DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 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.
Claim 9 is 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 9 recites “the imaging wire though which the access guide is inserted” appearing to suggest that access guide, which is the access tube, is inserted through the imaging wire. Based on Applicant’s Fig. 17, it appears to be the opposite, where the imaging wire is inserted through the access guide/access tube. There does not appear to be an embodiment in the present application where the access guide/access tube is inserted through the imaging wire.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(1) as being unpatentable by Murdeshwar (US2025/0235085).
Regarding claim 1, Murdeshwar discloses the bile duct/pancreatic duct treatment method, comprising: positioning an endoscope having a channel from a duodenum to an opening of a papilla (endoscope 14 may be a duodenoscope [0054]; Fig. 6: endoscope 14, having channel/lumen 62 [0039], is positioned in duodenum toward an opening of a papilla [0072]); inserting an imaging wire through the channel from the opening of the papilla to a common duct (imaging guidewire 102 can be configured as an imaging device that can be steered and navigated to a desired anatomic location [0032]; Fig. 6: imaging guidewire 102 is guided through sphincter of Oddi 186 [0074]), the imaging wire having an imaging unit at its distal end (Fig. 6 & 9: imaging guidewire 102 comprises imaging device 120 [0027]); inserting the imaging wire into one of cavities of a bile duct and a pancreatic duct while the endoscope remains positioned at the opening of the papilla (Fig. 6: surgeon can navigate guidewire 102 past entry 190 of common bile duct 182 into passage 192 of common bile duct 182 [0074]); observing the one of the cavities using the imaging unit (imaging guidewire 102 is navigated to anatomic duct 280 using viewing module 119 without accessory 106A attached [0084]); when treatment with a treatment tool is required, after inserting the imaging wire into the one of the cavities (imaging and viewing light of viewing module 119 can be used to view anatomic duct 280 before accessory 106 is attached to imaging guidewire 102 in order to assess the anatomy [0084]), inserting an access tube along the imaging wire into the one of the cavities (under-mounted accessory 106 or concentrically mounted accessory 104 [0031,0037]), the access tube and the imaging wire being separate and configured to be inserted independently of one another (imaging guidewire 102 guided to anatomic site for diagnosing and assessing before accessory 104 or 106 and instruments are inserted [0031]); and inserting the treatment tool through the access tube into the one of the cavities (accessory 106 comprises a body including working channel 160 guide another instrument [0031, 0051]).
Regarding claim 2, Murdeshwar discloses the bile duct/pancreatic duct treatment method according to claim 1, further disclosing the method comprising: inserting the imaging wire into the one of the cavities based on an image captured by the imaging unit (imaging guidewire 102 is navigated to anatomic duct 280 using viewing module 119 without accessory 106A attached [0084]).
Regarding claim 3, Murdeshwar discloses the bile duct/pancreatic duct treatment method according to claim 2, further disclosing the method comprising: inserting the imaging wire into the one of the cavities based on an X-ray contrast image in addition to the image captured (imaging guidewire 102 can be directed to the desired anatomic location using fluoroscopy, if desired [0032]).
Regarding claim 4, Murdeshwar discloses the bile duct/pancreatic duct treatment method according to claim 1, further disclosing the method comprising: treating a diseased part of the one of the cavities with the treatment tool arranged on a distal side of the access tube (Fig. 10: accessory 106 is formed of shaft 138, which comprises a distal end face 326, tools dependent on the required procedure such as jaws 308 and shaft 310 can extend past the distal end face 326 of accessory 106 to reach biological material 322 [0091]).
Regarding claim 5, Murdeshwar discloses the bile duct/pancreatic duct treatment method according to claim 1, further disclosing wherein the access tube has a lumen through which the imaging unit can be inserted (Fig. 11: accessory 106C having a guidewire channel 305, through which the guidewire 102 is inserted [0093]; Fig. 2A: concentrically mounted accessory 104 comprises shaft 126, and imaging guidewire 102 can be positioned within lumen 128 of shaft 126), and the access tube is inserted into the one of the cavities by moving the access tube toward the distal side relative to the imaging wire that passes through the lumen of the access tube (Fig. 11: accessory 104 and accessory 106 can be slid over imaging guidewire 102 to the anatomic site [0031]).
Regarding claim 6, Murdeshwar discloses the bile duct/pancreatic duct treatment method according to claim 5, further disclosing wherein before inserting the imaging wire into the one of the cavities, the access tube is inserted up to the common duct (Fig. 2A & 7A-C: imaging guidewire 102 would have to be inserted into the common duct in order for the accessory device 104 and deployable device 130 [0045-0046]/delivery device 204 [0075-0078] to also be inserted into the common duct for the stent to be deployed).
Regarding claim 7, Murdeshwar discloses the bile duct/pancreatic duct treatment method according to claim 6, further teaching the method comprising: inserting the imaging wire that passes through the access tube inserted up to the common duct into the one of the cavities (surgeon can navigate imaging guidewire 102 past entry 190 of common bile duct and into passage 192 of common bile duct [0074]; biological matter can be removed from the bile duct 182 or the pancreatic duct 188 [0072]).
Regarding claim 8, Murdeshwar discloses the bile duct/pancreatic duct treatment method according to claim 7, further disclosing the method comprising: inserting the access tube inserted up to the common duct into the one of the cavities by moving the access tube toward the distal end relative to the imaging wire (accessory 104 is slid over imaging guidewire 102 to anatomic site, accessory 106 can be slid alongside imaging guidewire 102 [0031] to reach the distal end of the imaging guidewire 102, which is already at the anatomic site for diagnosing and assessing anatomic features [0031]).
Regarding claim 9, Murdeshwar discloses the bile duct/pancreatic duct treatment method according to claim 1, further disclosing wherein the access tube is attached to the treatment tool (Fig. 11: accessory 106C comprises a working channel 302, which holds the a removal device 304, thus is attached to the removal device 304 [0093]) and is a ring-shaped access guide through which the imaging unit can be inserted (Fig. 11: accessory 106C is ring-shaped or tubular, imaging guidewire 102 is inserted through accessory 106C), and the access guide and the treatment tool are inserted into the one of the cavities by moving the access guide toward the distal end relative to the imaging wire (accessory 106C and instruments such as the removal device 304 are inserted to the anatomic site by moving the accessory 106C along the imaging guidewire 102, which is already at the anatomic site [0031]).
Regarding claim 10, Murdeshwar discloses the bile duct/pancreatic duct treatment method according to claim 4, further disclosing the method comprising: treating the diseased part of the one of the cavities with the treatment tool arranged on a proximal side of the imaging unit (instruments are on the proximal side of the imaging guidewire 102 when the instrument is inserted through the accessory 106C after the imaging guidewire has already been inserted into the anatomic site for diagnosing and assessing [0031]).
Regarding claim 11, Murdeshwar discloses the bile duct/pancreatic duct treatment method according to claim 10, further disclosing the method comprising: separating the imaging wire inserted into one of the cavities from the treatment tool (Fig. 11: instruments such as removal device 304 are inserted through working channel 302 and movable axially to be separated axially and laterally from the imaging guidewire 102 [0093-0096]); and treating the diseased part of the one of the cavities with the treatment tool (various instruments listed [0031], such as forceps, may be used as a removal device 304 to obtain tissue samples [0092]).
Regarding claim 12, Murdeshwar discloses the endoscopic instrument, comprising: an imaging wire having an imaging unit at its distal end (Fig. 6 & 9: imaging guidewire comprises imaging device 120 [0027]); and an access tube through which a treatment tool can be guided into one of cavities of a bile duct and a pancreatic duct, the access tube being configured to be advanced along the imaging wire into the one of the cavities while the imaging wire is disposed within the access tube (Fig. 2A: accessory 104 can be slid over imaging guidewire 102 to the anatomic site [0031]; Fig. 11: imaging guidewire 102 extends through accessory 106C [0093]), wherein the imaging wire and the access tube are relatively movable along a longitudinal direction of the endoscopic instrument (accessory 106C, configured similarly to accessory 106B [0095], is slidable relative to imaging guidewire 102 along a longitudinal direction of the duodenoscope [0031]; accessory 104 can be slid over imaging guidewire 102 to the anatomic site [0031]), and the access tube and the imaging wire are separate and configured to be inserted independently of one another (imaging guidewire 102 is first guided to anatomic site to facilitate diagnosing and assessing, once diagnosed, an accessory device 106 or 104 can be guided to the anatomic site via imaging guidewire 102 [0031], indicating imaging guidewire 102 and accessory devices are inserted into the cavity independently).
Regarding claim 13, Murdeshwar discloses the endoscopic instrument according to claim 12, further disclosing wherein the access tube has a lumen through which the imaging wire can be inserted (Fig. 11: accessory 106C comprises guidewire channel 305 [0093]; Fig. 2A: concentrically mounted accessory 104 comprises shaft 126 with lumen 128 through which the imaging guidewire 102 is inserted [0027-0028]).
Regarding claim 14, Murdeshwar discloses the endoscopic instrument according to claim 12, further disclosing wherein the access tube is attachable to the treatment tool (Fig. 2A: shaft 126 of accessory 104 may comprise a delivery device configured to carry deployable device 1300 comprising a stent [0046]; Fig. 11: accessory 106C may comprise working channel 302, in which removal device 304 may be inserted [0093]) and is a ring-shaped access guide through which the imaging wire can be inserted (Fig. 2A: accessory 104 is a ring-shaped tubular access guide, through which imaging guidewire 102 can be inserted, specifically in lumen 128 [0048]; Fig. 11: accessory 106C is a ring-shaped tubular access guide, through which imaging guidewire 102 can be inserted, specifically in guidewire channel 305 [0093, 0095]).
Regarding claim 15, Murdeshwar discloses the endoscopic instrument according to claim 12, further disclosing wherein the imaging unit includes an imaging section having a lens (nosecone 124 shields the viewing module 119 while allows light waves to pass through [0036]) and an image sensor (imaging device 120, imaging microchip [0053]), and an illumination section that irradiates light supplied from a light source device via an illumination fiber, and the illumination section is disposed around the imaging section (Fig. 2A & 2B: lighting devices 122A-122C, which may be light fibers, positioned around imaging device 120, which may be an imaging microchip [0053]).
Regarding claim 16, Murdeshwar discloses the endoscopic instrument according to claim 12, further disclosing wherein the access tube is configured to receive the imaging wire within an interior of the access tube (Fig. 2A: accessory 104 can be slid over imaging guidewire 102 to the anatomic site [0031] through lumen 128 [0038]; Fig. 11: imaging guidewire 102 extends through accessory 106C [0093]).
Regarding claim 17, Murdeshwar discloses the endoscopic instrument according to claim 12, further disclosing wherein the access tube is configured to be inserted into the one of the cavities after the imaging wire has been inserted into the one of the cavities (accessory device 106 is inserted in anatomic site after diagnosis and assessment using imaging guidewire 102 [0031]).
Regarding claim 18, Murdeshwar discloses the endoscopic instrument according to claim 13, further disclosing wherein the imaging wire is configured to pass through the lumen of the access tube and the access tube is configured to move relative to the imaging wire along a longitudinal direction (Fig. 2A: accessory 104 can be slid over imaging guidewire 102 to the anatomic site [0031] through lumen 128 [0038]; Fig. 11: imaging guidewire 102 extends through accessory 106C [0093]).
Regarding claim 19, Murdeshwar discloses the endoscopic instrument according to claim 12, further disclosing wherein the treatment tool is arranged on a distal side of the access tube (Fig. 10: accessory 106 is formed of shaft 138, which comprises a distal end face 326, jaws 308 and shaft 310 can extend past the distal end face 326 of accessory 106 to reach biological material 322 [0091]).
Regarding claim 20, Murdeshwar discloses the endoscopic instrument according to claim 12, further disclosing wherein the treatment tool is arranged on a proximal side of the imaging unit (Fig. 2B: working channel 160 of accessory device 106 can receive another instrument or device [0051]; accessory device 106 and instruments such as forceps may be inserted in anatomic site after diagnosis and assessment using imaging guidewire 102 [0031], therefore when the instrument such as forceps is passed through the accessory device 106, the instrument is arranged on the proximal side of the imaging guidewire 102).
Response to Arguments
Applicant’s arguments, filed April 14, 2026, with respect to the rejections of claims 1 and 12 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Murdeshwar (US2025/0235085).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LI-TING SONG whose telephone number is (571)272-5771. The examiner can normally be reached 8-5.
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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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/LI-TING SONG/Examiner, Art Unit 3795
/ANHTUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
06/30/26
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