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 .
Restriction
Applicants’ election of group I, claims 1-6, without traverse, is acknowledged and made final. Claims 7-8 are withdrawn from further consideration.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/24/2025, 11/22/2023 are 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 one or more processors configured to execute the instructions to: acquire captured images during removal of an endoscope;
estimate a relative posture change of an endoscope camera from the captured images; estimate an intestinal tract direction of a colon based on the posture change and a distance between a surface of colon and the endoscope camera using the captured images;
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
output, to a display device, a display image including an indicator presenting the direction in which the endoscope camera should be directed, wherein the indicator is displayed at least one of the upper, lower, left and right ends of the captured images.
Step 1
With respect to claims 1-6, 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:
An endoscopic examination support apparatus comprising:
a memory configured to store instructions; and one or more processors 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 an intestinal tract direction of a colon based on the posture change and a distance between a surface of colon and the endoscope camera using the captured images;
(d) 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
(e) output, to a display device, a display image including an indicator presenting the direction in which the endoscope camera should be directed, wherein the indicator is displayed at least one of the upper, lower, left and right ends of the captured images.
Above elements, (a)-(d), 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 using the captured image.
Step 2B
The above elements (a)-(d), 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 (e), outputting, to a display device, a display image including an indicator presenting the direction in which the endoscope camera should be directed, wherein the indicator is displayed at least one of the upper, lower, left and right ends of the captured images, 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 3-6 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, 3-6 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 line 7.
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 1-6 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 recites “estimate an intestinal tract direction of a colon based on the posture change and a distance between a surface of colon and the endoscope camera using the captured images,” in lines 6-7.
According to para [0007], and [0088], an intestinal tract direction is estimated based on the posture change and the distance. In the above recitation, it is unclear whether the captured images are used for estimating both the intestinal tract direction and the distance.
For the purpose of prosecution, the above feature is considered as –
estimate an intestinal tract direction of a colon based on the posture change and a distance between a surface of colon and the endoscope camera, wherein the distance is estimated using the captured images.
Appropriate correction/clarification is required.
In line 5, claim 1 recites “a relative posture change of an endoscope camera” and in line 6, the claim recites “the posture change” and in line 9, the claim recites “the relative posture.” These terms appear to refer to the same feature but are providing slightly different terms which makes the claim unclear.
Appropriate correction is required.
Claim 1 recites the limitation "the relative posture of the endoscope camera" in line 9. There is insufficient antecedent basis for this limitation in the claim.
Appropriate correction is required.
Claim 1 recites “acquire captured images during removal of an endoscope,” in line 4. In lines 8-9, the claim recites “calculate a direction in which the endoscope camera should be directed, based on the intestinal tract direction….” Thus, it is unclear whether the processor is configured to achieve above features during withdrawal or during insertion of the insertion portion or both. Appropriate correction is required.
For the purpose of prosecution, the examiner considers that the direction of camera is insertion direction during examination.
Appropriate correction is required.
Claims 2-6 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, 3-6, 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 one or more processors (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-3B and 4A-4D, 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; In this process, both the three-dimensional image data and the shape data by the sensors are used for having a spatial reference. Three-dimensional image data and the shape data are co-registered; Para [0073]-[0074], [0075]) of an endoscope camera from the captured images;
estimate an intestinal tract direction (vector 808; FIG. 8, annotated below) of a colon based on the posture change and a 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]) between a surface of colon and the endoscope camera using the captured images;
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, to a display device, a display image (FIG. 6A; composite image 800; display 110 of FIG. 8) including an indicator presenting the direction in which the endoscope camera should be directed (As shown in FIG. 6A, vector 608 indicates which direction operator O should steer the medical instrument in order to access the target 606 for a biopsy or for treatment. Para [0070]), wherein the indicator is displayed at least one of the upper, lower, left and right ends of the captured images (Vector 608 is displayed in lower end of the captured image.).
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 be utilized by a training system for system training or a user for viewing during surgery.
Regarding claim 3, 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 of the colon (Direction for intestinal tract is intended use).
Regarding claim 4, Duindam discloses wherein the one or more processors are further configured to execute the instructions to: detect a lesion candidate (As seen in FIG.8, intestinal tract direction and the lesion direction are shown in distinguishable manner; Targets such as tumors, lesions are provided.; Para [0085]) from the captured images.
Regarding claim 5, Duindam discloses wherein the one or more processors are further configured to execute the instructions to: wherein the direction in which the endoscope camera should be directed is the direction of the lesion (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. As seen in FIG.8, intestinal tract direction and the lesion direction are shown in distinguishable manner; Targets such as tumors, lesions are provided. Para [0085]).
Regarding claim 6, Duindam discloses wherein the one or more processors are further configured to execute the instructions to:
output 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. Para [0085]).
Claim(s) 2 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 2, Duindam does not expressly disclose wherein the one or more processors are further configured to execute the instructions to: estimate 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 captured images.
Yeung is directed to automated steering control of a robotic endoscope (abstract) and teaches wherein the one or more processors are further configured to execute the instructions to: estimate 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 captured 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. abstract).
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 Duindam to include a training model so that a tracking and control of the device could be updated and refined by using the machine learning system. Further, this would automate the system making the surgical process more convenient for a user.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 of the instant application is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/555,166 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Claim 2 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of copending Application No. 18/555,166 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Claim 3 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of copending Application No. 18/555,166 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Claims 5, 6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of copending Application No. 18/555,166 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
See claim comparisons below –
Instant claims
Claims of application
18/555,166
Claim 1. An endoscopic examination support apparatus comprising: a memory configured to store instructions; and
one or more processors configured to execute the instructions to:
acquire captured images during removal of an endoscope;
estimate a relative posture change of an endoscope camera from the captured images;
estimate an intestinal tract direction of a colon based on the posture change and a distance between a surface of colon and the endoscope camera using the captured images;
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
output, to a display device, a display image including an indicator presenting the direction in which the endoscope camera should be directed, wherein the indicator is displayed at least one of the upper, lower, left and right ends of the captured images.
Claim 1. An endoscopic examination support apparatus comprising:
a memory configured to store instructions; and
a processor configured to execute the instructions to:
acquire captured images during removal of an endoscope;
estimate a relative posture change of an
endoscope camera from the captured images;
estimate a distance between a surface of colon and the endoscope camera from the captured images; estimate an intestinal tract direction of the colon based on the posture change and the distance;
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;
output a display image including the direction in which the endoscope camera should be directed, to a display device.
Claim 2. The endoscopic examination support apparatus according to claim 1, wherein the one or more processors are further configured to execute the instructions to:
estimate 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 captured images.
Claim 3. The endoscopic examination support apparatus according to claim 1, 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.
Claim 3. The endoscopic examination support apparatus according to claim 1, wherein the direction in which the endoscope camera should be directed is the intestinal tract direction of the colon.
Claim 2. The endoscopic examination support apparatus according to claim 1, wherein the direction in which the endoscope camera should be directed is the intestinal tract direction.
Claim 5. The endoscopic examination support apparatus according to claim 4, wherein the one or more processors are further configured to execute the instructions to:
wherein the direction in which the endoscope camera should be directed is the direction of the lesion.
Claim 4. The endoscopic examination support apparatus according to claim 1,
wherein the direction in which the endoscope camera should be directed includes the intestinal tract direction and a lesion direction, and
wherein the processor outputs the display image which displays the intestinal tract direction and the lesion direction in a distinguishable manner.
Claim 6. The endoscopic examination support apparatus according to 5, wherein the one or more processors are further configured to execute the instructions to:
output the display image which displays the intestinal tract direction and the lesion direction in a distinguishable manner.
Claim 4. The endoscopic examination support apparatus according to claim 1, wherein the direction in which the endoscope camera should be directed includes the intestinal tract direction and a lesion direction, and
wherein the processor outputs the display image which displays the intestinal tract direction and the lesion direction in a distinguishable manner.
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.
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, 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
01/02/25