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 .
Response to Amendment
Applicant’s amendments filed 04/06/2026 have been filed. Current claims 1-15 are pending.
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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 and 5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim of U.S. Patent No. US 12,232,907 В2 (hereinafter “Patent122”) in view of Merritt et al., (US20160157808A1). Although the claims at issue are not identical, they are not patentably distinct from each other because they are anticipated by the patent.
Regarding claim 1, Patent 122 teaches an apparatus, comprising (col. 26 line 35 an IVUS system):
an intravascular imaging catheter (col. 26 line 36 intravascular imaging catheter); and
a processor circuit configured for communication with the intravascular imaging catheter, wherein the processor circuit is configured to (col. 26 lines 37-39):
control the intravascular imaging catheter to obtain a plurality of intravascular images during movement of the intravascular imaging catheter through a first blood vessel and a second blood vessel of a patient (col. 26 lines 59-64 the catheter takes a plurality of intravascular images as the catheter moves through the first and second named segments, which are different named segments of blood vessels);
output, to a display in communication with the processor circuit, a screen display comprising (col. 26 lines 40-42):
a live intravascular image area (col. 26 line 44 live intravascular image); and
an instruction area for a user, wherein the instruction area comprises a first instruction to the user is to apply a first label when the live intravascular image area depicts the first blood vessel (col. 26 lines 54- 58);
cause the live intravascular image area to display live the live plurality of intravascular images during movement (col. 26 line 59-62);
receive a first user input applying the first label to a first live intravascular image of the plurality of intravascular images (col. 26 line 65- col. 27 line 4), wherein the first user input is received when the first live intravascular image is displayed in the live intravascular image area (col. 27 lines 1-3), wherein the first live intravascular image depicts the first blood vessel (col. 26 lines 56-58 the first named segment label comprises the live intravascular image depicting the first name segment, which is of the first blood vessel); and
change the instruction area for the user in the screen display after the first user input is received (col. 27 line 61-62), wherein, after the first user input is received, the instruction area comprises a second instruction to the user to apply a second label when the live intravascular image area depicts the second blood vessel during movement(col. 27 63-67).
However, Patent 122 fails to explicitly disclose to control the intravascular imaging catheter to obtain images in a sequential manner.
In the same intravascular imaging field of endeavor, Merritt teaches to control the intravascular imaging catheter to obtain images in a sequential manner ([0045] intravascular imaging may be done in a continuous manner during a pullback procedure).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the apparatus of Patent122 with the process of Merritt, as this would allow clinicians to efficiently plan and evaluate the proposed therapy.
Regarding claim 2, modified Patent122 teaches the apparatus of claim 1, but Patent122 fails to claim wherein the movement of the intravascular imaging catheter comprises a same pullback, wherein the first blood vessel and the second blood vessel are continuous with one another such that the intravascular imaging catheter travels through the first blood vessel and the second blood vessel during the same pullback.
In the same intravascular imaging field of endeavor, Merritt teaches wherein the movement of the intravascular imaging catheter comprises a same pullback, wherein the first blood vessel and the second blood vessel are continuous with one another such that the intravascular imaging catheter travels through the first blood vessel and the second blood vessel during the same pullback ([0045] the images are acquired in a continuous manner during a pullback procedure, and thus the first and second blood vessels would be during the same pullback and would be continuous).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the apparatus of Patent122 with the process of Merritt, as this would allow clinicians to efficiently plan and evaluate the proposed therapy.
Regarding claim 3, modified Patent122 teaches the apparatus of claim 1, but Patent122 fails to claim wherein the first blood vessel and the second blood vessel comprise segments of a peripheral vasculature of the patient.
In the same intravascular imaging field of endeavor, Merritt teaches wherein the first blood vessel and the second blood vessel comprise segments of a peripheral vasculature of the patient ([0023] the system 100 can be used to asses peripheral vessels)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the apparatus of Patent122 with the process of Merritt, as this would allow clinicians to efficiently plan and evaluate the proposed therapy.
Regarding claim 4, modified Patent122 teaches the apparatus of claim 3, but Patent122 fails to claim wherein Merritt further teaches wherein the segments of the peripheral vasculature comprise veins of a leg of the patient.
In the same intravascular imaging field of endeavor, Merritt teaches the apparatus of claim 3, wherein Merritt further teaches wherein the segments of the peripheral vasculature comprise veins of a leg of the patient ([0023] the system can also be used to assess the legs).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the apparatus of Patent122 with the process of Merritt, as this would allow clinicians to efficiently plan and evaluate the proposed therapy.
Regarding claim 5, modified Patent122 teaches The apparatus of claim 1, wherein Patent122 further teaches wherein the first label comprises a name of the first blood vessel (col. 26 line 57), and wherein the second label comprises a name of the second blood vessel (col. 27 lines 64-65).
Regarding claim 13, modified Patent122 teaches the apparatus of claim 1, but Patent122 fails to claim wherein the intravascular imaging catheter is configured for intravascular ultrasound (IVUS).
In the same intravascular imaging field of endeavor, Merritt teaches wherein the intravascular imaging catheter is configured for intravascular ultrasound (IVUS) ([0008] IVUS data is obtained with the instruments).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the apparatus of Patent122 with the process of Merritt, as this would allow clinicians to efficiently plan and evaluate the proposed therapy.
Claim 6 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12232907B2 in view of Merritt and in further view of Raju et al., (US 20210345988 A1).
Regarding claim 6, modified Patent122 teaches the system of claim 5, but fails to explicitly disclose wherein the name of the first blood vessel comprises a common iliac vein (CIV), and wherein the name of the second blood vessel comprises an external iliac vein (EIV).
However in the same intravascular imaging field of endeavor, Raju teaches wherein the name of the first blood vessel comprises a common iliac vein (CIV) ([0033] the common iliac vein is imaged using IVUS), and wherein the name of the second blood vessel comprises an external iliac vein (EIV) ([0033] the external iliac vein is imaged using IVUS).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to substitute the first and second vessels of Patent122 with the common iliac vein and the external iliac vein of Raju, as both inventions relate to intravascular imaging, and would yield the predictable results of an imaging system that labels the common iliac vein and then the external iliac vein to one of ordinary skill in the art. One of ordinary skill would be able to perform such a substitution, and the results of modified Merritt using the common iliac vein and the external iliac vein as the targets are reasonably predictable.
Claims 7-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12232907B2 in view of Merritt and in further view of Soffer et al., (US20190365241A1). Although the claims at issue are not identical, they are not patentably distinct from each other because they are rendered obvious by the patent and prior art reference.
Regarding claim 7, modified Patent122 teaches the apparatus of claim 1, but fails to explicitly disclose, wherein, before the first user input is received, the screen display comprises a first button comprising the first label.
In the same intravascular imaging field of endeavor, Soffer teaches wherein, before the first user input is received, the screen display comprises a first button comprising the first label ([0012] the processor displays a drop down list so the user can label the anatomical area being displayed).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to combine the user interface of Patent122 with the drop down list of Soffer, as both inventions relate to user inputting identification means for anatomical images, and would yield the predictable result of using a drop down list to label vessels to one of ordinary skill in the art. One of ordinary skill in the art would be able to perform such a combination, and the results of modified Merritt using a drop down list to label vessels are reasonably predictable.
Regarding claim 8, modified Patent122 teaches the apparatus of claim 7, but is silent regarding wherein the first user input comprises a user selection of the first button.
In the same intravascular imaging field of endeavor, Soffer teaches wherein the first user input comprises a user selection of the first button ([0012] the processor displays a drop down list so the user can select the appropriate label for the anatomical area being displayed).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to combine the user interface of modified Patent122 with the drop down list of Soffer, as both inventions relate to user inputting identification means for anatomical images, and would yield the predictable result of using a drop down list to label vessels to one of ordinary skill in the art. One of ordinary skill in the art would be able to perform such a combination, and the results of modified Merritt using a drop down list to label vessels are reasonably predictable.
Regarding claim 9, modified Patent122 teaches the apparatus of claim 7, but is silent regarding wherein, after the first user input is received, the screen display comprises a second button comprising the second label.
However, in the same intravascular imaging field of endeavor, Soffer teaches wherein, after the first user input is received, the screen display comprises a second button comprising the second label. ([0012] the processor displays a drop down list so the user can select the appropriate label for the anatomical area being displayed, and would include more than one as it is a list).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to combine the user interface of modified Patent122 with the drop down list of Soffer, as both inventions relate to user inputting identification means for anatomical images, and would yield the predictable result of using a drop down list to label vessels to one of ordinary skill in the art. One of ordinary skill in the art would be able to perform such a combination, and the results of modified Merritt using a drop down list to label vessels are reasonably predictable.
Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12232907B2 in view of Merritt and in further view Wei et al., (WO2007002562A2). Although the claims at issue are not identical, they are not patentably distinct from each other because they are rendered obvious by the patent and prior art reference.
Regarding claim 10, modified Patent122 teaches the apparatus of claim 1, but fails to explicitly teach wherein, before the first user input is received, the instruction to the user is to identify a start of the first blood vessel, and wherein, after the first user input is received, the instruction to the user is to identify a start of the second blood vessel.
In the same vessel imaging field of endeavor, Wei teaches wherein, before the first user input is received, the user is to identify a start of the first blood vessel (Claim 11, the user selects an initial starting point in the imagery data, which is of the vessel), and wherein, after the first user input is received, the instruction to the user is to identify a start of the second blood vessel (Claim 11 after the first group of vessel candidates, a second group is identified and then segmented. This segmenting would result in identifying the start of the second blood, as segmenting identifies the beginning and ends of the vessel).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the apparatus of Patent122 with the user inputs of Wei, as this would facilitate coordinated retrieval of visual and non-visual data associated with a patient and interactive diagnosis process (see Wei [0031]).
Claims 11, 14, and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12232907B2 in view of Merritt and in further view Johnson et al., (WO2016046710A1). Although the claims at issue are not identical, they are not patentably distinct from each other because they are rendered obvious by the patent and prior art reference.
Regarding claim 11, modified Patent122 teaches the apparatus of claim 1, but fails to teach wherein the processor circuit is configured to receive a second user input applying the second label to a second intravascular image of the plurality of intravascular images, wherein the second user input is received when the second intravascular image is displayed in the intravascular image area, wherein the second intravascular image depicts the second blood vessel.
However, in the same intravascular imaging field of endeavor, Johnson teaches wherein the processor circuit is configured to receive a second user input applying the second label to a second intravascular image of the plurality of intravascular images (page 93 lines 3-18 the software does the name process for each detected vessel junction, therefore after the first input, a second recommendation for a different vessel junction will appear), wherein the second user input is received when the second intravascular image is displayed in the intravascular image area (page 93 lines 3-18 each displayed generated image is of the vessel, and the user may input a name to the detected vessel), wherein the second intravascular image depicts the second blood vessel (page 93 lines 3-18 each displayed generated image is of the vessel, and the user may input a name to the detected vessel).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the system of Patent122 with the input software of Johnson, as this would assist the surgeon in navigation the device through the vasculature to the destination site (see Johnson page 94 lines 8-10).
Regarding claim 14, modified Patent122 teaches the apparatus of claim 1, but is silent regarding wherein the processor circuit is configured to receive a user input identifying an access point for entry of the intravascular imaging catheter into the patient.
In the same IVUS imaging field of endeavor, Johnson teaches wherein the processor circuit is configured to receive a user input identifying an access point for entry of the intravascular imaging catheter into the patient (fig. 139 at step 13900 the software obtains from the user the insertion site page 91 lines 15-17).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the system of Patent122 with the software of Johnson, as this would assist the surgeon in navigation the device through the vasculature to the destination site (see Johnson page 94 lines 8-10).
Regarding claim 15, modified Patent122 teaches the apparatus of claim 14, but fails to explicitly disclose wherein the user input identifying the access point is representative of a direction of the movement of the intravascular imaging catheter such that the screen display is configured to provide the instruction to the user to apply the first label and the instruction to the user to apply the second label in a sequence based on the user input.
However in the same intravascular field of endeavor, Johnson teaches wherein the user input identifying the access point (page 91 lines 15-17 at step 13900 the software obtains from the user the insertion site and surgical procedure) is representative of a direction of the movement of the intravascular imaging catheter (page 91line 27-30 with the insertion site and destination, there is a pathway, which is a representation of the direction of movement) such that the screen display is configured to provide the instruction to the user to apply the first label and the instruction to the user to apply the second label in a sequence based on the user input (page 93 lines 3-18 the imaging device is advanced through the vasculature (via the pathway) and as the it is advanced from insertion site to the destination, the user will name/label the vessels).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the apparatus of Patent122 with the software of Johnson, as this would assist the surgeon in navigation the device through the vasculature to the destination site (see Johnson page 94 lines 8-10).
Claim 12 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12232907B2 in view of Merritt and in further view of Hiltner et all., (US20160007837A1). Although the claims at issue are not identical, they are not patentably distinct from each other because they are rendered obvious by the patent and prior art reference.
Regarding claim 12, modified Patent122 teaches the apparatus of claim 1, but fails to explicitly disclose wherein the screen display further comprises at least one of a speed indicator associated with movement of the intravascular imaging catheter.
In the same intravascular imaging field of endeavor, Hiltner teaches wherein the screen display further comprises at least one of a speed indicator associated with movement of the intravascular imaging catheter (fig. 2 translation user interface 222 displays translation data associated with the intravascular imaging device, and can include translation speed).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the display of Patent122 with the speed data of Hiltner, as this would allow for provide for better healthcare for the patient as they would supplement the healthcare professional’s diagnostic ability (see Hiltner [0005]).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 1-5, 11-15 are rejected under 35 U.S.C. 103 as being unpatentable over Merritt et al., (US20160157808A1) in view of Johnson et al., (WO2016046710A1) and in further view of Hiltner et all., (US20160007837A1) and Buras (US20210327304A1).
Regarding claim 1, Merritt teaches an apparatus, comprising (Abstract system for evaluating patient vasculature ):
an intravascular imaging catheter (fig. 1 instrument 140 is a catheter [0025]; [0026] the instrument 140 includes transducer for images ); and
a processor circuit configured for communication with the intravascular imaging catheter, wherein the processor circuit is configured to (fig. 1 computer device 110 is connector to the instruments [0034]):
control the intravascular imaging catheter to obtain a plurality of intravascular images during movement of the intravascular imaging catheter through a first blood vessel and a second blood vessel of a patient ([0046] the instruments 130 and 140 can take intravascular images while the catheter is moved through the vessels) in a sequential manner ([0045] Intravascular images are taken in a continuous (so sequential) manner during a pullback procedure);
output, to a display in communication with the processor circuit, a screen display comprising ([0065] display device 150 shows the data and is connected to computer device 110):
a intravascular image area ([0037] the display device is configured to output the intravascular data; [0045]-[0046] the images are continuously taken during the pullback procedure, and are taken simultaneously as the physiological and pressure measurements, and the computing device generates a visual display); and
cause the intravascular image area to display the plurality of intravascular images during movement ([0026] instrument 140 may take one or more IVUS images; [0045] the images are taken during the pullback procedure);
wherein the first intravascular image depicts the first blood vessel ([0026] the instrument 140 takes IVUS images, and the first one would be the first blood vessel; [0046] the instrument may be moved through the vessel and acquire intravascular images).
However Merritt is silent regarding a live intravascular image
In the same intravascular imaging field of endeavor, Hiltner teaches a live intravascular image ([0002] IVUS images and be displayed in real time)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to apply the technique of live display of IVUS images as taught by Hiltner to the the apparatus of Merritt, as both inventions relate to intravascular imaging, and would yield the predictable result of an intravascular imaging system that displays live images of the intravascular images to one of ordinary skill in the art. One of ordinary skill in the art would be able to apply such a technique, and the results of the apparatus of Merritt displaying live images are reasonably predictable. This would be an improvement as live imaging would improve diagnostic accuracy.
However, the combination of references is silent regarding an instruction for a user, wherein the instruction to the user is to apply a first label when the intravascular image area depicts the first blood vessel; receive a first user input applying the first label to a first intravascular image of the plurality of intravascular images, wherein the first user input is received when the first intravascular image is displayed in the intravascular image area change the instruction for the user in the screen display after the first user input is received wherein, after the first user input is received, the instruction to the user is to apply a second label when the intravascular image area depicts the second blood vessel.
However in the same intravascular field of endeavor, Johnson teaches an instruction area for a user, wherein the instruction to the user is to apply a first label when the intravascular image area depicts the first blood vessel (page 93 lines 13-18);
receive a first user input applying the first label to a first intravascular image of the plurality of intravascular images (page 93 lines 16-18 the surgeon can input a name), wherein the first user input is received when the first intravascular image is displayed in the intravascular image area (fig. 139 step 13914 within the generate images, the surgeon can assign a name page 93 lines 13-16),
an instruction for the user in the screen display after the first user input is received (page 93 lines 13-18 the software does the name process for each detected vessel junction, therefore after the first input, a second recommendation for a different vessel junction will appear), wherein, after the first user input is received, the instruction to the user is to apply a second label when the intravascular image area depicts the second blood vessel (page 93 lines 13-18 the software does the name process for each detected vessel junction, therefore after the first input, a second recommendation for a different vessel junction will appear).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the system of Merritt with the input software of Johnson, as this would assist the surgeon in navigation the device through the vasculature to the destination site (see Johnson page 94 lines 8-10).
However, the combination of references are still silent regarding changing the instruction for the user after the first user input is received.
In the same imaging field of endeavor, Buras teaches changing the instruction area for the user after the first user input is received ([0177]-[0178] the user manually labels each image, and each image is different as there is no overlap, so after each image is labeled a different image is provided).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to combine the sequentially acquired images of modified Merritt with the labeling system of Buras, as both inventions relate to image modification and would yield the predictable result of an imaging UI that has a different prompted image for each image to label to one of ordinary skill. One of ordinary skill would be able to perform such a combination, and the results of the system of modified Merritt having has a different prompted image for each image to label are reasonably predictable. One of ordinary skill in the art would understand that this modification to modified Merritt would read upon the limitation “change, based on the sequential manner, the instructions area for the user in the screen display”.
Regarding claim 2, modified Merritt teaches the system of claim 1, wherein Merritt further teaches wherein the movement of the intravascular imaging catheter comprises a same pullback, wherein the first blood vessel and the second blood vessel are continuous with one another such that the intravascular imaging catheter travels through the first blood vessel and the second blood vessel during the same pullback ([0045] the images are acquired in a continuous manner during a pullback procedure, and thus the first and second blood vessels would be during the same pullback and would be continuous)
Regarding claim 3, modified Merritt teaches the apparatus of claim 2, wherein Merritt further teaches wherein the first blood vessel and the second blood vessel comprise segments of a peripheral vasculature of the patient ([0023] the system 100 can be used to asses peripheral vessels)
Regarding claim 4, modified Merritt teaches the apparatus of claim 3, wherein Merritt further teaches wherein the segments of the peripheral vasculature comprise veins of a leg of the patient ([0023] the system can also be used to assess the legs)
Regarding claim 5, modified Merritt teaches the apparatus of claim 1, but is silent regarding wherein the first label comprises a name of the first blood vessel, and wherein the second label comprises a name of the second blood vessel.
In the same intravascular imaging field of endeavor Johnson teaches wherein the first label comprises a name of the first blood vessel, and wherein the second label comprises a name of the second blood vessel (page 93 lines 8-18 the surgeon can label the vessels with a name, and there are multiple, as each vessel imaged is labeled).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the system of Merritt with the input software of Johnson, as this would assist the surgeon in navigation the device through the vasculature to the destination site (see Johnson page 94 lines 8-10).
Regarding claim 11, modified Merritt teaches the apparatus of claim 1, but fails to teach wherein the processor circuit is configured to receive a second user input applying the second label to a second intravascular image of the plurality of intravascular images, wherein the second user input is received when the second intravascular image is displayed in the intravascular image area, wherein the second intravascular image depicts the second blood vessel.
However, in the same intravascular imaging field of endeavor, Johnson teaches wherein the processor circuit is configured to receive a second user input applying the second label to a second intravascular image of the plurality of intravascular images (page 93 lines 3-18 the software does the name process for each detected vessel junction, therefore after the first input, a second recommendation for a different vessel junction will appear), wherein the second user input is received when the second intravascular image is displayed in the intravascular image area (page 93 lines 3-18 each displayed generated image is of the vessel, and the user may input a name to the detected vessel), wherein the second intravascular image depicts the second blood vessel (page 93 lines 3-18 each displayed generated image is of the vessel, and the user may input a name to the detected vessel).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the system of Merritt with the input software of Johnson, as this would assist the surgeon in navigation the device through the vasculature to the destination site (see Johnson page 94 lines 8-10).
However Merritt is silent regarding a live intravascular image
In the same intravascular imaging field of endeavor, Hiltner teaches a live intravascular image ([0002] IVUS images and be displayed in real time)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to apply the technique of live display of IVUS images as taught by Hiltner to the apparatus of Merritt, as both inventions relate to intravascular imaging, and would yield the predictable result of an intravascular imaging system that displays live images of the intravascular images to one of ordinary skill in the art. One of ordinary skill in the art would be able to apply such a technique, and the results of the apparatus of Merritt displaying live images are reasonably predictable. This would be an improvement as live imaging would improve diagnostic accuracy.
Regarding claim 12, modified Merritt teaches the apparatus of claim 1, but fails to explicitly disclose wherein the screen display further comprises at least one of a speed indicator associated with movement of the intravascular imaging catheter.
In the same intravascular imaging field of endeavor, Hiltner teaches wherein the screen display further comprises at least one of a speed indicator associated with movement of the intravascular imaging catheter (fig. 2 translation user interface 222 displays translation data associated with the intravascular imaging device, and can include translation speed).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the display of modified Merritt with the speed data of Hiltner, as this would allow for provide for better healthcare for the patient as they would supplement the healthcare professional’s diagnostic ability (see Hiltner [0005]).
Regarding claim 13, modified Merritt teaches the apparatus of claim 1, wherein Merritt further teaches wherein the intravascular imaging catheter is configured for intravascular ultrasound (IVUS) ([0008] IVUS data is obtained with the instruments).
Regarding claim 14, modified Merritt teaches the apparatus of claim 1, but is silent regarding wherein the processor circuit is configured to receive a user input identifying an access point for entry of the intravascular imaging catheter into the patient.
In the same IVUS imaging field of endeavor, Johnson teaches wherein the processor circuit is configured to receive a user input identifying an access point for entry of the intravascular imaging catheter into the patient (fig. 139 at step 13900 the software obtains from the user the insertion site page 91 lines 15-17).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the system of Merritt with the software of Johnson, as this would assist the surgeon in navigation the device through the vasculature to the destination site (see Johnson page 94 lines 8-10).
Regarding claim 15, modified Merritt teaches the apparatus of claim 14, but fails to explicitly disclose wherein the user input identifying the access point is representative of a direction of the movement of the intravascular imaging catheter such that the screen display is configured to provide the instruction to the user to apply the first label and the instruction to the user to apply the second label in a sequence based on the user input.
However in the same intravascular field of endeavor, Johnson teaches wherein the user input identifying the access point (page 91 lines 15-17 at step 13900 the software obtains from the user the insertion site and surgical procedure) is representative of a direction of the movement of the intravascular imaging catheter (page 91 line 27-30 with the insertion site and destination, there is a pathway, which is a representation of the direction of movement) wherein the processor circuit is configured to provide the first instruction and the second instruction in the sequential manner (page 93 lines 3-18 the imaging device is advanced through the vasculature (via the pathway) and as the it is advanced from insertion site to the destination, the user will name/label the vessels).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the system of Merritt with the software of Johnson, as this would assist the surgeon in navigation the device through the vasculature to the destination site (see Johnson page 94 lines 8-10).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Merritt in view of Johnson and Buras as applied to claim 5 above, and further in view of Raju et al., (US 20210345988 A1)
Regarding claim 6, modified Merritt teaches the system of claim 5, but fails to explicitly disclose wherein the name of the first blood vessel comprises a common iliac vein (CIV), and wherein the name of the second blood vessel comprises an external iliac vein (EIV).
However in the same intravascular imaging field of endeavor, Raju teaches wherein the name of the first blood vessel comprises a common iliac vein (CIV) ([0033] the common iliac vein is imaged using IVUS), and wherein the name of the second blood vessel comprises an external iliac vein (EIV) ([0033] the external iliac vein is imaged using IVUS).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to substitute the first and second vessels of modified Merritt with the common iliac vein and the external iliac vein of Raju, as both inventions relate to intravascular imaging, and would yield the predictable results of an imaging system that labels the common iliac vein and then the external iliac vein to one of ordinary skill in the art. One of ordinary skill would be able to perform such a substitution, and the results of modified Merritt using the common iliac vein and the external iliac vein as the targets are reasonably predictable.
Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Merritt in view of Johnson, Hiltner, and Buras as applied to claim 1 above, and in further view of Soffer et al., (US20190365241A1).
Regarding claim 7, modified Merritt teaches the apparatus of claim 1, but fails to explicitly disclose, wherein, before the first user input is received, the screen display comprises a first button comprising the first label.
In the same intravascular imaging field of endeavor, Soffer teaches wherein, before the first user input is received, the screen display comprises a first button comprising the first label ([0012] the processor displays a drop down list so the user can label the anatomical area being displayed).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to combine the user interface of modified Merritt with the drop down list of Soffer, as both inventions relate to user inputting identification means for anatomical images, and would yield the predictable result of using a drop down list to label vessels to one of ordinary skill in the art. One of ordinary skill in the art would be able to perform such a combination, and the results of modified Merritt using a drop down list to label vessels are reasonably predictable.
Regarding claim 8, modified Merritt teaches the apparatus of claim 7, but is silent regarding wherein the first user input comprises a user selection of the first button.
In the same intravascular imaging field of endeavor, Soffer teaches wherein the first user input comprises a user selection of the first button ([0012] the processor displays a drop down list so the user can select the appropriate label for the anatomical area being displayed).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to combine the user interface of modified Merritt with the drop down list of Soffer, as both inventions relate to user inputting identification means for anatomical images, and would yield the predictable result of using a drop down list to label vessels to one of ordinary skill in the art. One of ordinary skill in the art would be able to perform such a combination, and the results of modified Merritt using a drop down list to label vessels are reasonably predictable.
Regarding claim 9, modified Merritt teaches the apparatus of claim 7, but is silent regarding wherein, after the first user input is received, the screen display comprises a second button comprising the second label.
However, in the same intravascular imaging field of endeavor, Soffer teaches wherein, after the first user input is received, the screen display comprises a second button comprising the second label. ([0012] the processor displays a drop down list so the user can select the appropriate label for the anatomical area being displayed, and would include more than one as it is a list).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to combine the user interface of modified Merritt with the drop down list of Soffer, as both inventions relate to user inputting identification means for anatomical images, and would yield the predictable result of using a drop down list to label vessels to one of ordinary skill in the art. One of ordinary skill in the art would be able to perform such a combination, and the results of modified Merritt using a drop down list to label vessels are reasonably predictable.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Merritt in view of Johnson, Hiltner, and Buras as applied to claim 1 above, and in further view of Wei et al., (WO2007002562A2).
Regarding claim 10, modified Merritt teaches the apparatus of claim 1, but fails to explicitly teach wherein, the first instruction is to identify a start of the first blood vessel, and wherein the second instruction is to identify a start of the second blood vessel
In the same vessel imaging field of endeavor, Wei teaches wherein, the first instruction is to identify a start of the first blood vessel (Claim 11, the user selects an initial starting point in the imagery data, which is of the vessel), and wherein the second instruction is to identify a start of the second blood vessel (Claim 11 after the first group of vessel candidates, a second group is identified and then segmented. This segmenting would result in identifying the start of the second blood, as segmenting identifies the beginning and ends of the vessel).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the apparatus of modified Merritt with the user inputs of Wei, as this would facilitate coordinated retrieval of visual and non-visual data associated with a patient and interactive diagnosis process (see Wei [0031]).
Response to Arguments
Applicant's arguments filed 04/06/2026 have been fully considered but they are not persuasive.
Regarding claim 1, Applicant has argued that Merritt, Johnson, and Buras do not disclose or suggest the “instruction area”, and further goes on the state that the prior art references do not disclose “of an instruction area having a first instruction to apply a first label when the live intravascular image area depicts the first blood vessel, and that changes, based on the sequential manner of catheter movement, to have a second instruction to apply a second label when the live intravascular image area depicts the second blood vessel during the movement.”
Examiner disagrees. Under Broadest Reasonable Interpretation (BRI), the term “instruction area” has simply been interpreted as an area that has an instruction of some kind. As such, in Johnson, being prompted by the software to accept or overriding the recommendation and assigning a different name constitute an instruction to accept or change the name, and thus reads upon instruction area. As for the remainder of the limitation, it is the combination of Merritt, Johnson, and Hiltner that teaches “an instruction area having a first instruction to apply a first label when the live intravascular image area depicts the first blood vessel, and that changes, based on the sequential manner of catheter movement, to have a second instruction to apply a second label when the live intravascular image area depicts the second blood vessel during the movement.”
The remaining claims are rejected for substantially the same reasons as above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL Y FANG whose telephone number is (571)272-0952. The examiner can normally be reached Mon - Friday 9:30 am - 6:00pm.
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/MICHAEL YIMING FANG/ Examiner, Art Unit 3798
/PASCAL M BUI PHO/ Supervisory Patent Examiner, Art Unit 3798
