DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “solver configured to implement Navier-Stokes equations” in claim 28.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim(s) 1, 4-13, 16-19, 23-25, and 27-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Petroff et al. (WO 2020/237024 A1, Nov. 26, 2020) (hereinafter “Petroff”) in view of Sakaguchi et al. (US 2025/0259303 A1, Aug. 14, 2025) (hereinafter “Sakaguchi”).
Regarding claim 1: Petroff discloses an imaging system for a patient comprising: an imaging probe, comprising: an elongate shaft comprising a proximal end, a distal portion, and a lumen extending between the proximal end and the distal portion ([022]); a rotatable optical core comprising a proximal end and a distal end, wherein at least a portion of the rotatable optical core is positioned within the lumen of the elongate shaft ([022]); and an optical assembly positioned proximate the distal end of the rotatable optical core, the optical assembly configured to direct light to tissue to be imaged and to collect reflected light from the tissue to be imaged ([022]); an imaging assembly constructed and arranged to optically couple to the imaging probe, the imaging assembly configured to emit light into the imaging probe and to receive the reflected light collected by the optical assembly ([022]); and a processing unit comprising a processor and a memory coupled to the processor, the memory configured to store instructions for the processor to perform an algorithm ([122]); wherein the system is configured to record image data based on the reflected light collected by the optical assembly, wherein the image data comprises data collected from a segment of a blood vessel during a pullback procedure ([108]), wherein the algorithm comprises an artificial intelligence algorithm ([244], [253]), wherein the artificial intelligence algorithm is trained to perform a side-branch identification [177], [217], [253]), and wherein the algorithm is configured to analyze the image data to: (i) identify one or more side branches in the segment of the blood vessel ([177], [217], [253]); (ii) generate, based at least in part on results of the side-branch identification, a three-dimensional model of the segment of the blood vessel including the one or more side-branches (fig. 7, [190]-[193]; 3D Navier-Stokes is a 3D model where "every significant morphological feature is represented" includes side branches and other geometrical features of the vessel); and (iii) perform a computational fluid dynamics calculation on the three- dimensional model to estimate at least one hemodynamic property of the segment of the blood vessel (fig. 7, [190]-[193]; 3D Navier-Stokes is a 3D model where "every significant morphological feature is represented").
While the identification of the side branches and other geometric features of the vessel can reasonably be understood to represent a segmentation (i.e. in order to be identified a feature must be separated from the background), Petroff does not explicitly disclose that the algorithm is configured to perform a side-branch segmentation.
Sakaguchi, in the same field of endeavor, discloses an intravascular imaging system that may be OCT ([0076]) which includes a processing unit comprising a processor and a memory coupled to the processor, the memory configured to store instructions for the processor to perform an algorithm ([0038]-[0039], [0041]); wherein the algorithm comprises an artificial intelligence algorithm ([0041]-[0042], [0046]), and wherein the artificial intelligence algorithm is trained to perform a side-branch segmentation ([0042], [0044]-[0046]). Sakaguchi further teaches that it is difficult to recognize a bifurcated portion of a blood vessel in a tomographic image and to discriminate between a main vessel and a side-branch, while the disclosed system provides an improvement in the ability to recognize a side-branch ([0006]-[0007]).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system of Petroff by including the side-branch segmentation of Sakaguchi in the process of identifying side branches in order to provide improved side-branch recognition/detection in view of the further teachings of Sakaguchi.
Regarding claim 2: Petroff and Sakaguchi disclose the system of claim 1, wherein the image data comprises OCT image data (Sakaguchi – [0076])
Regarding claim 4: Petroff and Sakaguchi disclose the system of claim 1, wherein the algorithm is configured to segment the image data (Petroff – [177]-[179]; Sakaguchi – [0042], [0044]-[0050]).
Regarding claim 5: Petroff and Sakaguchi disclose the system of claim 4, wherein the segmentation is selected from the group consisting of: procedural device segmentation; guide catheter segmentation; guidewire segmentation; implant segmentation; endovascular implant segmentation; flow-diverter segmentation; lumen segmentation; side-branch segmentation ; and combinations thereof (Petroff – [177]; Sakaguchi - [0042], [0044]-[0050]).
Regarding claim 6: Petroff and Sakaguchi disclose the system of claim 4, wherein the algorithm comprises a neural network trained to perform the segmentation (Petroff - [221] - algorithm 51, which is referenced in [177]-[179], is machine learning such as a convolutional network which is a type of neural network; Sakaguchi – [0046]).
Regarding claim 7: Petroff and Sakaguchi disclose the system of claim 1, wherein the algorithm is configured to produce a confidence metric configured to represent a quality of results of an image processing step (Petroff - [180], [252]-[253]).
Regarding claim 8: Petroff and Sakaguchi disclose the system of claim 1, wherein the artificial intelligence algorithm comprises at least one a machine learning algorithm, a deep learning algorithm, or a neural network (Petroff - [221] - algorithm 51, which is referenced in [177]-[179], is machine learning or deep learning such as a convolutional network which is a type of neural network; Sakaguchi – [0046]).
Regarding claim 9: Petroff and Sakaguchi disclose that the algorithm comprises a U-net algorithm (Sakaguchi – [0047]) and U-net inherently is “is configured to skip one or more layers of the neural network” (skip connections – see Siddique, Nahian, et al. "U-Net and its variants for medical image segmentation: theory and applications." arXiv preprint arXiv:2011.01118 (2020)).
Regarding claim 10: Petroff and Sakaguchi disclose the system of claim 1, wherein the algorithm comprises a single neural network trained to perform two or more image segmentation processes (Petroff - [177]-[179], algorithm 51; Sakaguchi - figs. 6 and 10 - the vessel walls/lumens/side branches and plaques are segmented).
Regarding claim 11: Petroff and Sakaguchi disclose the system of claim 1, wherein the algorithm is configured to receive image data in a single image domain, and wherein the algorithm is further configured to convert the image data into one or more additional image domains (Sakaguchi – [0048] – conv/deconv, [0082]-[0085] - oblique is converted to axial).
Regarding claim 12: Petroff and Sakaguchi disclose the system of claim 1, wherein the algorithm is configured to process the image data in one or more image domains selected from the group consisting of: the polar domain; the cartesian domain; the longitudinal domain; the en-face image domain; a domain generated by calculating image features, such as first and/or second order features, image texture, image entropy, homogeneity, correlation, contrast, energy, and/or any other image feature; and combinations thereof (Sakaguchi - [0048] – conv/deconv, [0082]-[0085] - oblique is converted to axial which is ”en-face”).
Regarding claim 13: Petroff and Sakaguchi disclose the system of claim 1, further comprising a graphical user interface configured to be displayed to a user (Petroff - [170] - user interface 55, [186]-[188], [252]-[253]; Sakaguchi - fig. 9, [0068]).
Regarding claim 16: Petroff and Sakaguchi disclose the system of claim 13, wherein the graphical user interface is configured to enable a user to review results of an image processing step (Petroff - [170] - user interface 55, [186]-[188], [252]-[253]; Sakaguchi - fig. 9 - G1 and G2, [0030], [0044], [0068]).
Regarding claim 17: Petroff and Sakaguchi disclose the system of claim 16, wherein the graphical user interface is further configured to enable a user to approve the results of the image processing step (Petroff - [177] - user interface 55, [186]-[188], [234], [240], [252]-[253]).
Regarding claim 18: Petroff and Sakaguchi disclose The system of claim 16, wherein the graphical user interface is further configured to enable a user to edit the results of the image processing step (Petroff - [188], [234], [240], [252]-[253]).
Regarding claim 19: Tominaga and Sakaguchi disclose the system of claim 16, wherein the algorithm comprises an artificial intelligence algorithm, and wherein the image processing step is performed by the artificial intelligence algorithm (Petroff - [221] - algorithm 51, which is referenced in [177]-[179], is machine learning such as a convolutional network which is a type of neural network; Sakaguchi – [0046]).
Regarding claim 23: Petroff and Sakaguchi disclose the system of claim 1. The limitation “wherein the system is configured to collect image data prior to an interventional procedure and after the interventional procedure” is merely the intended use of the system. However, Petroff discloses this function ([146], [241]).
Regarding claim 24: Petroff and Sakaguchi disclose the system of claim 23, wherein the algorithm is configured to compare a pre-intervention image data and a post-intervention image data and to quantify an effect of the interventional procedure (Petroff – [241])
Regarding claim 25: Petroff and Sakaguchi disclose the system of claim 1, wherein the algorithm comprises a bias (Petroff - [178] - weighting is bias).
Regarding claim 27: Petroff and Sakaguchi disclose the system of claim 1, wherein the algorithm is further configured to determine diameters of the one or more side branches (Petroff - [179]; Sakaguchi – [0062]).
Regarding claim 28: Petroff and Sakaguchi disclose the system of claim 27, wherein the computational fluid dynamics calculation is implemented by a solver configured to implement Navier-Stokes equations using boundary conditions determined from the diameters of the one or more side- branches (Petroff - [190] – any processor configured to implement the Navier-Stokes equation can be reasonably considered a “solver”; [0190] – “system 10 can be configured to include in its analysis (e.g. via algorithm 51) numerous geometric and other features of the imaged area, such as when every significant morphological feature is represented”; [0193] – “…such as when small morphological features effect the flow. Examples of these include: bifurcation lesions with significant stenosis”; while Petroff does not use the term “boundary condition,” the description of accounting for morphological features is the function performed by boundary conditions).
Regarding claim 29: Petroff and Sakaguchi disclose the system of claim 1, wherein the algorithm is configured to disregard side- branches having a diameter smaller than a threshold when generating the three-dimensional model (Petroff - [211]).
Claim(s) 14 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Petroff and Sakaguchi as applied to claim 13 above, and further in view of Grass et al. (WO 2022/268624 A1, Dec. 29, 2022) (hereinafter “Grass”).
Regarding claims 14 and 15: Petroff and Sakaguchi disclose the system of claim 13 but are silent on wherein the graphical user interface is configured to provide an image data quality indicator and wherein the image data quality indicator is displayed relative to a cross-sectional OCT image.
Grass, in the same field of endeavor, discloses a user interface for an intravascular imaging system which is configured to provide an image data quality indicator (pg. 10, lines 15-32), wherein the image data quality indicator is displayed relative to a cross-sectional OCT image (fig. 7; pg. 17, line 31 - pg. 18, line 12; pg. 3, line 29 - pg. 4, line 2 - the example given is IVUS however this could be performed using OCT). Grass further teaches that by indicating the value of the data quality metric in this manner, a physician may readily appreciate whether the data can be relied upon, alleviating some of the burden of its interpretation (pg. 2, lines 18-20); and that providing the value of the data quality metric for the current position of the interventional device in this manner helps to indicate to a physician whether the current position of the interventional device is a suitable position to make a measurement of the lumen diameter, for example (pg. 18, lines 9-12).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system of Petroff and Sakaguchi to include the image data quality indicator displayed relative to a cross-sectional OCT image as taught by Grass in order to achieve the benefits reduced burden on the physician and improved placement decision-making in view of the further teachings of Grass.
Claim(s) 20-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Petroff and Sakaguchi as applied to claim 13 above, and further in view of Tominaga et al. (US 2024/0013385 A1, Jan. 11, 2024) (hereinafter “Tominaga”).
Regarding claims 20-21: Petroff and Sakaguchi disclose the system of claim 13, but are silent on wherein the graphical user interface comprises multiple workspaces, and wherein the data displayed in each workspace is synchronized by a time index or a location index.
Tominaga, in the same field of endeavor, discloses an imaging system comprising an imaging probe substantially the same as the imaging probe of claim 1 (figs. 1 and 2, [0024], [0027]-[0028], probe 11 with catheter sheath 11a; [0029]-[0030], [0032] - imaging core within shaft 13; [0028] - optical transmitter and receiver 12b) and a graphical user interface comprising multiple workspaces, and wherein the data displayed in each workspace is synchronized by a time index or a location index (figs. 9 and 13, [0064], [0076]; figs. 9 and 13, [0064] - the x-axes in the two different "workspaces" are "synchronized", [0076] - the locations in the longitudinal view or "workspace" is "synchronized" to the corresponding cross-sectional views in the transverse "workspace"). Tominaga further discloses that by displaying such information, it is possible to assist the operator in specifying the reference portion ([0064]) and that by displaying such information, it is possible to assist the operator in performing stent implant ([0076]).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to implement the user interface of Petroff and Sakaguchi in the manner taught by Tominaga in order to better assist the user by providing all necessary data in a single display to support user decision making.
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Petroff and Sakaguchi as applied to claim 1 above, and further in view of Gopinath (US 2018/0085170 A1, Mar. 29, 2018) (hereinafter “Gopinath”).
Regarding claims 26: Petroff and Sakaguchi disclose the system of claim 25, including a user interface where multiple system parameters can be entered or adjusted (Petroff – [0186]), but are silent on wherein the bias can be entered and/or modified via the user interface.
Gopinath, in the same field of endeavor, discloses an intravascular imaging system (fig. 1) including a processor configured to perform an image processing algorithm ([0053]), wherein the algorithm comprises a bias and the system further comprises a user interface, wherein the bias can be entered and/or modified via the user interface ([0015], [0078], [0094]-[0099] – the weighting factors are the “bias”). Gopinath further teaches that the use of stent planning software as disclosed can improve patient outcome and reduce cath lab time ([0003]-[0005]).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system of Petroff and Sakaguchi by including the weighting (“bias”) adjustment interface of Gopinath in order to provide the additional benefits of improved patient outcome and reduced cath lab time in view of the further teachings of Gopinath.
Response to Arguments
Applicant’s arguments with respect to prior art rejection of all pending claims, filed 12/22/2025, have been fully considered but are moot in view of the updated grounds of rejection necessitated by amendment.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Li et al. (US 2020/0336422 A1, Jul. 16, 2020) – discloses providing a confidence metric to an AI image segmentation.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 CAROLYN A PEHLKE whose telephone number is (571)270-3484. The examiner can normally be reached 9:00am - 5:00pm (Central Time), Monday - Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chris Koharski can be reached at (571) 272-7230. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CAROLYN A PEHLKE/Primary Examiner, Art Unit 3799