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 07/23/2026. Claims 1-5, 21, and 23-27 have been amended. Claims 29-30 have been newly added. Claims 1-5, 11, 21 and 23-30 are currently pending in the application.
Response to Arguments
Applicant’s arguments, see pg. 5, filed 07/23/2026, with respect to the rejection of claim 23 under 35 U.S.C. 112(d) have been fully considered and are persuasive. The rejection has been withdrawn.
Applicant’s arguments, see pg. 6-10, filed 07/23/2026, with respect to the rejections of the claims under 35 U.S.C. 103 have been fully considered but they are not persuasive.
Applicant argues that the combination of Golden and Richardson fails to teach “pulling the first device along a longitudinal axis of the first device to retract [an entrance of a narrow distal segment] so as to transform the narrow distal segment from a relatively more curved narrow distal segment into a relatively more straight narrow distal segment” as recited by amended claim 1. Applicant further argues that the rejection relies on the principle of inherency and that the Examiner has not provided evidence that the result inevitably flows from the teaching of a reference.
The Examiner disagrees and notes that the rejection of the claim does not rely on inherency but on what Golden and Richardson clearly describe and show in the specification and figures. Golden teaches the method of claim 1 except for pulling the first device as claimed. Richardson teaches a related method, including the step of pulling a device along a longitudinal axis of the device to retract an entrance to a narrow distal segment of the bile duct to transform the segment from a relatively more curved segment to a relatively more straight segment, which allows for the insertion of other medical devices into the bile duct. All bile ducts have some curvature and Richardson clearly shows this in Fig. 1. Pulling on the papilla, as taught by Richardson, to move to the papilla away from the septum of the biliary tree causes some stretching and relative straightening of surrounding tissues which is clearly shown in Fig. 5-6 (see also Richardson’s abstract and paragraph [0014]).
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, 11, 21, and 23-30 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 claim 1, 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 entrance of a narrow distal segment in the bile duct (the device is inserted into the papilla 106 which is an entrance of a narrow distal segment of the bile duct, see Fig. 3A-3B); and advancing a second device within the narrow distal segment while the entrance 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 entrance is pulled by the first device along a longitudinal axis of the first device to retract the entrance so as to transform the distal segment from a relatively more curved distal segment into a relatively more straight distal segment.
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 entrance of a narrow distal segment in the bile duct and advancing a second device (guidewire 50) within the bile duct while the entrance is pulled by the first device along a longitudinal axis of the first device to retract the entrance so as to transform the distal segment from a relatively more curved distal segment into a relatively more straight distal segment in order to facilitate access to the bile duct by additional medical devices (see Abstract of Richardson, [0014], [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, as taught by Richardson, since doing so would facilitate access to the bile duct by additional medical devices.
Regarding claim 2, Golden discloses hooking the first device onto a lumen wall of a hollow organ within a papilla (the device 200 engages tissue within a 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 claim 4, 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 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 claim 21, Richardson further teaches pulling the papilla along the longitudinal axis of the first device by retracting the first device (see [0071]).
Regarding claim 23, Golden teaches the first device is inserted into the narrow distal segment while the narrow distal segment is curved (medical device 200 is inserted into the papilla which is considered an entrance into a narrow distal segment of the bile duct, see Fig. 3A-3B).
Regarding claim 24, Golden further teaches wherein the narrow distal segment is bent at an angle relative to the longitudinal axis of the first device (all bile ducts have some curvature and would therefore be bent at an angle relative to any device inserted into the opening of a papilla, see also Fig. 3A-3B of Golden).
Regarding claim 25, Golden further teaches wherein the narrow distal segment is meandering (the narrow distal segment in Golden is curved and therefore meandering, see Golden Fig. 3A-3B).
Regarding claim 26, Richardson further teaches wherein pulling the first device deforms the narrow distal segment into a shape that makes it easier to insert the second device (see [0014]).
Regarding claim 27, the combination of Golden and Richardson teaches the insertion method according to claim 24, wherein the relatively more straight narrow distal segment extends along the longitudinal axis of the first device (pulling on the papilla along the longitudinal axis of the first device as taught by Richardson would straighten the surrounding tissue along the longitudinal axis of the first device).
Regarding claim 28, the combination of Golden and Richardson fails to expressly teach wherein the first device is pulled by bending a bending portion of an endoscope.
However, it is noted that the first device (200) of Golden is delivered by a flexible endoscope (300, see Fig. 3A-3B) and so it is understood that pulling on the papilla by pulling the first device as taught by Richardson could either occur by retracting the first device directly or by bending the endoscope away from the papilla.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to pull the first device by bending a portion of an endoscope , as a matter of being obvious to try - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success (see KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385, 1395-97 (2007)), to obtain the predictable result of pulling the first device along its longitudinal axis since the only two choices are 1) retracting the first device away from the papilla by pulling the first device alone, or 2) retracting the first device by bending the endoscope away from the papilla. These are the only two options apparent to one of ordinary skill in the art, with there being no undue experimentation and there being a reasonable expectation of success at arriving at first device being pulled along its longitudinal axis.
Regarding claim 29, Golden further teaches the narrow distal segment is located in the bile duct near a sphincter of Oddi muscle and is narrower than a section situated further away from the sphincter of Oddi muscle (the narrow distal segment that is near the entrance of the papilla is near the sphincter of Oddi muscle and is narrower than the section of the bile duct that is further away from the papilla, see Fig. 3A-3B).
Regarding claim 30, Golden further teaches the narrow distal segment is located between an opening of a papilla and a bifurcation of the bile duct and a pancreatic duct (there is a narrow distal segment between the opening of the papilla and the bifurcation of the bile duct and pancreatic duct, see Fig. 1 and 3A-3B).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Golden and Richardson, as applied to claim 1, and further in view of Kiyokawa et al. (US 2016/0193454).
Regarding claim 3, 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.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Golden and Richardson, as applied to claim 1, and further in view of Topazian (US 2017/0112518).
Regarding claim 5, 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
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.
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/SERENITY A MILLER/Examiner, Art Unit 3771
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771
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