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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/22/2026 has been entered.
Response to Arguments
Applicant's arguments filed 06/22/2026 have been fully considered but they are not persuasive. For example, applicant argues “Neither Hoffman nor Raju, alone or in combination, discloses or suggests ‘automatically pre-select a plurality of imaging parameters for the new intravascular imaging procedure that are specific to the selectable NIVL imaging type or the selectable PTS imaging type,’ as recited by amended claim 1” and “while NIVL is mentioned in Raju, it is only as a diagnostic finding. Raju does not disclose or suggest NIVL as a selectable imaging type in a menu, let alone one that, when selected, causes automatic pre-selection of imaging parameters specific to NIVL. No disclosure or suggestion has been identified of NIVL as a selectable imaging mode with associated preset imaging parameters. Hoffman and Raju, even when combined, do not disclose or suggest all of the features of amended claim 1.” (REMARKS pg. 6-7). Examiner respectfully disagrees in that it is not Hoffman nor Raju alone which teaches/suggests NIVL as a selectable imaging type in and automatic pre-selection of imaging parameters specific to NIVL, but rather the combination of Hoffman and Raju together. Specifically, it is noted that Hoffman teaches selectable imaging modes and automatically pre-select a plurality of imaging parameters for a new intravascular imaging procedure that are specific to the selectable imaging type in at least [0056]-[0057] and [0048] and further teaches that the selection window 430 may include other modes 440 in [0047]. While Hoffman does not explicitly disclose what other modes entails, it is noted that Raju teaches IVUS imaging of an NIVL. Therefore, when combined with the teachings of Raju, a person having ordinary skill in the art would have recognized “other modes” as including at least an NIVL mode having corresponding set parameters in a plurality of both pre-acquisition stage settings and post-acquisition stage settings as disclosed in [0047] and selection thereof would necessarily automatically pre-select imaging parameters specific to NIVL upon selection of such an imaging type. Examiner further notes that applicant’s specification fails to provide any specific imaging parameters associated specifically to the NIVL mode, let alone any criticality of the imaging parameters which are pre-selected specific to NIVL. Specifically, it is noted that non-thrombotic ilica vein lesion or NIVL is disclosed in 5 instances in the specification ([0008], [0010], [0072], and [0074]) as merely generic examples of the type of anatomy to be imaged/imaging type for selection and no disclosure of specific imaging parameters used upon such selection of NIVL. Thus the combination of Hoffman to include pre-programmed imaging parameters (e.g. parameters initially set by a user) which are automatically pre-selected in response to selection of an NIVL imaging type (e.g. other modes 440 of Hoffman modified by Raju) is found to be an obvious modification to the teachings of Hoffman especially in light of Raju which teaches a desire to perform imaging for a non-thrombotic iliac vein lesion. For at least these reasons, applicant’s arguments with respect to the teachings of Hoffman and Raju are not found persuasive.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-6, 8 and 11-13 are rejected under 35 U.S.C. 103 as being obvious over Hoffman (US 20150133776 A1), hereinafter Hoffman in view of Raju et al. (US 8257265 A1), hereinafter Raju. Examiner notes that Hoffman is cited in applicant’s IDS filed 12/27/2024.
Regarding claim 1,
An apparatus (at least fig. 2 (200) and corresponding disclosure in at least [0030]), comprising:
An intravascular imaging catheter (at least fig. 2 (230) and corresponding disclosure in at least [0032]) configured to be positioned within peripheral vasculature ([0055] which discloses the method 600 may begin when a clinician positions an imaging device 230 into the vasculature of a patient at a target area (step 602), examiner notes that such an imaging device is configured to be positioned within any vasculature including the peripheral vasculature); and
A processor circuit (at least fig. 2 (202) and corresponding disclosure in at least [0040]) configured for communication with the intravascular imaging catheter (230), wherein the processor circuit is configured to:
Output, to a display communication with the processor circuit, a screen display (see at least figs. 4-5 and [0040] which discloses one of the programs 212 running on the CPU 2044 of the controller 202… provides a medical imaging system interface to facilitate the appropriate control of settings that may be applied in the imaging pipeline 300. Embodiments of such a medical imaging system interface are illustrated in figs. 4 and 5) comprising:
A first area (at least fig. 5 (430) and corresponding disclosure in at least [0047]) comprising an image type selection menu configured to receive a user input to start a new intravascular imaging procedure ([0047] As illustrated, the selection window 430 presents a stent mode 432, a plaque mode 434 (which appears selected in FIG. 4), a high penetration mode 436, a thrombosis mode 438, and may include other modes 440. By selecting any mode on the selection window 430, a user of the medical imaging system may set parameters in a plurality of both pre-acquisition stage settings and post-acquisition stage settings), wherein the image type selection menu comprising a plurality of selectable intravascular imaging types specific to the peripheral vasculature (see at least fig. 5 and [0047] disclosing the different imaging modes including plaque mode and thrombosis mode which are considered to be specific to peripheral vasculature as plaque and thrombosis occur in peripheral vasculature), wherein the plurality of intravascular imaging types comprises a selectable plaque imaging type, selectable a high penetration imaging type, a selectable stent imaging type, and a selectable thrombosis imaging types ([0047] and fig. 4);
A second area (at least fig. 5 (502) and corresponding disclosure in at least [0052]) comprising a case log configured to list one or more completed intravascular imaging procedures of the peripheral vasculature ([0052] which discloses a library including a filename, a file type, and a duration for each file. Examiner notes that the library includes a list of completed intravascular imaging procedures of the vasculature where the system would thus function to list procedures of any vasculature including the peripheral vasculature); and
A third area (at least fig. 5 (“Full View” or 410 from fig. 4) and corresponding disclosure in at least [0052]) configured to provide a summary of intravascular data of the peripheral vasculature for a selected procedure of the completed intravascular imaging procedures ([0052] which discloses the library 502 permits selection of a file of imaging data and the view button 506A may cause the file (considered a summary of intravascular data of the vasculature) to be displayed in both the full view window 410 and the ROI window 420 if a ROI 412 is selected),
Wherein the first area, the second area, and the third area are simultaneously displayed in the screen display (see at least fig. 5);
Receive, via the image type selection menu, a user input selecting one of the plurality of selectable intravascular imaging types ([0044]), and
In response to receiving the user input, automatically pre-select a plurality of imaging parameter for the new intravascular imaging procedure that are specific to the one of the plurality of selectable intravascular imaging types ([0048] In some embodiments, the ability of a user to adjust the parameters of the pipeline may be limited to a selection from the modes presented in the selection window 430 and [0049] which discloses By enabling the update mode the individually adjusted parameters of the individual settings may be automatically stored for future access by selecting the associated settings mode in the selection window 430. See also [0044] which discloses the selection window 430 includes a plurality of groups of settings, or setting groups, that are optimized for viewing a specific feature at the target area see also [0056]-[0057])
Hoffman further teaches wherein the plurality of selectable intravascular imaging types comprises selectable imaging types ([0047] and 440 of fig. 4), however, fails to explicitly teach wherein the plurality of intravascular imaging types comprises at least one of anon-thrombotic iliac vein lesion (NIVL) imaging type or a post-thrombotic syndrome (PTS) imaging type.
Raju, in a similar field of endeavor involving IVUS imaging, teaches a non-thrombotic iliac vein lesion imaging type (Col. 4 lines 34-45 which discloses NIVL lesions are readily visible through IVUS as subsegmental and focal (<2 cm), and occur near arterial crossover points near the upper or lower ends of the vein segment, finally, the wall thickness and lumen size of the rest of the vein segment are normal and the lesion which is readily determined by IVUs area measurement software included with IVUS machines. See also claim 1 and claims 7-8).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified the imaging types of Hoffman to include a non-thrombotic iliac vein lesion imaging type in order to allow for identification of such a lesion as taught by Raju (Col. 4 lines 34-35). Such a modification would allow for subsequent treatment of a non-thrombotic iliac vein legion for relieving both obstruction and reflux when such a lesion exists in a patient (Raju Col. 6 line 57- Col. 7 line 10), thereby providing additional beneficial uses of the system of Hoffman.
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Hoffman, as currently modified, to include a selectable non-thrombotic iliac vein lesion imaging type, receiving a selection of the selectable non-thrombotic iliac vein lesion imaging type, and automatically pre-selecting imaging parameters in order to provide a selectable other mode as disclosed Hoffman [0047] to thereby provide optimized imaging parameters for imaging a feature of interest (i.e. a non-thrombotic iliac vein lesion) as disclosed in Hoffman [0044].
Regarding claim 2,
Hoffman further teaches wherein the plurality of intravascular imaging modes specific to the peripheral vasculature comprises a plurality of disease types specific to the peripheral vasculature (see at least fig. 5 and [0047] disclosing the different imaging modes including plaque mode and thrombosis mode which are considered to be specific to peripheral vasculature as plaque and thrombosis occur in peripheral vasculature, where plaque and thrombosis are considered disease types specific to the peripheral vasculature)
Regarding claim 3,
Hoffman further teaches wherein the image type selection menu further comprises a thrombus imaging type (438).
Regarding claim 4,
Hoffman further teaches wherein each of the one or more completed intravascular imaging procedures listed in the case log comprises text identifying an intravascular imaging mode used when the respective intravascular imaging procedure was completed (see at least fig. 5 “Acq. Mode” and [0052] which discloses additionally, the library 502 includes an indication of the acquisition mode that was used in the collection of the associated imaging data and the data was acquired using the stent mode as selected in the imaging mode selection window 430.)
Regarding claim 5,
Hoffman further teaches wherein the processor circuit is configured to receive a user input to select the selected procedure from among the one or more completed intravascular imaging procedures ([0052] which discloses the library 502 permits selection of a file of imaging data and further presents buttons to view, archive, or delete the selected file).
Regarding claim 6,
Hoffman teaches the elements of claim 1 as previously stated. Hoffman further teaches wherein a selected image type is highlighted in the first area (see at least fig. 5), however, fails to explicitly teach the select procedure is highlighted in the case log.
Nonetheless, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Hoffman to also highlight the selected procedure in the case log in order to enhance a user’s knowledge about the file data displayed in the full view. In other words, such a modification would allow a user to readily recognize which procedure was selected from the case log for display in the full view region thereby preventing misdiagnosis/confusion regarding such selected data.
Regarding claim 8,
Hoffman further teaches wherein the summary of the intravascular data comprises an exemplary intravascular imaging frame from the selected procedure ([0052] which discloses The view button 506A may cause the file to be displayed in both the full view window 410 and the ROI window 420 if a ROI 412 is selected. see at least fig. 5 depicting an intravascular imaging frame in the full view area 410).
Regarding claim 11,
Hoffman further teaches wherein the processor circuit is configured to receive a user input marking a procedure of the one or more completed intravascular imaging procedures as a favorite or for archiving ([0052] which discloses selection of the archive button 506B may remove the file from the library 502 to an archive from which it may be retrieved later).
Regarding claim 12,
Hoffman further teaches wherein the intravascular imaging catheter is configured for intravascular ultrasound (IVUS) or optical coherence tomography (OCT) ([0055] The imaging device 230 may be an IVUS imaging device or an intravascular OCT imaging device).
Regarding claim 13,
Hoffman further teaches wherein the summary of the intravascular data comprises a numerical value from the selected procedure (see at least fig. 4 depicting a duration of 5.0 s as disclosed in [0052])
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Hoffman and Raju, as applied to claim 1 above, and further in view of Davies et al. (US 20150025330 A1), hereinafter Davies.
Regarding claim 7,
Hoffman teaches the elements of claim 1 as previously stated. Hoffman further teaches wherein the third area is configured to receive a user input ([0043] which discloses the full view window 410 also provides a user with the ability to select a region of interest, such as the ROI 412, for display in the ROI window 420. The ROI window 420 may allow for a full resolution view of the ROI 412 selection in the full view window 410 or simply a higher resolution view than in the full view window 410).
Hoffman fails to explicitly teach wherein the third area is configured to receive the user input to annotate the selected procedure as a pre-treatment intravascular imaging procedure or a post-treatment intravascular imaging procedure.
Davies, in a similar field of endeavor involving ultrasound imaging, teaches wherein an image is configured to receive user input to annotate a selected procedure as a pre-treatment intravascular imaging procedure or a post-treatment intravascular imaging procedure ([0071] which discloses the user is able to manually annotate the displayed image to include notes and/or input one or more of the measured parameter. Examiner notes that such manual annotating of a displayed image allows for annotating the image (and thus the selected procedure) however the user would like including annotating as a pre-treatment intravascular imaging procedure or a post-treatment intravascular imaging procedure).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified to have modified Hoffman to include receiving the user input to annotate the selected procedure as taught by Davies in order to allow a user to provide notes to the image data ([0071]) and selected procedure thereof. Such a modification would enhance the user’s review of such data at a later date, such that any comments/notes associated with the selected procedure are easily accessible.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Hoffman and Raju, as applied to claim 1 above, and further in view of Foreign Ozeki (JP 2010253017 A), hereinafter Ozeki. Examiner notes that citations to Ozeki are with respect to the translated copy provided herein.
Regarding claim 9,
Hoffman teaches the elements of claim 1 as previously stated. Hoffman fails to explicitly teach wherein the summary of the intravascular data comprises a name of a peripheral vessel from the selected procedure.
Ozeki, in a similar field of endeavor involving intravascular imaging, teaches displaying the name of the blood vessel part that is the imaging position of the displayed frame (pg. 4 fifth paragraph which discloses in the IVUS moving image, the name of the blood vessel part that is the imaging position of the displayed frame is displayed. See also pg. 6 first full paragraph)
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Hoffman to include a name of a peripheral vessel from the selected procedure with the image data as taught by Ozeki in order to allow a user to readily recognize the vessel which was imaged in the selected procedure and where the image was acquired. Such a modification would enhance a user’s ability to understand the image and location associated therewith upon review of the image data accordingly.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Hoffman and Raju, as applied to claim 13 above, and further in view of Cohen et al. (US 20150282890 A1), hereinafter Cohen.
Regarding claim 10,
Hoffman teaches the elements of claim 13 as previously stated. Hoffman fails to explicitly teach wherein the numerical value comprises a percentage of compression or percentage of occlusion from the selected procedure.
Cohen, in a similar field of endeavor involving vascular imaging, teaches wherein a summary of intravascular data is displayed and comprises numerical value, wherein the numerical value is a percentage of occlusion from a procedure (see at least fig. 38 (148) and corresponding disclosure in at least [0863]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Hoffman to include a percentage of occlusion from the selected procedure as taught by Cohen in order to provide additional diagnostic data regarding the vasculature from the selected procedure to the user. Such a modification would allow for enhanced review of the selected procedure such that the user may readily access the extent of the occlusion from the selected procedure thereby enhancing diagnostic evaluation.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE L KLEIN whose telephone number is (571)270-5204. The examiner can normally be reached Mon-Fri 7:30-4.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Kozak can be reached at 5712700552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BROOKE LYN KLEIN/Primary Examiner, Art Unit 3797
Prosecution Insights