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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/17/26 has been entered.
Response to Amendment
Receipt is acknowledged of applicant's amendment filed on 2/17/26. Claim 12 is cancelled. Claims 1, 3-7, 9, 11, 13-16 are currently pending and an action on the merits is as follows.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1, 3-7, 9, 11 and 13-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Millet et al. US 2014/0187920.
Regarding claim 1, Millet discloses a system, comprising:
a guidewire or catheter configured to be positioned within a blood vessel having a lesion, wherein the guidewire or catheter comprises a pressure sensor configured to acquire a plurality of pressure measurements of the blood vessel, wherein the pressure sensor is coupled to a distal portion of the guidewire or catheter ([¶39] sensors are attached to the distal end 154 of the catheter); and
a processor ([¶40] computing device 172) configured for communication with a display and the guidewire or catheter, wherein the processor is configured to:
communicate with an x-ray imaging device to obtain an x-ray image of the blood vessel ([¶8,66] the system receives imaging data including Xray);
control the guidewire or catheter to acquire the plurality of pressure measurements via the pressure sensor ([¶36-37] the pressures are measured over a distance of the vessel);
determine, based on the plurality of pressure measurements, a plurality of values of a pressure ratio associated with a plurality of locations within the blood vessel ([¶45,49] pressure ratios are calculated);
co-register the plurality of values of the pressure ratio with the x-ray image such that each value of the pressure ratio is associated with a corresponding location of the blood vessel ([¶49][FIG9] the pressure ratios are registered with the image and annotated on the display);
determine, based on the plurality of co-registered values of the pressure ratio, a change in the pressure ratio associated with the lesion and a length over which the change in the pressure ratio occurs ([¶39,45] FFR and iFR are determined);
classify the lesion as focal or diffuse based on the change in the pressure ratio and the length over which the change in the pressure ratio occurs ([¶49,71] whether the lesion is focal or diffuse is determined and annotated on the image); and
output, to the display, a screen display based on the classification of the lesion ([¶71]),
Millet does not specifically disclose the screen display comprises a text label comprising the classification. Millet does disclose that the system can determine various labels and indicators for the graphic image and annotating that image ([¶49,56]) as well as disclosing that text can be used ([¶59]) so it would have been obvious to one of ordinary skill in the art at the time of filing to label the lesions with a text label as the lesions are already determined as focal or diffuse and the labeling would indicate the nature and severity of the lesion in an easy to understand visual.
Regarding claim 3, Millet discloses the graphical representation is overlaid on the blood vessel in the x-ray image ([FIG9-15]).
Regarding claim 4, Millet discloses the processor is configured to:
receive a user input activating the identification of the lesion;
perform the identification of the lesion in response to the user input; and
include the graphical representation in the screen display in response to the user input ([¶59] the user can select the information to be displayed in the graphic).
Regarding claim 5, Millet discloses the screen display comprises an activation status corresponding to the identification of the lesion,
wherein, in response to the user input, the screen display comprises an on state for the activation status ([¶70] the overlay can be activated).
Regarding claim 6, Millet discloses the processor is configured to: receive a user input deactivating identification of the lesion; and output the screen display without the graphical representation ([¶59] the overlays can be turned on and off).
Regarding claim 7, Millet discloses the screen display comprises an activation status corresponding to the identification of the lesion, wherein, in response to the user input, the screen display comprises an off state for the activation status ([¶59] the overlays can be turned on and off).
Regarding claim 9, Millet discloses the processor is configured to analyze the x-ray image to identify an anatomical name for the blood vessel, and wherein the screen display comprises the anatomical name ([¶59] major vessels are labelled).
Regarding claim 11, Millet discloses wherein the x-ray image includes at least one of a two-dimensional angiographic image, a three-dimensional angiographic image, or a computed tomography angiographic (CTA) image ([¶8,66] various angiograms can be used).
Regarding claim 13, Millet discloses the screen display comprises an anatomical name for the blood vessel ([¶59] major vessels are labelled).
Regarding claim 14, Millet discloses the screen display comprises: an x-ray image; and a graphical representation of the lesion ([FIG9-15]).
Regarding claim 15, Millet discloses the processor is configured to perform identification the lesion ([¶59,71] the user can select the information to be displayed in the graphic. Slopes are determined to determine if lesions are focal or diffuse).
Regarding claim 16, Millet does not specifically disclose the text is overlaid on the x-ray image proximate to the lesions. Millet does disclose that the system can determine various labels and indicators for the graphic image and annotating that image ([¶49,56]) as well as disclosing that text can be used ([¶59]) so it would have been obvious to one of ordinary skill in the art at the time of filing to label the lesions with a text label as the lesions are already determined as focal or diffuse and the labeling would indicate the nature and severity of the lesion in an easy to understand visual.
Response to Arguments
Applicant's arguments filed 2/17/26 have been fully considered but they are not persuasive.
Regarding Applicant’s arguments that Miller does not disclose classifying the lesion as focal or diffuse or labeling the lesion as focal or diffuse on the display with text, Examiner respectfully disagrees. Millet discloses classifying the lesions and displaying that information ([¶49,71]) as well as determining FFR or iFR over a distance which is used in the calculation ([¶45,56]). Millet does not specifically disclose textually labeling the display images but Millet does disclose that the system can determine various labels and indicators for the graphic image and annotating that image ([¶49,56]) as well as disclosing that text can be used ([¶59]) so it would have been obvious to one of ordinary skill in the art at the time of filing to label the lesions with a text label as the lesions are already determined as focal or diffuse and the labeling would indicate the nature and severity of the lesion in an easy to understand visual.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Nijjer et al. “Pre-Angioplasty Instantaneous Wave-Free Ratio Pullback Provides Virtual Intervention and Predicts Hemodynamic Outcome for Serial Lesions and Diffuse Coronary Artery Disease.” Similarly determines if lesions are focal or diffuse.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL ANTHONY CATINA whose telephone number is (571)270-5951. The examiner can normally be reached 10-6pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Chen can be reached on 5712723672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL A CATINA/Examiner, Art Unit 3791 /TSE W CHEN/Supervisory Patent Examiner, Art Unit 3791