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 .
Response to Arguments
Applicant’s arguments, see p. 6, filed 19MAR2026, with respect to the Drawings have been fully considered and are persuasive. The objection to the Drawings has been withdrawn.
Applicant’s arguments, see p. 6, filed 19MAR2026, with respect to Claim 13 have been fully considered and are persuasive. The 35 U.S.C. § 112 rejection of Claim 13 has been withdrawn.
Applicant’s arguments, see p. 7, filed 19MAR2026, with respect to the rejection(s) of claim(s) 1-3, 7-13, and 15-16 under 35 U.S.C. § 102 have been fully considered and are moot in view of new grounds of rejection prompted by Applicant’s amendment to claims. A new ground(s) of rejection is made in view of Argent. The second and third walls of Argent are defined in an alternate way below which fulfills the claim requirements.
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, 2, 7-13, and 15-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20150359657 A1 (Argent et al.).
Regarding claim 1, Argent teaches an ostomy appliance (10) comprising:
first (12) and second (24) walls connected to each other;
a stoma-receiving opening (16) for receipt of a stoma;
a collecting cavity defined between the first and second walls wherein the stoma-receiving opening is fluidly connected to the collecting cavity (said cavity being between walls 12 and 24 [0022]);
a connection member (18) connected to the first wall for attaching the appliance to a user [0019];
a gas vent (at least 31 and 32) in the second wall for venting gas from the collecting cavity to atmosphere (Claim 41);
a filter (30) positioned over the gas vent (Claim 42), said filter defining a first discrete area (seen in Fig. 1);
a third wall (14), wherein said third wall overlies the filter (the wall being placed over the filter, while not shown in a clear side-view, it would be considered similar to the arrangement pictured in Fig. 7);
wherein the second wall includes a first surface (the body side) and the third wall includes a second surface (the side away from the body);
wherein the first and second surfaces face each other and are connected at a connection (at least 13 and 25, Fig. 3); and
wherein the connection defines a second discrete area (the area around at least 25).
Regarding claim 2, Argent further teaches the first wall (12), the second wall (24) and the third wall (14) are configured such that movement of the third wall away from the first wall at least partially separates the first and second walls so as to permit air (expansion of the cavity between second and third walls would result in movement of the second wall away from the first wall) to flow through the gas vent into the collecting cavity ([0022] describing the gas flow path).
Regarding claims 7-9, Argent further teaches a plurality of connections (at least 13 and 25) between the second (24) and third (14) walls; wherein
the connection between the second and third walls is an adhesive connection [0021] or a weld [0021].
Regarding claim 10, Argent further teaches the connection (25) is positioned vertically below the filter (30), in an in-use position of the appliance (as seen in Fig. 1).
Regarding claim 11, Argent further teaches the connection (13) is positioned at least partially above a generally horizontal line which extends through the stoma- receiving opening (16) (the connection being above and around the perimeter as seen in Figs. 1 and 2).
Regarding claim 12, Argent further teaches the connection (13) has a generally elongate axis which is inclined to a generally vertical axis of the ostomy appliance (10) (the connection being generally vertical at portions of the perimeter of the device as seen in Fig. 1).
Regarding claim 13, Argent is considered to teach the connection (13) has a generally elongate axis which intersects the filter (30) and/or gas vent (at least 31 and 32) as an axis may be selected to pass through as claimed.
Regarding claim 15, Argent further teaches the third wall (14) is positioned in an upper portion of the appliance (as shown in Fig. 4) and is connected (at 13 and 25) to the second wall (24) of the appliance.
Regarding claim 16, Argent further teaches the third wall (14) covers a top portion of the appliance (seen in Figs. 1 and 4) and extends downwardly at least past a main horizontal axis of the stoma-receiving opening (16).
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.
Claim(s) 6 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Argent in view of US 20170042723 A1 (Oberholtzer et al.).
Regarding claim 6, Argent fails to teach the third wall includes a comfort layer.
Oberholtzer teaches an ostomy appliance (10) (Fig. 3) wherein the third wall (11) includes a comfort layer [0054].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Argent to include the comfort layer of Oberholtzer to provide a soft, comfortable outer surface [Oberholtzer 0054], thereby improving the user experience.
Regarding claim 14, Argent teaches a slightly oblong shape as seen in Fig. 1 and therefore fails to teach first and second connections between the second and third walls where the first and second connections are mirror images of each other.
Oberholtzer teaches an ostomy appliance (10) (Fig. 3) comprising first and second connections (welds 20, 22, and 22a corresponding to the first and second welds of Argent) between the second and third walls (13 and 11) where the first and second connections are mirror images of each other (about axis A seen in Fig. 3).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the general device shape of Argent with the simple, symmetrical shape of Oberholtzer as a simple change is shape, thereby resulting in the connections as claimed. The change in form or shape, without any new or unexpected results, is an obvious engineering design. See In re Dailey, 149 USPQ 47 (CCPA 1966) (see MPEP § 2144.04).
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 HANS KALIHER whose telephone number is (303)297-4453. The examiner can normally be reached Monday-Friday 08:00-05:00 MT.
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/HANS KALIHER/Examiner, Art Unit 3781
/CATHARINE L ANDERSON/Primary Examiner, Art Unit 3781
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