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 1-22 have been canceled. It is noted that the claims filed 6/1/2026 should be a complete listing but rather start at claim 22 which is noted to be canceled. In the interest of compact prosecution, claims 1-21 are considered canceled as well as claim 22 which includes a status identifier which reads canceled.
Claims 23-36 are pending in the application and under current examination.
Withdrawn Rejections
All rejections of canceled claim 22 are withdrawn. New grounds of rejection necessitated by amendment are presented below.
The rejection of claim 22 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite is withdrawn. The rejection of claims 22 and 23 under 35 U.S.C. 103 as being unpatentable over Carty in view of Toth, CN’054, and Zander is withdrawn and modified as necessitated by amendment; the relevance of the previously cited references is maintained as detailed below. Subsequently, the rejection of claims 24-36 is withdrawn and newly presented below as necessitated by amendment to base claims 22 and 23.
Response to Arguments and Declaration
Applicant’s arguments filed 6/1/26 (hereafter, “Remarks”) have been fully considered and are addressed as follows. The declaration filed under 37 C.F.R. 1.132 is entered and also fully considered.
As to the Declaration of Enrico Frezza, inventor in the instant application, the Declaration establishes that Mr. Frezza is an expert in the field (points no. 1-6 of the Declaration) and argues that the instant invention cures unmet consumer need relative to hydrocolloid products on the market and commercial success (see points no. 7-10 and points no. 14-17 in particular). Applicant’s argument has been considered but is not persuasive since it is not supported by evidence in the record that persons who presumably were working on the problem were working for a duration of time and still unable to solve the problem. Additionally, Applicant opines that the cited reference do not teach the benefits alleged in the instant application and further opines the conclusion that the cited references fail to recognize the importance of creating an acne patch that consumers would feel comfortable wearing visible during normal daytime activities and social interactions and that one would not have been motivated to arrive at the claimed invention (points no. 11-13). In reply, these arguments have been considered but are not persuasive at least in view of the preponderance of evidence in the record.
As to Applicant’s remarks, regarding the previously issued rejections under 35 U.S.C. 103, Applicant argues that the combined art fails to teach all claimed limitations, specifically that a hydrocolloid material as in Carty is a hydrocolloid dressing as claimed. In reply, this argument is not persuasive in view of the terms detailed in the specification as filed. It is maintained that the specification as filed does not 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 such that the sheet claimed may reasonably encompass components included in the hydrocolloid material. See [0035]-[0037] and [0045] in particular of the specification as filed. In other words, Applicant appears to be arguing a narrower claim term meaning than is defined in the specification as filed. As to the claim language pertaining to coatings, Carty’s layers appear to be the same or substantially the same structure instantly claimed.
Applicant continues on page 7 of Remarks that the Office has not shown the hydrocolloid is a flexible sheet. In reply, this argument is not persuasive since Carty teaches the products may be peeled and pressed into sheets and otherwise encompass the instantly claimed elements such that Carty teaches a product the same or substantially the same as claimed (see Carty [0016], [0080], [0079], [0074] and Carty claim 27 in particular).
Accordingly, as argued in the remarks filed 6/1/2026 and as in the record previously addressed, Applicant’s arguments are not persuasive to overcome the rejection of record or the modified rejection as necessitated by amendment as detailed below.
Applicant concludes on page 8 of Remarks that “while several distinctions have been noted over the art of record, Applicant notes that there are several other features recited in the present claims which are neither taught nor suggested by the art of record.” In reply, Applicant's argument does 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 6/1/2026
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 33 and 34 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 33 and 34 depend from a canceled base claim 22. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Modified Grounds of Rejection Necessitated by Amendments filed 6/1/2026
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.
Claim 23 is 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 consisting of 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 23 as amended which now 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.
As to the device structure recited in claim 23, it is noted that 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]). See 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 claim 22 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.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 AUDREA B CONIGLIO whose telephone number is (571)270-1336. The examiner can normally be reached Monday - Thursday 7:00 a.m. - 5:30 p.m..
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/AUDREA B CONIGLIO/Primary Examiner, Art Unit 1617
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