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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/30/2025 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1, the claim limitations “a first marker representative of an estimated location of a first intraluminal image of the plurality of intraluminal images in the first extraluminal image; receive a user input to modify the first screen display, wherein the user input comprises moving the first marking, in the first screen display, from the determined location to the actual location such that, after the user input to modify the first screen display is received, a second screen display of the graphical user interface comprises: the first extraluminal image; a second marking representative of the actual location of the radiopaque portion in the first extraluminal image; and a second marker representative of an updated estimated location of the first intraluminal image in the first extraluminal image” in lines 23-34 was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The specification does disclose a first and second marker (see par. [0101], [0107], [0122]), and the first marker represent of determined location of the radiopaque portion which is the location of the intraluminal catheter (see par. [0101], [0107], [0122], [0126], [0130], [0148]), and second marker represent actual location of the radiopaque portion which is the location of the intraluminal catheter (see par. [0101], [0107], [0122], [0126], [0130], [0148]), but the specification and the figures of the current application do not explicitly state a first marker representative of an estimated location of a first intraluminal image of the plurality of intraluminal images in the first extraluminal image and a second marker representative of an updated estimated location of the first intraluminal image in the first extraluminal image.
Regarding claim 3, the claim limitation “the first screen display of the graphical user interface further comprises: a third marker representative of an estimated location of a second intraluminal image of the plurality of intraluminal images in the first extraluminal image, wherein the second intraluminal image is obtained prior to the first intraluminal image; a fourth marker representative of an estimated location of a third intraluminal image of the plurality of intraluminal images in the first extraluminal image, wherein the third intraluminal image is obtained after the first intraluminal image; and wherein the second screen display of the graphical user interface further comprises: a fifth marker representative of an updated estimated location of the second intraluminal image in the first extraluminal image, wherein a position of the fifth marker in the second screen display of the graphical user interface is based on the re-coregistration; and a sixth marker representative of an updated estimated location of the third intraluminal image in the first extraluminal image, wherein a position of the sixth marker in the second screen display of the graphical user interface is based on the re-coregistration” was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Dependent claims 2, 4-14 are rejected as they depend from rejected claim 1.
Claim Rejections - 35 USC § 102
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 15-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kunio et al. (WO 2021/055837; hereinafter Kunio).
Regarding claim 15, Kunio discloses a catheter with AI co-registration and marker detection. Kunio shows a system (see fig. 1A-B), comprising: a processor circuit (see 26, 40, 50 in fig. 1B) configured for communication with an extraluminal imaging device (see par. [0014], [0087], fig. 1B), wherein the processor circuit is configured to: receive a plurality of extraluminal images obtained by the extraluminal imaging device during movement of an intraluminal catheter along a guidewire within a body lumen of a patient (see par. [0014], [0081], [0082]), wherein the plurality of extraluminal images are obtained without a contrast agent within the body lumen (see par. [0020], [0096] and fig. 2 does not state that a contrast agent is used or injected into the patient for the angiography), wherein the plurality of extraluminal images show the guidewire and a radiopaque portion of the intraluminal catheter (see par. [0017], [0019], [0029], [0032], [0130], [0198]); determine a path of the movement based on corresponding locations of the radiopaque portion in the plurality of extraluminal images, wherein the path comprises a first shape (see par. [0014], [0017], [0081]-[0083], [0087], [0088], [0118]); output, to a display in communication with the processor circuit, a pathway review screen display associated with use of the intraluminal catheter during an intraluminal procedure of the patient (see par. [0014], [0017], [0019], [0029], [0032], [0087], [0130], [0198]), wherein the pathway review screen display comprises: an extraluminal image of the plurality of extraluminal images (see par. [0014], [0017], [0019], [0029], [0032], [0130], [0198]); and the path is the extraluminal image of the first shape (see par. [0014], [0017], [0019], [0029], [0032], [0130], [0198]); receive a user input to modify the pathway review screen display (see par. [0014], [0017], [0019], [0029], [0032], [0130], [0198]), wherein the user input comprises changing the path (see par. [0014], [0017], [0019], [0029], [0032], [0130], [0198]), in the pathway review screen display (see par. [0014], [0017], [0019], [0029], [0032], [0130], [0198]), to have a second shape matching a shape of the guidewire in the extraluminal image (see par. [0014], [0017], [0019], [0029], [0032], [0130], [0198]) such that, after the user input, the pathway review screen display comprises: the extraluminal image (see par. [0014], [0017], [0019], [0029], [0032], [0130], [0198]); and the path in the extraluminal image with the second shape (see par. [0014], [0017], [0019], [0029], [0032], [0130], [0198]).
Regarding claim 16, Kunio shows further comprising the intraluminal catheter (see fig. 1B), wherein the intraluminal catheter comprises an intravascular imaging catheter configured for (see par. [0015]) or OCT (see par. [0015]); wherein the extraluminal imaging device an x-ray imaging device (see par. [0025]); wherein the plurality of extraluminal images comprises a plurality of x-ray images (see par. [0020], [0025])), wherein the body lumen comprises a blood vessel of the patient (see par. [0020], [0025]); wherein the processor circuit is configured to: receive a plurality of intravascular images obtained by the intravascular imaging catheter during the movement of the intravascular imaging catheter (see par. [0015]); co-register the plurality intravascular images to positions along the path with the second shape (see par. [0087]-[0088], [0091]; and output, to the display, a intraluminal imaging review screen display comprising: a second x-ray image of the plurality of x-ray images (see par. [0017], [0019], [0029], [0032], [0088], [0130], [0198]); a intravascular image (see par. [0017], [0019], [0029], [0032], [0088], [0130], [0198]); and a marking in second x-ray image representative a corresponding position of the intravascular image along the path with the second shape (see par. [0017], [0019], [0029], [0032], [0088], [0130], [0198]).
Response to Arguments
The previous prior art rejection to claim 1 and all dependent claims thereof has been withdrawn in view of Applicant’s amendment to claim 1.
Applicant's arguments filed 12/30/2025 have been fully considered but they are not persuasive. In response to Applicant’s argument with respect to prior art rejection of claim 15, the examiner respectfully disagrees. The examiner maintains that prior art Kunio does show receiving a user input to modify the pathway review screen display, wherein the user input comprises changing the path, in the pathway review screen display, to have a second shape, matching of a shape of the guide-wire in the extraluminal image (see par. [0014], [0017], [0029], [0032], [0130], [0198]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Cathier et al. (2016/0270758) disclose integration ultrasound and X-ray modalities and Masaki et al. (US 2021/0369355) disclose robotic endoscope probe having orientation reference markers.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHAHDEEP MOHAMMED whose telephone number is (571)270-3134. The examiner can normally be reached Monday to Friday, 9am to 5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne M Kozak can be reached at (571)270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHAHDEEP MOHAMMED/Primary Examiner, Art Unit 3797