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 .
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.
Claims 1, 9-12, 14, and 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sheibley (US 2019/0105474 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). Regarding claim 9, 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). Regarding claim 19, 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 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 2-4, 6-8, 15-18 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 claims 2-4 and 6-8, Sheibley discloses the drain system of claim 1, but 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, with respect to claim 2, that the wire access area comprises a through hole, with respect to claim 3, that the wire access area comprises a weakened area of the wall of the drain, with respect to claim 4, that the system includes the wire, wherein the lumen of the drain is configured to receive the wire, with respect to claim 6, that the system comprises a radio-opaque border that surrounds at least a portion of the wire access area, with respect to claim 7, or that the radio-opaque border is formed by one or more radio-opaque markers, with respect to claim 8.
Lam teaches a puncturing assembly (Figs. 14A-C; ¶0096-0097) for the balloon (Figs. 3A-B and 14A-C, feats. 56 and 58; ¶0059) of a balloon catheter (Figs. 3A-B, feat. 10; ¶0059) comprising a wire (Figs. 14A-C, feat. 710; ¶0096) with a sharpened tip (712) within a shaft (702) which is inserted within the lumen (57) of the balloon catheter. The wire accesses the inner wall of the balloon (Figs. 14A-C, feat. 56) via a through hole in the shaft (706) and the lumen (57) of the balloon catheter and punctures the inner wall (Fig. 14B, feat. 56) in order to deflate the balloon (¶0097). 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). 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). Lam teaches that such a puncturing system advantageously enables the balloon 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, with respect to claim 2, so that the wire access area comprises a through hole, with respect to claim 3, so that the wire access area comprises a weakened area of the wall of the drain, with respect to claim 4, so that the system includes the wire, wherein the lumen of the drain is configured to receive the wire, with respect to claim 6, so the system comprises 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, in order to enable the balloon to be deflated quickly and facilitate removal of the drain system as taught by Lam.
Regarding claims 15-18, Sheibley discloses the method of claim 14, but 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, with respect to claim 15, that the wire access area is formed as a through hole, with respect to claim 16, 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, with respect to claim 17, or forming a radio-opaque border that surrounds at least a portion of the wire access area, with respect to claim 18.
As discussed above, Lam teaches a puncturing assembly (Figs. 14A-C; ¶0096-0097) for the balloon (Figs. 3A-B and 14A-C, feats. 56 and 58; ¶0059) of a balloon catheter (Figs. 3A-B, feat. 10; ¶0059) comprising a wire (Figs. 14A-C, feat. 710; ¶0096) with a sharpened tip (712) within a shaft (702) which is inserted within the lumen (57) of the balloon catheter. The wire accesses the inner wall of the balloon (Figs. 14A-C, feat. 56) via a through hole in the shaft (706) and the lumen (57) of the balloon catheter and punctures the inner wall (Fig. 14B, feat. 56) in order to deflate the balloon (¶0097). 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). 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). Lam teaches that such a puncturing system advantageously enables the balloon 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, with respect to claim 15, so that the wire access area is formed as a through hole, with respect to claim 16, so 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, with respect to claim 17, and so that forming a radio-opaque border that surrounds at least a portion of the wire access area, with respect to claim 18, in order to enable the balloon to be deflated quickly and facilitate removal of the drain system as taught by Lam.
Claim 5 is 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) 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 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 (US 2019/0105474 A1) in view of Raijman et al. (US 2019/0366059 A1).
Regarding claim 13, Sheibley discloses 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 disclosed by Sheibley 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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Williamson (US 2016/0089518 A1) discloses a balloon catheter with a deflation wire.
Penar (US 3,985,139 A) discloses a balloon catheter with a deflation wire.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at 5712727159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ARJUNA P CHATRATHI/Examiner, Art Unit 3781
/CATHARINE L ANDERSON/Primary Examiner, Art Unit 3781