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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/13/2026 has been entered.
Disposition of Claims
Claims 1, 3-10, 12, and 14 are pending.
Claims 2, 11, and 13 are canceled.
Response to Arguments
Applicant’s arguments, see Page 7, filed on 1/15/2026, with respect to the rejections under 35 U.S.C. § 112(b) of Claims 1, 3-10, 12, and 14 have been fully considered and are persuasive in light of amendments to the claims.
The rejections under 35 U.S.C. § 112(b) of Claims 1, 3-10, 12, and 14 have been withdrawn.
Applicant’s arguments, see Pages 7-13, filed on 1/15/2026, with respect to the rejections under 35 U.S.C. § 103 of Claims 1, 3-10, 12, and 24 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.
Claim Objections
Claims 1 and 14 are objected to because of the following informalities:
In claim 1, lines 22-23, “so that the papillary portion of the duodenum is aligned with the position registered in advance” should read “so that the papillary portion of the duodenum in the captured endoscope image is aligned with the position registered in advance.” The suggested modification enhances the clarity of the claim.
In claim 14, lines 5-6, “the insertion section is oriented to face” should read “the insertion and is oriented to face”
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Such claim limitations are:
“a holding member configured to hold the insertion section relative to a papillary portion of a duodenum” in claim 1 as described on pages 30-31 of Applicant’s specification.
“a second holding member for holding a route of the insertion section” in claim 8 as described on page 37 of Applicant’s specification.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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, 3-10, 12, and 14 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.
Claims 1 recites “capture an endoscope image” in lines 5 and 15 and “a captured endoscope image” in lines 14, 16, and 20-21. It is unknown if the captured endoscope image and the endoscope image are referring to the same image or an additional image. For the purposes of examination, “a captured endoscope image” is being interpreted as “the endoscope image.”
Claims 1 and 10 recite the limitation "the comparison” in l. 20 of claim 1 and l. 22 of claim 10. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, "and compare the captured endoscope image with an image of the papillary portion of the duodenum” is being interpreted as "and conduct a comparison between the captured endoscope image with an image of the papillary portion of the duodenum."
Claim 10 recites the limitation "the captured endoscope image" in lines 18 and 22. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, " the captured endoscope image " is being interpreted as " the endoscope image."
Claim 12 recites “a distal end side relative to the holding member” in line 3. Claim 10 introduces a distal end side relative to a holding member. It is unclear if applicant is referring to the distal end side presented in claim 10 or another distal end side. For the purposes of examination, “a distal end side relative to the holding member” is being interpreted as “the distal end side relative to the holding member.”
Claims 3, 5-9, and 14 are rejected as being dependent upon claims previously rejected under 35 USC § 112(b).
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 3 and 12 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
In regards to claim 3, the claim reads “wherein the second positioning comprises adjusting the position of the distal end section of the insertion section on a distal end side of the insertion section relative to the holding member holding the insertion section.”
Claim 1 reads “adjust a position of the distal end section of the insertion section during the second positioning by adjusting a distal end side relative to the holding member.” As such, claim 3 is improperly dependent as it fails to limit claim 1 from which it depends.
In regards to claim 12, the claim reads “wherein the second positioning comprises adjusting a position of the distal end section of the insertion section by the endoscopic operation on a distal end side relative to the holding member holding the insertion section.”
Claim 10 reads “adjusting a position of the distal end section of the insertion section during the second positioning by adjusting a distal end side relative to a holding member holding the insertion section.” As such, claim 12 is improperly dependent as it fails to limit claim 10 from which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
The present rejection(s) reference specific passages from cited prior art. However, Applicant is advised that the rejections are based on the entirety of each cited prior art. That is, each cited prior art reference “must be considered in its entirety”. (See MPEP 2141.02(VI)) Therefore, Applicant is advised to review all portions of the cited prior art if traversing a rejection based on the cited prior art
Claims 1, 3-4, 6-10, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Appl. Publ. No. 2020/0030575 A1 to Bogusky et al. (“Bogusky”) in view of U.S. Patent Appl. Publ. No. 2023/0200682 A1 to Yoshioka et al. (“Yoshioka”) and U.S. Patent Appl. Publ. No. 2016/0353970 A1 to Inoue (“Inoue”).
Regarding claim 1, Bogusky discloses a medical system (medical system 100; Fig. 1, paragraph 0053) comprising:
an endoscope configured to electrically drive an endoscopic operation (manipulator assembly 102 supports medical instrument 104 and may optionally include a plurality of actuators or motors that drive inputs on medical instrument 104 in response to commands from the control system (e.g. control system 112); Fig. 2A, paragraph 0056), the endoscopic operation comprising at least one of a forward and backward movement of an insertion section, a bending angle of a bending section of the insertion section, and a rolling rotation of the insertion section (other drive systems may move the distal end of medical instrument 104 in multiple degrees of freedom, which may include three degrees of linear motion (e.g., linear motion along the X,Y, Z Cartesian axes), in three degrees of rotational motion (e.g., rotation about the X, Y, Z Cartesian axes), and in bend, e.g. pitch and yaw about a longitudinal axis of the medical instrument 104; Fig. 2A, paragraph 0056), the endoscope being configured to capture an endoscope image (visualization system for capturing images from the distal end of medical instrument 104; Fig. 2A, paragraph 0057); and
a processor comprising hardware (the processors of control system 112 in Fig.1, and may be used for determining the position, orientation, speed, velocity, pose, external forces, and/or shape of distal end portion 228 and/or one or more segments along elongated device 226 using one or more sensors and/or imaging devices as described in further detail below; Fig. 2A, paragraph 0061), wherein the processor is configured to:
control the endoscopic operation to achieve a second positioning subsequent to the first positioning (in some implementations, movements of the medical instrument 104 are automatically completed by the control system 112 following a pre-planned path or using sensors to automatically drive through anatomy; Fig. 2A, paragraph 0059), the first positioning being where the insertion section is positioned with respect to the papillary portion of the duodenum (a distal segment 708 of the elongate device 202, such as the first segment 506, is positioned within the duodenum D of a patient, proximate to the major duodenal papilla… with the distal segment 708 in the flexible state, the medical instrument 226 may be telescopically advanced with the elongated device 202 such that the distal end 218 of the elongate device 202 is aligned with a distal end of the medical instrument 226; Fig. 7; paragraphs 0105-0106), the second positioning being where a distal end section of the insertion section is positioned with respect to the papillary portion of the duodenum based on a captured endoscope image (the steerable distal end 502 of the medical instrument 226 is positioned in a pose in a direction of the major duodenal papilla. The pose of the medical instrument 226 can be confirmed by using endoscopic views and identifying the anatomy (e.g. the major duodenal papilla) or using navigation techniques as described below with reference to Fig. 7A; Fig 7, paragraph 0106);
capture the endoscope image during or after the first positioning (the steerable distal end 502 of the medical instrument 226 is positioned in a pose in a direction of the major duodenal papilla. The pose of the medical instrument 226 can be confirmed by using endoscopic views and identifying the anatomy (e.g. the major duodenal papilla) or using navigation techniques as described below with reference to Fig. 7A; Fig 7, paragraph 0106); and
control the forward and backward movement of the insertion section, the bending angle of the bending section of the insertion section, and the rolling rotation of the insertion section by electrical driving to achieve the second positioning (in some examples, control system 112 may transmit signals instructing one or more actuators of manipulator assembly 102 to move medical instrument 104 … other drive systems may move the distal end of medical instrument 104 in multiple degrees of freedom, which may include three degrees of linear motion (e.g., linear motion along the X,Y, Z Cartesian axes), in three degrees of rotational motion (e.g., rotation about the X, Y, Z Cartesian axes), and in bend, e.g. pitch and yaw about a longitudinal axis of the medical instrument 104; Fig. 2A, paragraph 0056).
However, Bogusky does not explicitly teach a holding member configured to hold the insertion section relative to a papillary portion of a duodenum to achieve a first positioning of the insertion section and a processor configured to compare the captured endoscope image with an image of the papillary portion of the duodenum at a position registered in advance and automatically adjust a position of the distal end section of the insertion section during the second positioning by adjusting a distal end side relative to the holding member based on a result of the comparison between the captured endoscope image and the image of the papillary portion of the duodenum at the position registered in advance so that the papillary portion of the duodenum is aligned with the position registered in advance.
Yoshioka teaches a holding member configured to hold the insertion section relative to an intestinal canal to achieve a first positioning of the insertion section (since the outer diameter of the balloon 19 in the inflated state is formed depending on the tinner diameter of the intestinal canal 26, the insertion part 12a is in a state where the position of the insertion part 12a is fixed in the intestinal canal 26; Fig. 5, paragraph 0138) and adjusting a position of the distal end section of the insertion section during a second positioning by adjusting a distal end side relative to the holding member (“a state where is fixed” mentioned here includes a state where the position of the insertion part 12a in the insertion direction is fixed but the orientation of the distal end part 12d can be finely adjusted; Fig. 5, paragraph 0138). Yoshika teaches that use of a holding member helps ensure that the object of interest can be accurately irradiated with measurement light (paragraph 0138).
Yoshioka is considered to be analogous to the claimed invention because it is in the same field of endoscopes with a holding member. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the medical instrument of Bogusky to incorporate the teachings of Yoshioka by adding a holding member onto the insertion section for holding the insertion section relative to the papillary portion of the duodenum. Doing so would help to ensure that the object of interest can be accurately irradiated with measurement light, as recognized by Yoshioka.
Additionally, Inoue teaches a processor configured to compare the captured endoscope image with an image of the target anatomy at a position registered in advance and automatically adjust a position of the distal end section of the insertion section during the second positioning based on a result of the comparison between the captured endoscope image and the image of the target anatomy at the position registered in advance so that the target anatomy in the captured endoscope image is aligned with the position registered in advance (a similarity computation unit 75 working as a comparison unit is adapted to compare the previous (before movement) images taken by the imaging unit 1a and stored in the image storage unit 74 with current (after movement) images taken by the imaging unit 2A to compute the degree of similarity … A second driving-amount computation unit 76 is adapted to compute the driving amount for the driver unit 8 that drives the field-of-view adjustment mechanism 1b shown in Fig. 2 such that the imaging unit 1a directs from the position where the imaging unit 1a takes the current images to the position where the previously stored images were taken; Figs. 7A-8B, paragraphs 0057-0058). Inoue teaches positioning the distal end of the endoscope by comparing an image registered in advance to a current image for improving precision (paragraph 0085) thus, reducing errors in endoscopic treatment.
Inoue is considered to be analogous to the claimed invention because it is in the same field of endoscopes that are electrically driven with a controller. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the electrically driven positioning of the endoscope of Bogusky, as modified by Yoshioka, to incorporate the teachings of Inoue by automatically adjusting a position of the distal end section of the insertion section during the second positioning based on a comparison between the captured endoscope image and an image of the papillary portion of the duodenum at a position registered in advance so that the papillary portion is aligned with the position registered in advance. Doing so would help to improve precision, thus reducing errors in endoscopic treatment, as recognized by Inoue.
Regarding claim 3, Bogusky, as previously modified by Yoshioka and Inoue, discloses the medical system according to claim 1. Yoshioka further teaches wherein the second positioning comprises adjusting the position of the distal end section of the insertion section on a distal end side of the insertion section relative to the holding member holding the insertion section (“a state where is fixed” mentioned here includes a state where the position of the insertion part 12a in the insertion direction is fixed but the orientation of the distal end part 12d can be finely adjusted; Fig. 5, paragraph 0138).
Regarding claim 4, Bogusky, as previously modified by Yoshioka and Inoue, discloses the medical system according to claim 1. Bogusky further discloses wherein the second positioning comprises controlling the endoscopic operation such that an image of the papillary portion of the duodenum is captured at the position registered in advance on the endoscope image (a virtual navigational image in which the actual location of the distal segment 1702 is registered (i.e., dynamically referenced) with a preoperative or concurrent image/model; paragraph 0172).
Regarding claim 6, Bogusky, as previously modified by Yoshioka and Inoue, discloses the medical system according to claim 1. Yoshioka further teaches wherein the holding member is provided between a base end of the insertion section and a base end of the bending section of the insertion section (the predetermined position at which the balloon 19 is fixed to the insertion part 12a is closer to the proximal end of the insertion part 12a than the bendable part 12c and is a position where the distal end of the distal end portion 19a of the balloon 19 and the proximal end of the bendable part 12c coincide with each other; Fig. 2, paragraph 0136).
Regarding claim 7, Bogusky, as previously modified by Yoshioka and Inoue, discloses the medical system according to claim 1. Yoshioka further teaches wherein the holding member is a balloon that is inflated and is configured to come in contact with the inside of a body lumen so as to hold the insertion section with respect to the inside of the body lumen (since the outer diameter of the balloon 19 in the inflated state is formed depending on the tinner diameter of the intestinal canal 26, the insertion part 12a is in a state where the position of the insertion part 12a is fixed in the intestinal canal 26; Fig. 5, paragraph 0138).
Regarding claim 8, Bogusky, as previously modified by Yoshioka and Inoue, discloses the medical system according to claim 1. Specifically, Bogusky, as modified by Yoshioka and Inoue, teaches wherein the holding member is a first holding member. Bogusky further teaches wherein the medical system further comprises a second holding member for holding a route of the insertion section (once the distal end 218 of the elongated device 202 is positioned within the duodenum D, a segment 224 of the elongated device 202 proximal to the distal end 218 may be rigidized to support advancement of the medical instrument 226 within the patient anatomy; Fig. 6A-7; #202, paragraphs 0101-0102 and 0110-0111).
Regarding claim 9, Bogusky, as previously modified by Yueng and Inoue, discloses the medical system according to claims 1 and 8. Bogusky further teaches comprising an overtube having the second holding member, the overtube being configured to have a variable hardness that holds the route of the insertion section by being hardened (once the distal end 218 of the elongated device 202 is positioned within the duodenum D, a segment 224 of the elongated device 202 proximal to the distal end 218 may be rigidized to support advancement of the medical instrument 226 within the patient anatomy; Fig. 6A-7; #202, paragraphs 0101-0102 and 0110-0111).
Regarding claim 10, Bogusky discloses a cannulation method using an endoscope configured to electrically drive an endoscopic operation (manipulator assembly 102 supports medical instrument 104 and may optionally include a plurality of actuators or motors that drive inputs on medical instrument 104 in response to commands from the control system (e.g. control system 112); Fig. 2A, paragraph 0056), the endoscopic operation comprising at least one of a forward and backward movement of an insertion section, a bending angle of a bending section of the insertion section, and a rolling rotation of the insertion section (other drive systems may move the distal end of medical instrument 104 in multiple degrees of freedom, which may include three degrees of linear motion (e.g., linear motion along the X,Y, Z Cartesian axes), in three degrees of rotational motion (e.g., rotation about the X, Y, Z Cartesian axes), and in bend, e.g. pitch and yaw about a longitudinal axis of the medical instrument 104; Fig. 2A, paragraph 0056), the endoscope being configured to capture an endoscope image (visualization system for capturing images from the distal end of medical instrument 104; Fig. 2A, paragraph 0057), the cannulation method (method of use of the variable stiffness elongate device 202 with the medical instrument 226 for performing an endoscopic retrograde cholangiopancreatography (ERCP; Fig. 7-7A, paragraph 0103) comprising:
inserting the insertion section of the endoscope into a body (introduction of minimally invasive devices such as elongate device 202 and medical device 226, into patient anatomy; Fig. 4A-4B, paragraph 0078);
performing a first positioning of the insertion section with respect to a papillary portion of a duodenum (a distal segment 708 of the elongate device 202, such as the first segment 506, is positioned within the duodenum D of a patient, proximate to the major duodenal papilla… with the distal segment 708 in the flexible state, the medical instrument 226 may be telescopically advanced with the elongated device 202 such that the distal end 218 of the elongate device 202 is aligned with a distal end of the medical instrument 226; Fig. 7, paragraphs 0105-0106);
subsequent to the first positioning, capturing an endoscope image and performing a second positioning of a distal end section of the insertion section with respect to the papillary portion of the duodenum (the steerable distal end 502 of the medical instrument 226 is positioned in a pose in a direction of the major duodenal papilla. The pose of the medical instrument 226 can be confirmed by using endoscopic views and identifying the anatomy (e.g. the major duodenal papilla) or using navigation techniques as described below with reference to Fig. 7A; Fig 7, paragraph 0106), the second positioning including:
capturing the endoscope image during or after the first positioning (the steerable distal end 502 of the medical instrument 226 is positioned in a pose in a direction of the major duodenal papilla. The pose of the medical instrument 226 can be confirmed by using endoscopic views and identifying the anatomy (e.g. the major duodenal papilla) or using navigation techniques as described below with reference to Fig. 7A; Fig 7, paragraph 0106), and
automatically adjusting a position of the distal end section of the insertion section during the second positioning to the papillary portion of the duodenum (the steerable distal end 502 of the medical instrument 226 is positioned in a pose in a direction of the major duodenal papilla. The pose of the medical instrument 226 can be confirmed by using endoscopic views and identifying the anatomy (e.g. the major duodenal papilla) or using navigation techniques as described below with reference to Fig. 7A; Fig 7, paragraph 0106), and
control the forward and backward movement of the insertion section, the bending angle of the bending section of the insertion section, and the rolling rotation of the insertion section by electrical driving to achieve the second positioning (in some examples, control system 112 may transmit signals instructing one or more actuators of manipulator assembly 102 to move medical instrument 104 … other drive systems may move the distal end of medical instrument 104 in multiple degrees of freedom, which may include three degrees of linear motion (e.g., linear motion along the X,Y, Z Cartesian axes), in three degrees of rotational motion (e.g., rotation about the X, Y, Z Cartesian axes), and in bend, e.g. pitch and yaw about a longitudinal axis of the medical instrument 104; Fig. 2A, paragraph 0056); and
subsequent to the second positioning, performing cannulation from the papillary portion of the duodenum to a biliary duct (for example, the medical instrument 226 or other tool may be advanced through the ampulla of Vater AV to the common bile duct BD; Fig. 7-7A, paragraph 0108 and 0116).
However, Bogusky does not explicitly disclose holding the insertion section relative to the duodenum, comparing the captured endoscope image with an image of the papillary portion of the duodenum at a position registered in advance, and automatically adjusting a position of the distal end section of the insertion section during the second positioning by adjusting a distal end side relative to a holding member holding the insertion section based on a result of the comparison between the captured endoscope image and the image of the papillary portion of the duodenum at the position registered in advance so that the papillary portion of the duodenum is aligned with the position registered in advance.
Yoshioka teaches a holding member configured to hold the insertion section relative to an intestinal canal to achieve a first positioning of the insertion section (since the outer diameter of the balloon 19 in the inflated state is formed depending on the tinner diameter of the intestinal canal 26, the insertion part 12a is in a state where the position of the insertion part 12a is fixed in the intestinal canal 26; Fig. 5, paragraph 0138) and adjusting a position of the distal end section of the insertion section during a second positioning by adjusting a distal end side relative to the holding member (“a state where is fixed” mentioned here includes a state where the position of the insertion part 12a in the insertion direction is fixed but the orientation of the distal end part 12d can be finely adjusted; Fig. 5, paragraph 0138). Yoshika teaches that use of a holding member helps ensure that the object of interest can be accurately irradiated with measurement light (paragraph 0138).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the medical instrument of Bogusky to incorporate the teachings of Yoshioka by adding a holding member onto the insertion section for holding the insertion section relative to the papillary portion of the duodenum. Doing so would help to ensure that the object of interest can be accurately irradiated with measurement light, as recognized by Yoshioka.
Additionally, Inoue teaches a processor configured to compare the captured endoscope image with an image of a target anatomy at a position registered in advance and automatically adjust a position of the distal end section of the insertion section during the second positioning based on a result of the comparison between the captured endoscope image and the image of the target anatomy at the position registered in advance so that the target anatomy is aligned with the position registered in advance (a similarity computation unit 75 working as a comparison unit is adapted to compare the previous (before movement) images taken by the imaging unit 1a and stored in the image storage unit 74 with current (after movement) images taken by the imaging unit 2A to compute the degree of similarity … A second driving-amount computation unit 76 is adapted to compute the driving amount for the driver unit 8 that drives the field-of-view adjustment mechanism 1b shown in Fig. 2 such that the imaging unit 1a directs from the position where the imaging unit 1a takes the current images to the position where the previously stored images were taken; Figs. 7A-8B, paragraphs 0057-0058). Inoue teaches positioning the distal end of the endoscope by comparing an image registered in advance to a current image for improving precision (paragraph 0085) thus, reducing errors in endoscopic treatment.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the electrically driven positioning of the endoscope of Bogusky, as modified by Yoshioka, to incorporate the teachings of Inoue by automatically adjusting a position of the distal end section of the insertion section during the second positioning based on a comparison between the captured endoscope image and an image of the papillary portion of the duodenum at a position registered in advance so that the papillary portion is aligned with the position registered in advance. Doing so would help to improve precision, thus reducing errors in endoscopic treatment, as recognized by Inoue.
Regarding claim 12, Bogusky, as previously modified by Yoshioka and Inoue, discloses the cannulation method according to claim 10. Yoshioka further teaches wherein the second positioning comprises adjusting a position of the distal end section of the insertion section by the endoscopic operation on a distal end side relative to the holding member holding the insertion section (“a state where is fixed” mentioned here includes a state where the position of the insertion part 12a in the insertion direction is fixed but the orientation of the distal end part 12d can be finely adjusted; Fig. 5, paragraph 0138).
Claims 5 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Bogusky, in view of Yoshioka and Inoue, as applied to claims 1 and 10 above, and further in view of U.S. Patent Appl. Publ. No. 2019/0208990 A1 to Chelala et al. (“Chelala”).
Regarding claim 5, Bogusky, as previously modified by Yoshioka and Inoue, discloses the medical system according to claim 1. Bogusky further discloses wherein the second positioning comprising controlling the endoscopic operation such that the medical instrument faces toward a travelling direction of the biliary duct that is presumed from the endoscope image in which the image of the papillary portion is captured (the pose of the medical instrument 226 can be confirmed by using endoscopic views and identifying the anatomy (e.g. the major duodenal papilla) or using navigation techniques as described below with reference to Fig. 7A… in some implementations, the pose in the direction of the major duodenal papilla may be positioned at an optimal angle or approach to the major duodenal papilla to increase consistent successful cannulation of the common bile duct BD, while avoiding cannulation of the pancreatic duct; Fig. 7, paragraph 0106-0108). However, Bogusky does not explicitly disclose a treatment tool configured to be inserted into an insertion opening of a treatment tool channel of the endoscope, the treatment tool being raised inside the distal end section of the insertion section to protrude from a side surface of the distal end section of the insertion section, wherein the second positioning comprising controlling a raising angle of the treatment tool such that the treatment tool faces toward a travelling direction of the biliary duct that is presumed from the endoscope image in which an image of the papillary portion of the duodenum is captured.
Chelala teaches a treatment tool configured to be inserted into an insertion opening of a treatment tool channel of the endoscope (the endoscopic accessory tool 100 may be configured to extend through the working channel of a medical device, e.g., a duodenoscope; Fig. 1 and 3A, paragraph 0026), the treatment tool being raised inside the distal end section to protrude from a side surface of the distal end section (a distal portion 136 of the elongated tubular body 130 may include an opening 134 (e.g., side-opening, etc.) in communication with the first lumen 138. An elevator 140 (e.g., elevator mechanism, ramp, lift, etc.) may be disposed at a first location within the distal portion 136 of the elongated tubular body 130; Fig. 3A, paragraph 0026), wherein the second positioning comprising controlling the endoscopic operation and a raising angle of the treatment tool such that the treatment tool faces toward a travelling direction of the biliary duct that is presumed from the endoscope image in which an image of the papillary portion is captured (distal portion 116 of the elongated member 110 and/or the distal end of the cutting wire 120 may be configured to deliver real-time feedback information to a medical professional or computer processor, to manually or automatically adjust, e.g., increase or decrease, the frequency, direction, and/or duration of movement of the distal portion 116 of the elongate member 110; Fig. 1 and 2B, paragraphs 0021 and 0025). Chelala teaches that the raising base for the treatment tool helps facilitate entry of a guidewire and endoscopic accessory tool into and/or through challenging patient-specific anatomies (paragraph 0004).
Chelala is considered to be analogous to the claimed invention because it is in the same field of electrically driven duodenoscopes with automatic steering for approaching and treating the papillary portion of the duodenum and the biliary duct. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the distal end of the medical instrument of Bogusky, as modified by Yoshioka and Inoue, to incorporate the teachings of Chelala by adding a treatment tool passage and raising base for the treatment tool. Doing so would help facilitate entry of a guidewire and endoscopic accessory tool into and/or through challenging patient-specific anatomies, as recognized by Chelala. The raising base and medical instrument would be positioned in such a way to achieve the pose taught by Bogusky.
Regarding claim 14, Bogusky, as previously modified by Yoshioka and Inoue, discloses the cannulation method according to claim 10. Bogusky further teaches wherein the second positioning comprises controlling the endoscopic operation to position the medical instrument to face toward a travelling direction of a biliary duct that is presumed from the endoscope image in which an image of the papillary portion is captured (the pose of the medical instrument 226 can be confirmed by using endoscopic views and identifying the anatomy (e.g. the major duodenal papilla) or using navigation techniques as described below with reference to Fig. 7A… in some implementations, the pose in the direction of the major duodenal papilla may be positioned at an optimal angle or approach to the major duodenal papilla to increase consistent successful cannulation of the common bile duct BD, while avoiding cannulation of the pancreatic duct; Fig. 7, paragraph 0106-0108). However, Bogusky does not explicitly teach wherein the second positioning comprises controlling the endoscopic operation and a raising angle of a treatment tool such that a treatment tool that is inserted from an insertion opening of a treatment tool channel of the endoscope and is raised inside the distal end section of the insertion section to protrude from a side surface of the distal end section of the insertion section to face toward a travelling direction of a biliary duct that is presumed from the endoscope image in which an image of the papillary portion of the duodenum is captured.
Chelala teaches wherein the second positioning comprises controlling a raising angle of a treatment tool such that the treatment tool that is inserted into an insertion opening of a treatment tool channel of the endoscope (the endoscopic accessory tool 100 may be configured to extend through the working channel of a medical device, e.g., a duodenoscope; Fig. 1 and 3A, paragraph 0026) and is raised inside the distal end section to protrude from a side surface of the distal end section (a distal portion 136 of the elongated tubular body 130 may include an opening 134 (e.g., side-opening, etc.) in communication with the first lumen 138. An elevator 140 (e.g., elevator mechanism, ramp, lift, etc.) may be disposed at a first location within the distal portion 136 of the elongated tubular body 130; Fig. 3A, paragraph 0026) is oriented to face toward a travelling direction of a biliary duct that is presumed from the endoscope image in which an image of the papillary portion of the duodenum is captured (distal portion 116 of the elongated member 110 and/or the distal end of the cutting wire 120 may be configured to deliver real-time feedback information to a medical professional or computer processor, to manually or automatically adjust, e.g., increase or decrease, the frequency, direction, and/or duration of movement of the distal portion 116 of the elongate member 110; Fig. 1 and 2B, paragraphs 0021 and 0025). Chelala teaches that the raising base for the treatment tool helps facilitate entry of a guidewire and endoscopic accessory tool into and/or through challenging patient-specific anatomies (paragraph 0004).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the distal end of the medical instrument of Bogusky, as modified by Yoshioka and Inoue, to incorporate the teachings of Chelala by adding a treatment tool passage and raising base for the treatment tool. Doing so would help facilitate entry of a guidewire and endoscopic accessory tool into and/or through challenging patient-specific anatomies, as recognized by Chelala. The raising base and medical instrument would be positioned in such a way to achieve the pose taught by Bogusky.
Conclusion
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/OLIVIA GRACE STARKEY/Examiner, Art Unit 3795
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795