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 .
Information Disclosure Statement
The information disclosure statement (IDS) filed on July 3, 2024 is being considered by the examiner.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 3-13 are rejected under 35 U.S.C. 102(a)(1) as being unpatentable by Komi (US4,979,496).
Regarding claim 1, Komi discloses a bile duct/pancreatic duct treatment method, comprising: positioning an endoscope having a channel from a duodenum to an opening of a papilla (Fig. 17: insertion unit of mother endoscope can be inserted into duodenum, daughter endoscope having an insertion unit which can be introduced by transpapillary insertion [col. 1, lines 10-14]); inserting an imaging wire having an imaging unit at its distal end through the channel from the opening to a common duct (Fig. 17: although not explicitly disclosed as the common duct, it is known in human anatomy that the connecting area between the duodenum 100, bile duct 103, and pancreatic duct 102 is the common duct, as shown in Fig. 17, through which the insertion unit 21 of the daughter endoscope passes through); inserting the imaging wire into one of cavities of a bile duct and a pancreatic duct (insertion unit 21 of the daughter endoscope passes into the bile duct 102, as shown in Fig. 17, or the pancreatic duct 103); observing the one of the cavities using the imaging unit (the interior of the bile duct and pancreatic duct can be observed by introducing the insertion unit 21 of the daughter endoscope directly into papilla through forceps channel of the mother endoscope [col. 1, lines 15-18]); and if treatment with a treatment tool is required, inserting an access port through which the treatment tool can be inserted along the imaging wire into the one of the cavities (Fig. 17: being guided by tubes 9 and 29, guide tube 18 is inserted into bile duct 102 and pancreatic duct 103, and forceps 30 is inserted through the guide tube 18, along with the insertion unit 21 of the daughter endoscope; similarly imaged in Fig. 30, forceps 30 are placed into pancreatic duct 103 through the gap between the second guide tube 33 and the insertion unit 21 [col. 12, lines 23-26]).
Regarding claim 3, Komi 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 (prior to guide tube 18 being inserted into the pancreatic or bile duct 102/103, guide tube 9, containing core bar 11 [col. 7, lines 25-31; col. 8, lines 5-10], is inserted in the ducts 102/103 [col. 9, lines 5-10], and fluoroscopy, comprising x-ray is conducted to verify which duct the guide tube 9 and core bar 11 is located and depth of insertion [col. 6, lines 32-35]… once guide tube 18 has been placed, with the guidance of guide tube 9, core bar 11, and fluoroscopy, insertion unit 21 is inserted through the guide tube 18 into the ducts [col. 9, lines 14-16]).
Regarding claim 4, Komi 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 port (Fig. 17: various tool such as forceps 30 for treatment [col. 9, lines 29-31], shown on the distal side of guide tube 18).
Regarding claim 5, Komi discloses the bile duct/pancreatic duct treatment method according to claim 1, further disclosing wherein the access port is an access tube having a lumen through which the imaging unit can be inserted (Fig. 17: guide tube 18 comprises a lumen through which insertion unit 21 of the daughter endoscope passes through), 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. 15: guide tube 18 is inserted into the bile duct or the pancreatic duct, then the insertion unit 21 of the daughter endoscope 20 is inserted into the guide tube 18 through adaptor 19 [col. 9, lines 11-16]).
Regarding claim 6, Komi 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 (when the tip of the insertion unit 2 of the endoscope 1 is inserted into duodenum and the tip of the guide tube 18 is inserted into either bile duct or pancreatic duct 102, and the insertion unit 21 of the daughter endoscope is inserted into the guide tube 18 through adaptor 19, as shown in Fig. 15 [col. 9, lines 11-16]).
Regarding claim 7, Komi discloses the bile duct/pancreatic duct treatment method according to claim 6, further disclose 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 (Fig. 17: insertion unit 21 of daughter endoscope passes through guide tube 18, which has been inserted up the common duct into the pancreatic duct 102).
Regarding claim 8, Komi 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 (when the tip of the insertion unit 2 of the endoscope 1 is inserted into duodenum and the tip of the guide tube 18 is inserted into either bile duct or pancreatic duct 102, including the common duct, moving distally relative to the insertion unit 21 of the daughter endoscope… after placement of the guide tube 18, the insertion unit 21 of the daughter endoscope is inserted into the guide tube 18 through adaptor 19, as shown in Fig. 15 [col. 9, lines 11-16]).
Regarding claim 9, Komi discloses the bile duct/pancreatic duct treatment method according to claim 1, further disclosing wherein the access port is attached to the treatment tool and is a ring-shaped access guide through which the imaging unit can be inserted (Fig. 17: forceps 30 is inserted through the guide tube 18, therefore is attached to the guide tube 18; guide tube 18 is also an elongated ring-shaped tube through which the insertion unit 21 of the daughter endoscope is inserted through), 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 through which the access guide is inserted (when the tip of the guide tube 18 is inserted into either bile duct or pancreatic duct 102, the insertion unit 21 of the daughter endoscope is inserted into the guide tube 18 through adaptor 19, as shown in Fig. 15 [col. 9, lines 11-16]; guide tube 18 and forceps 30 are inserted through the pancreatic duct 102 and the bile duct 102 when the guide tube 18 is initially passed, shown in Fig. 14, and the forceps 30 are passed through, within the guide tube 18).
Regarding claim 10, Komi discloses the bile duct/pancreatic duct treatment method according to claim 9, 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 (forceps 30 are on the proximal side of the insertion unit 21 of the daughter endoscope when the forceps 30 are inserted into guide tube 18 after the insertion unit 21 has been inserted into the guide tube 18 [col. 12, lines 23-26]).
Regarding claim 11, Komi discloses the bile duct/pancreatic duct treatment method according to claim 9, further disclosing the method comprising: separating the imaging wire inserted into one of the cavities from the treatment tool; and treating the diseased part of the one of the cavities with the treatment tool (Fig. 17: forceps 30 is separable from the insertion unit 21 of the daughter endoscope, as the forceps 30 proceeds further distally into the pancreatic duct 102 than the insertion unit 21; Fig. 17: various tool such as forceps 30 for treatment [col. 9, lines 29-31], shown on the distal side of guide tube 18).
Regarding claim 12, Komi discloses an endoscopic instrument (mother endoscope 1), comprising: an imaging wire having an imaging unit at its distal end (daughter endoscope having an insertion unit 21 [col. 1, lines 10-14]); and an access port through which the imaging wire can be inserted (Fig. 17: guide tube 18 can be inserted into bile duct 102 and pancreatic duct 103, and insertion unit 21 of daughter endoscope can be inserted within the guide tube 18 [col. 9, lines 12-16]), wherein the imaging wire and the access port are relatively movable along a longitudinal direction of the endoscopic instrument (Fig. 14 & 15: insertion portion 21 of daughter endoscope and guide tube 18 are slidable within the forceps channel 3 along the length of mother endoscope 1 [col. 9, lines 12-16]).
Regarding claim 13, Komi discloses the endoscopic instrument according to claim 12, further disclosing wherein the access port is an access tube having a lumen through which the imaging wire can be inserted (guide tube 18 is a tube through which the insertion portion 21 of the daughter endoscope passes through [col. 9, lines 14-16]).
Claims 12 and 14 are rejected under 35 U.S.C. 102(a)(1) as being unpatentable by Arndt et al. (US5,904,648).
Regarding claim 12, Arndt discloses an endoscopic instrument, comprising: an imaging wire having an imaging unit at its distal end (fiberoptic bronchoscope 2); and an access port through which the imaging wire can be inserted (Fig. 8: wire guide loop 12 through which the fiberoptic bronchoscope is advanced through [col. 7, lines 9-11]), wherein the imaging wire and the access port are relatively movable along a longitudinal direction of the endoscopic instrument (Fig. 7-9: wire guide loop 12, attached to the catheter 6, and the fiberoptic bronchoscope 2 can move relative to one another along a longitudinal direction of the endotracheal tube 3).
Regarding claim 14, Arndt discloses the endoscopic instrument according to claim 12, further disclosing wherein the access port is attachable to a treatment tool and is a ring-shaped access guide through which the imaging wire can be inserted (Fig. 8-10: wire guide loop 12, which is ring-shaped, is attached to catheter 6; fiberoptic bronchoscope 2 is inserted through wire guide loop 12).
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.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Komi in view of Melsheimer (US2018/0092513).
Regarding claim 2, Komi discloses the bile duct/pancreatic duct treatment method according to claim 1, but does not explicitly disclose the method comprising: inserting the imaging wire into the one of the cavities based on an image captured by the imaging unit. In the same field of endeavor, Melsheimer teaches a method of endoscopy treatment, comprising: inserting an imaging wire into a body cavity based on an image captured by an imaging unit within the imaging wire (endoscopes may be used as an image system for navigation and diagnosis [0025]). In view of Melsheimer, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included within the method of Komi the step of inserting the imaging wire into the body cavity based on imaging captured by the imaging wire, as it is well-known the images captured by the imaging wire help the operator navigate the imaging wire through the body cavity.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Komi in view of Blanc et al. (US2025/0302289).
Regarding claim 15, Komi discloses the endoscopic instrument according to claim 12. Komi discloses the daughter endoscope comprising an ocular unit (20B) and an optical cable (20C) connected with an external light source ([col. 6, lines 39-42]), but fails to further define the imaging system of daughter endoscope. In the same field of endeavor, Blanc teaches a substantially similar endoscope (endoscopic probe for 20 [0048]), the endoscope comprising any suitable light-based imaging system, including an imaging unit comprising an imaging section having a lens and an image sensor or a fiber optic imaging system (imaging device 22 at the distal end of the endoscopic probe 20, imaging device comprises of camera which may be a CMOS or fiber optic image system or any other suitable light-based imaging system, camera may also comprise one or more lenses [0050]), an illumination section that irradiates light supplied from a light source device, and the illumination section is disposed around the imaging section (image device may also comprise light source 222, which may be an optical fiber or LED, which can be arranged circumferential to the camera [0050]). In view of Blanc, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have recognized a fiber optic imaging system or any light-based imaging system as an equivalent alternative to CMOS image sensor imaging system for capturing images within the endoscope art.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Arndt in view of Blanc et al. (US2025/0302289).
Regarding claim 15, Arndt discloses the endoscopic instrument according to claim 12. Arndt discloses the fiberoptic bronchoscope comprising optical viewing fiber and an optical lighting fiber ([col. 3, lines 38-40]), but fails to explicitly disclose further details of the fiberoptic bronchoscope, thus failing to disclose the imaging unit comprising an imaging section having a lens and an image sensor, an illumination section that irradiates light supplied from a light source device, and the illumination section is disposed around the imaging section. In the same field of endeavor, Blanc teaches a substantially similar endoscope used for bronchoscopy (endoscopic probe for 20 [0048] bronchoscopy [0016]), the endoscope comprising any suitable light-based imaging system, including an imaging unit comprising an imaging section having a lens and an image sensor or a fiber optic imaging system (imaging device 22 at the distal end of the endoscopic probe 20, imaging device comprises of camera which may be a CMOS or fiber optic image system or any other suitable light-based imaging system, camera may also comprise one or more lenses [0050]), an illumination section that irradiates light supplied from a light source device, and the illumination section is disposed around the imaging section (image device may also comprise light source 222, which may be an optical fiber or LED, which can be arranged circumferential to the camera [0050]). In view of Blanc, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have recognized a fiber optic imaging system as an equivalent alternative to CMOS image sensor imaging system for capturing images within the endoscope art.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See references cited in PTO-892.
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/LI-TING SONG/Examiner, Art Unit 3795
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
01/12/2026