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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 6/20/25 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.
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.
Claim(s) 1-2, 4, and 6-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Franano et al. (US 2011/0160682; hereinafter Franano) in view of Gaddis et al. (US 2014/0276027; hereinafter Gaddis), and Grossman (US 2019/0192217).
Franano shows an image acquisition medical device ([0054]) comprising: a flexible body portion that extends in an axial direction ([0036]); an image sensor that is disposed in the flexible body portion and that is configured to acquire an image of a hollow organ ([0054]); a contrast unit that protrudes toward a distal end side of the flexible body portion and that makes an orientation of a distal end portion of the flexible body portion visually recognizable (radiopaque guidewire and also radiopaque material can be coated on any combination of the other catheter components as desired; [0052]-[0054]); and relative positions of the image sensor and the contrast unit in an axial rotation direction are fixed (constrained by catheter body structure that extends in axial direction, such that the relative positions in the axial rotation direction are fixed, [0054]; Fig. 10); wherein the contrast unit includes a second portion that is spaced from the distal end of the flexible body portion, the second portion of the contrast unit extending radially away from the center axis of the body portion (Fig. 10).
Franano shows a medical system comprising: an image acquisition medical device comprised of a flexible body portion and an image sensor, the image sensor being disposed in the flexible body portion ([0054]).
Franano shows a method comprising: viewing, on a display, tomographic images of a distal end portion of an image wire comprised of: a flexible body portion that is positioned in a hollow organ ([0054]); an image sensor disposed in the flexible body portion and configured to acquire the tomographic images of the hollow organ ([0054]); and a contrast unit connected to a distal end of the flexible body portion and protruding in a distal direction from the distal end of the flexible body portion, with relative positions of the image sensor and the contrast unit in an axial rotation direction being fixed ([0054]).
Franano also shows wherein the contrast unit is a metal wire that protrudes in a direction intersecting the axial direction of the flexible body portion ([0052]-[0054]); wherein a distal end of the contrast unit is disposed at a position that overlaps the image sensor at a position separated outward in a radial outward direction from an axial center of the flexible body portion (Fig. 10); wherein the flexible body portion is a flexible wire (catheter is considered a flexible wire; [0036]); wherein the contrast unit includes a curved portion as seen in a side view of the image acquisition medical device (Fig. 10); wherein the contrast unit is J-shaped as seen in a side view of the image acquisition medical device (Fig. 10); wherein the flexible body portion includes a distal end, the contrast unit including a first portion positioned immediately adjacent the distal end of the flexible body portion, the first portion of the contrast unit extending in a distal direction along a center axis of the flexible body portion and away from the distal end of the flexible body portion (Fig. 10); wherein the flexible body portion possesses an outer diameter and the contrast unit possesses an outer diameter, the outer diameter of a distal end of the flexible body portion that is connected to a proximal end of the contrast unit being larger than an outer diameter of the proximal end of the contrast unit (Fig. 10).
Franano fails to show the flexible body portion visually recognizable in an angiographic image and in the tomographic image.
Franano fails to show a display device configured to display an angiographic image and a tomographic image acquired by the image acquisition medical device that is insertable into a hollow organ; a control device connected to the display device and configured to control a display content of the display device; and the control device being configured to control the display content to display an orientation of a distal end portion of the image acquisition medical device in the tomographic image.
Franano fails to show rotating the image wire that is positioned in a hollow organ so that an orientation of a distal end of the contrast unit changes in the tomographic images and the angiographic images on the display; and determining the orientation of a distal end portion of the flexible body portion by viewing a change in the orientation of the distal end of the contrast unit in the tomographic images and the angiographic images displayed on the display.
Franano also fails to show wherein the control device is configured to control the display content such that a left-right orientation of the image acquisition medical device on an angiographic image plane with respect to an axial direction and a left-right orientation of the tomographic image are matched and displayed on the display device.
Franano fails to show a distal end of the contrast unit being disposed at a position that overlaps the image sensor at a position separated outward in a radial outward direction from an axial center of the flexible body portion so that a plane perpendicular to the axial center of the flexible body portion and passing through the image sensor intersects the distal end of the contrast unit.
Gaddis discloses devices and methods for arteriovenous access including a wire having radiopaque markers ([0060]). Gaddis teaches the flexible body portion visually recognizable in an angiographic image and the tomographic image (co-register IVUS images with angiography data, [0082]); a display device configured to display an angiographic image and a tomographic image acquired by the image acquisition medical device that is insertable into a hollow organ ([0031], [0082]); a control device connected to the display device and configured to control a display content of the display device ([0031], [0043]-[0044]); and the control device being configured to control the display content to display an orientation of a distal end portion of the image acquisition medical device in the tomographic image ([0060], [0082]); rotating the image wire that is positioned in a hollow organ so that an orientation of a distal end of the contrast unit changes in the tomographic images and the angiographic images on the display ([0060], [0082]); and determining the orientation of a distal end portion of the flexible body portion by viewing a change in the orientation of the distal end of the contrast unit in the tomographic images and the angiographic images displayed on the display ([0060], [0082]); wherein the control device is configured to control the display content such that a left-right orientation of the image acquisition medical device on an angiographic image plane with respect to an axial direction and a left-right orientation of the tomographic image are matched and displayed on the display device (co-registration of images matches orientation, [0082]).
Grossman discloses methods and devices for imaging and treating fibroids. Grossman teaches a distal end of the contrast unit being disposed at a position that overlaps the image sensor at a position separated outward in a radial outward direction from an axial center of the flexible body portion so that a plane perpendicular to the axial center of the flexible body portion and passing through the image sensor intersects the distal end of the contrast unit (hooked needle 28 deployed within the limits of the imaging field of the imaging module 12; where any tool which will appear in contrast within the image may be considered as a contrast unit; [0037], Fig. 2C).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Franano to have utilized the medical device comprising radiopaque markers in a variety of different biological systems within the patient’s body, including during angiography as taught by Gaddis, as angiography is a common diagnostic imaging procedure, and will aid in specifically diagnosing the patient’s cardiovascular system. Gaddis further teaches that such monitoring is beneficial in situations in access procedures, and may avoid risks associated with DASS and thrombosis ([0005]-[0006]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Franano and Gaddis, such that the distal end of the contrast unit being disposed at a position that overlaps the image sensor as taught by Grossman, in order to maintain the distal tip of the device within the field of view of the image sensor, so that the operator may more easily visualize the end of the device while located within the patient as taught by Grossman. Furthermore, in the combined invention of Franano in which IVUS images are co-registered with angiography images as taught by Gaddis, the tool taught by Grossman which is arranged in view of the tomographic imaging sensor will be visible in both tomographic and angiographic images.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Franano et al. (US 2011/0160682; hereinafter Franano) in view of Gaddis et al. (US 2014/0276027; hereinafter Gaddis) and Grossman (US 2019/0192217). as applied to claim 1 above, and further in view of Hartmann et al. (US 2014/0357997; hereinafter Hartmann).
Franano fails to show wherein the image sensor is a phased array image sensor in which a plurality of sensor elements are arranged in a ring shape.
Hartmann discloses intraluminal imaging including radiopaque markers for combination with external imaging modalities such as an angiogram ([0046]). Hartmann teaches wherein the image sensor is a phased array image sensor in which a plurality of sensor elements are arranged in a ring shape ([0068]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Franano, Gaddis, and Grossman to utilize a ring shaped phase array sensor as taught by Hartmann, as the use of a ring shaped sensor allows for imaging data to be acquired from the entirety of the circumference of the vessel without rotation as taught by Hartmann ([0068]).
Response to Arguments
Applicant’s arguments with respect to the 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
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN CWERN whose telephone number is (571)270-1560. The examiner can normally be reached Monday - Friday, 8:00 am - 5:00 pm.
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, Christopher Koharski can be reached at (571) 272-7230. 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.
/JONATHAN CWERN/Primary Examiner, Art Unit 3797