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 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) 1-9, 13-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li et al (Pub.
No.: US 2020/0226422).
Regarding claim 1, Li et al disclose an intravascular imaging system, comprising:
a processor configured to be coupled to an intravascular imaging device [see 0189-0191 and figs
2A, 5E, 5G, 5H, 6B] by disclosing a cross-sectional image of an artery is shown that was obtained by using an intravascular probe P shown in an in-vivo environment with respect to a blood vessel B having a
vessel wall VW that defines a lumen L [see 0191];
wherein the processor is configured to generate a calcium map [see 0055, 0188 and figs 2A, 5E,
5G, 5H, 6B];
wherein the calcium map includes a longitudinal cross-sectional view with a topographic depiction of calcium [see 0040, 0055, 0121, 0135, 0188, figs 2A, 5E, 5G, 5H, 6B];
wherein one or more reference indicators are disposed along the calcium map, the one or more reference indicators (color indicia) being user-manipulatable [see 0105, 0121];
a display unit coupled to the processor, the display unit being configured to show a display
including the calcium map [see 0054-0056, 0135, 0188, figs 2A, 5E, 5G, 5H, 6B].
Regarding claim 2, Li et al disclose wherein the calcium map includes an indicator of calcium
depth to a vessel lumen surface [see figs 2A, 5E, 5G, 5H, 6B, 0151] by disclosing detected Ca depth
measured relative to lumen [see 0151].
Regarding claim 3, Li et al disclose wherein the calcium map includes an indicator of calcium
distance to a center of the intravascular imaging device [see 0074, 0174] by disclosing an interferometer
to obtain distance measurements relative to a blood vessel or objects disposed therein [see 0074, 0174]
and disclosing the position of an imaging probe P in the lumen, the vessel wall W, the adventitia AD, and
details relating to a calcium plaque and calcium angle [see 0190].
Regarding claim 4, Li et al disclose wherein the calcium map includes both an indicator of
calcium depth to a vessel lumen surface and an indicator of calcium depth to a vessel lumen surface [see
fig 2A, 5E, 5G, 5H, 6B, 0151] by disclosing detected Ca depth measured relative to lumen [see 0151].
Regarding claim 5, Li et al disclose wherein the topographic depiction of calcium includes a
topographic depiction of calcium depth to the vessel lumen surface [see fig 2A, 5E, 5G, 5H, 6B, 0151] by
disclosing detected Ca depth measured relative to lumen [see 0151].
Regarding claim 6, Li et al disclose wherein the topographic depiction of calcium includes a
topographic depiction of calcium distance to the center of the intravascular imaging device (imaging
probe) [see 0190, figs 5G-H] by disclosing the position of an imaging probe P in the lumen, the vessel
wall W, the adventitia AD, and details relating to a calcium plaque and calcium angle [see 0190].
Regarding claim 7, Li et al disclose wherein the topographic depiction of calcium includes both a
topographic depiction of calcium depth to the vessel lumen surface [see fig 2A, 5E, 5G, 5H, 6B, 0151] by
disclosing detected Ca depth measured relative to lumen [see 0151];
a topographic depiction of calcium distance to the center of the intravascular imaging device
[see 0074, 0174] by disclosing an interferometer to obtain distance measurements relative to a blood
vessel or objects disposed therein [see 0074, 0174] and disclosing the position of an imaging probe P in
the lumen, the vessel wall W, the adventitia AD, and details relating to a calcium plaque and calcium
angle [see 0190].
Regarding claim 8, Li et al disclose wherein the display includes a transverse cross-sectional
depiction of a blood vessel [see fig 2A, 5E, 5G, 5H, 6B, 0151, 0189-0191] by disclosing a cross-sectional
image of an artery is shown that was obtained by using an intravascular probe P shown in an in-vivo
environment with respect to a blood vessel B having a vessel wall VW that defines a lumen L [see 0191].
Regarding claim 9, Li et al disclose wherein the transverse cross-sectional depiction of the blood
vessel includes one or more treatment device representations overlaid thereon [see 0189, 13A-13B] by
disclosing performs real time calcium detection to correct for any alignment changes between the first
OCT pullback image and the current one and when the catheter tip arrives at the target calcium plaque
nodule, the high powered ablation laser turns on 584 to provide short bursts of energy to vaporize and
de-bulk the calcium nodule [see 0189].
Regarding claim 13, Li et al disclose wherein the intravascular imaging device includes an
intravascular ultrasound device [see 0074] by disclosing intravascular ultrasound (IVUS) can also be used
in probes to image portions of a blood vessel [see 0074, 0080].
Regarding claim 14, Li et al disclose wherein the intravascular imaging device includes an optical
coherence tomography device [see 0080, 0097].
Regarding claim 15, Li et al disclose an intravascular imaging system, comprising:
a processor configured to be coupled to an intravascular imaging device [see 0189-0191 and figs
2A, 5E, 5G, 5H, 6B] by disclosing a cross-sectional image of an artery is shown that was obtained by using
an intravascular probe P shown in an in-vivo environment with respect to a blood vessel B having a
vessel wall VW that defines a lumen L [see 0191];
wherein the processor is configured to generate a topographic depiction of calcium [see 0040,
0055, 0121, 0135, 0188, figs 2A, 5E, 5G, 5H, 6B];
wherein one or more reference indicators are disposed along the calcium map, the one or more reference indicators (color indicia) being user-manipulatable [see 0105, 0121];
a display unit coupled to the processor, the display unit being configured to show a display
including the topographic depiction of calcium [see 0054-0056, 0135, 0188, figs 2A, 5E, 5G, 5H, 6B].
Regarding claim 16, Li et al disclose wherein the topographic depiction of calcium includes a
topographic depiction of calcium depth to the vessel lumen surface [see figs 2A, 5E, 5G, 5H, 6B, 0151] by
disclosing detected Ca depth measured relative to lumen [see 0151].
Regarding claim 17, Li et al disclose wherein the topographic depiction of calcium includes a
topographic depiction of calcium distance to the center of the intravascular imaging device [see 0074,
0174] by disclosing an interferometer to obtain distance measurements relative to a blood vessel or
objects disposed therein [see 0074, 0174] and disclosing the position of an imaging probe P in the
lumen, the vessel wall W, the adventitia AD, and details relating to a calcium plaque and calcium angle
[see 0190].
Regarding claim 18, Li et al disclose wherein the topographic depiction of calcium includes both
a topographic depiction of calcium depth to the vessel lumen surface [see figs 2A, 5E, 5G, 5H, 6B, 0151]
by disclosing detected Ca depth measured relative to lumen [see 0151];
and a topographic depiction of calcium distance to the center of the intravascular imaging
device [see 0074, 0174] by disclosing an interferometer to obtain distance measurements relative to a
blood vessel or objects disposed therein [see 0074, 0174] and disclosing the position of an imaging
probe P in the lumen, the vessel wall W, the adventitia AD, and details relating to a calcium plaque and
calcium angle [see 0190].
Regarding claim 19, Li et al disclose wherein the intravascular imaging device includes an
intravascular ultrasound device [see 0074] by disclosing intravascular ultrasound (IVUS) can also be used
in probes to image portions of a blood vessel [see 0074, 0080].
Regarding claim 20, Li et al disclose an intravascular imaging system, comprising:
a catheter system including an intravascular ultrasound imaging device [see 0074, 0080];
a processor computed to the catheter system, the processor configured to process image data
received from the intravascular ultrasound imaging device [see 0189-0191 and figs 2A, 5E, 5G, 5H, 6B]
by disclosing a cross-sectional image of an artery is shown that was obtained by using an intravascular
probe P shown in an in-vivo environment with respect to a blood vessel B having a vessel wall VW that
defines a lumen L [see 0191];
wherein the processor is configured to use artificial intelligence (neural network. 0195) to
generate a topographic depiction of calcium depth to the vessel lumen surface [see figs 2A, 5E, 5G, 5H,
6B, 0151, 0195] by disclosing detected Ca depth measured relative to lumen [see 0151];
a topographic depiction of calcium distance to the center of the intravascular ultrasound
imaging device, or both [see 0074, 0174, 0189-0190, 5E, 5G, 5H, 6B] by disclosing an interferometer to
obtain distance measurements relative to a blood vessel or objects disposed therein [see 0074, 0174];
wherein one or more reference indicators are disposed along the calcium map, the one or more reference indicators (color indicia) being user-manipulatable [see 0105, 0121];
a display unit coupled to the processor, the display unit being configured to display the
topographic depiction of calcium depth to the vessel lumen surface [see figs 2A, 5E, 5G, 5H, 6B, 0151] by
disclosing detected Ca depth measured relative to lumen [see 0151];
the topographic depiction of calcium distance to the center of the intravascular ultrasound
imaging device, or both [see 0074, 0174, 0189-0190, 5E, 5G, 5H, 6B] by disclosing an interferometer to
obtain distance measurements relative to a blood vessel or objects disposed therein [see 0074, 0174]
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.
Claim(s) 10 is rejected under 35 U.S.C. 103 as being unpatentable over Li et al (Pub. No.: US
2020/0226422) in view of in view of Dascal et al (Pub. No.: US 2014/0270436).
Regarding claim 10, Li et al disclose one or more depictions an atherectomy device size [see
0189].
Li et al don't disclose a rotational atherectomy device.
Nonetheless, Dascal et al disclose a rotational atherectomy device [see 0173].
Therefore, it is obvious to one skilled in the art at time the invention was filed and would have
been motivated to combine Li et al and Dascal et al by using a rotational atherectomy device size; It
prepares the artery for optimal stent expansion by removing rigid calcium deposits; It helps restore
circulation in cases where traditional balloon angioplasty alone would be ineffective and it reduces the
risk of arterial damage during stent placement.
Claim(s) 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Liet al (Pub. No.: US
2020/0226422) in view of Chao et al (Pub. No.: US 2020/0129158).
Regarding claims 11-12, Li et al disclose a plurality of panels corresponding to different time
periods during an intervention [see 0152, 0154] by disclosing the data collection system 40 and the
angiography system 20 have a shared clock or other timing signals configured to synchronize angiography video frame time stamps and OCT image frame time stamps [see 0086] and the BPT time
ranges from greater than 0 to about 60 seconds. In one embodiment, the BPT time is less than about
180 seconds [see 0152, 0154]
Li et al don't disclose wherein the plurality of panels includes a pre-treatment panel, a lesion
prep panel, and a post-treatment panel.
Nonetheless, Chao et al disclose a pre-treatment panel, a lesion prep panel, and a post-
treatment panel [see 0037, 0074-0077].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would
have been motivated to combine Li et al and Chao et al by using a pre-treatment panel, a lesion prep
panel, and a post-treatment panel; to increase visualization.
Response to Arguments
Applicant's arguments filed 4/28/26 have been fully considered but they are not persuasive.
The double patenting rejections are moot due to the approved disclaimer.
Applicant argues claim 1 is amended to recite that one or more reference indicators are disposed along the calcium map, the one or more reference indicators being user-manipulatable. Li does not appear to teach or suggest these limitations. For example, Li does not appear to teach or suggest reference indicators disposed on a calcium map.
The examiner disagrees because Li et al disclose one or more reference indicators are disposed along the calcium map, the one or more reference indicators (color indicia) being user-manipulatable [see 0105, 0121].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOEL F BRUTUS whose telephone number is (571)270-3847. The examiner can normally be reached Mon-Sat, 11:00 AM to 7:00 PM.
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/JOEL F BRUTUS/Primary Examiner, Art Unit 3797
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