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 .
Status of Claims
As directed by the amendment filed on 22 November 2024: claim(s) 1, 2, 5, 8-9, 11-21 have been amended, claim(s) 6-7, 22-23 have been cancelled, claim(s) 24 have been added. Thus, claims 1-5, 8-21, and 24 are presently pending.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-5, 8-15, 18-21, and 24 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Scalise et al. (US 20210022911 A1).
Regarding Claim 1, Scalise’911 discloses a valve ("outlet body") for a urostomy appliance ("ostomy collection and drainage system"; Abstract) including: a body ("outlet body 420" [0126]) for connection to the urostomy appliance (see FIG. 1), an inlet and an outlet, connected by a flow path ([0111]; FIGs. 18-20), and a closure arrangement ("closure 440" [0111]; FIGs. 18-20) which is moveable between a closed position, in which the closure arrangement blocks the outlet, such that liquid cannot flow through the outlet, and an open position in which the outlet is open, such that liquid is permitted to flow out of the outlet ("closure 40 is removably coupled to the outlet body 20 to selectively open and close the outlet body 20" [0127]; FIG. 1), wherein the body includes first and second attachment surfaces (see Annotated FIG. 20), wherein the first attachment surface lies substantially in a first plane and the second attachment surface lies substantially in a second plane and the first and second planes are inclined with respect to each other (see Annotated FIG. 20) and wherein the outlet of the valve lies downstream of the inlet in a first direction (see FIG. 18), and each attachment surface extends away from the inlet in a second direction that is opposite to the first direction (see FIG. 18).
Annotated FIG. 20
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Regarding Claim 2, Scalise’911 discloses a valve ("outlet body") for a urostomy appliance ("ostomy collection and drainage system"; Abstract) including: a body ("outlet body 420" [0126]) for connection to the urostomy appliance (see FIG. 1), an inlet and an outlet, connected by a flow path that extends through the body ([0111]; FIGs. 18-20), and wherein the outlet of the valve lies downstream of the inlet in a first direction (see FIG. 18) and a closure arrangement ("closure 440" [0111]; FIGs. 18-20) which is moveable between a closed position, in which the closure arrangement blocks the outlet, such that liquid cannot flow through the outlet, and an open position in which the outlet is open, such that liquid is permitted to flow out of the outlet ("closure 40 is removably coupled to the outlet body 20 to selectively open and close the outlet body 20" [0127]; FIG. 1), wherein the body includes a first and a second attachment portion (see Annotated FIG. 20), each of which extends away from the inlet in a second direction that is opposite to the first direction, to provide one or more attachment surfaces for connection to the urostomy appliance ("outlet body 420 is configured for connection to the ostomy pouch 10" [0111]; Annotated FIG. 20).
Regarding Claim 3, Scalise’911 discloses the body includes a first and a second attachment portion, each of which extends away from the inlet (see Annotated FIG. 20).
Regarding Claim 4, Scalise’911 discloses the body includes first and second attachment surfaces (see Annotated FIG. 20).
Regarding Claim 5, Scalise’911 discloses the body includes a generally central portion through which the flow path extends, and/or wherein the first and second attachment surfaces are on different sides of the body (see Annotated FIG. 20).
Regarding Claim 8, Scalise’911 discloses each of the first and second attachment surfaces is substantially V or U shaped (see FIG. 18).
Regarding Claim 9, Scalise’911 discloses a portion of the first and second attachment surfaces define a wedge shape (see Annotated FIG. 20).
Regarding Claim 10, Scalise’911 discloses a second portion of the first and second attachment surfaces define a second wedge shape (see Annotated FIG. 20).
Regarding Claim 11, Scalise’911 discloses the first and second attachment surfaces meet and form a tip (see Annotated FIG. 20).
Regarding Claim 12, Scalise’911 discloses the first and or second attachment portion form tapering legs that extend away from the inlet (see Annotated FIG. 20).
Regarding Claim 13, Scalise’911 discloses the closure arrangement includes a bung portion "closure alignment edge 456 on an exterior surface of the closure 440" [0116]; FIG. 20) which is positioned in the outlet when the closure arrangement is in its closed position ("closure 440 is moved toward the outlet body 420 to position the second inner collar 442 in the outlet opening 422" [0124]) and preferably, the bung portion is held in the outlet by a friction / push fit ([0124]).
Regarding Claim 14, Scalise’911 discloses the closure arrangement includes a connection member that connects to the body ("closure 440 is moved toward the outlet body 420 to position the second inner collar 442 in the outlet opening 422" [0124]).
Regarding Claim 15, Scalise’911 discloses the first and / or second attachment surfaces are attachable to an outlet portion of a urostomy appliance ("outlet body 420 is configured for connection to the ostomy pouch 10" [0111]; FIG. 1).
Regarding Claim 18, Scalise’911 discloses a urostomy appliance ("ostomy collection and drainage system"; Abstract) including:
an attachment member, a first wall and a second wall, a stoma opening defined by the first wall, a collecting volume for receiving waste from the stoma, said collecting volume defined by the first and second walls, which are connected about their peripheries, an outlet portion formed from a first and a second outlet wall ([0077]; FIG. 1), and a valve, providing an outlet ("outlet body 420" [0126]), said valve being connected to the outlet portion, so that the outlet portion and valve provide a flow path between the collecting volume and the outlet ("outlet body 20 is positioned at a lower portion of the ostomy pouch 10 and is configured to selectively allow drainage of the contents from the internal collection area" [0078]), the valve further includes,
a body connected to the outlet portion ("outlet body 420" [0126]), wherein the body includes a first attachment portion and a second attachment portion (see Annotated FIG. 20),
an inlet ("inlet opening 14" [0077]; FIG. 1) connecting to the outlet by a flow path, wherein the flow path to the outlet is formed initially by the first wall and second wall, then by a combination of a first outlet wall, a second outlet wall and the first and second attachment portions of the valve, and then finally the flow path is formed entirely by the valve (0077-0080]).
Regarding Claim 19, Scalise’911 discloses the valve includes: a closure arrangement which is moveable between a closed position, in which the closure arrangement blocks the outlet, such that liquid cannot flow through the outlet, and an open position in which the outlet is open, such that liquid is permitted to flow out of the outlet ("closure 40 is removably coupled to the outlet body 20 to selectively open and close the outlet body 20" [0127]; FIG. 1).
Regarding Claim 20, Scalise’911 discloses the body includes a first and a second attachment portion (see Annotated FIG. 20), each of which extends away from the inlet and towards the collecting volume (see FIG. 1).
Regarding Claim 21, Scalise’911 discloses one or more external surface of the valve cooperates with one or more external surface of the outlet portion to form a smooth transition between the outlet portion and the valve ("outlet body 20 may be secured to the outer wall 12 for example, by heat sealing, with an adhesive, or by being formed together with the outer wall 12" [0078]).
Regarding Claim 24, Scalise’911 discloses the body includes a generally central portion through which the flow path extends (see FIG. 18), and/or wherein the first and second attachment surfaces are on different sides of the body (see Annotated FIG. 20).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Scalise’911 in view of Scalise’543 (US 20200046543 A1).
Regarding Claims 16-17, Scalise’911 fails to specify the body is made of a flexible material; the body is made of a single material. However, Scalise’543 teaches “an outlet body operably connected to the outlet, the outlet body having a discharge end, a cap configured for removable coupling with the outlet body, the cap configured to close the discharge end of the outlet body” (Abstract) wherein the body is made of a flexible material; the body is made of a single material (“outlet body 1550 may be molded from TPE or other similar material having a suitable elastic memory” [0068]). Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Scalise’911 to incorporate the teachings of Scalise’543 such that “the ostomy pouch may be maintained in a closed condition by way of an outlet body connected to the outlet and a cap disposed over and/or partially within the outlet body to seal the outlet body against egress of the contents of the collection pouch” ([0073]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. The references provided on the attached PTO-892 form are considered relevant to applicant’s disclosure and are cited to further show the general state of the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Cheng Fong "Ted" Yang whose telephone number is (571)272-8846. The examiner can normally be reached 10am - 6pm (EST) M-F.
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, Rebecca E. Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Adam Marcetich/ Primary Examiner, Art Unit 3781
Cheng Fong "Ted" Yang
Examiner
Art Unit 3781
Prosecution Insights