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 .
Response to Amendment
This Office action is responsive to the amendment filed 11/14/2025. Claims 1-2, 6-7, and 11 have been amended. Claims 19-20 have been cancelled and claims 21-22 are newly added. Claims 1-18, 21-22 are currently pending in the application with claims 12 and 15-18 being withdrawn from further consideration.
Response to Arguments
Applicant’s arguments, see pg. 6-7, filed 11/14/2025, with respect to the objections to the claims have been fully considered and are persuasive. The objections to the claims have been withdrawn.
Applicant’s arguments, see pg. 7-8, with respect to the rejections of the claims under 35 U.S.C. 102 and 103 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 Therefore, the rejection has been withdrawn.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 Richardson (US 2003/0078473).
Claim Rejections - 35 USC § 103
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.
Claims 1-2, 4, 6-8, 10-11, 13 and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Golden et al. (US 2014/0357946) in view of Richardson (US 2003/0078473).
Regarding claims 1 and 6, Golden discloses a method for insertion into a bile duct (see Fig. 3A-3B), comprising: inserting a first device (200) from a duodenum (107, see Fig. 1) into an opening of a papilla (106); and advancing a second device within the bile duct while the papilla is pulled by the first device (a guidewire can be passed through device 200 and into the bile duct while the papilla is pulled apart by device 200, see [0053]).
Golden fails to expressly teach the papilla is pulled by the first device along a longitudinal axis of the first device to change a shape of at least a portion of the bile duct.
Richardson, in the same field of art, teaches a related method for insertion into a bile duct (see Fig. 1-6) comprising inserting a first device (pulling biliary catheter 40) into an opening of a papilla and advancing a second device (guidewire 50) within the bile duct while the papilla is pulled by the first device along a longitudinal axis of the first device to change a shape of at least a portion of the bile duct in order to facilitate access to the bile duct by additional medical devices (see Abstract of Richardson, [0071] and Fig. 5-6).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the method of Golden to include the step of pulling the first device along a longitudinal axis of the first device to change a shape of at least a portion of the bile duct, as taught by Richardson, since doing so would facilitate access to the bile duct by additional medical devices.
Regarding claims 2 and 7, Golden discloses hooking the first device onto a lumen wall of a hollow organ within the papilla (the device 200 engages tissue at the opening of the papilla as shown in Fig. 3A-3B and can include teeth on the outer surface of legs 212 as described with reference to the embodiment of Fig. 4A-4B for better grip and applying greater outward force to improve access to the papilla, see [0056] and [0098]), before advancing the second device within the bile duct while the papilla is pulled by the first device (a guidewire can be passed through device 200 to gain access to the bile duct, see [0053]).
Regarding claims 4, 10 and 13, Golden discloses the second device is a guide wire, the first device has a lumen through which the guide wire can be inserted, and the guide wire is advanced within the lumen while the papilla is pulled by the first device (a guidewire can be passed through device 200, see [0053]).
Regarding claim 8, Golden further discloses the insertion method comprising: hooking the first device to a region closer to the opening of the papilla than to a part of the bile duct where there is a fold (the device 200 engages tissue at the opening of the papilla as shown in Fig. 3A-3B and as stated above, can include teeth for hooking onto tissue, see [0056] and [0098]).
Regarding claim 11, Golden further discloses wherein the first device is a forceps jaw (212, see Fig. 2A) having an edge on its outer peripheral surface (device 200 may have teeth on the outer surface of legs 212, see [00056] and [0098]).
Regarding claims 21 and 22, Richardson further teaches pulling the papilla along the longitudinal axis of the first device by retracting the first device (see [0071]).
Claims 3 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Golden and Richardson, as applied to claims 1 and 6 above, and further in view of Kiyokawa et al. (US 2016/0193454).
Regarding claims 3 and 9, the combination of Golden and Richardson teaches the insertion method according to claim 1, but fails to expressly teach removing the first device from an endoscope while a distal end of the second device indwells within the bile duct, after advancing the second device within the bile duct while the papilla is pulled by the first device.
Kiyokawa, in the same field of art, teaches a related method where a first device (1, see Fig. 39 and 41-42) is inserted into a papilla and removed from an endoscope (30) while a distal end of a second device (guidewire 27) is within the bile duct in order to introduce a basket (40) to a collect a calculus within the bile duct (see [0124]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the method of Golden and Richardson to include the step of removing the first device from an endoscope while a distal end of the second device indwells the bile duct, as taught by Kiyokawa, since doing so would allow a surgeon to deliver additional treatment to the surgical site to carry out a desired treatment or surgical procedure.
Claims 5 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Golden and Richardson, as applied to claims 1 and 10 above, and further in view of Topazian (US 2017/0112518).
Regarding claims 5 and 14, Golden further discloses wherein the second device is a guide wire (the second device is a guidewire, see [0053]), the first device is inserted into a first lumen of a multi-lumen tube (device 200 is inserted into a lumen of elongate member 302 which may include one or more channels, see [0050]).
Golden fails to expressly teach the guide wire is advanced within a second lumen of the multi-lumen tube. Instead, Golden teaches the guide wire is advanced through a lumen of the first device while the papilla is pulled by the first device (see [0053]).
Topazian, in the same field of art teaches a related method for insertion into a bile duct, where a first device (grasping device 220, see Fig. 2A-2B) is inserted into a first lumen of a multi-lumen tube (100) and a guidewire is inserted into a second lumen of the multi-lumen tube (see [0034]) and the guidewire is advanced within a second lumen of the multi-lumen tube while the papilla is pulled by the first device (see [0031]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the method of Golden so that the guidewire is advanced through a second lumen of the multi-lumen tube, as taught by Topazian, since doing so appears to be a suitable alternative to inserting the guidewire through a lumen of the first device and the modification would have yielded only predictable results, namely, cannulation of the bile duct.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
All of the documents cited in the attached PTO-892 teach related devices and methods for insertion into a bile duct.
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.
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/SERENITY A MILLER/Examiner, Art Unit 3771
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771