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 .
Response to Amendment
Applicant’s Amendment and Remarks , see Amendment filed February 4, 2026, is acknowledged. Claims 1, 13, and 21 have been amended and claim 23 has been canceled. Claims 1-22 and 24-30 remain pending.
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 1-22 and 24-30 are rejected under 35 U.S.C. 101 because the claimed invention is, considering all claim elements both individual and in combination as a whole, do not amount to significantly more than a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea).
Claim 1 sets forth:
Receiving a map of fractional flow reserve (FFR) assigning a multiplicity of FFR values to particular positions on each of a plurality of vascular segments of a vascular tree representing the vascular portion;
calculating an FFR impact score using the mapped FFR values, wherein calculating comprises computing, for one or more of the plurality of vascular segments, derivative- type information indicative of focality of stenotic lesions and integral-type information indicative of overall severity of perfusion impacts, the derivative-type and integral-type information being derived from differences in FFR along the vascular segments;
, wherein an element of the FFR impact score discards the mapping of FFR values to the particular positions, and wherein the graphical user interface:
indicating information associated with adjustment of the FFR impact score, wherein the information includes data describing measured and/or simulated changes in vascular state;
adjusting the FFR impact score based on a revised map of FFR, revised according to the indicated information and including one or more of: automatic virtual stenting, manual stent selection,
data measured after a stent implantation, or data measured through a plurality of diagnostic procedures; and
.
Step 1 - Claim 1 is directed to a method of estimating a clinical state of a vascular portion and therefore meets one of the categorical limitations of 35 U.S.C. 101. However, the above limitations, under their broadest reasonable interpretation, fall within the “Certain Mathematical concepts and mental processes grouping of abstract ideas, enumerated in MPEP 2106.04(a)(2)(II)(III), in that they recite a series of mathematical calculations and mental steps which produce an FFR impact score from FFR map data, receive user input and adjust the score based on the user input.
With respect to claim 1, the method merely receives map data and calculates an impact score using derivative and integral information, and adjusts the score based on user input. It is noted in MPEP 2106.04(a)(2)(II)(III), that the courts do not distinguish between mental processes that are performed entirely in the human mind and mental processes that require a human to use a physical aid (e.g., pen and paper or a slide rule) to perform the claim limitation. See, e.g., Benson, 409 U.S. at 67, 65, 175 USPQ at 674-75, 674 and further that the courts do not distinguish between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer. As the Federal Circuit has explained, "[c]ourts have examined claims that required the use of a computer and still found that the underlying, patent-ineligible invention could be performed via pen and paper or in a person’s mind." Versata Dev. Group v. SAP Am., Inc., 793 F.3d 1306, 1335, 115 USPQ2d 1681, 1702 (Fed. Cir. 2015). The use of a physical aid (e.g., pencil and paper or a slide rule) to help perform a mental step (e.g., a mathematical calculation) does not negate the mental nature of the limitation, but simply accounts for variations in memory capacity from one person to another.
Prong 2, Step 2A: The claim language also meets prong 2 of the step 2A analysis because the above-recited claim language does not integrate the abstract idea into a practical application. That is, there appears to be no tangible improvement in technology, effect of a particular treatment or prophylaxis, a particular machine or manufacture that is integrated, or transformation/reduction of a particular article to a different state or thing as a result of this claimed subject matter. As a result, step 2A is satisfied and the second step, step 2B, must be considered.
Step 2B: With regards to the second step 2B, the claim does not appear to recite additional elements that amount to significantly more. The addition of additional elements directed to a display including a graphical user interface is acknowledged. However, outputting to a display and user interface that responds to user input is not sufficient to be an improvement or an integration to another technology 2106.05 vi. Instructions to display two sets of information on a computer display in a non-interfering manner, without any limitations specifying how to achieve the desired result, Interval Licensing LLC v. AOL, Inc., 896 F.3d 1335, 1344-45, 127 USPQ2d 1553, 1559-60 (Fed. Cir. 2018); and 2106.05(g) (3) Whether the limitation amounts to necessary data gathering and outputting, (i.e., all uses of the recited judicial exception require such data gathering or data output). See Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; OIP Techs., Inc. v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1092-93 (Fed. Cir. 2015) (presenting offers and gathering statistics amounted to mere data gathering). This is considered in Step 2A Prong Two and Step 2B.iii. Selecting information, based on types of information and availability of information in a power-grid environment, for collection, analysis and display, Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1354-55, 119 USPQ2d 1739, 1742 (Fed. Cir. 2016);
In view of the above, independent claim 1 fails to recite patent-eligible subject matter under 35 U.S.C. 101. Claims 2-22 and 24-28 recite further limitations on abstract idea(s) that has/have already been recited. Claim 29 recites “stents” which are well-known, routine, and conventional as evidenced by page 20 lines 11-12 of the specification as originally filed. Claim 30 recites “CABG grafts” which are well-known, routine, and conventional as evidenced by page 20 lines 11-12 of the specification as originally filed. Thus, claims 1-22 and 24-30 are rejected under 35 U.S.C. 101.
Allowable Subject Matter
In view of the amendment to independent claim 1, incorporating allowable subject matter from claim 23, Claims 1-22 and 24-30 would be allowable if amended to overcome the rejection of the claims over 35 USC 101.
Note the statement for reasons for allowance of the claims over the prior art of record set forth in the examiner’s action dated November 4, 2025.
Response to Arguments
Applicant’s arguments, see Remarks, filed February 4, 2026 with respect to 35 U.S.C 103 have been fully considered and are persuasive. In view of the amendment to claim 1 incorporating allowable subject matter from claim 23, the rejection of claims 1-7, 9-11,13,17,21-22, and 24-30 under 35 USC 103 has been withdrawn.
Applicant's arguments, see Remarks, filed February 4, 2026, with respect to 35 U.S.C. 101, have been fully considered but they are not persuasive.
Applicant argues " These features, including responding to user input and displaying the calculated FRR impact score through a GUI, cannot be reasonably characterized as capable of being "performed by a human mind using mental steps or with pen and paper and Applicant respectfully submits that the claim recites a practical application, and thus is not "directed to" an abstract idea. "
The examiner respectfully disagrees, as noted above the courts do not distinguish between mental processes that are performed entirely in the human mind and mental processes that require a human to use a physical aid nor between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer. Adding user input as part of displaying the FFR score or the adjusted score as a result of user input merely serves to further narrow the abstract idea and adds insignificant extra-solution activity to the judicial exception - see MPEP 2106.05(g). The claim should add meaningful limitations beyond generally linking the use of the judicial exception to a particular technological environment to transform the judicial exception into patent-eligible subject matter. The phrase "meaningful limitations" has been used by the courts even before Alice and Mayo in various contexts to describe additional elements that provide an inventive concept to the claim as a whole.
Applicant also argues, “Amended claim 1 recites a particular improvement in “how” FFR data is processed, transformed, and presented and that the limitations of claim 1 are integrated into a practical application” .
The examiner respectfully disagrees, it is the examiner’s interpretation that the method when looked at as a whole is directed to an abstract idea that improves the data that is received thru normal and insignificant calculation and display with further interaction with a user to update or adjust the resulting data that is displayed and not an improvement of “how” the data is processed, transformed, or presented. The method starts with FFR mapping data, performs a calculation on that mapping data to create new data that represents the FFR impact score, displays the impact score and allows a user to further adjust the data to then display the resulting data as an adjusted FFR impact score. The claim does not appear to actively or positively apply or use the judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception - see MPEP 2106.05(e).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN L CASLER whose telephone number is (571)272-4956. The examiner can normally be reached M-Th 6:30 to 4:30.
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/BRIAN L CASLER/Primary Examiner, Art Unit 3791