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 .
Status of the Claims
Claims 1-3, 5-7, 9-12, 15-16, 20-24, 26-30 and 38 are pending.
Response to Arguments
Applicant's arguments filed 20AUG2025 have been fully considered but they are not persuasive.
Regarding the teachings of Oeelund, Applicant’s arguments are not persuasive. While the use of window-out dressings is well-known and the difference in intended use between the dressing of Oeelund and the instant device is not relevant. Oeelund is considered to teach the structure as claimed, with the proximal and distal relationships as noted in the rejection of claim 1. Regarding the orientation in relation to the skin of the user, these features are not claimed.
Regarding the stoma opening as previously cited, Applicant’s arguments are not persuasive. The stoma opening is required to extend through the carrier layer, adhesive material, and removable protection elements. As previously defined, said opening is the space inside created by the removal of (2). This opening fulfills the claim requirements as written as those portions of each layer are removed, creating an opening extending through them.
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, 5-7, 9-11, 15, 16, 20, 22, 24, and 27-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20150073325 A1 (Oeelund) in view of US 20140303594 A1 (Stockholm).
Regarding claims 1 and 2, Oeelund teaches an adhesive wafer (Figs. 1, 2) for attachment of a base plate for an ostomy appliance [0013, 0051], comprising:
a carrier layer (formed from at least 1 and 2) having a distal surface (facing away from the user) and a proximal surface (the skin-facing surface),
a removable protection element provided on a proximal surface of the adhesive material (the protection layer facilitating release of the adhesive through a non-stick layer [0021], said attachment being considered releasable),
a stoma-receiving opening extending through the carrier layer, the adhesive material and the removable protection element (the opening formed when component 2 is removed, as seen in Figs. 1 and 2, an opening necessarily being required for use in an ostomy system),
an uptake portion (1) surrounding the stoma-receiving opening provided on a proximal surface of the removable protection element and is configured to contain stomal effluents to prevent the adhesive material from being contaminated by stomal effluents (being formed of a porous material which is permeable to liquid [0020, 0023]),
wherein at least the uptake portion is adapted to be removed after the base plate is placed around the stoma ([0042-0044] describing the process wherein the central portion is removed to attach the adhesive to the skin and then the peripheral portion is removed).
Oeelund teaches piece-wise application of the device wherein the device is adhered to the skin surface and then portions are removed for the final application [0030], but fails to explicitly teach an adhesive material provided on the proximal surface of the carrier layer and adapted to adhere the base plate to a peristomal skin surface around a stoma of a user.
Stockholm teaches a composite dressing which is considered relevant art as the device focuses on the means for adhering to the skin. Stockholm teaches a system wherein a first adhesive (106) is applied to the skin to allow for aligning the device with a target location (via opening 122), said location corresponding to the stomal opening of Oeelund. During use of the device, the first adhesive layer is subsequently removed from the skin after alignment for final placement has occurred [0055].
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 carrier layer of Oeelund with the adhesive layer and associated release liner of Stockholm to maintain the device in position during the transition from initial placement to final placement. The combined device is therefore considered to teach an adhesive material provided on the proximal surface of the carrier layer and adapted to adhere the base plate to a peristomal skin surface around a stoma of a user
Regarding claim 3, the combined device of claim 1, as taught by Oeelund in view of Stockholm is considered to teach the uptake portion (1) is integral with and forms at least a portion of the proximal surface of the removable protection element (as described in claim 1) as the components are removably attached.
Regarding claim 5, Oeelund further teaches the uptake portion (1) covers an area corresponding to less than an entirety of an area of the adhesive material provided on the proximal surface of the carrier layer (formed of 1 and 2, as 1 forms a perimeter around 2, as seen in Fig. 1).
Regarding claim 6, each of the uptake portion and the removable protection element comprises at least one slit (shown lifted in Fig. 2) extending from a position at an inner edge of the uptake portion and the removable protection element defined by the stoma-receiving opening (formed by 2) to a position on an outer peripheral edge of each of the uptake portion and the removable protection element (as seen in Figs. 1 and 2).
Regarding claim 7, Oeelund in view of Stockholm fails to teach the uptake portion and the removable protection element each comprises at least two slits extending from the inner edge of the uptake portion and the removable protection element and extending to the outer peripheral edge of each of the uptake portion and the removable protection element.
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 slit of the device of claim 6 to comprise two (or more) slits to facilitate easy removal of the layer.
Mere duplication of parts has no patentable significance unless a new and unexpected result is produced. In re Harza, 124 USPQ 378, 380 (CCPA 1960). Further, it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Regarding claim 9, Oeelund in view of Stockholm fails to teach the uptake portion comprises a circular annular wafer provided with a stoma opening.
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 generally square shape of Oeelund to a circular shape. It is a matter of engineering design to shape an ostomy wafer in different ways, where the change in form or shape, without any new or unexpected results, is an obvious engineering design. See In re Dailey, 149 USPQ 47 (CCPA 1966) (see MPEP § 2144.04). Finally, one would have a reasonable expectation of success by changing the shape of the wafer to the claimed limitation.
Regarding claim 10, Oeelund in view of Stockholm, as presented in claim 3, fails to teach the uptake portion is provided on only a centre portion of the proximal surface of the adhesive material immediately and annularly surrounding the stoma- receiving opening, and wherein a release liner element is surrounding the uptake portion and covers a remainder of the proximal surface of the adhesive material of the base plate.
Stockholm further teaches adhesive (106), corresponding to the uptake portion, is generally centrally located on the device, as seen in in Fig. 3a wherein the target area 122, corresponding to the stomal opening, is bordered by adhesive (106) with the device extending laterally outward to further comprise additional adhesive elements.
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 Oeelund in view of Stockholm with the tiered, multilayer adhesive arrangement of Stockholm in order to provide staged application as described in [Stockholm 0055] where the device may be targeted to a location for ensuring proper location and adherence to the desired area.
The combined device is therefore considered to teach the uptake portion is provided on only a centre portion of the proximal surface of the adhesive material immediately and annularly surrounding the stoma- receiving opening, and wherein a release liner element is surrounding the uptake portion and covers a remainder of the proximal surface of the adhesive material of the base plate.
Regarding claim 11, Oeelund fails to explicitly teach the layer thicknesses, and therefore fails to teach the uptake portion is of greater thickness than the removable protection element.
Stockholm further teaches the removable protection element may have a thickness less than 150 microns [0071], while the adhesive layer may be 1 mm [0072].
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 undisclosed thickness of the removable protection element to be less than that of the uptake portion as release liners are generally thin and only possess enough thickness to form a stable layer, thereby reasonably being thinner than a porous layer intended to take on liquid as previously described.
Regarding claim 15, Oeelund further teaches the uptake portion (1 and 2) is configured to absorb the stomal effluents by absorption ([0023] describing the permeable material as being formed of fibrous materials which would absorb liquids).
Regarding claim 16, Oeelund further teaches the uptake portion (1 and 2) is configured to wick the stomal effluents (felt materials being considered capable of wicking [0023]).
Regarding claim 20, Oeelund further teaches the uptake portion (1 and 2) comprises an adhesive material (the adhesive described for skin attachment [0030]).
Regarding claim 22, Oeelund further teaches the removable protection element comprises a liner or sheet material, the layer being thin and flat, and therefore being considered a sheet material.
Regarding claim 24, Oeelund in view of Stockholm teaches use of fibrous material [0023], but fails to specifically teach the uptake portion comprises a material made from paper pulp.
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 uptake portion to comprise a material made from paper pulp as Oeelund teaches use of fibrous material [0023] and paper pulp is a commonly known absorbent fibrous material.
Regarding claim 27, Oeelund in view of Stockholm teaches a release liner (102) in the device of claim 1 and is therefore considered to teach the removable protection element is configured to be a release liner provided on the proximal surface of the adhesive material of the base plate.
Regarding claim 28, Oeelund further teaches the uptake portion (1 and 2) has a thickness of between 500 µm – 3 mm, and is therefore considered to teach a thickness between 50 - 1000 µ.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness. See MPEP § 2144.05.I.
Regarding claim 29, Oeelund teaches the uptake portion (1 and 2) has a thickness of 1-2 mm [0026], but Oeelund in view of Stockholm, as presented in claim 1, fails to teach the removable protection element is made from a polymeric sheet material having a thickness in a range of between 50 - 1000 p, and wherein the uptake portion covers an area corresponding to less than an entirety of an area of the adhesive material provided on the proximal surface of the carrier layer.
Stockholm further teaches the removable protection element (102) is made from a polymeric sheet material having a thickness in a range of between 50 - 1000 µ (teaching a thickness less than 150 µm), and wherein the uptake portion covers an area corresponding to less than an entirety of an area of the adhesive material provided on the proximal surface of the carrier layer (the device possessing various sizes of adhesive areas 106, 114).
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 material thicknesses and distribution of the device of claim 1 with those taught by Stockholm to control the adhesive characteristics of the device, thereby ensuring the device operates as intended.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness. See MPEP § 2144.05.I.
Regarding claim 30, Oeelund in view of Stockholm fails to teach the uptake portion is configured to have an uptake capacity ranging from 0.005 g/30s up to 10 g/30s of stomal effluents.
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 uptake capacity of the uptake portion in order to control both the rate and capacity of fluid uptake.
Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized, by routine experimentation, uptake capacity in the apparatus of Oeelund in view of Stockholm to obtain the desired balance between the flexibility and material feel [0004] with absorbent capacity (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oeelund in view of Stockholm and further in view of US 5998694 A (Jensen et al.).
Regarding claim 12, Oeelund in view of Stockholm fails to teach at least one of the uptake portion and the removable protection element is provided with a removal tab adapted to remove removal of the uptake portion and the removable protection element from the base plate.
Jensen teaches a composite dressing (10) (Fig. 1) which is considered relevant art as the device focuses on the means for adhering to the skin. Jensen further teaches the use of tabs (19 and 20) for use in removal of the removable protection element (11a and 11b).
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 removable protection element of Oeelund in view of Stockholm with the tabs of Jensen in order to facilitate removal without contacting the adhesive (Jensen Col. 5: ll. 60-63).
Claim(s) 21, 23, and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oeelund in view of Stockholm and further in view of US 20200022879 A1 (McMichael).
Regarding claims 21, 23, and 26, Oeelund in view of Stockholm teaches the inclusion of an absorbent layer (Oeelund 4) [0052], but fails to teach the uptake portion comprises a surfactant, or a super-absorbent material.
McMichael teaches a disposable absorbent stoma pad (100) (Fig. 2), said pad corresponding to the uptake portion of Oeelund in view of Stockholm. McMichael further teaches the use of surfactants [0053] and a super-absorbent material [0053].
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 uptake portion of Oeelund in view of Stockholm to include the surfactant or super-absorbent material of McMichael to control the absorbency characteristics of the uptake portion.
As McMichael teaches the layer may comprise super-absorbent particles, the combined device is considered to fulfill the claim requirement wherein the uptake portion comprises a particulate material dusted onto the proximal surface of the removable protection element.
“[D]usted onto the proximal surface of the removable protection element” is considered product-by-process claim requirement as a component formed of super-absorbent particles would necessarily possess said particles on the surface. The cited prior art teaches all of the positively recited structure of the claimed apparatus or product. The determination of patentability is based upon the apparatus structure itself. The patentability of a product or apparatus does not depend on its method of production or formation. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. See In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (see MPEP § 2113).
Claim(s) 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oeelund in view of Stockholm and further in view of US 20090312685 A1 (Olsen et al.).
Regarding claim 38, Oeelund in view of Stockholm fails to teach the uptake portion comprises a color-change indicator adapted to change color when the stomal effluents are contained by the uptake portion.
Olsen teaches an ostomy wafer (Fig. 1a) wherein a color-change moisture indicator is present [0038].
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 claim 1 to incorporate the color-changing indicator of Olsen so that the user is aware of moisture uptake [Olsen 0038].
The combined device is therefore considered to teach the uptake portion comprises a color-change indicator adapted to change color when the stomal effluents are contained by the uptake portion.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 8071126 B2 teaches a bandage wherein an adhesive layer is applied and subsequently removed during application.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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
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