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 1 July 2026: claim(s) 2 have been amended. Thus, claims 2 and 7-13 are presently pending.
Response to Arguments
Applicant’s arguments filed 1 July 2026, with respect to the rejection(s) of claim(s) 2 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Scalise et al. (US 20210022911 A1) as discussed below.
Claim Rejections - 35 USC § 103
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 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) 2 and 7-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Scalise et al. (US 20200046543 A1) and Scalise et al. (US 20210022911 A1).
Regarding Claim 2, Scalise discloses a valve ("interface assembly 122" [0045]; FIGs. 9-14) for a urostomy appliance ("drainable ostomy system 10" [0032]; FIG. 1) including:
a body ("outlet body 1050" [0059]) for connection to the urostomy appliance ([0059]; FIG. 2);
an inlet and an outlet (opposite sides of "opening 1056" [0059]), connected by a flow path (interior lumen of "opening 1056" [0059]); and
a closure arrangement (comprising "cap 1052" [0059]) 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 ("cap 152 may be removably disposed over the discharge end 158 of the outlet body 150" [0046]),
wherein the closure arrangement includes a first and a second connection member ("second latch 1068 includes a pair of loop or hook-like tabs" [0059]; FIG. 48), each of which connects to the body ("configured to engage the first latch 1060" [0059]; FIG. 48).
The Scalise fails to specify the closure arrangement is held against and contacts the body when the closure arrangement is in the open position. However, Scalise’911 teaches “an ostomy collection and drainage system” ([0011]) comprising a body (“outlet body 520” [0140]) and a closure arrangement (“closure 540” [0140]; FIGs. 45-50) wherein the closure arrangement is held against and contacts the body when the closure arrangement is in the open position (“outlet body 520 may include a docking system configured to hold the closure 540 in place when the closure 540 is not engaged in an outlet opening 522 of the outlet body 520” [0141]; FIG. 46). 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 to arrive at the claimed invention “such that the closure 540 does not interfere with draining of body waste collected in the ostomy pouch 500 through the outlet opening 522” ([0141]).
Regarding Claim 7, Scalise discloses the first connection member connects to a first side of the body and the second connection member connects to a second side of the body ([0059]; FIG. 48).
Regarding Claim 8, Scalise discloses the closure arrangement further includes a closure body ("cap 1052" [0059]; FIGs. 48-50).
Regarding Claim 9, Scalise discloses the first and / or second connection members include an elongate portion that extends from away from the closure body ([0059]; FIG. 50).
Regarding Claim 10, Scalise discloses the first connection member and the second connection member are located on opposing sides of the closure body ([0059]; FIG. 50).
Regarding Claim 11, Scalise discloses the first and second connection members hold the closure body in contact with the outlet when the closure arrangement is in its closed position ([0059]; FIG. 48).
Regarding Claim 12, Scalise teaches an embodiment wherein the first and / or the second connection members are resiliently deformable ("second latch 268 may be formed as a resilient arm" [0049]), so the connection between the closure arrangement and the body is flexible ("the cap and the bedside drainage adapter may be removable from the outlet body and interchangeable with one another depending on a condition, i.e., open or closed" [0044]). Therefore, it would have been obvious to modify Scalise "to properly position the cap 752 on the outlet body 750" [0055] such that "the cap is configured to couple with the outlet body so as to substantially or completely close and/or seal the outlet body against inadvertent leakage" ([0080]).
Regarding Claim 13, Scalise discloses a urostomy appliance including: an adhesive member for attaching to a user ("adhesive barrier" [0002]), a collecting volume defined by a first and second wall connected about their peripheries ("Ostomy pouches typically include flat, opposing side walls defining an internal collection cavity" [0002]), and a valve according to claim 2 ([0059]; FIGs. 48-52; see rejection for claim 2 above).
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.
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 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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Cheng Fong "Ted" Yang
Examiner
Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781
Prosecution Insights