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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/07/2025 has been entered.
Response to Amendment
The amendment filed on 11/07/2025 has been entered. Claims 1-11, 13 are pending. Claim 12 is allowed.
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.
Claim(s) 1-4, 6-7, is/are rejected under 35 U.S.C. 103 as being unpatentable over Fujii (US 20200008866) in view of Kaneko (US 20030187319) and further in view of Lennartz (US 20210177531) and Seibel (US 20060195014).
Regarding claim 1, Fujii discloses method of harvesting a target vessel from a body (Instrument including a cutter member 14; FIGS. 1, 5; Para [0033]), the method comprising:
inserting (FIG. 5; para [0033]) an elongated harvesting instrument (Instrument including a cutter member 14) into the body along a path of the target vessel, wherein the target vessel connects to at least one side branch (FIG. 5), and wherein the harvesting instrument includes a cutter (Cutter 14 has a cutter electrode 16; para [0032]) for applying thermal energy to sever and cauterize the side branch (vessel 11; branch13, FIG. 1, 5; electrocautery heating is applied only to the branch being cauterized so that less heat spreads to the tunnel or surrounding structures; para [0011], [0033], [0037]; claim 9).
Fujii does not expressly disclose capturing visible-light images from a distal tip of the instrument using an endoscopic camera mounted to the harvesting instrument within a dissected tunnel around the target vessel; capturing thermograms coinciding with the visible-light images using a thermal camera mounted to the harvesting instrument to characterize a temperature present at respective surfaces in the tunnel; rendering a video stream including the visible-light images and an overlay depicting temperatures present on at least some of the respective surfaces when applying the thermal energy to sever and cauterize the side branch; and presenting the video stream and overlay to a user on a display.
Kaneko is directed to a sentinel lymph node detecting apparatus (abstract) and teaches capturing visible-light images (visible-light CCU 3, visible light CCD 12; FIGS. 3, 5; para [0061], [0065]) from a distal tip (FIG. 1) of the instrument using an endoscopic camera (visible-light CCD 12; para [0065]) mounted to an instrument (endoscope 2; FIGS. 3, 6) within a dissected tunnel around the target vessel (FIG. 5; cavity 31; lymph vessel; para [0063]); capturing thermograms coinciding with the visible-light images using a thermal camera (An infrared object optical system 13, detecting temperature distribution; Infrared lymph node image; FIG. 4C; para [0067], [0071]; FIG.3; Para [0086]) mounted to the harvesting instrument to characterize a temperature present at respective surfaces in the tunnel (A temperature-change image obtained by the temperature change imaging means is superimposed on an endoscope image obtained by the endoscope imaging means, so as to identify the position of the sentinel lymph node; para [0023]);
rendering a video stream including the visible-light images (Computer color-enhanced image obtained by the sentinel lymph node detecting apparatus shown in FIG. 1; para [0032]-[0034], [0088]) and an overlay depicting the temperatures present on at least some of the respective surfaces when applying the thermal energy; and presenting the video stream and overlay to a user on a display (a temperature-change image obtained by the temperature change imaging means is superimposed on an endoscope image obtained by the endoscope imaging means, so as to identify the position of the sentinel lymph node; para [0023], [0076], [0088], [0166], [0181]-[0182]; Monitor 6; FIG. 1; para [0182], [0270]).
Lennartz is directed to methods of performing surgical operations (Para [0002]) and teaches rendering a video stream (Video or a still image) of the tissue “T”; Para [0047]; para [0036], [0056]) including the visible-light images depicting the temperatures present on at least some of the respective surfaces based on the thermal energy of the side branch (Cauterized tissue versus healthy tissue is imaged based on the temperature of the cauterized tissue versus healthy tissue; para [0056]).
Seibel is directed to apparatus and a method for diagnostic imaging within a body lumen using a scanning endoscope (para [0001]) and teaches rendering visible-light images and an overlay depicting temperatures present on at least some of the respective surfaces before and while applying the thermal energy to sever and cauterize a tissue (Both the IR and visible images are acquired during the laser surgery and/or cauterization. The IR image is a thermal image of the ROI (region of interest), which can be displayed on the interactive computer display as pseudo-color over a grayscale visible image. Para [0045]); and presenting the video stream and overlay to a user on a display (The medical practitioner monitors the progress of the IR radiation treatment by observing these acquired images on both the high resolution and interactive display monitors. Para [0045]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Fujii to include a color enhanced imaging process and methods in accordance with the teaching of Kaneko so that image of the tools and surgical area could be generated using both visible light image and infrared image so that low light images could be produced for the enhanced visibility of the surgical area. Further, it would have been obvious to further modify Fujii to image the healthy tissue and cauterized tissue based on the temperature distribution of the tissues when severing and cauterizing in accordance with the teaching of Lennartz so that cauterized tissue could be seen and the visibility of the surgical area is improved.
Further, it would have been obvious to further modify Fujii to include visible-light images and thermal image of at least some of the respective surfaces during applying the thermal energy to sever and cauterize a tissue so that accurate visibility of the surgical are could be provided during cauterization by way of having both the images during surgery.
Regarding claim 2, Fujii as modified, teaches wherein the overlay comprises a color tint including a plurality of colors corresponding to respective temperature magnitudes (Kaneko: A computer color-enhanced infrared image obtained by an infrared sensor is superimposed on an endoscope image obtained by visible-light CCD, and the synthesized endoscope infrared image is displayed on a display screen of the monitor. Abstract; para [0077]).
Regarding claim 3, Fujii as modified, teaches identifying the target vessel and the side branch, wherein the overlay depicts the temperatures present for at least a portion of the target vessel and of the side branch (Kaneko: A computer color-enhanced infrared image obtained by an infrared sensor is superimposed on an endoscope image obtained by visible-light CCD, and the synthesized endoscope infrared image is displayed on a display screen of the monitor. Abstract; para [0077]; Such modified image would include image of target vessel 11, including side branch 13 of Fujii; Note that the infrared image corresponds to the temperature.).
Regarding claim 4, Fujii as modified, teaches rendering a cutting indicator (Kaneko: Infrared lymph node image; FIG. 4C) to guide the cutter to an optimal location for severing the identified side branch to limit a heat load applied to the target vessel (Kaneko: Sentinel lymph node detection apparatus 1 using infrared imaging; sentinel lymph node; para [0083], [0086], [0088], [0089], [0090]; FIGS. 4C, 8, 18; The sentinel lymph node image can provide guidance to the cutter to an optimal location for severing; also see claim 1.).
Regarding claim 6, Fujii as modified, teaches accumulating a heat exposure (Fujii: high-frequency current to generate extreme heat in a very localized area; para [0011]) to which the target vessel is subjected (Kaneko: identifying of the sentinel lymph node 7. Para [0096]; sentinel lymph node detection apparatus 1 using infrared imaging; para [0083], [0089], [0090]; FIGS. 4C, 8).
Regarding claim 7, Fujii as modified teaches rendering a parametric display indicator corresponding to an accumulated heat exposure (Kaneko: identifying of the sentinel lymph node 7. Para [0096]; sentinel lymph node detection apparatus 1 using infrared imaging; para [0083], [0089], [0090]; FIGS. 4C, 8).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fujii (US 20200008866) in view of Kaneko (US 20030187319) and further in view of Lennartz (US 20210177531), Seibel (US 20060195014), and Ho (US 20190339850).
Regarding claim 8, Fujii does not expressly disclose rendering a diameter indicator according to an estimated diameter of the side branch.
Ho is directed to medical imaging and/or to the field of optical imaging (abstract) and teaches rendering a diameter indicator according to an estimated diameter of a side branch (Lumen diameter in the vessel view; a lumen diameter display; FIG. 2; [0069]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Fujii to estimate a diameter of a vessel in accordance with the teaching of Ho so that the size of the vessel could be known and used during surgery.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fujii (US 20200008866) in view of Kaneko (US 20030187319) and further in view of Lennartz (US 20210177531), Seibel (US 20060195014), Ho (US 20190339850) and Kabaya (US 20220280224).
Regarding claim 9 Fujii, does not expressly disclose determining a target energy for severing the side branch according to the estimated diameter of the side branch.
Kabaya is directed to a methods and systems for treating biological tissue using high frequency electrical energy and teaches determining a target energy for severing the side branch according to the estimated size of a side branch (Energy and other parameter look up table is provided for supplying power for corresponding to tissue size. Para [0078], [0108], [0111]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Fujii to include a step of determining a target energy for severing a vessel based on size of the vessel in accordance with the teaching of Kabaya so that appropriate energy could be supplied to the tissue during cutting minimizing damage to the side vessels.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fujii (US 20200008866) in view of Kaneko (US 20030187319) and further in view of Lennartz (US 20210177531), Seibel (US 20060195014), Ho (US 20190339850), Kabaya (US 20220280224) and Cosman (US 5233515).
Regarding claim 10, Fujii does not expressly disclose rendering an energy indicator according to the target energy.
Cosman is directed to real-time graphic display of heat lesioning parameters (abstract) and teaches rendering an energy indicator according to the target energy (temperature curve versus time display of a lesion; FIG. 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Fujii to include a display for energy so that a user could see the actual real-time energy value of the target so that a user can make an appropriate decision about energy supply to the target.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fujii (US 20200008866) in view of Kaneko (US 20030187319) and further in view of Lennartz (US 20210177531), Seibel (US 20060195014), and Carnes (US 20200226758).
Regarding claim 11, Fujii does not expressly disclose the display comprises an augmented reality display worn by the user.
Carnes is directed to augmented reality surgical system for viewing an augmented image of a region of interest during a surgical procedure (abstract) and teaches wherein the display is comprised of an augmented-reality display worn by the user (Infrared image may be obtained and added to augment image; para [0017]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Fujii to have an augmented reality in accordance with the teaching of Carnes so that augmented image of the vessels could be generated and used during surgery.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fujii (US 20200008866) in view of Kaneko (US 20030187319) and further in view of Lennartz (US 20210177531), Seibel (US 20060195014), and Leschinsky (US 20140236020).
Regarding claim 13, Fujii does not expressly disclose monitoring heat exposure to which the target vessel is subjected to limit a heat load applied to the target vessel.
Leschinsky is directed to remote thermographic assessment of tissue viability (abstract) and teaches monitoring heat exposure to which the target vessel is subjected to limit a heat load applied to the target vessel (amount of thermal radiation emitted by the tissue is measured by a thermal sensitive camera. Para [0055]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Fuji to include a system of measuring thermal radiation in accordance with the teaching of Leschinsky so that non-contact heat measurement could be used during surgery.
Response to Arguments
Applicant' s arguments 11/07/2025 have been fully considered and are persuasive. Therefore, the rejection dated 8/12/2025 has been withdrawn. However, upon further consideration a new rejection has been made in view of amendment.
In Para [0045], Seibel teaches rendering visible-light images and an overlay depicting temperatures present on at least some of the respective surfaces before and while applying the thermal energy to sever and cauterize a tissue (Both the IR and visible images are acquired during the laser surgery and/or cauterization. The IR image is a thermal image of the region of interest, which can be displayed on the interactive computer display as pseudo-color over a grayscale visible image. Para [0045]); and presenting the video stream and overlay to a user on a display (The medical practitioner monitors the progress of the IR radiation treatment by observing these acquired images on both the high resolution and interactive display monitors. Para [0045]).
Accordingly, claim 1 is rejected.
Allowable Subject Matter
Claim 5
The following is an examiner’s statement of reasons for allowance:
See allowable subject matter in the Office Action dated 3/26/2025 on pages 9-10.
Claim 12 encompasses similar inventive features as claim 5.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHANKAR R GHIMIRE whose telephone number is (571)272-0515. The examiner can normally be reached 8 AM - 5 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached at 571-272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHANKAR RAJ GHIMIRE/Examiner, Art Unit 3795
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
01/10/26