readable instructions configured to cause a computer to carry out a method according to claim 1 (see Itu, par 0083, fig. 10);
and a pressure transducer for obtaining a pressure measurement in an artery (i.e., a pressure wire) (see Itu, par 0054-0060).
With respect to claim 14, Itu as modified by Nahm teaches the method of claim 1, and further teaches that medical or surgical intervention is performed on the artery based upon the computed absolute volumetric flow rate (i.e., absolute volume flow rate values can be used intraoperatively and to provide real-time information regarding the current volumetric flow rate of the blood of a patient) (see Nahm, par 0014).
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Destiny J Cruickshank whose telephone number is (571)270-0187. The examiner can normally be reached M-F, 9am-6pm.
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, Charles Marmor II can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHARLES A MARMOR II/Supervisory Patent Examiner
Art Unit 3791
/D.J.C./ Examiner, Art Unit 3791