Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Information Disclosure Statement
1. The information disclosure statement (IDS) submitted on 04/11/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, this submission of the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 7 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 7, the limitation of “the stiffening member placed in the second lumen” is indefinite as claim 7 depends on claim 5 which recites the stiffening member placed in the third lumen. Thereby, it’s unclear how the same stiffening member is in both the second and third lumen at the same time or if they are two different stiffeners comprising a first stiffener and a second stiffener. For examination purposes, rephrase claim 7 to depend on claim 4 instead of claim 5.
Double Patenting
4. 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.
5. Claims 2-4, 12-15, 17-19, and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5, 7, and 13-17 of U.S. Patent No. 12295824.
6. Claim 2 of the instant application discloses An implantable device for implantation into tissue adjacent to a urethra connected to a bladder, comprising:an expandable balloon capable of expansion in the tissue adjacent to the urethra;an elongate conduit having a distal portion connected to the expandable balloon and a proximal portion, the elongate conduit including a first lumen in fluid communication with the expandable balloon to allow for filling of the expandable balloon; and a stiffener connected to the distal portion of the elongate conduit to reduce rotation of the implantable device after the implantation.
Regarding claim 2 of the instant application, U.S. Patent No. 12295824 claim 1 discloses An implantable device for implantation into tissue adjacent to an urethra connected to a bladder, comprising: an expandable balloon capable of expansion in the tissue adjacent to the urethra connected to an elongate conduit, the elongate conduit configured to provide for a plurality of lumens including a first inner lumen for fluid communication between a first end of the elongate conduit at a proximal portion of the implantable device and the expandable balloon at a second end at a distal portion of the implantable device and a second inner lumen; and a plurality of distal hooks positioned at a distal tip of the elongate conduit to be deployed distally to the expandable balloon, wherein the implantable device is configured for implantation within the tissue with the expandable balloon adjacent the urethra for adjustable coaptation to the urethra, wherein the plurality of distal deployable hooks is configured to be deployed into the tissue adjacent the urethra after positioning the implantable device to provide fixation of the implantable device in the tissue adjacent the urethra, wherein the expandable balloon and the plurality of distal hooks are arranged for the expandable balloon to shield the bladder from being punctured by the plurality of distal hooks positioned at the distal tip of the elongate conduit when the expandable balloon is expanded, and wherein a stiffener comprising an aperture for filling the expandable balloon is disposed onto an expandable balloon portion of the elongate conduit.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the difference between claim 2 of the current application and claim 1 of patent 12295824 lies in the fact that the patented claims include many more elements and is thus much more specific. Thus, the invention of claim 1 of patent 12295824 in effect a “species” of the “generic” invention of current application claim 2. It has been held that the generic invention is “anticipated” by the “species". See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claim 2 of the current application is anticipated by claim 1 of patent (12295824), it is not patentably distinct from claim 1 of patent 12295824.
All of the limitations of claim 3 can be found in claim 1 of U.S. Patent No. 12295824.
All of the limitations of claim 4 can be found in claims 1 and 15-16 of U.S. Patent No. 12295824.
All of the limitations of claim 12 can be found in claim 14 of U.S. Patent No. 12295824.
All of the limitations of claim 13 can be found in claims 2-3, 5, 7 of U.S. Patent No. 12295824.
All of the limitations of claim 14 can be found in claims 2 and 13 of U.S. Patent No. 12295824.
All of the limitations of claim 15 can be found in claim 1 of U.S. Patent No. 12295824.
All of the limitations of claim 17 can be found in claim 1 of U.S. Patent No. 12295824.
This is a nonstatutory double patenting rejection.
7. Claim 18 of the instant application discloses A method of treating incontinence in a human having a bladder, a urethra connected to the bladder, and tissue adjacent the urethra, the method comprising:improving continence of the human expanding a balloon of an implantable device implanted in the human with the balloon placed in the tissue adjacent the urethra, the implantable device including the balloon and an elongate conduit having a distal portion connected to the balloon and a proximal portion, the elongate conduit including a lumen in fluid communication with the balloon to allow for filling of the balloon; andreducing rotation of the implantable device after being placed in the human by using a stiffener of the implantable device..
Regarding claim 18 of the instant application, U.S. Patent No. 12295824 claim 17 discloses A method of treating incontinence in a human using tissue adjacent a urethra of the human connected to a bladder of the human, comprising: introducing to the tissue adjacent to a urethra of the human an implantable device including an expandable balloon capable of expansion in the tissue adjacent to the urethra connected to an elongate conduit, the elongate conduit configured to provide for a plurality of lumens including a first inner lumen for fluid communication between a first end of the elongate conduit at a proximal portion of the implantable device and the expandable balloon at a second end at a distal portion of the implantable device and a second inner lumen; positioning the expandable balloon relative to the bladder and urethra of the human; deploying a plurality of distal hooks into the tissue adjacent the urethra after positioning the implantable device to provide fixation of the implantable device in the tissue adjacent the urethra, the plurality of distal hooks positioned at a distal tip of the elongate conduit to be deployed distally to the expandable balloon; and expanding the expandable balloon to shield the bladder from being punctured by the plurality of distal hooks at the distal tip of the elongate conduit, wherein the implantable device is configured for implantation within the tissue with the expandable balloon adjacent the urethra for adjustable coaptation to the urethra, and wherein a stiffener comprising an aperture for filling the expandable balloon is disposed onto an expandable balloon portion of the elongate conduit..
Although the conflicting claims are not identical, they are not patentably distinct from each other because the difference between claim 18 of the current application and claim 17 of patent 12295824 lies in the fact that the patented claims include many more elements and is thus much more specific. Thus, the invention of claim 17 of patent 12295824 in effect a “species” of the “generic” invention of current application claim 18. It has been held that the generic invention is “anticipated” by the “species". See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claim 18 of the current application is anticipated by claim 17 of patent (12295824), it is not patentably distinct from claim 17 of patent 12295824.
All of the limitations of claim 19 can be found in claim 17 of U.S. Patent No. 12295824.
All of the limitations of claim 21 can be found in claim 17 of U.S. Patent No. 12295824.
This is a nonstatutory double patenting rejection.
8. Claims 5- 6 are rejected on the ground of provisional nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12295824 in view of claims 2 and 5-7 of Copending App. 15371591.
Regarding claim 5, U.S. Patent No. 12295824 claim 1 discloses An implantable device for implantation into tissue adjacent to an urethra connected to a bladder, comprising: an expandable balloon capable of expansion in the tissue adjacent to the urethra connected to an elongate conduit, the elongate conduit configured to provide for a plurality of lumens including a first inner lumen for fluid communication between a first end of the elongate conduit at a proximal portion of the implantable device and the expandable balloon at a second end at a distal portion of the implantable device and a second inner lumen; and a plurality of distal hooks positioned at a distal tip of the elongate conduit to be deployed distally to the expandable balloon, wherein the implantable device is configured for implantation within the tissue with the expandable balloon adjacent the urethra for adjustable coaptation to the urethra, wherein the plurality of distal deployable hooks is configured to be deployed into the tissue adjacent the urethra after positioning the implantable device to provide fixation of the implantable device in the tissue adjacent the urethra, wherein the expandable balloon and the plurality of distal hooks are arranged for the expandable balloon to shield the bladder from being punctured by the plurality of distal hooks positioned at the distal tip of the elongate conduit when the expandable balloon is expanded, and wherein a stiffener comprising an aperture for filling the expandable balloon is disposed onto an expandable balloon portion of the elongate conduit.
Although the conflicting claims are not identical, they are not patentably distinct from each other because (1) the claims of patent 12295824 are directed to a device/method having the essential structural features as claimed in the instant application. (2) The instant application differs from the patent 12295824 in that it recites the limitation of a third lumen, and the stiffener comprises a stiffening member placed in the third lumen.
Copending App. 15371591 claims 2 and 7, however, teaches a third lumen, and the stiffener comprises a stiffening member placed in the third lumen.
In view of the teachings of Patent 12295824, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the stiffener with elongate conduit of Patent 12295824 by incorporating the stiffener in a third lumen of Copending App. 15371591 for providing internal stiffening.
This is a provisional nonstatutory double patenting rejection.
Regarding claim 6, U.S. Patent No. 12295824 claim 1 discloses An implantable device for implantation into tissue adjacent to an urethra connected to a bladder, comprising: an expandable balloon capable of expansion in the tissue adjacent to the urethra connected to an elongate conduit, the elongate conduit configured to provide for a plurality of lumens including a first inner lumen for fluid communication between a first end of the elongate conduit at a proximal portion of the implantable device and the expandable balloon at a second end at a distal portion of the implantable device and a second inner lumen; and a plurality of distal hooks positioned at a distal tip of the elongate conduit to be deployed distally to the expandable balloon, wherein the implantable device is configured for implantation within the tissue with the expandable balloon adjacent the urethra for adjustable coaptation to the urethra, wherein the plurality of distal deployable hooks is configured to be deployed into the tissue adjacent the urethra after positioning the implantable device to provide fixation of the implantable device in the tissue adjacent the urethra, wherein the expandable balloon and the plurality of distal hooks are arranged for the expandable balloon to shield the bladder from being punctured by the plurality of distal hooks positioned at the distal tip of the elongate conduit when the expandable balloon is expanded, and wherein a stiffener comprising an aperture for filling the expandable balloon is disposed onto an expandable balloon portion of the elongate conduit.
Although the conflicting claims are not identical, they are not patentably distinct from each other because (1) the claims of patent 12295824 are directed to a device/method having the essential structural features as claimed in the instant application. (2) The instant application differs from the patent 12295824 in that it recites the limitation of the stiffening member has varying stiffness and is configured to provide more stiffening at a distal end of the implantable device than at a proximal end of the implantable device.
Copending App. 15371591 claims 2 and 5-6, however, the stiffening member has varying stiffness and is configured to provide more stiffening at a distal end of the implantable device than at a proximal end of the implantable device.
In view of the teachings of Patent 12295824, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the stiffener with elongate conduit of Patent 12295824 by incorporating the stiffener in a third lumen of Copending App. 15371591 for providing varying stiffness therethrough.
This is a provisional nonstatutory double patenting rejection.
9. Claims 7-8, 10-11 and 20 are rejected on the ground of provisional nonstatutory double patenting as being unpatentable over claims 1, 17, and 19 of U.S. Patent No. 12295824 in view of claims 21 and 36-39 of Copending App. 14169988.
Regarding claim 7, U.S. Patent No. 12295824 claim 1 discloses An implantable device for implantation into tissue adjacent to an urethra connected to a bladder, comprising: an expandable balloon capable of expansion in the tissue adjacent to the urethra connected to an elongate conduit, the elongate conduit configured to provide for a plurality of lumens including a first inner lumen for fluid communication between a first end of the elongate conduit at a proximal portion of the implantable device and the expandable balloon at a second end at a distal portion of the implantable device and a second inner lumen; and a plurality of distal hooks positioned at a distal tip of the elongate conduit to be deployed distally to the expandable balloon, wherein the implantable device is configured for implantation within the tissue with the expandable balloon adjacent the urethra for adjustable coaptation to the urethra, wherein the plurality of distal deployable hooks is configured to be deployed into the tissue adjacent the urethra after positioning the implantable device to provide fixation of the implantable device in the tissue adjacent the urethra, wherein the expandable balloon and the plurality of distal hooks are arranged for the expandable balloon to shield the bladder from being punctured by the plurality of distal hooks positioned at the distal tip of the elongate conduit when the expandable balloon is expanded, and wherein a stiffener comprising an aperture for filling the expandable balloon is disposed onto an expandable balloon portion of the elongate conduit.
Although the conflicting claims are not identical, they are not patentably distinct from each other because (1) the claims of patent 12295824 are directed to a device/method having the essential structural features as claimed in the instant application. (2) The instant application differs from the patent 12295824 in that it recites the limitation of the stiffener comprises placed in the second lumen.
Copending App. 14169988 claims 21 and 36-37, however, teaches the stiffener in the second lumen.
In view of the teachings of Patent 12295824, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the stiffener with elongate conduit of Patent 12295824 by incorporating the stiffener in the second lumen of Copending App. 14169988 for providing internal stiffening.
This is a provisional nonstatutory double patenting rejection.
Regarding claim 8, U.S. Patent No. 12295824 claim 1 discloses An implantable device for implantation into tissue adjacent to an urethra connected to a bladder, comprising: an expandable balloon capable of expansion in the tissue adjacent to the urethra connected to an elongate conduit, the elongate conduit configured to provide for a plurality of lumens including a first inner lumen for fluid communication between a first end of the elongate conduit at a proximal portion of the implantable device and the expandable balloon at a second end at a distal portion of the implantable device and a second inner lumen; and a plurality of distal hooks positioned at a distal tip of the elongate conduit to be deployed distally to the expandable balloon, wherein the implantable device is configured for implantation within the tissue with the expandable balloon adjacent the urethra for adjustable coaptation to the urethra, wherein the plurality of distal deployable hooks is configured to be deployed into the tissue adjacent the urethra after positioning the implantable device to provide fixation of the implantable device in the tissue adjacent the urethra, wherein the expandable balloon and the plurality of distal hooks are arranged for the expandable balloon to shield the bladder from being punctured by the plurality of distal hooks positioned at the distal tip of the elongate conduit when the expandable balloon is expanded, and wherein a stiffener comprising an aperture for filling the expandable balloon is disposed onto an expandable balloon portion of the elongate conduit.
Although the conflicting claims are not identical, they are not patentably distinct from each other because (1) the claims of patent 12295824 are directed to a device/method having the essential structural features as claimed in the instant application. (2) The instant application differs from the patent 12295824 in that it recites the limitation of the stiffener placed in the second lumen.
Copending App. 14169988 claims 21 and 36-37, however, teaches the stiffener in the second lumen.
In view of the teachings of Patent 12295824, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the stiffener with elongate conduit of Patent 12295824 by incorporating the stiffener in the second lumen of Copending App. 14169988 for providing internal stiffening.
This is a provisional nonstatutory double patenting rejection.
Regarding claim 10, U.S. Patent No. 12295824 claim 1 discloses An implantable device for implantation into tissue adjacent to an urethra connected to a bladder, comprising: an expandable balloon capable of expansion in the tissue adjacent to the urethra connected to an elongate conduit, the elongate conduit configured to provide for a plurality of lumens including a first inner lumen for fluid communication between a first end of the elongate conduit at a proximal portion of the implantable device and the expandable balloon at a second end at a distal portion of the implantable device and a second inner lumen; and a plurality of distal hooks positioned at a distal tip of the elongate conduit to be deployed distally to the expandable balloon, wherein the implantable device is configured for implantation within the tissue with the expandable balloon adjacent the urethra for adjustable coaptation to the urethra, wherein the plurality of distal deployable hooks is configured to be deployed into the tissue adjacent the urethra after positioning the implantable device to provide fixation of the implantable device in the tissue adjacent the urethra, wherein the expandable balloon and the plurality of distal hooks are arranged for the expandable balloon to shield the bladder from being punctured by the plurality of distal hooks positioned at the distal tip of the elongate conduit when the expandable balloon is expanded, and wherein a stiffener comprising an aperture for filling the expandable balloon is disposed onto an expandable balloon portion of the elongate conduit.
Although the conflicting claims are not identical, they are not patentably distinct from each other because (1) the claims of patent 12295824 are directed to a device/method having the essential structural features as claimed in the instant application. (2) The instant application differs from the patent 12295824 in that it recites the limitation of the stiffener positioned outside the elongate conduit.
Copending App. 14169988 claims 21 and 39, however, teaches the stiffener as a coil externally on the elongate conduit.
In view of the teachings of Patent 12295824, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the stiffener with elongate conduit of Patent 12295824 by incorporating the stiffener coil on the elongate conduit of Copending App. 14169988 for providing external stiffening.
This is a provisional nonstatutory double patenting rejection.
Regarding claim 11 U.S. Patent No. 12295824 claim 1 discloses An implantable device for implantation into tissue adjacent to an urethra connected to a bladder, comprising: an expandable balloon capable of expansion in the tissue adjacent to the urethra connected to an elongate conduit, the elongate conduit configured to provide for a plurality of lumens including a first inner lumen for fluid communication between a first end of the elongate conduit at a proximal portion of the implantable device and the expandable balloon at a second end at a distal portion of the implantable device and a second inner lumen; and a plurality of distal hooks positioned at a distal tip of the elongate conduit to be deployed distally to the expandable balloon, wherein the implantable device is configured for implantation within the tissue with the expandable balloon adjacent the urethra for adjustable coaptation to the urethra, wherein the plurality of distal deployable hooks is configured to be deployed into the tissue adjacent the urethra after positioning the implantable device to provide fixation of the implantable device in the tissue adjacent the urethra, wherein the expandable balloon and the plurality of distal hooks are arranged for the expandable balloon to shield the bladder from being punctured by the plurality of distal hooks positioned at the distal tip of the elongate conduit when the expandable balloon is expanded, and wherein a stiffener comprising an aperture for filling the expandable balloon is disposed onto an expandable balloon portion of the elongate conduit.
Although the conflicting claims are not identical, they are not patentably distinct from each other because (1) the claims of patent 12295824 are directed to a device/method having the essential structural features as claimed in the instant application. (2) The instant application differs from the patent 12295824 in that it recites the limitation of the stiffener positioned inside the elongate conduit.
Copending App. 14169988 claims 21 and 38, however, teaches the stiffener as a coil internally inside the elongate conduit.
In view of the teachings of Patent 12295824, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the stiffener with elongate conduit of Patent 12295824 by incorporating the stiffener coil in the elongate conduit of Copending App. 14169988 for providing internal stiffening.
This is a provisional nonstatutory double patenting rejection.
Regarding claim 20 U.S. Patent No. 12295824 claim 17 discloses A method of treating incontinence in a human using tissue adjacent a urethra of the human connected to a bladder of the human, comprising: introducing to the tissue adjacent to a urethra of the human an implantable device including an expandable balloon capable of expansion in the tissue adjacent to the urethra connected to an elongate conduit, the elongate conduit configured to provide for a plurality of lumens including a first inner lumen for fluid communication between a first end of the elongate conduit at a proximal portion of the implantable device and the expandable balloon at a second end at a distal portion of the implantable device and a second inner lumen; positioning the expandable balloon relative to the bladder and urethra of the human; deploying a plurality of distal hooks into the tissue adjacent the urethra after positioning the implantable device to provide fixation of the implantable device in the tissue adjacent the urethra, the plurality of distal hooks positioned at a distal tip of the elongate conduit to be deployed distally to the expandable balloon; and expanding the expandable balloon to shield the bladder from being punctured by the plurality of distal hooks at the distal tip of the elongate conduit, wherein the implantable device is configured for implantation within the tissue with the expandable balloon adjacent the urethra for adjustable coaptation to the urethra, and wherein a stiffener comprising an aperture for filling the expandable balloon is disposed onto an expandable balloon portion of the elongate conduit. Also, claim 19 discloses a pushrod in the second inner lumen to place the implantable device in position.
Although the conflicting claims are not identical, they are not patentably distinct from each other because (1) the claims of patent 12295824 are directed to a device/method having the essential structural features as claimed in the instant application. (2) The instant application differs from the patent 12295824 in that it recites the limitation of the stiffener placed in the second lumen.
Copending App. 14169988 claims 21 and 36-37, however, teaches the stiffener in the second lumen.
In view of the teachings of Patent 12295824, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the stiffener with elongate conduit of Patent 12295824 by incorporating the stiffener in the second lumen of Copending App. 14169988 for providing internal stiffening.
This is a provisional nonstatutory double patenting rejection.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 2-4, 9-10, and 18-19 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Cook et al. (U.S. Patent No. 5964806) in view of Jorgensen (U.S. Patent Pub. No. 7022106).
Regarding claim 2, Cook discloses An implantable device 20 (Col. 4, lines 64-67 and Figures 4-6, a patient’s incontinence is treated by positioning one or more of the implantable devices 20 adjacent to at least one side of a patient’s urethra) for implantation into tissue adjacent to a urethra connected to a bladder, comprising: an expandable balloon 22 (Col 2, Lines 51-52 and Figures 4-6, during the postoperative adjustments, the adjustable element 22 is expanded or contracted due to fluid volume introduced into the chamber) capable of expansion in the tissue adjacent to the urethra; an elongate conduit 36 (Col 8, Lines 40-50 and Figures 4-6, tubular elongate body 36 has a peripheral surface 38. The adjustable element 22 has at least one opening through the continuous wall 24 to which the peripheral surface 38 is connected to and sealed to the adjustable element 22) having a distal portion (Col 8, Lines 64-65, second distal end 52 at distal portion) connected to the expandable balloon and a proximal portion 40, the elongate conduit 36 including a first lumen 48 (Col 8, Lines 56-62, first interior passageway 48 extending longitudinally in the tubular elongate body 36 from a first port 50 at the proximal end 40 to a second port 52 in fluid communication with the chamber 28) in fluid communication with the expandable balloon 22 to allow for filling of the expandable balloon 22; and a second inner lumen 54 (Col 8, Lines 64-65, second interior passageway 54 at distal portion).
However, Cook fails to explicitly disclose a stiffener connected to the distal portion of the elongate conduit to reduce rotation of the implantable device after the implantation.
Jorgensen teaches an analogous implantable device (Col. 4, lines 1-67, Col. 5, lines 1-13, and Figure 2A, Ring shaped band 48, helical coils 67, inner ballon stiffener taper 49 of varying increased distal stiffness, and solder/weld 47 on exterior surface of elongate conduit 42 continue into distal expandable balloon portion 46. There is also an aperture 52 at a section of stiffening taper 49 of elongate conduit 42 within balloon 46 for inflating/deflating balloon 46) wherein a stiffener 48, 49, 67, 47(Col. 4, lines 1-67, Col. 5, lines 1-13, and Figure 2A) connected to the analogous distal portion of the analogous elongate conduit 42 to reduce rotation of the analogous implantable device after the analogous implantation.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify the elongate conduit of Cook, so that there is a stiffener connected to the distal portion of the elongate conduit to reduce rotation of the implantable device after the implantation, as taught by Jorgensen, in order to provide an improved implantable device with an enhanced elongate conduit having external stiffeners that provide stability to the distal expandable balloon for desirable steady operation without movement (Jorgensen, Col. 4, lines 1-67, Col. 5, lines 1-13).
Regarding claim 3, the combination of Cook in view of Jorgensen discloses the invention as described above and further discloses wherein the stiffener48, 49, 67, 47 (Jorgensen, Col. 4, lines 1-67, Col. 5, lines 1-13, and Figure 2A, Ring shaped band 48, helical coils 67, inner ballon stiffener taper 49 of varying increased distal stiffness, and solder/weld 47 on exterior surface of elongate conduit 42 continue into distal expandable balloon portion 46. There is also an aperture 52 at a section of stiffening taper 49 of elongate conduit 42 within balloon 46 for inflating/deflating balloon 46) is connected to the distal portion of the elongate conduit 36 (Cook, Col 8, Lines 40-50 and Figures 4-6)and inside (Jorgensen, Col. 4, lines 1-67, Col. 5, lines 1-13, and Figure 2A, annular stiffener section 49 inside expandable balloon 46 with aperture 52 to fill balloon 46) the expandable balloon 22 (Cook, Col 2, Lines 51-52 and Figures 4-6), the stiffener comprising an annular member 49 (Jorgensen, Col. 4, lines 1-67, Col. 5, lines 1-13, and Figure 2A) including an aperture 52 (Jorgensen, Col. 4, lines 1-67, Col. 5, lines 1-13, and Figure 2A) positioned to allow the expandable balloon to be filled through the first lumen 48 (Cook, Col 8, Lines 56-62).
Regarding claim 4, the combination of Cook in view of Jorgensen discloses the invention as described above. Cook further discloses wherein the elongate conduit 36 comprises a second lumen 54 (Col 8, Lines 64-65, second interior passageway 54 at distal portion) configured to accommodate an implantation tool 17 (col. 12, lines 15-17, obturator 17 within second lumen) configured to place the implantable device in position during implantation of the implantable device.
Regarding claim 9, the combination of Cook in view of Jorgensen discloses the invention as described above and further discloses wherein the stiffener48, 49, 67, 47 (Jorgensen, Col. 4, lines 1-67, Col. 5, lines 1-13, and Figure 2A, Ring shaped band 48, helical coils 67, inner ballon stiffener taper 49 of varying increased distal stiffness, and solder/weld 47 on exterior surface of elongate conduit 42 continue into distal expandable balloon portion 46. There is also an aperture 52 at a section of stiffening taper 49 of elongate conduit 42 within balloon 46 for inflating/deflating balloon 46) is connected to the distal portion of the elongate conduit 36 (Cook, Col 8, Lines 40-50 and Figures 4-6) and positioned outside (Jorgensen, Col. 4, lines 1-67, Col. 5, lines 1-13, and Figure 2A, distal end of taper stiffener section 49 of 42 extends distally past balloon 46) the expandable balloon 22 (Cook, Col 2, Lines 51-52 and Figures 4-6).
Regarding claim 10, the combination of Cook in view of Jorgensen discloses the invention as described above and further discloses wherein the stiffener48, 49, 67, 47 (Jorgensen, Col. 4, lines 1-67, Col. 5, lines 1-13, and Figure 2A, Ring shaped band 48, external helical coil 67, inner ballon stiffener taper 49 of varying increased distal stiffness, and solder/weld 47 on exterior surface of elongate conduit 42 continue into distal expandable balloon portion 46. There is also an aperture 52 at a section of stiffening taper 49 of elongate conduit 42 within balloon 46 for inflating/deflating balloon 46) comprises a coil 67 (Jorgensen, Col. 4, lines 1-67, Col. 5, lines 1-13, and Figure 2A ) on the elongate conduit 36 (Cook, Col 8, Lines 40-50 and Figures 4-6).
Regarding claim 18, Cook discloses A method of treating incontinence in a human having a bladder, a urethra connected to the bladder, and tissue adjacent the urethra, the method comprising:improving continence of the human expanding a balloon 22 (Col 2, Lines 51-52 and Figures 4-6, during the postoperative adjustments, the adjustable element 22 is expanded or contracted due to fluid volume introduced into the chamber)of an implantable device 20 (Col. 4, lines 64-67 and Figures 4-6, a patient’s incontinence is treated by positioning one or more of the implantable devices 20 adjacent to at least one side of a patient’s urethra) implanted in the human with the balloon 22 placed in the tissue adjacent the urethra, the implantable device20 including the balloon 22 and an elongate conduit 36 (Col 8, Lines 40-50 and Figures 4-6, tubular elongate body 36 has a peripheral surface 38. The adjustable element 22 has at least one opening through the continuous wall 24 to which the peripheral surface 38 is connected to and sealed to the adjustable element 22) having a distal portion (Col 8, Lines 64-65, second distal end 52 at distal portion) connected to the balloon 22 and a proximal portion 40, the elongate conduit 36 including a lumen 48 (Col 8, Lines 56-62, first interior passageway 48 extending longitudinally in the tubular elongate body 36 from a first port 50 at the proximal end 40 to a second port 52 in fluid communication with the chamber 28) in fluid communication with the balloon 22 to allow for filling of the balloon 22;
However, Cook fails to explicitly disclose reducing rotation of the implantable device after being placed in the human by using a stiffener of the implantable device.
Jorgensen teaches an analogous implantable device (Col. 4, lines 1-67, Col. 5, lines 1-13, and Figure 2A, Ring shaped band 48, helical coils 67, inner ballon stiffener taper 49 of varying increased distal stiffness, and solder/weld 47 on exterior surface of elongate conduit 42 continue into distal expandable balloon portion 46. There is also an aperture 52 at a section of stiffening taper 49 of elongate conduit 42 within balloon 46 for inflating/deflating balloon 46) with reducing rotation of the analogous implantable device after being placed in the human by using a stiffener 48, 49, 67, 47(Col. 4, lines 1-67, Col. 5, lines 1-13, and Figure 2A) of the analogous implantable device.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify the elongate conduit of Cook, so that reducing rotation of the implantable device after being placed in the human by using a stiffener of the implantable device, as taught by Jorgensen, in order to provide an improved implantable device with an enhanced elongate conduit having external stiffeners that provide stability to the distal expandable balloon for desirable steady operation without movement (Jorgensen, Col. 4, lines 1-67, Col. 5, lines 1-13).
Regarding claim 19, the combination of Cook in view of Jorgensen discloses the invention as described above and further discloses wherein using the stiffener 48, 49, 67, 47 (Jorgensen, Col. 4, lines 1-67, Col. 5, lines 1-13, and Figure 2A, Ring shaped band 48, helical coils 67, inner ballon stiffener taper 49 of varying increased distal stiffness, and solder/weld 47 on exterior surface of elongate conduit 42 continue into distal expandable balloon portion 46. There is also an aperture 52 at a section of stiffening taper 49 of elongate conduit 42 within balloon 46 for inflating/deflating balloon 46) comprises using an annular stiffening member 49 (Jorgensen, Col. 4, lines 1-67, Col. 5, lines 1-13, and Figure 2A) connected to the distal portion of the elongate conduit 36 (Col 8, Lines 40-50 and Figures 4-6), disposed inside(Jorgensen, Col. 4, lines 1-67, Col. 5, lines 1-13, and Figure 2A, annular stiffener section 49 inside expandable balloon 46 with aperture 52 to fill balloon 46) the balloon 22 (Cook, Col 2, Lines 51-52 and Figures 4-6), and including an aperture 52 (Jorgensen, Col. 4, lines 1-67, Col. 5, lines 1-13, and Figure 2A) positioned to allow the balloon 22 (Cook, Col 2, Lines 51-52 and Figures 4-6) to be filled through the lumen 48 (Cook, Col 8, Lines 56-62).
Claims 2, 4-5, 7-8, and 18, as best understood given by the 35 USC 112(B) above, are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Cook et al. (U.S. Patent No. 5964806) in view of Reifart et al. (U.S. Patent Pub. No. 20060129178).
Regarding claim 2, Cook discloses An implantable device 20 (Col. 4, lines 64-67, a patient’s incontinence is treated by positioning one or more of the implantable devices 20 adjacent to at least one side of a patient’s urethra) for implantation into tissue adjacent to a urethra connected to a bladder, comprising: an expandable balloon 22 (Col 2, Lines 51-52 and Figures 4-6, during the postoperative adjustments, the adjustable element 22 is expanded or contracted due to fluid volume introduced into the chamber) capable of expansion in the tissue adjacent to the urethra; an elongate conduit 36 (Col 8, Lines 40-50 and Figures 4-6, tubular elongate body 36 has a peripheral surface 38. The adjustable element 22 has at least one opening through the continuous wall 24 to which the peripheral surface 38 is connected to and sealed to the adjustable element 22) having a distal portion (Col 8, Lines 64-65, second distal end 52 at distal portion) connected to the expandable balloon and a proximal portion 40, the elongate conduit 36 including a first lumen 48 (Col 8, Lines 56-62, first interior passageway 48 extending longitudinally in the tubular elongate body 36 from a first port 50 at the proximal end 40 to a second port 52 in fluid communication with the chamber 28) in fluid communication with the expandable balloon 22 to allow for filling of the expandable balloon 22; and a second inner lumen 54 (Col 8, Lines 64-65, second interior passageway 54 at distal portion).
However, Cook fails to explicitly disclose a stiffener connected to the distal portion of the elongate conduit to reduce rotation of the implantable device after the implantation.
Reifart teaches an analogous implantable device 10 (Paragraphs 33, 40-41 and Figures 1-2, implantable device 10 with elongate conduit 12 having a first lumen 16 for filling balloon 20, second lumen 14 with stiffener 26 therein, and third lumen 18 with stiffener 50 therein that extend to distal balloon section 20) comprising an analogous second lumen 14 and stiffener 26, 50 connected to the analogous distal portion of the analogous elongate conduit 12 to reduce rotation of the analogous implantable device 10 after the analogous implantation
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify the elongate conduit of Cook, so that there is a stiffener connected to the distal portion of the elongate conduit to reduce rotation of the implantable device after the implantation, as taught by Reifart, in order to provide an improved implantable device with an enhanced elongate conduit having external stiffeners that provide stability to the distal expandable balloon with smoother transition and guidewire feed (Reifart, Paragraphs 17, 33 and 40-41).
Regarding claim 4, the combination of Cook in view of Reifart discloses the invention as described above. Cook further discloses wherein the elongate conduit 36 comprises the second lumen 54 (Col 8, Lines 64-65, second interior passageway 54 at distal portion) configured to accommodate an implantation tool 17 (col. 12, lines 15-17, obturator 17 within second lumen) configured to place the implantable device in position during implantation of the implantable device.
Regarding claim 5, the combination of Cook in view of Reifart discloses the invention as described above but fails to explicitly disclose wherein the elongate conduit comprises a third lumen, and the stiffener comprises a stiffening member placed in the third lumen.
Reifart further teaches wherein the analogous elongate conduit 12 (Paragraphs 33, 40-41 and Figures 1-2, implantable device 10 with elongate conduit 12 having a first lumen 16 for filling balloon 20, second lumen 14 with stiffener 26 therein, and third lumen 18 with stiffener 50 therein that extend to distal balloon section 20) comprises a third lumen 18, and the stiffener 26,50 comprises a stiffening member 50 placed in the third lumen 18.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify the elongate conduit of Cook in view of Reifart, so that the elongate conduit comprises a third lumen, and the stiffener comprises a stiffening member placed in the third lumen , as taught by Reifart, in order to provide an improved implantable device with an enhanced elongate conduit having an additional third lumen with an additional second stiffener for increased stability and support throughout the elongate conduit to prevent collapse of the majority of the elongate conduit (Reifart, Paragraphs 17, 33, and 40-41).
Regarding claim 7, the combination of Cook in view of Reifart discloses the invention as described above and further discloses wherein the stiffener 26, 50 (Reifart Paragraphs 33, 40-41 and Figures 1-2, annular stiffener 26 in second lumen 14) comprises an annular stiffening member placed in the second lumen 54 (Cook, Col 8, Lines 64-65).
Regarding claim 8, the combination of Cook in view of Reifart discloses the invention as described above and further discloses wherein the stiffener 26, 50 (Reifart Paragraphs 33, 40-41 and Figures 1-2, annular stiffener 26 capable of being placed in second lumen 14 after implantation) is configured to be placed in the second lumen 54 (Cook, Col 8, Lines 64-65) after the implantable device is placed in position.
Regarding claim 18, Cook discloses A method of treating incontinence in a human having a bladder, a urethra connected to the bladder, and tissue adjacent the urethra, the method comprising:improving continence of the human expanding a balloon 22 (Col 2, Lines 51-52 and Figures 4-6, during the postoperative adjustments, the adjustable element 22 is expanded or contracted due to fluid volume introduced into the chamber)of an implantable device 20 (Col. 4, lines 64-67 and Figures 4-6, a patient’s incontinence is treated by positioning one or more of the implantable devices 20 adjacent to at least one side of a patient’s urethra) implanted in the human with the balloon 22 placed in the tissue adjacent the urethra, the implantable device20 including the balloon 22 and an elongate conduit 36 (Col 8, Lines 40-50 and Figures 4-6, tubular elongate body 36 has a peripheral surface 38. The adjustable element 22 has at least one opening through the continuous wall 24 to which the peripheral surface 38 is connected to and sealed to the adjustable element 22) having a distal portion (Col 8, Lines 64-65, second distal end 52 at distal portion) connected to the balloon 22 and a proximal portion 40, the elongate conduit 36 including a lumen 48 (Col 8, Lines 56-62, first interior passageway 48 extending longitudinally in the tubular elongate body 36 from a first port 50 at the proximal end 40 to a second port 52 in fluid communication with the chamber 28) in fluid communication with the balloon 22 to allow for filling of the balloon 22; and a second inner lumen 54 (Col 8, Lines 64-65, second interior passageway 54 at distal portion).
However, Cook fails to explicitly disclose reducing rotation of the implantable device after being placed in the human by using a stiffener of the implantable device.
Reifart teaches an analogous implantable device 10 (Paragraphs 33, 40-41 and Figures 1-2, implantable device 10 with elongate conduit 12 having a first lumen 16 for filling balloon 20, second lumen 14 with stiffener 26 therein, and third lumen 18 with stiffener 50 therein that extend to distal balloon section 20) comprising an analogous second lumen 14 with reducing rotation of the analogous implantable device10 after being placed in the human by using a stiffener 26, 50 of the analogous implantable device 10.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify the elongate conduit of Cook, so that reducing rotation of the implantable device after being placed in the human by using a stiffener of the implantable device, as taught by Reifart, in order to provide an improved implantable device with an enhanced elongate conduit having external stiffeners that provide stability to the distal expandable balloon with smoother transition and guidewire feed (Reifart, Paragraphs 17, 33 and 40-41).
Claims 2 and 11 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Cook et al. (U.S. Patent No. 5964806) in view of Burton et al. (U.S. Patent No. 6579224).
Regarding claim 2, Cook discloses An implantable device 20 (Col. 4, lines 64-67, a patient’s incontinence is treated by positioning one or more of the implantable devices 20 adjacent to at least one side of a patient’s urethra) for implantation into tissue adjacent to a urethra connected to a bladder, comprising: an expandable balloon 22 (Col 2, Lines 51-52 and Figures 4-6, during the postoperative adjustments, the adjustable element 22 is expanded or contracted due to fluid volume introduced into the chamber) capable of expansion in the tissue adjacent to the urethra; an elongate conduit 36 (Col 8, Lines 40-50 and Figures 4-6, tubular elongate body 36 has a peripheral surface 38. The adjustable element 22 has at least one opening through the continuous wall 24 to which the peripheral surface 38 is connected to and sealed to the adjustable element 22) having a distal portion (Col 8, Lines 64-65, second distal end 52 at distal portion) connected to the expandable balloon and a proximal portion 40, the elongate conduit 36 including a first lumen 48 (Col 8, Lines 56-62, first interior passageway 48 extending longitudinally in the tubular elongate body 36 from a first port 50 at the proximal end 40 to a second port 52 in fluid communication with the chamber 28) in fluid communication with the expandable balloon 22 to allow for filling of the expandable balloon 22.
However, Cook fails to explicitly disclose a stiffener connected to the distal portion of the elongate conduit to reduce rotation of the implantable device after the implantation.
Burton teaches an analogous implantable device 1500 (Col 20, Lines 40-67 and Figure 15, implantable device assembly 1500 with elongate conduit 1506 comprising metal coil stiffener 1550 extending towards distal end 1524 near distal balloons 1504) comprising a stiffener 1550 connected to the analogous distal portion 1524 of the analogous elongate conduit 1506 to reduce rotation of the analogous implantable device 1500 after the analogous implantation.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify the elongate conduit of Cook, so that there is a stiffener connected to the distal portion of the elongate conduit to reduce rotation of the implantable device after the implantation, as taught by Burton, in order to provide an improved implantable device with an enhanced elongate conduit having an internal coil stiffener that provide stability to the distal expandable balloon for desirable steady operation allowing for the forces applied along the longitudinal axis of the implantable device to be transferred to the distal end (Burton, Col 20, Lines 40-67).
Regarding claim 11, the combination of Cook in view of Burton discloses the invention as described above and further discloses wherein the stiffener 1550 (Burton, Col 20, Lines 40-67 and Figure 15, metal coil stiffener 1550 inside/within elongate conduit 1506) comprises a coil 1550 (Burton, Col 20, Lines 40-67 and Figure 15) disposed inside of the elongate conduit 36 (Cook, Col 8, Lines 40-50 and Figures 4-6).
Claims 6 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Cook et al. (U.S. Patent No. 5964806) in view of Reifart et al. (U.S. Patent Pub. No. 20060129178), as applied to claim 5, and in further view of Jorgensen (U.S. Patent Pub. No. 7022106).
Regarding claim 6, the combination of Cook in view of Reifart discloses the invention as described above but fails to explicitly disclose wherein the stiffening member has varying stiffness and is configured to provide more stiffening at a distal end of the implantable device than at a proximal end of the implantable device.
Jorgensen teaches an analogous implantable device (Col. 4, lines 1-67, Col. 5, lines 1-13, and Figure 2A, Ring shaped band 48, helical coils 67, inner ballon stiffener taper 49 of varying increased distal stiffness, and solder/weld 47 on exterior surface of elongate conduit 42 continue into distal expandable balloon portion 46. There is also an aperture 52 at a section of stiffening taper 49 of elongate conduit 42 within balloon 46 for inflating/deflating balloon 46) wherein the analogous stiffening member has varying stiffness and is configured to provide more stiffening (Col. 4, lines 55-67, coil 67 of varying stiffness and stiffening taper 49 section of increased stiffness at distal end) at an analogous distal end of the analogous implantable device than at an analogous proximal end of the analogous implantable device.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify a stiffness profile of the stiffener of Cook in view of Reifart, so that the stiffening member has varying stiffness and is configured to provide more stiffening at a distal end of the implantable device than at a proximal end of the implantable device as taught by Jorgensen, in order to provide an improved implantable device with an enhanced elongate conduit having varying degrees of stiffness throughout the elongate conduit with increased stiffness at the distal end to increasingly support the distal balloon and further moment arms away from the operator (Jorgensen, Col. 4, lines 55-67).
Claims 12 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Cook et al. (U.S. Patent No. 5964806) in view of Jorgensen (U.S. Patent Pub. No. 7022106), as applied to claim 2, and in further view of Orlowski (U.S. Patent Pub. No. 20100145266 ; Applicable under 102(e) pre-aia date filed 01/21/2008).
Regarding claim 12, the combination of Cook in view of Jorgensen discloses the invention as described above but fails to explicitly disclose wherein the expandable balloon comprises a wall including a portion microtextured to further reduce the rotation of the implantable device after the implantation.
Orlowski teaches an analogous implantable device 1(Paragraphs 45, 73, 104, urinary tract catheter implant with balloon having micro/nano meter micro-rough surface) wherein the analogous expandable balloon comprises an analogous wall including a portion microtextured to further reduce the rotation of the analogous implantable device after the analogous implantation.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify a wall surface of the expandable balloon of Cook in view of Jorgensen, so that the expandable balloon comprises a wall including a portion microtextured to further reduce the rotation of the implantable device after the implantation, as taught by Orlowski, in order to provide an improved implantable device with an enhanced expandable balloon that is textured for improved therapeutic properties and securement at the urinary tract area (Orlowski, Paragraphs 45, 73, 104).
Claims 13-14 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Cook et al. (U.S. Patent No. 5964806) in view of Jorgensen (U.S. Patent Pub. No. 7022106), as applied to claim 2, and in further view of Cates et al. (U.S. Patent Pub. No. 20040230282).
Regarding claim 13, the combination of Cook in view of Jorgensen discloses the invention as described above but fails to explicitly disclose an ingrowth collar or sleeve encircling the elongate conduit near the expandable balloon and made of a bioresorbable material, the ingrowth collar or sleeve configured to allow ingrowth to provide adhesion of the implantable device to the tissue adjacent to the urethra.
Cates teaches an analogous implantable device 200 (Paragraphs 65-67 and 69, and Figures 3B-3C and 4, elongate conduit 240 with expandable balloon 330,350 at distal portion and having a distal sleeve 230 having helical shape 470-474 for ingrowth ) with an analogous elongate conduit 12 comprising an ingrowth collar/sleeve 230 encircling the analogous elongate conduit 240 near the analogous expandable balloon and made of a bioresorbable material (Paragraph 75), the ingrowth collar/sleeve 230 configured to allow ingrowth to provide adhesion of the analogous implantable device 200 to the tissue adjacent to the urethra.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify the elongate conduit of Cook in view of Jorgensen, so that there is an ingrowth collar or sleeve encircling the elongate conduit near the expandable balloon and made of a bioresorbable material, the ingrowth collar or sleeve configured to allow ingrowth to provide adhesion of the implantable device to the tissue adjacent to the urethra, as taught by Cates, in order to provide an improved implantable device with an enhanced elongate conduit that promotes tissue ingrowth and subsequent chronic fixation (Cates, Paragraphs 65-67 and 69).
Regarding claim 14, the combination of Cook in view of Jorgensen discloses the invention as described above but fails to explicitly disclose further comprising a helical sleeve structure on the elongate conduit.
Cates teaches an analogous implantable device 200 (Paragraphs 65-67 and 69, and Figures 3B-3C and 4, elongate conduit 240 with expandable balloon 330,350 at distal portion and having a distal sleeve 230 having helical shape 470-474 for ingrowth ) with an analogous elongate conduit 12 comprising a helical sleeve 230 structure on the analogous elongate conduit 240.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify the elongate conduit of Cook in view of Jorgensen, so that there is a helical sleeve structure on the elongate conduit, as taught by Cates, in order to provide an improved implantable device with an enhanced elongate conduit that promotes tissue ingrowth and subsequent chronic fixation via the helical sleeve at the distal end (Cates, Paragraphs 65-67 and 69).
Claims 15 and 21 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Cook et al. (U.S. Patent No. 5964806) in view of Jorgensen (U.S. Patent Pub. No. 7022106), as applied to claim 2 and 18, respectively, and in further view of Hall et al. (U.S. Patent Pub. No. 20040186507).
Regarding claim 15, the combination of Cook in view of Jorgensen discloses the invention as described above but fails to explicitly disclose one or more hooks configured to fix the implantable device to the tissue adjacent the urethra.
An embodiment of Figures 13A-13B of Hall teaches an analogous implantable device 70 (Paragraph 84 and Figures 13A-13B, catheter 70 implanted in tissue lumen and anchored to tissue with first lumen 84 for balloon and second lumen 74 for anchoring) with one (this part of “or” statement is not being examined) 100 (Paragraph 84 and Figures 13A-13b, guidewire 100 in second lumen 74 anchors to tissue to anchor implantable catheter 70 and is located proximally to balloon 80) configured to fix the analogous implantable device70 to the similar tissue.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify a second inner lumen of the implantable device implanted adjacent the tissue of the urethra of Cook in view of Jorgensen, so that there is one hook configured to fix the implantable device to the tissue, as taught by the embodiment of Figures 13A-13B of Hall, in order to provide an improved implantable device with the second inner lumen having a proximal exit for an anchor to be recessed and deployed through during and after implantation positioning for implantation precisely at desirable tissue fixation locations nearby and proximal to the expandable balloon (Hall, Paragraph 84).
Regarding claim 21, the combination of Cook in view of Jorgensen discloses the invention as described above but fails to explicitly disclose further comprising reducing migration of the implantable device in the human by using one or more hooks of the implantable device.
An embodiment of Figures 13A-13B of Hall teaches an analogous implantable device 70 (Paragraph 84 and Figures 13A-13B, catheter 70 implanted in tissue lumen and anchored to tissue with first lumen 84 for balloon and second lumen 74 for anchoring) with reducing migration of the analogous implantable device 70 in the human by using one (this part of “or” statement is not being examined) 100 (Paragraph 84 and Figures 13A-13b, guidewire 100 in second lumen 74 anchors to tissue to anchor implantable catheter 70 and is located proximally to balloon 80) of the analogous implantable device 70.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify a second inner lumen of the implantable device implanted adjacent the tissue of the urethra of Cook in view of Jorgensen, so that reducing migration of the implantable device in the human by using one or more hooks of the implantable device, as taught by the embodiment of Figures 13A-13B of Hall, in order to provide an improved implantable device with the second inner lumen having a proximal exit for an anchor to be recessed and deployed through during and after implantation positioning for implantation precisely at desirable tissue fixation locations nearby and proximal to the expandable balloon (Hall, Paragraph 84).
Claims 15 and 17 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Cook et al. (U.S. Patent No. 5964806) in view of Jorgensen (U.S. Patent Pub. No. 7022106), as applied to claim 2, and in further view of Hall et al. (U.S. Patent Pub. No. 20040186507).
Regarding claim 15, the combination of Cook in view of Jorgensen discloses the invention as described above but fails to explicitly disclose one or more hooks configured to fix the implantable device to the tissue adjacent the urethra.
An embodiment of Figures 10-11 of Hall teaches an analogous implantable device 40 (Paragraph 80 and Figures 10-11, catheter 40 implanted in tissue lumen and anchored to tissue) with (this part of “or” statement is not being examined) 100 (Paragraphs 65, 76-77, 80, and Figure 11, plurality of anchor guidewires 100 that anchor catheter 40 into tissue that are positioned and recessed/deployed at distal tip exit 48 distally to balloon 52) positioned at an analogous distal tip 48 (Paragraphs 76-77 and Figure 11) configured to fix the analogous implantable device 40 to the similar tissue.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify a distal end of the implantable device implanted adjacent the tissue of the urethra of Cook in view of Jorgensen, so that there are hooks configured to fix the implantable device to the tissue, as taught by the embodiment of Figures 10-11 of Hall, in order to provide an improved implantable device with an enhanced distal tip exit for an anchor to be recessed and deployed through during and after implantation positioning for implantation precisely at desirable tissue fixation locations (Hall, Paragraph 80).
Regarding claim 17, the combination of Cook in view of Jorgensen in view of the embodiment of Figures 10-11 of Hall discloses the invention as described above and further discloses wherein the hooks 100 (Hall, Paragraphs 65, 76-77, 80, and Figure 11, plurality of anchor guidewires 100 that anchor catheter 40 into tissue that are positioned and recessed/deployed at distal tip exit 48 distally to balloon 52) comprise a plurality of hooks 100 (Hall, Paragraphs 65, 76-77, 80, and Figure 11) at a distal tip of the elongate conduit 36 (Cook, Col 8, Lines 40-50 and Figures 4-6).
Claim 16 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Cook et al. (U.S. Patent No. 5964806) in view of Jorgensen (U.S. Patent Pub. No. 7022106) in view of Hall et al. (U.S. Patent Pub. No. 20040186507), as applied to claim 15, and in further view of Cates et al. (U.S. Patent Pub. No. 20040230282) and Miller (U.S. Patent Pub. No. 20070270890).
Regarding claim 16, the combination of Cook in view of Jorgensen in view of the embodiment of Figure 13 of Hall discloses the invention as described above and further discloses wherein the elongate conduit 36 (Cook, Col 8, Lines 40-50 and Figures 4-6) comprises a second lumen 54 (Cook, Col 8, Lines 64-65, second interior passageway 54 at distal portion), and the one (Paragraph 84 and Figures 13A-13b, guidewire 100 in second lumen 84 anchors to tissue to anchor implantable catheter 70 and is located proximally to balloon 80) configured to be deployed by through the second lumen.
However, the combination of Cook in view of Jorgensen in view of the embodiment of Figure 13 of Hall fails to explicitly disclose (1) the hook is a nitinol hook; (2) the hook being threaded through the second lumen.
Cates teaches an analogous implantable device 200 (Paragraph 89 and Figure 11, implantable transthoracic cardiac monitoring and/or stimulation system 200) wherein an analogous hook (Paragraph 89, helical coil 260) comprises a nitinol hook (Paragraph 99, coil 260 is manufactured using a shape memory alloy such as, for example, Nitinol, such that coil 260 has a first, non-penetrating shape, when being advanced through the dissection path. Upon being subjected to body temperature or artificially heated, coil 260 returns to a shape such as described above to affect fixation).
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify a material of each of the hook of Cook in view of Jorgensen in view of the embodiment of Figure 13 of Hall, so that the hook comprises a nitinol hook, as taught by Cates, in order to provide an improved implantable device with an enhanced hook able to return to a shape to affect fixation upon being subjected to body temperature for further improvement in anchoring the implantable device (Cates, Paragraph 99).
However, the combination of Cook in view of Jorgensen in view of the embodiment of Figure 13 of Hall in view of Cates fails to explicitly disclose (2) the hook being threaded through the second lumen.
Miller teaches an analogous implantable device 30 (Paragraph 36 and Figure 3A, implant device 30) with the analogous hook 82A,84A (Paragraph 36 and Figure 3A, slidably threading retraction line 82a connected with needle carrier hook 84A through inner lumen 56A) being threaded through the analogous inner lumen 56A.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify the hook through the second lumen of Cook in view of Jorgensen in view of the embodiment of Figure 13 of Hall in view of Cates, so that the the hook is threaded through the lumen, as taught by Miller, in order to provide an improved implantable device with an enhanced hook with a threading of the hook (Miller, Paragraph 36). Thereby, allowing for increased accurate incremental threading motion of the deployable hooks.
Claim 20 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Cook et al. (U.S. Patent No. 5964806) in view of Reifart et al. (U.S. Patent Pub. No. 20060129178), as applied to claim 18, and in further view of Hall et al. (U.S. Patent Pub. No. 20040186507).
Regarding claim 20, the combination of Cook in view of Reifart discloses the invention as described above and further discloses wherein the elongate conduit 36 (Cook, Col 8, Lines 56-62) comprises an additional lumen54 (Cook, Col 8, Lines 64-65, second interior passageway 54 at distal portion) configured to accommodate a tool 17 (Cook, Col. 12, lines 15-17, obturator 17 within second lumen) configured to place the implantable device (Cook, Col 8, Lines 40-50 and Figures 4-6) in position during implantation of the implantable device and using the 26,50 (Reifart, Paragraphs 33, 40-41 and Figures 1-2, implantable device 10 with elongate conduit 12 having a first lumen 16 for filling balloon 20, second lumen 14 with stiffener 26 therein, and third lumen 18 with stiffener 50 therein that extend to distal balloon section 20).
However, the combination of Cook in view of Reifart fails to explicitly disclose placing the stiffener after the implantable device is placed in position.
An embodiment of Figures 10-11 of Hall teaches an analogous implantable device 40 Paragraphs 65, 68, 76-77, 80and Figures 10-11, catheter 40 implanted in tissue lumen and anchored to tissue with guidewire 100 through inner lumen and directly into tissue myocardium after the catheter 40 has already been placed in position adjacent the tissue; Examiner notes that a guidewire material provides inherent increased stiffness to the lumen) with placing an analogous stiffener 100 after the analogous implantable device40 is placed in position.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify the stiffener of Cook in view of Reifart, so that the stiffener is placed after the implantable device is placed in position, as taught by the embodiment of Figures 10-11 Hall, in order to provide an improved implantable device with an enhanced stiffener that is inserted after implantation when the elongate conduit is already adjacent the target tissue site for desirable control and stability (Hall, Paragraphs 65, 68, 76-77, and 80).
Conclusion
21. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
O’Donnell (US 20070043255 A1) teaches an implantable device for treating pelvic prolapse with an elongated conduit 9 and hooks 6,42 at a distal tip 41 for fixation to tissue adjacent the urethra.
Conclusion
22. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael Milo whose telephone number is (571)272-6476. The examiner can normally be reached on Mon-Fri 7:00-5:00.
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/MICHAEL MILO/
Art Unit 3786
/ALIREZA NIA/Supervisory Patent Examiner, Art Unit 3786