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 § 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.
Claims are 1, 3-5, 8-9, 11-12, 14, 17-18 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Gopinath et al. (US 2019/0365480; hereinafter Gopinath), in view of Cohen et al. (US 2023/0190228; hereinafter Cohen).
Regarding claim 1, Gopinath discloses a stent expansion display. Gopinath shows an apparatus for an intravascular ultrasound (IVUS) imaging system (see par. [0023]), comprising: a display (see par. [0056]); an interface configured to couple to an IVUS catheter (see par. [0023], [0052], fig. 1A); a processor coupled to the interface and the display (see fig. A1); and a memory device (see par. [0058]) comprising instruction, which when executed by the processor cause the IVUS imaging system to: receive a series of IVUS images of a vessel of a patient (see par. [0040], [0045], [0053]), the series of IVUS images comprising a plurality of frames (see par. [0044], [0057]); receive an indication of a location of a stent in the vessel (see par. [0054]); determine a location for a proximal key frame based on a proximal end of the stent (see fig. 2A, 2B, 5A-B, 6A-B and 7; par. [0070], [0076], [0080], [0085]); determine a location for a distal key frame based on a distal end of the stent (see fig. 2A, 2B, 5A-B, 6A-B and 7; par. [0070], [0076], [0080], [0085]); determine a proximal expansion of the stent based in part on the location of the proximal key frame (see fig. 2A, 2B, 5A-B, 6A-B and 7; par. [0070], [0076], [0080], [0085]); determine a distal expansion of the stent based in part on the location of the distal key frame (see fig. 2A, 2B, 5A-B, 6A-B and 7; par. [0070], [0076], [0080], [0085]); generate a first graphical user interface (GUI) component comprising an indication of a cross-section view of the vessel captured in one of the plurality of frames (see 209 in fig. 2A); generate a second GUI component comprising indications of at least one menu option (see fig. 2A, 5A; par. [0067]); generate a third GUI component comprising indications of at least one layout option (see fig. 2A); generate a fourth GUI component comprising indications of a longitudinal view of the vessel captured in the plurality of frames, the proximal key frame, the distal key frame, the proximal expansion, the distal expansion, and the location of the stent relative to the vessel (see fig. 2A, 2B, 5A-B, 6A-B and 7; par. [0076], [0080], [0085]); generate a GUI comprising the first, second, third, and fourth GUI components (see fig. 2A), wherein the first GUI component is disposed between the second and third GUI components (see fig. 2A) ; and render the GUI and send the rendered GUI to the display (see par. [0075]).
Furthermore, Gopinath teaches a physician can set a stent expansion threshold as a percentage of stent expansion (see par. [0070]), and stent expansion percentage [0106], and different levels of expansion along different regions of the stent (see fig. 2B), Gopinath fails to explicitly state determining and displaying a proximal expansion value and distal expansion value of the stent.
Cohen discloses a system and device to display enhanced stent deployment using intravascular image. Cohen teaches determining a proximal expansion value and distal expansion value of the stent (see abstract; par. [0010], [0070], [0116], [0120]; fig. 11).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of determining and displaying a proximal expansion value and distal expansion value of the stent in the invention of Gopinath, as taught by Cohen, to provide additional information to assess whether the stent was correctly positioned and expanded withing the vessel.
Regarding claim 3, Gopinath and Cohen disclose the invention as substantially as described in the 103 rejection above, furthermore, Gopinath shows wherein the fourth GUI component comprises a representation of the vessel and a lumen of the vessel (see fig. 2A and 2B).
Regarding claim 4, Gopinath and Cohen disclose the invention as substantially as described in the 103 rejection above, furthermore, Gopinath shows wherein the fourth GUI component comprises a mirrored reflection of the representation about a longitudinal axis (see fig. 2A and 2B).
Regarding claim 5, Gopinath and Cohen disclose the invention as substantially as described in the 103 rejection above, furthermore, Gopinath shows wherein the fourth GUI component comprises a colored, shaded, or patterned area between the lumen and the mirrored reflection of the lumen and the proximal key frame and the distal key frame to indicate the location of the stent relative to the vessel (see fig. 2A and 2B).
Regarding claim 8, Gopinath and Cohen disclose the invention as substantially as described in the 103 rejection above, furthermore, Gopinath shows that the memory device further comprising instructions that when executed by the processor cause the IVUS imaging system to: determine the distal expansion of the stent based on a minimum stent area (MSA) divided by a lumen area for areas distal of a minimum key frame (see par. [0070]); and determine the proximal expansion of the stent based on the minimum stent area (MSA) divided by the lumen area for areas proximal of the minimum key frame (see par. [0070]).
Regarding claim 9, Gopinath and Cohen disclose the invention as substantially as described in the 103 rejection above, furthermore, Gopinath shows that wherein the distal expansion of the stent and the proximal expansion of the stent are represented as percent (see par. [0070]), wherein the indication of the distal expansion of the stent comprises a line between the minimum frame marker and a distal end of the stent and a graphical indication of the percent of distal expansion (see par. [0070]), and wherein the indication of the proximal expansion of the stent comprises a line between the minimum frame marker and a proximal end of the stent and a graphical indication of the percent of proximal expansion (see par. [0070]).
Regarding claim 11, Gopinath discloses a stent expansion display. Gopinath at least one machine readable storage device, comprising a plurality of instructions that in response to being executed by a processor of an intravascular ultrasound (IVUS) imaging system (see par. [0023]) cause the processor to :receive a series of IVUS images of a vessel of a patient (see par. [0040], [0045], [0053]), the series of IVUS images comprising a plurality of frames (see par. [0044], [0057]); receive an indication of a location of a stent in the vessel (see par. [0054]); determine a location for a proximal key frame based on a proximal end of the stent (see fig. 2A, 2B, 5A-B, 6A-B and 7; par. [0070], [0076], [0080], [0085]); determine a location for a distal key frame based on a distal end of the stent (see fig. 2A, 2B, 5A-B, 6A-B and 7; par. [0070], [0076], [0080], [0085]); determine a proximal expansion of the stent based in part on the location of the proximal key frame (see fig. 2A, 2B, 5A-B, 6A-B and 7; par. [0070], [0076], [0080], [0085]); determine a distal expansion of the stent based in part on the location of the distal key frame (see fig. 2A, 2B, 5A-B, 6A-B and 7; par. [0070], [0076], [0080], [0085]); generate a first graphical user interface (GUI) component comprising an indication of a cross-section view of the vessel captured in one of the plurality of frames (see 209 in fig. 2A); generate a second GUI component comprising indications of at least one menu option (see fig. 2A, 5A; par. [0067]); generate a third GUI component comprising indications of at least one layout option (see fig. 2A); generate a fourth GUI component comprising indications of a longitudinal view of the vessel captured in the plurality of frames, the proximal key frame, the distal key frame, the proximal expansion, the distal expansion, and the location of the stent relative to the vessel (see fig. 2A, 2B, 5A-B, 6A-B and 7; par. [0076], [0080], [0085]); generate a GUI comprising the first, second, third, and fourth GUI components (see fig. 2A), wherein the first GUI component is disposed between the second and third GUI components (see fig. 2A); and render the GUI for display on a display (see par. [0075]).
Furthermore, Gopinath teaches a physician can set a stent expansion threshold as a percentage of stent expansion (see par. [0070]), and stent expansion percentage [0106], and different levels of expansion along different regions of the stent (see fig. 2B), Gopinath fails to explicitly state determining and displaying a proximal expansion value and distal expansion value of the stent.
Cohen discloses a system and device to display enhanced stent deployment using intravascular image. Cohen teaches determining a proximal expansion value and distal expansion value of the stent (see abstract; par. [0010], [0070], [0116], [0120]; fig. 11).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of determining and displaying a proximal expansion value and distal expansion value of the stent in the invention of Gopinath, as taught by Cohen, to provide additional information to assess whether the stent was correctly positioned and expanded withing the vessel.
Regarding claim 12, Gopinath and Cohen disclose the invention as substantially as described in the 103 rejection above, furthermore, Gopinath shows wherein the fourth GUI component comprises a representation of the vessel and a lumen of the vessel (see fig. 2A and 2B), a mirrored reflection of the representation a longitudinal axis (see fig. 2A and 2B).
Regarding claim 14, Gopinath and Cohen disclose the invention as substantially as described in the 103 rejection above, furthermore, Gopinath shows further comprising instructions that in response to being executed by the processor cause the processor to: determine the distal expansion of the stent based on a minimum stent area (MSA) divided by a lumen area for areas distal of a minimum key frame (see par. [0070]); and determine the proximal expansion of the stent based on the minimum stent area (MSA) divided by the lumen area for areas proximal of the minimum key frame (see par. [0070]).
Regarding claim 17, Gopinath discloses a stent expansion display. Gopinath shows a method for an intravascular ultrasound (IVUS) imaging system (see par. [0023]), comprising: receiving a series of IVUS images of a vessel of a patient (see par. [0040], [0045], [0053]), the series of IVUS images comprising a plurality of frames (see par. [0044], [0057]); receiving an indication of a location of a stent in the vessel (see par. [0054]); determine a location for a proximal key frame based on a proximal end of the stent (see fig. 2A, 2B, 5A-B, 6A-B and 7; par. [0070], [0076], [0080], [0085]); determine a location for a distal key frame based on a distal end of the stent (see fig. 2A, 2B, 5A-B, 6A-B and 7; par. [0070], [0076], [0080], [0085]); determine a proximal expansion of the stent based in part on the location of the proximal key frame (see fig. 2A, 2B, 5A-B, 6A-B and 7; par. [0070], [0076], [0080], [0085]); determine a distal expansion of the stent based in part on the location of the distal key frame (see fig. 2A, 2B, 5A-B, 6A-B and 7; par. [0070], [0076], [0080], [0085]); generating a first graphical user interface (GUI) component comprising an indication of a cross-section view of the vessel captured in one of the plurality of frames (see 209 in fig. 2A); generating a second GUI component comprising indications of at least one menu option (see fig. 2A and 5A; par. [0067]); generating a third GUI component comprising indications of at least one layout option (see fig. 2A); generating a fourth GUI component comprising indications of a longitudinal view of the vessel captured in the plurality of frames, the proximal key frame, the distal key frame, the proximal expansion, the distal expansion, and the location of the stent relative to the vessel (see fig. 2A, 2B, 5A-B, 6A-B and 7; par. [0076], [0080], [0085]); generating a GUI comprising the first, second, third, and fourth GUI components (see fig. 2A), wherein the first GUI component is disposed between the second and third GUI components (see fig. 2A); and rendering the GUI for display on a display. (see par. [0075]).
Furthermore, Gopinath teaches a physician can set a stent expansion threshold as a percentage of stent expansion (see par. [0070]), and stent expansion percentage [0106], and different levels of expansion along different regions of the stent (see fig. 2B), Gopinath fails to explicitly state determining and displaying a proximal expansion value and distal expansion value of the stent.
Cohen discloses a system and device to display enhanced stent deployment using intravascular image. Cohen teaches determining a proximal expansion value and distal expansion value of the stent (see abstract; par. [0010], [0070], [0116], [0120]; fig. 11).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of determining and displaying a proximal expansion value and distal expansion value of the stent in the invention of Gopinath, as taught by Cohen, to provide additional information to assess whether the stent was correctly positioned and expanded withing the vessel.
Regarding claim 18, Gopinath and Cohen disclose the invention as substantially as described in the 103 rejection above, furthermore, wherein the fourth GUI component comprises a representation of the vessel and a lumen of the vessel (see fig. 2A and 2B), wherein the fourth GUI component comprises a mirrored reflection of the representation a longitudinal axis (see fig. 2A and 2B), and wherein the fourth GUI component comprises a colored, shaded, or patterned area between the lumen and the mirrored reflection of the lumen to indicate the location of the stent relative to the vessel (see fig. 2A and 2B).
Regarding claim 21, Gopinath and Cohen disclose the invention as substantially as described in the 103 rejection above, furthermore, Gopinath shows that the memory device further comprising instructions that when executed by the processor cause the IVUS imaging system to: determine the distal expansion of the stent based on a minimum stent area (MSA) divided by a lumen area for areas distal of a minimum key frame (see par. [0070]); and determine the proximal expansion of the stent based on the minimum stent area (MSA) divided by the lumen area for areas proximal of the minimum key frame (see par. [0070]).
Claims are 10, 15-16, 19 are rejected under 35 U.S.C. 103 as being unpatentable over Gopinath et al. (US 2019/0365480; hereinafter Gopinath), in view of Cohen et al. (US 2023/0190228; hereinafter Cohen) as applied to claims 1, 11 and 17 above, and further in view of Kunio et al. (US 20190099080; hereinafter Kunio).
Regarding claim 10, Gopinath and Cohen disclose the invention substantially as described in the 102 rejection above, furthermore, Gopinath shows a user input device (see par. [0023]), but fails to explicitly state the memory device further comprising instructions that when executed by the processor cause the IVUS imaging system to receive, via the input device, an indication to move the proximal key frame, the distal key frame, or the proximal key frame and the distal key frame.
Kunio discloses detecting and displaying stent expansion. Kunio teaches memory device further comprising instructions that when executed by the processor cause the IVUS imaging system to receive, via the input device, an indication to move the proximal key frame, the distal key frame, or the proximal key frame and the distal key frame (see par. [0092], [0093]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of memory device further comprising instructions that when executed by the processor cause the IVUS imaging system to receive, via the input device, an indication to move the proximal key frame, the distal key frame, or the proximal key frame and the distal key frame in the invention of Gopinath and Cohen, as taught by Kunio, to be able to interpret information with the ability to re-evaluate the interpreted information after a user modification using the graphical user interface to optimize stenting.
Regarding claim 15, Gopinath and Cohen disclose the invention substantially as described in the 102 rejection above, furthermore, Gopinath shows a user input device (see par. [0023]), but fails to explicitly state an indication to move the proximal key frame, the distal key frame, or the proximal key frame and the distal key frame; determine an updated distal expansion of the stent and/or an updated proximal expansion of the stent based on the moved proximal key frame and/or the moved distal key frame (see par. [0092], [0093]).
Kunio discloses detecting and displaying stent expansion. As best understood of the indefinite claim limitation, Kunio teaches an indication to move the proximal key frame, the distal key frame, or the proximal key frame and the distal key frame; determine an updated distal expansion of the stent and/or an updated proximal expansion of the stent based on the moved proximal key frame and/or the moved distal key frame (see par. [0092], [0093]); and determine an updated distal expansion of the stent and/or an updated proximal expansion of the stent based on the moved proximal key frame and/or the moved distal key frame (see par. [0092], [0093]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of an indication to move the proximal key frame, the distal key frame, or the proximal key frame and the distal key frame; determine an updated distal expansion of the stent and/or an updated proximal expansion of the stent based on the moved proximal key frame and/or the moved distal key frame in the invention of Gopinath and Cohen, as taught by Kunio, to be able to interpret information with the ability to re-evaluate the interpreted information after a user modification using the graphical user interface to optimize stenting.
Regarding claim 16, Gopinath and Cohen disclose the invention substantially as described in the 102 rejection above, furthermore, Gopinath shows further comprising instructions that in response to being executed by the processor cause the processor to regenerate the fourth GUI component (see fig. 2A), but fails to explicitly state the GUI to include an indication of the updated distal expansion of the stent and/or the updated proximal expansion of the stent.
Kunio discloses detecting and displaying stent expansion. Kunio teaches the GUI to include an indication of the updated distal expansion of the stent and/or the updated proximal expansion of the stent (see par. [0092], [0093]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of the GUI to include an indication of the updated distal expansion of the stent and/or the updated proximal expansion of the stent in the invention of Gopinath and Cohen, as taught by Kunio, to provide additional information to the display for the user to intemperate, and the ability to re-evaluate the interpreted information after a user modification using the graphical user interface to optimize stenting.
Regarding claim 19, Gopinath and Cohen disclose the invention substantially as described in the 102 rejection above, furthermore, Gopinath shows a user input device (see par. [0023]) and fourth GUI (see fig. 1A), but fails to explicitly state an indication to move the proximal key frame, the distal key frame, or the proximal key frame and the distal key frame; determining an updated distal expansion of the stent and/or an updated proximal expansion of the stent based on the moved proximal key frame and/or the moved distal key frame; and regenerating the component and the GUI to include an indication of the updated distal expansion of the stent and/or the updated proximal expansion of the stent.
Kunio discloses detecting and displaying stent expansion. Kunio teaches an indication to move the proximal key frame, the distal key frame, or the proximal key frame and the distal key frame; determining an updated distal expansion of the stent and/or an updated proximal expansion of the stent based on the moved proximal key frame and/or the moved distal key frame (see par. [0092], [0093]); and regenerating the component and the GUI to include an indication of the updated distal expansion of the stent and/or the updated proximal expansion of the stent (see par. [0092], [0093]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of an indication to move the proximal key frame, the distal key frame, or the proximal key frame and the distal key frame; determining an updated distal expansion of the stent and/or an updated proximal expansion of the stent based on the moved proximal key frame and/or the moved distal key frame; and regenerating the component and the GUI to include an indication of the updated distal expansion of the stent and/or the updated proximal expansion of the stent in the invention of Gopinath and Cohen, as taught by Kunio, to provide additional information to the display for the user to intemperate, and the ability to re-evaluate the interpreted information after a user modification using the graphical user interface to optimize stenting.
Response to Arguments
Applicant's arguments filed on 03/03/2026 have been fully considered but they are not persuasive.
In response to Applicant’s arguments on pages 7-10, with respect to prior art rejection of independent claims, the examiner respectfully disagrees. The examiner maintains that combined invention of Gopinath and Cohen does disclose all the claim limitation set forth in the independent claims, particularly the claim limitation of determining a proximal expansion value and distal expansion value of the stent. As stated in the previous Office action, prior art Gopinath teaches a physician can set a stent expansion threshold as a percentage of stent expansion (see par. [0070]), and stent expansion percentage [0106], and different levels of expansion along different regions of the stent (see fig. 2B), and the examiner has relied on prior art Cohen to teach determining and displaying a proximal expansion value and distal expansion value of the stent (see abstract; par. [0010], [0070], [0116], [0120]; fig. 11). The examiner notes the claim limits determining “a proximal expansion value of the stent” and “distal expansion value of the stent”, but the claim does not explicitly state what are the value (e.g. area, diameter, circumference, etc.), and the claim does not limit proximal “end” and distal “end”. The examiner notes that any determined values of stent along the vessel would read on proximal and distal expansion value of the sten. In par. [0116], Cohen teaches IVUS system configured to measure minimum stent area, maximum stent area, minimum stent expansion and a maximum stent expansion. Furthermore in abstract, par. [0007], [0008], [0010], [0076], [0077], Cohen teaches determining stent expansion scores and cross-section areas of the stent within the vessel. Furthermore in par. [0078], Cohen teaches that the expansion scores maybe include a ratio and percentage corresponding to the cross-section area or diameter of the stent.
The applicant further argues that Cohen does not recite “proximal” and “distal”, however, the independent claim do not limit proximal end stent expansion value and distal end expansion value. Cohen teaches stent expansion values withing the vessel at different location which read on the proximal expansion value of stent and distal expansion value of stent. Furthermore in par. [0111] and [0113], Cohen teaches locating proximal and distal end of stent using marker and determining length and distance between the proximal and distal markers.
Furthermore, the Applicant argues that Cohen teaches selects one IVUS frame and measure and display frame-specific information rather than two fixed proximal and distal values for the stent ends, the examiner respectfully disagrees. Claim 1 limits a GUI component comprising an indication of a cross-section view of the vessel captures in one of the plurality of frames (see lines 17-18 in claim 1). Further more as stated above, the independent claims do not limit the measuring between distal end and proximal end of the stent.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Cohen et al. (US 2020/0029932) disclose system and methods for displaying multiple intraluminal images in luminal assessment with medical imaging.
THIS ACTION IS MADE FINAL. 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 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