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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 of U.S. Patent No. 12, 150, 810. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claim discloses all of the claimed limitations as follow:
an intravascular imaging system, comprising:
a processor configured to be coupled to an intravascular imaging device
a processor configured to be coupled to an intravascular imaging device
wherein the processor is configured to generate a calcium map
wherein the calcium map includes a longitudinal cross-sectional view with a topographic depiction of calcium [see column 17 lines 18-35].
a display unit coupled to the processor, the display unit being configured to show a display including the calcium map
Claim 15 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 of U.S. Patent No. 12, 150, 810. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claim discloses all of the claimed limitations as follow:
an intravascular imaging system, comprising:
a processor configured to be coupled to an intravascular imaging device;
wherein the processor is configured to generate a topographic depiction of calcium;
a display unit coupled to the processor, the display unit being configured to show a display including the topographic depiction of calcium [see column 17 lines 18-35].
Claim 20 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 16 of U.S. Patent No. 12, 150, 810. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claim discloses all of the claimed limitations as follow:
an intravascular imaging system, comprising:
a catheter system including an intravascular ultrasound imaging device;
a processor computed to the catheter system, the processor configured to process image data received from the intravascular ultrasound imaging device;
wherein the processor is configured to use artificial intelligence to generate a topographic depiction of calcium depth to the vessel lumen surface;
a topographic depiction of calcium distance to the center of the intravascular ultrasound imaging device, or both;
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;
the topographic depiction of calcium distance to the center of the intravascular ultrasound imaging device, or both [see column 18 lines 18-35].
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];
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];
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];
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 Li et 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.
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 3798