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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 2nd and March 19th, 2026 has been entered.
Response to Arguments
Applicant’s arguments with respect to the rejections under 35 U.S.C. 112(b) have been fully considered. The rejections under 35 U.S.C. 112(b) have been withdrawn. However, additional rejections are added.
Applicant’s arguments with respect to the rejections under 35 U.S.C. 103 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Objections
Claim 17 is objected to because of the following informalities:
“wherein the treatment” in Claim 17 line 2 should recite “wherein the planned treatment”.
Appropriate correction is required.
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 1-4, 6, 8-11, 13, and 15-17 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 lines 15-16 (claims 2-4, 6, 8-11, and 15-17 by virtue of depending from claim 1) and Claim 13 lines 13 recite the limitation “co-register[ing] a plurality of values of a pressure ratio with an x-ray image of the blood vessel”. It is unclear how the plurality of values of a pressure ratio can be co-registered with an x-ray image when the x-ray image has not been previously obtained/received and the plurality of values of a pressure ratio have not been previously calculated.
Claim 1 is suggested to recite “wherein, to generate the GUI, the processor circuit is configure to: receive an x-ray image of the blood vessel; calculate a plurality of values of a pressure ratio based on the plurality of pressure measurements; co-register a plurality of values of a pressure ratio with an x-ray image of the blood vessel” and Claim 13 is suggested to recite “wherein generating the GUI comprises: receiving an x-ray image of the blood vessel; calculating a plurality of values of a pressure ratio based on the plurality of pressure measurements; co-registering a plurality of values of a pressure ratio with an x-ray image of the blood vessel”.
Claim Rejections - 35 USC § 101
Claims 1-4, 6, 8-11, 13, and 15-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. 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 13 follows:
STEP 1
Regarding claims 1 and 13, the claims recite a series of structural elements and/or a series of steps or acts, including a system. Thus, the claims are directed to a machine and/or a process, which is one of the statutory categories of invention.
STEP 2A, PRONG ONE
The claim is then analyzed to determine whether it is directed to any judicial exception. The steps of:
generate a graphical user interface (GUI) for planning a treatment for the blood flow blockage, wherein the planned treatment comprises at least a planned first stent;
automatically segment the blood vessel into: a first segment of interest comprising a total change in the pressure ratio greater than a threshold, and a first proximal segment and a first distal segment each comprising the total change in the pressure ratio less than the threshold;
automatically determine a planned first stent length and a planned first stent location for the planned first stent;
the planned first stent location comprises a planned proximal landing zone within the first proximal segment and a planned distal landing zone within the first distal segment
set forth a judicial exception. These steps describe a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea.
STEP 2A, PRONG TWO
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. Claim 1 recites an intravascular pressure-sensing guidewire; a processor circuit configured for communication with the intravascular-sensing guidewire; control the intravascular pressure-sensing guidewire to obtain a plurality of pressure measurements during a movement of the intravascular pressure-sensing guidewire within a blood vessel comprising a blood flow blockage; provide the GUI to a display in communication with the processor circuit; co-register a plurality of values of a pressure ratio with an x-ray image of the blood vessel; the GUI comprises the x-ray image and a graphical representation of the planned first stent overlaid on the x-ray image at the planned first stent location, which is merely adding insignificant pre-solution and insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The obtained pressure measurements, the provided GUI, and the co-registered values of a pressure ratio with an x-ray image, does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on obtained pressure measurements, the provided GUI, and the co-registered values of a pressure ratio with an x-ray image, nor does the method use a particular machine to perform the Abstract Idea.
Regarding claim 1, the system recited in the claim is a generic device comprising generic components configured to perform the abstract idea. The recited system, intravascular pressure-sensing guidewire, and processor circuit configured for communication are configured to perform pre-solutional data gathering activity, the processor and display are configured to perform insignificant extra-solution activity, and the processor is configured to perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application.
The system recited in claim 1 is a generic device comprising generic components configured to perform the abstract idea. The recited system, intravascular pressure-sensing guidewire, processor circuit configured for communication are generic components (as evidenced by Romanowski (US 20180000420 A1 – previously cited) discloses in para. [0012, 0020-0021] a conventional system for performing one or more diagnostic or therapeutic procedures utilizing a guidewire assembly comprising an external device 106 (signal processor) and guidewire assembly 102 including a physiological sensor 108 and the non-patent literature of record - Zurich Medical Inc. Pressure Guidewire System Model 100, 2020, [Specification Sheet]) configured to perform pre-solutional data gathering activity, the processor and display are generic components configured to perform insignificant extra-solution activity, and the processor is configured to perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application.
STEP 2B
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:
intravascular pressure-sensing guidewire;
processor circuit configured for communication with the intravascular-sensing guidewire;
control the intravascular pressure-sensing guidewire to obtain a plurality of pressure measurements during a movement of the intravascular pressure-sensing guidewire within a blood vessel comprising a blood flow blockage;
provide the GUI to a display in communication with the processor circuit;
co-register a plurality of values of a pressure ratio with an x-ray image of the blood vessel;
the GUI comprises the x-ray image and a graphical representation of the planned first stent overlaid on the x-ray image at the planned first stent location.
The controlling, providing, co-registering, and graphical representation steps are well-understood, routine and conventional activities for those in the field of medical diagnostics. Further, the controlling, providing, co-registering, and graphical representation steps are each recited at a high level of generality such that it amounts to insignificant pre-solution activity and insignificant extra-solution activity, e.g., mere data gathering and data outputting steps 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, controlling, providing, co-registering, and graphical representation 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. Claims 2-4, 6, 8, 9-11, 15-16, 17 are directed to more abstract ideas, which does not add anything significantly more. The steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 6, 11, 13, and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Anderson (US 20160135787 A1 – previously cited) in view of Li (US 20190320913 A1), and further in view of Sonck (US 20230320682 A1).
Regarding claim 1, Anderson discloses a system (system 150, para. [0063], fig. 4), comprising: an intravascular pressure-sensing guidewire (instruments 152/175, fig. 4, “pressure-sensing intravascular … guidewire”, para. [0063-0066, 0074, 0077]); and a processor circuit (computing device 172, fig. 4, “ movement control device”, para. [0061, 0064]) configured for communication (“communicatively coupled”, para. [0063-0066], fig. 4) with the intravascular pressure-sensing guidewire(instruments 152/175, as seen in fig. 4, para. [0063-0066, 0074, 0077]), wherein the processor circuit (computing device 172, fig. 4, “ movement control device”, para. [0061, 0064]) is configured to: control the intravascular pressure-sensing guidewire (“controlled automatically”, para. [0061]) to obtain a plurality of pressure measurements (“obtaining pressure measurements”, para. [0076, 0097]) during a movement of the intravascular pressure-sensing guidewire within a blood vessel comprising a blood flow blockage (510/610, figs. 5-6, “pullback procedure”, para. [0061, 0076, 0097]); generate a graphical user interface (GUI) for planning a treatment for the blood flow blockage (“PCI planning … graphical user interface”, para. [0007, 0072]), wherein the planned treatment comprises at least a planned first stent (“stent 902”, para. [0107], figs. 9-10); and provide the GUI to a display in communication with the processor circuit (display device 180, para. [0068]), wherein, to generate the GUI, the processor circuit is configured to: co-register a plurality of values of a pressure ratio with an x-ray image of the blood vessel (“externally-obtained … x-ray images … o-registration … simultaneously collecting pressure measurements and angiography data can facilitate co-registration”; “display … visual representation of a pressure ratio and a visual representation of vessel”, para. [0074-0076, 0088]); segment the vessel into segments (as seen in fig. 7 & 9 & 27; “automatically identify the vessel … markers 708 indicative of a location within the vessel … line segments … separated by varying distances … 710, 712 … intervals”, para. [0076, 0096-0097]); automatically determine a planned first stent length and a planned first stent location for the planned first stent (“determine one or more recommended characteristics of a stent to be deployed … location, length, diameter, material, and/or other characteristics can be automatically generated by a computing device”, para. [0099; 0106-0107, 0134], stent 902/2702, figs. 9-10 & 27-28), wherein the GUI comprises the x-ray image and a graphical representation of the planned first stent overlaid on the x-ray image at the planned first stent location (as seen in figs. 9 & 27, “externally-obtained angiographic images, x-ray images”; “generate display data to cause a stent to be displayed within the vessel 702”; “graphical representation of a stent 902 positioned in the visual representation … angiographic image”, para. [0074, 0096, 0099, 0107]).
Anderson does not expressly disclose that the processor circuit is configured to automatically segment the blood vessel into: a first segment of interest comprising a total change in the pressure ratio greater than a threshold, and a first proximal segment and a first distal segment each comprising the total change in the pressure ratio less than the threshold.
However, Li directed to devices, systems, and methods configured for use in assessing the severity of one or more blockages in a blood vessel discloses a processor circuit (processor 88, para. [0074]) configured to automatically segment the blood vessel (“Automatic Step Detection (ASD) process and/or algorithm”, para. [0074, 0106, 0109, 0112]) into: a first segment of interest comprising a total change in the pressure ratio greater than a threshold (stepped change 344, as seen in fig. 4 & stepped changes 44, 144, 244, as seen in fig. 3; “identification and labeling of significant stepped changes in the pressure ratio curve … more significant or rapid within a certain window (e.g. above a certain threshold change)”, para. [0074, 0106, 0109, 0112]), and a first proximal segment and a first distal segment (non-stepped portions 343, as seen in fig. 4 & non-stepped regions 43, 143, 243, as seen in fig. 3) each comprising the total change in the pressure ratio less than the threshold (“the change in the pressure ratio values within a certain window are less significant, or more gradual (e.g. below a certain threshold change)”, para. [0074, 0106, 0109, 0112]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Anderson, such that the processor circuit is configured to automatically segment the blood vessel into: a first segment of interest comprising a total change in the pressure ratio greater than a threshold, and a first proximal segment and a first distal segment each comprising the total change in the pressure ratio less than the threshold, in view of the teachings of Li, as this would aid in better/accurately identifying the start and stop of significant stenosed areas for treatment (Li, para. [0053-0054]).
Anderson further discloses wherein the planned first stent location (figs. 9-10 & 17) comprises a planned proximal landing zone (unlabeled, but as seen in fig. 9 & ends 1706, fig. 17) and a planned distal landing zone (unlabeled, but as seen in fig. 9 & end notation 1006, fig. 10 & ends 1706, fig. 17).
Anderson, as modified by Li hereinabove, does not disclose wherein the planned first stent location comprises a planned proximal landing zone within the first proximal segment and a planned distal landing zone within the first distal segment.
However, Sonck directed to means and methods for determining the patterns of blockage or restriction to the blood flow through a coronary vessel discloses a planned proximal landing zone within the first proximal segment and a planned distal landing zone within the first distal segment (“healthy landing zones proximal and distal to the lesion are identified”; “‘landing’ the stents on healthy coronary segments … reducing the risk of restenosis and thrombosis”; “display … visually co-register”, para. [0009, 0090, 0100], fig. 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Anderson, as modified by Li hereinabove, such that the planned first stent location comprises a planned proximal landing zone within the first proximal segment and a planned distal landing zone within the first distal segment, in view of the teachings of Sonck, as this would aid in reducing the risk of restenosis and thrombosis by identifying/indicating healthy landing zones for the stent.
Regarding claim 2, Anderson, as modified by Li and Sonck hereinabove, discloses the system of claim 1. Anderson, as modified by Li and Sonck hereinabove, does not expressly disclose wherein, to perform the automatic segmentation, the processor circuit is configured to: compare the total change in the pressure ratio for the first segment of interest to the threshold; compare the total change in the pressure ratio for the first proximal segment to the threshold; and compare the total change in the pressure ratio for the first distal segment to the threshold.
However, Li discloses wherein, to perform the automatic segmentation (“Automatic Step Detection (ASD) process and/or algorithm”, para. [0074]), the processor circuit (processor 88, para. [0074]) is configured to: compare the total change in the pressure ratio for the first segment of interest to the threshold (“compared”; “pressure ratio … stepped changes … above a certain threshold change”, para. [0052, 106, 0112], 44, 244, fig. 3 & 344, fig. 4); compare the total change in the pressure ratio for the first proximal segment to the threshold (“compared”; “change in the pressure ratio values… non-stepped regions … below a certain threshold change”, para. [0052, 0106, 0112], 43, 143, fig. 3 & 343, fig. 4); and compare the total change in the pressure ratio for the first distal segment to the threshold (“compared”; “change in the pressure ratio values… non-stepped regions … below a certain threshold change”, para. [0052, 0106, 0112], 243, fig. 3 & 343, fig. 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Anderson, as modified by Li and Sonck hereinabove, such that to perform the automatic segmentation, the processor circuit is configured to: compare the total change in the pressure ratio for the first segment of interest to the threshold; compare the total change in the pressure ratio for the first proximal segment to the threshold; and compare the total change in the pressure ratio for the first distal segment to the threshold, in view of the teachings of Li, as this would aid in better/accurately identifying the start and stop of significant stenosed areas for treatment (Li, para. [0053-0054]).
Regarding claim 3, Anderson, as modified by Li and Sonck hereinabove, discloses the system of claim 2. Anderson, as modified by Li and Sonck hereinabove, does not expressly disclose wherein, to perform the automatic segmentation, the processor circuit is configured to: determine that the total change in the pressure ratio for the first segment of interest is greater than the threshold; determine that the total change in the pressure ratio for the first proximal segment is less than the threshold; and determine that the total change in the pressure ratio for the first distal segment is less than the threshold.
However, Li discloses wherein, to perform the automatic segmentation(“Automatic Step Detection (ASD) process and/or algorithm”, para. [0074]), the processor circuit (processor 88, para. [0074]) is configured to: determine that the total change in the pressure ratio for the first segment of interest is greater than the threshold (“determination”; “pressure ratio … stepped changes … above a certain threshold change”, para. [0053, 0074, 106-0107, 0112], 44, 244, fig. 3 & 344, fig. 4); determine that the total change in the pressure ratio for the first proximal segment is less than the threshold (“determination”; “change in the pressure ratio values… non-stepped regions … below a certain threshold change”, para. [0053, 0074, 0106-0107, 0112], 43, 143, fig. 3 & 343, fig. 4); and determine that the total change in the pressure ratio for the first distal segment is less than the threshold (“determination”; “change in the pressure ratio values… non-stepped regions … below a certain threshold change”, para. [0053, 0074, 0106-0107, 0112], 243, fig. 3 & 343, fig. 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Anderson, as modified by Li and Sonck hereinabove, such that to perform the automatic segmentation, the processor circuit is configured to; determine that the total change in the pressure ratio for the first segment of interest is greater than the threshold; determine that the total change in the pressure ratio for the first proximal segment is less than the threshold; and determine that the total change in the pressure ratio for the first distal segment is less than the threshold, in view of the teachings of Li, as this would aid in better/accurately identifying the start and stop of significant stenosed areas for treatment (Li, para. [0053-0054]).
Regarding claim 6, Anderson, as modified by Li and Sonck hereinabove, discloses the system of claim 1, wherein the processor circuit (computing device 172, fig. 4, para. [0064]) is further configured to calculate a predicted value of the pressure ratio to result after at least the planned first stent (“calculated pressure ratio over time … fig. 10”; “pressure ratio curve 1004 … anticipated changes … result of deployment of the stent … ideally creating perfect or near perfect flow … corrected pressure ratio value 1010”, para. [0089, 0109-0110], fig. 10).
Regarding claim 11, Anderson, as modified by Li and Sonck hereinabove, discloses the system of claim 1, wherein the GUI comprises: a graphical representation associated with the plurality of values of the pressure ratio (as seen in figs. 9-10 & 27-28, “screen display ... visual representation of a pressure ratio”, para. [0108]); and a graphical representation of the planned first stent length (description 2708, figs. 27-28, para. [0133]). Anderson, as modified by Li and Sonck hereinabove, does not disclose a graphical representation of the total change in the pressure ratio for the first segment of interest.
However, Li discloses a graphical representation of the total change in the pressure ratio for the first segment of interest (label 59, fig. 3, “amplitude of the stepped increase 44”, para. [0107]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Anderson, as modified by Li and Sonck hereinabove, such that the GUI comprises a graphical representation of the total change in the pressure ratio for the first segment of interest, in view of the teachings of Li, as this would aid in better/accurately identifying significant stenosed areas for treatment (Li, para. [0053-0054]).
Regarding claim 15, Anderson, as modified by Li and Sonck hereinabove, discloses the system of claim 1, wherein the processor circuit (computing device 172, para. [0064, 0079], fig. 4) is configured to determine, based on the plurality of pressure measurements, the plurality of values of the pressure ratio (“calculate a pressure ratio … based on … pressure measurements”, para. [0018, 0079], pressure ratio fields 714, figs. 9-10 & 27).
Regarding claim 16, Anderson, as modified by Li and Sonck hereinabove, discloses the system of claim 1, wherein at least one of the planned first stent length or the planned first stent location (as seen in figs. 9-10 & 27-28, “recommended stent length”, para. [0134]) comprises the planned first stent (stent 2702, fig. 27) extending across the first segment of interest (as seen in figs. 9-10 & 27-28, “highlight a region within the vessel 702 in which the stent is inserted”, para. 0107, 0134]).
Regarding claim 17, Anderson, as modified by Li and Sonck hereinabove, discloses the system of claim 1, wherein the treatment further comprises a planned second stent ( stents 2502 and 2504, as seen in fig. 25, “two stents”, para. [0129]), wherein the processor (computing device 172, fig. 4, para. [0064]) is configured to: automatically segment the blood vessel into a second segment of interest comprising the total change in the pressure ratio greater than the threshold (Anderson, “segment”, para. [0097]; & Li, 244 in fig. 3, “Automatic Step Detection (ASD) process and/or algorithm”, para. [0074, 0106, 0109, 0112]); and automatically determine a planned second stent length and a planned second stent location for the planned second stent (as seen in figs. 25-26, “automatically calculate at least one of the stent length and the length of the graphical representation of the stent”, para. [0082, 0085, 0129]), wherein the GUI comprises a graphical representation of the planned second stent overlaid on the x-ray image (as seen in fig. 25 “externally-obtained angiographic images, x-ray images”; “generate display data to cause a stent to be displayed within the vessel 702”; “ visual representation of a vessel having two graphical representations of stents”, para. [0074, 0096, 0099, 0107, 0129]).
Regarding claim 13, Anderson, as modified by Li and Sonck hereinabove, discloses the method as the subject matter of claim 13 is analogous to the subject matter of claim 1.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Anderson in view of Li and Sonck, as applied to claim 17 above, and further in view of Merritt (US 20160015327 A1).
Regarding claim 4, Anderson, as modified by Li and Sonck hereinabove, discloses the system of claim 17. Anderson, as modified by Li and Sonck hereinabove, does not disclose wherein, to perform the automatic segmentation, the processor circuit is configured to: determine a combined total change comprising: the total change in the pressure ratio for the first segment of interest; and the total change in the pressure ratio for the second segment of interest; and determine the planned first stent location and the planned second stent location based on the combined total change.
However, Merritt discloses a processor circuit (computing device 172, fig. 4, para. [0032]) configured to determine a combined total change (“multiple plaque stenoses … 190 and 192 … pressure ratio is calculated to determine the combined effect”; “gradients/changes in the pressure ratio”, para. [0041-0042, 0052], figs. 5a-5b) comprising: the total change in the pressure ratio for the first segment of interest (“pressure ratios can be calculated for each sensor 186 over time to determine the individual effect of each stenosis along the length of the vessel 184 … changes”; “gradients/changes in the pressure ratio”; “sections”, para. [0041-0042, 0052, 0057], 190, figs. 5a-b); and the total change in the pressure ratio for the second segment of interest (“pressure ratios can be calculated for each sensor 186 over time to determine the individual effect of each stenosis along the length of the vessel 184 … changes”; ““gradients/changes in the pressure ratio”; “sections”, para. [0041-0042, 0052, 0057], 192, figs. 5a-b); and Merritt further discloses that the pressure ratios can enable an operator to distinguish stenoses that are individually benign but collectively acute, and determine which obstructions have the largest overall contribution (para. [0042]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Anderson, as modified by Li and Sonck hereinabove, such that to perform the automatic segmentation, the processor circuit is configured to: determine a combined total change comprising: the total change in the pressure ratio for the first segment of interest; and the total change in the pressure ratio for the second segment of interest, in view of the teachings of Merritt, as this would aid in distinguishing stenoses that are individually benign but collectively acute, and determining which obstructions have the largest overall contribution.
Anderson, as modified by Li, Sonck, and Merritt hereinabove, further discloses the processor circuit (computing device 172, fig. 4, para. [0064]) is configured to determine the planned first stent location and the planned second stent location based on the combined total change (Anderson, “stent position … determination of the one or more characteristics can be based on … computed pressure ratio(s) … a threshold pressure ratio … location … automatically”; “positioning … stent … PCI planning can include determining to treat one or both of the lesions … inserted along the visual representation of the pressure ratio”, para. [0106-0107, 0129-0131], as seen in figs. 25-26; & Merritt, para. [0041-0042, 0052, 0057]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Anderson in view of Li and Sonck, as applied to claim 17 above, and further in view of Rangwala (US 20090226063 A1 – previously cited).
Regarding claim 8, Anderson, as modified by Li and Sonck hereinabove, discloses 8 the system of claim 17. Anderson, as modified by Li and Sonck hereinabove, does not disclose wherein the processor circuit is configured to determine the planned first stent location and the planned second stent location such that a distance between the planned first stent and the planned second stent exceeds a minimum distance.
However, Rangwala directed to systems and devices for applying image enhancement techniques for viewing medical/treatment devices in situ discloses a first stent and a second stent (“first stent”; “second stent”, para. [0096-0099], figs. 13A-C) and that a distance between the planned first stent and the planned second stent exceeds a minimum distance (“stent overlap … multiple stents … threshold values database … correlate measured overlap length to a score … Grade 0 can range from 0 mm-5 mm … distance”, para. [0096-0099]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Anderson, as modified by Li and Sonck hereinabove, such that the processor circuit is configured to determine the planned first stent location and the planned second stent location such that a distance between the planned first stent and the planned second stent exceeds a minimum distance, in view of the teachings of Rangwala, as this would aid in categorizing the stent overlap and provide a recommendation to the physician/and or user to prevent too much overlapping because based on clinical outcome studies and other research, it has been, in an example, determined, statistically determined, and/or clinically determined that there is a correlation between type I stent overlap, and stent fracture (Rangwala, para. [0096-0099]).
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Anderson in view of Li and Sonck, as applied to claim 1 above, and further in view of Gopinath (US 20200142575 A1 – previously cited).
Regarding claim 9, Anderson, as modified by Li and Sonck hereinabove, discloses the system of claim 1. Anderson, as modified by Li and Sonck hereinabove, does not disclose wherein the processor circuit is configured to identify a location along the blood vessel of a side branch.
However, Gopinath directed to invasive and noninvasive image data collection systems including a processor 80 discloses wherein the processor circuit (80, fig. 1) is configured to identify a location along the blood vessel of a side branch (“side branch detection 102”, fig. 2, para. [0084], Abstract). Gopinath further discloses that it is typically the case that during stent deployment it is desirable to avoid stenting a side branch (para. [0010]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Anderson, as modified by Li and Sonck hereinabove, such that the processor circuit is configured to identify a location along the blood vessel of a side branch, in view of the teachings of Gopinath, as this would aid in creating a three-dimensional visualization of the treatment site and assess side branch location during stenting to avoid stenting a side branch.
Regarding claim 10, Anderson, as modified by Li, Sonck, and Gopinath hereinabove, discloses the system of claim 9. Anderson, as modified by Li, Sonck, and Gopinath hereinabove, does not expressly disclose wherein the processor circuit is configured to determine the planned first stent location such that the planned first stent does not cross the side branch.
However, Gopinath directed to invasive and noninvasive image data collection systems including a processor 80 discloses wherein the processor circuit (80, fig. 1) is configured to determine the planned first stent location such that the planned first stent does not cross the side branch (“one or more stent”; “avoid stenting a side branch”; “visualizing stents … relative to side branches … to avoid the jailing of vessels thereof”, para. [0020, 0058, 0061]). Gopinath further discloses that side branches can be occluded or “jailed” by stent struts and jailing can have an undesired ischemic impact (para. [0007]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Anderson, as modified by Li, Sonck, and Gopinath hereinabove, such that the processor circuit is configured to determine the planned first stent location such that the planned first stent does not cross the side branch, in view of the teachings of Gopinath, as this would avoid the jailing of vessels by avoiding the stenting of a side branch.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Merritt (US 20160008084 A1) directed to systems, and methods configured to assess the severity of a blockage in a vessel (figs. 11-12); Venugopal (US 20230144624 A1) directed to systems and methods for detecting stenosis (figs. 6-7).
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/A.E.H./Examiner, Art Unit 3791
/AURELIE H TU/Primary Examiner, Art Unit 3791
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