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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/12/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 1 is recited below –
An endoscopic examination support apparatus comprising:
a memory configured to store instructions; and
a processor configured to execute the instructions to:
(a) acquire captured images during removal of an endoscope;
(b) estimate a relative posture change of an endoscope camera from the captured images;
(c) estimate a distance between a surface of colon and the endoscope camera from the captured images;
(d) estimate an intestinal tract direction of the colon based on the posture change and the distance;
(e) calculate a direction in which the endoscope camera should be directed, based on the intestinal tract direction and the relative posture of the endoscope camera; and
(f) output a display image including the direction in which the endoscope camera should be directed, to a display device.
Step 1
With respect to claims 1-5, at step 1, the claims are directed to an apparatus, which is eligible.
Step 2A
With respect to the consideration at step 2A, the following elements are directed to an abstract idea:
a memory configured to store instructions; and
a processor configured to execute the instructions to:
(a) acquire captured images during removal of an endoscope;
(b) estimate a relative posture change of an endoscope camera from the captured images;
(c) estimate a distance between a surface of colon and the endoscope camera from the captured images;
(d) estimate an intestinal tract direction of the colon based on the posture change and the distance; and
(e) calculate a direction in which the endoscope camera should be directed, based on the intestinal tract direction and the relative posture of the endoscope camera.
Above elements are mental processes performed on a generic computer. Acquiring images by a computer is well known and conventional. From the captured images, posture change could be estimated by observing the images by human eyes. Estimating a distance between a surface of colon and the endoscope camera from the captured images can be made by human eyes based on the color and depth of the image area. Estimating an intestinal tract direction of the colon based on the posture change and the distance is also is well-understood or conventional because once the image of the colon is obtained, by observing the image of the colon and its orientation and the direction in which the endoscope camera should be directed could be determined by observation.
Step 2B
The above elements (a)-(e), are recited in high level of generality for making observations and estimates. As explained by the Supreme Court, the addition of insignificant extra-solution activity does not amount to an inventive concept, particularly when the activity is well-understood or conventional. See MPEP 2106.05(g).
Regarding element (f), outputting a display image including the direction in which the endoscope camera should be directed, to a display device is an additional step which appears to be merely the invocation of a general-purpose computer display and does not amount to significantly more.
Further, the dependent claims 2-5 merely include limitations that either further define the abstract idea (and thus don’t make the abstract idea any less abstract) or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they’re merely incidental or token additions to the claims that do not alter or affect how the claimed functions/steps are performed.
Accordingly, claims 1-5 are not patent eligible and rejected under 35 U.S.C. 101.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 recite the limitation "a surface of colon" in lines 10.
Instead, this limitation should be recited as “a surface of a colon."
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-8 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recite the limitation "the relative posture of the endoscope camera" in lines 14-15. There is insufficient antecedent basis for this limitation in these claims.
Appropriate correction is required.
In lines 7-8, claim 1 recites “a relative posture change of an endoscope” and in line 12, the claim recites “the posture change” and in lines 14-15 the claim recites “the relative posture”
This claim is unclear because the applicant is providing different terms for the same feature. Appropriate correction is required.
Claim 1 recites “acquire captured images during removal of an endoscope,” in lines 5-6. In lines 14-17, the claim recites “the endoscope should be directed, based on the intestinal track direction.
Thus, in the above claim, it is unclear whether the claims are reciting the features during insertion or during withdrawal of the insertion portion or both.
Appropriate correction is required.
Claims 2-8 are rejected for being dependent on a rejected base claim.
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) 1-2, 4-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Duindam (US 20190320878) in view of Freedman (US 20220369920).
Regarding claim 1, Duindam discloses an endoscopic examination support apparatus (FIG. 1) comprising: a memory (FIG. 2A) configured to store instructions; and
a processor (computer processor; FIG. 2A; para [0040]) configured to execute the instructions to:
acquire captured images (registered real-time images and prior-time anatomic images during an image-guided procedure are provided; abstract; 3D image of the anatomy with the medical instrument disposed therein; FIG. 5; Three-dimensional image data may include data representing at least a portion of a medical instrument 304 positioned within the anatomy of the patient P as shown in FIGS. 3A-B and 4A-D, 8; para [0063]);
estimate a relative posture change (speed, velocity pose or shape of the tip is determined using imaging devices; para [0046]; Speed represent the position change; When the direction vector 808 is provided and is used for moving the instrument in real time, a real-time new data is used which requires calculation of relative position change of the instrument 304. FIG. 8) of an endoscope camera from the captured images;
estimate a distance between a surface of colon and the endoscope camera from the captured images (When the medical instrument 804 is provided, the relative position of the instrument from the surface is utilized when a model 802 is generated. Estimating vector 808 requires estimating its position/distance with respect to the surface.);
estimate an intestinal tract direction (vector 808; FIG. 8, annotated below) of the colon based on the posture change and the distance (As shown in FIG. 8, the vector 808 is based on posture change and distance from the target in real-time. The trajectory vector 808 may be generated in response to a request from the operator O or based on a calculated distance from the target 806. Para [0081]);
calculate a direction in which the endoscope camera should be directed (In FIG. 8, vector 808 points to the direction in which the endoscope should be directed. ), based on the intestinal tract direction and the relative posture of the endoscope camera (As shown in FIG. 8, this direction is based on the relative posture of the distal tip of the instrument 804 and distance from the surface of the target; Note that the image 800 includes a surface of bronchial passage; the model 802; para [0077]); and
output a display image(composite image 800; display 110 of FIG. 8) including the direction in which the endoscope camera should be directed, to a display device.
Duindam does not expressly disclose the captured images acquired during removal of an endoscope.
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Freedman is directed to endoscopy procedures (abstract; para [0002]) and teaches acquiring captured images during removal of an endoscope (image captured during withdrawal; para [0057]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Duindam to include capture images during removal of the endoscope so that images during both the insertion and removal could be used in image data set which can then be utilized by a training system for system training or a user for viewing during surgery.
Regarding claim 2, Duindam discloses wherein the direction (Direction 808 for bronchial passage; FIG. 8) in which the endoscope camera should be directed is the intestinal tract direction (Direction for intestinal tract is intended use).
Regarding claim 4, Duindam discloses wherein the direction in which the endoscope camera should be directed includes the intestinal tract direction and a lesion direction (The preoperative model may include a number of targets such as tumors, lesions, or other regions of tissue to be accessed during a medical procedure. Para [0085]), and wherein the processor outputs the display image which displays the intestinal tract direction and the lesion direction in a distinguishable manner (As seen in FIG.8, intestinal tract direction and the lesion direction are shown in distinguishable manner; Targets such as tumors, lesions are provided.).
Regarding claim 5, Duindam discloses wherein the processor generates an intestinal tract model based (surface model 802; FIG. 8) on the posture change (In FIG. 8, vector 808 points to the direction in which the endoscope should be directed. When the direction vector 808 is provided and is used for moving the instrument in real time, a real-time new data is used which requires calculation of relative position change of the instrument 304. FIG. 8) and the distance (As shown in FIGS. 8, 11, the distance is automatically used because it is referenced with the lumens and surface features (such as tumors or growth) of lung.), and estimates the intestinal tract direction based on the intestinal tract model (Track direction 808 is shown in the model 802 in reference to both the lumen in the lung and the tumor. FIG. 8).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Duindam (US 20190320878) in view of Freedman (US 20220369920) and further in view of Yeung (US 20180296281).
Regarding claim 3, Duindam does not expressly disclose wherein the processor estimates the posture change using a machine learning model that is trained, in advance, to estimate a depth and the posture change of the endoscope camera from the endoscopic images.
Yeung is directed to automated steering control of a robotic endoscope (abstract) and teaches wherein the processor estimates the posture change using a machine learning model that is trained, in advance, to estimate a depth and the posture change of the endoscope camera from the endoscopic images (The analysis performed by the machine learning architecture is refined using one or more sets of training data as input; steering control system may use a pre-trained ANN architecture. Para [0007], [0064], [0086]; Position dada of the distal portion relative to the center or the wall of the colon [0085]; a processor is configured to generate a steering control output signal to control the one or more actuation units based on an analysis of the first input data stream using a machine learning architecture, wherein the steering control output signal adapts to changes in the data of the first input data stream in real time.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Duindam to include a training model so that a training model could be provided by a user to train and utilize the trained machine learning system.
Claim(s) 6-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Duindam (US 20190320878) in view of Freedman (US 20220369920) and further in view of Popovic (US 20150073265).
Regarding claim 6, Duindam does not expressly disclose wherein the processor outputs the display image in which a trajectory of postures of the endoscope camera is superimposed and displayed on the intestinal tract model.
Popovic is directed to a system and methods for guided endoscope navigation (abstract) and teaches wherein the processor outputs the display image in which a trajectory of postures of the endoscope camera is superimposed and displayed (an endoscope trace 208 is overlaid onto an endoscope image to show the motion of the endoscope; FIG. 2A; para [0032]) on the intestinal tract model (endoscope image 202; FIG. 2A, reproduced below).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Duindam to include a trajectory of postures of the endoscope camera in a display in accordance with the teaching of Popovic so that user can see the trajectory as the endoscope (device) advances into the lumen.
Regarding claim 7, Duindam as modified teaches wherein the processor outputs the display image in which the intestinal tract model is viewed in a direction in which overlap of the postures of the endoscope camera in the trajectory is small (Popovic: Note the small overlap of postures in FIG. 2A).
Regarding claim 8, Duindam as modified teaches wherein the processor outputs the display image in which a trajectory of postures of the endoscope camera and the direction in which the endoscope camera should be directed are superimposed and displayed on the captured image (Popovic: Note the superimposed trajectory of postures of the endoscope in FIG. 2A; para [0032]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO- 892.
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 on 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
12/28/2025