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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08/29/2025 has been entered.
Claim Rejections - 35 USC § 112
Claims 1-2, 5-6, 15-16 and 18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Newly submitted amendments to Claim 1 reading “the multi-port connector comprising a housing into which the drainage port, the distal balloon inflation port, the proximal balloon inflation port, the irrigation infusion port, and the sealant infusion port are integrated” lacks support in the drawings and specification. Both the figures and the specification of the present case fail to show or mention a multi-port connector comprising a housing. Appropriate correction and/or clarification 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), the distal balloon (DD) configured to expand and seal against a bladder to inhibit fluid from entering the bleeding tissue space (Baran Col. 6 Lines 28-30); 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 the proximal balloon (D) and the distal balloon (DD) (Baran Col. 6 Lines 24-50).
However, Baran fails to teach a drainage port fluidly coupled to a bladder port near the distal end to maintain a fluid flow path along the catheter from the bladder port to the drainage port; the distal balloon inflation port proximal to the bladder port; and 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 a sealant through the sealant delivery port to the bleeding tissue space between the proximal balloon and the distal balloon in order to decrease bleeding.
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 fluid flow path along the catheter (20) from the bladder port (38) to the drainage port (Hildebrand Col. 5 Lines 51-57); a distal balloon inflation port (42) near the proximal end and fluidly coupled to a distal balloon (30) near the distal end (24) of the catheter (20) and proximal to the bladder port (38), the distal balloon (30) configured to expand and seal against one or more of a bladder neck (54) or a bladder (46) to inhibit fluid from entering the bleeding tissue space from the bladder (46) (Hildebrand Col. 5 Lines 51-68, Col. 6 Lines 1-10; Figs. 1-2); the drainage port for draining urine from the bladder after insertion of the catheter during a medical procedure and 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).
Hildebrand further teaches a proximal balloon inflation port (78) fluidly coupled to a proximal balloon (34) located proximal to the distal balloon (30), the proximal balloon (34) affixed to the catheter (20) to maintain a fixed distance between the proximal balloon (34) and the distal balloon (30) (Hildebrand Col. 5 Lines 18-40; 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), and the sealant delivery port (56) configured to deliver a sealant through the sealant delivery port (56) to the bleeding tissue space (90) between the proximal balloon (34) and the distal balloon (30) in order to decrease bleeding (Hildebrand Col. 5 Line 64 to Col. 6 Line 23; Fig. 4 - wherein Hildebrand discloses all of the relevant structure to deliver a sealant and thus inherently possess the functionally defined limitations thereof); the sealant delivery port for delivery of fluids into the prostatic urethra (Hildebrand Col. 5 Line 64 to Col. 6 Line 23, Col. 10 Lines 16-17).
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 near the proximal end and fluidly coupled to a bladder port near the distal end to maintain a fluid flow path along the catheter from the bladder port to the drainage port; the distal balloon inflation port proximal to the bladder port as disclosed by Hildebrand for draining urine from the bladder after insertion of the catheter during a medical procedure and 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).
Furthermore, 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 a sealant infusion port near the proximal end 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 a sealant through the sealant delivery port to the bleeding tissue space between the proximal balloon and the distal balloon in order to decrease bleeding as disclosed by Hildebrand, the sealant delivery port for delivery of fluids into the prostatic urethra (Hildebrand Col. 5 Line 64 to Col. 6 Line 23, Col. 10 Lines 16- 17). It is noted here that in the modified device of Baran in view of Hildebrand, one of ordinary skill in the art would recognize that the proximal balloon (D) of Baran is configured to be expanded within the cavity to compress a sealant delivered to the cavity against the internal surface of the bleeding tissue space within the capsule of the prostate (Baran Col. 6 Lines 24-50 - teaching expanding the proximal balloon to compress a medicament delivered from pores within the proximal balloon delivered to the cavity against the internal surface of the tissue space within the capsule of the prostate).
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, the multi-port connector comprising a housing into which the drainage port, the distal balloon inflation port, the proximal balloon inflation port, the irrigation infusion port, and the sealant infusion port are integrated. 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), the multi-port connector comprising a housing into which 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 Baran in view of Hildebrand and Walker to comprise a multi-port connector positioned at the proximal end, the multi-port connector comprising a housing into which the drainage port, the distal balloon inflation port, the proximal balloon inflation port, the irrigation infusion port, and the sealant infusion port are integrated 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 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 4] 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 Baran et al. (USPN 4,423,725) above, and further still 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 fluid flow path 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) 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), the distal balloon (30) configured to expand and seal against a bladder to inhibit fluid from entering the bleeding tissue space (wherein the Gerrans catheter with distal balloon inherently possesses the claimed structure to perform the function of expanding and sealing against a bladder to inhibit fluid from entering the bleeding tissue space from the bladder (See MPEP 2112(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), the proximal balloon (28) affixed to the catheter (24, 26) to maintain a fixed distance between the proximal balloon (28) and 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), and the sealant delivery port (56) configured to deliver a sealant through the sealant delivery port (56) to the bleeding tissue space between the proximal balloon (28) and the distal balloon (30) in order to decrease bleeding (although Gerrans does not explicitly recite delivery of a sealant, Gerrans catheter possesses the claimed structure to perform such a function (See MPEP 2112(1)).
However, Aljuri 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 fails to explicitly teach wherein the proximal balloon is configured to be expanded within the cavity to compress a sealant delivered to the cavity against the internal surface of the tissue space within the capsule of the prostate. However, such a function is merely a product of the Gerrans catheter structure, wherein the technique of expanding the proximal balloon within the cavity to compress a sealant delivered to the cavity against the internal surface of the tissue space within the capsule of the prostate is well within the ordinary skill of a practitioner of prostate surgeries. This is particularly the case where Baran explicitly teaches said technique.
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 proximal balloon (D) configured to be expanded within the cavity of a prostate to compress a sealant delivered to the cavity against the internal surface of the tissue space within the capsule of the prostate (Baran Col. 6 Lines 24-50 - teaching expanding the proximal balloon to compress a medicament delivered from pores within the proximal balloon delivered to the cavity against the internal surface of the tissue space within the capsule of the prostate). The technique as disclosed by Baran wherein repeated inflation of the proximal balloon massages and dilates the prostatic urethra (Baran Col. 6 Lines 32-37).
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 performed the function of expanding the proximal balloon within the cavity to compress a sealant delivered to the cavity against the internal surface of the tissue space within the capsule of the prostate with the catheter of Gerrans in view of Walker, the technique as disclosed by Baran wherein repeated inflation of the proximal balloon massages and dilates the prostatic urethra (Baran Col. 6 Lines 32-37).
Gerrans in view of Walker above, and further in view of Baran fail to individually teach a multi-port connector positioned at the proximal end, the multi-port connector comprising a housing into which the drainage port, the distal balloon inflation port, the proximal balloon inflation port, the irrigation infusion port, and the sealant infusion port are integrated. Although each of Gerrans, Walker and Baran 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 comprising a housing into which 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 above, and further in view of Baran to comprise a multi-port connector positioned at the proximal end, the multi-port connector comprising a housing into which the drainage port, the distal balloon inflation port, the proximal balloon inflation port, the irrigation infusion port, and the sealant infusion port are integrated 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 Baran above, and further still in view of Martin teach all of the limitations of Claim 1. Gerrans in view of and Walker above, and further in view of Baran above, and further still 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 Baran above, and further still 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(1); 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 Baran above, and further still 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 Baran above, and further still 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 Baran above, and further still 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 Baran et al. (USPN 4,423,725) above, and further still 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 Baran above, and further still in view of Martin teach all of the limitations of Claim 1. Gerrans in view of and Walker above, and further in view of Baran above, and further still 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 Baran above, and further still 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 Baran et al. (USPN 4,423,725) above, and further still 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 Baran above, and further still 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 Baran above, and further still 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 Baran above, and further still 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.
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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, the multi-port connector comprising a housing into which the drainage port, the distal balloon inflation port, the proximal balloon inflation port, the irrigation infusion port, and the sealant infusion port are integrated. 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), the multi-port connector comprising a housing into which 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 Patent ‘924 in view of Walker to comprise a multi-port connector positioned at the proximal end, the multi-port connector comprising a housing into which the drainage port, the distal balloon inflation port, the proximal balloon inflation port, the irrigation infusion port, and the sealant infusion port are integrated as disclosed by Martin for providing a single multi-port connector for all infusion, inflation, and drainage operations (Martin ¶ 0029).
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 ¶ 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 08/29/2025 have been fully considered but they are not persuasive. Applicant’s arguments directed to 103 obviousness rejections begin in the middle of Page 5 of the response. With regard to prior art Walker and for the purpose of expediting prosecution, examiner no longer relies upon elements 20, but rather element 30. At the top of Page 6 of the response, applicant argues “the cited references alone or in combination do not disclose or suggest amended claim 1.” Applicant goes on to argue Baran fails to teach “a multi-port connector” as recited in Claim 1. Although prior art Gerrans, Baran, Hildebrand, and Walker do not disclose a multi-port connector comprising 5 different ports. All of Gerrans, Baran, Hildebrand, and Walker teach multi-port connectors for their respective devices. It is examiner’s position that such a connector for five different ports is inherent in the Baran in view of Hildebrand and Walker rejection of Claim 1 and the Gerrans in view of Walker above, and further in view of Baran rejection of Claim 1. The same could be said for the double patenting rejection of Claim as well. However, for purposes of expediting prosecution in the present case, examiner has provided applicant with a 5 multi-port connector at a proximal end of a double balloon catheter. Such an embodiment is inherent in catheters comprising 5 different ports for inflation/infusion/aspiration.
Applicant’s arguments move to Claim 5 in the middle of Page 6 of the response. There, applicant makes the argument that fluid infused into balloon D would not inflate balloon D. Examiner disagrees with this argument where fluid entering into balloon D would naturally inflate said balloon, it being simply a matter of fluid mechanics (pore size in relation to the velocity in which fluid is infused into said balloon). Such a concept is well within the ordinary skill of the present art.
Conclusion
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/WILLIAM R FREHE/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783