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 Arguments
Applicant's arguments, see Remarks, filed 6/18/2026, with respect to 35 U.S.C. 101, have been fully considered but they are not persuasive.
Applicant argues in view of the limitations set forth I claim 1, “A human mind cannot process continuous or near-continuous mapped volumetric FFR data, sever the specific geometric coordinates of those data points, and mathematically map them to predefined vascular volumes to trigger automated user interface outputs. Thus, amended claim 1 does not recite a mental step, especially when considered in its entirety.”
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, “a claim integrates an exception into a practical application when it improves another technology or technical field. Here, amended claim 1 improves the technical field of vascular disease analysis and clinical decision support. As explained in the specification, traditional methods (such as the SYNTAX Score) rely on human visual estimation and heuristics, which create significant "noise" and incorrect categorization for borderline patients. Amended claim 1 provides a technical solution to this technical problem by integrating the FFR calculation into a rigid, automated, and objective rule-set.” and “Amended claim 1 recites exactly how a treatment is selected by executing a specific algorithmic comparison”.
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 and to then select an appropriate procedure based on the 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).
Furthermore, the method steps are performed on a generic computer( note paragraphs [0043] – [0051]) and do not appear to improve the functioning of the computer or the technology for applying the treatment. Once the FFR impact score is determined an appropriate treatment is “selected” which could be automated by a computer or done manually by an operator and the particular treatment protocol ( CABG, PCI, or OMT) is presumably performed as is well known. The added steps of selecting a particular treatment serve to merely limit the abstract idea.
Also, applicant noted in the remarks and as set forth in the specification: “traditional methods (such as the SYNTAX Score) rely on human visual estimation and heuristics, which create significant "noise" and incorrect categorization for borderline patients. Amended claim 1 provides a technical solution to this technical problem by integrating the FFR calculation into a rigid, automated, and objective rule-set.” , the mere automation of a manual process is not sufficient to show an improvement in computer functionality. Thus applicant’s claims do not appear to improve the functioning of the computer itself or any other technology or technical field.
Applicant further argues, “ Similar to the claims in McRO, Inc. v. Bandai Namco Games America, amended claim 1 uses a specific set of automated rules to achieve a result that previously required subjective human evaluation. Amended claim 1 does not merely instruct a user to "apply the results." Amended claim 1 sets forth subject matter that executes a specific logic tree based on the mathematically derived diffusion variables to automatically output a specific treatment selection (CABG, PCI, or OMT). This specific application avoids preemption and integrates the calculations into a practical application.” and “amended claim 1 recites, with emphasis added, "...generating a plurality of score elements, wherein generating the plurality of score elements comprises extracting the multiplicity of FFR values from a context of the particular positions to discard the mapping
of the FFR values to the particular positions, calculating a respective score element of the plurality of score elements for each vascular segment of the plurality of vascular segments, and retaining an association of each respective score element to a particular vascular segment
of the plurality of vascular segments."
Such subject matter is a non-routine technical transformation of vascular data. Standard practice maps FFR values directly to physical anatomical locations. The subject matter of amended claim 1 deliberately breaks this mapping, discarding geometric/positional contexts while retaining anatomical segment associations to compute "derivative-type" and "integral- type" information. This specialized computational architecture, combined with the subsequent automated logic rules, adds meaningful subject matter so that claim 1 is patent-eligible under Step 2B.”
The examiner respectfully disagrees, the rules and result in McRO, Inc. v. Bandai Namco Games America were directed to a specific improvement in the technology to produce "accurate and realistic lip synchronization and facial expressions in animated characters" that previously could only be produced by human animators” which were directed to a tangible improved product. Applicants claims do not result in an improved procedure once the FFR impact score is calculated, the result is simply used to select a further known procedure. It is the examiner’s interpretation that applicant’s improvement is in the abstract idea itself performed on a generic computer and not an improvement in the computer performing the abstract idea or in the particular technology or medical procedure being performed once the FFR impact score is determined. Applicant’s specification does not appear to clearly set forth sufficient details with respect to a specific improvement in technology that is more than the abstract idea itself as a result of integrating the FFR calculation into a rigid, automated, and objective rule-set.
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 1,3-5,7-22,24-25 and 29-30 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.
Regarding claim 1, the claim has been amended to include the following language: “wherein generating the plurality of score elements comprises extracting the multiplicity of FFR values from a context of the particular positions to discard the mapping of the FFR values to the particular positions, calculating a respective score element of the plurality of score elements for each vascular segment of the plurality of vascular segments, and retaining an association of each respective score element to a particular vascular segment of the plurality of vascular segments” , and “ determining a degree of diffusion of the stenotic lesions by at least comparing a total drop in the revised FFR along a given vascular segment to a maximum drop in the revised FFR within a predefined volume of the given vascular segment”, “ selecting the CABG when the degree of diffusion indicates a severely diffuse disease”, “ selecting the PCI when the degree of diffusion indicates a focal disease and a multivessel score element of the revised FFR impact score indicates three or more occluded vascular segments”, and “selecting the OMT when the degree of diffusion indicates a focal disease and the multivessel score element indicates two or fewer occluded vascular segments”.
The applicant refers to Original claims 2, 6, and 26-28 and paragraphs [0080], [0085], [0121] for support for the amendment. However the specification does discuss “score elements” throughout, however does not specifically set forth where the generating the score elements comprising “extracting the multiplicity of FFR values from a context of the particular positions to discard the mapping of the FFR values to the particular positions, calculating a respective score element of the plurality of score elements for each vascular segment of the plurality of vascular segments, and retaining an association of each respective score element to a particular vascular segment of the plurality of vascular segments” . Paragraph [0080] of the specification sets forth “emphasizing information about disease state itself, while de-emphasizing (removing) certain information contingent on particulars of a subject's vascular geometry and/or the completeness of the vascular model. In particular, conversion, starting from a map of FFR, extracts FFR values from the context of particular positions along vascular extents to produce a score which does not include this association. In some embodiments, the conversion uses a multiplicity of FFR values (e.g., at least 3, 5, 10, 20, 30 or more FFR values) from each of a plurality (e.g., 2, 3, 4, 5, 6, 7, 8, 9, 10 or more) of vascular segments, each defined between a branch end, a root start, and/or a position of vascular branching (bifurcation or trifurcation, for example).” But this does not appear to refer to how the score elements are specifically generated.
The specification does not appear to specifically set forth “determining a degree of diffusion of the stenotic lesions by at least comparing a total drop in the revised FFR along a given vascular segment to a maximum drop” , paragraph [0038] sets forth “estimating a clinical state of a vascular portion, the method comprising: 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; and calculating an FFR impact score using the mapped FFR values, wherein the FFR impact score comprises an element comparing a total drop in FFR along at least one of the vascular segments to a maximum drop in FFR along the vascular segment.” However does not specifically set forth determining “the degree of diffusion”. The specification does appear to set forth “selecting a CABG or PCI or OMT based on the degree of diffusion”.
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 1,3-5,7-22,24-25 and 29-30 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) that continuously or near-continuously assigns assigning a multiplicity of FFR values to particular positions on each vascular segment 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 vascular segments 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 calculating the FFR impact score further comprises generating a plurality of score elements, wherein generating the plurality of score elements comprises extracting the multiplicity of FFR values from a context of the particular positions to discard the mapping of the FFR values to the particular positions, calculating a respective score element of the plurality of score elements for each vascular segment of the plurality of vascular segments, and retaining an association of each respective score element to a particular vascular segment of the plurality of vascular segments;
, wherein an element of the FFR impact score discards the mapping of FFR values to the particular positions, wherein the graphical user interface: responds to user input 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]]
, the revised FFR impact score; and
selecting a treatment procedure based on the revised FFR impact score, wherein the treatment procedure comprises an optimal medical therapy (OMT), a percutaneous coronary intervention (PCI), or a coronary artery bypass graft (CABG),
wherein selecting the treatment procedure comprises:
determining a degree of diffusion of the stenotic lesions by at least comparing a total drop in the revised FFR along a given vascular segment to a maximum drop in the revised FFR within a predefined volume of the given vascular segment;
selecting the CABG when the degree of diffusion indicates a severely diffuse disease;
selecting the PCI when the degree of diffusion indicates a focal disease and a multivessel score element of the revised FFR impact score indicates three or more occluded vascular segments; and
selecting the OMT when the degree of diffusion indicates a focal disease and the multivessel score element indicates two or fewer occluded vascular segments.
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 and selects a treatment procedure based on the generated score.
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 and then selects a desired treatment based on the score. 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.
Regarding claim 1, 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 then allows for the “selection” of a specific treatment protocol which is 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 and then a particular treatment is selected based on the determined impact score.
The method steps are performed on a generic computer( note paragraphs [0043] – [0051]) and do not appear to improve the functioning of the computer or the technology for applying the treatment. Once the FFR impact score is determined an appropriate treatment is “selected” which could be automated by a computer or done manually by an operator and the particular treatment protocol ( CABG, PCI, or OMT) is presumably performed as is well known. The added steps of selecting a particular treatment serve to merely limit the abstract idea.
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).
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.
Regarding claims 3 and 4, the claims are directed to the type of values and nature of the FFR map which serves to merely limit the abstract idea and do not appear to improve the functioning of the computer or the technology for applying the treatment nor do the claims 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).
Regarding claim 5, the claims are directed to the particulars of the vascular tree model which serves to merely limit the abstract idea and do not appear to improve the functioning of the computer or the technology for applying the treatment nor do the claims 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).
Regarding claims 7,9,13-22 the claims are directed to the type of values and nature of the impact score which serves to merely limit the abstract idea and do not appear to improve the functioning of the computer or the technology for applying the treatment nor do the claims 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).
Regarding claims 8, 10 - 12 the claims are directed to further defining and limiting the vascular segments and further defining portion or distance of the vascular segments which serves to merely limit the abstract idea and do not appear to improve the functioning of the computer or the technology for applying the treatment nor do the claims 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).
Regarding claim 24 the claims are directed to comparing impact scores which serves to merely limit the abstract idea and do not appear to improve the functioning of the computer or the technology for applying the treatment nor do the claims 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).
Regarding claims 25 and 29-30, the claims are directed to scheduling or planning specific procedures based on the scores which serves to merely limit the abstract idea and do not appear to improve the functioning of the computer or the technology for applying the treatment nor do the claims 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).
Thus, claims 1,3-5,7-22,24-25 and 29-30 are rejected under 35 U.S.C. 101.
Allowable Subject Matter
Claims 1,3-5,7-22,24-25 and 29-30 would be allowable if amended to overcome the rejection of the claims over 35 USC 101 and 35 USC 112(a) first paragraph.
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.
Conclusion
THIS ACTION IS MADE FINAL. 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 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor 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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/BRIAN L CASLER/Primary Examiner, Art Unit 3791
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