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 § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-16 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Mino et al. (US 2024/0197403 A1, Jun. 20, 2024) (hereinafter “Mino”).
Regarding claim 1: Mino discloses a system comprising: a flexible elongate device including an optical imaging device and a working channel (figs. 1 and 10, echoendoscope 120, [0070] - "treatment instrument channels…inside insertion portion 111"; [0073] - "image pickup section", [0075], [0083]); an acoustic imaging device carried by the flexible elongate device, the acoustic imaging device configured to generate a plurality of acoustic images of a region of interest (figs. 2A-2B and 11A-11B, ultrasound transducer section 133, [0074], [0080]); an interventional tool extendable through the working channel of the flexible elongate device ([0070], [0076], [0254]); and a control system configured to: receive the plurality of acoustic images of the region of interest from the acoustic imaging device and provide guidance for inserting the interventional tool along a path through an anatomic orifice and an anatomic passageway of the region of interest, wherein the guidance is generated based on the plurality of acoustic images ([0082]-[0083] - imaging and control system; [0200], fig. 16 and associated description; [0270], [0286] - projected navigation path 518, where the path extends from an anatomic orifice through anatomic passageways as shown in at least figs. 3A and 12A and [0080], [0263]).
Regarding claim 2: Mino discloses the system of claim 1, wherein providing the guidance includes: generating a model of the region of interest from the plurality of acoustic images (0200], fig. 16 and associated description; [0270], [0286] - projected navigation path 518); and displaying the model of the region of interest and a representation of the interventional tool advancing along the path through the anatomic orifice and the anatomic passageway of the region of interest ([0111], [0131], [0202], [0215], [0270], [0310]).
Regarding claim 3: Mino discloses the system of claim 2, wherein providing the guidance further includes: displaying, with the model, a marker illustrating the path through the anatomic orifice and the anatomic passageway of the region of interest ([0295], [0297] - projected navigation path 518, where the path extends from an anatomic orifice through anatomic passageways as shown in at least figs. 3A and 12A and [0080], [0263]; "path 518…can be displayed in one color and overlaid…live navigation path can be displayed in a different color...").
Regarding claim 4: Mino discloses the system of claim 2, wherein the optical imaging device is configured to generate an image of a field of view and wherein providing the guidance further includes displaying a synthetic endoscopic image generated from the model, the synthetic endoscopic image corresponding to a perspective of the optical imaging device needed to align an interventional tool trajectory along the path ([0270] - real-time optical endoscopic image overlaid on virtual EUS image, where the ultrasound image and optical image have "corresponding" viewpoints based on their physical structure as shown in figs. 2A-B and 11A-B; while it is unclear how not clear how "needed to align" limits the structure of the optical imaging device or the display, the image of Mino is considered to be capable of performing this function).
Regarding claim 5: Mino discloses the system of claim 4, wherein the control system is further configured to adjust a position and an orientation of the flexible elongate device until a real-time image of the field of view of the optical imaging device matches the synthetic endoscopic image ([0292]- “one or more operational parameters of the EUS probe can be determined or adjusted…such operational parameters may include a position of the EUS probe to aim a center of the anatomical target, a desired rotating angle of the EUS probe, or a contact force between the EUS probe and a surface of the anatomical target.”).
Regarding claim 6: Mino discloses the system of claim 2, wherein the control system is further configured to register the model to the flexible elongate device and the interventional tool ([0284], [0307] - "alignment"; fig. 16, steps 720-730, [0301]-[0302]).
Regarding claim 7: Mino discloses the system of claim 1 wherein providing the guidance includes: displaying the plurality of acoustic images of the region of interest, the plurality of acoustic images showing a guide device advancing along the path through the anatomic orifice and the anatomic passageway of the region of interest, wherein the interventional tool is configured to advance over the guide device ([0085] - "information used for generating the tissue acquisition plan (e.g., real-time EUS images) can be displayed to the operating physician as a guidance during the procedure", [0114], [0284] - "a real-time perioperative image", [0297] - "or other steerable elongate instrument such as a guidewire", where [0132] - guidewire or guide sheath “guide device” can be the actuated instrument).
Regarding claim 8: Mino discloses The system of claim 7, wherein displaying the plurality of acoustic images includes displaying at least one selected guidance image of the plurality of acoustic images that includes the path ([0270] - "a real-time perioperative endoscopic image (e.g., an EUS image…)" where the navigation plan "includes the path"; [0292], [0295], [0297] - projected navigation path 518, where the path extends from an anatomic orifice through anatomic passageways as shown in at least figs. 3A and 12A).
Regarding claim 9: Mino discloses the system of claim 8, wherein the control system is further configured to align a guide channel of the acoustic imaging device with the path visible in the selected guidance image ([0292]- “one or more operational parameters of the EUS probe can be determined or adjusted…such operational parameters may include a position of the EUS probe to aim a center of the anatomical target, a desired rotating angle of the EUS probe, or a contact force between the EUS probe and a surface of the anatomical target” where the “guide channel” passes through the EUS probe and is therefore aligned to the path).
Regarding claim 10: Mino discloses the system of claim 9, wherein the guide device is a guidewire insertable through the guide channel aligned with the path through the anatomic orifice and the anatomic passageway ([0297] - "or other steerable elongate instrument such as a guidewire"; [0132] - guidewire or guide sheath “guide device” can be the actuated instrument).
Regarding claim 11: Mino discloses the system of claim 1 wherein the optical imaging device is configured to generate an image of a field of view, wherein the region of interest is obscured by tissue surrounding the anatomic orifice while the plurality of acoustic images of the region of interest are received from the acoustic imaging device (figs. 3A-3B and 12A-12B - the region of interest is inside the body and therefore "obscured by tissue surrounding the anatomic orifice"; [0073], [0084], [0256], [0267] - "a field of view" is considered to be an inherent property of an endoscopic optical image acquired using a camera).
Regarding claim 12: Mino discloses the system of claim 11, wherein the flexible elongate device includes an endoscope ([0066]).
Regarding claim 13: Mino discloses the system of claim 1 further comprising a localization device carried by the flexible elongate device and configured to provide the guidance for inserting the interventional tool ([0275]).
Regarding claim 14: Mino discloses the system of claim 13, wherein the localization device includes a localization sensor configured to reference the plurality of acoustic images to a common reference frame ([0275]).
Regarding claim 15: Mino discloses the system of claim 14, wherein the localization sensor is fixed relative to the acoustic imaging device ([0275]).
Regarding claim 16: Mino discloses the system of claim 14, wherein the localization sensor includes an optical fiber sensor ([0275]).
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.
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.
Claim(s) 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mino in view of Gono et al. (US 2023/0148847 A1, May 18, 2023) (hereinafter “Gono”).
Regarding claim 17: Mino discloses the system of claim 13, including that the system is used to perform procedures such as ERCP cannulation ([0078]). While Mino discloses that the system may use a guidewire ([0132], [0277]), Mino does not provide an explicit description of the structural relationship between the guidewire and the flexible elongate device.
Gono, in the same field of endeavor, discloses a system for performing ERCP cannulation ([0090]-[0092]) comprising a flexible elongate device (endoscope 2011) where a guidewire is extendable from the flexible elongate device ([0092]) where the guidewire is visible in a plurality of images acquired by the endoscope and is used as part of the positioning guidance ([0112]).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide a guidewire with the system of Mino as taught by Gono in view of the teachings of Gono that this is a standard part of the procedure performed by both Mino and Gono.
Regarding claim 18: Mino as modified by Gono discloses the system of claim 17, wherein the acoustic imaging device is integrated with the flexible elongate device and the guide device is a guidewire extendable through the working channel of the flexible elongate device (Mino - figs. 2A-2B, 11A-11B, [0074], [0257]; Gono – the structural arrangement of the guidewire with respect to the endoscope corresponds to the working channel and distal end portion of Mino as shown in at least figs. 2 and 28).
Regarding claim 19: Mino as modified by Gono discloses the system of claim 17, further comprising an acoustic imaging tool including the acoustic imaging device, wherein the acoustic imaging tool is separable from the flexible elongate device ([0274] - second, separate EUS probe). While Mino and Gono do not specify which EUS probe would be used with the guidewire, since both EUS probes of Mino perform the same function it would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide the guidewire as extendable through either of the acoustic imaging tools of Mino in order to provide alternate paths for performing the ERCP procedure.
Regarding claim 20: Mino discloses the system of claim 1 wherein the path has a substantially straight trajectory from the anatomic orifice (see the “substantially straight” portion of the esophagus as shown in figs. 3A and 12A) and that the system is used to perform procedures such as ERCP cannulation ([0078]). However, Mino is silent on the structural properties of the endoscope and does not explicitly disclose that the interventional tool is generally rigid for traversing the path having the substantially straight trajectory.
Gono, in the same field of endeavor, discloses a system for performing ERCP cannulation ([0090]-[0092]) comprising a flexible elongate device (endoscope 2011) which “generally rigid” (fig. 23, [0159] - each of bending pieces 2112 would be rigid in order to perform the steering function in response to the pull wires) for traversing a path having a substantially straight trajectory (see the “substantially straight” portion of the esophagus shown in at least figs. 1 and 20).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to implement the flexible elongate device of Mino using the “generally rigid” bending pieces of Gono in order to provide a steering function for performing the ERCP procedure.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Duindam et al. (US 2020/0054399 A1, Feb. 20, 2020) – discloses an ultrasound endoscope with navigation planning and visualization functions
Shapira et al. (US 2024/0366202 A1, Nov. 7, 2024) – substantially discloses the limitations of claim 1
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAROLYN A PEHLKE whose telephone number is (571)270-3484. The examiner can normally be reached 9:00am - 5:00pm (Central Time), Monday - Friday.
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, Chris 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.
/CAROLYN A PEHLKE/ Primary Examiner, Art Unit 3799
Prosecution Insights