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 .
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-2 and 4-10 in the reply filed on June 24, 2026 is acknowledged. The traversal has been found to be persuasive and the restriction requirement is hereby withdrawn.
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 8 and 18 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.
Regarding claims 8 and 18, the phrase "e.g.,…" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For examination purposes, the limitations follow “e.g.” are considered to not be part of the claimed invention.
With regards to claim 8, in line 19, it is unclear as to whether the “display” is referring to the same “display” set forth in line 3 of the claim or referring to a different “display”. For examination purposes, Examiner assumes the latter. Claim 18 is similarly rejected.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-2, 4-10, 11-12 and 14-22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Klaiman et al. (US Pub No. 2014/0107479), as evidenced by Cohen et al. (US Pub No. 2010/0172556).
With regards to claims 1, 11 and 21, Klaiman et al. disclose a method, a non-transitory computer-readable storage medium and an image processing apparatus comprising:
one or more processors (10) (paragraph [0311], referring to the processor (10) which is used to perform the procedure; Figures 1-2) that operate to:
obtain one or more intravascular images of one or more imaging modalities of an object or target during a pullback of a probe or catheter (paragraph [0338], referring to one or more angiographic image streams being acquired; paragraphs [0462], [0472]-[0473], referring to the endoluminal data acquisition device (72) which may be an OCT probe that acquires endoluminal data points in the form of endoluminal images and wherein “movement (e.g., pullback) of the endoluminal data-acquisition device is performed in the course of a continuous injection of contrast agent performed under fluoroscopic imaging”; Figures 1, 7);
detect one or more arterial branches in the one or more intravascular images (paragraph [0343], referring to the QCA performed in step 4 of Fig. 2 is “preceded by enhancement of the suitable frames selected in frame 2. Such enhancement is typically performed according to the techniques described with reference to step 5, e.g., in accordance with techniques described in WO 10/058,398 to Cohen, US 2010/0172556 to Cohen, and/or US 2010/0228076 to Blank, all of which applications are incorporated herein by reference”, wherein Cohen et al. (US Pub No. 2010/0172556) discloses that the enhancement comprises detecting one or more arterial branches in the one or more intravascular images via segmentation (see paragraphs [0560], [0564], [0569], [0579] of Cohen et al. which discloses enhancement of the vessels using segmentation/filter/edge detection of the curvilinear structures which correspond to vessels/arterial branches present in the image, wherein [0562] of Cohen et al. sets forth that the greatest visibility/enhancement of coronary arteries (i.e. arterial branches) can be selected);
calculate or determine a pressure loss or change (i.e. “pressure drop”) of the one or more arterial branches detected in the one or more intravascular images (paragraph [0349], referring to determination of the “pressure drop” which can be determined by comparing pressure at the location of interest to pressure at a second location; Figure 2, see step 8, referring to “Calculation of flow and/or pressure drop along the luminal section…”); and
automatically calculate one or more Fractional Flow Reserve (FFR) values using the one or more intravascular images and using the calculated or determined pressure loss or change of the one or more arterial branches (paragraphs [0349], [0382], referring to determining FFR from data derived from the angiogram, such as the geometry of the lumen, the aortic pressure, etc.; paragraphs [0399]-[0418], referring to equations for FFR which take into account lumen geometry, pressure, etc.; Figure 9, step 9);
automatically calculate one or more areas of the detected one or more arterial branches (paragraphs [0341], [0385], referring to the geometry-indication-receiving functionality (14) determining the cross-sectional area of the lumen at locations along the lumen; paragraph [0403], referring to parameters such as cross-sections being determined automatically from angiographic images of the lumen); and
provide or display information to determine or assist in determining whether a stenosis and/or another medical condition exists in or overlaps with one or more of the calculated one or more areas of the detected one or more arterial branches based on the calculated one or more FFR values (paragraphs [0350]-[0352], referring to an output-generation functionality (22) driving display (24) to display the luminal-flow-related index (i.e. FFR), wherein multiple FFR values may be displayed along the luminal section comprising the stenosis, wherein a FFR color legend (46) can be used to indicate FFR values of locations along the lumen; in particular, paragraph [0352] referring to “in response to determining that the subject's FFR passes a first threshold value, an output is generated on the display indicating that treatment of the subject (e.g., by deploying a stent at the stenosis) is recommended”; Figure 4, note that the displayed FFR values which assist in determining the existence of stenosis for treatment overlaps with the regions of the lumen wherein area is calculated).
With regards to claims 2, 12 and 22, Klaiman et al. disclose that the one or more processors further operate to one or more of the following: detect lumen area(s) using a lumen detection method or technique; detect a minimum lumen area (As) and define a stenotic area (L); construct a carpet view of the pullback ;in a case where an arterial branch of the detected one or more arterial branches is within or has a portion that passes through or is within, or the calculated area or areas of the arterial branch is within or overlaps with, the stenotic area, reduce a velocity of a fluid or other object passing through the branch or lumen; calculate a diastolic and systolic Stenotic Flow Reserve(s) (SFR) using the velocity, the stenotic area (L), and the minimum lumen area (As); and/or use the SFR to calculate the Fractional Flow Reserve (FFR) (paragraph [0082], referring to determining a cross-sectional area of the lumen by performing a quantitative vessel analysis on the angiographic image(s); paragraphs [0313]-[0313, referring to two or more measured diameters being used to calculate the cross-sectional area of the lumen and/or by performing densitometry on the angiographic images; paragraph [0459], referring to cross-sectional areas being automatically calculated by solving computational fluid dynamics equations).
With regards to claims 4 and 14, Klaiman et al. disclose the one or more processors further operate to detect a stenotic area in the one or more intravascular images (paragraph [0351], referring to the system automatically identifying the stenosis); and to calculate the FFR values for the stenotic area only where the pressure loss or change of the one or more arterial branches is occurring (paragraph [0349], referring to “the pressure drop induced by the stenosis is determined and is then used to calculate a luminal-flow-related index (e.g., FFR)”, and therefore the FFR is dependent on the pressure drop being determined and therefore the FFR is “only” calculated where the pressure loss/change/drop is occurring).
With regards to claims 5 and 15, Klaiman et al. disclose that the object or target is an organ, a tissue, a sample, a portion of a patient, a vessel, a blood vessel, or a patient (Abstract; paragraph [0033], referring to the “vessel”/”lumen” terms referring to structures within the body, such as arteries and veins (i.e. vessel/blood vessel, and thus a portion of a patient/body, etc.).
With regards to claims 6 and 16, Klaiman et al. disclose that the one or more processors further operate to:determine whether a Percutaneous Coronary Intervention (PCI) is needed for the object or target; in a case where it is determined that the object or target needs the PCI, perform the PCI, or, in a case where it is determined that the object or target does not need the PCI, save the images; in a case where the PCI is to be performed, plan the PCI; in a case where the PCI is performed, assess or evaluate procedural success of the PCI; evaluate the physiology of the object or target; and/or in a case where the object is a vessel or blood vessel, evaluate the physiology of the vessel and/or a lesion of the vessel (paragraphs [0021], [0352], referring to FFR serving as a decision support tool for determining whether the stenosis should be treated such as by implanting/deploying a stent, which is, as is known in the art, a type of percutaneous coronary intervention (i.e. also known as coronary angioplasty with stenting) procedure).
With regards to claims 7 and 17, Klaiman et al. disclose that the one or more processors further operate to reduce a cost of using the image processing apparatus and to reduce an interventional risk during PCI procedure(s) by avoiding wire or other object insertion (paragraphs [0027]-[0028], [0031], referring to “typically” inserting into vessels a wire equipped with sensors to measure FFR, wherein for some applications, determining a luminal-flow-related index using angiographic data facilitates determination of such an index “even in cases in which determination of the index via insertion of a wire would be physiologically difficult”, and therefore the processors meet the limitation as the invention uses angiographic data/images to determine FFR, thus avoiding the need for a wire). Alternatively, the processor is not positively recited as performing a PCI procedure and therefore the limitation of claim 7 is directed to an intended use of the claimed apparatus. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Since the processor of Klaiman et al. is capable of being used with any procedure, including a procedure that avoids the use of wire or other object insertion, Klaiman et al. meets the limitation.
With regards to claims 8 and 18, Klaiman et al. disclose that the one or more processors further operate to one or more of the following:(i) display an image for each of the one or more imaging modalities on a display, wherein the one or more imaging modalities include one or more of the following: an imaging modality for a tomography image; an imaging modality for an Optical Coherence Tomography (OCT) image; an imaging modality for a fluorescence image; an imaging modality for a near-infrared fluorescence (NIRF) image; an imaging modality for a near- infrared fluorescence (NIRF) image in a predetermined view (e.g., a carpet view, an indicator view, etc.); an imaging modality for a near-infrared auto-fluorescence (NIRAF) image; an imaging modality for a near-infrared auto-fluorescence (NIRAF) image in a predetermined view (e.g., a carpet view, an indicator view, etc.); an imaging modality for a three-dimensional (3D) rendering; an imaging modality for a 3D rendering of a vessel; an imaging modality for a 3D rendering of a vessel in a half-pipe view or display; an imaging modality for a 3D rendering of the object; an imaging modality for a lumen profile; an imaging modality for a lumen diameter display; an imaging modality for a longitudinal view; computer tomography (CT); Magnetic Resonance Imaging (MRI); Intravascular Ultrasound (IVUS); an imaging modality for an X-ray image or view; and an imaging modality for an angiography view;(ii) display an image for each of the one or more imaging modalities on a display, wherein the one or more imaging modalities include two or more of the following: an imaging modality for a tomography image; an imaging modality for an Optical Coherence Tomography (OCT) image; an imaging modality for a fluorescence image; an imaging modality for a near-infrared fluorescence (NIRF) image; an imaging modality for a near- infrared fluorescence (NIRF) image in a predetermined view (e.g., a carpet view, an indicator view, etc.); an imaging modality for a near-infrared auto-fluorescence (NIRAF)image; an imaging modality for a near-infrared auto-fluorescence (NIRAF) image in a predetermined view (e.g., a carpet view, an indicator view, etc.); an imaging modality for a three-dimensional (3D) rendering; an imaging modality for a 3D rendering of a vessel; an imaging modality for a 3D rendering of a vessel in a half-pipe view or display; an imaging modality for a 3D rendering of the object; an imaging modality for a lumen profile; an imaging modality for a lumen diameter display; an imaging modality for a longitudinal view; computer tomography (CT); Magnetic Resonance Imaging (MRI); Intravascular Ultrasound (IVUS); an imaging modality for an X-ray image or view; and an imaging modality for an angiography view; and/or (iii) change or update the displays for each of the one or more imaging modalities based on a calculated FFR and/or based on a request to update or change the displays after calculating the FFR (paragraph [0351], referring to displaying an angiogram image (41); paragraph [0472], referring to fluoroscopic imaging and OCT imaging being performed, wherein the endoluminal image (i.e. OCT image) may be displayed; Figure 4, which displays an angiogram image/lumen profile/imaging modality for an angiography view).
With regards to claims 9 and 19, Klaiman et al. disclose that the one or more processors further operate to one or more of the following: (i) receive information for an interventional device (i.e. stent) to be used for a Percutaneous Coronary Intervention (PCI); and/or (ii) in a case where the interventional device is a stent, perform one or more of:detecting stent expansion or underexpansion, detecting stent apposition or malapposition, performing co-registration, performing imaging, displaying a notification regarding the detected stent expansion or underexpansion, displaying a notification regarding the detected stent apposition or malapposition, and confirming stent placement (paragraphs [0021], [0352], referring to FFR serving as a decision support tool for determining whether the stenosis should be treated such as by implanting/deploying a stent (i.e. interventional device), which is, as is known in the art, a type of percutaneous coronary intervention (i.e. also known as coronary angioplasty with stenting) procedure).
With regards to claims 10 and 20, Klaiman et al. disclose that the one or more processors operate to one or more of the following:(i) employ information on a two-dimensional (2D) and/or three-dimensional (3D) structure or structures for the target or object to create or construct/reconstruct a computational fluid dynamics (CFD) model or result for the target or object; (ii) use 2D or 3D results and/or 2D or 3D structure(s) and calculate the one or more FFR values and/or one or more instantaneous wave-free ratio (iFR) values;(iii) employ computational fluid dynamics (CFD) to calculate one or more pressures and to have or obtain the one or more FFR values and/or one or more instantaneous wave-free ratio (iFR) values; (iv) in a case where it is determined that the stenosis and/or the another medical condition exists in or overlaps with the one or more of the calculated one or more areas of the detected one or more arterial branches based on the calculated one or more FFR values, provide information on one or more treatment options for the stenosis and/or the another medical condition, and/or provide information to determine or assist in determining whether to treat the stenosis and/or the another medical condition;(v) use the one or more FFR values and/or one or more instantaneous wave-free ratio (iFR) values in real-time;(vi) calculate pressure(s) and/or include a lamp parameter/circuit analog model;(vii) include or use an Optical Coherence Tomography (OCT) or Intravascular Ultrasound (IVUS) images or frames FFR method that uses anatomic information; and/or (viii) process anatomic information where the anatomic information includes at least a volume of a vessel (paragraph [0417]-[0418], referring to the use of computational fluid dynamics equations to obtain pressure and FFR; paragraph [0353], referring to iFR being determined by the processor as an alternative to, or in addition to the processor determining FFR; paragraph [0352], referring to determining that a stent should be deployed based on the subject’s FFR; paragraph [0466], referring to obtaining OCT images).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Millett et al. (US Pub No. 2014/0187920) disclose utilizing increased or decreased pressure differential to identify the location of the lesion or stenosis within the vessel and assess the severity of the lesion or stenosis, wherein FFR calculations and associated proximal and distal pressure measurements and ratios are included in an enhanced angiographic image (380) (paragraphs [0057]-[0065]; Figure 13)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE L FERNANDEZ whose telephone number is (571)272-1957. The examiner can normally be reached Monday-Friday 9:00 AM - 5:30 PM (ET).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pascal Bui-Pho can be reached at (571) 272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE L FERNANDEZ/Primary Examiner, Art Unit 3798
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