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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on December 18th, 2025 has been entered.
Claim Status
Claim amendments filed December 18th, 2025 have been entered. Claims 1-3, 5, 8, 10-17, 19, 21-25 remain currently pending. Claims 4, 6-7, 9, 18, 20-22 remain cancelled. Claims 1 and 25 have been amended. All previously set forth claim objections have been overcome.
Response to Arguments
Applicant's arguments filed December 18th, 2025 have been fully considered but they are not persuasive.
Regarding applicant’s argument pertaining to Falconer that Falconer provides no teaching or suggestion of a detent based on the definitions of “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” and “a device for positioning and holding one mechanical part in relation to another in a manner such that the device can be released by force applied to one of the parts”, examiner disagrees in that the element 46 to which the examiner points provides a mechanism to maintain element 44 within until the user aligns with element 48 upon which element 44 can be released from element 46 when force is applied in the perpendicular direction to the longitudinal direction of element 44.
Regarding applicants’ argument that element 9 of Jepsen does not fit the definition of a detent, again examiner respectfully disagrees in that the slot 9 temporarily keeps the element 10 positioned within it until force is applied such that element 10 is released into element 11 where it can move freely. As such the examiner does not find this argument persuasive.
Regarding applicant’s argument pertaining to Allen, that Allen does not teach a detent comprising a raised protrusion configured to engage the one or more protrusion during a rotation of the outlet element such that the detent contacts and rides over one or more of the protrusions during the rotation, as pertaining to the rejection presented below, the examiner does not find this argument persuasive as Allen is currently not being relied upon to teach these elements but is simply relied upon to teach the placement of the elements adjacent to the housing as seen in the below rejection of claim 16. As Falconer and Jepsen are relied upon for the structure of the detent, the arguments pertaining to the structure of the detent and protrusion in Allen are considered moot.
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 23-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Falconer (U.S. Patent No. 6,021,928) 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, the detent comprising a raised protrusion, or the detent contacting and riding over the one or more of the protrusions when the outlet element is at or near the limit position during rotation 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 comprising a raised protrusion and provision of an audible or tactile confirmation that the outlet element is at, or near, the limit position, Jepsen teaches a detent 9 comprising raised protrusions (12 and 13) configured to ride over a protrusion 10 (protrusion 10 slides within detent 9) wherein 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 detent 9 includes a 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 to have comprised the raised protrusions within that 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, 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 of Jepsen suggest the outlet valve as claimed in claim 1. Falconer further discloses 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 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 a point during rotation of the outlet element that corresponds to the second end of the arc of rotation).
Regarding claim 8, Falconer in view of 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 of 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).
PNG
media_image1.png
446
633
media_image1.png
Greyscale
Illustrative diagram of Fig. 7 and 8 of Falconer.
Regarding claim 11, Falconer in view of 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 of 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 of 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 of 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 of 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 of 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).
PNG
media_image2.png
326
697
media_image2.png
Greyscale
Illustrative diagram of Figs. 1 and 2 of Falconer.
Regarding claim 19, Falconer in view of 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 of 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 of 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, the detent comprising a raised protrusion, or the detent contacting and riding over the one or more of the protrusions when the outlet element is at or near the limit position during rotation 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 detent comprising a raised protrusion and provision of an audible or tactile confirmation that the outlet element is at, or near, the limit position, Jepsen teaches a detent 9 comprising raised protrusions (12 and 13) configured to ride over a protrusion 10 (protrusion 10 slides within detent 9) wherein 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 detent 9 includes a 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 to have included a bump within that interacts with the protrusion in which the detent rides over, 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.
Claim(s) 2, 3, and 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 Jepsen (U.S. Publication 2017/0156919) and further in view of Allen (U.S. Publication 2022/0054296).
Regarding claims 2, 3, and 16 Falconer in view of Jepsen suggest the outlet valve as claimed in claim 1 (Claims 2 and 3 dependent from) and claim 15 (Claim 16 dependent from). Falconer discloses the valve base comprising the detent and the outlet element comprising one protrusion, but does not expressly disclose two or more protrusions, or 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 as the detent is arranged on the housing and the protrusions are arranged on element 30).
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 Jepsen to be in the 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).
Regarding the presence of the outlet element comprising two or more protrusions, Falconer teaches the detent comprising two protrusion (elements 12 and 13) that interact with one protrusion 10 of the element interacting with the detent.
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 protrusions of the detent and protrusions of the interacting element, as taught by Jepsen, to have been arranged in a reversed arrangement wherein there was two protrusions on the interacting element and only one protrusion in the detent, 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 protrusions ability to interact and ride over one another to create a tactile feedback when at the limit positions defined by the protrusions. 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
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at 571-272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/PETER DANIEL SMITH/Examiner, Art Unit 3781
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781