DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08/03/2026 has been entered.
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, 9, 11-12, and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Gopinath et al. (US 2019/0365480; hereinafter Gopinath), in view of Fujimura et al. (“Stent Expansion Indexes to Predict Clinical Outcomes”; JACC: Cardiovascular Interventions; Vol. 14, NO. 15, 2021; hereinafter Fujimura).
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 minimum 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. Furthermore, Gopinath teaches minimum key stent area (see par. [0070]), but fails to explicitly state wherein the distal expansion value of the stent is determined based on the MSA divided by a lumen area for areas distal of a minimum key frame, and wherein the proximal expansion value of the stent is determined based on the MSA divided by the lumen area for areas proximal of the minimum key frame.
Fujimura discloses different methods of calculating stent expansion. Fujimura teaches distal expansion value of stent is determined based on MSA divided by a lumen area for areas distal of a minimum key frame (see fig. 1 and 3; tables 3-4), and wherein proximal expansion value of the stent is determined based on the MSA divided by lumen area for areas proximal of the minimum key frame (see fig. 1 and 3; tables 3-4).
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 wherein the distal expansion value of the stent is determined based on MSA divided by a lumen area for areas distal of a minimum key frame, and wherein the proximal expansion value of the stent is determined based on MSA divided by lumen area for areas proximal of the minimum key frame in the invention of Gopinath, as taught by Fujimura, to provide additional information to assess whether the stent was correctly positioned and expanded withing the vessel.
Regarding claim 3, Gopinath and Fujimura 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 Fujimura 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 Fujimura 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 9, Gopinath and Fujimura 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 minimum 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. Furthermore, Gopinath teaches minimum key stent area (see par. [0070]), but fails to explicitly state wherein the distal expansion value of the stent is determined based on the MSA divided by a lumen area for areas distal of a minimum key frame, and wherein the proximal expansion value of the stent is determined based on the MSA divided by the lumen area for areas proximal of the minimum key frame.
Fujimura discloses different methods of calculating stent expansion. Fujimura teaches distal expansion value of stent is determined based on MSA divided by a lumen area for areas distal of a minimum key frame (see fig. 1 and 3; tables 3-4), and wherein proximal expansion value of the stent is determined based on the MSA divided by lumen area for areas proximal of the minimum key frame (see fig. 1 and 3; tables 3-4).
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 wherein the distal expansion value of the stent is determined based on MSA divided by a lumen area for areas distal of a minimum key frame, and wherein the proximal expansion value of the stent is determined based on MSA divided by lumen area for areas proximal of the minimum key frame in the invention of Gopinath, as taught by Fujimura, to provide additional information to assess whether the stent was correctly positioned and expanded withing the vessel.
Regarding claim 12, Gopinath and Fujimura 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 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]); determining 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]); determining 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]); determining 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]); determining 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 minimum 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. Furthermore, Gopinath teaches minimum key stent area (see par. [0070]), but fails to explicitly state wherein the distal expansion value of the stent is determined based on the MSA divided by a lumen area for areas distal of a minimum key frame, and wherein the proximal expansion value of the stent is determined based on the MSA divided by the lumen area for areas proximal of the minimum key frame.
Fujimura discloses different methods of calculating stent expansion. Fujimura teaches distal expansion value of stent is determined based on MSA divided by a lumen area for areas distal of a minimum key frame (see fig. 1 and 3; tables 3-4), and wherein proximal expansion value of the stent is determined based on the MSA divided by lumen area for areas proximal of the minimum key frame (see fig. 1 and 3; tables 3-4).
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 wherein the distal expansion value of the stent is determined based on MSA divided by a lumen area for areas distal of a minimum key frame, and wherein the proximal expansion value of the stent is determined based on MSA divided by lumen area for areas proximal of the minimum key frame in the invention of Gopinath, as taught by Fujimura, to provide additional information to assess whether the stent was correctly positioned and expanded withing the vessel.
Regarding claim 18, Gopinath and Fujimura 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).
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 Fujimura et al. (“Stent Expansion Indexes to Predict Clinical Outcomes”; JACC: Cardiovascular Interventions; Vol. 14, NO. 15, 2021; hereinafter Fujimura) 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 Fujimura n 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 Fujimura, 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 Fujimura 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 Fujimura, 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 Fujimura 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 Fujimura, 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 Fujimura 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 Fujimura, 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 08/03/2026 with respect to prior art rejection of the independent claims have been considered but are moot because the new ground of rejection does not rely on any rejection applied in the prior office action of record for any teaching or matter specifically challenged in the argument. The examiner has provided new prior art Fujimura to teach the newly amended claim limitation in the independent claims.
Conclusion
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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/SHAHDEEP MOHAMMED/ Primary Examiner, Art Unit 3797
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