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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 07/28/26, 01/20/26, 07/30/25 and 03/17/25 have been considered by the examiner.
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 1-20 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 computer-implemented method of calculating blood flow metrics using sensor 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 following limitations set forth a judicial exception:
receiving or accessing a user-specific anatomical model and a first set of physiological characteristics of a user;
calculating a first value of a blood flow metric of the user based on the user- specific anatomical model and the first set of physiological characteristics;
receiving or calculating a second set of physiological characteristics of the user by accessing or receiving sensor data of the user's blood flow and/or sensor data of the user's physiological characteristics; and
calculating second value of the blood flow metric of the user based on the user- specific anatomical model and the second set of physiological characteristics of the user.,
These limitations set forth a judicial exception. These steps describe 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 calculating a first value of a blood flow metric of the user based on the user- specific anatomical model and the first set of physiological characteristics, and second value of the blood flow metric of the user based on the user- specific anatomical model and the second set of physiological characteristics of the user, which is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The calculating of blood flow metrics based on models does not provide an improvement to the technological field, the system does not effect a particular treatment or effect a particular change based on the model, 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:
sensor data, physiological characteristics
Additionally, claims 8, 9, 16 and 17 recite
wearable device
data storage device
processor
computer
The providing and recording steps are well-understood, routine and conventional activities for those in the field of medical diagnostics. Further, the providing and recording 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
Dependent claims 2-7, 10-15 and 18-20 also fail to add something more to the abstract independent claims as they merely further limit the abstract idea.
Therefore, claims 1-20 are not patent eligible under 35 USC 101.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4, 8-12 and 16-20 are rejected under 35 U.S.C. 102(a)(1) as being unpatentable over Fonte (U.S. Patent Number 9087147).
Fonte was submitted in Applicant’s IDS
Regarding claim 1, Fonte teaches a computer-implemented method of calculating blood flow metrics using sensor data, the method comprising: receiving or accessing a user-specific anatomical model and a first set of physiological characteristics of a user [col. 2: lines 21-67, col. 19: lines 30-36, col. 21: line 65-col. 22: line 25]; calculating a first value of a blood flow metric of the user based on the user- specific anatomical model and the first set of physiological characteristics [col. 2: lines 41-67]; receiving or calculating a second set of physiological characteristics of the user by accessing or receiving sensor data of the user's blood flow and/or sensor data of the user's physiological characteristics [col. 20: lines 9-17, col. 22: lines 26-43]; and calculating second value of the blood flow metric of the user based on the user- specific anatomical model and the second set of physiological characteristics of the user [col. 20: lines 9-17, col. 22: lines 26-43]
Regarding claims 2, 10 and 18, Fonte further teaches determining a blood flow model to use to calculate the second value of the blood flow metric; and updating the blood flow model based on the sensor data [col. 37: lines 3-37]
Regarding claims 3, 11 and 19, Fonte further teaches the blood flow model is based on a user-specific boundary condition, and updating the blood flow model comprises updating the user-specific boundary condition based on the sensor data [fig. 24A, elements 612, 622; col. 37: lines 3-37]
Regarding claims 4, 12 and 20, Fonte further teaches the blood flow model is based on the user-specific anatomical model, and updating the blood flow model comprises updating the user-specific anatomical model based on the sensor data [fig. 24A, elements 612, 622; col. 37: lines 3-37]
Regarding claims 8 and 16, Fonte further teaches the sensor data is provided by one or more wearable devices associated with the user [col. 22: lines 26-43].
Regarding claim 9, Fonte teaches a system for calculating blood flow metrics using sensor data, the system comprising: a data storage device storing instructions of calculating blood flow metrics using sensor data [col. 18: line 66-col. 19: line 19]; and a processor configured to execute the instructions to perform a method [col. 18: line 66-col. 19: line 19] including: receiving or accessing a user-specific anatomical model and a first set of physiological characteristics of a user [col. 2: lines 21-67, col. 19: lines 30-36, col. 21: line 65-col. 22: line 25]; calculating a first value of a blood flow metric of the user based on the user-specific anatomical model and the first set of physiological characteristics [col. 2: lines 41-67]; receiving or calculating a second set of physiological characteristics of the user by accessing or receiving sensor data of the user's blood flow and/or sensor data of the user's physiological characteristics [col. 20: lines 9-17, col. 22: lines 26-43]; and calculating second value of the blood flow metric of the user based on the user-specific anatomical model and the second set of physiological characteristics of the user [col. 20: lines 9-17, col. 22: lines 26-43]
Regarding claim 17, Fonte teaches a non-transitory computer readable medium for use on a computer system containing computer-executable programming instructions for performing a method of calculating blood flow metrics using sensor data [col. 18: line 66-col. 19: line 19], the method comprising: receiving or accessing a user-specific anatomical model and a first set of physiological characteristics of a user [col. 2: lines 21-67, col. 19: lines 30-36, col. 21: line 65-col. 22: line 25]; calculating a first value of a blood flow metric of the user based on the user- specific anatomical model and the first set of physiological characteristics [col. 2: lines 41-67]; receiving or calculating a second set of physiological characteristics of the user by accessing or receiving sensor data of the user's blood flow and/or sensor data of the user's physiological characteristics [col. 20: lines 9-17, col. 22: lines 26-43]; and calculating second value of the blood flow metric of the user based on the user- specific anatomical model and the second set of physiological characteristics of the user [col. 20: lines 9-17, col. 22: lines 26-43]
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 5-7 and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Fonte
Regarding claims 5 and 13, Fonte teaches a computer-implemented method of calculating blood flow metrics using sensor data, as disclosed above
An alternate embodiment of Fonte further teaches receiving stored sensor data associated with the user, wherein the stored sensor data is collected at a first point in time prior to collection of the sensor data of the user's blood flow or collection of the sensor data of the user's physiological characteristics [col. 41: lines 29-49]; determining a blood flow model based on the stored sensor data; and calculating the second value of the blood flow metric of the user further based on the determined blood flow model [col. 41: line 50-col. 42: line 28]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Fonte, to incorporate receiving stored sensor data associated with the user, wherein the stored sensor data is collected at a first point in time prior to collection of the sensor data of the user's blood flow or collection of the sensor data of the user's physiological characteristics; determining a blood flow model based on the stored sensor data; and calculating the second value of the blood flow metric of the user further based on the determined blood flow model, for determining patient-specific blood flow characteristics, as evidence by Fonte [col. 41: lines 50-56].
Regarding claims 6 and 14, another embodiment of Fonte teaches receiving stored sensor data associated with an individual other than the user; determining a blood flow model based on the stored sensor data; and calculating the second value of the blood flow metric of the user further based on the determined blood flow model [col. 51: lines 35-51].
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Fonte, to incorporate receiving stored sensor data associated with an individual other than the user; determining a blood flow model based on the stored sensor data; and calculating the second value of the blood flow metric of the user further based on the determined blood flow model, for simulating treatment for the patient, as evidence by Fonte [col. 51: lines 44-51].
Regarding claims 7 and 15, another embodiment of Fonte further teaches identifying a user group associated with the user; identifying the individual based on the user group associated with the user [col. 51: lines 35-51].
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Fonte, to incorporate identifying a user group associated with the user; identifying the individual based on the user group associated with the user, for simulating treatment for the patient, as evidence by Fonte [col. 51: lines 44-51].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GRACE L ROZANSKI whose telephone number is (571)272-7067. The examiner can normally be reached M-F 8:30am-5pm, alt F 8:30am-5pm.
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/GRACE L ROZANSKI/Examiner, Art Unit 3791
/ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
