DETAILED ACTION
Response to Amendment
This Office Action is responsive to the amendment filed on 01/30/2026. As indicated by the amendment: claims 1, 8, 11-12 and 16 have been amended, claims 4-5, 9-10 and 13 have been cancelled, and new claims 21-25 have been added. In response to the corrected drawings and specification, the objections to the drawings have been withdrawn. Claims 1-3, 6-8, 11-12 and 14-25 are presently pending in the application.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-3, 6-8, 11-12 and 14-25 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Independent claims 1 and 11 have been amended to recite "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". Applicant states that support for this recitation is found in paragraph [0028] of the specification. It discloses:
In examples, shaft 108 can be configured in sections having different rigidities to, for example, concentrate the ability of shaft 108 to be steered in a particular section of guide sheath 102. For example, distal end portion 139A of shaft 108 (e.g., approximately the most-distal 10 ten to twenty percent) can be configured to be more flexible than the remaining proximal portion 139B so that the pull wires can pull the distal end of shaft 108 at a sharp angle (e.g., approximately thirty to ninety degrees), which can be useful in guiding cholangioscope 104 into common bile duct 212 (FIG. 7) from duodenum 202 (FIG. 7). Sectioning of the flexibility of shaft 108 can allow more rigid portions proximal of the distal flexible portion to provide stiffening to cholangioscope to allow cholangioscope to use native steering capabilities more effectively (e.g., without binding as described above). For example, proximal portion 139B can have a rigidity that is more rigid than cholangioscope 104 so that when cholangioscope 104 is steered, e.g., by tensioning of one or more pull wires 146A and 146B, cholangioscope 104 can be pushed into the desired direction by the pulling of pull wires 146A and 146B.
The above disclosure states that the distal and proximal portions have different rigidities such that the distal end portion is flexible/less rigid for steering. Contrary to that contended by Applicant, the above disclosure does not recite creating the different rigidities of proximal and distal portions by fabricating the portions each from a different material having different stiffnesses. Moreover, it is well-known in the art that the flexibility/rigidity of the distal end portion of a sheath can be increased/reduced by: forming slits or slots through the outer circumference of the sheath, reducing the wall thickness, using a different material, etc. The specification does not disclose: 1) how the flexibility/rigidity of distal end portion is increased/reduced, or 2) the structure of the distal end portion. As Applicant has neither specifically disclosed how the flexibility/rigidity of distal end portion is increased/reduced, nor the structure of the distal end portion, it cannot narrowly select a technique to achieve a broadly disclosed concept. Accordingly, claims 1-3, 6-8, 11-12 and 14-25 fail to comply with the written description requirement.
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 Gottumukkala (US 2010/0256446 A1) in view of Yoshitani et al. (US 2020/0100652 A1).
Regarding claim 1, Gottumukkala 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 Gottumukkala 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. Yoshitani teaches an analogous guide sheath (3; Fig. 1; par. [0040]) wherein the proximal end portion (Figs. 1 and 2 - proximal end portion of 3a that is connected to the distal end of 5) is fabricated from a first material having a first stiffness (15/17/18; par. [0075] and [0095]; Fig. 2 – proximal end portion of 3a wherein the laminated material of 17/18 has a large percentage of hard resin 18) and the distal end portion (Figs. 1 and 2 – 3b and distal portion of 3a) is fabricated from a second material having a second stiffness (15/17/18; par. [0075] and [0095]; Fig. 2 – distal end portion of 3a wherein the laminated material of 17/18 has a large percentage of soft resin 17), wherein the first stiffness is greater than the second stiffness (par. [0075] and [0095]-[0096]). Yoshitani teaches that the distal end portion is soft so as to be easily inserted into the body, and that the proximal end portion is harder so as to enhance operability (par. [0004]). It would have been obvious to one having ordinary skill in the art to make the distal end portion of the guide sheath from a material with a lower stiffness than the stiffness of the material for the proximal end portion, as taught by Yoshitani, such that the distal end portion is soft and can be easily inserted into the body, and that the proximal end portion is harder so as to enhance operability, as taught by Yoshitani.
Regarding claim 2, Gottumukkala in view of Yoshitani 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, Gottumukkala in view of Yoshitani 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, Gottumukkala in view of Yoshitani 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, Gottumukkala in view of Yoshitani disclose the direct peroral cholangioscope system of claim 1, wherein the tissue retrieval device (220) comprises forceps (222; par. [0055]).
Regarding claim 8, Gottumukkala in view of Yoshitani 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, Gottumukkala 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 Gottumukkala's system, and applicant's invention, to perform equally well with either the outer diameter taught by Gottumukkala 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 Gottumukkala 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 Gottumukkala.
Regarding claim 21, Gottumukkala in view of Yoshitani 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, Gottumukkala in view of Yoshitani 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, Gottumukkala in view of Yoshitani 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, Gottumukkala in view of Yoshitani 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, Gottumukkala in view of Yoshitani 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 Gottumukkala (US 2010/0256446 A1) in view of Yoshitani et al. (US 2020/0100652 A1) in view of Tilson et al. (US 2021/0138187 A1).
Regarding claim 11, Gottumukkala 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 Gottumukkala, 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 Gottumukkala 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. Yoshitani teaches an analogous guide sheath (3; Fig. 1; par. [0040]) wherein the proximal end portion (Figs. 1 and 2 - proximal end portion of 3a that is connected to the distal end of 5) is fabricated from a first material having a first stiffness (15/17/18; par. [0075] and [0095]; Fig. 2 – proximal end portion of 3a wherein the laminated material of 17/18 has a large percentage of hard resin 18) and the distal end portion (Figs. 1 and 2 – 3b and distal portion of 3a) is fabricated from a second material having a second stiffness (15/17/18; par. [0075] and [0095]; Fig. 2 – distal end portion of 3a wherein the laminated material of 17/18 has a large percentage of soft resin 17), wherein the first stiffness is greater than the second stiffness (par. [0075] and [0095]-[0096]). Yoshitani teaches that the distal end portion is soft so as to be easily inserted into the body, and that the proximal end portion is harder so as to enhance operability (par. [0004]). It would have been obvious to one having ordinary skill in the art to make the distal end portion of the guide sheath from a material with a lower stiffness than the stiffness of the material for the proximal end portion, as taught by Yoshitani, such that the distal end portion is soft and can be easily inserted into the body, and that the proximal end portion is harder so as to enhance operability, as taught by Yoshitani.
Although Gottumukkala 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 Gottumukkala 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, Gottumukkala in view of Yoshitani 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, Gottumukkala in view of Yoshitani 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, Gottumukkala in view of Yoshitani 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, Gottumukkala in view of Yoshitani in view of Tilson disclose the method of claim 12[[11]], 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, Gottumukkala in view of Yoshitani 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, Gottumukkala in view of Yoshitani 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, Gottumukkala in view of Yoshitani 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, Gottumukkala in view of Yoshitani 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 claim amendments and Remarks, filed 01/30/2026, with respect to the rejection(s) of claim(s) 1 and 11 under 35 USC 102 and 35 USC 103, respectively, 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 Yoshitani, as discussed above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 RYNAE E BOLER whose telephone number is (571)270-3620. The examiner can normally be reached Mon - Fri 9:00-5:00.
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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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/RYNAE E BOLER/Examiner, Art Unit 3795
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795 5/21/26
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