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 .
Priority
This application is a 371 of PCT/US23/80380 filed 11/17/2023 which claims benefit of provisional application 63/384,186 filed 11/17/2022.
Information Disclosure Statement
The information disclosure statements (IDS) submitted were filed on 04/29/2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities:
In ¶ [0054], “Womerlsey (eqn. 9)” should be corrected to:
“Womersley (eqn. 9)”
In ¶ [0086] page 27, “surgical intervation” should be corrected to:
“surgical intervention”
Appropriate correction is required.
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 5-8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. Claims 5-8 do not fall within at least one of the four categories of patent eligible subject matter because the claimed invention is directed towards an aneurysm physiomarker. An aneurysm physiomarker is not a process, a machine, a manufacture, or a composition of matter. From reviewing the specification, the broadest reasonable interpretation of an aneurysm physiomarker appears to be a number or value calculated from analysis of data. An aneurysm physiomarker is therefore considered or interpreted to be as information or data per se, which does not fall within at least one of the four statutory categories. See MPEP § 2106.03 (I).
Allowable Subject Matter
Claims 1-4 are allowed.
The following is a statement of reasons for the indication of allowable subject matter:
Within the context of claim 1, no combination of prior art was found to teach or reasonably suggest to the ordinarily skilled artisan “determining a critical threshold beyond which an area of the blood vessel in the MRI scan fluctuates unboundedly under infinitesimal perturbations… and generating a flutter parameter for describing an onset of an instability triggering fluttering of a vessel wall of the blood vessel in the MRI scan, wherein generating the flutter parameter is based on at least the analyzing of the single 4D flow MRI scan, determining the critical threshold, and the selecting the base flow”.
The closest prior art references found are Vlachos (US20240074670) and Pfaller (“On the Periodicity of Cardiovascular Fluid Dynamics Simulations”). Vlachos teaches a method for estimating wall shear stress (WSS) from analyzing 4D flow MRI of blood vessels such as the aorta (Abstract, [0007], [0044-0045], [0047]). Vlachos teaches wherein the WSS provides clinical indication on growth and rupture of intracranial cerebral aneurysms and may thus act as an aneurysm physiomarker ([0066], Claims 9-10). Vlachos therefore teaches a method for deriving an aneurysm physiomarker, comprising at least analyzing a single 4D flow MRI scan associated with a blood vessel of a patient. Vlachos further teaches wherein WSS may be estimated via computational fluid dynamics (CFD) simulations ([0019], [0040]). Regarding selection of blood flow comprising a periodic limit cycle following a pulsatile waveform of blood pressure over a cardiac cycle, Pfaller teaches such a feature. Pfaller teaches simulating cardiovascular fluid dynamics or 3D blood flow (Title, Page 3574). Pfaller teaches simulating blood flow until it, and pressure, reaches a periodic state (Page 3578, left column). Pfaller teaches wherein the periodic state is defined as two consecutive cardiac cycles yielding results for pressure and flow rate that agree within a given tolerance, and that this corresponds to a limit cycle of a model (Page 3574). Pfaller further teaches assuming that the model is subjected to periodic pulsatile inflow (Page 3574). Pfaller therefore teaches selecting, or simulating, a blood flow comprising a periodic limit cycle following a pulsatile waveform of blood pressure (pulsatile flow) over a cardiac cycle. However, Pfaller fails to associate the blood flow with a blood vessel in an MRI scan nor wherein the blood flow is selected as a base flow or reference flow. Moreover, Vlachos and Pfaller fail to teach determination of a critical threshold beyond which an area of a blood vessel in an MRI scan fluctuates unboundedly under infinitesimal perturbations and generation of a flutter parameter for describing an onset of an instability triggering fluttering of a vessel wall of the blood vessel in the MRI scan.
Examiner Remarks
Regarding patent subject matter eligibility of claims 1-4, the invention is not directed to an abstract idea comprising a mental process performable in the human mind or with pen and paper. The invention includes analysis 4D flow data from an MRI scan and determination of a critical threshold beyond which an area of a blood vessel in the MRI scan fluctuates unboundedly under infinitesimal perturbations. Infinitesimal perturbations are immeasurably or incalculably small such that a human mind, or eye, would not be able to reliably analyze to produce an accurate assessment. Therefore, a computer is required for animating the 4D flow MRI scan data and for determining a critical threshold of an area of a blood vessel in the 4D flow MRI scan data. Moreover, the generated flutter parameter is a value which quantifies the risk of future abnormal growth and aneurysm progression by using a single 4D flow MRI scan and without the need of waiting for a second clinical follow-up years later, thus giving the invention a practical application.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TOMMY T LY whose telephone number is (571) 272-6404. The examiner can normally be reached M-F 12:00pm-8:00pm eastern time.
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, Anhtuan Nguyen can be reached at 571-272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TOMMY T LY/ Examiner, Art Unit 3797
/JOSEPH M SANTOS RODRIGUEZ/ Primary Examiner, Art Unit 3797
Prosecution Insights