DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claims 6 and 15 are objected to because the limitation “wherein suction lumen” should read “wherein the suction lumen”.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-3 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Radl et al (US 2021/0113749) in view of Horgan et al (US 2016/0143739).
Regarding Claim 1, Radl discloses a suction tube assembly (122A, Figs. 17-20) for use in a device for collecting urine (120, Fig. 17; ¶ [0071]) comprising:
an elongated shape retention element (malleable wire 130, Figs. 19-20; ¶ [0072, 0078]); and
a suction tube body (multi-slot end piece 128, Figs. 17-20) having a suction lumen (slots 134A-D, Figs. 19-20; ¶ [0075-0077]) providing a suction path from a first end thereof to a second end thereof (¶ [0075-0077]), and a second shape retention lumen (central passageway 136, Figs. 19-20) receiving the elongated shape retention element (130, Figs. 19-20; ¶ [0078]) therein.
Radl is silent whether the elongated shape retention element has rounded terminal ends.
Horgan teaches a medical device using shape memory, thus directed to the same field of problem solving of providing a shape retention element in a medical device without harming the patient, where the elongated shape retention element (128, Fig. 13) has rounded terminal ends (¶ [0155]) to prevent damage to the patient by having the edges rounded rather than sharp (¶ [0154-0155]).
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 elongated shape retention element of Radl to have rounded terminal ends, as taught by Horgan, to prevent damage to the patient by having the edges rounded rather than sharp (as motivated by Horgan ¶ [0154-0155]), as sharp edges of the shape retention element of Radl may pierce through the suction device and then injure the patient but rounded edges would be less likely to pierce through the device or the patient.
Regarding Claim 2, Radl further discloses the shape retention element (130, Figs. 19-20) is formed with a predefined curvature (¶ [0078]; even if the device is formed completely straight and bent by the end user, the predefined curvature in that instance would be no curvature).
Regarding Claim 3, Radl further discloses the shape retention element (130, Figs. 19-20) comprises a ductile metal and is bendable to a predefined shape (¶ [0078]; even if the device is formed completely straight and bent by the end user, the predefined curvature in that instance would be no curvature).
Regarding Claim 5, Radl further discloses the suction tube body (128, Figs. 19-20) is generally cylindrical.
Claim(s) 4 and 10-14 are rejected under 35 U.S.C. 103 as being unpatentable over Radl et al (US 2021/0113749) in view of Meyer et al (US 2022/0117774) further in view of Horgan et al (US 2016/0143739).
Regarding Claim 4, Radl/Horgan is silent whether the shape retention element has embossed features on at least a portion of an external surface.
Meyer teaches a urine collection device, thus being in the same field of endeavor, with a shape retention element (shape memory material 614c, Fig. 6c) with embossed features (at least one narrowed region 648, Fig. 6c; ¶ [0098]) on at least a portion of an external surface to facilitate manufacturing of the urine collection device (¶ [0097-0098]).
Therefore, it would have been obvious to modify the shape retention element of Radl/Horgan to have embossed features on at least a portion of an external surface, as taught by Meyer, to facilitate manufacturing of the urine collection device (as motivated by Meyer ¶ [0097-0098]).
Regarding Claim 10, Radl discloses a device for collecting urine (120, Figs. 17-20; ¶ [0071]) comprising:
a tubular fluid permeable core having a cylindrical external surface (liquid permeable cover 122B, Figs. 17-20); and
a suction tube assembly (124, Figs. 17-20) extending through an interior of the core assembly (122B, Figs. 17-20) and having a first end disposed inside the core assembly (122B, Figs. 17-20) and a second end (124B, Figs. 17-20) exiting the core assembly (122B, Figs. 17-20), the suction tube assembly (124, Figs. 17-20) comprising:
an elongated shape retention element (malleable wire 130, Figs. 19-20; ¶ [0072, 0078]); and
a suction tube body (multi-slot end piece 128, Figs. 17-20) having a suction lumen (slots 134A-D, Figs. 19-20; ¶ [0075-0077]) providing a suction path from a first end thereof to a second end thereof (¶ [0075-0077]), and a second shape retention lumen (central passageway 136, Figs. 19-20) receiving the elongated shape retention element (130, Figs. 19-20; ¶ [0078]) therein.
Radl is silent whether the device comprises a permeable fluid core assembly comprising a fluid permeable wicking cover disposed on the external surface of the tubular fluid permeable core, an elongated, capsular-shaped, fluid impermeable housing having a reservoir at a lower end, an outlet port at an upper end, and an elongated window extending at least partially between the lower end and the upper end, the core assembly received within the housing such that the core assembly is disposed within an extends across the elongated window, and wherein the suction tube assembly extends through the interior of the core assembly and having a first end disposed in the reservoir and a second end exiting the housing through the outlet port, and wherein the elongated shape retention element has rounded terminal ends.
Meyer teaches a urine collection device, thus being in the same field of endeavor, with a permeable fluid core assembly (porous material 110, Fig. 1C) comprising a tubular fluid permeable core (fluid permeable support 122, Fig. 1C) having a cylindrical external surface (Figs. 1C-1D) and a fluid permeable wicking cover (fluid permeable membrane 120, Fig. 1C; ¶ [0041]) disposed on the external surface of the tubular fluid permeable core (122, Figs. 1C-1D); an elongated, capsular-shaped, fluid impermeable housing (102, Figs. 1A-1C) having a reservoir (124, Fig. 1C) at a lower end (126, Fig. 1C), an outlet port (108, Fig. 1C) at an upper end (128, Fig. 1C), and an elongated window (opening 106, Figs. 1A-1C) extending at least partially between the lower end (126, Fig. 1C) and the upper end (128, Fig. 1C) such that the core assembly (110, Fig. 1C) is disposed within and extends across the elongated window (106, Fig. 1C); and a suction tube assembly (112, Figs. 1A-1C) extending through an interior of the core assembly (110, Figs. 1C) and having a first end (130, Fig. 1C) disposed in the reservoir (124, Fig. 1C) and a second end exiting the housing (102, Fig. 1C) through the outlet port (108, Fig. 1C). This structure allows the device to be comfortably used with a female patient while minimizing leaks and skin discomfort (¶ [0026-0029]).
Therefore, it would have been obvious to modify the device of Radl to have a fluid permeable wicking cover disposed on the external surface of the tubular fluid permeable core, an elongated, capsular-shaped fluid impermeable housing having a reservoir at a lower end, an outlet port at an upper end, and an elongated window extending at least partially between the lower end and the upper end, the core assembly received within the housing such that the core assembly is disposed within and extends across the elongated window, as taught by Meyer, which allows the device to be comfortably used with a female patient while minimizing leaks and skin discomfort (¶ [0026-0029]). The combination of Radl/Meyer will have the suction tube assembly extending through the interior of the core assembly and having a first end disposed in the reservoir and a second end exiting the housing through the outlet port.
Radl/Meyer is silent whether the elongated shape retention element has rounded terminal ends.
Horgan teaches a medical device using shape memory where the elongated shape retention element (128, Fig. 13) has rounded terminal ends (¶ [0155]) to prevent damage to the patient by having the edges rounded rather than sharp (¶ [0154-0155]).
Therefore, it would have been obvious to modify the elongated shape retention element of Radl/Meyer to have rounded terminal ends, as taught by Horgan, to prevent damage to the patient by having the edges rounded rather than sharp (as motivated by Horgan ¶ [0154-0155]), as sharp edges of the shape retention element of Radl/Meyer may pierce through the suction device and then injure the patient but rounded edges would be less likely to pierce through the device or the patient.
Regarding Claim 11, Radl further discloses the shape retention element (130, Figs. 19-20) is formed with a predefined curvature (¶ [0078]; even if the device is formed completely straight and bent by the end user, the predefined curvature in that instance would be no curvature).
Regarding Claim 12, Radl further discloses the shape retention element (130, Figs. 19-20) comprises a ductile metal and is bendable to a predefined shape (¶ [0078]; even if the device is formed completely straight and bent by the end user, the predefined curvature in that instance would be no curvature).
Regarding Claim 13, Radl/Meyer/Horgan is silent whether the shape retention element has embossed features on at least a portion of an external surface.
Meyer teaches a urine collection device with a shape retention element (shape memory material 614c, Fig. 6c) with embossed features (at least one narrowed region 648, Fig. 6c; ¶ [0098]) on at least a portion of an external surface to facilitate manufacturing of the urine collection device (¶ [0097-0098]).
Therefore, it would have been obvious to modify the shape retention element of Radl/Meyer/Horgan to have embossed features on at least a portion of an external surface, as taught by Meyer, to facilitate manufacturing of the urine collection device (as motivated by Meyer ¶ [0097-0098]).
Regarding Claim 14, Radl further discloses the suction tube body (128, Figs. 19-20) is generally cylindrical.
Claim(s) 6-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Radl et al (US 2021/0113749) in view of Horgan et al (US 2016/0143739) further in view of Sklar et al (US 2007/0249999).
Regarding Claim 6, Radl/Horgan is silent whether the suction tube body has a D-shaped cross-section with a planar surface and a rounded surface, wherein suction lumen is oriented adjacent the planar surface and wherein the shape retention lumen is oriented adjacent the rounded surface.
Sklar teaches a multi-lumen catheter, thus being in the same field of endeavor, where the suction tube body (2110, Fig. 21) has a D-shaped cross-section (see Fig. 21; ¶ [0159]) with a planar surface and a rounded surface (see Fig. 21), wherein the suction lumen (lumen accepting catheter 2120, Fig. 21) is oriented adjacent the planar surface and wherein the shape retention lumen (lumens accepting steering wires 2140, Fig. 21) is oriented adjacent the rounded surface. This structure allows the central lumen to be fluidly connected to the underlying tissue over a significant surface area (¶ [0159]).
Therefore, it would have been obvious to modify the suction tube body of Radl/Horgan to have a D-shaped cross-section with a planar surface and a rounded surface, wherein the suction lumen is oriented adjacent the planar surface and wherein the shape retention lumen is oriented adjacent the rounded surface, as taught by Sklar. This structure allows the central lumen to be fluidly connected to the underlying tissue over a significant surface area (as motivated by Sklar ¶ [0159]).
Regarding Claim 7, Radl further discloses the shape retention element (130, Figs. 19-20) is formed with a predefined curvature (¶ [0078]; even if the device is formed completely straight and bent by the end user, the predefined curvature in that instance would be no curvature).
Regarding Claim 8, Radl further discloses the shape retention element (130, Figs. 19-20) comprises a ductile metal and is bendable to a predefined shape (¶ [0078]; even if the device is formed completely straight and bent by the end user, the predefined curvature in that instance would be no curvature).
Claims 9 is rejected under 35 U.S.C. 103 as being unpatentable over Radl et al (US 2021/0113749) in view of Horgan et al (US 2016/0143739) further in view of Sklar et al (US 2007/0249999) further in view of Meyer et al (US 2022/0117774).
Regarding Claim 9, Radl/Horgan/Sklar is silent whether the shape retention element has embossed features on at least a portion of an external surface.
Meyer teaches a urine collection device with a shape retention element (shape memory material 614c, Fig. 6c) with embossed features (at least one narrowed region 648, Fig. 6c; ¶ [0098]) on at least a portion of an external surface to facilitate manufacturing of the urine collection device (¶ [0097-0098]).
Therefore, it would have been obvious to modify the shape retention element of Radl/Horgan/Sklar to have embossed features on at least a portion of an external surface, as taught by Meyer, to facilitate manufacturing of the urine collection device (as motivated by Meyer ¶ [0097-0098]).
Claim(s) 15-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Radl et al (US 2021/0113749) in view of Meyer et al (US 2022/0117774) further in view of Horgan et al (US 2016/0143739) further in view of Sklar et al (US 2007/0249999).
Regarding Claim 15, Radl/Meyer/Horgan is silent whether the suction tube body has a D-shaped cross-section with a planar surface and a rounded surface, wherein suction lumen is oriented adjacent the planar surface and wherein the shape retention lumen is oriented adjacent the rounded surface.
Sklar teaches a multi-lumen catheter, thus being in the same field of endeavor, where the suction tube body (2110, Fig. 21) has a D-shaped cross-section (see Fig. 21; ¶ [0159]) with a planar surface and a rounded surface (see Fig. 21), wherein the suction lumen (lumen accepting catheter 2120, Fig. 21) is oriented adjacent the planar surface and wherein the shape retention lumen (lumens accepting steering wires 2140, Fig. 21) is oriented adjacent the rounded surface. This structure allows the central lumen to be fluidly connected to the underlying tissue over a significant surface area (¶ [0159]).
Therefore, it would have been obvious to modify the suction tube body of Radl/Meyer/Horgan to have a D-shaped cross-section with a planar surface and a rounded surface, wherein the suction lumen is oriented adjacent the planar surface and wherein the shape retention lumen is oriented adjacent the rounded surface, as taught by Sklar. This structure allows the central lumen to be fluidly connected to the underlying tissue over a significant surface area (as motivated by Sklar ¶ [0159]).
Regarding Claim 16, Radl further discloses the shape retention element (130, Figs. 19-20) is formed with a predefined curvature (¶ [0078]; even if the device is formed completely straight and bent by the end user, the predefined curvature in that instance would be no curvature).
Regarding Claim 17, Radl further discloses the shape retention element (130, Figs. 19-20) comprises a ductile metal and is bendable to a predefined shape (¶ [0078]; even if the device is formed completely straight and bent by the end user, the predefined curvature in that instance would be no curvature).
Regarding Claim 18, Radl/Meyer/Horgan/Sklar is silent whether the shape retention element has embossed features on at least a portion of an external surface.
Meyer teaches a urine collection device with a shape retention element (shape memory material 614c, Fig. 6c) with embossed features (at least one narrowed region 648, Fig. 6c; ¶ [0098]) on at least a portion of an external surface to facilitate manufacturing of the urine collection device (¶ [0097-0098]).
Therefore, it would have been obvious to modify the shape retention element of Radl/Meyer/Horgan/Sklar to have embossed features on at least a portion of an external surface, as taught by Meyer, to facilitate manufacturing of the urine collection device (as motivated by Meyer ¶ [0097-0098]).
Conclusion
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/JESSICA ARBLE/ Primary Examiner, Art Unit 3781