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
Claim amendments filed April 14th, 2026 have been entered. Claims 1, 5, 8, 10-17, 19, 23-27 are currently pending and under consideration. Claims 2-3, 4, 6-7, 9, 18, 20-22 have been cancelled. Claims 1 and 25 have been amended. Claims 26 and 27 have been newly added. All previously set forth claim objections have been overcome.
Response to Arguments
Applicant's arguments filed April 14th, 2026 have been considered but are not found to be persuasive.
Regarding applicant’s arguments pertaining to claims 1 and 25, examiner agrees that the amended claim limitations have overcome the previously presented rejection of record. However, in light of the teachings of Nakagami (U.S. Publication 2020/0271232) these limitations are seen to have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention. Applicant’s arguments have thus been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
Claim(s) 1, 5, 8, 10-15, 17, 19, and 23-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Falconer (U.S. Patent No. 6,021,928) in view of Nakagami (U.S. Publication 2020/0271232) and further in view of Jepsen (U.S. Publication 2017/0156919).
Regarding claim 1, Falconer discloses an outlet valve for an drainage bag comprising: a valve base (Fig. 3) for attachment to a face of the bag (Col. 2 lines 58-65 attachment portion 20 welded to the wall of the drainage bag), the valve base (Fig. 3) defining a base opening 40 for receiving a liquid output from the bag (Col. 3 lines 12-22 allows fluid in bag to communicate with tap member); and an outlet element (Fig. 5) configured to be axially fixed relative to the valve base (Col. 3 lines 23-49 held by recess 46 with engaged projection 44 within tubular housing and thus maintains axial alignment) and rotatable (Col. 3 lines 1-11 rotatably moved) relative to the valve base from a closed configuration (Col. 3 lines 1-11 closed position) in which discharge of the liquid received through the base opening is prevented, to an open configuration (Col. 3 lines 1-11 open position) in which discharge of the liquid received through the base opening is enabled; wherein an outer face (face of valve base opposite to face attached to bag 12) of the valve base comprises (detent located on housing 34 which is continuous with outer face of valve base and as such the detent is on the outer face of the valve base) a detent (46) and the outlet element comprises a protrusion (44); wherein the detent is configured to engage the one or more protrusions during a rotation of the outlet element (Col. 3 lines 23-49 projection 44 slides in recess 46 as tap member is moved between open and closed positions) such that the detent contacts and rides over the protrusion during the rotation (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 comprises an outlet tube 22 at its distal end and the outlet element is rotatable such that the outlet tube moves through an arc of rotation (Figs. 6 through 8 illustrate different positions along arc of rotation from closed to open configuration), and wherein at a first end of the arc of rotation, the outlet element is in the closed configuration (Fig. 6 shows outlet element positioned at first end of rotation in closed position), and at a second end of the arc of rotation, the outlet element is in the open configuration (Fig. 8 shows outlet element at second end of rotation in open position), and wherein the detent is configured to engage at least one protrusion at a point during rotation of the outlet element that does not correspond to the first end of the arc of rotation (detent engages protrusion throughout entire arc of rotation and therefore engages protrusion at multiple points that do not correspond to the first end of the arc of rotation); wherein the detent is configured to contact and ride over at least one protrusion when the outlet element is at, or near a limit position (Fig. 8 shows limit position of outlet element in arc of rotation to open), wherein the limit position is defined as a point on the arc of rotation at which the outlet element is furthest from the first end and also still in the closed configuration (detent is in contact with and rides over the protrusion throughout the arc of rotation from the closed position to the open position and therefore includes at and near the limit position of the outlet element).
Falconer does not expressly disclose the outlet valve being for an ostomy bag, an outer face of the valve base comprising a detent comprising an elongate raised protrusion and the outlet element comprising two or more protrusions arranged around the circumference of an outer face of an intake tube at the same distance along the intake tube and spaced apart around the circumference of the intake tube; wherein the detent on the outer face of the valve base is configured to engage the two or more protrusions during a rotation of the outlet element such that the detent contacts and rides over one or more of the two or more protrusions during the rotations, wherein the detent is configured to engage at least one protrusion of the two or more protrusions at a point during rotation of the outlet element that does not correspond to the first end of the arc of rotations; wherein the detent is configured to contact and ride over at least one protrusion of the two or more protrusions when the outlet element is at, or near a limit position to provide one or both of an audible or tactile confirmation that the outlet element is at, or near, the limit position.
Regarding the outlet valve being for an ostomy bag, however, the limitations of “ostomy bag” are considered functional language (describe the function of the bag to be used for the purpose of 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 the disclosed bag is further stated for use for body waste or body fluids (Col. 1 lines 5-7). As such, it is capable of performing the functions as claimed (i.e., it is capable of functioning as an ostomy bag).
Regarding the detent and two or more protrusions, Nakagami, in the same field of endeavor of fluid controlling valves (Title flow path switching device), teaches an outer face (¶0110 outer surface) of a valve base 101 comprising a detent (one of protrusions 152) comprising an elongate raised protrusion (¶0110 protrusion; Fig. 1 shows elongate nature of protrusions 152) and an outlet element (102 and 124) comprising two or more protrusions (¶0111 protrusions formed on both the outer cylinder and the handle so that the protrusions on the outer cylinder and the handle get over each other; protrusions in place of recesses 153) arranged around the circumference (Fig. 17 shows arrangement of elements 153 around circumference of intake tube 102 within 101) of an outer face of an intake tube 102 at the same distance along the intake tube (positioned at the same lateral positioning of the intake tube in element 124) and spaced apart around the circumference of the intake tube (Fig. 17 shows spacing apart along the circumference of element 153); wherein the detent on the outer face of the valve base is configured to engage the two or more protrusions during a rotation of the outlet element such that the detent contacts and rides over one or more of the two or more protrusions during the rotations (¶0110 152 and 152 formed so that 152 engage with 153 when the plug reaches the second position while the user is rotating the plug from the first position toward the second position and when the plug reaches the first position while the user is rotating the plug from the second position toward the first position, ¶0111 protrusions on the outer cylinder and the handle get over each other, i.e. ride over), wherein the detent is configured to engage at least one protrusion of the two or more protrusions at a point during rotation of the outlet element that does not correspond to a first end of the arc of rotations (engages when the plug reaches the second position while the user is rotating the plug from the first position toward the second position); wherein the detent is configured to contact and ride over at least one protrusion of the two or more protrusions when the outlet element is at, or near a limit position to provide one or both of an audible or tactile confirmation that the outlet element is at, or near, the limit position (¶0110 when 152 engage 153 resistance to rotation of the plug occurs, giving the user who is gripping the handle the feel of a click).
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 outer face of the valve base and the outlet element to have included the protrusions as taught by Nakagami for the purpose of providing a click mechanism that makes the user aware that the plug is located a particular flow configuration of the device (¶0109 may include a click mechanism that makes the user aware that the plug is located at the first position or the second position).
Nakagami does not expressly suggest the limit position being defined as a point on the arc of rotation at which the outlet element is furthest from a first end and still in a closed configuration. However, Nakagami, suggests the click mechanism (¶0109 click mechanism) giving the user gripping the handle the feel of a click (¶0110 giving the user who is gripping the handle the feel of a click) and this click mechanism being comprised of the protrusions detailed above that “get over each other” (¶0111 so that the protrusions on the outer cylinder and the handle get over each other) but does not expressly disclose whether the second position intended to be reach occurs after the riding over or before the riding over contact of the protrusion.
However, it would have been obvious to try to one of ordinary skill in the art at the time the invention was made to have the second position occur after the riding over of the protrusion, thus leading the protrusion to be placed at a limit position corresponding to a position immediately prior and thus a point at which the outlet element is furthest from the first configuration but still not in the second configuration since there are only a finite number of predictable solutions. Either the “click” felt by the user indicates the second position at the point before the protrusions ride over one another or after one another. Furthermore, Nakagami further suggest providing a full stop restriction protrusion that restricts rotation of the device such that rotation fully stops at the first or second position ¶0112 which would suggest that if the protrusions were capable of riding over one another during rotation this rotation would have to occur before the first/second position is reached. Thus, making the limit position at which the protrusion is located be defined as a point on the arc of rotation at which the outlet element is furthest from a first end and still in a closed configuration, would have been obvious because “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp”. If this leads to the anticipated success, it is likely that product was not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103."KSR, 550 U.S. at 421, 82 USPQ2d at 1397. See MPEP 2143.
Furthermore, Jepsen, in the same field endeavor of valved outlets for ostomy devices (Abstract), teaches raised protrusions (12 and 13) configured to ride over a detent comprising an elongate protrusion 10 at a limit position (position of recess 9 just prior to annular recess 11) that defines the point furthest from the first end at which the outlet element is in the closed configuration with protrusion 10 entering annular recess 11 when in the open configuration, the raised protrusion 12 that 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 of Falconer in view of Nakagami to have positioned such that it interacts with the protrusion in which the detent rides over and provides tactile confirmation that the outlet element is at, or near, the limit position, that defines the point furthest from the first end at which the outlet element is in the 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.
Regarding claim 5, Falconer in view Nakagami and Jepsen suggest the outlet valve as claimed in claim 1. Falconer in view of Nakagami in view of Jepsen further suggest the detent is further configured to engage at least one protrusion at a point during rotation of the outlet element that corresponds to the second end of the arc of rotation (detent riding over the protrusions at the limit position into the open configuration would result in engagement of the protrusion during rotation of the outlet element that corresponds to the second end of the arc of rotation, i.e. the open configuration).
Regarding claim 8, Falconer in view Nakagami and Jepsen suggest the outlet valve as claimed in claim 1. Falconer further discloses the outlet tube is rotatable in a plane generally perpendicular to an attachment face of the valve base (arc of rotation occurs in plane perpendicular to attachment face 20 as seen in figs. 6-8).
Regarding claim 10, Falconer in view Nakagami and Jepsen suggest the outlet valve as claimed in claim 1. Falconer further discloses the outlet element is configured such that in the limit position, in use, the outlet tube is angled generally upwards and at an acute angle to the valve base (see below illustrative diagram of Fig. 7 and 8).
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Illustrative diagram of Fig. 7 and 8 of Falconer.
Regarding claim 11, Falconer in view Nakagami and Jepsen suggest the outlet valve as claimed in claim 1. Falconer further discloses the outlet element (Fig. 5) defines an intake opening 28 in fluid connection with the outlet tube 22, wherein: in the open configuration the base opening and the intake opening are partially or fully aligned such that liquid may be received into the intake opening from the base opening and discharged through the outlet tube (Fig. 8 shows alignment of base opening 40 and 28 to result in open configuration); and in the closed configuration the base opening and the intake opening are not aligned such that discharge of the liquid received through the base opening is prevented (Fig. 6 and 7 show opening 28 out of alignment with opening 40 to result in closed configuration of valve).
Regarding claim 12, Falconer in view Nakagami and Jepsen suggest the outlet valve as claimed in claim 11. Falconer further discloses the intake opening is arranged in a curved lateral wall of the outlet element (arranged in wall of barrel 24 which is tubular and curved).
Regarding claim 13, Falconer in view Nakagami and Jepsen suggest the outlet valve as claimed in claim 11. Falconer further discloses the outlet element further comprises an intake tube 24, the intake tube 24 and the outlet tube 22 together defining a continuous hollow bore for passage of the liquid from the intake opening to an outlet opening arranged at an end of the outlet tube distal to the intake tube (wall of 24 continuous with wall of 22).
Regarding claim 14, Falconer in view Nakagami and Jepsen suggest the outlet valve as claimed in claim 13. Falconer further discloses the outlet element has a generally L-shaped form, the intake tube being arranged at an angle of substantially 90 degrees to the outlet tube (Col. 2 lines 66-67, generally L-shaped, Fig. 5 element 24 can be seen to be at 90 degree angle to 22).
Regarding claim 15, Falconer in view Nakagami and Jepsen suggest the outlet valve as claimed in claim 13. Falconer further discloses a housing 34 protrudes from an outer face 20 of the valve base (Fig. 3), the housing defining a cylindrical bore, a portion of the intake tube being rotatably mounted with the cylindrical bore (Col. 3 lines 12-22, tubular housing receives barrel).
Regarding claim 17, Falconer in view Nakagami and Jepsen suggest the outlet valve as claimed in claim 13. Falconer further discloses the outlet element rotates about an axis of rotation arranged generally parallel to an attachment face of the valve base and generally horizontally in use (see below illustrative diagram of Figs 1 and 2 below).
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Illustrative diagram of Figs. 1 and 2 of Falconer.
Regarding claim 19, Falconer in view Nakagami and Jepsen suggest the outlet valve as claimed in claim 1. Falconer further discloses wherein in the closed configuration the base opening is obstructed by a wall of the outlet element (Figs. 6 and 7 show wall of 24 obstructing opening 40).
Regarding claim 23, Falconer in view Nakagami and Jepsen suggest the outlet valve of claim 1. Falconer further discloses an ostomy (see above functional claim language explanation of claim 1) bag 10, wherein the outlet valve is attached to an outer face (outer face of front wall 12) of the ostomy bag 10.
Regarding claim 24, Falconer in view Nakagami and Jepsen suggest the outlet valve of claim 23. Falconer further discloses wherein: in the closed configuration the outlet element substantially overlies a cavity of the ostomy bag (Fig. 1 shows outlet element 22 overlying bag 10); and in the open configuration at least a portion of the outlet element extends across a lower edge of the cavity of the ostomy bag (Fig. 2 shows element 22 extending across lower edge of the bag).
Regarding claim 25, Falconer discloses an outlet valve (Fig. 1) for a drainage bag comprising: a valve base (Fig. 3) for attachment to a face of the bag appliance (Col. 2 lines 58-65 attachment portion 20 welded to the wall of the drainage bag), the valve base defining a base opening 40 for receiving a liquid output from the bag (Col. 3 lines 12-22 allows fluid in bag to communicate with tap member); and an outlet element (Fig. 5) configured such that the outlet element does not slide axially relative to the valve base (Col. 3 lines 23-49 held by recess 46 with engaged projection 44 within tubular housing and thus maintains axial alignment) and is rotatable (Col. 3 lines 1-11 rotatably moved) relative to the valve base through an arc of rotation (Figs. 6 through 8 illustrate different positions along arc of rotation from closed to open configuration) around an axis of rotation (see illustrative diagram of Figs. 1 and 2 of Falconer above in rejection of claim 17) defined through the base and from a first end of the arc of rotation (Fig. 6 shows outlet element positioned at first end of rotation in closed position) to a second end of the arc rotation (Fig. 8 shows outlet element at second end of rotation in open position), such that a portion of the outlet element moves from a closed configuration (Fig. 6) in which discharge of the liquid received through the base opening is prevented, to an open configuration (Fig. 8) in which discharge of the liquid received through the base opening is enabled; wherein at the first end of the arc of rotation, the outlet element is in the closed configuration (Fig. 6 shows outlet element positioned at first end of rotation in closed position), and at the second end of the arc of rotation, the outlet element is in the open configuration (Fig. 8 shows outlet element at second end of rotation in open position); wherein a limit position (Fig. 7) of the portion of the outlet element is defined at a point on the arc of rotation furthest from the first end at which the outlet element is in the closed configuration; wherein an outer face (face of valve base opposite to face attached to bag 12) of the valve base comprises (detent located on housing 34 which is continuous with outer face of valve base and as such the detent is on the outer face of the valve base) a detent 46 and the outlet element comprises a protrusion 44; and wherein the detent is configured to engage the one or more protrusions during a rotation of the outlet element (Col. 3 lines 23-49 projection 44 slides in recess 46 as tap member is moved between open and closed positions) such that the detent contacts and rides over the protrusion (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) when the outlet element is at or near the limit position during rotation (detent is in contact with and rides over the protrusion throughout the arc of rotation from the closed position to the open position and therefore includes at and near the limit position of the outlet element) wherein rotation about the axis alone transitions the outlet element between the closed configuration and the open configuration (valve only rotated on axis of rotation during operation between closed and open configurations).
Falconer does not expressly disclose the outlet valve being for an ostomy bag, an outer face of the valve base comprising a detent comprising an elongate raised protrusion and the outlet element comprising two or more protrusions arranged around the circumference of an outer face of an intake tube at the same distance along the intake tube and spaced apart around the circumference of the intake tube; wherein the detent on the outer face of the valve base is configured to engage the two or more protrusions during a rotation of the outlet element such that the detent contacts and rides over one or more of the two or more protrusions during the rotations, wherein the detent is configured to engage at least one protrusion of the two or more protrusions at a point during rotation of the outlet element that does not correspond to the first end of the arc of rotations; wherein the detent is configured to contact and ride over at least one protrusion of the two or more protrusions when the outlet element is at, or near a limit position to provide one or both of an audible or tactile confirmation that the outlet element is at, or near, the limit position.
Regarding the outlet valve being for an ostomy bag, however, the limitations of “ostomy bag” are considered functional language (describe the function of the bag to be used for the purpose of 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 the disclosed bag is further stated for use for body waste or body fluids (Col. 1 lines 5-7). As such, it is capable of performing the functions as claimed (i.e., it is capable of functioning as an ostomy bag).
Regarding the detent and two or more protrusions, Nakagami, in the same field of endeavor of fluid controlling valves (Title flow path switching device), teaches an outer face (¶0110 outer surface) of a valve base 101 comprising a detent (one of protrusions 152) comprising an elongate raised protrusion (¶0110 protrusion; Fig. 1 shows elongate nature of protrusions 152) and an outlet element (102 and 124) comprising two or more protrusions (¶0111 protrusions formed on both the outer cylinder and the handle so that the protrusions on the outer cylinder and the handle get over each other; protrusions in place of recesses 153) arranged around the circumference (Fig. 17 shows arrangement of elements 153 around circumference of intake tube 102 within 101) of an outer face of an intake tube 102 at the same distance along the intake tube (positioned at the same lateral positioning of the intake tube in element 124) and spaced apart around the circumference of the intake tube (Fig. 17 shows spacing apart along the circumference of element 153); wherein the detent on the outer face of the valve base is configured to engage the two or more protrusions during a rotation of the outlet element such that the detent contacts and rides over one or more of the two or more protrusions during the rotations (¶0110 152 and 152 formed so that 152 engage with 153 when the plug reaches the second position while the user is rotating the plug from the first position toward the second position and when the plug reaches the first position while the user is rotating the plug from the second position toward the first position, ¶0111 protrusions on the outer cylinder and the handle get over each other, i.e. ride over), wherein the detent is configured to engage at least one protrusion of the two or more protrusions at a point during rotation of the outlet element that does not correspond to a first end of the arc of rotations (engages when the plug reaches the second position while the user is rotating the plug from the first position toward the second position); wherein the detent is configured to contact and ride over at least one protrusion of the two or more protrusions when the outlet element is at, or near a limit position to provide one or both of an audible or tactile confirmation that the outlet element is at, or near, the limit position (¶0110 when 152 engage 153 resistance to rotation of the plug occurs, giving the user who is gripping the handle the feel of a click).
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 outer face of the valve base and the outlet element to have included the protrusions as taught by Nakagami for the purpose of providing a click mechanism that makes the user aware that the plug is located a particular flow configuration of the device (¶0109 may include a click mechanism that makes the user aware that the plug is located at the first position or the second position).
Nakagami does not expressly suggest the limit position being defined as a point on the arc of rotation at which the outlet element is furthest from a first end and still in a closed configuration. However, Nakagami, suggests the click mechanism (¶0109 click mechanism) giving the user gripping the handle the feel of a click (¶0110 giving the user who is gripping the handle the feel of a click) and this click mechanism being comprised of the protrusions detailed above that “get over each other” (¶0111 so that the protrusions on the outer cylinder and the handle get over each other) but does not expressly disclose whether the second position intended to be reach occurs after the riding over or before the riding over contact of the protrusion.
However, it would have been obvious to try to one of ordinary skill in the art at the time the invention was made to have the second position occur after the riding over of the protrusion, thus leading the protrusion to be placed at a limit position corresponding to a position immediately prior and thus a point at which the outlet element is furthest from the first configuration but still not in the second configuration since there are only a finite number of predictable solutions. Either the “click” felt by the user indicates the second position at the point before the protrusions ride over one another or after one another. Furthermore, Nakagami further suggest providing a full stop restriction protrusion that restricts rotation of the device such that rotation fully stops at the first or second position ¶0112 which would suggest that if the protrusions were capable of riding over one another during rotation this rotation would have to occur before the first/second position is reached. Thus, making the limit position at which the protrusion is located be defined as a point on the arc of rotation at which the outlet element is furthest from a first end and still in a closed configuration, would have been obvious because “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp”. If this leads to the anticipated success, it is likely that product was not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103."KSR, 550 U.S. at 421, 82 USPQ2d at 1397. See MPEP 2143.
Furthermore, Jepsen, in the same field endeavor of valved outlets for ostomy devices (Abstract), teaches raised protrusions (12 and 13) configured to ride over a detent comprising an elongate protrusion 10 at a limit position (position of recess 9 just prior to annular recess 11) that defines the point furthest from the first end at which the outlet element is in the closed configuration with protrusion 10 entering annular recess 11 when in the open configuration, the raised protrusion 12 that 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 of Falconer in view of Nakagami to have been positioned such that it interacts with the protrusion in which the detent rides over and provides tactile confirmation that the outlet element is at, or near, the limit position, that defines the point furthest from the first end at which the outlet element is in the 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.
Regarding claims 26 and 27, Falconer in view of Nakagami and Jepsen suggest the outlet valve of claims 17 and 25 respectively. Nakagami further suggests a length of each of the two or more protrusions being aligned in parallel with an axis of rotation.
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Illustrative diagram of Fig. 1 of Nakagami.
Thus, the modification of the device of the device of Falconer with the teachings of Nakagami as detailed in the above rejection of claims 1 and 25 would have resulted in a length of each of the two or more protrusions being aligned in parallel with an axis of rotation.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Falconer (U.S. Patent No. 6,021,928) in view of Nakagami (U.S. Publication 2020/0271232) and further in view of Jepsen (U.S. Publication 2017/0156919) and Allen (U.S. Publication 2022/0054296).
Regarding claim 16 Falconer in view of Nakagami and Jepsen suggest the outlet valve as claimed in claim 15. Falconer in view of Nakagami and Jepsen do not expressly disclose the detent being arranged on the outer face of the valve base adjacent to the housing and the protrusions arranged on the intake tube adjacent to the housing.
However, Allen in the same field of endeavor of valves for ostomy bags (Abstract) discloses a detent 42 arranged on (¶0031 42 formed in planar member 26) an outer face 26 adjacent to (¶0031 adjacent to entrance to passage 24 formed by housing 38) a housing 38 and two or more protrusions (¶0032 first formation may include multiple projections which are spaced apart from each other around the outer surface of the body to ensure engagement) arranged on a body 14 adjacent to housing (as 42 is adjacent and 40 is in line with 42 it is also adjacent).
Regarding the positioning of the detent and protrusion adjacent to the housing, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have rearranged the detent and protrusion of Falconer in view of Nakagami and Jepsen to have been located adjacent to the housing since this claimed position of the detent and protrusion being on the intake tube and outer face of the valve base adjacent to the housing does not change the detent and protrusions ability to maintain the position of the device and ride over one another to create a tactile feedback when at the limit position of rotation. Since applicant has not given any criticality to why the position of the detent and protrusion disclosed has any importance to the function of the claimed device, the Federal Circuit held that, where the only difference between the prior art and the claims was the position of a claimed element and altering the position of that claimed element would not have modified the operation of the device, the claimed device was not patentably distinct from the prior art device because it merely involved the rearrangement of parts. See MPEP 2144. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER DANIEL SMITH whose telephone number is (571)272-8564. The examiner can normally be reached Monday - Friday 7:30am-5:00pm.
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/PETER DANIEL SMITH/Examiner, Art Unit 3781
/PHILIP R WIEST/Primary Examiner, Art Unit 3781
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