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 statement (IDS) submitted on July 15, 2025, July 31, 2025 and August 12, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings filed on July 15, 2025 are accepted.
Claim Objections
Claims 4 and 9 are objected to because of the following informalities:
Claims 4 and 9: the term “FFR” should be corrected to --fractional flow reserve (FFR)--.
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 1, 3-6 and 8-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claims 1-5 is directed to a “method” which describes one of the four statutory categories of patentable subject matter, i.e., a process.
Claims 6-10 are drawn to a “system” which describes one of the four statutory categories, i.e., a machine.
Step 2A of the subject matter eligibility test (see MPEP 2106.04).
Prong One:
Claims 1 and 6 recite (“sets forth” or “describes”) the abstract idea of “a mental process” (MPEP 2106.04(a)(2).III.), substantially as follows: determining a plurality of sets of Pd/Pa ratios based on the plurality of sampled distal pressure (Pd) values and the plurality of sampled proximal pressure (Pa) values, wherein each of the plurality of sets of Pd/Pa ratios includes Pd/Pa ratios that are determined through an entirety of one heart cycle; generating a plot of the plurality of sets of Pd/Pa ratios over time; and simultaneously displaying a plurality of markers, each located at a minimum Pd/Pa ratio within one of the sets of Pd/Pa ratios over the entirety of the corresponding heart cycle.
In claims 1 and 6, the above recited steps can be practically performed in the human mind, with the aid of a pen and paper. If a person were to visually examine, i.e., perform an observation on the plurality of sampled distal pressure (Pd) values and the plurality of sampled proximal pressure (Pa) values, either in a printout or an electronic format, he/she would be able to identify the Pd and Pa values of a heart cycle, determine the ratios of Pd/Pa and the minimum ratio among the ratios, make a plot of these ratios over time using a pen and paper, and note a marker on the minimum ratio on the plot using a pen. He/she would be able to repeat these steps for different Pd and Pa values of different heart cycle to obtain a plurality of sets of ratios. To simultaneously display the marker over the minimum ratio merely requires the person to examine the ratio and mark the minimum when identifying it. There is nothing recited in the claim to suggest an undue level of complexity in how the ratios and the minimum ratios are determined, how the plot is generated and how the markers are placed. Therefore, a person would be able to perform the above identified claim limitations mentally.
Prong Two: Claims 1 and 6 do not include additional elements that integrate the mental process into a practical application.
This judicial exception is not integrated into a practical application. In particular, claim 1 recites (1) receiving, at an intravascular data processing system, a plurality of sampled distal pressure (Pd) values and a plurality of sampled proximal pressure (Pa) values; and (2) a display system. Claim 6 recites (3) an interface system configured to receive intravascular pressure data including a plurality of distal pressure (Pd) values measured by an intravascular data collection probe and a plurality of proximal pressure (Pa) values during a pullback of the intravascular data collection probe through the blood vessel; one or more memory storage devices; and a processor; and (4) a display system.
The steps in (1) and (3) represent merely data gathering or pre-solution activities that are necessary for use of the recited judicial exception and are recited at a high level of generality with conventionally used tools.
An intravascular data processing system is conventionally known as a processing system that process intravascular data. An interface system is conventionally known as a tool to receive data. An intravascular data collection probe is conventionally known as a probe that collects intravascular data. To collect that data during the pullback of the probe is the timing of when the Pd and Pa values are sampled. And data sampling is not an actively recited step or component of the method nor the system.
In regard to the processing system, one or more memory storage devices and the processor, a claim that requires computer may still recite a mental process. MPEP 2106.04(a)(2).III.C.: “Performing a mental process on a generic computer, in a computer environment, or using a computer as a tool to perform the steps are considered a mental process”.
The steps in (2) and (4) represents merely outputting by a display as a post-solution activity and is recited at a high level of generality. A display is conventionally known to display information.
As a whole, the additional elements merely serve to gather and feed information to the abstract idea and to output a notification based on the abstract idea, while generically implementing it on conventionally used tools. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. No improvement to the technology is evident, and the display of the minimum ratios and the markers are not outputted in any way such that a practical benefit is realized. Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application.
Step 2B of the subject matter eligibility test (see MPEP 2106.05).
Claims 1 and 6 do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above, claim 1 recites (1) receiving, at an intravascular data processing system, a plurality of sampled distal pressure (Pd) values and a plurality of sampled proximal pressure (Pa) values; and (2) a display system. Claim 6 recites (3) an interface system configured to receive intravascular pressure data including a plurality of distal pressure (Pd) values measured by an intravascular data collection probe and a plurality of proximal pressure (Pa) values during a pullback of the intravascular data collection probe through the blood vessel; one or more memory storage devices; and a processor; and (4) a display system.
These steps represents mere data gathering, data outputting or pre/post/extra-solution activities that are necessary for use of the recited judicial exception and are recited at a high level of generality.
The steps in (1) and (3) represent merely data gathering or pre-solution activities that are necessary for use of the recited judicial exception and are recited at a high level of generality with conventionally used tools.
An intravascular data processing system is conventionally known as a processing system that process intravascular data. An interface system is conventionally known as a tool to receive data. An intravascular data collection probe is conventionally known as a probe that collects intravascular data. To collect that data during the pullback of the probe is the timing of when the Pd and Pa values are sampled. And data sampling is not an actively recited step or component of the method nor the system.
In regard to the processing system, one or more memory storage devices and the processor, a claim that requires computer may still recite a mental process. MPEP 2106.04(a)(2).III.C.: “Performing a mental process on a generic computer, in a computer environment, or using a computer as a tool to perform the steps are considered a mental process”.
The steps in (2) and (4) represents merely outputting by a display as a post-solution activity and is recited at a high level of generality. A display is conventionally known to display information.
Hence, for similar reasons set forth in Step 2A, Prong Two above, the additional elements do not provide an inventive concept under Step 2B.
Accordingly, these additional steps amount to no more than insignificant conventional extra-solution activity. Mere insignificant conventional extra-solution activity cannot provide an inventive concept. The claims hence are not patent eligible.
Dependent Claims
The dependent claims incorporate all the limitations of their respective independent claims. The following analysis focus on the limitations recited in the dependent claims to determine whether they merely recite further abstract idea, or whether or not they recite additional elements that may either amount to significantly more than the abstract idea in their respective independent claims, or may integrate the abstract idea in their respective independent claims to a practical application.
The following dependent claims merely further describe the extra-solution activities and therefore, do not amount to significantly more than the judicial exception or integrate the abstract idea into a practical application for similar reasons as stated in the analysis for their respective independent claims, hence are patent ineligible:
describing the display (claims 3 and 8 – a user interface)
describing the display content (claims 4-5 and 9-10)
Taken alone and in combination, the additional elements do not integrate the judicial exception into a practical application at least because the abstract idea is not applied, relied on, or used in a meaningful way. They also do not add anything significantly more than the abstract idea. Their collective functions merely provide computer/electronic implementation and processing, and no additional elements beyond those of the abstract idea. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. There is no indication that the combination of elements improves the functioning of a computer, output device, improves technology other than the technical field of the claimed invention, etc. Therefore, the claims are rejected as being directed to non-statutory subject matter.
Based on the above consideration and analysis, claims 1, 3-6 and 8-10 are patent ineligible, i.e., rejected under 35 U.S.C. 101.
It is noted that claims 2 and 7 are eligible. Specifically, claims 2 and 7 set forth an additional step to filter the plurality of sets of Pd/Pa ratios using a filter having a time constant, wherein the time constant is in a range of 1% to 50% of a heart cycle length. This step is not well known and therefore the respective claims as a whole thus amounts to significantly more than the exception itself.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 1 recites in lines 3-4 “a plurality of sampled distal pressure (Pd) values and a plurality of sampled proximal pressure (Pa) values” that renders the scope of the claim indefinite. It is unclear what object these pressure values refer to. For examination purpose, it is interpreted such that these Pd and Pa pressure values are collected over time by an intravascular data collection probe through the blood vessels.
Claim 1 recites in line 12 “a plurality of markers, each located at a minimum Pd/Pa ratio within one of the sets of Pd/Pa ratios” that renders the scope of the claim indefinite. It is unclear whether the plurality of markers are located at one minimum ratio of one set of the ratios, or each of the markers is located at each minimum ratio within each one of the sets. For examination purpose, it is interpreted such that a plurality of minimum Pd/Pa ratios are determined, wherein each of the plurality of minimum Pd/Pa ratios is a minimum Pd/Pa ratio within each of the plurality of sets of Pd/Pa ratios over the entirety of the corresponding heart cycle; and the plurality of markers are each located at the minimum Pd/Pa ratio within each one of the plurality of sets of Pd/Pa ratios over the entirety of the corresponding heart cycle. This rejection applied to claim 6 for the substantially identical limitations recited in the last three lines of the claim.
The dependent claims of the above rejected claims are rejected due to their dependency.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5-7, 9-11, 14 and 16 of U.S. Patent No. 11,350,843 in view of Svanerudh et al., US 2002/0072880 A1, hereinafter Svanerudh.
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications appear to disclose substantially identical subject matter with the instant claims being simply broader than the patent claims.
Both the instant application and the ‘843 patent disclose a method of determining one or more diagnostic metrics to assess a blood vessel, and an intravascular data analysis system to assess a blood vessel.
Claims 1 and 9 of ‘843 reads on claims 1 and 6 of the instant application, respectively, including “a minimum Pd/Pa ratio within one of the sets of Pd/Pa ratios over the entirety of the corresponding heart cycle”.
Claims 1 and 9 of ‘843 does not teach that a marker is located at a minimum Pd/Pa value.
However, in an analogous intravascular blood vessel assessment field of endeavor, Svanerudh teaches that
a marker is located at a minimum Pd/Pa value ([0089]: the monitor displays the Pd/Pa continuously as a graph,…the system automatically marks the point on the curve representing the minimum…by placing a vertical line across the screen at that point (of course any other kind of marker can be used)).
Hence, when ‘843 and Svanerudh are combined, the marking on the minimum of Svanerudh applies to each of the minimum in ‘843, hence reading on the claimed limitation of “simultaneously displaying a marking at a minimum Pd/Pa ratio”.
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the device and method of ‘843 employ such a feature associated with simultaneously displaying a plurality of markers, each located at a minimum Pd/Pa ratio taught in Svanerudh for the advantage of “enabling the physician to directly assess whether the calculated value is reasonable”, as suggested in Svanerudh, [0089].
Claims 2, 5, 6, 7, 10, 14, and 16 of ‘843 read on claims 2-5 and 7-10 of the instant application, respectively.
Claims 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-9, 12 and 14 of U.S. Patent No. 11,883,138.
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications appear to disclose substantially identical subject matter with the instant claims being simply broader than the patent claims.
Both the instant application and the ‘138 patent disclose a method of determining one or more diagnostic metrics to assess a blood vessel, and an intravascular data analysis system to assess a blood vessel.
Claims 1 and 7 of ‘138 reads on claims 1 and 6 of the instant application, respectively, including “a minimum Pd/Pa ratio within one of the sets of Pd/Pa ratios over the entirety of the corresponding heart cycle”.
Claims 1 and 7 of ‘138 does not teach that a marker is located at a minimum Pd/Pa value.
However, in an analogous intravascular blood vessel assessment field of endeavor, Svanerudh teaches that
a marker is located at a minimum Pd/Pa value ([0089]: the monitor displays the Pd/Pa continuously as a graph,…the system automatically marks the point on the curve representing the minimum…by placing a vertical line across the screen at that point (of course any other kind of marker can be used)).
Hence, when ‘138 and Svanerudh are combined, the marking on the minimum of Svanerudh applies to each of the minimum in ‘138, hence reading on the claimed limitation of “simultaneously displaying a marking at a minimum Pd/Pa ratio”.
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the system and method of ‘138 employ such a feature associated with simultaneously displaying a plurality of markers, each located at a minimum Pd/Pa ratio taught in Svanerudh for the advantage of “enabling the physician to directly assess whether the calculated value is reasonable”, as suggested in Svanerudh, [0089].
Claims 2, 4, 5, 6, 8, 12, 14 and 9 of ‘138 read on claims 2-5 and 7-10 of the instant application, respectively.
Claims 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6 and 14 of U.S. Patent No. 12,440,154.
Although the claims at issue are not identical, they are not patentably distinct from each other.
In regard to claims 1-5, both the instant application and ‘154 appear to disclose substantially identical subject matter except for specifically being just directed to the method and not the intravascular data analysis system. However, the intravascular analysis system is configured to perform the steps of the method claims 1-5, one of ordinary skill in the art would find it obvious to merely have a more general invention that does not necessarily involve the data analysis system that is configured to perform the method steps.
In regard to claims 6-10, both the instant application and ‘154 appear to disclose substantially identical subject matter except for them being simply broader than the patent claims.
Based on the above consideration, claims 1 and 2 of ‘154 combined reads on claims 1 and 6 of the instant application, respectively, including “a minimum Pd/Pa ratio within one of the sets of Pd/Pa ratios over the entirety of the corresponding heart cycle”.
Claims 1 and 2 of ‘154 combined does not teach that a marker is located at a minimum Pd/Pa value.
However, in an analogous intravascular blood vessel assessment field of endeavor, Svanerudh teaches that
a marker is located at a minimum Pd/Pa value ([0089]: the monitor displays the Pd/Pa continuously as a graph,…the system automatically marks the point on the curve representing the minimum…by placing a vertical line across the screen at that point (of course any other kind of marker can be used)).
Hence, when ‘154 and Svanerudh are combined, the marking on the minimum of Svanerudh applies to each of the minimum in ‘154, hence reading on the claimed limitation of “simultaneously displaying a marking at a minimum Pd/Pa ratio”.
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the system of ‘154 employ such a feature associated with simultaneously displaying a plurality of markers, each located at a minimum Pd/Pa ratio taught in Svanerudh for the advantage of “enabling the physician to directly assess whether the calculated value is reasonable”, as suggested in Svanerudh, [0089].
Claims 1 and 2 of ‘154 combined reads on claims 2 and 7 of the instant application.
Claim 6 of ‘154 reads on claims 3 and 8 of the instant application.
Claim 14 of ‘154 reads on claims 4 and 9 of the instant application.
Claim 3 of ‘154 reads on claims 5 and 10 of the instant application.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Svanerudh et al., US 2002/0072880 A1. This reference disclose a method and system for determining one or more diagnostic metrics to assess a blood vessel. The method performs, and the system is configured to sample a plurality of distal pressure values and proximal pressure values, determine a set of Pd/Pa values, determine the minimum value in the set, and display a representation of the minimum Pd/Pa value. It does not teach that the measurement of the ratio is determined through an entirety of one heart cycle.
Davies et al., US 2015/0025398 A1. This reference discloses a set of Pd/Pa values in a diagnostic window within a heart cycle, and displays the values. It does not teach that the measurement of the ratio is determined through an entirety of one heart cycle.
Turcott et al., US 7,324,848 B1. This reference discloses data reducing method and system for analyzing hemodynamic signals such as pressure signals, and determining a minimum value from the filtered set of pressure data. It disclose sample reduction by reducing the size of the sampling window, which is considered reading on “filtering the set of pressure data using a filter having a time constant”. However, it does not teach that the measurement of the ratio is determined through an entirety of one heart cycle.
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/YI-SHAN YANG/Primary Examiner, Art Unit 3798
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