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 .
Election/Restrictions
Claim 22 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/08/2025. Claims 1-9 and 15-20 drawn to a non-elected species have been canceled. While applicant states new claims 21-23 are supported by the elected species, claim 22 recites “wherein the inflatable balloon is adapted to extend within the pancreatic duct” which applies to non-elected Species II: Fig. 6 because the inflatable balloon 80 of elected Species III: Fig. 7 “is adapted not to extend within the PD 16 (as the inflatable balloon 72 [of Fig. 6] does)” ([0062]). Therefore, claim 22 has been withdrawn.
Applicant’s election without traverse of Species III, claims 10-14, 21 and 23 in the reply filed on 12/08/2025 is acknowledged.
Claim Objections
Claims 21 and 23 are objected to because of the following informalities: Claims 21 and 23 recite “the pancreatic duct” in line 2, respectively, which should read “the patient’s pancreatic duct” for consistency purposes. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 10, 12-14, 21 and 23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Richardson (US 2003/0078473 A1).
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]).
Regarding claim 12, Richardson discloses wherein the inflatable balloon (96) is disposed along a side of the atraumatic distal tip (92; Figs. 11-13).
Regarding claim 13, Richardson discloses wherein the inflatable balloon (96), when in its collapsed configuration, forms part of the atraumatic distal tip (Figs. 11-12).
Regarding claim 14, Richardson discloses wherein the cannulation device (90) is adapted for accessing the patient's common bile duct (126) from a position proximate the patient's ampulla of vater (as Fig. 13 allows for access to the common bile duct 126 when the balloon 96 is positioned the papilla of Vater 122 i.e. the opening of the ampulla of vater).
Regarding claim 21, Richardson discloses wherein the inflatable balloon (96) is configured to be positioned to close off access to the pancreatic duct (128; as access to 128 is closed due to the closure of 122; Fig. 13).
Regarding claim 23, Richardson discloses wherein the inflatable balloon (96) is adapted not to extend within the pancreatic duct (128), but merely to block access to the pancreatic duct (128; as access to 128 is closed due to the closure of 122; Fig. 13).
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) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Richardson (US 2003/0078473 A1) in view of Loiterman (US 4,983,165).
Regarding claim 11, Richardson discloses when the inflatable balloon (96) is inflated, access to either the common bile duct or the pancreatic duct is enabled via one or more openings in the distal end of the cannulation device ([0084]) but fails to explicitly disclose 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, thereby helping to align the guidewire port with the common bile duct.
However, Loiterman teaches a cannulation device (tubular member 1; Fig. 1) comprising an atraumatic distal tip (blunt distal tip 15 that may be flat, rounded or tapered; column 3, lines 38-41) an inflatable balloon (balloons 4) adapted to, when inflated, push the atraumatic distal tip (2) away from a patient's vessel of a bifurcation and towards the other vessel of the bifurcation, thereby helping to align a guidewire port (one of the working channels 9) with a particular vessel for the purpose of deflecting or aiming the atraumatic distal tip of the cannulation device at the desired branch through which a guidewire (6) is then slidably advanced (Figs. 4-6; column 4, lines 19-34).
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 balloon of Richardson to have multiple compartments that may be selectively inflated to push the atraumatic distal tip away from the patient’s pancreatic duct and towards the patient’s common bile duct, thereby helping to align the guidewire port with the common bile duct in light of the teachings of Loiterman in order to deflect or aim the atraumatic distal tip of the cannulation device at a desired branch of the body to more accurately advance additional medical tools to the common bile duct.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Kruse et al. (US 2025/0152748 A1) is noted for teaching a balloon catheter (32) for occluding the pancreatic duct (Fig. 6). Skerven (US 2010/0168665 A1) is noted for teaching a catheter with an inflatable balloon to help deflect the distal tip of the catheter into the patient’s common bile duct (Fig. 4). Sterman et al. (US 6,699,231 B1) is noted for teaching a balloon catheter (282) for occluding the pancreatic duct (Fig. 6H).
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.
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/SARAH A LONG/Primary Examiner, Art Unit 3771