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 .
Terminal Disclaimer
The terminal disclaimer filed on 14 August 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of Granet; Rosemary et al. (US 11857454 B2) has been reviewed and is accepted. The terminal disclaimer has been recorded.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-6 and 8 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 12 and 15 of Granet ‘744; Rosemary et al. (US 11129744 B2) in view of Hansen; Michael (US 20070005034 A1).
Regarding pending claim 1, Granet ‘744 claims all limitations in patented claim 1, namely a device capable of protecting a user's or patient's skin and collecting effluent from a bodily drain tube (claim 1, An ostomy appliance or faceplate);
comprising: a substrate, comprising a generally planar shape with two surfaces (claim 1, An ostomy appliance or faceplate);
a flange, disposed on and attached to the substrate, the flange being disposed on a second surface of the substrate (claim 1, a non-circular substantially D-shaped flange).
Granet ‘744 does not explicitly claim that the device protects a user's or patient's skin and collects effluent from a bodily drain tube. However, Granet ‘744 implies that the appliance interfaces with a patient’s skin and collects fluid since ostomy appliances are constructed for these specific roles.
Granet ‘744 does not explicitly claim that the substrate’s first surface comprises adhesive. Hansen discloses a substrate comprising adhesive for attachment to a user or patient (¶ [0041] FIG. 1 shows an ostomy support garment 1 … an adhesive wafer 5 for adhering to the user's skin).
Hansen explains how to fasten an ostomy appliance to a user’s skin, according to a common feature of ostomy appliances. Regarding the rationale and motivation to modify Granet ‘744 with Hansen’s adhesive, see the discussion of Granet ‘454 from the previous office action.
Regarding pending claims 2-6, Granet ‘744 claims all limitations in patented claims 1, 12 and 15 as shown in table 2.
Table 2: Granet ‘744 double patenting
Pending claim
Granet ‘744
Pending claim
Granet ‘744
Pending claim
Granet ‘744
2
12
4
1
6
1
3
15
5
1
Regarding pending claim 8, Granet ‘744 does not explicitly disclose that the substrate comprises a hydrocolloid material.
Hansen incorporates a reference to Olsen; Hans (US 5800415 A) (¶ [0032]). Olsen discloses a device wherein the substrate comprises a hydrocolloid material (col. 3, lines 50-60, a thin, washable layer 11 of adhesive, which may, for example, be a hydrogel adhesive).
Hansen and Olsen select a common and minimally irritating adhesive for securing the device to the user’s skin, according to the discussion of Granet ‘454 above.
Claims 1-5 and 8 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 2, 4 and 5 of Granet ‘453; Rosemary et al. (US 11857453 B2) in view of Hansen; Michael (US 20070005034 A1).
Regarding pending claim 1, Granet ‘453 claims all limitations in patented claim 1, namely a device capable of protecting a user's or patient's skin and collecting effluent from a bodily drain tube (claim 1, An ostomy appliance being a wafer, barrier, or faceplate);
comprising: a substrate, comprising a generally planar shape with two surfaces (claim 1, An ostomy appliance being a wafer, barrier, or faceplate);
a flange, disposed on and attached to the substrate, the flange being disposed on a second surface of the substrate (claim 1, with a non-circular flange).
Granet ‘453 does not explicitly claim that the device protects a user's or patient's skin and collects effluent from a bodily drain tube. However, Granet ‘454 implies that the appliance interfaces with a patient’s skin and collects fluid since ostomy appliances are constructed for these specific roles.
Granet ‘453 does not explicitly claim that the substrate’s first surface comprises adhesive. Hansen discloses a first surface of a substrate comprising adhesive for attachment to a user or patient (¶ [0041] FIG. 1 shows an ostomy support garment 1 … an adhesive wafer 5 for adhering to the user's skin).
Hansen explains how to attach an ostomy appliance to a user’s skin, and demonstrates a common feature of ostomy appliances according to the discussion of Granet ‘454 from the previous office action.
Regarding pending claims 2-5, Granet ‘453 claims all limitations in patented claims 1, 2, 4 and 5 as shown in table 3.
Table 3: Granet ‘453 double patenting
Pending claim
Granet ‘453
Pending claim
Granet ‘453
2
4
4
1
3
5
5
2
Regarding pending claim 8, Granet ‘453 does not explicitly disclose that the substrate comprises a hydrocolloid material.
Hansen incorporates a reference to Olsen; Hans (US 5800415 A) (¶ [0032]). Olsen discloses a device wherein the substrate comprises a hydrocolloid material (col. 3, lines 50-60, a thin, washable layer 11 of adhesive, which may, for example, be a hydrogel adhesive).
Hansen and Olsen select a common and minimally irritating adhesive for securing the device to the user’s skin, according to the discussion of Granet ‘454 above.
Response to Arguments
The objections to the drawings are withdrawn in view of the amended drawings filed 16 July 2026.
The objection to claim 5 for minor informalities and the rejection of claim 3 under 35 USC § 112 are withdrawn in view of the amendments filed 16 July 2026.
The terminal disclaimer filed on 14 August 2026 has overcome the rejections citing Granet; Rosemary et al. (US 11857454 B2). However, the terminal disclaimer does not list Granet; Rosemary et al. (US 11129744 B2) or Granet; Rosemary et al. (US 11857453 B2). Therefore, the rejections citing these patents are maintained. Examiner attempted to contact Applicant's representative regarding the pending double patenting rejections.
Allowable Claims
Claims 7, 8, 10 and 11 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Alternatively, the double patenting rejections may be overcome by a timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d).
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter.
Applicant’s arguments filed 16 July 2026 regarding Espina; Eden R. (US 5935115 A), Calco; Wayne A. (US 20140121649 A1), Steer; Peter L. (US 5957905 A) and Palmieri; Beniamino (US 20080065032 A1) have been considered. Examiner advances additional reasons for allowance.
Espina, the closest art of record, lacks a break in a perimeter of the flange which permits items to be inserted into the flange through the break.
Instead, Espina discloses a solid flange and requires a user to insert a tube lengthwise through its central opening (col. 2, lines 45-50, Catheter 60 extends within the interior of collection bag 40 between second opening 46 and first opening 42).
Also of record, Scherr; George H. (US 20070225652 A1) discloses a flange comprising a break which permits items to be inserted into the flange through the break (¶ [0027] The catheter-securing patch as depicted in FIG. 1 …, the patch is cut in a circular form (FIG. 1) and a slit (FIG. 1--No. 1) which extends from the edge of the patch to the center of a hole cut in the patch (FIG. 1--No. 2) provides the insertion site of the patch over a catheter).
Another previously cited reference, Calco; Wayne A. (US 20140121649 A1) similarly discloses a flange capable of accommodating items inserted through a break (¶ [0022], The adhesive layer 70 and the absorbent ring 80 may each have slits 72, 82, respectively, in registration with the slit edge formed in the cover sheet; ¶ [0024] FIGS. 6-9 … The structure 90 includes a slit 90B extending from the port to the periphery, to allow the structure to be opened sufficiently to fit around the existing tube in the patient's body).
However, neither Scherr nor Calco is configured to support a pouch or bag. Instead, these references support only a catheter or tube, and provide no anchor or coupling for a pouch or bag.
A newly cited reference, Fabo; Tomas et al. (US 20100331785 A1) discloses a flange comprising a break which permits items to be inserted into the flange through the break (¶ [0035] When applying the dressing 1 around an opening in the skin out of which an object projects, the slit 9 is opened so that the hole 8 can be arranged surrounding the object, such as a tube).
However, Fabo does not contemplate supporting a bag or pouch. Instead, Fabo’s outer surface consists of a flat plastic film which covers an absorbent material, and which are unsuitable for supporting a bag or pouch (¶ [0031], Said body 4 of absorbent material is covered by a second plastic film 5 which extends beyond the circumference of the body 4; ¶ [0037] The material in the body 4 is wholly or partly foam, for example polyurethane foam. However, fibrous absorbent materials, such as wadding, felt, nonwoven, textiles, can be used in the present invention).
Also newly cited, McMichael; Donald (US 20200022879 A1) describes a stoma pad including a flange comprising a break which permits items to be inserted into the flange through the break (¶ [0061], Further, a slit 116 can extend from the opening 114 to the periphery 124 of the upper layer 106, and a portion of a hinge 120 can be located at the periphery 124 … The slit 116 can allow the upper layer 106 of the absorbent stoma pad 100 to pass around the tube 56 of the feeding tube 50; ¶ [0062], The fastening means 118 can also be disposed on the lower surface 132 of the upper layer 106 on one or both sides of the slit 116, where the fastening means 118 extends from the opening 114 to the periphery 124 along the slit 116).
However, McMichael does not configure the pad to support a pouch or bag and instead shows a convex upper surface that lacks a coupling for a bag (Fig. 2).
Conclusion
THIS ACTION IS MADE FINAL. 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 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.
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/Adam Marcetich/
Primary Examiner, Art Unit 3781
