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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-9, 11, 14-20, and 24 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “wherein the protective panel the outlet is formed between the protective panel and the outer wall of the pouch” which is unclear and therefore indefinite. The amended claim portion is interpreted to read as “wherein
Response to Arguments
Applicant's arguments filed 09OCT2025 have been fully considered but they are not persuasive.
The combination of Wiltshire in view of Master is considered to teach the amended device as claimed. The use of welds 30’’’a-c (attachment regions) form outlets for material as previously cited and the outlet exists between the protective panel and outer wall as claimed.
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) 1-9, 11, 14-17, 19 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20160058604 A1 (Wiltshire et al.) in view of US 20130253455 A1 (Master et al.).
Regarding Claim 1, Wiltshire teaches an ostomy pouch (10) (Figs. 7 and 8), comprising:
an inner wall (12′′′) and an outer wall (14′′′a and 14′′′b) sealed about at least part of the periphery thereof [0030] to define a cavity (20′′′) for containing a stomal output [0033], the cavity including an upper section (above 30′′′a, 30′′′b, and 30′′′c), a lower section (below 30a, 30b, and 30c) (Fig. 7); and
a filter system, comprising:
a vent 28′′′ [0046] in the outer wall of the pouch for the release of gas from within the cavity to outside of the pouch; and
a pre-filter arrangement comprising a protective panel (16′′′) which defines a filter chamber (the area between 16′′′ and 14′′′) about the vent, and into which at least liquid and gaseous stomal output may enter, in use (slit 26′′′ acting as a path for gas flow [0034] and allowing liquid to pass through [0036]);
wherein the filter chamber comprises an outlet allowing liquid stomal output to migrate out from the filter chamber (path 40 allowing waste to drain downward from cavity 22′′′ to 20′′′ [0036]);
wherein the outlet is formed between the protective panel and the outer wall of the pouch (as seen in Figs. 7 and 8 wherein path 40 travels between the protective panel and the outer wall); and
wherein the protective panel is attached to the outer wall of the pouch at one or more attachment regions (peripheral weld 31 [0032] and welds 30’’’a, 30’’’b, and 30’’’c [0045]), 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 and a peripheral seal forming the cavity (flow path 40 moving around said attachment regions to the outlet).
Wiltshire fails to teach a waisted section located between the upper section and the lower section.
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 ostomy pouch of Wiltshire 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 Claims 2 and 3, Wiltshire further teaches the pre-filter arrangement is configured to control the content of stomal output in contact with the vent (as described in [0034] where the areas between 14′′′ and 16′′′ are intended as a path for gas flow and allow waste to escape the area);
wherein the filter chamber comprises an inlet (26′′′) allowing gaseous stomal output to migrate into the filter chamber [0034];
Regarding Claim 4, Wiltshire fails to teach the inlet comprises a plurality of apertures in the protective panel.
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.
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, 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).
Wiltshire fails to teach a plurality of apertures in the protective panel.
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 single aperture in the protective panel of Wiltshire with a plurality of apertures as the mere duplication of parts, without any new or unexpected results, is within the ambit of one of ordinary skill in the art. See In re Harza, 124 USPQ 378 (CCPA 1960) (see MPEP § 2144.04).
Regarding Claim 11, Wiltshire further teaches an inlet (26′′′) for the filter chamber acts as an outlet for liquid stomal output ([0036] describing flow through the inlet slit, said slit not acting as a valve and therefore not preventing fluid egress).
Regarding Claims 14-15, Wiltshire further the protective panel is attached to the outer wall of the pouch at one or more attachment regions [0032], the one or more attachment regions thereby defining an outlet in the form of one or more gaps between adjacent attachment regions (the areas between 30′′′a/b/c), and/or between an attachment region and the peripheral seal forming the cavity,
wherein the protective panel is attached to the outer wall of the pouch at the one or more attachment regions by one or more welds (welds 30′′′, 31′′′, and 29′′′ [0032]),
wherein the one or more welds comprise a plurality of spot welds (30′′′ being spot welds), the plurality of spot welds defining multiple attachment regions and multiple gaps therebetween (as seen in Fig. 7),
Regarding Claim 16, wherein the one or more welds comprise a pair of bar welds (29′′′ and 32′′′), the pair of bar welds defining a pair of attachment regions with a single gap therebetween (as seen in Wiltshire Annotated Figs. 7 and 8. It is noted that 32′′′ appears mislabeled as 31′′′ in Fig. 8, where 31′′′ is the peripheral weld [0032]).
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Wiltshire Annotated Figs. 7 and 8
Regarding Claim 17, Wiltshire further teaches the outlet (the path between 30′′′ as described in claim 1) is located below the vent (28′′′) with the pouch in its in-use orientation (Fig. 7).
Regarding Claim 19, Wiltshire further teaches the filter system (as described in claim 1) is configured such that the protective panel (16′′′) is positioned within the cavity (20′′′) and defines a filter chamber in the upper section of the pouch (Fig. 8),
Regarding Claim 24, Wiltshire further teaches the protective panel (16’’’) is attached to the inner wall (12′′′) and outer wall (14′′′a and 14′′′b) about its periphery (via weld 31’’’ [0045]) except for at least a portion of a lowermost edge (forming the previously cited outlet) of the protective panel where it is attached to the outer wall at the one or more attachment regions only (30’’’a-c).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wiltshire in view of Master as evidenced by US 7559922 B2 (Botten).
Regarding Claim 18, Wiltshire fails to teach the filter system comprises an odor filter.
Masters further teaches the filter system comprises an odor filter, via Botten which is incorporated by reference [0045], (Botten Col. 3: ll. 44-46).
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 filter system of Wiltshire in view of Masters to incorporate the odor filter of Botten to deodorize escaping gasses (Botten Col. 1: ll. 15-18).
Claim(s) 20 is rejected under 35 U.S.C. 103 as being unpatentable over Wiltshire in view of Masters, and further in view of US 5348546 A (Norton).
Regarding Claim 20, 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]).
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 Wiltshire in view of Masters 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
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 extension fee 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
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781