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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/17/2025 has been entered.
Status of the Claims
Claims 1-4, 7-12, and 21 have been canceled. Claims 5, 6, and 13-20 are withdrawn. Claims 22-36 are pending and under current examination.
Withdrawn Rejections
The rejection of claim 22 as previously presented is withdrawn and newly issued as necessitated by amendment. Additional rejections necessitated by amendment are presented below in order to address the amendments to the claim preambles specifically the preambles of claims 23 and 24 now reciting an intended use, however it is noted that no new reference is cited.
Response to Arguments
Applicant’s arguments filed 11/17/2025 (hereafter, “Remarks”) have been fully considered and are addressed as follows. Applicant’s delineation of the rejections of record; cited art relied upon; and MPEP guidance as outlined on page 7 of Remarks is noted.
Applicant argues that the combined art of record fails to render obvious the claims presented. Later in Remarks, Applicant takes the position that the cited art does not teach or render obvious all claimed features, particularly noting that each independent claim recites “a hydrocolloid dressing for the treatment of acne that is a flexible sheet or wafer”. In reply, this argument is not persuasive for the reasons detailed below.
Applicant on page 8 of Remarks defines the problem to be solved in the instant application to be “providing a better solution for acne”, in alleged contrast with Carty which Applicant characterizes as enhancing adhesive properties of an adhesive composition. In reply, this argument is not persuasive in view of the problem to be solved being only limited by the selected active agents and structural components of the device and not an intended use. The reason to modify the reference may suggest what the inventor has done but for a different purpose or to solve a different problem. Here, Toth provides an adhesive advantage improvement to Carty’s adhesive component, and the additional references provide rationale for particular benefit agents, known in the art.
At the bottom of page 8 of Remarks, Applicant asserts that it has been surprisingly discovered that by properly formulating the hydrocolloid dressing and active agent, the absorption capability of the hydrocolloid dressing is desirably not reduced. In reply, Applicant’s argument has been fully considered but is not persuasive since data of practical and statistical significance supporting Applicant’s conclusion are not readily apparent.
On page 9 of Remarks, Applicant argues that differences between claim 22 and Carty and Toth are substantial. Applicant notes Carty and Toth’s materials including hydrocolloids are different with unknown liquid absorption characteristics in what Applicant characterizes as an entirely different device. In response, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Applicant concludes that Carty and Toth are not enabled to practice the teaching of the applicant’s claimed invention. In reply, Applicant’s argument has been considered, however it is unclear what undue experimentation Applicant is arguing would be necessary to operate the prior art. As currently understood, all references cited are considered prior art for all that they teach per MPEP 2121.01.
Applicant argues that one would have to select water soluble agent(s) which is not an essential feature of Carty and Toth. In reply, this argument amounts to an argument of a limitation not claimed.
Applicant asserts that one would have had no reason to select a polyurethane foam or film in view of other options. Applicant argues that the polyurethane foam of the instant invention may be part of the hydrocolloid dressing, as a possible alternative. In reply, it is maintained that Carty specifies adhesives to be laminated onto a polyurethane film (see [0079]) thereby establishing a reasonable expectation of success as well as an explicit motivation by naming polyurethane film for use in a device for the very same purpose of topical application.
Applicant concludes that the waterproof wafer of the instant application is not a device derived from Carty and Toth. In reply, the elements taught by Carty and Toth are maintained as relevant, however, it is unclear where Applicant references the “waterproof” language. This appears to be an argument directed to a limitation not claimed.
On page 10 of Remarks, Applicant argues that “there are several other features recited in the present claims which are neither taught nor suggested by the art of record.” Applicant's arguments do not comply with 37 CFR 1.111(c) because they do not clearly point out the patentable novelty which he or she thinks the claims present in view of the state of the art disclosed by the references cited or the objections made. Further, they do not show how the amendments avoid such references or objections.
New Grounds of Rejection Necessitated by Amendments filed 11/17/2025
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.
Claim 22 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The structure of component “a” of claim 22 is unclear. The interrelatedness of the device components and surfaces thereof may be interpreted differently. Is it the removable layer or the flexible sheet or wafer consisting of a hydrocolloid dressing comprising a polyurethane foam or film which covers the non-contacting side of the dressing? Also, what does “that is a flexible sheet or wafer and is self-adhesive” modify? Does it modify the dressing or the device or the removable layer, or another interpretation? The sentence structure is confusing, and the placement of commas does not sufficiently clarify modifiers.
Modified Grounds of Rejection Necessitated by Amendments filed 11/17/2025
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 22 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Carty (WO2014/159798A1) in view of Toth (US 2013/0296762 A1), CN103143054A (previously cited), and Zander (“Treatment of acne vulgaris with salicylic acid pads”, Zander et al., Clinical Therapeutics, 01 Mar 1992, 14(2): 247-253; PMID 1535287).
Claim 23 is drawn to a device comprising a hydrocolloid dressing that is a flexible sheet or wafer and is self adhesive wherein the hydrocolloid dressing comprising an adhesive and coating as further specified in the claims, and wherein the device further comprises a specified active agent which is salicylic acid in an amount of from 0.5 to 0.9%, a polyurethane foam or film, a further adhesive, and additional optional components as further specified in the claims. It is noted that the specification as filed does not clearly define or limit the claimed “hydrocolloid [dressing]” by identifying or limiting its components beyond any sheet or wafer containing materials that form a gel in the presence of water (see [0034], [0035], and [0037] for instance); as such, the claim language stating that the “flexible sheet or wafer consisting of” a hydrocolloid and an active agent may reasonably encompass any components included in the hydrocolloid material; this definition does not exclude additional components such as an adhesive or adjuvants such as absorbents or physical stabilizing components. See [0035]-[0037] and [0044] of the specification as filed. As to the intended use in the preamble, this language does not further limit the structure otherwise addressed wherein the prior art teaches topical application of formulations which may include those known to function as anti-acne agents.
Carty teaches adhesive compositions which may comprise active agents such as pharmaceutical agents such as anti-acne agents (see abstract, in particular; see also paragraph [0038]). Carty’s active agents are included in amounts of 0.5% to 10% by weight of the total formulation in a hydrocolloid adhesive formulation (see [0057]). Carty teaches the adhesive formulations may be hydrocolloids with adhesive properties (see [0016]) and that these products may be peeled (see [0080] in particular) and that the adhesive formulations are made by being pressed into sheets (see [0079]) which are considered “a flexible sheet or wafer”. It is noted that Carty’s requisite components (adhesive, vehicle, absorbent, crystallization inhibitor) as recited in Carty’s claim 27 for instance are understood to constitute according to Applicant’s own definitions and examples, a “hydrocolloid” material. Carty’s adhesive compositions may form a layer, coating, or other region of adhesive that enables the article to be adhered to a wide range of surfaces including skin (see [0074])(“wherein the flexible sheet or wafer is self-adhesive to a skin surface”). Carty further teaches that the adhesive compositions can be used with articles including layers covering the adhesive layer or coating such as a release liner (see [0074]), which is considered a “removable layer” as claimed. Carty’s adhesive may be based on butyl rubber for instance (see [0022])(limitation of claim 23) and may further include an absorbent which is a crosslinked sodium carboxymethyl cellulose (see [0027])(limitation of claim 23) which may be present as a swellable component (a dispersion for instance) and a layer or coating (see [0074] in particular). Carty specifies adhesives to be laminated onto a polyurethane film (see [0079])(limitation “c” in claim 23).
As to the adhesive location recited in claim 23(d), Carty teaches that the adhesive may comprise a layer, coating, or region (see [0074]), and it is the examiner’[s position that the particular pattern or “region” constitutes a design choice which the artisan would have been motivated to select and optimize to have the desired adhesive properties (i.e., more adhesive product for relatively more adhesive efficacy). Nonetheless, it is not apparent that Carty’s product necessarily comprises a further adhesive as recited.
Toth cures this deficiency. Toth teaches a self-sealing dressing for application to the skin of a human and comprising an adhesive layer component in a wound dressing (see abstract, in particular). Toth specifies hydrocolloid adhesives among those which may be employed (see [0031]). Toth identifies that in some similar dressings known in the art a leak may undesirably be formed along the edge of a dressing (see [0045] and [0046]). Toth specifies that a gel adhesive may be patterned along a selected portion of a rear surface of a substrate such as adjacent to exposed outer edge surfaces (see [0016]). Toth further describes an exemplary embodiment in which a layer of additional adhesive may be applied to a portion of a top surface of the substrate around the perimeter of a tube opening in a dressing in order to prevent leaking and provide good attachment to the surface of the skin.
Both Carty and Toth are directed to adhesive wound dressings including hydrocolloid-containing ones. It would have been prima facie obvious to one of ordinary skill in the art to add additional adhesive (i.e., an additional layer) around edge portions of a wound dressing as suggested by Toth to the products of Carty, with a reasonable expectation of success. One would have been motivated to do so based on Toth’s teaching that leaks and undesired seal breakage along openings including edges may be remedied by the inclusion of additional and/or “aggressive” adhesive on the pattern of the dressing product.
While Carty generally teaches anti-acne agents may be included, Carty does not provide sufficient motivation for selecting an anti-acne agent from the multiplicity of active agents Carty encompasses. CN103143054A cures this deficiency and teaches anti-inflammatory hydrocolloid dressing material to be used for promoting wound healing (see title). The hydrocolloid dressing comprises salicylic acid in an amount of 1% to 3%, a range nearly the instantly claimed ranges, and, moreover, Zander teaches acne vulgaris to be similarly treatable with salicylic acid in amounts of 0.5 and 2% (see abstract, in particular).
Both Carty and CN103143054A are directed to hydrocolloid products topically applicable for skin benefits. It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to include salicylic acid as taught by CN103143054A to be useful in a hydrocolloid dressing in the hydrocolloid adhesive dressings of Carty, with a reasonable expectation of success. One would have been motivated to do so based on CN103143054A’s teaching of hydrocolloid dressings incorporating salicylic acid for use in anti-inflammatory, antiseptic, analgesic applications for wound healing in safe and convenient form (see CN103143054A abstract in particular). Further, it would have been prima facie obvious to one of ordinary skill in the art to reduce the amount of salicylic acid from 1-3% as taught by CN103153054A to an amount of 0.5% as taught by Zander, with a reasonable expectation of success. One would have been motivated to do so since Zander teaches salicylic acid to be desirably useful for treating acne vulgaris in a concentration slightly lower than CN103153054A’s range.
As to the amount of active agent included, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to adjust the amount of this component to have the desired efficacy, with a reasonable expectation of success. One would have been motivated to do so as part of routine optimization procedures and specifically to control the amount of antibacterial and/or antifungal efficacy (see [0006]). As to the claim limitations reciting ranges of salicylic acid present in an amount such as “about 0.5% to 0.9%”, a range nearly overlapping with the aforementioned cited art’s 1 to 3% range, a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985). Moreover, it is noted that Applicant’s own definition of “about” allows for a variance of 20%, thereby indicating that the claims may be interpreted to include the values disclosed in the cited art. Further regarding the ranges of salicylic acid recited in claims 24-27, it would have been obvious to perform routine optimization procedures with regard to the desired amount of salicylic acid as is routine in the art in order to maximize benefits and minimize harms (i.e., in the case of salicylic acid, undesirably dry skin upon topical application).
Since component “e” and “f”, of claim 23 is considered optional, it is not further addressed here.
Regarding claim 22 which recites closed language with regard to the device which consists of a hydrocolloid dressing, an active agent and aloe vera and vitamin A components as further specified in the claims, as noted previously in the record, Applicant’s own definition of “hydrocolloid dressing” allows for the inclusion of a wide variety of components with a hydrocolloid dressing material, so adjuvants and the like are not interpreted, in view of the specification as filed, to be excluded by the closed language. Moreover, the “device” claimed may encompass the hydrocolloid dressing in which layers or backings outside of a self-adhesive hydrocolloid would be considered and properly interpreted to be outside of the device structure claimed. Accordingly, the limitations of claim 22 are addressed above in regard to claim 23. Moreover, the functional properties of not reducing absorption capability and formulated to treat acne appear inseparable from the product itself, so these features are considered to be met by the cited art as outlined above; there appears to be no structural distinction between the device described in the specification as filed and a hydrocolloid dressing device comprising the active agent as claimed.
Regarding the new claim language in claim 22, “a removable layer on an inner surface of the device, and a flexible sheet or wafer consisting of a hydrocolloid dressing comprising a polyurethane foam or film, covering the non-contacting side of the dressing, that is a flexible sheet or wafer and is self adhesive”, Toth teaches this structure to be used for the very same purpose of topical application. Toth teaches a dressing in the form of a laminate including a substrate having a top surface and a rear surface and an adhesive layer disposed over a portion of the rear surface of the substrate wherein the substrate may be a thin polyurethane film. Toth’s “rear” surface is the face that contacts the skin or wound and is comparable to the dressing or “inner” side of the instant invention, to which a release film may be removed prior to topical application (see [0024]). Se also Toth at [0014]-[0020] and Fig. 2.
Claims 24-36 are rejected under 35 U.S.C. 103 as being unpatentable over Carty (WO2014/159798A1) in view of Toth (US 2013/0296762 A1), CN103143054A, and Zander (“Treatment of acne vulgaris with salicylic acid pads”, Zander et al., Clinical Therapeutics, 01 Mar 1992, 14(2): 247-253; PMID 1535287) as applied to claims 22 and 23 above, and further in view of Chamberland et al. (US 8,858,988 B2) and Hayward et al. (US 5,585,109).
Carty, Toth, CN10314305A, and Zander do not specify aloe vera and vitamin A as recited in claims 24, 28-31, 33, 34, 35, and 36. Chamberland and Hayward cure this deficiency. The self-adhesive feature recited in claim 32 is further addressed above by Toth, however claim 32 is rejected here since it depends from claim 27, which depends from claim 24.
As to the aloe vera, Chamberland cures this deficiency. Chamberland teaches compositions for treating wounds and burns and skin injuries (see title). See also column 3, lines 16-20. Chamberland specifies in an embodiment that aloe vera gel is incorporated into a composition for wound dressing wherein the aloe vera is included in an amount of 1% (see column 6, line 11) and generally discloses an amount of about 1% to about 10% aloe vera gel (see Chamberland claim 1). This amount is considered to meet the instantly recited amount of “0.5%”.
Both CN103143054A and Chamberland are directed to wound treatment products. It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to add aloe vera as taught by Chamberland to the formulations of Carty and CN103143054A with a reasonable expectation of success. One would have been motivated to do so to aid wound healing or the treatment of traumatized dermal tissues or skin injuries based on Chamberland’s teachings and the state of the art generally taught by Chamberland and subsequently to perform routine optimization procedures with regard to the precise amount in order to achieve the desired end result. One reasonably would have expected the aloe vera to retain its known functional benefit along a continuum such that one may have adjusted its amount depending on the desired benefit and relative presence in the total composition, as is customary in the art.
Regarding the vitamin A component, Hayward cures this deficiency. Hayward is directed to salicylic acid formulations to be administered for cosmetic benefit (see abstract, in particular). Hayward teaches vitamin A palmitate among particularly preferred vitamins to be included in the salicylic acid containing formulations (see column 3, lines 27 and 28). Hayward demonstrates this ingredient in a moisturizing product to be used in an amount of 1.0 parts by weight (see Example 2). Hayward’s amount of 1.0% by weight is considered to meet the instantly recited amount of “0.5%” since Hayward generally teaches ranges coupled with the term “about” indicating that the known functional benefit components may be adjusted so to achieve the desired end result as is customary in the art.
Both CN103143054A and Hayward are directed to topically applicable salicylic acid formulations. It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to add vitamin A such as its palmitate form as taught by Hayward to the salicylic acid containing formulations of Carty and CN103143054A, with a reasonable expectation of success. One would have been motivated to do so based on Hayward’s teaching of this ingredient as a particularly preferred vitamin useful in formulations applied to the skin and based on Hayward’s selection and embodiment of this particular ingredient in Hayward’s example.
Further regarding the recited amount of 0.5% of individual components addressed above, and specifically regarding claims 28, 29, 30, and 31, where the prior art’s nearest teaching is “about 1%” and as applicable here, a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985).
Conclusion
No claim is allowed.
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/AUDREA B CONIGLIO/Primary Examiner, Art Unit 1617