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
Applicant amended claims 1, 3-4, 7, 14, and 16-18, and canceled claims 2, 6, and 15. Claims 1, 3-5, 7-14, and 16-20 are currently pending.
Response to Arguments
Applicant’s arguments, see pages 5-6 of Applicant’s Remarks, filed 05/11/26, with respect to the rejections of claims 1, 9-12, 14, and 19-20 under 35 U.S.C. 102(a)(1) as anticipated by Sheibley, of claims 2-4, 6-8, and 15-18 under 35 U.S.C. 103 as obvious over Sheibley in view of Lam, of claim 5 as obvious in further view of Newcomb, and of claim 13 as obvious in further view of Raijman have been fully considered and are not persuasive.
Applicant argues that the needle of Lam (Figs. 14A-C, feat. 710) is not the same as a wire. However, the needle of Lam is a thin object that is long enough to extend the length of the catheter to reach the balloon of the catheter, and therefore has a wire-like aspect ratio.
Applicant further argues that Lam does not disclose or teach “a permanently bent wire tip that is angled such that the wire is able to reach the wire access area” as required by amended claims 1 and 14. However, Lam teaches an alternate embodiment (Figs. 8A-C; ¶0081-0083) comprising resilient cutting members with wire-like aspect ratios and a permanently bent wire tip. Please see the rejection below for more details.
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.
Claims 1, 3-4, 7-12, 14, 16, and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Sheibley (US 2019/0105474 A1) in view of Lam et al. (US 2017/0086868 A1).
Regarding claim 1, Sheibley discloses a biliary drain system (Figs. 1 and 3; ¶0047, 0055, and 0057) comprising: a drain (Fig. 3, feat. 4; ¶0057) having a first end (1) and a second end (2), wherein the drain also includes a lumen that connects the first end to the second end (Figs. 3 and 5-9, feat. 7; ¶0057 and 0060-0063); and a balloon mounted to the drain and configured to mount within a stricture of a bile duct of a patient (Fig. 3, feat. 3; ¶0055 and 0057), wherein the balloon includes a first end, a second end, and a center portion, and wherein a size of a first end of the balloon is greater than a size of the center portion of the balloon (¶0053: the balloon may be dumbbell shaped).
Sheibley does not disclose that the drain includes a wire access area adjacent to the balloon, wherein the wire access area is configured to receive a wire to puncture the balloon or that the system includes the wire, wherein the lumen of the drain is configured to receive the wire, and wherein the wire includes a permanently bent wire tip that is angled such that the wire is able to reach the wire access area.
Lam teaches puncturing assemblies for the balloon (Figs. 3A-B, feats. 56 and 58; ¶0059) of a balloon catheter (Figs. 3A-B, feat. 10; ¶0059). Lam teaches an embodiment (Figs. 8A-C, feat. 300; ¶0081-0083) in which the puncturing assembly comprises one or more resilient cutting members (326; ¶0082) which are bent or curved (Figs. 8A-C) so that sharpened tips (324) are angled to puncture the wall of the catheter (56) to deflate the balloon (¶0083). The bent or curved tips (Figs. 8A-C, feat. 324) are bent both when withdrawn into a protection sleeve (Figs. 8A and 8C, feat. 320; ¶0082) and when puncturing the wall of the catheter (Fig. 8B), and therefore they are permanently bent or curved. The one or more resilient cutting members have a high aspect ratio (Figs. 8A-C) and are therefore wires. Lam teaches that such a puncturing assembly advantageously enables the ballon to be deflated quickly to facilitate removal of the balloon catheter (¶0069). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system disclosed by Sheibley so that the drain includes a wire access area adjacent to the balloon, wherein the wire access area is configured to receive a wire to puncture the balloon and so that the system includes the wire, wherein the lumen of the drain is configured to receive the wire, and wherein the wire includes a permanently bent wire tip that is angled such that the wire is able to reach the wire access area in order to enable the balloon to be deflated quickly and facilitate removal of the drain system as taught by Lam.
Regarding claim 3, Sheibley in view of Lam suggests the system of claim 1. Lam further teaches that the inner wall (56) comprises a through hole after being pierced (Fig. 8C, feat. 55). Therefore, Sheibley in view of Lam further suggests that the wire access area comprises a through hole.
Regarding claim 4, Sheibley in view of Lam suggests the system of claim 1. Lam further teaches that the inner wall (56) of the lumen (57) may have one or more regions of reduced structural integrity to promote intentional rupture (¶0072). Therefore, Sheibley in view of Lam further suggests that the wire access area comprises a weakened area of a wall of the drain.
Regarding claims 7-8, Sheibley in view of Lam suggests the system of claim 1. Lam further teaches that two radio-opaque markings may be positioned at the two working ends of the balloon, which would therefore form a border surrounding the wire access area at the inner wall of the balloon, in order to help visualize the location of the balloon (¶0062). Therefore, Sheibley in view of Lam further suggests a radio-opaque border that surrounds at least a portion of the wire access area, with respect to claim 7, and so that the radio-opaque border is formed by one or more radio-opaque markers, with respect to claim 8.
Regarding claim 9, Sheibley in view of Lam suggests the system of claim 1. Sheibley further discloses that the drain includes a balloon valve lumen that is configured to receive a gas to inflate the balloon (Figs. 5-9, feat. 8; ¶0057 and 0060-0063). Regarding claim 10, Sheibley further discloses that the drain includes a first plurality of drain holes (Figs. 3 and 5, feat. 5; ¶0059-0060) positioned on a first portion of the drain that is between a first end of the drain (Fig. 3, feat. 1) and the balloon (Fig. 3, feat. 3). Regarding claim 11, Sheibley further discloses that the drain includes a second plurality of drain holes (Figs. 3 and 5, feat. 5; ¶0059-0060) positioned on a second portion of the drain that is between a second end of the drain (Fig. 3, feat. 2) and the balloon (Fig. 3, feat. 3). Regarding claim 12, Sheibley further discloses that a size of the second end of the balloon is greater than the size of the center portion of the balloon (¶0053: the balloon may be dumbbell shaped).
Regarding claim 14, Sheibley discloses a method of forming a biliary drain (Figs. 1 and 3; ¶0047, 0053, 0055, and 0057), the method comprising: forming a drain (Fig. 3, feat. 4; ¶0057) having a first end (1) and a second end (2), wherein the drain is formed to include a lumen that connected the first end to the second end (Figs. 3 and 5-9, feat. 7; ¶0057 and 0060-0063); forming a balloon (Fig. 3, feat. 3; ¶0053, 0055, and 0057) that has a first end, a second end, and a center portion, wherein the balloon is formed such that a size of the first end of the balloon is greater than a size of the center portion of the balloon (¶0053: the balloon may be dumbbell shaped); and mounting the balloon to the drain (¶0053, lines 20-28).
Sheibley does not disclose that forming the drain includes forming a wire access area adjacent to a position at which the balloon is mounted to the drain, wherein the wire access area is configured to receive a wire to puncture the balloon, or that the method includes forming the wire, wherein the lumen of the drain is configured to receive the wire, and wherein the wire is formed to include a permanently bent wire tip that is angled such that the wire is able to reach the wire access area.
Lam teaches puncturing assemblies for the balloon (Figs. 3A-B, feats. 56 and 58; ¶0059) of a balloon catheter (Figs. 3A-B, feat. 10; ¶0059). Lam teaches an embodiment (Figs. 8A-C, feat. 300; ¶0081-0083) in which the puncturing assembly comprises one or more resilient cutting members (326; ¶0082) which are bent or curved (Figs. 8A-C) so that sharpened tips (324) are angled to puncture the wall of the catheter (56) to deflate the balloon (¶0083). The bent or curved tips (Figs. 8A-C, feat. 324) are bent both when withdrawn into a protection sleeve (Figs. 8A and 8C, feat. 320; ¶0082) and when puncturing the wall of the catheter (Fig. 8B), and therefore they are permanently bent or curved. The one or more resilient cutting members have a high aspect ratio (Figs. 8A-C) and are therefore wires. Lam teaches that such a puncturing assembly advantageously enables the ballon to be deflated quickly to facilitate removal of the balloon catheter (¶0069). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method disclosed by Sheibley so that forming the drain includes forming a wire access area adjacent to a position at which the balloon is mounted to the drain, wherein the wire access area is configured to receive a wire to puncture the balloon and so that the method includes forming the wire, wherein the lumen of the drain is configured to receive the wire, and wherein the wire is formed to include a permanently bent wire tip that is angled such that the wire is able to reach the wire access area in order to allow the formed balloon to be deflated quickly and facilitate removal of the drain system as taught by Lam.
Regarding claim 16, Sheibley in view of Lam suggests the method of claim 14. Lam further teaches that that the inner wall (56) comprises a through hole after being pierced (Fig. 8C, feat. 55). Therefore, Sheibley in view of Lam further suggests that the wire access area is formed as a through hole.
Regarding claim 17, Sheibley in view of Lam suggests the method of claim 14. Lam further teaches that the inner wall (56) of the lumen (57) may have one or more regions of reduced structural integrity to promote intentional rupture (¶0072). Therefore, Sheibley in view of Lam further suggests that the wire access area is formed as a weakened area of a wall of the drain such that the weakened area is more susceptible to a puncture than a remainder of the wall of the drain.
Regarding claim 18, Sheibley in view of Lam suggests the method of claim 14. Lam further teaches that two radio-opaque markings may be positioned at the working ends of the balloon, which would therefore form a border surrounding the wire access area at the inner wall of the balloon, in order to help visualize the location of the balloon (¶0062). Therefore, Sheibley in view of Lam further suggests that the method includes forming a radio-opaque border that surrounds at least a portion of the wire access area.
Regarding claim 19, Sheibley in view of Lam suggests the method of claim 14. Sheibley further discloses that forming the drain includes forming a balloon valve lumen in the drain that is configured to receive a gas to inflate the balloon (Figs. 5-9, feat. 8; ¶0057 and 0060-0063). Regarding claim 20, Sheibley further discloses that forming the drain includes forming a first plurality of drain holes (Figs. 3 and 5, feat. 5; ¶0059-0060) positioned on a first portion of the drain that is between the first end of the drain (Fig. 3, feat. 1) and the balloon (Fig. 3, feat. 3) and forming a second plurality of drain holes (Figs. 3 and 5, feat. 5; ¶0059-0060) positioned on a second portion of the drain that is between a second end of the drain (Fig. 3, feat. 2) and the balloon (Fig. 3, feat. 3).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Sheibley in view of Lam, and in further view of Newcomb et al. (US 2006/0161102 A1).
Regarding claim 5, Sheibley in view of Lam suggests the system of claim 4, but does not disclose that the drain is made of a first material and the weakened area of the wall of the drain is made of a second material to facilitate a puncture through the wire access area.
Newcomb teaches a balloon dilation catheter (Figs. 2-3, feat. 1; ¶0037) which comprises a frangible, controlled failure portion (Fig. 3, feat. 6; ¶0038) in fluid communication with the inflation lumen (10) of the balloon (7). The frangible, controlled failure portion may rupture in order to rapidly deflate the balloon to release pressure (¶0027-0029 and 0043-0044). Because the controlled failure portion is frangible and releases pressure from the balloon, it is a homologous structure to the weakened area in the wall of the drainage catheter suggested by Sheibley in view of Williamson and in further view of Lam. The frangible controlled failure portion may be a thin film of material (¶0029-0032) which is a different material from the catheter shaft wall (¶0022). Newcomb teaches that such a frangible, weakened area advantageously allows the balloon to safely deflate without rupturing the balloon inside the body of the patient in the event of a higher than design pressure within the balloon (¶0005-0007 and 0043-0044). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system suggested by Sheibley in view of Lam so that the drain is made of a first material and the weakened area of the wall of the drain is made of a second material to facilitate a puncture through the wire access area in order to allow allows the balloon to safely deflate without rupturing the balloon inside the body of the patient in the event of a higher than design pressure within the balloon as taught by Newcomb.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Sheibley in view of Lam and in further view of Raijman et al. (US 2019/0366059 A1).
Regarding claim 13, Sheibley in view of Lam suggests the system of claim 1, but does not disclose that the balloon comprises a hybrid balloon that is a hybrid between a high pressure balloon and a compliant balloon.
Raijman teaches a dilation catheter system (Figs. 13-15, feat. 100; ¶0068-0069), which may be used in a biliary duct (¶0069) comprising a dilation balloon (104) with proximal (122) and distal (124) bulbs, forming a similar dog-bone or dumbbell shape to the balloon disclosed by Sheibley. The dilation balloon is a high pressure expandable balloon which expands to a particular diameter at a given internal pressure (¶0089-0090 and 0093) and also has some compliance depending on the diameter after inflation (¶0100-0102). Raijman teaches that such a balloon configuration ensures proper seating and minimal migration within a stricture (¶0069 and 0097-0100). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system suggested by Sheibley in view of Lam so that the balloon comprises a hybrid balloon that is a hybrid between a high pressure balloon and a compliant balloon in order to ensure proper seating and minimal migration within a stricture as taught by Raijman.
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 ARJUNA P CHATRATHI whose telephone number is (571)272-8063. The examiner can normally be reached M-F 8:30-5:00.
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/ARJUNA P CHATRATHI/Examiner, Art Unit 3781
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781
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