DETAILED ACTION
Response to Amendment
This Office Action is responsive to the after-final response filed on 07/28/2026. Claims 1-3, 6-8, 11-12 and 14-25 are presently pending in the application.
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.
Claim(s) 1-3, 6-8 and 21-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Raju (US 2010/0256446 A1) in view of Nakajima (US 2015/0073215 A1).
Regarding claim 1, Raju discloses a direct peroral cholangioscope
system (Fig. 2) comprising: a guide sheath (196; par. [0053]-[0054]; Fig. 3) comprising:
a proximal end portion (Fig. 3 - proximal end portion of 196 that is connected to the distal end of 156); a distal end portion (portion including 200, 198 and a distal portion of 196; par. [0054]; Fig. 3); and a lumen (202; par. [0051]; Fig. 4) extending between the proximal end portion and the distal end portion (Figs. 3-4); wherein the guide sheath (196) is sized to pass through an esophagus of a patient (par. [0008], [0039] and [0056]); an endoscope (102; par. [0048]) comprising: an elongate body (146; Fig. 3; par. [0050]) extending from a proximal end to a distal end; an imaging device (par. [0044] and [0049]; Fig. 2) coupled to the elongate body (146) proximate the distal end; and a passage (Fig. 4 - passage through 146 which 220 extends; par. [0062]) extending at least partially through the elongate body (146) and exiting at the distal end (Fig. 4); wherein the elongate body (146) is sized to pass through the lumen (202; par. [0055]); and a tissue retrieval device (220; Fig. 4; par. [0055]) configured to pass through the passage (Fig. 4) and retrieve tissue from within
the patient (par. [0055]).
Although Raju discloses that the distal end portion (portion including 200, 198 and distal portion of 196; par. [0054]; Fig. 3) is flexible, it does not specifically disclose wherein the proximal end portion is fabricated from a first material having a first stiffness and the distal end portion is fabricated from a second material having a second stiffness, wherein the first stiffness is greater than the second stiffness. Nakajima teaches an analogous guide sheath (100; Fig. 1; par. [0039]) wherein the proximal end portion (117; par. [0040]) is fabricated from a first material having a first stiffness (par. [0032] – rigid resin) and the distal end portion (116; par. [0040]) is fabricated from a second material having a second stiffness (par. [0024] – flexible resin), wherein the first stiffness is greater than the second stiffness (par. [0024] and [0032]). Nakajima teaches that the proximal end portion is harder in order to facilitate insertion of the endoscope into the guide sheath (par. [0032]). It would have been obvious to one having ordinary skill in the art to make the proximal end portion of the guide sheath from a material with a harder stiffness than the stiffness of the material for the proximal end portion, as taught by Nakajima, such that the distal end portion flexible, and that the proximal end portion is harder in order to facilitate insertion of the endoscope, as taught by Nakajima.
Regarding claim 2, Raju in view of Nakajima disclose the direct peroral cholangioscope system of claim 1, wherein the guide sheath (196) further comprises steering capabilities (par. [0054] and [0058]; Figs. 5-6).
Regarding claim 3, Raju in view of Nakajima disclose the direct peroral cholangioscope system of claim 2, wherein the steering capabilities comprise a pull wire (230/232; par. [0058]; Figs. 5-6) extending along the guide sheath (196; Fig. 5-6).
Regarding claim 6, Raju in view of Nakajima disclose the direct peroral cholangioscope system of claim 2, wherein the endoscope (102) comprises native steering capabilities (control wires/130/132; par. [0043] and [0050]).
Regarding claim 7, Raju in view of Nakajima disclose the direct peroral cholangioscope system of claim 1, wherein the tissue retrieval device (220) comprises forceps (222; par. [0055]).
Regarding claim 8, Raju in view of Nakajima disclose the direct peroral cholangioscope system of claim 1, wherein an outer diameter of the guide sheath is in the range of approximately 10 mm to approximately 12 mm (par. [0066]); wherein a diameter of the elongate body is in the range of approximately 8 mm to approximately 10 mm (par. [0066]); wherein an outer diameter of the passage is in the range of
approximately 3.2 mm (par. [0066]).
However, Raju does not specifically disclose wherein an outer diameter of the passage is in the range of approximately 5 mm to approximately 6 mm. At the time the invention was effectively filed, it would have been an obvious matter of design choice to a person of ordinary skill in the art to make the outer diameter of the passage 5 mm apart because Applicant has not disclosed that a 5 mm passage provides an advantage, is used for a particular purpose, or solves a stated problem. Applicant explicitly discloses "[i]n examples, D4 can be in the range of approximately 5.0 mm to approximately 6.0 mm. In additional examples, D4 can be in the range of approximately 2.0 mm to approximately 3.0 mm" (see par. [0038] of the published application). One of ordinary skill in the art, furthermore, would have expected Raju's system, and applicant's invention, to perform equally well with either the outer diameter taught by Raju or the claimed 5 mm to 6 mm range because both diameters would perform the same function of inserting and removing a tissue retrieval device. Therefore, it would have been prima facie obvious to modify Raju to obtain the invention as specified in claim 8 because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Raju.
Regarding claim 21, Raju in view of Nakajima disclose the direct peroral cholangioscope system of claim 1, wherein the distal end portion (portion including 200, 198 and a distal portion of 196; par. [0054]; Fig. 3) comprises a distal-most twenty percent of the guide sheath (Figs. 5-6 – see bend angle of the bending portion ranging between thirty to ninety degrees; par. [0058]). The Examiner notes that Applicant discloses that the distal end portion is approximately the most-distal ten to twenty percent of the shaft in order to allow the pull wires to pull the distal end of the shaft approximately thirty to ninety degrees (see par. [0028] of the published specification).
Regarding claim 22, Raju in view of Nakajima disclose the direct peroral cholangioscope system of claim 21, wherein the first stiffness of the proximal end portion of the guide sheath is more rigid than the elongate body of the endoscope (par. [0015]).
Regarding claim 23, Raju in view of Nakajima disclose the direct peroral cholangioscope system of claim 21, wherein the guide sheath (196) comprises a continuous tubular body having a substantially uniform outer diameter from the proximal end portion to the distal end portion (Figs. 3 and 8).
Regarding claim 24, Raju in view of Nakajima disclose the direct peroral cholangioscope system of claim 2, wherein the elongate body of the endoscope is configured to freely slide within the lumen of the guide sheath (par. [0051] and [0062]).
Regarding claim 25, Raju in view of Nakajima disclose the direct peroral cholangioscope system of claim 24, wherein the endoscope (104; par. [0048]) comprises steering wires (par. [0043] – control wires form the angulation knobs) capable of being simultaneously operated with the steering capabilities of the guide sheath (Figs. 3 and 8; capable of such intended use).
Claim(s) 11-12 and 14-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Raju (US 2010/0256446 A1) in view of Nakajima et al. (US 2015/0073215 A1) in view of Tilson et al. (US 2021/0138187 A1).
Regarding claim 11, Raju discloses a method of performing a direct peroral cholangioscopy procedure, the method comprising: inserting an endoscope (102) into a guide sheath (196; par. [0008], [0015], [0039], [0047] and [0056]) wherein the guide sheath comprises: a proximal end portion (Fig. 3 - proximal end portion of 196 that is connected to the distal end of 156); a distal end portion (portion including 200, 198 and distal portion of 196; par. [0054]; Fig. 3); and a lumen (202; par. [0051]; Fig. 4) extending between the proximal end portion and the distal end portion (Figs. 3-4); inserting the guide sheath (196) and endoscope (102) into the stomach of a patient (par. [0008], [0015], [0039], [0047] and [0056]); inserting the guide sheath (196) and endoscope (102) into the duodenum of the patient (par. [0008], [0015], [0039], [0047] and [0056]); positioning the endoscope (102) proximate the sphincter of Oddi (par. [0056]; the Examiner notes that the sphincter of Oddi is a muscular valve surrounding the papilla Vater that controls the flow of bile and pancreatic fluid. Thus, positioning the endoscope in the duodenum and proximate the ampulla of Vater, a disclosed by Raju, is also positioning it proximate the sphincter of Oddi); inserting a tissue retrieval device (220; par. [0055]) into the endoscope (102); positioning the tissue retrieval device (220) in the common bile duct of the patient (par. [0047], [0055]-[0056]); and collecting biological matter with the tissue retrieval device (220; par. [0047], [0055]-[0056]).
Although Raju discloses that the distal end portion (portion including 200, 198 and distal portion of 196; par. [0054]; Fig. 3) is flexible, it does not specifically disclose wherein the proximal end portion is fabricated from a first material having a first stiffness and the distal end portion is fabricated from a second material having a second stiffness, wherein the first stiffness is greater than the second stiffness. Nakajima teaches an analogous guide sheath (100; Fig. 1; par. [0039]) wherein the proximal end portion (117; par. [0040]) is fabricated from a first material having a first stiffness (par. [0032] – rigid resin) and the distal end portion (116; par. [0040]) is fabricated from a second material having a second stiffness (par. [0024] – flexible resin), wherein the first stiffness is greater than the second stiffness (par. [0024] and [0032]). Nakajima teaches that the proximal end portion is harder in order to facilitate insertion of the endoscope into the guide sheath (par. [0032]). It would have been obvious to one having ordinary skill in the art to make the proximal end portion of the guide sheath from a material with a harder stiffness than the stiffness of the material for the proximal end portion, as taught by Nakajima, such that the distal end portion flexible, and that the proximal end portion is harder in order to facilitate insertion of the endoscope, as taught by Nakajima.
Although Raju discloses positioning the endoscope proximate the sphincter of Oddi (par. [0056]) and that the guide sheath (196) has a bending section (198; par. [0058]), it does not specifically disclose turning a distal end of the endoscope with the guide sheath to position the endoscope proximate the sphincter of Oddi. Tilson teaches an analogous method wherein the steerable portion (8302z; Figs. 70A-70B) at the distal end of the guide sheath (8300) is turned such that a distal end of the endoscope (8391) with the guide sheath (8300) to position the endoscope (8391) proximate the sphincter of Oddi (par. [0334]; Figs. 70A-70B). Tilson teaches that bending the guide sheath advantageously deflects the endoscope and directs it towards the papilla, achieving direct visualization as a result (par. [0334]). It would have been obvious to bend the guide sheath of Raju at its distal end using its angulation controls, in order to deflect the endoscope and direct it towards the papilla such that direct visualization can be achieved, as taught by Tilson.
Regarding claim 12, Raju in view of Nakajima in view of Tilson disclose the method of claim 11, wherein turning a distal end of the endoscope (102) with the guide sheath (196) to position the endoscope (102) proximate the sphincter of Oddi comprises tensioning a pull wire (230/232; Fig. 5; par. [0057] and [0068]) of the guide sheath (Figs. 4-5 and 12) and wherein tensioning a pull wire (230/232) of the guide sheath (196) comprises bending a distal bending section (198) of the guide sheath (196) with the pull wire (230/232; Fig. 5).
Regarding claim 14, Raju in view of Nakajima in view of Tilson disclose the method of claim 11, wherein inserting the guide sheath (196) and the endoscope (102) into the duodenum of the patient comprises turning (bending) the endoscope with the guide sheath (Tilson: par. [0334]; Figs. 70A-70B).
Regarding claim 15, Raju in view of Nakajima in view of Tilson disclose the method of claim 14, wherein turning the endoscope (102) with the guide sheath (196) comprises tensioning a pull wire (230/232) of the guide sheath (196; par. [0057] and [0068]; Fig. 5).
Regarding claim 16, Raju in view of Nakajima in view of Tilson disclose the method of claim 12, wherein positioning the tissue retrieval device (220) in the common bile duct of the patient comprises steering the endoscope (102) with native steering capabilities (130/134/angulation wires; par. [0041], [0047], [0050] and [0056]).
Regarding claim 17, Raju in view of Nakajima in view of Tilson disclose the method of claim 16, further comprising inserting the endoscope (102) into the sphincter of Oddi (par. [0047] and [0056]).
Regarding claim 18, Raju in view of Nakajima in view of Tilson disclose the method of claim 17, wherein inserting the endoscope (102) into the sphincter of Oddi comprises pushing the endoscope (102) against the guide sheath (196; when the endoscope bends via elevators or pull-wires of the guide sheath; par. [0047], [0056] and [0068]; Figs. 4-5).
Regarding claim 19, Raju in view of Nakajima in view of Tilson disclose the method of claim 11, wherein collecting biological matter with the tissue retrieval device (220) comprises withdrawing the tissue retrieval device (220) from the endoscope (120; par. [0055]).
Regarding claim 20, Raju in view of Nakajima in view of Tilson disclose the method of claim 19, wherein collecting biological matter with the tissue retrieval device further comprises reinserting the tissue retrieval device (220; par. [0055]).
Response to Arguments
Applicant’s arguments, see Remarks, filed 07/28/2026, with respect to the rejection(s) of claim(s) 1 and 11 under 35 USC 112 and 35 USC 103 have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in light of Raju in view Nakajima, as discussed above.
Conclusion
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/RYNAE E BOLER/Examiner, Art Unit 3795
/ANHTUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
8/18/26
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