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 § 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, 9-11, 13, 15-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
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 claims 1 and 9 follows:
Regarding claims 1 and 11, the claims recite a method and system for evaluation and quantifying coronary artery functional disease. Thus, the claim is directed to a method and system which are statutory categories of invention.
The claim is then analyzed to determine whether it is directed to a judicial exception. The following limitations set forth the judicial exception:
Claims 1 and 11 (substantially the same with minor grammatical differences):
“generating an FFR curve…”
“calculating a value… distal part of the coronary vessel;”
Claim 11
“identify a presence… higher than .7”
These limitations describe a mental process and/or a mathematical calculation. The Examiner notes that nothing from the claims suggest that the limitations cannot be practically performed by a human or using simple pen/paper methods (particularly the curved limitation).
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. Therefore, the claim does not provide an improvement to the technological field, the system does not effect a particular treatment or effect a particular change, 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 generating fractional flow reserve (FFR) using at least one of a catheter and a pressure wire comprising at least one pressure sensor, a catheter and a pressure wire coupled to a motorized device with a fixed pullback speed, a catheter and a pressure wire comprising multiple built-in pressure sensors, and a device configured to provide FFR values derived
from angiography or CT angiography, generating an FFR curve by mapping FFR values along the length of the coronary vessel, and calculating a value of a functional outcome index (FOI) based on a formula. The generating and calculating 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.
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 generating and calculating steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
Response to Arguments
Regarding the previous 35USC112(b) rejections, those rejections are withdrawn.
Applicant's arguments filed 6/25/26 have been fully considered but they are not persuasive.
Examiner and Applicant had an interview to further discuss the 101 rejection previously presented. It was noted to the applicant that the claim itself does not actually perform a therapeutic action but rather provides a suggestion or in other words outputs extra-solution activity based on analysis done by well understood, routine, and conventional components. The claims would have to actively perform a therapy step to overcome 101 via having a practical application. Further, it is noted that the prior art of record clearly establishes that the structural options for the data gathering (e.g. catheters recited in claim 11) at least individually would have been well known at the time of filing. Examiner has proposed possibly considering a combination of such components since there appears to be some support for a combination, however, an updated search would be required to make a final determination.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEX M VALVIS whose telephone number is (571)272-4233. The examiner can normally be reached 9:00-5:00 M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jonathan Moffat can be reached at 571-272-4390. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ALEX M. VALVIS
Supervisory Patent Examiner
Art Unit 3791
/ALEX M VALVIS/ Supervisory Patent Examiner, Art Unit 3791
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