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 Objections
Claim 1 is objected to because of the following informalities: Line 11 reading “to inhibit fluid” should read --to inhibit the fluid--. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: Line 28 reading “and proximal balloon” should read --and the proximal balloon--. Appropriate correction is required.
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, 5 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Baran et al. (USPN 4,423,725) in view of Hildebrand (USPN 5,419,763) and Walker (USPN 6,183,437) above, and further in view of Martin (USPGPub 2017/0172580).
Re Claim 1, Baran teaches a catheter for reducing bleeding within a cavity comprising an internal surface of a bleeding tissue space within a capsule of a prostate (Baran Figs. 1-2; Col. 3 Lines 5-13, Col. 6 Lines 24-50), the catheter comprising: a distal end and a proximal end (Baran Figs. 1-2); a distal balloon inflation port (AD) coupled to a distal balloon (DD) near the distal end of the catheter (Baran Col. 4 Lines 39-43); and a proximal balloon inflation port (Q) fluidly coupled to a proximal balloon (D) located proximal to the distal balloon (DD) (as seen in Baran Figs. 1-2; Col. 4 Lines 26-32), the proximal balloon (D) affixed to the catheter to maintain a fixed distance between a center of the proximal balloon (D) and a center of the distal balloon (DD) (Baran Col. 6 Lines 24-50), wherein the proximal balloon is radially expanded and located proximal to the distal balloon (DD) (Baran Figs. 1-2).
In the present case, the limitations “the distal balloon configured to expand and seal against a bladder to inhibit fluid from entering the bleeding tissue space” and “wherein the proximal balloon is configured to be radially expanded within the cavity to directly compress a medicament delivered to the cavity between the proximal balloon and the internal surface of the bleeding tissue space such that the medicament is applied to the internal surface of the bleeding tissue space within the capsule of the prostate” are being viewed as functional limitations and inherent characteristics of the structure of prior art Baran (See MPEP 2114-I). This is particularly the case given the teachings of Baran (Baran Col. 3 Lines 5-28, Col. 4 Lines 51-65, Col. 6 Lines 28-30).
However, Baran fails to teach a drainage port fluidly coupled to a bladder port near the distal end to maintain a flow path of a fluid along the catheter from the bladder port to the drainage port, the bladder port and the drainage port configured to enable continuous drainage of the fluid from a bladder while a distal balloon and a proximal balloon are both in an expanded state; the distal balloon inflation port proximal to the bladder port. Hildebrand teaches a catheter (20) for reducing bleeding within a cavity comprising an internal surface (48) of a bleeding tissue space (90) within a capsule of a prostate (92) (Hildebrand Figs. 1-2 and 4), the catheter (20) apparatus comprising: a distal end (24) and a proximal end (26) (as seen in Hildebrand Fig. 2); a drainage port (Hildebrand Col. 5 Lines 51-57 - describing drainage lumen 38 extending from distal end of catheter to proximal end of catheter) fluidly coupled to a bladder port (38) near the distal end, to maintain a flow path of a fluid along the catheter (20) from the bladder port (38) to the drainage port (Hildebrand Col. 5 Lines 51-57); a distal balloon (30) proximal to the bladder port (38) (Hildebrand Figs. 1-2), the drainage port for draining urine from the bladder after insertion of the catheter during a medical procedure, wherein proper catheter placement can be confirmed when urine is drained from the bladder (Hildebrand Col. 5 Lines 51-57 and Col. 6 Lines 30-35).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had the catheter of Baran comprise a drainage port fluidly coupled to a bladder port near the distal end to maintain a flow path of a fluid along the catheter from the bladder port to the drainage port as disclosed by Hildebrand for draining urine from the bladder after insertion of the catheter during a medical procedure, wherein proper catheter placement can be confirmed when urine is drained from the bladder (Hildebrand Col. 5 Lines 51-57 and Col. 6 Lines 30-35). In the present case, the limitation “the bladder port and the drainage port configured to enable continuous drainage of the fluid from a bladder while a distal balloon and a proximal balloon are both in an expanded state; the distal balloon inflation port proximal to the bladder port” is being viewed as a functional limitation and an inherent characteristic of the structure of prior art Hildebrand (See MPEP 2114-I).
Baran also fails to teach a sealant infusion port fluidly coupled to a sealant delivery port near the distal end, wherein the sealant delivery port is located between the proximal balloon and the distal balloon, the sealant delivery port configured to deliver the sealant through the sealant delivery port to 1) the bleeding tissue space between the proximal balloon and the distal balloon and 2) the bleeding tissue space between a proximal opening of the capsule of the prostate and the proximal balloon in order to decrease bleeding in the bleeding tissue space, and wherein the sealant comprises one or more of a therapeutic agent, a hemostatic agent, or a biological surgical glue.
Hildebrand further teaches a proximal balloon (34) located proximal to the distal balloon (30) (Hildebrand Figs. 1-2); and a sealant infusion port (44) fluidly coupled to a sealant delivery port (56) near the distal end (24), wherein the sealant delivery port (56) is located between the proximal balloon (34) and the distal balloon (30) (as seen in Hildebrand Fig. 2), wherein a sealant comprises one or more of a therapeutic agent (Hildebrand Col. 7 Lines 49-55), the sealant delivery port for delivery of fluids into the enclosed prostatic urethra (Hildebrand Col. 5 Line 64 to Col. 6 Line 23, Col. 10 Lines 16-17) and the therapeutic agent for treating a condition of the prostate (Hildebrand Col. 7 Lines 49-55).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had the catheter of Baran comprise a sealant infusion port fluidly coupled to a sealant delivery port near the distal end, wherein the sealant delivery port is located between the proximal balloon and the distal balloon and a sealant comprises one or more of a therapeutic agent, the configuration as disclosed by Hildebrand wherein the sealant delivery port delivers fluids into the enclosed prostatic urethra (Hildebrand Col. 5 Line 64 to Col. 6 Line 23, Col. 10 Lines 16-17) and the therapeutic agent for treating a condition of the prostate (Hildebrand Col. 7 Lines 49-55). In the present case, the limitation “the sealant delivery port configured to deliver a sealant through the sealant delivery port to 1) the bleeding tissue space between the proximal balloon and the distal balloon and 2) the bleeding tissue space between a proximal opening of the capsule of the prostate and the proximal balloon in order to decrease bleeding in the bleeding tissue space” is being viewed as a functional limitation and an inherent characteristic of the structure of prior art Hildebrand (See MPEP 2114-I). This is particularly the case where creation of the bleeding tissue space is merely a product of positioning the balloons, something well within the skill of one of ordinary skill in the present art.
Baran also fails to teach an irrigation infusion port fluidly coupled to an irrigation delivery port located distally to the distal balloon, the irrigation infusion port and irrigation delivery port configured to introduce irrigation fluid into the bladder. Walker teaches a catheter (69) for treatment of the prostate (67) (Walker Fig. 3) comprising a distal balloon (62), an irrigation infusion port (30) fluidly coupled to an irrigation delivery port (64) located distally to the distal balloon (62), the irrigation infusion port (30) and irrigation delivery port (64) configured to introduce irrigation fluid into the bladder (61) (Walker Col. 9 Lines 11-18) for flush-irrigating the bladder with a rush of irrigant as well as providing constant urinary irrigation (Walker Col. 5 Lines 48-52).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included with the catheter of Baran an irrigation infusion port near the proximal end, the irrigation infusion port fluidly coupled to an irrigation delivery port located distally to the distal balloon, the irrigation infusion port and irrigation delivery port configured to introduce irrigation fluid into the bladder as disclosed by Walker, for flush-irrigating the bladder with a rush of irrigant as well as providing constant urinary irrigation (Walker Col. 5 Lines 48-52).
Baran in view of Hildebrand and Walker fail to individually teach a multi-port connector positioned at the proximal end and integrating the drainage port, the distal balloon inflation port, the proximal balloon inflation port, the irrigation infusion port, and the sealant infusion port. Although each of Baran, Hildebrand and Walker teach multi-port connectors, none of the aforementioned references teach a single multi-port connector comprising five individual ports. Martin teaches a catheter (10) for use in a closed tissue space (Martin ¶ 0002), said catheter (10) comprising a multi-port connector (as seen in Martin Fig. 2) positioned at a proximal end of said catheter (10) and integrating a drainage port (15), a distal balloon inflation port (11), a proximal balloon inflation port (12), an irrigation infusion port (13), and a sealant infusion port (14) for providing a single multi-port connector for all infusion, inflation, and drainage operations (Martin ¶ 0029).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the catheter of Baran in view of Hildebrand and Walker to comprise a multi-port connector positioned at the proximal end and integrating the drainage port, the distal balloon inflation port, the proximal balloon inflation port, the irrigation infusion port, and the sealant infusion port as disclosed by Martin for providing a single multi-port connector for all infusion, inflation, and drainage operations (Martin ¶ 0029).
Re Claim 2, Baran in view of Hildebrand and Walker above, and further in view of Martin teach all of the limitations of Claim 1. Baran in view of Hildebrand and Walker above, and further in view of Martin disclose all of the structure of Claim 1 and inherently possess the functionally defined limitations thereof. Therefore, Baran in view of Hildebrand and Walker above, and further in view of Martin disclose wherein the catheter is configured to prevent the sealant from occluding a distal opening of the bleeding tissue space, a proximal opening of the bleeding tissue space, and a path extending therebetween (See MPEP 2112(1); wherein the Baran distal balloon (DD) inflates to seal a distal opening leading to the bladder and a urethra balloon (DP) inflates to seal the proximal opening leading to the urethra of the penis, thus preventing the sealant from occluding either end of the prostatic capsule).
Re Claim 5, Baran in view of Hildebrand and Walker above, and further in view of Martin teach all of the limitations of Claim 1. Baran teaches wherein the proximal balloon (D) comprises a plurality of pores (M) (Baran Col. 5 Lines 23-32), wherein the sealant infusion port and the proximal balloon inflation port (Q) are the same port (Baran Col. 4 Lines 28-32; Figs. 1-2 - wherein port Q provides fluid to be delivered through pores M), and wherein the sealant introduced into the catheter is delivered to the proximal balloon (D) to expand the proximal balloon (D) and to subsequently enter the cavity through the plurality of pores (M) of the proximal balloon (D) (Baran Figs. 1-2; Col. 4 Lines 28- 32, Col. 5 Lines 23-32). It is noted here again that although Baran Figs. 1-2 and the detailed descriptions thereof are directed to a tracheal embodiment of the catheter, Baran envisions a similar device and techniques to be used in the urethra (Baran Col. 3 Lines 5-13, Col. 6 Lines 24-50). Furthermore, Baran inherently possesses the claimed structure to perform delivery of a sealant from said plurality of pores (M) of proximal balloon (D) (See MPEP 2112(1)).
Re Claim 18, Baran in view of Hildebrand and Walker above, and further in view of Martin teach all of the limitations of Claim 1. Baran further teaches wherein the proximal balloon (D) is configured to be expanded independently of the distal balloon (DD) (Baran Col. 4 Lines 26-32 and 39-43).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Baran et al. (USPN 4,423,725) in view of Hildebrand (USPN 5,419,763) and Walker (USPN 6,183,437) above, and further in view of Martin (USPGPub 2017/0172580) as applied to Claim 1 above, and further in view of Auyoung (USPGPub 2013/0238038).
Re Claim 15, Baran in view of Hildebrand and Walker above, and further in view of Martin teach all of the limitations of Claim 1. Baran in view of Hildebrand and Walker above, and further in view of Martin fail to disclose wherein the distal balloon is in fluid communication with the proximal balloon, and wherein inflating the proximal balloon also inflates the distal balloon. Auyoung discloses a balloon catheter (10) (Auyoung Fig. 1) comprising a proximal balloon (14) and a distal balloon (16) wherein the distal balloon (16) is in fluid communication with the proximal balloon (14), and wherein inflating the proximal balloon (14) also inflates the distal balloon (16) for the purpose of simultaneous balloon inflation (Auyoung ¶ 0025). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the distal balloon and proximal balloon of Baran in view of Hildebrand and Walker above and further in view of Martin to be in fluid communication with each other, wherein inflating the proximal balloon also inflates the distal balloon as disclosed by Auyoung for the purpose of simultaneous balloon inflation (Auyoung ¶ 0025).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Baran et al. (USPN 4,423,725) in view of Hildebrand (USPN 5,419,763) and Walker (USPN 6,183,437) above, and further in view of Martin (USPGPub 2017/0172580) as applied to Claim 1 above, and further in view of Makower (USPGPub 2007/0208252).
Re Claim 16, Baran in view of Hildebrand and Walker above, and further in view of Martin teach all of the limitations of Claim 1. Baran discloses a distal balloon (DD) and a proximal balloon (D) (Baran Figs. 1-2). However, Baran in view of Hildebrand and Walker above, and further in view of Martin fail to disclose wherein one or more of the distal balloon and the proximal balloon is coated with a hemostatic agent. Makower discloses a balloon catheter (40) (Makower Figs. 4-4J) wherein a balloon (46) is coated with a hemostatic agent for transfer of the hemostatic agent onto tissue contacted by the balloon (Makower ¶ 0090). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured one or more of the distal balloon and the proximal balloon of Baran in view of Hildebrand and Walker above, and further in view of Martin wherein one or more of the distal balloon and the proximal balloon is coated with a hemostatic agent as disclosed by Makower for transfer of the hemostatic agent onto bleeding tissue contacted by the balloon, thus reducing bleeding (Makower ¶ 0090).
Claims 1-2, 5-6 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Gerrans et al. (USPGPub 2012/0259215) in view of Walker (USPN 6,183,437) above, and further in view of Martin (USPGPub 2017/0172580).
Re Claim 1, Gerrans teaches a catheter (24, 26) for reducing bleeding within a cavity comprising an internal surface of a bleeding tissue space within a capsule of a prostate (Gerrans Figs. 3A-3D), the catheter (24, 26) comprising: a distal end and a proximal end; a drainage port (86) coupled to a bladder port (50) near the distal end to maintain a flow path of a fluid along the catheter (24, 26) from the bladder port (50, SOA) to the drainage port (86) (Gerrans Figs. 2A-2B; ¶ 0060, 0086 - teaching lumen 50 acting as a bypass lumen for bodily fluids across the catheter; see Annotated Fig. 2A below displaying bladder port); a distal balloon inflation port (83, 84) fluidly coupled to a distal balloon (30) near the distal end of the catheter (24, 26) and proximal to the bladder port (50, 50A) (Gerrans ¶ 0060, 0085; Fig. 1).
Gerrans further teaches a proximal balloon inflation port (81, 82) fluidly coupled to a proximal balloon (28) located proximal to the distal balloon (30) (Gerrans ¶ 0060, 0085; Fig. 1), said proximal balloon being radially expandable, the proximal balloon (28) affixed to the catheter (24, 26) to maintain a fixed distance between a center of the proximal balloon (28) and a center of the distal balloon (30) (Gerrans ¶ 0068 - wherein a fixed distance between the balloons may be adjusted); and a sealant infusion port (46) fluidly coupled to a sealant delivery port (56) near the distal end (Gerrans Figs. 2A-2B; ¶ 0060, 0084), wherein the sealant delivery port (56) is located between the proximal balloon (28) and the distal balloon (30) (as seen in Gerrans Fig. 2A), wherein a sealant comprises a therapeutic agent (Gerrans ¶ 0070).
In the present case, the limitations “the bladder port and the drainage port configured to enable continuous drainage of the fluid from a bladder while a distal balloon and a proximal balloon are both in an expanded state”, “the distal balloon configured to expand and seal against one or more of a bladder neck or the bladder to inhibit fluid from the bladder from entering the bleeding tissue space”, “wherein the proximal balloon is configured to be radially expanded within the cavity to directly compress a sealant delivered to the cavity between the proximal balloon and the internal surface of the bleeding tissue space such that the sealant is applied to the internal surface of the bleeding tissue space within the capsule of the prostate”, and “the sealant delivery port configured to deliver a sealant through the sealant delivery port to 1) the bleeding tissue space between the proximal balloon and the distal balloon and 2) the bleeding tissue space between a proximal opening of the capsule of the prostate and the proximal balloon in order to decrease bleeding in the bleeding tissue space” are being viewed as functional limitations and inherent characteristics of the structure of prior art Gerrans (See MPEP 2114-I).
However, Gerrans fails to teach an irrigation infusion port fluidly coupled to an irrigation delivery port located distally to the distal balloon, the irrigation infusion port and irrigation delivery port configured to introduce irrigation fluid into the bladder. Walker teaches a catheter (69) for treatment of the prostate (67) (Walker Fig. 3) comprising a distal balloon (62), an irrigation infusion port (30) fluidly coupled to an irrigation delivery port (64) located distally to the distal balloon (62), the irrigation infusion port (30) and irrigation delivery port (64) configured to introduce irrigation fluid into the bladder (61) (Walker Col. 9 Lines 11-18) for flush-irrigating the bladder with a rush of irrigant as well as providing constant urinary irrigation (Walker Col. 5 Lines 48-52).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included with the catheter of Gerrans an irrigation infusion port fluidly coupled to an irrigation delivery port located distally to the distal balloon, the irrigation infusion port and irrigation delivery port configured to introduce irrigation fluid into the bladder as disclosed by Walker, for flush-irrigating the bladder with a rush of irrigant as well as providing constant urinary irrigation (Walker Col. 5 Lines 48-52).
Gerrans in view of Walker fail to individually teach a multi-port connector positioned at the proximal end integrating the drainage port, the distal balloon inflation port, the proximal balloon inflation port, the irrigation infusion port, and the sealant infusion port. Although each of Gerrans and Walker teach multi-port connectors, none of the aforementioned references teach a single multi-port connector comprising five individual ports. Martin teaches a catheter (10) for use in a closed tissue space (Martin ¶ 0002), said catheter (10) comprising a multi-port connector (as seen in Martin Fig. 2) positioned at a proximal end of said catheter (10), the multi-port connector integrating a drainage port (15), a distal balloon inflation port (11), a proximal balloon inflation port (12), an irrigation infusion port (13), and a sealant infusion port (14) are integrated for providing a single multi-port connector for all infusion, inflation, and drainage operations (Martin ¶ 0029). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the catheter of Gerrans in view of Walker to comprise a multi-port connector positioned at the proximal end integrating the drainage port, the distal balloon inflation port, the proximal balloon inflation port, the irrigation infusion port, and the sealant infusion port as disclosed by Martin for providing a single multi-port connector for all infusion, inflation, and drainage operations (Martin ¶ 0029).
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Re Claim 2, Gerrans in view of and Walker above, and further in view of Martin teach all of the limitations of Claim 1. Gerrans in view of and Walker above, and further in view of Martin disclose all of the structure of Claim 1 and inherently possess the functionally defined limitations thereof. Therefore, Gerrans in view of and Walker above, and further in view of Martin disclose wherein the catheter is configured to prevent the sealant from occluding a and a path extending therebetween (See MPEP 2112-I); wherein the Gerrans distal balloon (30) inflates to seal a distal opening and a proximal balloon (28) inflates to seal the proximal opening, thus preventing the sealant from occluding either end of the cavity enclosed by said balloons).
Re Claim 5, Gerrans in view of and Walker above, and further in view of Martin teach all of the limitations of Claim 1. Gerrans teaches wherein the proximal balloon (28) comprises a plurality of pores (96) (as seen in Gerrans Figs. 5A-5C), wherein the sealant infusion port (92) and the proximal balloon inflation port (92) are the same port, and wherein the sealant introduced into the catheter is delivered to the proximal balloon (28) to expand the proximal balloon (28) and to subsequently enter the cavity through the plurality of pores (96) of the proximal balloon (as seen in Gerrans Figs. 5A-5C). It is noted here again that although Gerrans inherently possesses the claimed structure to perform delivery of a sealant from said plurality of pores (96) of proximal balloon (28) (See MPEP 2112(1).
Re Claim 6, Gerrans in view of and Walker above, and further in view of Martin teach all of the limitations of Claim 1. Gerrans teaches wherein the proximal balloon (28) is configured to be expanded near a proximal opening of the tissue space to seal the proximal opening, and wherein the sealant delivery port (56) is positioned distally with respect to the proximal balloon (28) to deliver the sealant in the cavity between a sealed distal opening and a sealed proximal opening (Gerrans Fig. 2A; ¶ 0056).
Re Claim 18, Gerrans in view of and Walker above, and further in view of Martin teach all of the limitations of Claim 1. Gerrans further teaches wherein the proximal balloon (28) is configured to be expanded independently of the distal balloon (30) (Gerrans ¶ 0058, 0063).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Gerrans et al. (USPGPub 2012/0259215) in view of Walker (USPN 6,183,437) above, and further in view of Martin (USPGPub 2017/0172580) as applied to Claim 1 above, and further in view of Auyoung (USPG Pub 2013/0238038).
Re Claim 15, Gerrans in view of and Walker above, and further in view of Martin teach all of the limitations of Claim 1. Gerrans in view of and Walker above, and further in view of Martin fail to disclose wherein the distal balloon is in fluid communication with the proximal balloon, and wherein inflating the proximal balloon also inflates the distal balloon. Auyoung discloses a balloon catheter (10) (Auyoung Fig. 1) comprising a proximal balloon (14) and a distal balloon (16) wherein the distal balloon (16) is in fluid communication with the proximal balloon (14), and wherein inflating the proximal balloon (14) also inflates the distal balloon (16) for the purpose of simultaneous balloon inflation (Auyoung ¶ 0025). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the distal balloon and proximal balloon of Gerrans in view of and Walker above, and further in view of Martin to be in fluid communication with each other, wherein inflating the proximal balloon also inflates the distal balloon as disclosed by Auyoung for the purpose of simultaneous balloon inflation (Auyoung ¶ 0025).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Gerrans et al. (USPGPub 2012/0259215) in view of Walker (USPN 6,183,437) above, and further in view of Martin (USPGPub 2017/0172580) as applied to Claim 1 above, and further in view of Makower (USPGPub 2007/0208252).
Re Claim 16, Gerrans in view of and Walker above, and further in view of Martin discloses all of the limitations of Claim 1. Gerrans discloses a distal balloon (30) and a proximal balloon (28) (Gerrans Fig. 2A). However, Gerrans in view of and Walker above, and further in view of Martin fail to disclose wherein one or more of the distal balloon and the proximal balloon is coated with a hemostatic agent. Makower discloses a balloon catheter (40) (Makower Figs. 4- 4J) wherein a balloon (46) is coated with a hemostatic agent for transfer of the hemostatic agent onto tissue contacted by the balloon (Makower ¶ 0090). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured one or more of the distal balloon and the proximal balloon of Gerrans in view of and Walker above, and further in view of Martin wherein one or more of the distal balloon and the proximal balloon is coated with a hemostatic agent as disclosed by Makower for transfer of the hemostatic agent onto bleeding tissue contacted by the balloon, thus reducing bleeding (Makower ¶ 0090).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2, 5-6 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-4, 16-17, 24 and 26 of USPN 11,553,924, hereinafter Patent '924, in view of Walker (USPN 6,183,347) above, and further in view of Martin (USPGPub 2017/0172580).
Re Claim 1, the limitations of Claims 1-2 and 24 of Patent '924 teach all of the limitations of Claim 1 in the present case but for an irrigation infusion port near the proximal end, the irrigation infusion port fluidly coupled to an irrigation delivery port located distally to the distal balloon, the irrigation infusion port and irrigation delivery port configured to introduce irrigation fluid into the bladder. Walker teaches a catheter (69) for treatment of the prostate (67) (Walker Fig. 3) comprising a distal balloon (62), an irrigation infusion port (30) fluidly coupled to an irrigation delivery port (64) located distally to the distal balloon (62), the irrigation infusion port (30) and irrigation delivery port (64) configured to introduce irrigation fluid into the bladder (61) (Walker Col. 9 Lines 11-18) for flush-irrigating the bladder with a rush of irrigant as well as providing constant urinary irrigation (Walker Col. 5 Lines 48-52). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included with the catheter of Patent '924 an irrigation infusion port near the proximal end, the irrigation infusion port fluidly coupled to an irrigation delivery port located distally to the distal balloon, the irrigation infusion port and irrigation delivery port configured to introduce irrigation fluid into the bladder as disclosed by Walker, for flush irrigating the bladder with a rush of irrigant as well as providing constant urinary irrigation (Walker Col. 5 Lines 48-52).
The claims of Patent '924 are silent as to a multi-port connector positioned at the proximal end and integrating the drainage port, the distal balloon inflation port, the proximal balloon inflation port, the irrigation infusion port, and the sealant infusion port. In addition, Walker's multi-port connector fails to teach five individual ports. Martin teaches a catheter (10) for use in a closed tissue space (Martin ¶ 0002), said catheter (10) comprising a multi-port connector (as seen in Martin Fig. 2) positioned at a proximal end of said catheter (10) and integrating a drainage port (15), a distal balloon inflation port (11), a proximal balloon inflation port (12), an irrigation infusion port (13), and a sealant infusion port (14) for providing a single multi-port connector for all infusion, inflation, and drainage operations (Martin ¶ 0029).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the catheter of Patent '924 in view of Walker to comprise a multi-port connector positioned at the proximal end, the multi-port connector integrating the drainage port, the distal balloon inflation port, the proximal balloon inflation port, the irrigation infusion port, and the sealant infusion port as disclosed by Martin for providing a single multi-port connector for all infusion, inflation, and drainage operations (Martin ¶ 0029).
In the present case, the limitations “the bladder port and the drainage port configured to enable continuous drainage of the fluid from a bladder while a distal balloon and a proximal balloon are both in an expanded state”, “the distal balloon configured to expand and seal against one or more of a bladder neck or the bladder to inhibit fluid from the bladder from entering the bleeding tissue space”, “wherein the proximal balloon is configured to be radially expanded within the cavity to directly compress a sealant delivered to the cavity between the proximal balloon and the internal surface of the bleeding tissue space such that the sealant is applied to the internal surface of the bleeding tissue space within the capsule of the prostate”, and “the sealant delivery port configured to deliver a sealant through the sealant delivery port to 1) the bleeding tissue space between the proximal balloon and the distal balloon and 2) the bleeding tissue space between a proximal opening of the capsule of the prostate and the proximal balloon in order to decrease bleeding in the bleeding tissue space” are being viewed as functional limitations and inherent characteristics of the structure of prior art Patent ‘924 (See MPEP 2114-I).
Re Claims 2, 5-6 and 16: Claim 2 of the present case is disclosed by Claim 26 of Patent '924. Claim 5 of the present case is disclosed by Claim 3 of Patent '924. Claim 6 of the present case is disclosed by Claim 4 of Patent '924. Claim 16 of the present case is disclosed by Claims 16-17 of Patent '924.
Re Claim 18, Patent '924 in view of Walker above, and further in view of Martin teach all of the limitations of Claim 1. The claims of Patent '924 are silent as to the proximal balloon is configured to be expanded independently of the distal balloon. Martin teaches a distal balloon (30) and a proximal balloon (20), wherein the proximal balloon (20) is configured to be expanded independently of the distal balloon (30) where the particular medical procedure being performed may require only a single balloon to be inflated (Martin 1 0029). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had the proximal balloon and distal balloon of Patent '924 in view of Walker above, and further in view of Martin be configured such that the proximal balloon is expanded independently of the distal balloon as disclosed by Martin the particular medical procedure being performed may require only a single balloon to be inflated (Martin ¶ 0029).
Claim 15 is rejected on the ground of nonstatutory double patenting as being unpatentable over Claim 1 of Patent '924 in view of Walker (USPN 6,183,347) above, and further in view of Martin (USPGPub 2017/0172580) as applied to Claim 1 above, and further in view of Auyoung (USPGPub 2013/0238038).
Re Claim 15, Claim 1 of Patent '924 in view of and Walker above, and further in view of Martin teach all of the limitations of Claim 1. The claims of Patent '924 in view of and Walker above, and further in view of Martin fail to disclose wherein the distal balloon is in fluid communication with the proximal balloon, and wherein inflating the proximal balloon also inflates the distal balloon. Auyoung discloses a balloon catheter (10) (Auyoung Fig. 1) comprising a proximal balloon (14) and a distal balloon (16) wherein the distal balloon (16) is in fluid communication with the proximal balloon (14), and wherein inflating the proximal balloon (14) also inflates the distal balloon (16) for the purpose of simultaneous balloon inflation (Auyoung ¶ 0025). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the distal balloon and proximal balloon of Claim 1 of Patent '924 in view of and Walker to be in fluid communication with each other, wherein inflating the proximal balloon also inflates the distal balloon as disclosed by Auyoung for the purpose of simultaneous balloon inflation (Auyoung ¶ 0025).
Terminal Disclaimer
A terminal disclaimer may be effective to overcome a nonstatutory double patenting rejection over a reference patent (37 CFR 1.321(b) and (c)). A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional, the reply must be complete. MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/PatentForms. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/TerminalDisclaimer.
Response to Arguments
Applicant’s arguments filed 04/17/2026 with respect to 112 new matter rejection of Claims 1-2, 5-6, 15-16 and 18 have been fully considered and are persuasive. Due to clarifying amendments to Claim 1, the 112 new matter rejection is hereinafter withdrawn.
Applicant's arguments filed 04/17/2026 have been fully considered but they are not persuasive. On Page 9 of the response, applicant argues Baran does not disclose or suggest a proximal balloon "a proximal balloon inflation port" that is "fluidly coupled to the proximal balloon" where Baran discloses that anesthetic canal S has an opening Q at the near end and an opening O at the far end through which anesthetic (or other surgical fluid) may be pumped into the space between internal cuff E and external cuff D. However, this anesthetic or other surgical fluid inflates the proximal balloon (D). Examiner does not rely on internal balloon in rejecting the present case. On Page 10 of the response, applicant argues prior art Gerrans fails to teach functional language of Claim 1. However, Gerrans need not explicitly teach functional language so long as Gerrans comprises all of the structure to carry out said function. In the present case, Gerrans does in fact comprise the structure to carry out the functional language of Claim 1. Nothing in Gerrans prevents the proximal balloon being inflated when it is in the position of Gerrans Fig. 3D. The same could be said for the last paragraph of Page 10 where Gerrans comprises all of the structure to perform the function of a proximal balloon radially expanded within the cavity to directly compress a sealant delivered to the cavity between the proximal balloon and the internal surface of the bleeding tissue space.” With regard to the first full paragraph of Page 11 of the response, applicant argues the prior art fails to teach the functional language of “the bladder port and the drainage port configured to enable continuous drainage of the fluid from a bladder while a distal balloon and a proximal balloon are both in an expanded state.” Examiner relies upon Walker to teach the aforementioned limitation. Nothing in Walker prevents Walker from carrying out a continuous drainage of fluids from the bladder while balloons are inflated.
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 WILLIAM R FREHE whose telephone number is (571)272-8225. The examiner can normally be reached 10:30AM-7:30PM.
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/WILLIAM R FREHE/Examiner, Art Unit 3783 /NILAY J SHAH/Primary Examiner, Art Unit 3783
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