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 .
Priority
Priority for this application is claimed as far back as the provisional application 62/924,326 on 10/22/2019. However, the limitation of “a positioning member mounted on said elongated suction tube at a predetermined position with respect to said distal end, said positioning member engaging said cover at a predetermined position whereupon said single opening of said elongated suction tube is held at said predetermined distance from said interior point of said elongated bore” appears to be new matter with respect to said provisional application, as well as most of the CIP and DIV parent applications. As there appears to be support in the CIP of application # 18/074,714 for the limitation, claims 1 and 11, and their dependent claims will be treated with priority leading to said application’s filing date of 05/23/2022.
Moreover, claims 2 and 12 further describe the positioning member in a manner that is not supported by application # 18/074,714, as well as none of the parent applications, namely the positioning member being a retention clip with a piercing projection. Therefore, claims 2 and 12, as well as their dependents 3-6 and 13-14 will be treated with the priority of the effective filing date of the instant application on 01/27/2025.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 8, 11, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Sanchez (US 20170266031) in view Van Den Heuvel (US 20080287894), and further in view of Moulden (US 20150088068), Denton (US 20100094173), and Kuntz (US 4747166).
Regarding claim 1, Sanchez, discloses an external catheter configured for external disposition in fluid communication with a urethra opening of the female (abstract), whereupon urine voided by the female is received by said external catheter (paragraph 0076), said external catheter comprising:
a cover formed of a liquid permeable material (fig. 32, permeable membrane 1630), said cover being a self-supporting elongated member having a proximal end, a distal end and an elongated bore extending from an entryway opening at said proximal end to an interior point adjacent said distal end of said cover (fig. 32, permeable membrane 1630 has an opening at a proximal end and a distal end, wherein a bore extends from the proximal end to the distal end, including an interior point adjacent said distal end);
an elongated suction tube (1621) having a proximal end, a distal end, and a central passageway extending between said proximal end of said elongated suction tube and said distal end of said elongated suction tube (fig. 32, tube 1621 with an internal lumen), said proximal end of said elongated suction tube being configured to be coupled to a source of suction (fig. 1 demonstrates the general assembly including a vacuum source 170), said distal end of said elongated suction tube having a single opening (fig. 32, tube 1621 has a single opening, also demonstrated in embodiment in fig. 34 with tube 1821), said elongated suction tube being flexible and being configured to be introduced through said entryway opening for disposition within said bore of said cover (fig. 32, tube 1621 inside elongated bore of permeable membrane 1630),
Sanchez does not teach whereupon said single opening is located a predetermined distance from said interior point to result in a hollow chamber of a predetermined length within said cover, said hollow chamber being contiguous with said single opening and in fluid communication therewith, whereupon regulated suction from the suction source applied through said central passageway of said elongated suction tube to said chamber draws urine voided by the female through said cover into said chamber and from there through said elongated suction tube out of said proximal end of said suction tube for collection;
a malleable wire extending along at least a portion of said elongated suction tube, said malleable wire being configured to be bent to enable said external catheter to be configured to a desired shape for comfortable disposition adjacent the urethra opening of the female; and
a positioning member mounted on said elongated suction tube at a predetermined position with respect to said distal end, said positioning member engaging said cover at a predetermined position whereupon said single opening of said elongated suction tube is held at said predetermined distance from said interior point of said elongated bore.
However, Van Den Heuvel teaches a urine collecting device (abstract) wherein said single opening is located a predetermined distance from the distal end to result in a hollow chamber of a predetermined length (fig. 3, tapered end 4 leaves a hollow chamber of a length), said hollow chamber being contiguous with the single opening of the tube (fig. 3, hollow chamber of tapered end 4 contiguous with outlet tube 1), whereupon suction is applied through the central passageway of the elongated suction tube to said chamber draws urine through the cover into the chamber and from there through the suction tube for collection (fig. 3, tapered end 4 has fluid leave into urine outlet tube 1)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Sanchez such that said single opening is located a predetermined distance from said interior point to result in a hollow chamber of a predetermined length within said cover, said hollow chamber being contiguous with said single opening and in fluid communication therewith, whereupon suction from the suction source applied through said central passageway of said elongated suction tube to said chamber draws urine voided by the female through said cover into said chamber and from there through said elongated suction tube out of said proximal end of said suction tube for collection, as taught by Van Den Heuvel, for the purpose of providing a suitable means of channeling urine towards the chamber and avoiding leakage (see Van Den Heuvel, paragraph 0044).
Sanchez is silent to the utilization of regulated suction.
However, Moulden teaches wherein suction regulators are routinely used to regulate level of suction delivered from a central supply system to the patient (paragraph 0005).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Sanchez such that it utilizes regulated suction, as taught by Moulden, for the purpose of providing a means of regulating the level of suction delivered for patient safety (see Moulden, paragraph 0005).
Sanchez does not teach a malleable wire extending along at least a portion of said elongated suction tube, said malleable wire being configured to be bent to enable said external catheter to be configured to a desired shape for comfortable disposition adjacent the urethra opening of the female; and a positioning member mounted on said elongated suction tube at a predetermined position with respect to said distal end, said positioning member engaging said cover at a predetermined position whereupon said single opening of said elongated suction tube is held at said predetermined distance from said interior point of said elongated bore.
However, Denton teaches a drain catheter (abstract) with a malleable wire extending along at least a portion of the suction tube, said malleable wire being configured to be bent to enable the catheter to be configured to a desired shape for comfortable disposition as desired (paragraph 0048 describes a length of malleable wire associated with the drain conduit in a plastically deformable drain conduit)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Sanchez such that it includes a malleable wire extending along at least a portion of said elongated suction tube, said malleable wire being configured to be bent to enable said external catheter to be configured to a desired shape for comfortable disposition adjacent the urethra opening of the female, as taught by Denton, for the purpose of providing a suitable means of permitting shape adjustments to the conduit (see Denton, paragraph 0048).
Sanchez does not teach a positioning member mounted on said elongated suction tube at a predetermined position with respect to said distal end, said positioning member engaging said cover at a predetermined position whereupon said single opening of said elongated suction tube is held at said predetermined distance from said interior point of said elongated bore.
However, Kuntz teaches a urine drainage device (abstract) that comprises a positioning member (fig. 2, retaining ring 32) mounded on the suction tube at a predetermined position with respect to the distal end of the tube (fig. 2, retaining ring 32 positioned on the pad 12a), said positioning member engaging said cover at a predetermined position whereupon said single opening of said elongated suction tube is held at said predetermined distance from said interior point of said elongated bore (fig. 2, retaining ring 32 holds internal tube portion 30 at a predetermined position).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Sanchez such that it includes a positioning member mounted on said elongated suction tube at a predetermined position with respect to said distal end, said positioning member engaging said cover at a predetermined position whereupon said single opening of said elongated suction tube is held at said predetermined distance from said interior point of said elongated bore, as taught by Kuntz, for the purpose of providing a sealing effect so that air does not get past the tubing into the interior of the device (see Kuntz, col. 3, lines 58-68, and col. 4, lines 1-16).
Regarding claim 8, Sanchez discloses wherein said cover is formed of a sponge material (paragraph 0169, “The material can also have sponge-like properties such that the material can maintain shape when wet”).
Regarding claim 11, Sanchez discloses a method for automatically removing by suction urine voided by a female patient (abstract) comprising:
providing an external female catheter comprising a cover (fig. 32, permeable membrane 1630), an elongated suction tube (fig. 32, elongated suction tube 1621), said cover being formed of a liquid permeable material and being a self-supporting elongated member having a proximal end, a distal end and an elongated bore extending from an entryway opening at said proximal end to an interior point adjacent said distal end (fig. 32, permeable membrane 1630 has an opening at a proximal end and a distal end, wherein a bore extends from the proximal end to the distal end, including an interior point adjacent said distal end), said elongated suction tube having a proximal end, a distal end and a central passageway extending between said proximal end and said distal end (fig. 32, tube 1621 with an internal lumen with a proximal end and a distal end), said proximal end of said elongated suction tube being configured to be coupled to a source of suction (fig. 1 demonstrates the general assembly including a vacuum source 170), said distal end of said elongated suction tube having a single opening (fig. 32, tube 1621 has a single opening, also demonstrated in embodiment in fig. 34 with tube 1821),;
disposing said cover of said external catheter adjacent the urethra opening of the female (abstract); and
applying suction from a suction source through said elongated suction tube to said chamber to draw urine voided by the female through said cover (paragraph 0076) and from there through said elongated suction tube out of said proximal end of said suction tube for collection (paragraph 0076).
Sanchez does not teach a malleable wire and a positioning member, the elongated suction tube being flexible, said malleable wire extending along at least a portion of said elongated suction tube and being configured to be bent, said positioning member being mounted on said elongated suction tube at a predetermined position with respect to said distal end of said elongated suction tube, said elongated suction tube with said positioning member mounted thereon extending through said entryway opening for disposition within said bore of said cover, whereupon said single opening is located a predetermined distance from said interior point to result in a hollow chamber of a predetermined length within said cover, said hollow chamber being contiguous with said single opening and in fluid communication therewith, bending said malleable wire to configure said external catheter to a desired shape for comfortable disposition adjacent the urethra opening of the female wherein the suction is regulated suction, and wherein urine is drawn through the cover into said chamber.
However, Van Den Heuvel teaches a urine collecting device (abstract) wherein said single opening is located a predetermined distance from the distal end to result in a hollow chamber of a predetermined length (fig. 3, tapered end 4 leaves a hollow chamber of a length), said hollow chamber being contiguous with the single opening of the tube (fig. 3, hollow chamber of tapered end 4 contiguous with outlet tube 1), whereupon suction is applied through the central passageway of the elongated suction tube to said chamber draws urine through the cover into the chamber and from there through the suction tube for collection (fig. 3, tapered end 4 has fluid leave into urine outlet tube 1). Urine would then be drawn through the cover into the chamber (paragraph 0044).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed in Sanchez such that said single opening is located a predetermined distance from said interior point to result in a hollow chamber of a predetermined length within said cover, said hollow chamber being contiguous with said single opening and in fluid communication therewith, wherein urine is drawn through the cover into the chamber, as taught by Van Den Heuvel, for the purpose of providing a suitable means of channeling urine towards the chamber and avoiding leakage (see Van Den Heuvel, paragraph 0044).
Sanchez is silent to the utilization of regulated suction.
However, Moulden teaches wherein suction regulators are routinely used to regulate level of suction delivered from a central supply system to the patient (paragraph 0005).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed in Sanchez such that it utilizes regulated suction, as taught by Moulden, for the purpose of providing a means of regulating the level of suction delivered for patient safety (see Moulden, paragraph 0005).
Sanchez does not teach a malleable wire and a positioning member, the elongated suction tube being flexible, said malleable wire extending along at least a portion of said elongated suction tube and being configured to be bent, said positioning member being mounted on said elongated suction tube at a predetermined position with respect to said distal end of said elongated suction tube, said elongated suction tube with said positioning member mounted thereon extending through said entryway opening for disposition within said bore of said cover, bending said malleable wire to configure said external catheter to a desired shape for comfortable disposition adjacent the urethra opening of the female.
However, Denton teaches a drain catheter (abstract) with a malleable wire extending along at least a portion of the suction tube, said malleable wire being configured to be bent to enable the catheter to be configured to a desired shape for comfortable disposition as desired (paragraph 0048 describes a length of malleable wire associated with the drain conduit in a plastically deformable drain conduit).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed in Sanchez such that it comprises a malleable wire, said malleable wire extending along at least a portion of said elongated suction tube and being configured to be bent, and bending said malleable wire to configure said external catheter to a desired shape for comfortable disposition adjacent the urethra opening of the female, as taught by Denton, for the purpose of providing a suitable means of permitting shape adjustments to the conduit (see Denton, paragraph 0048).
Sanchez does not teach a positioning member, said positioning member being mounted on said elongated suction tube at a predetermined position with respect to said distal end of said elongated suction tube, said elongated suction tube with said positioning member mounted thereon extending through said entryway opening for disposition within said bore of said cover.
However, Kuntz teaches a urine drainage device (abstract) that comprises a positioning member (fig. 2, retaining ring 32) mounded on the suction tube at a predetermined position with respect to the distal end of the tube (fig. 2, retaining ring 32 positioned on the pad 12a), said positioning member engaging said cover at a predetermined position whereupon said single opening of said elongated suction tube is held at said predetermined distance from said interior point of said elongated bore (fig. 2, retaining ring 32 holds internal tube portion 30 at a predetermined position).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method discloses in Sanchez such that it comprises a positioning member, said positioning member being mounted on said elongated suction tube at a predetermined position with respect to said distal end of said elongated suction tube, said elongated suction tube with said positioning member mounted thereon extending through said entryway opening for disposition within said bore of said cover, as taught by Kuntz, for the purpose of providing a sealing effect so that air does not get past the tubing into the interior of the device (see Kuntz, col. 3, lines 58-68, and col. 4, lines 1-16).
Regarding claim 17, Sanchez discloses wherein said cover is formed of a sponge material (paragraph 0169, “The material can also have sponge-like properties such that the material can maintain shape when wet”).
Claims 2 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Sanchez in view of Van Den Heuvel, Moulden, Denton, and Kuntz, and further in view of Darling (US 3572340).
Regarding claim 2, Sanchez, as modified by Kuntz, discloses wherein said positioning member comprises a retention clip (see Kuntz, fig. 2, retaining ring 30) including an interior surface configured for engaging an outer surface portion of said elongated suction tube (fig. 2, retaining ring 30, by virtue of being a ring, has an interior surface to engage with the suction tube) to secure said retention clip thereon (fig. 2, retaining ring 32 secured to tubing), but does not teach wherein said retention clip also comprising at least one piercing projection for engaging a portion of said cover to preclude said cover from movement with respect to said elongated suction tube.
However, Darling teaches wherein a connection to the foam pad can be made by utilizing pointed projections to puncture the foam pad (col. 8, lines 64-75).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Sanchez in view of Kuntz such that said retention clip also comprising at least one piercing projection for engaging a portion of said cover to preclude said cover from movement with respect to said elongated suction tube, as taught by Darling, for the purpose of providing a suitable structure that assists in securing the retention clip to the foam pad (see Darling, col. 8, lines 64-75).
Regarding claim 12, Sanchez, as modified by Kuntz, discloses wherein said positioning member comprises a retention clip (see Kuntz, fig. 2, retaining ring 30) including an interior surface configured for engaging an outer surface portion of said elongated suction tube (fig. 2, retaining ring 30, by virtue of being a ring, has an interior surface to engage with the suction tube) to secure said retention clip thereon (fig. 2, retaining ring 32 secured to tubing), but does not teach wherein said retention clip also comprising at least one piercing projection for engaging a portion of said cover to preclude said cover from movement with respect to said elongated suction tube.
However, Darling teaches wherein a connection to the foam pad can be made by utilizing pointed projections to puncture the foam pad (col. 8, lines 64-75).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Sanchez in view of Kuntz such that said retention clip also comprising at least one piercing projection for engaging a portion of said cover to preclude said cover from movement with respect to said elongated suction tube, as taught by Darling, for the purpose of providing a suitable structure that assists in securing the retention clip to the foam pad (see Darling, col. 8, lines 64-75).
Claims 3-4 and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Sanchez in view of Van Den Heuvel, Moulden, Denton, Kuntz, and Darling, and further in view of Dong (US 20210205589).
Regarding claim 3, Sanchez does not teach wherein said elongated suction tube is a corrugated member including plural sequentially spaced corrugations separated by respectively spaced intermediate recesses, and wherein said retention clip is configured to be mounted contiguous with a preselected one of said corrugations.
However, Dong teaches wherein said elongated suction tube is a corrugated member including plural sequentially spaced corrugations separated by respectively spaced intermediate recesses (fig. 3a, wall 101 of catheter 100 shown as corrugated with corrugations and recesses in between) and wherein said retention clip is configured to be mounted contiguous with a preselected one of said corrugations (fig. 3A, fixator 200 contiguous with one of the corrugations).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Sanchez such that said elongated suction tube is a corrugated member including plural sequentially spaced corrugations separated by respectively spaced intermediate recesses, and wherein said retention clip is configured to be mounted contiguous with a preselected one of said corrugations, as taught by Dong, for the purpose of providing a suitable means of allowing the adaptor to better attach to the tubing with corresponding notches or corrugations (see Dong, paragraph 0118, “said elongated suction tube is a corrugated member including plural sequentially spaced corrugations separated by respectively spaced intermediate recesses, and wherein said retention clip is configured to be mounted contiguous with a preselected one of said corrugations.”)
Regarding claim 4, Sanchez does not teach wherein said preselected one of said corrugations includes an external surface is of a predetermined annular shape, and wherein said interior surface of retention clip includes an annular recess and an annular ridge located immediately adjacent said annular recess, said annular recess of said retention clip being of a corresponding shape to said predetermined annular shape of said preselected one of said corrugations for receipt thereof, with said annular ridge of said retention clip being in engagement with an intermediate recess located immediately adjacent said preselected one of said corrugations.
However, Dong teaches wherein said preselected one of said corrugations includes an external surface is of a predetermined annular shape (fig. 1, corrugations in an annular shape), and wherein said interior surface of retention clip includes an annular recess and an annular ridge located immediately adjacent said annular recess (paragraph 0118, “the corrugations can engage with corresponding corrugations, notch or indentation on a fixator to limit axial movement of the catheter with respect to that fixator”), said annular recess of said retention clip being of a corresponding shape to said predetermined annular shape of said preselected one of said corrugations for receipt thereof (paragraph 0118), with said annular ridge of said retention clip being in engagement with an intermediate recess located immediately adjacent said preselected one of said corrugations (paragraph 0118).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Sanchez such that said preselected one of said corrugations includes an external surface is of a predetermined annular shape, and wherein said interior surface of retention clip includes an annular recess and an annular ridge located immediately adjacent said annular recess, said annular recess of said retention clip being of a corresponding shape to said predetermined annular shape of said preselected one of said corrugations for receipt thereof, with said annular ridge of said retention clip being in engagement with an intermediate recess located immediately adjacent said preselected one of said corrugations, as taught by Dong, for the purpose of providing a suitable means of allowing the adaptor to better attach to the tubing with corresponding notches or corrugations (see Dong, paragraph 0118, “said elongated suction tube is a corrugated member including plural sequentially spaced corrugations separated by respectively spaced intermediate recesses, and wherein said retention clip is configured to be mounted contiguous with a preselected one of said corrugations.”).
Regarding claim 13, Sanchez does not teach wherein said elongated suction tube is a corrugated member including plural sequentially spaced corrugations separated by respectively spaced intermediate recesses, and wherein said retention clip is configured to be mounted contiguous with a preselected one of said corrugations.
However, Dong teaches wherein said elongated suction tube is a corrugated member including plural sequentially spaced corrugations separated by respectively spaced intermediate recesses (fig. 3a, wall 101 of catheter 100 shown as corrugated with corrugations and recesses in between) and wherein said retention clip is configured to be mounted contiguous with a preselected one of said corrugations (fig. 3A, fixator 200 contiguous with one of the corrugations).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Sanchez such that said elongated suction tube is a corrugated member including plural sequentially spaced corrugations separated by respectively spaced intermediate recesses, and wherein said retention clip is configured to be mounted contiguous with a preselected one of said corrugations, as taught by Dong, for the purpose of providing a suitable means of allowing the adaptor to better attach to the tubing with corresponding notches or corrugations (see Dong, paragraph 0118, “said elongated suction tube is a corrugated member including plural sequentially spaced corrugations separated by respectively spaced intermediate recesses, and wherein said retention clip is configured to be mounted contiguous with a preselected one of said corrugations.”)
Regarding claim 14, Sanchez does not teach wherein said preselected one of said corrugations includes an external surface is of a predetermined annular shape, and wherein said interior surface of retention clip includes an annular recess and an annular ridge located immediately adjacent said annular recess, said annular recess of said retention clip being of a corresponding shape to said predetermined annular shape of said preselected one of said corrugations for receipt thereof, with said annular ridge of said retention clip being in engagement with an intermediate recess located immediately adjacent said preselected one of said corrugations.
However, Dong teaches wherein said preselected one of said corrugations includes an external surface is of a predetermined annular shape (fig. 1, corrugations in an annular shape), and wherein said interior surface of retention clip includes an annular recess and an annular ridge located immediately adjacent said annular recess (paragraph 0118, “the corrugations can engage with corresponding corrugations, notch or indentation on a fixator to limit axial movement of the catheter with respect to that fixator”), said annular recess of said retention clip being of a corresponding shape to said predetermined annular shape of said preselected one of said corrugations for receipt thereof (paragraph 0118), with said annular ridge of said retention clip being in engagement with an intermediate recess located immediately adjacent said preselected one of said corrugations (paragraph 0118).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Sanchez such that said preselected one of said corrugations includes an external surface is of a predetermined annular shape, and wherein said interior surface of retention clip includes an annular recess and an annular ridge located immediately adjacent said annular recess, said annular recess of said retention clip being of a corresponding shape to said predetermined annular shape of said preselected one of said corrugations for receipt thereof, with said annular ridge of said retention clip being in engagement with an intermediate recess located immediately adjacent said preselected one of said corrugations, as taught by Dong, for the purpose of providing a suitable means of allowing the adaptor to better attach to the tubing with corresponding notches or corrugations (see Dong, paragraph 0118, “said elongated suction tube is a corrugated member including plural sequentially spaced corrugations separated by respectively spaced intermediate recesses, and wherein said retention clip is configured to be mounted contiguous with a preselected one of said corrugations.”).
Claims 5-6 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Sanchez in view of Van Den Heuvel, Moulden, Denton, and Kuntz Darling, and Dong, and further in view of Schervinsky (US 20040006311).
Regarding claim 5, Sanchez, as modified by Dong, does not teach wherein said malleable wire is located within said central passageway and comprises an elongated member having a proximal end and a distal end, said proximal end of said malleable wire being configured to be located within a predetermined one of said corrugations whereupon said distal end of said malleable wire is located adjacent said single opening.
However, Denton teaches wherein a length of malleable wire to hold the shape of the catheter may be associated with the drain conduit (paragraph 0048). Moreover, because the malleable wire is within the catheter tubing, said proximal end of said malleable wire would be configured to be located within a predetermined one of said corrugations.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Sanchez in view of Dong such that said malleable wire is located within said central passageway and comprises an elongated member having a proximal end and a distal end, said proximal end of said malleable wire being configured to be located within a predetermined one of said corrugations, as taught by Denton, for the purpose of providing a suitable means of permitting shape adjustments to the conduit (see Denton, paragraph 0048).
Sanchez, as modified by Denton, is silent to wherein said distal end of the malleable wire is located adjacent said single opening.
However, Schervinsky teaches a drain catheter (abstract) wherein a malleable wire extends substantially the entire length of the tube (fig. 4 shows a constraint wire 490 that is attached from the proximal end of the drain to the distal end, paragraph 0095)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Sanchez in view of Denton such that said distal end of the malleable wire is located adjacent said single opening, as taught by Schervinsky, for the purpose of providing a suitable structure that would grant the benefit of the wire across most of the length of the tubing.
Regarding claim 6, Sanchez, as modified by Denton, is silent to wherein said distal end of said malleable wire is in the form of a rounded bend, and wherein said proximal end of said malleable wire is in the form of a rounded bend.
However, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Sanchez in view of Denton such that said distal end of said malleable wire is in the form of a rounded bend, and wherein said proximal end of said malleable wire is in the form of a rounded bend, since it has been held that a mere change in shape without persuasive evidence that the changed chape would be significant would be obvious (see MPEP 2144.04(IV)(B)).
Regarding claim 16, Sanchez, as modified by Denton, is silent to wherein said malleable wire includes a proximal end and a distal end, and wherein said proximal end of said malleable wire is in the form of a rounded bend, and wherein said distal end of said malleable wire is in the form of a rounded bend.
However, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed in Sanchez in view of Denton such that said malleable wire includes a proximal end and a distal end, and wherein said proximal end of said malleable wire is in the form of a rounded bend, and wherein said distal end of said malleable wire is in the form of a rounded bend, since it has been held that a mere change in shape without persuasive evidence that the changed chape would be significant would be obvious (see MPEP 2144.04(IV)(B)).
Claims 7 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Sanchez in view of Van Den Heuvel, Moulden, Denton, and Kuntz, and further in view of Scanlon (US 20070207186).
Regarding claim 7, Sanchez does not teach wherein said malleable wire is located within said central passageway of said elongated suction tube, and wherein said elongated suction tube is opaque so that said malleable wire is not visible through said elongated suction tube.
However, Denton teaches wherein the malleable wire is located within the passageway of the suction tube (paragraph 0048 describes a length of malleable wire associated with the drain conduit in a plastically deformable drain conduit).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Sanchez such that said malleable wire is located within said central passageway of said elongated suction tube, and wherein said elongated suction tube is opaque so that said malleable wire is not visible through said elongated suction tube, as taught
Sancehz, as modified by Denton, is silent to wherein the elongated suction tube is opaque so that said malleable wire is not visible through said elongated suction tube.
However, Scanlon teaches a material that is usable in catheters (paragraph 0161) that can be completely opaque, translucent, or transparent (paragraph 0147).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Sanchez in view of Denton such that elongated suction tube is opaque so that said malleable wire is not visible through said elongated suction tube, as taught by Scanlon, as it appears that opaque, translucent, and transparent materials for catheters are equivalents known in the art (see Scanlon, paragraph 0147).
Regarding claim 15, Sanchez does not teach wherein said malleable wire is located within said central passageway of said elongated suction tube, and wherein said elongated suction tube is opaque so that said malleable wire is not visible through said elongated suction tube.
However, Denton teaches wherein the malleable wire is located within the passageway of the suction tube (paragraph 0048 describes a length of malleable wire associated with the drain conduit in a plastically deformable drain conduit).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Sanchez such that said malleable wire is located within said central passageway of said elongated suction tube, and wherein said elongated suction tube is opaque so that said malleable wire is not visible through said elongated suction tube, as taught
Sancehz, as modified by Denton, is silent to wherein the elongated suction tube is opaque so that said malleable wire is not visible through said elongated suction tube.
However, Scanlon teaches a material that is usable in catheters (paragraph 0161) that can be completely opaque, translucent, or transparent (paragraph 0147).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Sanchez in view of Denton such that elongated suction tube is opaque so that said malleable wire is not visible through said elongated suction tube, as taught by Scanlon, as it appears that opaque, translucent, and transparent materials for catheters are equivalents known in the art (see Scanlon, paragraph 0147).
Claims 9-10 and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Sanchez in view of Van Den Heuvel, Moulden, Denton, and Kuntz, and further in view of Davis (US 5429620).
Regarding claim 9, Sanchez does not teach wherein said proximal end of said elongated suction tube comprises a connector including a sidewall having an external surface that tapers towards said proximal end of said elongated suction tube.
However, Davis teaches a means of connection (106) that has a sidewall having an external surface that tapers towards the respective tubing (fig. 9, coupling 146 connecting to drainage tube 10 in a tapered manner).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Sanchez such that said proximal end of said elongated suction tube comprises a connector including a sidewall having an external surface that tapers towards said proximal end of said elongated suction tube, as taught by Davis, for the purpose of preventing leakage or separation under normal circumstances (see Davis, col. 3, lines 1-7).
Regarding claim 10, Sanchez does not teach wherein said connector includes at least one annular ridge extending about said external surface of said sidewall.
However, Davis teaches at least one annular ridge extending about said external surface of said sidewall (fig. 9, coupling 146 has multiple annular ridges)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Sanchez such that said connector includes at least one annular ridge extending about said external surface of said sidewall, as taught by Davis, for the purpose of preventing leakage or separation under normal circumstances (see Davis, col. 3, lines 1-7).
Regarding claim 18, Sanchez does not teach wherein said proximal end of said elongated suction tube comprises a connector including a sidewall having an external surface that tapers towards said proximal end of said elongated suction tube.
However, Davis teaches a means of connection (106) that has a sidewall having an external surface that tapers towards the respective tubing (fig. 9, coupling 146 connecting to drainage tube 10 in a tapered manner).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Sanchez such that said proximal end of said elongated suction tube comprises a connector including a sidewall having an external surface that tapers towards said proximal end of said elongated suction tube, as taught by Davis, for the purpose of preventing leakage or separation under normal circumstances (see Davis, col. 3, lines 1-7).
Regarding claim 19, Sanchez does not teach wherein said connector includes at least one annular ridge extending about said external surface of said sidewall.
However, Davis teaches at least one annular ridge extending about said external surface of said sidewall (fig. 9, coupling 146 has multiple annular ridges)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Sanchez such that said connector includes at least one annular ridge extending about said external surface of said sidewall, as taught by Davis, for the purpose of preventing leakage or separation under normal circumstances (see Davis, col. 3, lines 1-7).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Bell (US 4840625) teaches a tapering connector with annular ridges.
Tokartz (US 4681572) teaches a female urinary incontinence device
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/Brandon W. Levy/Examiner, Art Unit 3781
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