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 Status
The amendment filed December 5th, 2025 has been entered. Claims 1, 4, 6-14, and 16-27 are currently pending in the application. Claims 1, 19, and 20 have been amended. Claim 27 has been newly added. Claims 2, 3, 5, and 15 remain cancelled.
Response to Arguments
Applicant's arguments filed December 5th, 2025 have been fully considered but they are not persuasive.
Regarding applicants remarks pertaining to claim 25, while applicant’s arguments may have been persuasive, applicant has amended claim 1 from which claim 25 depends and as such changed the scope of the claims present. This change in scope necessitated the new rejection presented below and the rejection of claim 25 is presented below. As the amendment of claim 1 has changed the scope of the claims and necessitated the amendment of the rejection as presented below this rejection is made final.
Regarding applicant’s argument that none of the cited reference teach a detent, but instead they all teach a dent or a slot within which a protrusion slides or is received and does not constitute a mechanism that temporarily keeps one part in a certain position relative to that of another and can be released by applying force to one of the parts, examiner disagrees in that Falconer specifically describes applying force to the device to position the device both into and out of the recess and the recess maintaining the positioning of the device and as such is seen to fall into the definition of detent provided by Merriam Webster (as recess 46, detent is defined by Merriam-Webster as a device for positioning and holding one mechanical part in relation to another in a manner such that device can be released by force applied to one of the parts, recess 46 holds element 44 and thus tap member 16 captive within the tubular device when forced through the notch 48 with a snap-action until forcibly removed Col. 3 lines 23-49), however, the current amended claim limitation has overcome the previous rejection provided and a new interpretation of the art has been provided below that provides for a detent that is a protrusion placed outside and adjacent to the housing as now claimed and as such the applicant’s arguments are not found to be persuasive.
Regarding applicant’s arguments pertaining to claim 25 in response to the curved ramp upon which the handle of that device lies in the closed position with the outlet tube being two distinct elements, the current claim limitations requires that the ridge abut the outlet portion such that a portion of it has restricted access to it to avoid unintended rotation, the fact that a handle also abuts the ridge of 50 and also has a portion in which access is restricted is the ability of element 50 to restrict access to each of these elements is not mutually exclusive and can happen concurrently. As such the examiner does not find this argument persuaive.
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.
Claim1, 4, 6-14, and 16-27 are 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.
The terms “relatively rigid component” and “relatively flexible outlet tube portion” in claims 1, 4,6, 7, 8, 12, 13, 16, and 19-23 and “relatively rigid connector” in claims 1 and 23 are a relative terms which renders the claim indefinite. The terms “relatively rigid” and “relatively flexible” are not defined by the claim in that they have not clearly indicated to what component they are considered “relatively” rigid and relatively flexible to, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In order to be “relatively” flexible and rigid, it must be established as to what the relative flexibility and rigidity is relative to and as this has not been clearly established by the specification or the claim limitations these terms are considered indefinite. For the purpose of examination the relative rigidity of the component and connector is being treated to mean that it exhibits more rigidity than the outlet tube portion and the outlet tube portion exhibits more flexibility than the component and connector such that the relatively rigid outlet tube portion is rigid in relation to the relatively flexible outlet tube portion and the relatively flexible outlet tube is flexible in relation to the relatively rigid outlet tube portion.
The remaining claims are herein rejected as being dependent upon a rejection claim.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 4, 6-14, 16-20, and 23-26 are rejected under 35 U.S.C. 103 as being unpatentable over Falconer (U.S. Patent No. 6,021,928 with reference to European Patent Application EP-0753323-A1) in view of Lutz (U.S. Patent No. 6,132,408), Wong (U.S. Publication 2021/0206541 as reliant upon provisional application No. 62/957,538 disclosure filed on January 6th, 2020) and Allen (U.S. Publication 2022/0054296) and further in view of Jepsen (U.S. Publication 2017/0156919).
Regarding claim 1 and 23, Falconer discloses an outlet valve 14 for a urine collection appliance 10 comprising:
a valve base (Fig. 3 integral elements 18 and 20) for attachment to a face 12 of the urine collection appliance 10, the valve base (18 and 20) defining a base opening 40 for receiving a liquid output from the ostomy appliance 10; and
an outlet element 16 configured to be rotatable relative to the valve base 20 from a closed configuration (Fig. 1) in which discharge of the liquid received through the base opening 40 is prevented, to an open configuration (Fig. 2) in which discharge of the liquid received through the base opening is enabled;
a detent (as recess 46, detent is defined by Merriam-Webster as a device for positioning and holding one mechanical part in relation to another in a manner such that device can be released by force applied to one of the parts, recess 46 holds element 44 and thus tap member 16 captive within the tubular device when forced through the notch 48 with a snap-action until forcibly removed Col. 3 lines 23-49) integrally formed with the valve base (Col. 2 lines 5865 tap body 18 has an integral attachment portion 20, recess 46 integral with tap body 18 and thus integral with valve base, integral elements 18 and 20) outside and adjacent to (detent 46 formed on outer surface of housing 34 and is adjoined with the housing and therefore adjacent to housing according to definition of Oxford dictionary stating the definition of adjacent to be “next to or adjoining something else”) a housing 34 configured to receive therein the outlet element (dimensioned to receive barrel 24 of outlet element); and
a first protrusion 44 integrally formed with an outer face of the outlet element (integrally formed with element 30 which is integrally attached to outer face of element 22) arranged adjacent to a portion of the outlet element received in the housing (Fig. 5 shows element 44 adjacent to barrel 24 which is received in the housing), the first protrusion configured to ride over the detent (projection slides in the recess and recess contacts sides of protrusion with the detent being placed beyond the projection on the three sides of the projection and thus riding over, with over being defined using its adverb definition according to https://www.dictionary.com/browse/over stating beyond the upper surface of something);
wherein the outlet element 16 comprises a relatively rigid component 16 rotatably attached to the valve base 20, and an outlet tube portion (Col. 4 lines 43-52, external drainage tube) affixed (coupled with snap-fit connector 30 described in Falconer EP-07533230-A1) to the relatively rigid component 16, and in the open configuration (See Falconer, Col. 3 lines 1-12 regarding open and closed configurations), the relatively rigid component 16 defining a fluid pathway between the base opening 40 and the outlet tube portion (See Col. 4 lines 18-42 of Falconer regarding fluid pathway) and is configured to receive liquid directly from the base opening 40 and then deliver the liquid directly (See Col. 4 lines 18-42 of Falconer regarding fluid pathway) to an outlet opening (end of drainage tube) of the outlet tube portion;
and a relatively rigid connector (snap-fit connector 30 described in Falconer EP-07533230-A1, Abstract relatively rigid plastics material).
Falconer does not expressly disclose the valve being for an ostomy appliance; a detent integrally formed with the valve base outside and adjacent to the housing, the detent being a raised elongate protrusion extending from a face of the valve base, a second protrusion wherein the first and second protrusions are spaced apart around the outer face of the outlet element, the first protrusion riding over the detent providing at least one of audible and tactile confirmation the outlet element has been moved out of its initial closed configuration, the second protrusion configured to ride over the detent providing at least one of audible and tactile confirmation the outlet element reached or is approaching a closed configuration; the rigidity of the device, the flexibility of the outlet tube portion attached to a relatively rigid component, or a diameter of the outlet tube portion or connector.
However, regarding the valve being for an ostomy appliance, the limitation of “for an ostomy appliance” is considered functional language (denotes how the valve is to be used, i.e., with an ostomy appliance). While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Falconer discloses all the structure as claimed, and is further used as a drain for a device used to collect human waste products. As such, it is capable of performing the functions as claimed (i.e., it is capable of being used with an ostomy appliance).
Regarding the device having first and second protrusions spaced apart around the outer face of the outlet element, Allen, in the same field of endeavor of ostomy outlet elements, teaches a detent (42 as recess/groove ¶0030) integrally formed with a face (face of 26 opposite of a valve base 26 outside and adjacent to (¶0031 outside and adjacent to entrance to passage 24 formed by housing 38) a housing 38 configured to receive therein a body 14 comprising an outlet element 30 and two or more (¶0032 first formation may include multiple projections which are spaced apart from each other around the outer surface of the body to ensure engagement) protrusions arranged on a body 14 adjacent to housing (as 42 is adjacent and 40 is in line with 42 it is also adjacent).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the projection/detent formation of Falconer that performs the function of retaining the outlet element within the valve body for the projection/detent formation of Allen since these elements perform the same function of retaining an element within a passage. Simply substituting one element retaining means for another would yield the predictable result of allowing a(n) element to be retained within a cylindrical passage way. See MPEP 2143.
Regarding the detent being a raised elongate protrusion extending from a face of the valve base and providing a tactile or audible confirmation of the outlet element being moved out of an initial closed configuration and reaching or approaching a closed configuration respectively, Jepsen, in the same field of endeavor of ostomy appliance valves, teaches a recess 9 comprising raised elongate protrusions (12 and 13) extending from the face of the recess (protruding inherently has a dimension extending from the surface that they protrude from) configured to ride over a protrusion 10 (protrusion 10 slides within detent 9 and rides over 12 and 13 such that the user feels the bumps during twisting of the valve stem ¶0027) with the first protrusion 13 riding over the detent 10 at a position (position of recess 9 just prior to annular recess 11 marked by protrusion 12) that indicates through tactile feedback (¶0027 tactile feedback) the outlet element 6 has moved out of its initial closed configuration (in fully closed position element 10 past element 13 rides over 13 to indicated moving into recess 9 towards open position), and the second protrusion 12 riding over the detent 10 at a position that indicates through tactile feedback (¶0027 tactile feedback) the outlet element is approaching the closed configuration (When detent 10 is in channel 11 as it approaches channel 9 rides over indent 12 indicating that it is approaching fully closed configuration) provides tactile feedback to the user of the position of the valve with regard to its open and closed configuration (¶0027 bumps are there to provide tactile feedback to the user of the position of the valve stem with respect to the housing…when the user feels the proximal bump 12 during twisting of the valve stem, the user will know that the annular recess has been reached) for the purpose of providing tactile feedback to the user as to the open and closed configuration of the device ¶0027.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the detent and protrusions of Falconer in view of Allen to have comprised a raised elongate protrusion within the recess that interacts with the protrusions taught by Allen in which the detent rides over and provides tactile confirmation of the outlet element being moved out of its initial closed configuration and approaching a closed configuration , as taught by Jepsen, for the purpose of providing tactile feedback to the user as to the open and closed configuration of the device ¶0027.
As the recess of Falconer in view of Allen is continuous with the face of the valve base facing away from the attachment face, any protrusion present within the recess would necessarily protrude from the recess and thus protrude from the face of the valve base.
Regarding the component being relatively rigid, Falconer does not expressly disclose whether the device is made out of a rigid or flexible material however, the only movement that falconer discloses the device having is in regards to the movement of the from the open position to the closed position and vice versa through the manipulation of the user handle occurring to rotate the fixtures in relation to one another, the individual components are shown to maintain the same formation throughout the entire process and therefore are considered to be rigid enough to maintain their originally molded form. Furthermore, it would have been obvious to one of ordinary skill in the art to have had the components of the device formed from a relatively rigid material as the device requires elements such as 44 to remain in position (channel 46) in order to properly function and making the elements allowing for this connection flexible rather than rigid would have resulted in nonintentional failure of the device during use. Therefore, it is obvious for the component 16 to have been made of a relatively rigid material in order to remain in the placement required for proper function and avoid failure of the device.
Regarding the outlet tube portion being relatively flexible in comparison to the relatively rigid component (the relatively rigid component relatively more rigid than the relatively flexible outlet tube portion), and the relatively flexible outlet tube portion having an outlet diameter marginally smaller than a connector diameter of the relatively rigid connector such that, on insertion of the relatively rigid connector into the relatively flexible outlet tube portion in use, the relatively flexible outlet tube portion flexes to accommodate the relatively rigid connector (Claim 23), the disclosure of Falconer fails to disclose the characteristics of the outlet tube portion or the mechanism by which the outlet tube portion is connected to the connector other than saying that stepped portion grip the internal surface of the plastic tube (Col. 2 lines 18-37).
However, Lutz, in the same field of endeavor of urostomy bags, teaches an outlet tube 12 that is flexible and has a constant diameter along its length (Col. 3 lines 10-25), wherein an outlet diameter (Col. 3 lines 10-25, constant diameter along its length) is marginally smaller than a connector diameter of a connector such that, on insertion of the connector into the flexible outlet tube portion, the flexible outlet tube flexes to accommodate the connector (Figure 2 shows the portion 12A flexing around the inserted portion of element 18) for the purpose of securely and sealingly connecting the tube to the flow pathway of the bag (Col. 3 lines 26-40) and easily positioning the discharge end of the device over the opening of a waste receptacle such as a toilet or urinal (Col. 3 lines 10-25).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted outlet tube portion of Falconer that performs the function of guiding fluid flow out of the fluid collection device for the outlet tube portion of Lutz since these elements perform the same function of guiding fluid flow out of a collection device. Simply substituting one fluid guiding means for another would yield the predictable result of allowing a(n) fluid collection appliance to guide fluid output. See MPEP 2143.
Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have performed this substitution for the purpose of securely and sealingly connecting the tube to the flow pathway of the bag (Col. 3 lines 26-40 of Lutz) and easily positioning the discharge end of the device over the opening of a waste receptacle such as a toilet or urinal (Col. 3 lines 10-25 of Lutz) as taught by Lutz.
As the component of Falconer is considered rigid (see above) and the outlet tube of Lutz considered flexible, the combination of the teachings of Lutz with the disclosure of Falconer rendered obvious the limitation of the relatively rigid component being relatively more rigid than the relatively flexible outlet tube portion.
Falconer in view of Lutz do not expressly disclose or suggest the relatively flexible outlet tube portion permanently affixed by over-moulding onto the relatively rigid component, as while Lutz further teaches the tube being permanently attached to the bottom opening 100B (Col. 3 lines 26-40 of Lutz), Lutz does not expressly teach how this permanent attachment would take place and if it would include the permanent attachment of the tube to the rigid component through additional structure or through bonding means.
However, Wong, in the same field of endeavor of liquid transport through an outlet element capable of opening and closing ¶0065, discloses permanently affixing a relatively flexible (¶0055 flexible material) component 51 to a relatively rigid (¶0055 rigid material) component 52 by over-moulding the flexible component onto the rigid component (¶0016 overmolded as a unitary structure, ¶0025 applying a material of the spout into the overmolding mold for overmolding the spout around the linking portion of the reinforcement unit) for the purpose of forming as a unitary structure (¶0016) that has higher strength and increased twisting torque to prevent releasing and separation of the spout from the base.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the rigid and flexible components of Falconer in view of Lutz to have been permanently affixed (as suggested by Lutz Col. 3 lines 26-40) by overmoulding, as taught by Wong for the purpose of forming a unitary structure (¶0016) that has higher strength and increased twisting torque to prevent releasing and separation of one component from the other.
Regarding claim 4, Falconer in view of Lutz, Wong, Allen, and Jepsen suggest the outlet valve of claim 1. Falconer further discloses the relatively rigid component 16 having a tubular and generally L-shaped form (See Abstract and Col. 3 lines 23-49 regarding shape as well as Figure 9).
Regarding claim 6, Falconer in view of Lutz, Wong, Allen, and Jepsen suggest the outlet valve of claim 1. Falconer further discloses the relatively rigid component 16 comprising a protruding flange 30 for gripping by the user in use.
Regarding claim 7, Falconer in view of Lutz, Wong, Allen, and Jepsen suggest the outlet valve of claim 1. Falconer further discloses the outlet element 16 comprising an outlet tube 22, the outlet tube 22 comprising the relatively flexible outlet tube portion (outlet tube 22 connected to connector which is connected to flexible outlet tube portion).
Regarding claim 8, Falconer in view of Lutz, Wong, Allen, and Jepsen suggest the outlet valve of claim 7. Falconer in view of Lutz and Wong further suggest the relatively rigid component 16 comprising an intake tube 24 and a relatively rigid outlet tube portion (portion below element 58), the relatively rigid outlet tube portion being affixed to the relatively flexible outlet tube portion (affixed through connection to connector which is connected to flexible outlet tube portion).
Regarding claim 9, Falconer in view of Lutz, Wong, Allen, and Jepsen suggest the outlet valve of claim 8. Falconer further discloses the intake tube 24 and the outlet tube 22 together defining a continuous hollow bore for passage of the liquid from an intake opening 28 to the outlet opening arranged at an end 12B of the outlet tube 22 distal to the intake tube 24 (See Col. 4 lines 18-42).
Regarding claim 10, Falconer in view of Lutz, Wong, Allen, and Jepsen suggest the outlet valve of claim 9. Falconer further discloses the outlet element 16 having a generally L-shaped form, the intake tube 24 optionally being arranged at an angle of substantially 90 degrees to the outlet tube 22 (See Figure 9 for 90 degree angle).
Regarding claim 11, Falconer in view of Lutz, Wong, Allen, and Jepsen suggest the outlet valve of claim 9. Falconer further discloses a housing 34 protruding from an outer face of the valve base 20, the housing 34 defining a cylindrical bore, a portion of the intake tube 24 being rotatably mounted with the cylindrical bore (See illustrative diagram of Figure 4 of Falconer below; See Col. 4 lines 18-42 regarding rotation).
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Regarding claim 12, Falconer in view of Lutz, Wong, Allen, and Jepsen suggest the outlet valve of claim 1. The above substitution of the outlet tube of Falconer for the outlet tube of Lutz further suggests the relatively flexible outlet tube portion being formed from a deformable material as the outlet tube of Lutz is described to be flexible and the term flexible is defined as bendable which inherently requires the material to be deformable which is defined as being changed in shape according to Merriam-Webster dictionary. As such the above substitution of the outlet tube of falconer for the outlet tube of Lutz would have rendered the limitation of outlet tube portion being formed from a deformable material obvious to one of ordinary skill in the art, since imply substituting one fluid guiding means for another would yield the predictable result of allowing a(n) fluid collection appliance to guide fluid output. See MPEP 2143. See above rejection of claim 1.
Regarding claim 13, Falconer in view of Lutz, Wong, Allen, and Jepsen suggest the outlet valve of claim 1. Falconer in view of Lutz and Wong do not expressly disclose or suggest the relatively rigid component being formed from a material having a Shore hardness of at least 50A. However, the device of Falconer would require the relatively rigid components to be sufficiently rigid enough in order to maintain connection with the base during rotation of the device during operation.
As such, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have optimized the hardness to be a Shore hardness of at least 50A for the relatively rigid component as it would have been obvious to have made the relatively rigid component hard enough to be consistently manipulated by the user while maintaining the connection of the components to one another in order to prevent failure of the rotation mechanism of the device, since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in art In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05.
Regarding claim 14, Falconer in view of Lutz, Wong, Allen, and Jepsen suggest the outlet valve of claim 1. Falconer further discloses the outlet element 16 being rotatable about an axis of rotation 56 arranged generally parallel to an attachment face of the valve base 20 and generally horizontally in use (See illustrative diagram of Figure 1 below).
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Regarding claim 16, Falconer in view of Lutz, Wong, Allen, and Jepsen suggest the outlet valve of claim 1. Falconer in view of Lutz do not expressly disclose the valve base 20 being formed of a material which is more rigid than the relatively flexible outlet tube portion. However, as described above in the rejection of claim 1, it would have been obvious to one of ordinary skill in the art to have made the base of a material more rigid than the relatively flexible outlet tube portion for the purpose of preventing flexing during the rotation of the device from closed to open positions and thus preventing failure of the device during operation.
Regarding claim 17, Falconer in view of Lutz, Wong, Allen, and Jepsen suggest the outlet valve of claim 1. Falconer in view of Lutz, Wong, Allen, and Jepsen do not expressly disclose or suggest an ostomy appliance being coupled to the valve as the valve of Falconer is coupled to a waste collecting appliance.
However, Allen, in the same field of endeavor of valves for ostomy appliances, further teaches coupling a valve 10 to an ostomy appliance 20 for the purpose of providing a mechanism for the drainage of the ostomy appliance ¶0001.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the waste collection appliance of Falconer that performs the function of collecting bodily fluids from a patient for the ostomy appliance of Allen since these elements perform the same function of collecting bodily fluids from a patient. Simply substituting one bodily fluid collection means for another would yield the predictable result of allowing a device to collect bodily fluids. See MPEP 2143.
Regarding claim 18, Falconer in view of Lutz and Wong and further in view of Allen suggest the outlet valve of claim 17. Falconer further discloses in the closed configuration (Fig. 1) the outlet element 16 substantially overlying a cavity (see below illustrative diagram of Figure 6) of the ostomy appliance (20 of Allen); and in the open configuration (Fig. 2) at least a portion 22 of the outlet element 16 extends across a lower edge (see illustrative diagram of Figure 8 below) of the cavity of the ostomy appliance (20 of Allen).
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Illustrative diagram of Figure 6, 7, and 8 Falconer (U.S. Patent No. 6,021,928).
Regarding claim 19, Falconer discloses an outlet valve 14 for a urine collection appliance 10 comprising:
a valve base 20 for attachment to a face 12 of the urine collection appliance 10, the valve base 20 defining a base opening 40 for receiving a liquid output from the ostomy appliance 10; and
an outlet element 16 configured to be rotatable relative to the valve base 20 from a closed configuration in which discharge of the liquid received through the base opening 40 is prevented, to an open configuration in which discharge of the liquid received through the base opening is enabled;
a detent (as recess 46, detent is defined by Merriam-Webster as a device for positioning and holding one mechanical part in relation to another in a manner such that device can be released by force applied to one of the parts, recess 46 holds element 44 and thus tap member 16 captive within the tubular device when forced through the notch 48 with a snap-action until forcibly removed Col. 3 lines 23-49) integrally formed with the valve base (Col. 2 lines 5865 tap body 18 has an integral attachment portion 20, recess 46 integral with tap body 18 and thus integral with valve base, integral elements 18 and 20) outside and adjacent to (detent 46 formed on outer surface of housing 34 and is adjoined with the housing and therefore adjacent to housing according to definition of Oxford dictionary stating the definition of adjacent to be “next to or adjoining something else”) a housing 34 configured to receive therein the outlet element (dimensioned to receive barrel 24 of outlet element); and
a first protrusion 44 integrally formed with an outer face of the outlet element (integrally formed with element 30 which is integrally attached to outer face of element 22) arranged adjacent to a portion of the outlet element received in the housing (Fig. 5 shows element 44 adjacent to barrel 24 which is received in the housing), the first protrusion configured to ride over the detent (projection slides in the recess and recess contacts sides of protrusion with the detent being placed beyond the projection on the three sides of the projection and thus riding over, with over being defined using its adverb definition according to https://www.dictionary.com/browse/over stating beyond the upper surface of something);
wherein the outlet element 16 comprises a component 16 rotatably attached to the valve base 20, and an (Col. 4 lines 43-52, external drainage tube) affixed (coupled with snap-fit connector 30 described in EP-07533230-A1) to the component 16 defining a continuous bore (defines continuous pathway for fluid flow through the component through drainage tube when affixed) for passage of the liquid from the component 16 to an outlet opening (end of drainage tube) of the outlet tube portion, wherein in the open configuration the component 16 is configured to receive liquid directly from the base opening 40 and then deliver it to the outlet tube portion (See Col. 3 lines 1-12 regarding open and closed configurations and Col. 4 lines 18-42 regarding fluid flow).
Falconer does not expressly disclose the valve being for an ostomy appliance; a detent integrally formed with the valve base outside and adjacent to the housing, the detent being a raised elongate protrusion extending from a face of the valve base, a second protrusion wherein the first and second protrusions are spaced apart around the outer face of the outlet element, the first protrusion riding over the detent providing at least one of audible and tactile confirmation the outlet element has been moved out of its initial closed configuration, the second protrusion configured to ride over the detent providing at least one of audible and tactile confirmation the outlet element reached or is approaching a closed configuration; the rigidity of the device, the flexibility of the outlet tube portion attached to a relatively rigid component, or a diameter of the outlet tube portion or connector.
However, regarding the valve being for an ostomy appliance, the limitation of “for an ostomy appliance” is considered functional language (denotes how the valve is to be used, i.e., with an ostomy appliance). While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Falconer discloses all the structure as claimed, and is further used as a drain for a device used to collect human waste products. As such, it is capable of performing the functions as claimed (i.e., it is capable of being used with an ostomy appliance).
Regarding the device having first and second protrusions spaced apart around the outer face of the outlet element, Allen, in the same field of endeavor of ostomy outlet elements, teaches a detent (42 as recess/groove ¶0030) integrally formed with a face (face of 26 opposite of a valve base 26 outside and adjacent to (¶0031 outside and adjacent to entrance to passage 24 formed by housing 38) a housing 38 configured to receive therein a body 14 comprising an outlet element 30 and two or more (¶0032 first formation may include multiple projections which are spaced apart from each other around the outer surface of the body to ensure engagement) protrusions arranged on a body 14 adjacent to housing (as 42 is adjacent and 40 is in line with 42 it is also adjacent).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the projection/detent formation of Falconer that performs the function of retaining the outlet element within the valve body for the projection/detent formation of Allen since these elements perform the same function of retaining an element within a passage. Simply substituting one element retaining means for another would yield the predictable result of allowing a(n) element to be retained within a cylindrical passage way. See MPEP 2143.
Regarding the detent being a raised elongate protrusion extending from a face of the valve base and providing a tactile or audible confirmation of the outlet element being moved out of an initial closed configuration and reaching or approaching a closed configuration respectively, Jepsen, in the same field of endeavor of ostomy appliance valves, teaches a recess 9 comprising raised elongate protrusions (12 and 13) extending from the face of the recess (protruding inherently has a dimension extending from the surface that they protrude from) configured to ride over a protrusion 10 (protrusion 10 slides within detent 9 and rides over 12 and 13 such that the user feels the bumps during twisting of the valve stem ¶0027) with the first protrusion 13 riding over the detent 10 at a position (position of recess 9 just prior to annular recess 11 marked by protrusion 12) that indicates through tactile feedback (¶0027 tactile feedback) the outlet element 6 has moved out of its initial closed configuration (in fully closed position element 10 past element 13 rides over 13 to indicated moving into recess 9 towards open position), and the second protrusion 12 riding over the detent 10 at a position that indicates through tactile feedback (¶0027 tactile feedback) the outlet element is approaching the closed configuration (When detent 10 is in channel 11 as it approaches channel 9 rides over indent 12 indicating that it is approaching fully closed configuration) provides tactile feedback to the user of the position of the valve with regard to its open and closed configuration (¶0027 bumps are there to provide tactile feedback to the user of the position of the valve stem with respect to the housing…when the user feels the proximal bump 12 during twisting of the valve stem, the user will know that the annular recess has been reached) for the purpose of providing tactile feedback to the user as to the open and closed configuration of the device ¶0027.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the detent and protrusions of Falconer in view of Allen to have comprised a raised elongate protrusion within the recess that interacts with the protrusions taught by Allen in which the detent rides over and provides tactile confirmation of the outlet element being moved out of its initial closed configuration and approaching a closed configuration , as taught by Jepsen, for the purpose of providing tactile feedback to the user as to the open and closed configuration of the device ¶0027.
As the recess of Falconer in view of Allen is continuous with the face of the valve base facing away from the attachment face, any protrusion present within the recess would necessarily protrude from the recess and thus protrude from the face of the valve base.
Regarding the component being relatively rigid, Falconer does not expressly disclose whether the device is made out of a rigid or flexible material however, the only movement that falconer discloses the device having is in regards to the movement of the from the open position to the closed position and vice versa through the manipulation of the user handle occurring to rotate the fixtures in relation to one another, the individual components are shown to maintain the same formation throughout the entire process and therefore are considered to be rigid enough to maintain their originally molded form. Furthermore, it would have been obvious to one of ordinary skill in the art to have had the components of the device formed from a relatively rigid material as the device requires elements such as 44 to remain in position (channel 46) in order to properly function and making the elements allowing for this connection flexible rather than rigid would have resulted in nonintentional failure of the device during use. Therefore, it is obvious for the component 16 to have been made of a relatively rigid material in order to remain in the placement required for proper function and avoid failure of the device.
Regarding the outlet tube portion being relatively flexible, the disclosure of Falconer fails to disclose the characteristics of the outlet tube portion.
However, Lutz, in the same field of endeavor of urostomy bags, discloses an outlet tube 12 that is flexible and has a constant diameter along its length (Col. 3 lines 10-25), wherein an outlet diameter (Col. 3 lines 10-25, constant diameter along its length) is marginally smaller than a connector diameter of a connector such that, on insertion of the connector into the flexible outlet tube portion, the flexible outlet tube flexes to accommodate the connector (Figure 2 shows the portion 12A flexing around the inserted portion of element 18) for the purpose of securely and sealingly connecting the tube to the flow pathway of the bag (Col. 3 lines 26-40) and easily positioning the discharge end of the device over the opening of a waste receptacle such as a toilet or urinal (Col. 3 lines 10-25).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted outlet tube portion of Falconer that performs the function of guiding fluid flow out of the fluid collection device for the outlet tube portion of Lutz since these elements perform the same function of guiding fluid flow out of a collection device. Simply substituting one fluid guiding means for another would yield the predictable result of allowing a(n) fluid collection appliance to guide fluid output. See MPEP 2143.
Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have performed this substitution for the purpose of securely and sealingly connecting the tube to the flow pathway of the bag (Col. 3 lines 26-40 of Lutz) and easily positioning the discharge end of the device over the opening of a waste receptacle such as a toilet or urinal (Col. 3 lines 10-25 of Lutz) as taught by Lutz.
As the component of Falconer is considered rigid (see above) and the outlet tube of Lutz considered flexible, the combination of the teachings of Lutz with the disclosure of Falconer renders obvious would have obviated the limitation of the relatively rigid component being relatively more rigid than the relatively flexible outlet tube portion.
Falconer in view of Lutz do not expressly disclose or suggest the relatively flexible outlet tube portion permanently affixed by over-moulding onto the relatively rigid component, as while Lutz further teaches the tube being permanently attached to the bottom opening 100B (Col. 3 lines 26-40 of Lutz), Lutz does not expressly teach how this permanent attachment would take place and if it would include the permanent attachment of the tube to the rigid component through additional structure or through bonding means.
However, Wong, in the same field of endeavor of liquid transport through an outlet element capable of opening and closing ¶0065, discloses permanently affixing a relatively flexible (¶0055 flexible material) component 51 to a relatively rigid (¶0055 rigid material) component 52 by over-moulding the flexible component onto the rigid component (¶0016 overmolded as a unitary structure, ¶0025 applying a material of the spout into the overmolding mold for overmolding the spout around the linking portion of the reinforcement unit) for the purpose of forming as a unitary structure (¶0016) that has higher strength and increased twisting torque to prevent releasing and separation of the spout from the base.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the rigid and flexible components of Falconer in view of Lutz to have been permanently affixed (as suggested by Lutz Col. 3 lines 26-40) by overmoulding, as taught by Wong for the purpose of forming a unitary structure (¶0016) that has higher strength and increased twisting torque to prevent releasing and separation of the spout from the base.
Regarding claim 20, Falconer discloses an outlet valve 14 for a urine collection appliance 10 comprising:
a valve base 20 for attachment to a face 12 of the urine collection appliance 10, the valve base 20 defining a base opening 40 for receiving a liquid output from the ostomy appliance 10; and
an outlet element 16 configured to be rotatable relative to the valve base 20 from a closed configuration in which discharge of the liquid received through the base opening 40 is prevented, to an open configuration in which discharge of the liquid received through the base opening is enabled;
a detent (as recess 46, detent is defined by Merriam-Webster as a device for positioning and holding one mechanical part in relation to another in a manner such that device can be released by force applied to one of the parts, recess 46 holds element 44 and thus tap member 16 captive within the tubular device when forced through the notch 48 with a snap-action until forcibly removed Col. 3 lines 23-49) integrally formed with the valve base (Col. 2 lines 5865 tap body 18 has an integral attachment portion 20, recess 46 integral with tap body 18 and thus integral with valve base, integral elements 18 and 20) outside and adjacent to (detent 46 formed on outer surface of housing 34 and is adjoined with the housing and therefore adjacent to housing according to definition of Oxford dictionary stating the definition of adjacent to be “next to or adjoining something else”) a housing 34 configured to receive therein the outlet element (dimensioned to receive barrel 24 of outlet element); and
a first protrusion 44 integrally formed with an outer face of the outlet element (integrally formed with element 30 which is integrally attached to outer face of element 22) arranged adjacent to a portion of the outlet element received in the housing (Fig. 5 shows element 44 adjacent to barrel 24 which is received in the housing), the first protrusion configured to ride over the detent (projection slides in the recess and recess contacts sides of protrusion with the detent being placed beyond the projection on the three sides of the projection and thus riding over, with over being defined using its adverb definition according to https://www.dictionary.com/browse/over stating beyond the upper surface of something);
wherein the outlet element 16 comprises a component 16 rotatably attached to the valve base 20 and having a tubular and generally L-shaped form (see Figure 9), and an outlet tube portion (Col. 4 lines 43-52, external drainage tube) affixed (affixed through snap-fit connector) to the component 16;
wherein in the open configuration the component 16 is configured to transmit (See Col. 4 lines 18-42 regarding fluid flow) the liquid to an outlet opening (outlet of outlet tube portion) of the outlet tube portion (Col. 4 lines 43-52, external drainage tube).
Falconer does not expressly disclose the valve being for an ostomy appliance; a detent integrally formed with the valve base outside and adjacent to the housing, the detent being a raised elongate protrusion extending from a face of the valve base, a second protrusion wherein the first and second protrusions are spaced apart around the outer face of the outlet element, the first protrusion riding over the detent providing at least one of audible and tactile confirmation the outlet element has been moved out of its initial closed configuration, the second protrusion configured to ride over the detent providing at least one of audible and tactile confirmation the outlet element reached or is approaching a closed configuration; the rigidity of the device, the flexibility of the outlet tube portion attached to a relatively rigid component, or a diameter of the outlet tube portion or connector.
However, regarding the valve being for an ostomy appliance, the limitation of “for an ostomy appliance” is considered functional language (denotes how the valve is to be used, i.e., with an ostomy appliance). While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Falconer discloses all the structure as claimed, and is further used as a drain for a device used to collect human waste products. As such, it is capable of performing the functions as claimed (i.e., it is capable of being used with an ostomy appliance).
Regarding the device having first and second protrusions spaced apart around the outer face of the outlet element, Allen, in the same field of endeavor of ostomy outlet elements, teaches a detent (42 as recess/groove ¶0030) integrally formed with a face (face of 26 opposite of a valve base 26 outside and adjacent to (¶0031 outside and adjacent to entrance to passage 24 formed by housing 38) a housing 38 configured to receive therein a body 14 comprising an outlet element 30 and two or more (¶0032 first formation may include multiple projections which are spaced apart from each other around the outer surface of the body to ensure engagement) protrusions arranged on a body 14 adjacent to housing (as 42 is adjacent and 40 is in line with 42 it is also adjacent).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the projection/detent formation of Falconer that performs the function of retaining the outlet element within the valve body for the projection/detent formation of Allen since these elements perform the same function of retaining an element within a passage. Simply substituting one element retaining means for another would yield the predictable result of allowing a(n) element to be retained within a cylindrical passage way. See MPEP 2143.
Regarding the detent being a raised elongate protrusion extending from a face of the valve base and providing a tactile or audible confirmation of the outlet element being moved out of an initial closed configuration and reaching or approaching a closed configuration respectively, Jepsen, in the same field of endeavor of ostomy appliance valves, teaches a recess 9 comprising raised elongate protrusions (12 and 13) extending from the face of the recess (protruding inherently has a dimension extending from the surface that they protrude from) configured to ride over a protrusion 10 (protrusion 10 slides within detent 9 and rides over 12 and 13 such that the user feels the bumps during twisting of the valve stem ¶0027) with the first protrusion 13 riding over the detent 10 at a position (position of recess 9 just prior to annular recess 11 marked by protrusion 12) that indicates through tactile feedback (¶0027 tactile feedback) the outlet element 6 has moved out of its initial closed configuration (in fully closed position element 10 past element 13 rides over 13 to indicated moving into recess 9 towards open position), and the second protrusion 12 riding over the detent 10 at a position that indicates through tactile feedback (¶0027 tactile feedback) the outlet element is approaching the closed configuration (When detent 10 is in channel 11 as it approaches channel 9 rides over indent 12 indicating that it is approaching fully closed configuration) provides tactile feedback to the user of the position of the valve with regard to its open and closed configuration (¶0027 bumps are there to provide tactile feedback to the user of the position of the valve stem with respect to the housing…when the user feels the proximal bump 12 during twisting of the valve stem, the user will know that the annular recess has been reached) for the purpose of providing tactile feedback to the user as to the open and closed configuration of the device ¶0027.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the detent and protrusions of Falconer in view of Allen to have comprised a raised elongate protrusion within the recess that interacts with the protrusions taught by Allen in which the detent rides over and provides tactile confirmation of the outlet element being moved out of its initial closed configuration and approaching a closed configuration , as taught by Jepsen, for the purpose of providing tactile feedback to the user as to the open and closed configuration of the device ¶0027.
As the recess of Falconer in view of Allen is continuous with the face of the valve base facing away from the attachment face, any protrusion present within the recess would necessarily protrude from the recess and thus protrude from the face of the valve base.
Regarding the component being relatively rigid, Falconer does not expressly disclose whether the device is made out of a rigid or flexible material however, the only movement that falconer discloses the device having is in regards to the movement of the from the open position to the closed position and vice versa through the manipulation of the user handle occurring to rotate the fixtures in relation to one another, the individual components are shown to maintain the same formation throughout the entire process and therefore are considered to be rigid enough to maintain their originally molded form. Furthermore, it would have been obvious to one of ordinary skill in the art to have had the components of the device formed from a relatively rigid material as the device requires elements such as 44 to remain in position (channel 46) in order to properly function and making the elements allowing for this connection flexible rather than rigid would have resulted in nonintentional failure of the device during use. Therefore, it is obvious for the component 16 to have been made of a relatively rigid material in order to remain in the placement required for proper function and avoid failure of the device.
Regarding the outlet tube portion of the device being flexible, the disclosure of Falconer fails to disclose the characteristics of the outlet tube.
However, Lutz, in the same field of endeavor of urostomy bags, discloses an outlet tube 12 that is flexible and has a constant diameter along its length (Col. 3 lines 10-25), wherein an outlet diameter (Col. 3 lines 10-25, constant diameter along its length) is marginally smaller than a connector diameter of a connector such that, on insertion of the connector into the flexible outlet tube portion, the flexible outlet tube flexes to accommodate the connector (Figure 2 shows the portion 12A flexing around the inserted portion of element 18) for the purpose of securely and sealingly connecting the tube to the flow pathway of the bag (Col. 3 lines 26-40) and easily positioning the discharge end of the device over the opening of a waste receptacle such as a toilet or urinal (Col. 3 lines 10-25).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted outlet tube portion of Falconer that performs the function of guiding fluid flow out of the fluid collection device for the outlet tube portion of Lutz since these elements perform the same function of guiding fluid flow out of a collection device. Simply substituting one fluid guiding means for another would yield the predictable result of allowing a(n) fluid collection appliance to guide fluid output. See MPEP 2143.
Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have performed this substitution for the purpose of securely and sealingly connecting the tube to the flow pathway of the bag (Col. 3 lines 26-40 of Lutz) and easily positioning the discharge end of the device over the opening of a waste receptacle such as a toilet or urinal (Col. 3 lines 10-25 of Lutz) as taught by Lutz.
As the component of Falconer is considered rigid (see above) and the outlet tube of Lutz considered flexible, the combination of the teachings of Lutz with the disclosure of Falconer renders obvious the limitation of the relatively rigid component being relatively more rigid than the relatively flexible outlet tube portion.
Falconer in view of Lutz do not expressly disclose or suggest the relatively flexible outlet tube portion permanently affixed by over-moulding onto the relatively rigid component, as while Lutz further teaches the tube being permanently attached to the bottom opening 100B (Col. 3 lines 26-40 of Lutz), Lutz does not expressly teach how this permanent attachment would take place and if it would include the permanent attachment of the tube to the rigid component through additional structure or through bonding means.
However, Wong, in the same field of endeavor of liquid transport through an outlet element capable of opening and closing ¶0065, discloses permanently affixing a relatively flexible (¶0055 flexible material) component 51 to a relatively rigid (¶0055 rigid material) component 52 by over-moulding the flexible component onto the rigid component (¶0016 overmolded as a unitary structure, ¶0025 applying a material of the spout into the overmolding mold for overmolding the spout around the linking portion of the reinforcement unit) for the purpose of forming as a unitary structure (¶0016) that has higher strength and increased twisting torque to prevent releasing and separation of the spout from the base.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the rigid and flexible components of Falconer in view of Lutz to have been permanently affixed (as suggested by Lutz Col. 3 lines 26-40) by overmoulding, as taught by Wong for the purpose of forming a unitary structure (¶0016) that has higher strength and increased twisting torque to prevent releasing and separation of the spout from the base.
Regarding claim 24, Falconer in view of Lutz, Wong, Allen, and Jepsen suggest the outlet valve of claim 11. Falconer further discloses the portion of the intake tube being rotatably mounted within the cylindrical bore comprising a retention feature comprising an annular recess (Col. 4 lines 53-67, ridge 70 formed by an o-ring which is fitted over the barrel and retained in position by seating in an annular recess) configured to engage a corresponding annular protrusion 70 arranged on a wall of the housing inside the cylindrical bore (Col. 4 lines 53-67, “provides a seal between the barrel and the interior surface of the housing” indicates that the protrusion 70 is in contact and thus arranged on a wall of the housing inside the cylindrical bore).
Regarding claim 25, Falconer in view of Lutz, Wong, Allen, and Jepsen suggest the outlet valve of claim 1. Falconer further discloses a ridge 50 provided on an outer face of the valve base (provided on face of 20, the ridge configured to abut a portion of the outlet element in the closed configuration (Fig. 6 shows element 50 abutting lower portion of 16) and provide a barrier to restrict access to at least part of the outlet element and avoid unintended rotation (Col. 3 lines 50-59 reduces risk of the tap accidently being pulled open by an object becoming caught behind the handle).
Regarding claim 26, Falconer in view of Lutz, Wong, Allen, and Jepsen suggest the outlet valve of claim 1. Falconer further discloses the appliance comprising a sealing line (Col. 2 lines 58-65, lower peripheral seam of the bag 10) arranged adjacent to and below (Col. 2 lines 58-65, tap positioned adjacent to the lower peripheral seam, Fig. 2 shows lower peripheral seam below the base opening 40) the base opening for passing liquid to the outlet element and limiting liquid collecting within the ostomy appliance below the base opening (provides the lower limit to which fluid can flow as the seam is sealed preventing fluid flow past that point thus limiting liquid collecting within the appliance to the seam).
Falconer does not expressly disclose the sealing line being welded. However, the claimed phrase “welded” is being treated as a product by process limitation as a material that results from the welding process. As set forth in MPEP 2113, “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 in the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695,698,227 USPQ 964,966 (Fed. Cir. 1985). Examiner notes since there was no evidence provided by the applicant that the process of being welded imparts structural difference onto the end product of the claimed invention that is not present in the prior art, the limitation “welded” is being given very little patentable weight.
Furthermore, Falconer teaches forming a seam of the bag through welding (Col. 1 lines 56-67) for the purpose of providing a strong and reliable seal.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the lower peripheral seam of Falconer that performed the function of fluidically sealing of a joint of a device for the welded seam of Falconer since these elements perform the same function of sealing a joint of two elements such that fluid cannot pass. Simply substituting one fluidically sealed jointing means for another would yield the predictable result of allowing a joint to be fluidically sealed. See MPEP 2143.
As mentioned in claim 1, Falconer does not expressly disclose the appliance being an “ostomy appliance” however, the limitation of “ostomy” is considered functional language (denotes how the appliance is to be used, i.e., with an ostomy). While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Falconer discloses all the structure as claimed, and is further used as a fluid collection device used to collect human waste products. As such, it is capable of performing the functions as claimed (i.e., it is capable of being used with an ostomy).
Regarding claim 27, Falconer in view of Lutz, Wong, Allen, and Jepsen suggest the outlet valve of claim 1. Falconer in view of Lutz, Wong, Allen, and Jepsen as rejected above in claim 1 do not expressly disclose or suggest the detent comprising a material that is relatively less rigid than a material forming the first and second protrusions to facilitate passing of the detent and the first and second protrusion over each other in use.
However, Allen, in the same field of endeavor of valve arrangements for ostomy appliances, further teaches making a component that is to be road over by another a body, out a material that is relatively more flexible than the body that is riding over for the purpose of allowing for temporary flexing of the relatively more flexible component away from the body riding over to aid the movement of the body over the element and return to its normal shape after the riding over has occurred (¶0036 planar member 26 made from relatively more flexible material than body 14 such that the planner member flexes “away from the first formation 40 as the body is moved towards its position in the second formation 42 to aid movement of the body into position and then return to its normal shape).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the detent out of a material that is relatively less rigid than a material forming the first and second protrusions to facilitate passing of the detent and the first and second protrusions over each other in use, as taught by Allen, for the purpose of aiding the movement of the first and second protrusions over the detent when they ride over the detent such that it is easier to move the protrusions over the detent into the positions before and after the detent. This would have the expected benefit of ensuring that movement of the outlet element along the pathway between open and closed positions is not overly encumbered by the contact between the detent and the protrusions which would result in the device being easier to manipulate between open and closed positions while still retaining the function of detent and protrusions.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Falconer (U.S. Patent No. 6,021,928 with reference to European Patent Application EP-0753323-A1) in view of Lutz (U.S. Patent No. 6,132,408), Wong (U.S. Publication 2021/0206541 as reliant upon provisional application No. 62/957,538 disclosure filed on January 6th, 2020) and Allen (U.S. Publication 2022/0054296) and further in view of Jepsen (U.S. Publication 2017/0156919); and further in view of Burgess et al. (U.S. Publication 2009/0030379).
Regarding claim 21, Falconer in view of Lutz and Wong suggest the outlet valve of claim 1. Falconer in view of Lutz do not expressly disclose or suggest the valve base and relatively rigid components being formed from polypropylene, high-density polyethylene, acrylonitrile butadiene styrene, or polycarbonate.
However, in the same field of endeavor of drainage bag valves, Burgess discloses making rigid or semi-rigid plastic materials of an outlet device from polyethylene, polypropylene or polycarbonate (¶0032) as these materials are examples of rigid or semi-rigid plastics.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the rigid material of the valve of Falconer that performs the function of providing enough rigidity for the device to function for the rigid plastic materials of either polypropylene or polycarbonate as taught by Burgess as these are materials are known in the art to be rigid and would perform the same function of allowing enough rigidity to the device to be manipulated by the user. Simply substituting one rigid material for another would yield the predictable result of the device being rigid.
Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to make the valve base and relatively rigid components out of polypropylene or polycarbonate, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Falconer (U.S. Patent No. 6,021,928 with reference to European Patent Application EP-0753323-A1) in view of Lutz (U.S. Patent No. 6,132,408), Wong (U.S. Publication 2021/0206541 as reliant upon provisional application No. 62/957,538 disclosure filed on January 6th, 2020) and Allen (U.S. Publication 2022/0054296) and further in view of Jepsen (U.S. Publication 2017/0156919); and further in view of Brault-Guyon et al. (U.S. Publication 2015/0306372).
Regarding claim 22, Falconer in view of Lutz and Wong suggest the outlet valve of claim 1. Falconer in view of Lutz do not expressly disclose or suggest the relatively flexible outlet tube portion being formed from ethylene-vinyl acetate or a thermoplastic elastomer.
However, in the same field of endeavor of fluid conducting flexible tubing, Brault-Guyon teaches a tube formed from ethylene-vinyl acetate ¶0030 for the purpose of increasing adherence between the connector and the tube once these have been attached ¶0034.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have formed the tube of Falconer from ethylene-vinyl acetate as taught by Brault-Guyon for the purpose of increasing adherence between the connector and the tube once these have been attached ¶0034.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/PETER DANIEL SMITH/Examiner, Art Unit 3781
/PHILIP R WIEST/Primary Examiner, Art Unit 3781