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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11MAY2026 has been entered.
Response to Arguments
Applicant’s arguments, see page 1, filed 11MAY2026, with respect to the rejection(s) of claim(s) 1-9, 11, 14-20, and 24 under 35 U.S.C. § 103 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 US 20170042723 A1 (Oberholtzer et al.) in view of US 20130253455 A1 (Master et al.).
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) 1-3, 11, 17, 18, and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20170042723 A1 (Oberholtzer et al.) in view of US 20130253455 A1 (Master et al.).
Regarding Claim 1, Oberholtzer teaches an ostomy pouch (16) (Figs. 3-5), comprising:
an inner wall (12) and an outer wall (11) sealed about at least part of the periphery thereof (welded along the periphery [0052]) to define a cavity (the interior between the inner and outer walls) for containing a stomal output [0027], the cavity including an upper section and a lower section (Oberholtzer Annotated Fig. 3); and
a filter system, comprising:
a vent (24) in the outer wall of the pouch for the release of gas from within the cavity to outside of the pouch [0003]; and
a pre-filter arrangement comprising a protective panel (13) which defines a filter chamber about the vent (the area between the protective panel and the outer wall, Fig. 4), and into which at least liquid and gaseous stomal output may enter (at least through the openings between (22) and (22a), Fig. 3), in use, the filter chamber being defined in the upper section of the pouch (as seen in Fig. 4);
wherein the filter chamber comprises an outlet (between (22) and (22a)) allowing liquid stomal output to migrate out from the filter chamber [0055]; and
wherein the protective panel is welded directly to the outer wall of the pouch at one or more attachment regions along a lowermost edge of the filter chamber at, proximal to, or above the central section (via weld (22), as described in [0052]), the one or more attachment regions thereby defining the outlet in the form of one or more gaps between adjacent attachment regions, and/or between an attachment region (Oberholtzer Annotated Fig. 3) and a peripheral seal (the weld between the inner and outer walls [0052] forming the cavity.
Oberholtzer fails to teach a waisted section located between the upper section and the lower section, instead teach a central section, as seen in Oberholtzer Annotated Fig. 3.
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Oberholtzer Annotated Fig. 3
Masters teaches an ostomy pouch (10) (Fig. 1) comprising a waisted section (Masters Annotated Fig. 1) located between the upper section (22) and the lower section (24).
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Masters Annotated Fig. 1
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 central section of Oberholtzer with the waisted section of Master so the device has a more compact profile, wherein in the compacted state, the lower section acts as a shield to prevent waste from entering the filter area [Masters 0019].
Regarding Claim 2, Oberholtzer further teaches the pre-filter arrangement is configured to control the content of stomal output in contact with the vent (24) (protrusions (25) creating flow paths to control flow of stomal output).
Regarding Claim 3, Oberholtzer further teaches the filter chamber comprises an inlet (Oberholtzer Annotated Fig. 3) allowing gaseous stomal output to migrate into the filter chamber.
Regarding Claim 11, Oberholtzer is considered to teach an inlet for the filter chamber acts as the outlet for liquid stomal output (Oberholtzer Annotated Fig. 3), as both the inlets and outlets allow flow.
Regarding Claim 17, Oberholtzer further teaches the outlet (Oberholtzer Annotated Fig. 3) is located below the vent (24) with the pouch in its in-use orientation (as seen in Fig. 3).
Regarding Claim 18, Oberholtzer further teaches the filter system comprises an odor filter ([0003] describing the removal of odorous gas).
Regarding Claim 24, Oberholtzer further teaches the protective panel (13) is attached to the inner and outer walls about its periphery (as described in [0052]) except for at least a portion of a lowermost edge of the protective panel where it is attached to the outer wall at the one or more attachment regions only (through welds (22) and (22a), as described in [0052]).
Claim(s) 4-9, 15, and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oberholtzer in view of Masters, and further in view of US 20160058604 A1 (Wiltshire et al.).
Regarding Claim 4, Oberholtzer fails to teach the inlet comprises a plurality of apertures in the protective panel.
Wiltshire teaches an ostomy pouch (10) (Figs. 7 and 8), comprising an inner wall (12′′′), an outer wall (14′′′a and 14′′′b) and a pre-filter arrangement comprising a protective panel (16′′′) wherein the filter chamber comprises an inlet (26′′′) allowing gaseous stomal output to migrate into the filter chamber [0034];
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 protective panel to comprise a plurality of apertures to ensure a flow path exists irrespective of device position [Wiltshire 0036].
It has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Regarding Claims 5-9, Oberholtzer fails to teach the claimed apertures.
Wiltshire further teaches the one or more apertures comprise a cut or slot in the protective panel (26′′′ being a slit [0036]), being shaped as an s-cut in the protective panel (Fig. 7);
wherein the one or more apertures are positioned at a distance from the vent (being on opposite sides of 23′′′ as viewed in Figs. 7 and 8, with the inlet above the vent);
wherein the one or more apertures are angled at an angle greater than zero with respect to a horizontal axis through the pouch, with the pouch in its in-use orientation (the “S” shape being angled 180° from horizontal as viewed in Fig. 7).
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 apertures of Claim 4 to ensure there is a gas flow path between the inner wall and protective panel
Regarding Claim 15, Oberholtzer further teaches the one or more welds (at least (22) and (22a)) comprise a plurality of spot welds (22a), the plurality of spot welds defining multiple attachment regions and multiple gaps therebetween (Fig. 3).
Regarding Claim 16, Oberholtzer further teaches the one or more welds (at least (22) and (22a)) comprise a pair of bar welds ((22) and a single (22a) forming bar-shaped welds), the pair of bar welds defining a pair of attachment regions with a single gap therebetween (Fig. 3).
Claim(s) 20 is rejected under 35 U.S.C. 103 as being unpatentable over Oberholtzer in view of Masters and Wiltshire, and further in view of US 5348546 A (Norton).
Regarding Claim 20, Oberholtzer fails to teach a separation wall between the inner and outer walls defining the cavity into first and second cavity chambers; wherein the separation wall comprises a filtering element which is fluid-permeable, operable to filter fluid stomal output from solid stomal output.
Wiltshire further teaches a separation wall (33′′′) between the inner and outer walls defining the cavity into first and second cavity chambers (20′′′ and 22′′′ [0034]).
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 Oberholtzer to incorporate the separation wall of Wiltshire to increase available cavity space [Wiltshire 0045].
Wiltshire fails to teach the separation wall comprises a filtering element which is fluid-permeable, operable to filter fluid stomal output from solid stomal output.
Norton teaches an ostomy pouch (80) (Fig. 8) comprising a separation wall (81) between the inner (71 body-facing side) and outer walls (71 non-body-facing side) defining the cavity into first and second cavity chambers, the chambers created on each side of (81) (Fig. 8); wherein the separation wall comprises a filtering element, namely perforations, which is fluid-permeable, operable to filter fluid stomal output from solid stomal output (Col. 5: ll. 43-45).
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 Oberholtzer in view of Masters and Wiltshire to incorporate the separation wall of Norton to minimize clogging (Norton Abstract), the filtering element being able to be incorporated into any known ostomy bag with filter (Norton Col. 6: ll. 1-6).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 6659988 B1 discloses an ostomy pouch with inner and outer walls, a protective panel, and filter.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached on (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HANS KALIHER/Examiner, Art Unit 3781
/PHILIP R WIEST/Primary Examiner, Art Unit 3781
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