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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/29/2026 has been entered.
Response to Amendment
The amendment of 01/29/2026 has been entered and fully considered by the examiner. Claim 1-3, 6, 10, 11, and 17 are amended. Claims 7-9, 12, 13, 16 are canceled. Claim 18 and 19 are added. Claims 1-6, 10, 11, 14, 15, and 17-18 are currently pending in the application with claim 1 being independent.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 18, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Furuichi (WO Publication No. 2016/136579A1) hereinafter “Furuichi” in view of Shimizu et al. (U.S. Publication No. 2016/0206267) hereinafter “Shimizu” and Mancini et al. (U.S. Publication No. 2003/0171894) hereinafter “Mancini”.
Regarding claim 1, Furuichi discloses an apparatus [apparatus of Furuichi; see abstract], comprising:
a processor [signal processing unit including a microprocessor; see page 5, fourth paragraph of Furuichi] configured for communication [see page 7, fourth and fifth full paragraph disclosing the signal processing unit connected to the imaging catheter] with an intravascular imaging catheter [catheter 101; see FIG. 1 and page 4, fourth and fifth paragraph disclosing a catheter with optical fiber and including transmitting light from the tip of the catheter and receiving reflected light] wherein the processor configured to:
receive imaging data from the intravascular imaging catheter [see page 6, second paragraph of Furuichi] as the intravascular imaging catheter is moved through a blood vessel; [see page 6, third paragraph disclosing that the fiber is moveable along the optical axis direction along arrow 226; see FIG. 2]
generate, based on the imaging data, a longitudinal view of the blood vessel; [see page 9, third paragraph and FIG. 6a; longitudinal image 610]
output, to a display in communication with the processor, a single screen comprising:
the longitudinal view of the blood vessel [see FIG. 6A; section 610 is the longitudinal view]; and
Furuichi does not expressly disclose that the processor is configured to identify, based on the imaging data, a distal reference location, a proximal reference location, and a minimum lumen area (MLA) location define a segment corresponding to a planned location for a stent, wherein the segment extends between the distal reference location and the proximal reference location such that the segment comprises a plurality of locations of the blood vessel: calculate a segment percent stenosis using the imaging data for the plurality of locations of the segment, wherein the segment percent stenosis is not specific to only one location of the blood vessel such that the segment percent stenosis is distinct from a value specific to the distal reference location, a value specific to the proximal reference, and a value specific to the MLA location; and that the single screen comprises a distal end marker identifying the distal reference location a proximal end marker identifying the proximal reference location a graphical representation of the segment extending between the distal end marker and the proximal end marker and the segment percent stenosis
Shimizu, directed towards determination of a suitable area of the vessel for stent placement [see abstract of Shimizu] further discloses that the processor is configured to identify, based on the imaging data, a distal reference location,[a first position 731 is the distal reference as it is positioned towards the distal end of the vessel; see FIG. 7 and [0072]] a proximal reference location [a first position 732 is the proximal reference as it is positioned towards the proximal end of the vessel; see FIG. 7 and [0072]] and a minimum lumen area (MLA) location [the position 733 where the cross-sectional area is the smallest ; see FIG. 7 and [0072]] define a segment corresponding to a planned location for a stent, [see [0053]; the determination of the first and second positions are for a stent indwelling determination] wherein the segment extends between the distal reference location and the proximal reference location such that the segment comprises a plurality of locations of the blood vessel:[see FIG. 7] and that the single screen comprises a distal end marker identifying the distal reference location a proximal end marker identifying the proximal reference location a graphical representation of the segment extending between the distal end marker and the proximal end marker [see FIG. 7 shows both the distal position and the proximal position and the segment of the vessel extending in between]
Mancini, directed towards stenosis study of vascular structures based on imaging [see abstract of Mancini] further discloses that the processor is configured to calculate a segment percent stenosis using the imaging data for the plurality of locations of the segment, [see FIG. 7, column 412 showing the percentage Stenosis for different segments 402; see [0146]] wherein the segment percent stenosis is not specific to only one location of the blood vessel such that the segment percent stenosis is distinct from a value specific to the distal reference location, a value specific to the proximal reference, and a value specific to the MLA location; .[see [0151] and FIG. 7; the percent stenosis is for the entire segment] and that the single screen comprises of the segment percent stenosis [see [0144] and FIG. 7; the percentage stenosis is outputted on the display; it would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the displayed content on the screen to include this output as well in order to display more data relevant to the user. Further, it has been held that forming in one piece an article that has formerly been formed in two pieces and putting them together involves only routine skill in the art. Howard v. Detroit Stove Works, 150, U.S. 164 (1893)]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the design of Furuichi further such that the processor is configured to identify, based on the imaging data, a distal reference location, a proximal reference location, and a minimum lumen area (MLA) location define a segment corresponding to a planned location for a stent, wherein the segment extends between the distal reference location and the proximal reference location such that the segment comprises a plurality of locations of the blood vessel: and that the single screen comprises a distal end marker identifying the distal reference location a proximal end marker identifying the proximal reference location a graphical representation of the segment extending between the distal end marker and the proximal end marker according to the teachings of Shimizu in order to determine an indwelling position or a size of a stent [see [0004] of Shimizu]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the design of Furuichi further such that the processor is configured to calculate a segment percent stenosis using the imaging data for the plurality of locations of the segment, wherein the segment percent stenosis is not specific to only one location of the blood vessel such that the segment percent stenosis is distinct from a value specific to the distal reference location, a value specific to the proximal reference, and a value specific to the MLA location; and that the single screen comprises of the segment percent stenosis according to the teachings of Mancini in order to determine the risk of any abnormality in different sections of the vessel [see [0008]-[0009] of Mancini]
Regarding claim 18, Furuichi as modified by Shimizu and Mancini discloses all the limitations of claim 1 [see rejection of claim 1 above]
Shimizu further discloses that the MLA location is between the distal reference location and the proximal reference location [see FIG. 9 of Shimizu; further, since only the segment between the two distal and proximal points are calculated, it is inherent that the MLA would be somewhere in that segment (i.e. between the end points of distal and proximal reference locations]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the design of Furuichi as modified by Shimizu and Mancini further such that that the MLA location is between the distal reference location and the proximal reference location Shimizu in order to determine an indwelling position or a size of a stent [see [0004] of Shimizu]
Regarding claim 22, Furuichi as modified by Shimizu and Mancini discloses all the limitations of claim 1 [see rejection of claim 1 above]
Furuichi further disclose that the single screen further comprises: a slider configured to be moved along the longitudinal view; a measurement specific to the only one location identified by the slider. [see FIG. 6A-6B; section 630 includes both lumen diameter and lumen area at the location of the slider]
Claims 2-4, 6, and 19-21are rejected under 35 U.S.C. 103 as being unpatentable over Furuichi (WO Publication No. 2016/136579A1) hereinafter “Furuichi” in view of Shimizu et al. (U.S. Publication No. 2016/0206267) hereinafter “Shimizu” and Mancini et al. (U.S. Publication No. 2003/0171894) hereinafter “Mancini” as applied to claim 1 above and further in view of Gopinath (U.S. Publication No. 2018/0085170) hereinafter “Gopinath”.
Regarding claim 2, Furuichi as modified by Shimizu and Mancini discloses all the limitations of claim 20 [see rejection of claim 20 below]
Shimizu further discloses wherein the single screen further comprises: a MLA marker identifying the MLA location and a third measurement specific to the MLA location. [see FIG. 9; the position 733 marker is the position of the MLA; see [0072]; the vascular diameter or cross-sectional area of the ML is also calculated for determination of the smallest value; see [0073]]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the design of Furuichi as modified by Shimizu and Mancini further such that the single screen further comprises a MLA marker identifying the MLA location and a third measurement specific to the MLA location according to the teachings of Shimizu in order to determine an indwelling position or a size of a stent [see [0004] of Shimizu]
Regarding claim 3, Furuichi as modified by Shimizu and Mancini discloses all the limitations of claim 4 [see rejection of claim 4 below]
Furuichi further discloses that the lumen diameter comprises at least one of an average diameter, a minimum diameter, or a maximum diameter. [see page 11, last paragraph and FIG. 6A; both the minor diameter (minimum diameter) and the major diameter (maximum diameter) of the cross section with lumen area are displayed]
Regarding claim 4, Furuichi as modified by Shimizu and Mancini discloses all the limitations of claim 22 [see rejection of claim 1 above]
Furuuchi further discloses that wherein the measurement specific to the only one location identified by the slider comprises at least one of: a numerical value of a lumen area; or a numerical value of a lumen diameter [see FIG. 6A-6B; section 630 includes both lumen diameter and lumen area at the location of the slider]
Regarding claim 6, Furuichi as modified by Shimizu and Mancini discloses all the limitations of claim 22 [see rejection of claim 18 above]
Furuichi as modified by Shimizu and Mancini does not disclose that the location identified by the movable slider is different from than the distal reference, the proximal refence and the minimum lumen area
Gopinath, directed towards intravascular imaging [see abstract of Gopinath], further discloses wherein the location identified by the movable slider is different from than the distal reference, the proximal refence and the minimum lumen area [see FIG. 5A-B of Gopinath; the location corresponding to distal and proximal references are allocated with LZ1 and LZ2; the measurements of MLA is calculated but the position is not shown. The location shown is the location of the maker 166 is chosen by the user as disclosed in [0103]-[0104] of Gopinath]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the design of Furuichi as modified by Shimizu and Mancini further such that the location identified by the movable slider is different from than the distal reference, the proximal refence and the minimum lumen area according to the teachings of Gopinath in order to provide a visual output to the user of the size of the lumen of the vessel at each desired point as well as the minimum lumen area point and increase the accuracy of any diagnosis. [see [0068], last 2 lines]
Regarding claim 19, Furuichi as modified by Shimizu and Mancini discloses all the limitations of claim 20 [see rejection of claim 20 above]
Furuichi further discloses that the processor is configured to generate a plurality of transverse views along the length of the blood vessel, [see page 10, paragraph before last discloses that a plurality of cross-sectional images is generated and for each one of these images, the lumen area and the normalized lumen area is calculated]
Gopinath further discloses that wherein the single screen further comprises a transverse view of the plurality of transverse views e [see FIG. 5A-5B]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the design of Furuichi as modified by Shimizu and Mancini further such that the single screen further comprises a transverse view of the plurality of transverse views according to the teachings of Gopinath in order to provide a visual output to the user of the size of the lumen of the vessel at each desired point as well as the minimum lumen area point and increase the accuracy of any diagnosis. [see [0068], last 2 lines]
Regarding claim 20, Furuichi as modified by Shimizu and Mancini discloses all the limitations of claim 1 [see rejection of claim 1 above]
Furuichi as modified by Shimizu and Mancini does not disclose that the single screen further comprises: a first measurement specific to the distal reference location; and a second measurement specific to the proximal reference location.
Gopinath further discloses that the single screen further comprises: a first measurement specific to the distal reference location; and a second measurement specific to the proximal reference location. [see FIG. 5B; the diameter of the distal end, proximal end and the MLA location is shown on the screen]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the design of Furuichi as modified by Shimizu and Mancini further such that the single screen further comprises: a first measurement specific to the distal reference location; and a second measurement specific to the proximal reference location according to the teachings of Gopinath in order to provide a visual output to the user of the size of the lumen of the vessel at each desired point as well as the minimum lumen area point and increase the accuracy of any diagnosis. [see [0068], last 2 lines]
Regarding claim 21, Furuichi as modified by Shimizu and Mancini and Gopinath discloses all the limitations of claim 1 [see rejection of claim 1 above]
Gopinath further discloses that each of the first measurement and the second measurement comprises a lumen diameter. [see FIG. 5B; the diameter of the distal end, proximal end and the MLA location is shown on the screen]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the design of Furuichi as modified by Shimizu and Mancini further such that each of the first measurement and the second measurement comprises a lumen diameter according to the teachings of Gopinath in order to provide a visual output to the user of the size of the lumen of the vessel at each desired point as well as the minimum lumen area point and increase the accuracy of any diagnosis. [see [0068], last 2 lines]
Claims 10 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Furuichi (WO Publication No. 2016/136579A1) hereinafter “Furuichi” in view of Shimizu et al. (U.S. Publication No.) hereinafter “Shimizu” and Mancini et al. (U.S. Publication No. 2003/0171894) hereinafter “Mancini” as applied to claim 1 above, and further in view of Zhong et al. (U.S. Publication No. 2019/0029625) hereinafter “Zhong”.
Regarding claim 10, Furuichi in view of Shimizu and Mancini discloses all the limitations of claim 1 [see rejection of claim 1 above]
Furuichi in view of Shimizu and Mancini does not expressly disclose wherein the single screen further comprises a percent stenosis specific to only one location.
Zhong, directed towards identification intravascular imaging and their analysis [see abstract of Zhong] further discloses that wherein the plurality of measurements comprises a numerical value of a percent stenosis. [see FIG. 12a; the percent stenosis is calculated and displayed]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the design of Furuichi as modified by Gopinath and Miller further such that the plurality of first measurements comprises a numerical value of a percent stenosis according to the teachings of Merritt in order to allow for identification and classification of lesions present in an image and assist in their diagnosis, so that treatment option can be tailored to the specific characteristics of the patient's lesion and improve the effectiveness of the treatment. [see [0002] of Zhong]
Regarding claim 23, the percent stenosis specific to the only one location comprises the percent stenosis specific to the MLA location. [see FIG. 12a; the percent stenosis is calculated and displayed including L2 which is the MLA location since it has the least diameter in that section]
Claims 14, 15 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Furuichi (WO Publication No. 2016/136579A1) hereinafter “Furuichi” in view of Shimizu et al. (U.S. Publication No. 2016/0206267) hereinafter “Shimizu” and Mancini et al. (U.S. Publication No. 2003/0171894) hereinafter “Mancini” as applied to claims 1 and 16 above and further in view of Miller (U.S. Publication No. 2014/0276085) hereinafter “Miller”.
Regarding claim 14, Furuichi in view of Shimizu and Mancini discloses all the limitations of claim 17 [see rejection of claim 17 below]
Furuichi in view of Shimizu and Mancini does not disclose that the processor is configured to determine at least one of the lumen border or the vessel border.
Miller, directed towards intravascular imaging and analysis [see abstract of Miller] further disclose that the processor is configured to determine at least one of the lumen border or the vessel border. [see FIG. 11 of Miller]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the design of Furuichi in view of Shimizu and Mancini further and determine at least one of the lumen borders or the vessel border according to the teachings of Miller in order to provide a visual output to the user of the size of the lumen of the vessel and increase the accuracy of any diagnosis.
Regarding claim 15, Furuichi in view of Shimizu and Mancini discloses all the limitations of claim 17 [see rejection of claim 17]
Miller further disclose that the transverse view area further comprises a highlighted area disposed between the lumen border and the vessel border. [see FIG. 11 of Miller; the area between the two circles is the area between the internal lumen wall (i.e. lumen border) and external lumen wall (vessel border); it would be further obvious to an ordinary skilled in the art to highlight that rea to visually emphasize it as highlighting an image is a routine and ordinary in the art]
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It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the design of Furuichi in view of Gopinath and Miller further such that transverse view area further comprises a highlighted area disposed between the lumen border and the vessel border according to the teachings of Miller in order to provide a visual output to the user of the size of the lumen of the vessel and increase the accuracy of any diagnosis.
Regarding claim 17 Furuichi in view of Shimizu and Mancini discloses all the limitations of claim 18 [see rejection of claim 18 above]
Furuichi in view of Shimizu and Mancini does not expressly disclose wherein each of the first measurement and second measurement is associated with at least one of a lumen border or a vessel border of the blood vessel, wherein the single screen further comprises an outline of at least one of the lumen border or the vessel border overlaid on the first transverse view.
Miller further discloses wherein each of the first measurement and second measurement is associated with at least one of a lumen border or a vessel border of the blood vessel, wherein the single screen further comprises an outline of at least one of the lumen border or the vessel border overlaid on the first transverse view. [see FIG. 11 of Miller; the area between the two circles is the area between the internal lumen wall (i.e. lumen border) and external lumen wall (vessel border); it would be further obvious to an ordinary skilled in the art to highlight that rea to visually emphasize it as highlighting an image is a routine and ordinary in the art]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the design of Furuichi as modified by Gopinath further such that wherein each of the first measurement and second measurement is associated with at least one of a lumen border or a vessel border of the blood vessel, wherein the single screen further comprises an outline of at least one of the lumen border or the vessel border overlaid on the first transverse view according to the teachings of Miller in order to provide a visual output to the user of the size of the lumen of the vessel and increase the accuracy of any diagnosis
Response to Arguments
Applicant’s arguments with respect to claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARJAN - SABOKTAKIN whose telephone number is (303)297-4278. The examiner can normally be reached M-F 9 am-5pm CT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Carey can be reached at (571) 270-7235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARJAN SABOKTAKIN/Examiner, Art Unit 3797
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795