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 Rejections - 35 USC § 102
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.
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-6, 9-17, 19-23-30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Davis (US 20180228642 A1).
Regarding Claim 1, fluid collection system (Fig 32 ¶[0107] system 200), comprising:
a fluid collection device (Figs 1-7, 32 ¶[0052] urine collection device 10) including a sump positioned within the fluid collection device (Figs 1-7 ¶[0053] cap 28), a fluid impermeable barrier (Figs 1-7 ¶[0052] external covering 20 is fluid impermeable) at least partially defining an opening (Figs 1-7 ¶[0052] covering 20 defines fenestration 30), and a fluid permeable body within the fluid collection device positioned to be at least proximate to skin of a user when the fluid collection device is in use (Figs 1-7 ¶[0056-0058] outer collection layer 40 is fluid permeable and is placed in contact with the user); and
a tube connector positioned at least partially outside the fluid collection device and in fluid communication with the sump (Figs 1-7 ¶[0060] tube 32 has a first end 33 disposed outside the device 10 and a second end 34 disposed within the sump 28), the tube connector having a first end region proximate to the fluid collection device (Figs 1-7 ¶[0060] tube 32 has a first end region at the second end 34 disposed within the sump 28) and a second end region distal to the fluid collection device that is in fluid communication with the sump (Figs 1-7 ¶[0060] tube 32 has a second end region at the first end 33 disposed outside the device 10 which is in fluid communication with the sump 28), the tube connector being adjustable between multiple orientations that adjust positioning of the second end region relative to the first end region whilst functionally maintaining the fluid communication between the second end region and the sump (¶[0062-0065] tube 32 may comprise a shape retaining element that may be manipulated by a person in various directions and is configured to retain its shape following the manipulation), wherein the tube connector includes at least one of: an articulated region having multiple tubular members embedded in a material of the articulated region such that the tube connector is adjustable between multiple orientations outside of the fluid collection device that adjust positioning of the second end region relative to the first end region whilst functionally maintaining the fluid communication between the second end region and the sump (Fig 11C ¶[0064] tube 32 comprises multiple wires 32c embedded within tube 32 to allow manipulation to adjust the shape of the tube and to retain the shape once formed).
Regarding Claim 2, Davis discloses that the tube connector includes the articulated region having the multiple tubular members embedded in the material of the articulated region such that the tube connector is adjustable between the multiple orientations outside of the fluid collection device that adjust positioning of the second end region relative to the first end region whilst functionally maintaining the fluid communication between the second end region and the sump (Fig 11C ¶[0060][0064] tube 32 comprises multiple wires 32c embedded within tube 32 to allow manipulation to adjust the shape of the tube and to retain the shape once formed. This adjustment is necessarily done outside of the device. Tube 32 is configured to evacuate fluid out from cap/sump 28).
Regarding Claim 3, the Examiner recognizes claim 3 as a "product-by-process" claim. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process (see MPEP 2113).
As a product claim, Examiner has determined claim 3 requires the tube connector to comprise the following structural elements in addition to those in the claims from which they depend: an articulated region having multiple tubular members embedded in a material of the articulated region such that the tube connector is adjustable between multiple orientations outside of the fluid collection device that adjust positioning of the second end region relative to the first end region whilst functionally maintaining the fluid communication between the second end region and the sump.
In the prior art rejection in this Office action, Examiner considers claim 3 to be met when a reference teaches these structural limitations. The articulated region is discussed above for claim 1.
Regarding Claim 4, Davis discloses that the multiple tubular members are generally rigid and spaced from one another within a tubular and flexible fluid impermeable material of the articulated region (Fig 11C ¶[0060][0064] wires 32c are spaced from one another and provide a level of rigidity to the tube 32 while still allowing enough flexibility to position the device. It is understood that the tube 32 is fluid impermeable because it is configured to evacuate fluid out the cap 28).
Regarding Claim 5, Claim 1 from which Claim 5 depends does not explicitly require the tubular member having the impermeable membrane covering the spun plastic. Thus, such limitations of Claim 5 regarding the tubular member having the impermeable membrane covering the spun plastic is disclosed by Davis as Davis discloses the tube connector being an articulated region having multiple tubular members embedded in a material of the articulated region such that the tube connector is adjustable between multiple orientations outside of the fluid collection device that adjust positioning of the second end region relative to the first end region whilst functionally maintaining the fluid communication between the second end region and the sump as discussed above in Claim 1.
Regarding Claim 6, Claim 1 from which Claim 6 depends does not explicitly require the base including the first end region and the elbow including the second end region, the elbow being pivotably secured to the base. Thus, such limitations of Claim 6 regarding the base including the first end region and the elbow including the second end region, the elbow being pivotably secured to the base is disclosed by Davis as Davis discloses the tube connector being an articulated region having multiple tubular members embedded in a material of the articulated region such that the tube connector is adjustable between multiple orientations outside of the fluid collection device that adjust positioning of the second end region relative to the first end region whilst functionally maintaining the fluid communication between the second end region and the sump as discussed above in Claim 1.
Regarding Claim 9, Davis discloses that the first end region of the tube connector is positioned within the sump of the fluid collection device (Figs 1-7 ¶[0060] tube 32 has a first end region at the second end 34 disposed within the sump 28).
Regarding Claim 10, Davis discloses that the tube connector is secured to the fluid collection device (Fig 1-7 tube 32 is secured to device 10).
Regarding Claim 11, Davis discloses a fluid collection device tube detachably secured to the first end region of the tube connector (Fig 1-7, ¶[0081] inner core 42 is fully capable of being removed from the device 10 and surrounds the first end region of tube 32 disposed within cap 28), the fluid collection device tube extending into the sump and providing fluid communication between the sump and the tube connector (Figs 1-7 ¶[0081] 42 extends into the sump and wicks fluids into the cap 28 to then be evacuated via tube 32).
Regarding Claim 12, Davis discloses a vacuum tube secured or securable to the second end region of the tube connector and configured to provide fluid communication between the tube connector and a vacuum source (Fig 32 ¶[0107] discharge tube line 202 is coupled to the second end region of 32 and provides fluid communication to vacuum source 210).
Regarding Claim 13, Davis discloses a fluid collection container and the vacuum source configured to draw fluid discharged in the fluid collection device out of the fluid collection device, through the tube connector, and through the vacuum tube into the fluid collection container (Fig 32 ¶[0107] external collection reservoir 204 receives fluid drawn by vacuum source 210 from device 10 and tube 32).
Regarding Claim 14, Davis discloses that the fluid collection device is configured as a female external catheter urine collection device and the fluid permeable body is positioned within the female external catheter urine collection device to be disposed at least proximate to a urethra of a female user (Figs 1-7 and 10 ¶[0061] device 10 is shown with the outer collection layer positioned proximate to a urethra of a female user).
Regarding Claim 15, Davis discloses that the fluid collection device is configured as a male external urine collection device and the fluid permeable body is positioned within the male external catheter urine collection device to be disposed at least proximate to a urethra of a male user (¶[0051] device may be used with male patients and would be placed with the fluid permeable body positioned proximate the user’s urethra).
Regarding Claim 16, Davis discloses that the sump and the tube connector are positioned at a distal end region of the male external urine collection device (Figs 1-7, cap 28 and end 34 of tube 32 are positioned and a distal end region).
Regarding Claim 17, Davis discloses an additional tube connector secured or securable to a proximate end region of the male external urine collection device and an additional tube providing fluid communication between the tube connector and the additional tube connector (Fig 20 ¶[0079] device 10 may include an additional curved tube extension 35 secured to proximate end region 33 of tube 32, thus providing fluid communication therethrough).
Regarding Claim 19, Davis discloses the tube connector being adjustable between multiple orientations that adjust positioning of the second end region relative to the first end region whilst functionally maintaining the fluid communication between the second end region and the sump includes at least one of: the tube connector being adjustable between a first orientation having the second end region of the tube connector angled a first amount from the first end region of the tube connector and a second orientation having the second end region of the tube connector angled a second amount from the first end region different than the first amount whilst functionally maintaining the fluid communication between the second end region of the tube connector and the sump (Figs 1-7, 11C ¶[0064] tube 32 can be manipulated by a person (e.g., a healthcare provider or a user) in various directions and is configured to retain its shape following the manipulation. The curvature of device 10 is adjustable to fit the anatomy of any user. Thus, tube 32 may be adjustable between a first and second orientation as claimed).
Regarding Claim 20, Davis discloses a method of collecting fluid (Fig 33 ¶[01409] method 300 for using a device for collecting urine), comprising: positioning a fluid collection device (Figs 1-7 and 10, device 10) on a user with a fluid permeable body of the fluid collection device proximate to skin of the user (Figs 1-7 and 10 ¶[0061] device 10 is shown with the outer collection layer positioned proximate to a urethra of a female user), the fluid collection device including a sump positioned within the fluid collection device (Figs 1-7 ¶[0053] cap 28) and a fluid impermeable barrier (Figs 1-7 ¶[0052] external covering 20 is fluid impermeable); adjusting a position of a first end region of a tube connector in fluid communication with the sump (Figs 1-7 ¶[0060] tube 32 has a first end region at the second end 34 disposed within the sump 28) relative to a second end region of the tube connector whilst functionally maintaining the fluid communication between the second end region and the sump (Figs 1-7 ¶[0060] tube 32 has a second end region at the first end 33 disposed outside the device 10 which is in fluid communication with the sump 28) to orient the tube connector to a selected orientation (¶[0062-0065] tube 32 may comprise a shape retaining element that may be manipulated by a person in various directions and is configured to retain its shape following the manipulation), wherein the tube connector includes at least one of: an articulated region having multiple tubular members embedded in a material of the articulated region such that the tube connector is adjustable between multiple orientations outside of the fluid collection device that adjust positioning of the second end region relative to the first end region whilst functionally maintaining the fluid communication between the second end region and the sump (Fig 11C ¶[0064] tube 32 comprises multiple wires 32c embedded within tube 32 to allow manipulation to adjust the shape of the tube and to retain the shape once formed), and drawing fluid discharged in the fluid collection device from the sump, through the tube connector, and into a fluid collection container (Fig 32 shows the fluid pathway from collection device 10, which includes cap 28 and tube 32 into container 204).
Regarding Claim 21, Davis discloses that adjusting a position of a first end region of a tube connector in fluid communication with the sump relative to a second end region of the tube connector includes bending the tube connector outside of the fluid collection device at the articulated region of the tube connector having the multiple tubular members embedded in the material of the articulated region from a first orientation having the second end region of the tube connector angled a first amount from the first end region of the tube connector to a second orientation having the second end region of the tube connector angled a second amount from the first end region different than the first amount (Fig 11C ¶[0060][0064] tube 32 comprises multiple wires 32c embedded within tube 32 to allow manipulation to adjust the shape of the tube and to retain the shape once formed. This adjustment is necessarily done outside of the device. Tube 32 is configured to evacuate fluid out from cap/sump 28. Tube 32 can be manipulated by a person (e.g., a healthcare provider or a user) in various directions and is configured to retain its shape following the manipulation. The curvature of device 10 is adjustable to fit the anatomy of any user. Thus, tube 32 may be adjustable between a first and second orientation as claimed).
Regarding Claim 22, Claim 20 from which Claim 22 depends does not explicitly require the tubular member having the impermeable membrane covering the spun plastic. Thus, such limitations of Claim 22 regarding the tubular member having the impermeable membrane covering the spun plastic is disclosed by Davis as Davis discloses the tube connector being an articulated region having multiple tubular members embedded in a material of the articulated region such that the tube connector is adjustable between multiple orientations outside of the fluid collection device that adjust positioning of the second end region relative to the first end region whilst functionally maintaining the fluid communication between the second end region and the sump to orient the tube connector to a selected orientation as discussed above in Claim 20.
Regarding Claim 23, Claim 20 from which Claim 23 depends does not explicitly require the base including the first end region and the elbow including the second end region, the elbow being pivotably secured to the base. Thus, such limitations of Claim 6 regarding the base including the first end region and the elbow including the second end region, the elbow being pivotably secured to the base is disclosed by Davis as Davis discloses the tube connector being an articulated region having multiple tubular members embedded in a material of the articulated region such that the tube connector is adjustable between multiple orientations outside of the fluid collection device that adjust positioning of the second end region relative to the first end region whilst functionally maintaining the fluid communication between the second end region and the sump to orient the tube connector to a selected orientation as discussed above in Claim 20.
Regarding Claim 26, Davis discloses inserting the first end region of the tube connector into the sump of the fluid collection device (Figs 1-7 ¶[0060] tube 32 has a first end region at the second end 34 disposed within the sump 28).
Regarding Claim 27, Davis discloses detachably securing a fluid collection device tube to the first end region of the tube connector (Fig 1-7, ¶[0081] inner core 42 is fully capable of being removed from the device 10 and surrounds the first end region of tube 32 disposed within cap 28), the fluid collection device tube extending into the sump and providing fluid communication between the sump and the tube connector (Figs 1-7 ¶[0081] 42 extends into the sump and wicks fluids into the cap 28 to then be evacuated via tube 32).
Regarding Claim 28, Davis discloses securing a vacuum tube to the second end region of the tube connector to provide fluid communication between the tube connector and a vacuum source (Fig 32 ¶[0107] discharge tube line 202 is coupled to the second end region of 32 and provides fluid communication to vacuum source 210).
Regarding Claim 29, Davis discloses positioning a fluid collection device on a user with a fluid permeable body of the fluid collection device proximate to a skin of the user includes positioning the fluid collection device on a female user with the fluid permeable body of the fluid collection device proximate to the urethra of the female user (Figs 1-7 and 10 ¶[0061] device 10 is shown with the outer collection layer 40 exposed through fenestration 30 positioned proximate to a urethra of a female user) through an opening defined by the fluid impermeable barrier (Figs 1-7 ¶[0052] covering 20 defines fenestration 30).
Regarding Claim 30, Davis discloses positioning a fluid collection device on a user with a fluid permeable body of the fluid collection device proximate to a skin of the user includes inserting a penis of a male user through an opening in the fluid impermeable barrier to position the urethra of the male user proximate to the fluid permeable body (¶[0051] device may be used with male patients and would be placed with the fluid permeable body 42 positioned proximate the user’s urethra, thus positioning at least a portion of the user’s penis within fenestration 30 defined by covering 20).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claims 18 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Davis (US 20180228642 A1) in view of Obst (US 20200405523 A1).
Regarding Claim 18, Davis is silent whether the fluid collection device is configured as a fluid collection device for removing wound drainage.
However, Obst teaches a fluid containment system to contain fluid from body orifices, thus from the same field of endeavor, wherein the fluid collection device is configured as a fluid collection device for removing wound drainage (Fig 1 ¶[0031] containment system may be used for wound drainage, drawing leakage into an effluent container) in order to contain leaked bodily fluid to prevent skin irritation, infection, and pain (¶[0002]).
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 of Obst so that the fluid collection device is configured as a fluid collection device for removing wound drainage, as taught by Obst in order to contain leaked bodily fluid to prevent skin irritation, infection, and pain (as motivated by Obst ¶[0002]).
Regarding Claim 31¸ Davis discloses positioning a fluid collection device on a user with a fluid permeable body of the fluid collection device proximate to a skin of the user as set forth above for claim 20.
Davis is silent regarding positioning the fluid collection device proximate to a wound on the skin of the user.
However, Obst teaches a fluid containment system to contain fluid from body orifices, thus from the same field of endeavor, wherein the fluid collection device is positioned proximate to a wound on the skin of the user (Fig 1 ¶[0031] containment system may be used for wound drainage, drawing leakage into an effluent container) in order to contain leaked bodily fluid to prevent skin irritation, infection, and pain (¶[0002]).
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 of Obst so that the fluid collection device is positioned proximate to a wound on the skin of the user, as taught by Obst in order to contain leaked bodily fluid to prevent skin irritation, infection, and pain (as motivated by Obst ¶[0002]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY LEE FLYNN whose telephone number is (571)272-8255. The examiner can normally be reached Monday-Friday 7:30-5 ET.
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TIMOTHY LEE. FLYNN
Examiner
Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781