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 Arguments
The previous objection of claims 21 and 23 due to minor informalities has been withdrawn in light of applicant’s amendments made 4/16/2026.
The rejection of claims 10, 12-14, 21 and 23 under 35 U.S.C. 102(a)(1) as being anticipated by Richardson (US 2003/0078473 A1) has been withdrawn in light of applicant’s amendment made 4/16/2026. Specifically, Richardson does not teach an inflatable balloon asymmetrically disposed relative to the atraumatic distal tip with the inflatable balloon offset to one side of the guidewire port.
Applicant’s arguments with respect to claims 10-11, 13-14, 21 and 23 have been considered but are moot because the new ground of rejection does not rely on any reference in the prior art rejection of record for any teaching or matter specifically challenged in the argument. However, as discussed below, the newly added reference Motai et al. (US 8,545,394 B2) teaches said limitation.
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(s) 10-11, 13-14, 21 and 23-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Richardson (US 2003/0078473 A1) in view of Motai et al. (US 8,545,394 B2).
Regarding claim 10, Richardson discloses a cannulation device (biliary catheter 90; Figs. 11-13) adapted to be advanced through an endoscope (as catheter 90 may be advanced through an endoscope similar to biliary catheter 16 being advanced through endoscope 10 of Fig. 1) to a position proximate a patient's duodenum (as an endoscope may be passed through a patient until it reaches the duodenum similar to that of Fig. 1; [0032]) in order to gain access to the patient's common bile duct (common bile duct 126; Fig. 13), the cannulation device comprising: an elongate shaft (generally cylindrical portion 91) extending to an atraumatic distal tip (tapered distal end 92 is considered atraumatic as the tapered portion facilitates a lower profile for insertion which is less traumatic during delivery); a guidewire lumen (inner lumen 94; Fig. 11) extending through the elongate shaft (inner lumen 94 may be utilized as a guidewire lumen; [0078]), the guidewire lumen terminating at a guidewire port (opening 93) disposed within the atraumatic distal tip (Figs. 11-13); an inflatable balloon (balloon 96) disposed relative to the atraumatic distal tip (Figs. 11-13), the inflatable balloon (96) inflatable from a collapsed configuration (Figs. 11-12) to an expanded configuration (Fig. 13) in which the inflatable balloon is adapted to occlude the patient's pancreatic duct (as Fig. 13 shows the papilla of Vater 122 occluded; thus, flow from the pancreatic duct 128 is blocked from flowing into the duodenum i.e. occluding the pancreatic duct 128 and/or the balloon 96 is dimensioned to be positioned between the pancreatic duct 128, the common bile duct 126 and the papilla of Vater 122 to directly contact the orifice and occlude the pancreatic duct 128 because in some patients, the orifice of the papilla of Vater 122 is positioned against the contralateral wall 125, or septum, separating the pancreatico-biliary ducts [0083] and the balloon 96 is inflated to a diameter that is greater than the orifice of the papilla of Vater 122 [0084]; thus, when the papilla of Vater 122 is positioned against the contralateral wall 125 and the balloon is inflated, prior to pulling the catheter 90, the pancreatic duct 128 would be occluded [0084]); and an inflation lumen (inflation lumen 95) extending through the elongate shaft and fluidly coupled with the inflatable balloon (Fig. 11; [0077]).
Richardson fails to disclose the inflatable balloon is asymmetrically disposed relative to the atraumatic distal tip with the inflatable balloon offset to one side of the guidewire port, in which the inflatable balloon is adapted to occlude the patient’s pancreatic duct while directing the guidewire port toward the patient’s common bile duct.
However, Motai teaches a cannulation device (Fig. 22) adapted to be advanced through an endoscope (endoscope 100) to a position proximate a patient’s duodenum (Fig. 22), the cannulation device comprising: an elongate shaft (endoscope treatment instrument/tube 21 coming out of endoscope 100; Fig. 22) and an inflatable balloon (balloon B1) asymmetrically disposed relative to an atraumatic distal tip with the inflatable balloon offset to one side of the cannulation device (Fig. 22), the inflatable balloon (B1) inflatable from a collapsed configuration to an expanded configuration (inflatable outward in a radial direction of the tube; column 10, lines 1-4) in which the inflatable balloon is adapted to occlude the patient’s pancreatic duct (Fig. 22) while directing the cannulation device toward the patient’s common bile duct (Fig. 22; as the distal end of the tube is bent into the common bile duct; columns 9-10, lines 61-67, 1-5) for the purpose of deforming or bending the distal end for selective cannulation (column 9, lines 50-55).
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 inflatable ballon of Richardson to be asymmetrical disposed relative to the atraumatic distal tip with the inflatable balloon offset to one side of the guidewire port so that when the inflatable balloon is in the expanded configuration it is adapted to occlude the patient’s pancreatic duct while directing the guidewire port toward the patient’s common bile duct in light of the teachings of Motai in order to selectively deform or bend the cannulation device into the common bile duct.
Regarding claim 24, Richardson discloses a cannulation device (biliary catheter 90; Figs. 11-13) adapted to be advanced through an endoscope (as catheter 90 may be advanced through an endoscope similar to biliary catheter 16 being advanced through endoscope 10 of Fig. 1) to a position proximate a patient's duodenum (as an endoscope may be passed through a patient until it reaches the duodenum similar to that of Fig. 1; [0032]) in order to gain access to the patient's common bile duct (common bile duct 126; Fig. 13), the cannulation device comprising: an elongate shaft (generally cylindrical portion 91) extending to an atraumatic distal tip (tapered distal end 92 is considered atraumatic as the tapered portion facilitates a lower profile for insertion which is less traumatic during delivery); a guidewire lumen (inner lumen 94; Fig. 11) extending through the elongate shaft (inner lumen 94 may be utilized as a guidewire lumen; [0078]), the guidewire lumen terminating at a guidewire port (opening 93) disposed within the atraumatic distal tip (Figs. 11-13); an inflatable balloon (balloon 96) disposed relative to the atraumatic distal tip (Figs. 11-13), the inflatable balloon (96) inflatable from a collapsed configuration (Figs. 11-12) to an expanded configuration (Fig. 13) in which the inflatable balloon is adapted to occlude the patient's pancreatic duct (as Fig. 13 shows the papilla of Vater 122 occluded; thus, flow from the pancreatic duct 128 is blocked from flowing into the duodenum i.e. occluding the pancreatic duct 128 and/or the balloon 96 is dimensioned to be positioned between the pancreatic duct 128, the common bile duct 126 and the papilla of Vater 122 to directly contact the orifice and occlude the pancreatic duct 128 because in some patients, the orifice of the papilla of Vater 122 is positioned against the contralateral wall 125, or septum, separating the pancreatico-biliary ducts [0083] and the balloon 96 is inflated to a diameter that is greater than the orifice of the papilla of Vater 122 [0084]; thus, when the papilla of Vater 122 is positioned against the contralateral wall 125 and the balloon is inflated, prior to pulling the catheter 90, the pancreatic duct 128 would be occluded [0084]); and an inflation lumen (inflation lumen 95) extending through the elongate shaft and fluidly coupled with the inflatable balloon (Fig. 11; [0077]).
Richardson fails to disclose the inflatable balloon is disposed along a lateral side of the atraumatic distal tip with the inflatable balloon asymmetrically offset from the guidewire port, in which the inflatable balloon is adapted to occlude the patient’s pancreatic duct while directing the guidewire port toward the patient’s common bile duct.
However, Motai teaches a cannulation device (Fig. 22) adapted to be advanced through an endoscope (endoscope 100) to a position proximate a patient’s duodenum (Fig. 22), the cannulation device comprising: an elongate shaft (endoscope treatment instrument/tube 21 coming out of endoscope 100; Fig. 22) and an inflatable balloon (balloon B1) asymmetrically and laterally disposed relative to an atraumatic distal tip with the inflatable balloon offset to one side of the cannulation device (Fig. 22), the inflatable balloon (B1) inflatable from a collapsed configuration to an expanded configuration (inflatable outward in a radial direction of the tube; column 10, lines 1-4) in which the inflatable balloon is adapted to occlude the patient’s pancreatic duct (Fig. 22) while directing the cannulation device toward the patient’s common bile duct (Fig. 22; as the distal end of the tube is bent into the common bile duct; columns 9-10, lines 61-67, 1-5) for the purpose of deforming or bending the distal end for selective cannulation (column 9, lines 50-55).
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 inflatable ballon of Richardson to be disposed along a lateral side of the atraumatic distal tip with the inflatable balloon asymmetrically offset from the guidewire port so that when the inflatable balloon is in the expanded configuration it is adapted to occlude the patient’s pancreatic duct while directing the guidewire port toward the patient’s common bile duct in light of the teachings of Motai in order to selectively deform or bend the cannulation device into the common bile duct.
Regarding claims 11 and 25, Richardson modified discloses wherein the inflatable balloon is further adapted to, when inflated, push the atraumatic distal tip away from the patient's pancreatic duct and towards the patient's common bile duct (Fig. 22 of Motai), thereby helping to align the guidewire port with the common bile duct (Fig. 22 of Motai).
Regarding claims 13 and 26, Richardson modified discloses the invention as claimed above, and Richardson further discloses wherein the inflatable balloon (96), when in its collapsed configuration, forms part of the atraumatic distal tip (Figs. 11-12).
Regarding claims 14 and 27, Richardson modified discloses wherein the cannulation device is adapted for accessing the patient's common bile duct from a position proximate the patient's ampulla of vater (Fig. 22 of Motai).
Regarding claims 21 and 28, Richardson modified discloses wherein the inflatable balloon (B1 of Motai) is configured to be positioned to close off access to the pancreatic duct (203; Fig. 22 of Motai).
Regarding claims 23 and 29, Richardson modified discloses wherein the inflatable balloon (B1 of Motai) is adapted not to extend within the pancreatic duct (203), but merely to block access to the pancreatic duct (203; Fig. 22 of Motai).
Regarding claim 30, Richardson discloses a cannulation device (biliary catheter 90; Figs. 11-13) adapted to be advanced through an endoscope (as catheter 90 may be advanced through an endoscope similar to biliary catheter 16 being advanced through endoscope 10 of Fig. 1) to a position proximate a patient's duodenum (as an endoscope may be passed through a patient until it reaches the duodenum similar to that of Fig. 1; [0032]) in order to gain access to the patient's common bile duct (common bile duct 126; Fig. 13), the cannulation device comprising: an elongate shaft (generally cylindrical portion 91) extending to a tapered distal tip (tapered distal end 92 is considered atraumatic as the tapered portion facilitates a lower profile for insertion which is less traumatic during delivery); a guidewire lumen (inner lumen 94; Fig. 11) extending through the elongate shaft (inner lumen 94 may be utilized as a guidewire lumen; [0078]), the guidewire lumen terminating at a guidewire port (opening 93) disposed at a distal terminus of the tapered distal tip (Figs. 11-13); an inflatable balloon (balloon 96) disposed relative to the tapered distal tip (Figs. 11-13), the inflatable balloon (96) inflatable from a collapsed configuration (Figs. 11-12) to an expanded configuration (Fig. 13) in which the inflatable balloon is adapted to occlude the patient's pancreatic duct (as Fig. 13 shows the papilla of Vater 122 occluded; thus, flow from the pancreatic duct 128 is blocked from flowing into the duodenum i.e. occluding the pancreatic duct 128 and/or the balloon 96 is dimensioned to be positioned between the pancreatic duct 128, the common bile duct 126 and the papilla of Vater 122 to directly contact the orifice and occlude the pancreatic duct 128 because in some patients, the orifice of the papilla of Vater 122 is positioned against the contralateral wall 125, or septum, separating the pancreatico-biliary ducts [0083] and the balloon 96 is inflated to a diameter that is greater than the orifice of the papilla of Vater 122 [0084]; thus, when the papilla of Vater 122 is positioned against the contralateral wall 125 and the balloon is inflated, prior to pulling the catheter 90, the pancreatic duct 128 would be occluded [0084]); and an inflation lumen (inflation lumen 95) extending through the elongate shaft and fluidly coupled with the inflatable balloon (Fig. 11; [0077]).
Richardson fails to disclose the inflatable balloon is disposed along a tapered sidewall of the tapered distal tip with the inflatable balloon asymmetrically offset to one side of the guidewire port, in which the inflatable balloon is adapted to occlude the patient’s pancreatic duct while directing the guidewire port toward the patient’s common bile duct.
However, Motai teaches a cannulation device (Fig. 22) adapted to be advanced through an endoscope (endoscope 100) to a position proximate a patient’s duodenum (Fig. 22), the cannulation device comprising: an elongate shaft (endoscope treatment instrument/tube 21 coming out of endoscope 100; Fig. 22) and an inflatable balloon (balloon B1) asymmetrically and laterally disposed relative to an atraumatic distal tip with the inflatable balloon offset to one side of the cannulation device (Fig. 22), the inflatable balloon (B1) inflatable from a collapsed configuration to an expanded configuration (inflatable outward in a radial direction of the tube; column 10, lines 1-4) in which the inflatable balloon is adapted to occlude the patient’s pancreatic duct (Fig. 22) while directing the cannulation device toward the patient’s common bile duct (Fig. 22; as the distal end of the tube is bent into the common bile duct; columns 9-10, lines 61-67, 1-5) for the purpose of deforming or bending the distal end for selective cannulation (column 9, lines 50-55).
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 inflatable ballon of Richardson to be disposed along a tapered sidewall of the tapered distal tip with the inflatable balloon asymmetrically offset to one side of the guidewire port so that when the inflatable balloon is in the expanded configuration it is adapted to occlude the patient’s pancreatic duct while directing the guidewire port toward the patient’s common bile duct in light of the teachings of Motai in order to selectively deform or bend the cannulation device into the common bile duct.
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 SARAH A LONG whose telephone number is (571)270-3865. The examiner can normally be reached Monday-Friday 9am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at (571)272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SARAH A LONG/Primary Examiner, Art Unit 3771
Prosecution Insights