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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/02/2026 has been entered.
Response to Amendment
The amendment filed 01/02/2026 has been entered. Claim 12 has been amended. Claims 12-23 remain pending in this application.
Response to Arguments
Applicant’s arguments with respect to claim(s) 12-23 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant argues that the prior art does not disclose or suggest the collection bag being connected to the attachment member via the tubular section. A new grounds of rejection is made over Langhorn in view of Stroebech.
Claim Objections
Claims 13-23 are objected to because of the following informalities:
Claims 13-23, ln. 1 should read [[A]] The body waste collecting system---
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 16-18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 16-18 recite “the attachment flange comprises an annular flange portion”. Claim 12, from which claims 16-18 ultimately depend, recites “the attachment flange is provided with an inner flange portion arranged closest to the opening in the attachment member and an outer flange portion”. Such embodiment requiring: an inner flange portion, an outer flange portion, and an annular flange portion is not described in the specification. Claims 16-18 will be interpreted as: wherein the inner flange portion and/or the inner flange portion are provided on the inside and/or outside of the annular groove, respectively, said annular flange being provided with a skin friendly adhesive.
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.
Claim(s) 12-14 and 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Langhorn et al. (Pub. No.: US 2021/0085510 A1) in view of Stroebech et al. (Pub. No.: US 2010/0204665 A1).
Regarding claim 12, Langhorn discloses (fig. 14, annotated fig. 14) a body waste collection system (abstract) comprising:
An attachment member (body side member 20) arranged to be attached to a user (¶ 0116), said attachment member comprising an opening (32) which is arranged to be in communication with a stoma of a user (¶ 0116) and an attachment flange (i.e., body side member 20) which is arranged to encircle said opening (fig. 14) and which is arranged to be attached to skin of the user such that a fluid tight seal is established between the attachment flange and the skin of the user around the stoma, respectively (¶ 0036), said attachment flange being provided with a skin friendly adhesive (31) on a skin contacting surface (proximal surface 24) of said attachment flange (¶ 0116), and
A collection bag (15) connected to the attachment member (fig. 19, ¶ 0132),
wherein
The attachment flange is provided with an inner flange portion arranged closest to the opening in the attachment member and an outer flange portion arranged further away from the opening in the attachment member than the inner flange portion (annotated fig. 14),
The attachment member further comprising a tubular section (upstanding flange 58, fig. 19) extending away from the attachment flange (¶ 0132, fig. 14), said tubular section being in fluid communication with the opening in the attachment flange (fig. 19) and being attached to the attachment flange at a location between the inner and outer flange portions (annotated fig. 14), and
The collection bag being connected to the attachment flange via the tubular section (¶ 0131, fig. 19).
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Langhorn annotated fig. 14
Langhorn fails to disclose that the opening is arranged to be in fluid communication with an anus of the user, the attachment flange arranged to be attached to perianal skin of the user such that a fluid tight seal is established between the attachment flange and the perianal skin of the user around the anus respectively.
However, such limitations of claim 12 relate to the intended use of the system, which, in this case, imparts no further limitations on the structure of the device. The body waste collection system of Olsen is capable of being arranged at an anus of the user and using the device for this purpose requires only routine skill in the art (See § MPEP 2114 II).
Further, Stroebech teaches (fig. 1) a body waste collecting system (abstract) and thus in the same field of endeavor, comprising an attachment member (adhesive wafer) comprising an opening which is arranged to be in fluid communication with a body opening of a user (abstract), the body opening being an anus or a stoma (¶ 0081), and an attachment flange which is arranged to encircle said opening and which is arranged to be attached to perianal skin of the user (¶ 0061) such that a fluid tight seal is established between the attachment flange and the perianal skin of the user around the anus respectively (¶ 0077).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the body waste collecting system of Langhorn such that rather than attachment to a stoma of the user, it is attached to an anus of the user, as taught by Stroebech, as such body waste collecting systems can be used on both an anus or a stoma (Stroebech, ¶ 0081).
Regarding claim 13, Langhorn discloses wherein the attachment flange comprises an annular groove (pocket 24) between the inner and outer flange portions (annotated fig. 14).
Regarding claim 14, Langhorn discloses wherein the annular groove is filled or is able to be filled with an adhesive (manipulatable material 36, ¶ 0119, ¶ 0113).
Regarding claim 16, Langhorn discloses wherein the inner flange portion and/or the inner flange portion are provided on the inside and/or outside of the annular groove, said annular flange being provided with a skin friendly adhesive (annotated fig. 14, ¶ 0116).
Regarding claim 17, Langhorn discloses wherein the inner flange portion and/or the inner flange portion are provided on the inside and/or outside of the annular groove, said annular flange being provided with a skin friendly adhesive (see annotated fig. 14, ¶ 0116).
Claims 15 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Langhorn in view of Stroebech, as applied to claim 14 above, and further in view of Becker et al. (Pub. No.: US 2017/0020712 A1).
Regarding claim 15, Langhorn in view of Stroebech fail to disclose wherein the adhesive in the groove has an elongation at break from 150 to 4000%.
Becker teaches (fig. 1) an attachment member (base plate) for a body waste collecting system (abstract) and thus in the same field of endeavor, the attachment member comprising a flexible top film (1) coated with a skin friendly adhesive (¶ 0106), wherein the flexible top film has an elongation at break of from 250% to 700% (¶ 0069), and wherein the skin friendly adhesive is capable of following the elongations of the flexible top film without breaking or substantially changing characteristics (¶ 0025). Thus, Becker teaches an adhesive having an elongation at break of from 250% to 700% which falls within the claimed range of 150% to 4000%.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the adhesive in the groove of Langhorn in view of Stroebech such that it has an elongation at break from 150 to 4000%, as taught by Becker, in order to provide an adhesive that will not break or change in characteristics (Becker ¶ 0025) upon use.
Regarding claim 18, Langhorn discloses wherein the inner flange portion and/or the inner flange portion are provided on the inside and/or outside of the annular groove, said annular flange being provided with a skin friendly adhesive (annotated fig. 14, ¶ 0116).
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Langhorn in view of Stroebech, as applied to claim 12 above, and further in view of Friske (Pub. No.: US 2013/0035654 A1)
Regarding claim 19, Langhorn in view of Stroebech fail to disclose wherein the annular flange portions are provided with through going openings to allow skin arranged underneath the annular flange portions to breathe.
Friske teaches (fig. 1-2) a body waste collecting system (pouch 10) and thus in the same field of endeavor, comprising an attachment flange (face plate 24), wherein the attachment flange is provided with through going openings to allow skin arranged underneath the attachment flange to breathe (¶ 0014).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the annular flange portions of Langhorn in view of Stroebech such that they are provided with through going openings, as taught by Friske, in order to prevent irritation of the skin of the user by allowing the skin to breathe.
Regarding claim 20, Langhorn discloses wherein the annular flange portions are covered by a thin permeable film which is covered by a skin friendly adhesive (¶ 0045). Accordingly, Langhorn in view of Stroebech and further in view of Friske teach wherein the through going holes in the annular flange portions are covered by a thin permeable film which is covered by a skin friendly adhesive.
Claims 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Langhorn in view of Stroebech, as applied to claim 13 above, and further in view of Cesa et al. (Pub. No.: US 2019/0060105 A1).
Regarding claim 21, Langhorn in view of Stroebech fail to disclose wherein the attachment member comprises elongated chimneys circularly arrayed in the annular groove and extending perpendicularly to the plane of the groove, said chimneys connecting the user’s skin to the outer surface of the attachment flange.
Cesa teaches (fig. 1, 3, 10) a body waste collection system (collection apparatus 200, fig. 10) and thus in the same field of endeavor, comprising an attachment member (barrier 126) comprising elongated chimneys (vents 130) circularly arrayed (fig. 1) in order to permit air to flow to prevent an accumulation of moisture that could lead to infection, irritation, or other adverse conditions (¶ 0065).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the attachment member of Langhorn in view of Stroebech such that it includes the elongated chimneys of Cesa circularly arrayed in the annular groove and extending perpendicular to the plane of the groove such that said chimneys connect the user’s skin to the outer surface of the attachment flange, in order to permit air to flow to prevent an accumulation of moisture that could lead to infection, irritation, or other adverse conditions (Cesa ¶ 0065).
Regarding claim 22, Langhorn discloses an adhesive on a skin-facing surface of the attachment member (¶ 0116). Thus, Langhorn in view of Cesa teach wherein the chimneys are surrounded by adhesive.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Langhorn in view of Stroebech, as applied to claim 12 above, and further in view of Sund et al. (Pub. No.: US 2021/0275342 A1).
Regarding claim 23, Langhorn in view of Stroebech fail to disclose wherein the attachment flange of the attachment member is arranged as a two layer structure comprising an inner permeable film and an outer impermeable film separated by an air permeable gap.
Sund teaches (fig. 1-3) a body waste collecting system (ostomy appliance, abstract) and thus in the same field of endeavor comprising an attachment flange (adhesive wafer 10) that is arranged as a two layer structure comprising an inner permeable film (release layer 110, ¶ 0024) and an outer impermeable film (backing layer 30, ¶ 0050) separated by an air permeable gap (fig. 1) that releases a neutralizer to neutralize the body waste output (¶ 0018).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the attachment flange of the attachment member of Langhorn in view of Stroebech such that it is arranged as a two layer structure comprising an inner permeable film and an outer impermeable film separated by an air permeable gap, as taught by Sund, in order to release a neutralizer to neutralize the body waste output (Sund ¶ 0018).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Hanuka (Pub. No.: US 2013/0060213 A1) discloses a body waste collecting system comprising a collection bag being connected via a tubular section.
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/MEAGAN NGO/Examiner, Art Unit 3781
/LESLIE R DEAK/Primary Examiner, Art Unit 3799 20 January 2026