DETAILED ACTION
Status of Claims
Claims 1-13 are currently pending. Claims 1-8 are currently under consideration and are the subject of this Office Action. This is the first Office Action on the merits of the claims. Non-elected claims 9-13 are withdrawn from consideration. 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 Office Action: Non-Final.
Election/Restrictions
Applicant’s election of the claims of Group I (claims 1-8) in the response filed on November 21, 2025 (to the September 24, 2025 Requirement for Restriction) is acknowledged. In response to applicant’s election, the claims of Group II (claims 9-13) are withdrawn from further consideration pursuant to 37 C.F.R. § 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant has elected the claims of Group I without traverse.
Accordingly, the September 24, 2025 Requirement for Restriction is made FINAL, and claims 1-8 are examined as follows.
Claim Rejections - 35 USC § 112 – Written Description
The following is a quotation of the first paragraph of 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 1-8 are rejected under 35 U.S.C. § 112(a) or, (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contain 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(s), at the time the application was filed, had possession of the claimed invention.
Claims 1 and 6-8 recite:
1. A patch for attachment on the skin, comprising:
a base sheet; and
a film disposed on the base sheet, wherein a thickness of the film is configured to be decreased by an activating material.
[…]
6. The patch of claim 1, wherein the film includes:
a first layer adjacent to the base sheet; and
a second layer arranged on one side of the first layer, wherein the second layer includes an effective material configured to be delivered to the skin.
7. The patch of claim 6, further comprising:
an interlayer arranged between the first layer and the base sheet, wherein the interlayer has a smaller adhesive force than the second layer.
8. The patch of claim 7, wherein an adhesive force of the interlayer is configured to be decreased in response to contact with a solution.
which requires:
“a film disposed on the base sheet” (which may be a “first layer” and “second layer”) for the functional requirement, “wherein a thickness of the film is configured to be decreased by an activating material”; and
an “interlayer” for the functional requirements, “wherein the interlayer has a smaller adhesive force than the second layer” and “wherein an adhesive force of the interlayer is configured to be decreased in response to contact with a solution.”
However, the instant specification provides inadequate written description of structure to support the functional requirements of the claimed invention so that one of ordinary skill in the art could conclude that the inventors had possession of the claimed invention. In this regard, it is noted that MPEP § 2163 II. A. 3. (a) ii) states:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A), above), reduction to drawings (see i)(B), above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
The disclosure must allow one skilled in the art to visualize or recognize the identity of the subject matter purportedly described. Univ. of Rochester v. G.D. Searle, 69 USPQ2d 1886, 1892 (CAFC 2004). A description of what a material does, rather than of what it is, usually does not suffice to provide an adequate written description of the invention. Univ. of Cal. V. Eli Lilly, 119 F.3d 1559, 1568 (Fed. Cir. 1997). Furthermore, to the extent that a functional description can meet the requirement for an adequate written description, it can do so only in accordance with PTO guidelines stating that the requirement can be met by disclosing "sufficiently detailed, relevant identifying characteristics,” including “functional characteristics when coupled with a known or disclosed correlation between function and structure.” Univ. of Rochester v. G.D. Searle, 69 USPQ2d 1427, 1432 (DC WNY 2003).
A review of the instant published application, US 2024/0082607 A1,
at par. [0006]-[0018], [0037]-[0040], [0044]-[0059], [0063]-[0075], [0078]-[0080], [0084]-[0088] & Fig.’s 1-2 discusses the “film” in terms of attachment to the other components of the instant “patch”;
at par. [0089]-[0093] discussing interactions with an “activating material,” for which par. [0053]-[0056] describes “the activating material AM may be water applied or sprayed on the surface of film 100, or cosmetics such as toners and creams” or “a secretion secreted by the skin”;
at par. [0094]-[0113] and Table 1 discusses UV absorption/blocking functions of a patch with multiple “Test Items,” wherein the “Test Items” appear to correspond to an “effective material” of the instant application; and
at par. [0045]-[0048], [0069]-[0072], [0080]-[0083], [0086]-[0088] discussing the “interlayer” with adhesive properties.
but no disclosure of what material, namely chemical material the instant “film” is formed of for the functional requirements, “wherein a thickness of the film is configured to be decreased by an activating material,” and likewise for the “interlayer.” Therefore, the instant specification provides inadequate written description of structure to support the functional requirements of the claimed invention so that one of ordinary skill in the art could conclude that the inventors had possession of the claimed invention. In this regard, it is noted that MPEP § 2163 II. A. 3. (a) ii) states:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A), above), reduction to drawings (see i)(B), above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
The disclosure must allow one skilled in the art to visualize or recognize the identity of the subject matter purportedly described. Univ. of Rochester v. G.D. Searle, 69 USPQ2d 1886, 1892 (CAFC 2004). A description of what a material does, rather than of what it is, usually does not suffice to provide an adequate written description of the invention. Univ. of Cal. V. Eli Lilly, 119 F.3d 1559, 1568 (Fed. Cir. 1997). Furthermore, to the extent that a functional description can meet the requirement for an adequate written description, it can do so only in accordance with PTO guidelines stating that the requirement can be met by disclosing “sufficiently detailed, relevant identifying characteristics,” including “functional characteristics when coupled with a known or disclosed correlation between function and structure.” Univ. of Rochester v. G.D. Searle, 69 USPQ2d 1427, 1432 (DC WNY 2003).
A review of the published application discusses the instant “film” in terms of attachment to the other components of the instant “patch,” interactions with a particular “activating material,” and V absorption/blocking functions with particular a “effective material,” whereas instant claim 1 (and similarly for claims 6-8) encompasses any and all possible “film” and “interlayer” materials for the claimed functional requirements. However, applicant has not provided any descriptive support to show that any or all “film” materials may be incorporated into the instant “patch” or “interlayer” for the claimed functional requirements. It is noted that the disclosure of species may provide an adequate written description of a genus when the species disclosed is representative of the genus. However, in the instant case, applicant has not described the instant “film” (including “first layer,” “second layer” and possible interlayer”) by any relevant identifying chemical structural characteristics commensurate with the instant specification. For example, the instant “film” encompasses melting of polycrystalline colloidal films composed of diameter-tunable microgel spheres of N-isopropylacrylamide at solid-vapor interfaces, wherein vapor is an “activating material.” See Peng, Y. et al., Melting of Colloidal Crystal Films, Phys. Rev. Lett., 104 (2010) 205703, pp. 1-4, at abstract & p. 1, par. 1-3. Mere statements that modifications can be made without departing from the scope of the invention, or statements of intent that the claims are intended to cover all generic and specific features of the invention, are not sufficient for a skilled artisan to know what type of “film” or “interlayer” materials for the instant “patch” applicant had in possession at the time the instant application was filed, or whether or not the “film” and “interlayer” may be formed of the same or different chemical components. Therefore, applicant has neither disclosed any relevant or identifying characteristics of the instant “film” or “interlayer,” nor shown possession of the entire genus by of a representative number of species.
Therefore, claim 1 is rejected for lack of written description. Subsequent claims 2-8 depend on claim 1, and thus, are rejected for lack of written description as well.
Claim Rejections – 35 U.S.C. § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. § 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-5 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by LEE (KR 10-2011-0062277 A, Publ. Jun. 10, 2011; as evidenced by English language translation of KR 10-2011-0062277 A; on 11/20/2023 IDS hereinafter, “Lee”).
Page and paragraph numbers for Lee refer to the English language translation of KR 10-2011-0062277 A.
Lee is directed to:
COSMETIC COMPOSITION OF MULTI-PORE PATCH FOR SKIN IMPROVEMENT OF TWO-FORM TYPE USING LYOPHILIZATION
Abstract
PURPOSE: A cosmetic composition of two types prepared by freeze-drying for improving skin condition is provided to improve stability of an active ingredient. CONSTITUTION: A cosmetic composition of two types comprises: a first formulation of liquid phase of gel phase, containing an ingredient which promotes skin absorption; and a second formulation which is prepared by freeze-drying and formulating a composition containing water dispersible polymer and skin care ingredients. The water dispersible polymer is collagen or denatured collagen and natural polymers or synthetic polymers. The natural polymer is hyaluronic acid. The first formulation additionally contains emulsifier or antiseptic.
Lee, title & abstract. In this regard, Lee teaches “a two-part skin improvement cosmetic composition comprising a porous patch 2 formulated with a lyophilized patch,” wherein “dissolving the patch at the skin surface with a liquid or gel 1 agent containing a component that promotes absorption […] can dissolve the patch when used”:
In one embodiment, the present invention is a lyophilized composition comprising a component that promotes the absorption of the skin-effect active ingredient into the skin and which can dissolve the following two agents when used, and a composition containing the skin-effect active ingredient by anhydrous It provides a two-part skin improvement cosmetic composition comprising a porous patch 2 formulated with a lyophilized patch of.[Lee, p. 2, par. 7]
As another aspect, the present invention is a lyophilized composition comprising a component that promotes the absorption of the skin-effect active ingredient into the skin and can dissolve the following two agents when used, and a composition comprising the skin-effect active ingredient Provided is a skin improvement cosmetic kit comprising a porous patch 2 formulated with anhydrous lyophilized patches.[Lee, p. 2, par. 8]
As another aspect, the present invention comprises a skin-cosmetic active ingredient containing a component that promotes the absorption of the skin-care active ingredient into the skin and applying the first agent that can dissolve the following two agents in use. Provided is a method of using a two-part skin improvement cosmetic composition by attaching a porous patch two formulated with anhydrous lyophilized patches to the skin by lyophilizing the composition.[Lee, p. 2, par. 9]
Some of the active ingredients for skin care are present in a stable state in the liquid phase, there are some components that can be preserved for a long time in the solution phase, but when formulated in the liquid phase unstable in the liquid phase, there is a component that is less effective activity over time during storage and distribution.[Lee, p. 2, par. 10]
The present invention provides a cosmetic composition comprising a skin improvement component in an anhydrous patch by a lyophilization process in a method for stably formulating all active ingredients regardless of the stability of ingredients in a solution.[Lee, p. 2, par. 11]
In the present invention, the patch 2 is an active ingredient for skin beauty by dissolving the patch at the skin surface with a liquid or gel 1 agent containing a component that promotes absorption of the skin improvement component into the skin and which can dissolve the patch when used. Can be more effectively absorbed into the skin.[Lee, p. 2, par. 12]
That is, in the two-part skin improvement patch of the present invention, after applying an appropriate amount of a liquid or gel-like agent to the skin, a porous patch 2 agent in the form of a sheet made of a water-dispersible polymer containing the active ingredient for skin beauty is stably applied to the skin. When attached, it slowly melts and adheres to the skin, forming a uniform patch protection film on the skin. Therefore, even when the application is evenly attached to the desired thickness and width even in a severe bend on the face due to acne and wounds.[Lee, p. 2, par. 13]
(Lee, p. 2, par. 7-13), and exemplifies a mixture of synthetic or natural polymers with ascorbyl glucoside that is dispersed on a “silicone release-treated polyester (peeled layer)”:
Comparative Example 1-5 and Example 1-6 Preparation of Two-Lyophilized Porous Patch Type
Hydroxypropylmethyl cellulose and hydroxyethyl cellulose were prepared as synthetic polymers, and collagen, heat-modified collagen, and hyaluronic acid were prepared as natural polymers.[Lee, p. 5, par. 1]
Each of the polymers and combinations thereof was prepared as a patch through a freeze-drying process by dissolving ascorbyl glucoside as 2.0% of the weight of the final patch as a skin improvement component using an aqueous solution of the weight ratio shown in Tables 1 to 2 below.[Lee, p. 5, par. 2]
The patch was prepared by dispersing the mixtures of Comparative Examples 1 to 5 and Examples 1 to 6 at 25 ° C. with heating, stirring, and then sterilizing by filtration and using a doctor blade on a silicone release-treated polyester (peeled layer). After coating, the porous patch was prepared by freeze drying at reduced pressure at -40 ° C, and cut into 2 cm x 2 cm to prepare each sample.[Lee, p. 5, par. 3]
Lee, p. 5, par. 1-3.
Regarding independent claim 1 and the requirements:
1. A patch for attachment on the skin, comprising:
a base sheet; and
a film disposed on the base sheet, wherein a thickness of the film is configured to be decreased by an activating material.
Lee clearly teaches a mixture of synthetic or natural polymers with ascorbyl glucoside that is dispersed on a “silicone release-treated polyester (peeled layer)” (Lee, p. 5, par. 1-3), WHEREBY it is noted:
the “silicone release-treated polyester (peeled layer)” (Lee, p. 5, par. 3) reads on a “base sheet” of claim 1;
the “Hydroxypropylmethyl cellulose and hydroxyethyl cellulose” synthetic polymers or “collagen, heat-modified collagen, and hyaluronic acid” natural polymers (Lee, p. 5, par. 1) with “ascorbyl glucoside” (Lee, p. 5, par. 2) dispersed on the “silicone release-treated polyester (peeled layer)” (Lee, p. 5, par. 3) reads on a “film disposed on the base sheet” of claim 1; and
“after applying an appropriate amount of a liquid or gel-like agent to the skin, a porous patch 2 agent in the form of a sheet made of a water-dispersible polymer containing the active ingredient for skin beauty is stably applied to the skin” and “it slowly melts and adheres to the skin, forming a uniform patch protection film on the skin” (Lee, p. 2, par. 13), reads on “wherein a thickness of the film is configured to be decreased by an activating material” of claim 1, as well as the requirements of claim 3 for:
3. The patch of claim 1, wherein the activating material is configured to be sprayed on the film, applied on the film, or secreted from the skin on which the film is attached.
Thus, Lee anticipates claims 1 and 3.
Regarding claims 2 and 4-5, it is noted that the requirements:
2. The patch of claim 1, wherein a transparency of the film is configured to be enhanced in response to the film being activated by the activating material.
[…]
4. The patch of claim 1, wherein in response to the film being activated, softness of the film is configured to be increased.
5. The patch of claim 1, wherein the activating material is configured to melt the film.
are functional limitations. In this regard, it is noted that the structure, material or act in the claim that is connected to (i.e., performs) the recited function is the combination of recited elements of claim 1, which achieve the resulting transparency, softness and melting effects. Therefore, the broadest reasonable interpretation (see MPEP § 2111 with respect to broadest reasonable interpretation) of the functional language is: intended transparency, softness and melting effects of a composition that meets the structural requirements of claim 1. Because this functional language merely recites the intended result of the recited structural limitations, it imposes no patentable distinction on the claim (i.e., the functional language is not further limiting beyond the noted structural limitations). Therefore, one of ordinary skill in the art would understand that a composition meeting the structural requirements of claim 1 will achieve the intended result of the functional limitations and fall within the boundaries of the claims. Nonetheless, Lee teaches “a two-part skin improvement cosmetic composition comprising a porous patch 2 formulated with a lyophilized patch,” wherein “dissolving the patch at the skin surface with a liquid or gel 1 agent containing a component that promotes absorption […] can dissolve the patch when used” (Lee, p. 2, par. 7-13), which appears to read on the functional limitations of claims 2 and 4-5.
Thus, Lee anticipates claims 2 and 4-5.
Claim Rejections – 35 U.S.C. § 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 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 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 C.F.R. § 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 1-8 are rejected under 35 U.S.C. § 103 as being unpatentable over LEE (KR 10-2011-0062277 A, Publ. Jun. 10, 2011; as evidenced by English language translation of KR 10-2011-0062277 A; on 11/20/2023 IDS hereinafter, “Lee”), in view of BATHE (Bathe, R. & Kapoor, R., Transdermal drug delivery system: formulation, development and evaluation-An overview, Int. J. Biomed Adv. Res., 6 (2015) pp. 1-10; hereinafter, “Bathe”).
The teachings of Lee, as set forth in the above rejection of claim 1-5 under 35 U.S.C. § 102 (a)(1) by Lee are hereby incorporated. However, Lee DOES NOT TEACH a “film” with a “first layer” and “second layer,” or an “interlayer” per the requirements of claims 6-8 for:
6. The patch of claim 1, wherein the film includes:
a first layer adjacent to the base sheet; and
a second layer arranged on one side of the first layer, wherein the second layer includes an effective material configured to be delivered to the skin.
7. The patch of claim 6, further comprising:
an interlayer arranged between the first layer and the base sheet, wherein the interlayer has a smaller adhesive force than the second layer.
8. The patch of claim 7, wherein an adhesive force of the interlayer is configured to be decreased in response to contact with a solution.
Based on the state of the art, an artisan of ordinary skill would have found each of these features obvious.
Bathe, for instance, is directed to:
Transdermal drug delivery system: formulation, development and evaluation-An overview
Abstract
In a transdermal drug delivery system the drug is applied in a relatively high dosage to the inside of a patch, which is worn on the skin for an extended period of time. Through a diffusion process, the drug enters the bloodstream directly through the skin. Since there is high concentration on the patch and low concentration in the blood, the drug will keep diffusing into the blood for a long period of time, maintaining the constant concentration of drug in the blood flow. Transdermal drug delivery system was introduced to overcome the difficulties of drug delivery through oral route. The conventional oral dosage forms have significant setbacks of poor bioavailability due to hepatic first pass metabolism. To improve characters of transdermal drug delivery system (TDDS) was emerged, which will improve the therapeutic efficacy and safety of drugs by specific sites within the body, thereby reducing both the size and number of doses. This review article describes the methods of preparation of different types of transdermal patches such as matrix patches, reservoir type, membrane matrix, drug-in-adhesive patches and micro reservoir patches.
Bathe, title & abstract. In this regard, Bathe discusses a “membrane-permeation controlled system” featuring a “drug reservoir [that] is formulated by directly dispersing the drug in an adhesive polymer e.g. Poly (isobutylene) or poly (acrylate) adhesive and then spreading the medicated adhesive, by solvent casting or hot melt, on to a flat sheet of drug impermeable metallic plastic backing to form a thin drug reservoir layer”:
2. Adhesive Dispersion – Type Systems: This is a simplified form of the membrane-permeation controlled system. As shown in fig.5, the drug reservoir is formulated by directly dispersing the drug in an adhesive polymer e.g. Poly (isobutylene) or poly (acrylate) adhesive and then spreading the medicated adhesive, by solvent casting or hot melt, on to a flat sheet of drug impermeable metallic plastic backing to form a thin drug reservoir layer. On the top of the drug reservoir layer, thin layers of non-medicated, rate-controlling adhesive polymer of a specific permeability and constant thickness are applied to produce an adhesive diffusion – controlled delivery system.
Fig 5: Adhesive dispersion type system
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(Bathe, p. 4, par. 9, Fig. 5), whereby it is noted:
Bathe’s “Adhesive layer” (Bathe, p. 4, par. 9, Fig. 5) relates to “a first layer adjacent to the base sheet” of claim 6;
Bathe’s “Drug reservoir layer” (Bathe, p. 4, par. 9, Fig. 5) relates to “a second layer arranged on one side of the first layer, wherein the second layer includes an effective material configured to be delivered to the skin” of claim 6; and
Bathe’s “Rate-controlling adhesive layer” (Bathe, p. 4, par. 9, Fig. 5) relates to an “an interlayer arranged between the first layer and the base sheet” of claim 7.
In light of these teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to manufacture Lee’s patch (Lee, p. 5, par. 1-3) with:
Bathe’s “Adhesive layer” and “Rate-controlling adhesive layer” (Bathe, p. 4, par. 9, Fig. 5) (Bathe, p. 4, par. 9, Fig. 5), and
Lee’s “Hydroxypropylmethyl cellulose and hydroxyethyl cellulose” synthetic polymers or “collagen, heat-modified collagen, and hyaluronic acid” natural polymers (Lee, p. 5, par. 1) with “ascorbyl glucoside” (Lee, p. 5, par. 2) likened to Bathe’s “Drug reservoir layer” (Bathe, p. 4, par. 9, Fig. 5).
One would have been motivated to do so with a reasonable expectation of success since both Lee and Bathe are concerned with similar problems in the art, namely the construction of patches for delivering active agents to the skin. Lee, abstract; bathe, abstract. Further, it is well within the skill of the ordinary artisan to select suitable components known in the art for constructing patches for delivering active agents to the skin. Doing so amounts to no more than combining prior art elements according to known methods to yield predictable results, namely the manufacture Lee’s patch (Lee, p. 5, par. 1-3) with
Bathe’s “Adhesive layer” in order to obtain the advantage of attaching a “Drug-impermeable metallic plastic laminate”(Bathe, p. 4, par. 9, Fig. 5), and
Bathe’s “Rate-controlling adhesive layer” (Bathe, p. 4, par. 9, Fig. 5) in order to obtain the advantage of a layer for controlling drug release.
See MPEP § 2144.07 stating that the selection of a known material based on its suitability for its intended use is prima facie obvious, which cites Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945), wherein “Reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle.”
Thus, the prior art renders claim 6 obvious.
Regarding claim 7 and the requirement, “wherein the interlayer has a smaller adhesive force than the second layer,” manufacture Lee’s patch (Lee, p. 5, par. 1-3) with Bathe’s “Rate-controlling adhesive layer” (Bathe, p. 4, par. 9, Fig. 5) adjacent Lee’s “silicone release-treated polyester (peeled layer)” (Lee, p. 5, par. 3), thereby reasonably meeting this requirement.
Thus, the prior art renders claim 7 obvious.
Regarding claim 8, it is noted that the requirement, “wherein an adhesive force of the interlayer is configured to be decreased in response to contact with a solution,” appears to be a functional limitation. In this regard, it is noted that the structure, material or act in the claim that is connected to (i.e., performs) the recited function is the combination of recited elements of claim 7, which achieve the resulting adhesive effect. Therefore, the broadest reasonable interpretation (see MPEP § 2111 with respect to broadest reasonable interpretation) of the functional language is: an intended adhesive effect of a composition that meets the structural requirements of claim 7. Because this functional language merely recites the intended result of the recited structural limitations, it imposes no patentable distinction on the claim (i.e., the functional language is not further limiting beyond the noted structural limitations). Therefore, one of ordinary skill in the art would understand that a composition meeting the structural requirements of claim 7 will achieve the intended result of the functional limitation[s] and fall within the boundaries of the claims.
Thus, the prior art renders claim 8 obvious.
Claim Rejections - Nonstatutory Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-6 are provisionally rejected on the ground of nonstatutory double patenting over claims 1-3 and 7 of copending US Application No. 18/514,790 (‘790 Application), in view of the disclosure of LEE (KR 10-2011-0062277 A, Publ. Jun. 10, 2011; as evidenced by English language translation of KR 10-2011-0062277 A; on 11/20/2023 IDS hereinafter, “Lee”). This is a provisional double patenting rejection since the conflicting claims have not in fact been patented.
Although the conflicting claims are not identical, they are not patentably distinct because the instant claims as well as the copending claims are drawn to a patch for attachment to skin comprising a base sheet and a film disposed on the base sheet. Although the ‘790 Application recites a “[film] having a preset thickness deviation range” (‘790 Application, claim 1) with “water permeability or gas permeability” (‘790 Application, claim 1), i.e., an activating material of claim 1, the ‘790 Application, however, DOES NOT EXPRESSLY RECITE “a thickness of the film [that] is configured to be decreased by an activating material” as required independent claim 1, which is well within the purview of the ordinarily skilled artisan.
Lee for instance, is directed to a cosmetic composition of multi-pore patch for skin improvement of two-form type using lyophilization. Lee, title & abstract. In this regard, Lee teaches a mixture of synthetic or natural polymers with ascorbyl glucoside that is dispersed on a “silicone release-treated polyester (peeled layer).” Lee, p. 5, par. 1-3. Further, in this regard, Lee teaches that “after applying an appropriate amount of a liquid or gel-like agent to the skin, a porous patch 2 agent in the form of a sheet made of a water-dispersible polymer containing the active ingredient for skin beauty is stably applied to the skin,” wherein “it slowly melts and adheres to the skin, forming a uniform patch protection film on the skin” (Lee, p. 2, par. 13), which relates to “a thickness of the film [that] is configured to be decreased by an activating material” of claim 1.
In light of these teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to manufacture the patch of the ‘790 Application with a “film disposed on the base sheet” (‘790 Application, claim 1), wherein the film is composed of “an appropriate amount of a liquid or gel-like agent” to “form of a sheet made of a water-dispersible polymer” that “slowly melts and adheres to the skin” (Lee, p. 2, par. 13). One would have been motivated to do so with a reasonable expectation of success in order to obtain the advantage of a polymer that “slowly melts and adheres to the skin, forming a uniform patch protection film on the skin” (Lee, p. 2, par. 13), for which “preset thickness deviation range” of the ‘790 Application (‘790 Application, claim 1) could be optimized for “water permeability or gas permeability” (‘790 Application, claim 2).
Thus, claims 1-2 of the ‘790 Application per Lee render claim 1 obvious.
Claims 2 and 4-5 is met by claims 1-2 of the ‘790 Application per Lee as drawn to functional limitations of a patch meeting the structural requirements of claim 1.
Claim 3 is met by claims 1-2 of the ‘790 Application per Lee as a recitation of intended use of a patch meeting the structural requirements of claim 1.
Claim 6 is met by claims 3 and 7 of the ‘790 Application.
Claims 7-8 are provisionally rejected on the ground of nonstatutory double patenting over claims 1-3 and 7 of copending US Application No. 18/514,790 (‘790 Application), in view of the disclosure of LEE (KR 10-2011-0062277 A, Publ. Jun. 10, 2011; as evidenced by English language translation of KR 10-2011-0062277 A; on 11/20/2023 IDS hereinafter, “Lee”), as applied to claim 1-6, above, and further in view of the disclosure of BATHE (Bathe, R. & Kapoor, R., Transdermal drug delivery system: formulation, development and evaluation-An overview, Int. J. Biomed Adv. Res., 6 (2015) pp. 1-10; hereinafter, “Bathe”) This is a provisional double patenting rejection since the conflicting claims have not in fact been patented.
The teachings of the ‘790 Application and Lee, as set forth above, are hereby incorporated. However, to the extent that the ‘790 Application DOES NOT RECITE an “interlayer” per the requirements of claims 7-8 is well within the purview of the ordinarily skilled artisan.
Bathe, for instance, is directed to an overview of transdermal drug delivery system formulation, development and evaluation. Bathe, title & abstract. In this regard, Bathe teaches a “Rate-controlling adhesive layer” (Bathe, p. 4, par. 9, Fig. 5), which relates to an “an interlayer arranged between the first layer and the base sheet” of claims 7-8, and functional requirements recited therein. In light of these teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to manufacture the patch of the ‘790 Application (‘790 Application, claim 1) per Lee, as discussed above, with a “Rate-controlling adhesive layer” per Bathe (Bathe, p. 4, par. 9, Fig. 5). One would have been motivated to do so in order to obtain the advantage of a “Rate-controlling adhesive layer” (Bathe, p. 4, par. 9, Fig. 5) in order to obtain the advantage of a layer for controlling drug release Bathe, p. 4, par. 9, Fig. 5.
Thus, claims 1-3 and 7 of the ‘790 Application per Lee and Bathe render claims 7-8 obvious.
Conclusion
Claims 1-8 are rejected. No claims are allowed.
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/DOMINIC LAZARO/Primary Examiner, Art Unit 1611