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 .
Priority
Acknowledgment is made of applicant's claim for foreign priority based on application EP 23189742.2, filed in The European Patent Office on 04 August 2023. It is noted, however, that Applicant has not filed a certified copy of the EP 23189742.2 application as required by 37 CFR 1.55.
Claim Objections
The claims contain minor informalities.
In claim 15, the language “… to the outside surface of the front wall; or (iii) [[or]] the inside surface of the sheet …” should be changed for consistent formatting.
In claim 16, the language “… the rear wall [[may]] being opaque and the front wall …” should be changed for clarity.
Claim Interpretation
Claim 11 calls for “…wherein the at least one comfort layer formed on the front wall is spaced from the front wall.”
The specification describes this feature with language similar to the claim (¶ [0052], The comfort layer may cover the outside surface of the front wall, but may be spaced from and separable from the front wall). However, the specification does not further explain how these layers are spaced apart.
The specification describes how the front comfort layer comprises two parts which can be pulled apart (¶ [0084] The overlap provides an opening, whereby the upper part 6a and lower part 6b can be pulled apart so that the ostomate/user can view the stoma or the contents of the pouch through the (transparent) front wall 3). The only spacing between the comfort layer and front wall appears to be the thickness of the lower part 6b, which displaces the upper part 6a from the front wall 3.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 18 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim does not fall within at least one of the four categories of patent eligible subject matter.
Claim 18 describes how to measure CIE L*a*b* values with a spectrophotometer. The claim specifies settings for a defines parameters for an X-Rite SP64 spectrophotometer, but does not constitute a process, machine, manufacture or composition of matter.
This claim depends on parent claim 1, and is phrased as “An ostomy pouch according to claim 1 wherein …” The claim does not constitute a process, since no steps are positively recited. The claim is not a machine or manufacture, since it does not recite any structural or physical features. The claim is not a composition of matter, since it does not describe any substances or ingredients.
Claim Rejections - 35 USC § 112(b)
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.
Claim 18 is 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 pre-AIA the applicant regards as the invention.
Claim 18 specifies how the CIE L*a*b* values are defined and measured with a spectrophotometer manufactured by X-Rite, Series SP64. This claim appears to define the subject matter with a trade name, and is therefore indefinite.
If a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, then the claim does not comply with the requirements of the 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). See also Eli Lilly & Co. v. Apotex, Inc., 837 Fed. Appx. 780, 784-85, 2020 USPQ2d 11531 (Fed. Cir. 2020). Also see MPEP 2173.05(u).
Claim 18 further calls for “…The hue angle indicates the colour C*: Chroma (Value: 0-100) Gray is 0 and 100 is a fully saturated colour Standard tolerance: CMC2: i: L*=2, hº=Variable ellipse, C=1, Cf=1 (Commercial factor expends ellipse).” This language is ambiguous because it contains narrative or indefinite language. The claims must be in one sentence form only. Note the format of the claims in the cited patents.
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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-18 are rejected under 35 U.S.C. 103 as being unpatentable over Hoggarth; Marcus et al. (US 20210100678 A1) in view of Tsunoda; Arika (US 20220071817 A1).
Regarding claim 1, Hoggarth discloses an ostomy pouch (¶ [0001], [0196] A first example embodiment of an ostomy appliance 1 according to the present disclosure is shown in FIGS. 1 to 6);
comprising: a front wall; a rear wall (¶ [0196], As shown in FIGS. 1 and 2, the ostomy appliance 1 may generally comprise an inner wall 2, an outer wall 3); and
an inlet for receiving human waste (¶ [0198] As shown in FIGS. 2 and 3, the inner wall 2 is provided with a stomal inlet 20 for receiving the stomal output into the cavity);
wherein, the pouch has a comfort layer provided at least on the front wall (¶ [0196], outer comfort layer 6; ¶ [0201] The inner comfort layer 5 and the outer comfort layer 6 may be formed of a flexible sheet material. The flexible sheet material may comprise a fabric layer; ¶ [0202] The inner comfort layer 5 and the outer comfort layer 6 may comprise at least one fabric layer and at least one film layer);
wherein at least the comfort layer on the front wall has a colour (¶ [0398] In this table, the column “Colour” refers to the colour of the outermost layer of the ostomy appliance. “Neutral” refers to the presence of an outer comfort layer 6 having an opaque, neutral colour).
Hoggarth is silent regarding the comfort layer’s color in the CIE L*a*b* color code system. Tsunoda discloses disposable wearable articles having colored nonwoven fabric (¶ [0001], [0010], [0021], [0076] FIGS. 1 to 6 show an example of the underpants-type disposable diaper);
comprising: a front wall (¶ [0077] This underpants-type disposable diaper has outer member 20 forming front body F and back body B and inner member 10 integrally fixed on the internal surface side of the outer member 20; ¶ [0212] In order to make the present underpants-type disposable diaper a colored product, the second sheet layer 20B having portions exposed to the product external surface may be of a colored nonwoven fabric; ¶ [0214] As shown in FIG. 29, the colored nonwoven fabric 100 is a composite nonwoven fabric composed of a plurality of layers laid one on top of another … the outermost layer 101 preferably has a color of the second lightness higher than the first lightness);
a region for receiving human waste (¶ [0079] The inner member 10 has a structure, as shown in FIGS. 4 to 6, including liquid pervious top sheet 11, liquid impervious sheet 12 made of, for example, polyethylene, and absorbent body 13 interposed therebetween which absorbs and holds excrement);
wherein the front wall has a colour with a value in the range of L*=56.0 to 59.0, a*=+2.0 to +5.0 and b*=0.0 to +3.0 measured in the CIE L*a*b* colour code system (¶ [0219], it is preferred, for example, that the color of the first lightness has a CIELAB L* value of 20 to 90, and the absolute value of at least one of a* and b* values is 0 to 40. Specifically, the colored layer 110 may be colored in a color of a relatively low lightness, such as beige, gray, pink, blue, purple, or yellow).
Tsunoda demonstrates how to construct a textile layer with a neutral color that is quantified by a color space system, specifically the CIE lab system. One would be motivated to modify Hoggarth with Tsunoda’s CIE L*a*b* values since Hoggarth calls for a neutral color (¶ [0398] In this table, the column “Colour” refers to the colour of the outermost layer of the ostomy appliance. “Neutral” refers to the presence of an outer comfort layer 6 having an opaque, neutral colour). Therefore, it would have been obvious to modify Hoggarth with Bendix’s CIE L*a*b* values in order to provide a neutral colored textile layer.
Regarding claim 19, Hoggarth and Tsunoda describe all features of the claimed invention as discussed for claim 1. Claim 19 expresses a method only in terms of providing or applying the various walls, inlet and sheets of claim 1.
Regarding claims 2-5 and 17, Hoggarth is silent regarding the comfort layer’s CIE L*a*b* values. Tsunoda discloses a fabric layer with specified CIE L*a*b* values:
CIE L*a*b* parameter
Claimed ranges
Tsunoda’s ranges
L*
57.0 to 58.0,
56.0 to 59.0
20 to 90, ¶ [0219]
a*
+3.0 to +4.0,
+2.0 to +5.0
0 to 40, ¶ [0219]
b*
1.0 to 2.0,
0.0 to +3.0
0 to 40, ¶ [0219]
Tsunoda provides a textile layer with specified CIE L*a*b* values. Regarding the rationale and motivation to modify Hoggarth with Tsunoda’s CIE L*a*b* values, see the discussion of claim 1 above.
Regarding claims 6 and 9-16, Hoggarth discloses an ostomy pouch further comprising a comfort layer on the rear wall (¶ [0196], an inner comfort layer 5);
wherein the front wall on which at least one comfort layer is formed is transparent or translucent (¶ [0398], In these examples the outer wall 3 is transparent and the inner wall 2 is opaque, e.g. white);
wherein there are no opaque intervening walls between the front wall and the comfort layer provided thereon (Fig. 2, the outer wall 3 directly contacts outer comfort layer 6);
wherein the at least one comfort layer formed on the front wall is spaced from the front wall (¶ [0213], The first part 6a and the second part 6b may be separable from each other in the overlap region 15 to form a window opening for viewing the cavity. The overlap region 15 may extend obliquely from at or near a mid-point of the first edge 10a to at or near a mid-point of the fourth edge 10d);
wherein an opening is provided in the comfort layer provided in the front wall, through which an ostomate may inspect stomal output (¶ [0213], The first part 6a and the second part 6b may be separable from each other in the overlap region 15 to form a window opening for viewing the cavity);
wherein the comfort layer comprises a sheet of absorbent woven comfort material; wherein the absorbent woven comfort material is polyester and/or cotton (¶ [0108] Additionally or alternatively, in some embodiments the at least one fabric layer may comprise a woven or a non-woven textile layer. The fabric layer may comprise polyester, nylon, viscose, polyethylene or polypropylene; ¶ [0202] The inner comfort layer 5 and the outer comfort layer 6 may comprise at least one fabric layer and at least one film layer. The at least one fabric layer may comprise a non-woven textile layer but is preferably a woven textile layer. The woven textile layer may comprise one or more of polyester, nylon, viscose, polyethylene and polypropylene);
wherein the comfort layer comprises a sheet of comfort material having an outside surface and an opposite inside surface (Figs. 2, 10, 11, comfort layers 5 and 6 comprise fabric and therefore have two surfaces);
the outside surface of the sheet of comfort material forming at least part of the outside surface of the pouch (Figs. 2, 10, 11, comfort layers 5 and 6 have outward facing surfaces that form the outermost surfaces of the pouch); and
(ii) the inside surface of the sheet of comfort material being laminated across its entire surface to a continuous layer of film material, with no intervening adhesive, at least part of the continuous layer of film material being adjacent, facing and unbonded to the outside surface of the front wall (¶ [0202] The inner comfort layer 5 and the outer comfort layer 6 may comprise at least one fabric layer and at least one film layer … The at least one film layer may be laminated to the at least one fabric layer, and optionally may be laminated to the at least one fabric layer over an entire area of the inner comfort layer 5 and the outer comfort layer 6);
comprising a cavity for storing stomal output, the cavity defined by the rear wall and the front wall (¶ [0197] The inner wall 2 and the outer wall 3 are joined together to define a cavity for containing a stomal output);
the rear wall and front wall being formed of flexible plastic film, joined at their peripheries (¶ [0099] Additionally or alternatively, in some embodiments the flexible sheet material of the inner wall and/or the outer wall may comprise polyvinylidene chloride (PVDC) and/or ethylene-vinyl acetate (EVA); ¶ [0199] The inner wall 2 and outer wall 3 may be joined together around their peripheral edges by use of welding, adhesive or equivalent means. Welding is a preferred method of joining the inner wall 2 and the outer wall 3);
the rear wall being opaque and the front wall being transparent or translucent (¶ [0398], In these examples the outer wall 3 is transparent and the inner wall 2 is opaque, e.g. white);
the rear wall and front wall each having corresponding inside and outside surfaces whereby the inside surfaces of the rear and front walls form the interior of the cavity and the outside surfaces of the rear and front walls form the exterior of the cavity (¶ [0197], The inner wall 2 and the outer wall 3 are of flexible sheet material; ¶ [0198] As shown in FIGS. 2 and 3, the inner wall 2 is provided with a stomal inlet 20 for receiving the stomal output into the cavity);
the comfort layer covering the outside surface of the front wall, but able to be spaced from and separable from the front wall (¶ [0213], The first part 6a and the second part 6b may be separable from each other in the overlap region 15 to form a window opening for viewing the cavity).
Regarding claim 7, Hoggarth and Tsunoda are silent whether the comfort layer on the rear wall has the same colour as the comfort layer on the front wall.
However, selecting the same color for both comfort layers would have simplified the pouch’s construction since both layers can be constructed from a single web of material cut into overlapping shapes.
Regarding claim 8, Hoggarth and Tsunoda do not explicitly disclose that the comfort layer on the rear wall has a contrasting colour to that on the front wall and has a lower L* value.
Hoggarth calls for a neutral color (¶ [0398], “Neutral” refers to the presence of an outer comfort layer 6 having an opaque, neutral colour). Tsunoda describes a range of neutral colors including beige or gray, where a* and b* have values near zero (¶ [0219], and it is preferred, for example, that the color of the first lightness has a CIELAB L* value of 20 to 90, and the absolute value of at least one of a* and b* values is 0 to 40. Specifically, the colored layer 110 may be colored in a color of a relatively low lightness, such as beige, gray, pink, blue, purple, or yellow).
A skilled artisan would have been able to modify Hoggarth with Tsunoda’s CIE L*a*b* values by selecting two closely matched shades of beige or gray. For example, Tsunoda’s embodiments include regions with different colors (¶ [0216], For example, the intermediate portion L and the both end portions in the width direction WD may be colored in different colors, or the waist end portions 23 regions and the remaining regions may be colored in different colors; ¶ [0217], It is also possible to take measures to print only on the internal surface of the composite nonwoven fabric so that the coloring component does not reach the outermost layer 101, by which colored nonwoven fabric 100 having partially colored portions or colored nonwoven fabric 100 having a plurality of colored potions in different colors may be obtained; ¶ [0222], Accordingly, the color difference ΔE between the colors of the second and the third lightness is preferably 30 or less).
Regarding claim 18, Hoggarth is silent regarding CIE L*a*b* values. Tsunoda discloses a fabric layer with defined CIE L*a*b* values (¶ [0219]).
Tsunoda does not explicitly disclose that the CIE L*a*b* values are measured with a spectrophotometer of a specific manufacturer, brand or settings. However, the CIE L*a*b* color standard is an internationally recognized system defined in 1976 which applies to any equipment or software complying this standard. In other words, the CIE L*a*b* color standard applies universally to any system that uses it.
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).
Claim 1 is provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claim 1 of application 18/519449 to Young; Alice et al. (US 20240091049 A1).
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Regarding pending claim 1, Young claims substantially all limitations in claim 1.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Bendix; Jakob et al. US 20140296807 A1
Akthakul; Ariya et al. US 20200009184 A1
Tsunoda; Arika US 20220087878 A1
Ierulli; Joseph V. US 20220347002 A1
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/Adam Marcetich/
Primary Examiner, Art Unit 3781