DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of the Claims
Claims 1-8, 14, and 22 previously were canceled; claims 10, 16,17, 20, 21, and 26-28 are newly canceled. Claims 24-25 previously were withdrawn. Claims 9, 11-13, 15, 18, 19, and 23 are pending and under current examination.
Withdrawn Rejections
All rejections of claims 10, 16, 17, 20, 21, and 26-28 are withdrawn in view of Applicant’s cancelation of these claims.
The rejection of claims 9-13, 15-21, and 23 under 35 U.S.C. 103 as being unpatentable over Katz in view of Ignatious is withdrawn in view of the claim amendments filed 3/2/2026. New grounds of rejection necessitated by amendment are presented below.
Claim Objections, New
Claim 9 is objected to because of the following informalities: the grammatical format of the claim should be the format of a sentence. The last two lines of the claim appear to include grammatical and/or punctuation errors by reciting “the skin patch dissolves forms a transparent film…”. Specifically “dissolves forms” appears grammatically erroneous. Appropriate correction is required.
Response to Arguments
Applicant’s arguments filed 3/2/2026 (hereafter, “Remarks”) have been fully considered and are addressed as detailed below following each respective section.
Maintained Rejections
Claim Rejections - 35 USC § 112(a), New Matter
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 9, 11, 12, 13 and 15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 9 recites “and the skin patch remains separate from the active agent until application of the skin patch to skin”. While this language appears directed to an intended use or a stepwise method of using the claimed kit, should this language be interpreted as structural limitation, this language constitutes new matter. Applicant’s remarks filed 10/30/25 assert that the claims as amended present no new matter, however it is noted that specific support for this amended claim language is not explicitly cited. The examiner has reviewed the specification as filed, and an explicit or implicit separation either as a structural feature or a use does not appear to be described in the specification as filed.
Response to Arguments Regarding Previously Issued Rejections under 35 U.S.C. 112
Applicant argues on page 1 of Remarks filed 3/2/2026 that the claims have been amended such that the previously issued rejection is now moot and that the problematic claim language has been removed. Upon review, the problematic language is noted to remain in the claims as amended. Accordingly, all rejections of claims remaining in the application are maintained.
New Grounds of Rejection Necessitated by Amendments of 3/2/2026
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 9, 11-13, 15, 18, 19, and 23 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Katz (US20100183519) in view of Ignatious (WO01/54667). References newly applied as necessitated by amendment.
The instant claims are drawn to a skin care kit comprising an active agent; a dissolvable skin patch comprising a matrix of hydrophilic fibers; and instructions for applying the active agent to the skin. Claim 9 encompasses functional language describing that the skin patch is adapted to dissolve upon being applied to skin and wetted and remains separate from the active agent until application of the skin patch to skin. Claim 9 also includes stepwise language of “thereafter applying the skin patch over the active agent and wetting the skin patch either after application to the skin or before application to the skin”; this stepwise language does not appear to further structurally limit the claimed product but rather appears an intended use or a method of use and subsequent description of what happens as an effect of performing a process with the claimed product. The term “pre-wetting” as in line 3 describes an intended use and not a structural distinguishing feature over the claimed component which is a solution comprising an active agent.
Regarding the previously examined claim language “and the skin patch remains separate from the active agent until application of the skin patch to skin”, in the absence of description of this feature in the specification as filed as noted above under the new grounds of rejection necessitated by amendment, this language is interpreted to describe a functional property that occurs upon stepwise application of the patch to a skin surface. Where the prior art teaches topical application and specifically topical application to a mucosal surface and where the prior art is to be used for the very same purpose as the kit instantly claimed, the prior art is considered to meet the function and/or effect claimed and as previously addressed in regard to previously examined claim 14.
Katz teaches a topical formulation which is a liquid or gel (see title and [0011]) that comprises a therapeutic agent which may be an anti-inflammatory agent (see [0183] and [0191] in particular) by administration orally, vaginally, rectally, or ophthalamically (see [0109]). The formulation may be applied by spraying to form a coating on a surface of a dressing (see [0207]) and may be administered in a liquid, lotion, cream, gel, spray, etc. or by a microfiber for instance (see [0219]). Katz specifically includes formulations for treating inflammation (see [0002], [0016], [0273], among others) as well as anti-inflammatory active agents (see [0031]). Katz’s product may include kits (see [0042]) and compositions may be applied using transdermal patches (see [0237]); the kits may include instructions describing administering (see [0293]), considered instructions for applying the active agent to skin, as recited in claim 9. Katz’s disclosed active agents are considered at least a medicament (limitation of claim 13). Katz teaches patches as a dosage form which may be used to provide controlled delivery of a compound to a body and that this dosage form may be made by and applied to the skin (see [0241], [0237], [0238]).
As to the components which are an active agent, a solution, and patch, it is the examiner’s position that Katz teaches each component in a skin care kit such that it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to make separable, integral, or continuous these components in order to store and deliver an active agent topically and using benefits of known skin patch products based on Katz and further in view of Ignatious as detailed below. One would have been motivated to do so to provide controlled delivery of a pharmaceutical or cosmetic active agent such as from a solution as taught by Katz and controllably based on dissolving patch properties as also taught by Katz.
Katz does not teach the particular fibers which are necessarily hydrophilic as in claim 9 or electro spun hydrophilic fibers which are polyvinyl pyrrolidone as in instant claim 12.
Regarding the matrix of hydrophilic fibers recited in claim 9 as well as the electrospun PVP fibers recited in claim 12, Ignatious teaches dressing products comprised of electrospun fibers of polyvinyl pyrrolidone (see page 11, lines 14-25) wherein a drug may be bioavailable by being embedded into the fiber (page 5, lines 29-31) for topical administration to a mucosal surface to delivering an anti-inflammatory agent for instance (page 4, line 15; page 5, line 11; page 8, line 19; Ignatious claim 14). The fibers may be cut and processed as a sheet in a quick-dissolving product (see page 17, lines 4-5), considered a matrix of hydrophilic fibers as recited in claim 9. Ignatious elaborates that rapidly dissolving dosage forms comprise an electrospun water soluble polymer such that the rapid dissolving dosage form disintegrates in a rapid manner (page 7, lines 15-19). Ignatious’ dosage forms are for topical delivery with particular orientation towards oral application but explicitly pertaining also to topical delivery uses (see page 7, lines 31-34). Ignatious further explicitly states that “the fibers may also be cut and processed as a sheet for further administration with agents to form a polymeric film, which may be quick-dissolving” (page 17, lines 2-5); this teaching is interpreted to teach a product which is structurally indistinguishable from a “dissolvable skin patch” as recited in the claims.
Both Katz and Ignatious are directed to products including topically applicable pharmaceutical materials including those for administering an active agent which may be an anti-inflammatory agent. Katz teaches topical application (see [0299]) as does Ignatious (see page 7, line 33). It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to combine teachings of Katz and Ignatious to produce a topical dressing which is a polymeric fiber polyvinyl pyrrolidone sheet or patch type product as taught by Ignatious for delivering an active agent topically as taught by Katz, with a reasonable expectation of success. To do so would have constituted combining prior art elements according to known methods to yield predictable results, with a reasonable expectation of success. One would have been motivated to do so to provide a delivery vehicle for administering an active agent topically to the tissue which is skin or any topical body surface which is skin or an oral cavity.
As to the language in claims 9 as amended, and claim 15 describing the functional effects of performing a method of use of the claimed patch, wherein upon being applied and wetted, the skin patch dissolves and the active agent is delivered to the skin and/or is adapted to do so, and wherein the skin patch remains separate from the active agent until application of the skin patch to skin, since the prior art teaches the same polymeric fiber which is polyvinyl pyrrolidone produced by electrospinning and teaches a patch type product thereof, the prior art teaches a fiber product having the same or substantially the same properties and functions including dissolution parameters and reaction to being wetted. As to a presence of active ingredients present in a skin patch in a dry state and adapted to remain separate from the active agent until application of the skin patch to skin, Ignatious teaches electrospinning and solvent removal thereby resulting a patch as claimed; specifically, until liquid is applied on the surface of the skin, it appears the patch in the prior art may be considered to remain separate in this way from the active agent until wetted at the time o application of the skin patch to skin, at which time the active agent would be in solution whereby said solution may dissolve the patch product upon combination. Further regarding the adhesive character recited in claim 15, here, a product and its properties are inseparable.
Regarding claim 11, Ignatious has been cited above for its teaching of the particular components used in an electrospun fiber product. Ignatious teaches an embodiment in which the polymeric carrier is water soluble (see claim 6) as well as an alternative. As such, Ignatious teaches a matrix lacking hydrophobic fibers by teaching water soluble carrier product since water soluble materials are hydrophilic and therefore the opposite of hydrophobic. See also Ignatious page 12, lines 1-6 which discloses alternative embodiments.
As to claims 18 and 19, Katz teaches an embodiment considered an alternative in which hydrophilic materials are employed as carriers for an active agent (see [0258]); since the prior art teaches the same polymeric fiber and teaches a patch type product thereof, the prior art teaches a fiber product having the same or substantially the same properties and functions including dissolution parameters and reaction to being wetted. It would have been obvious to select the desired polymer material based on the desired functionality (see Ignatious page 11, lines 1-6). Furthermore, since Katz and Ignatious teach a product having the same components instantly claimed and to be used in the same manner as the intended use of the claimed kit, the prior art is considered to teach a product mechanically strong enough to apply to skin without tearing.
As to claim 23, in addition to the hydrophilic carrier and hydrophobic carrier embodiments addressed above, Ignatious also teaches a combination carrier comprising hydrophilic and hydrophobic polymer component (see page 12, lines 5-7). The intended use newly recited has been addressed above. Ignatious further defines the state of the art wherein immediate, delayed and modified release systems can be designed by appropriate choice of polymeric carrier and drug combination (i.e., amount, selection) for instance (see page 5, lines 25-27) thereby providing motivation for combining hydrophilic and hydrophobic (water soluble and water insoluble, respectively) polymer carriers with an active ingredient in order to control dissolution properties in aqueous solution (“upon wetting”). As to the disposition of the one or more active ingredients on and/or within the matrix, Ignatious teaches dressing products comprised of electrospun fibers of polyvinyl pyrrolidone (see page 11, lines 14-25) wherein a drug may be bioavailable by being embedded into the fiber (page 5, lines 29-31) for topical administration to a mucosal surface to delivering an anti-inflammatory agent for instance (page 4, line 15; page 5, line 11; page 8, line 19; Ignatious claim 14). The inclusion of the active agent in and/or on the fibers has been otherwise addressed in the record and appears to be an alternate embodiment of the kit embodiment addressed above in claim 9.
Response to Arguments – 35 U.S.C. 103
Regarding rejections under 35 U.S.C. 103 over the combination of Katz and Ignatious, Applicant argues that Katz and Ignatious do not suggest a kit that includes an active agent and a skin patch functioning as claimed. In reply, it is maintained that it would have been prima facie obvious to combine Katz and Ignatious to produce a topical dressing (that is, a sheet or pad type product) which is a polymeric fiber PVP in particular as taught by Ignatious for delivering an active agent topically as taught by Katz and further functioning and/or adapted to function as otherwise described in the instant claims. It is noted that the claims under examination are drawn to a kit product and not a method of making or a method of using a product.
Applicant takes the position on page 6 of Remarks that Ignatious teaches mixed drug and carrier components, opposite what is claimed. In reply, it is noted that Applicant’s own definition of nanofibers for instance at page 2, lines 21-22 of the specification as filed does not appear to be alternative to or in violation of the structure Ignatious considered as a whole teaches. Ignatious additionally teaches alternative embodiments and also teaches that not only may the nanofibers be electrospun after premixing with drugs, but also that post mixing during fabrication may be used to make disintegrating topically applicable materials (see page 7, lines 31-34). Moreover, Applicant appears to be arguing a more limited definition of “separate” as in line 6 of claim 9 than is supported in the specification as filed. For instance, where Ignatious teaches. Nevertheless, in view of the claim language as amended and in view of Applicant’s arguments, it is noted that Katz teaches that the formulation can be sprayed onto a tissue or biomaterial surface to achieve a therapeutic coating which may be uniform, alone, or in combination with an overlying dressing (see [0207]) thereby indicating a separation consistent with the claim language under current examination.
Applicant argues that Ignatious’ topical delivery intended use would have no purpose to pre-wet as in the instant claims and concludes that modification of Ignatious instead of integration of active agent within a patch product would not be practical with the intended administrations. Applicant concludes that Ignatious and Katz together do not teach what is claimed.
In reply, first of all, topical application to an oral mucosal surface is considered topical application. Secondly, the claims under examination encompass an intended use of being topically applicable to skin, however the claims under examination are not limited to process steps, and the prior art appears capable of meeting the claimed function and otherwise structurally indistinguishable from the claimed adaptation. Finally, disclosed examples and preferred embodiments do not constitute a teaching away from Ignatious and Katz’s broader disclosure.
Applicant argues that Katz’s patches include mixed active and patch components and no separate pre-wetting solution as claimed. In reply, this new limitation is addressed below by the new grounds of rejection necessitated by amendment. Specifically, it is the examiner’s position that it would have been obvious to combine and/or make separable the claimed elements for the very same purpose as taught in the cited references in a kit product, with a reasonable expectation of success as detailed below. Arguments as to a method of making a product or a method of using a product are considered limitations not claimed.
Regarding claim 23, Applicant argues that neither Ignatious or Katz teach the structural components claimed nor do they teach controlled dosage per unit time by ratio of hydrophilic to hydrophobic fibers or suggest control achieved as in the instant claims. In reply, it is the examiner’s position that since the prior art renders obvious the kit elements as claimed the prior art also teaches the function and/or effects also claimed.
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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