DETAILED ACTION
This is a Final Rejection for Application 18/626,694 filed April 4, 2024. The present application claims priority to U.S. Provisional Application No. 63/495,000, filed April 7, 2023. Claims 1-20 are currently pending.
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 .
Response to Amendment
The examiner acknowledges the amended claim filed July 27, 2026. In response to the amended claims, new grounds of rejection are presented below. The 35 USC § 102 claim rejections have been withdrawn because of the amendments.
Response to Arguments
Applicants’ arguments with respect to the 35 USC § 102 claim rejections and the 35 USC § 103 claim rejections as unpatentable over, or obvious in view of, Wittmayer indicated in the Office action filed March 11, 2026, have been considered but are moot because the new ground of rejection does not rely on Wittmayer as applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Wittmayer is provided as a teaching reference in the new grounds of rejection below, so arguments not directed at the combination of Kivivuori in view of Wittmayer are moot.
In response to applicant's argument that the references are nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, all the references are in the inventor’s field of endeavor, which is bandages, dressings, and/or absorbent pads. Further, it has been held that “In a simple mechanical invention a broad spectrum of prior art must be explored and it is reasonable to permit inquiry into other areas where one of ordinary skill in the art would be aware that similar problems exist.” Stevenson v. Int'l Trade Comm., 612 F.2d 546, 550, 204 USPQ 276, 280 (CCPA 1979).
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicants’ arguments with regards to the combination of Kivivuori and Wittmayer have been fully considered but they are not persuasive. Applicant argues that “Wittmayer itself does not disclose aloe and witch hazel together in the same formulation for insect-bite pruritus, and does not disclose zinc oxide as a UPF agent.” This argument is unpersuasive as Wittmayer discloses witch hazel and aloe vera as active agents in the patch in [0106]- [0143]. Zinc oxide is also disclosed as an active agent in [0652]. In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the motivation provided for adding these agents to Kivivuori is that these materials may all be added to a hydrocolloid adhesive to be released to the skin of the patient because they are listed as agents that are helpful in pain relief patches. The motivation to make this combination does not need to be the same motivation that Applicant provides.
In response to applicant's argument that the combination does not disclose the specific purpose of insect-bite pruritus management with UPF protection for scar prevention, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art to patentably distinguish the claimed invention from the prior art. If the prior art structure can perform the intended use, then it meets the claim. The prior art is capable of insect-bite pruritus management with UPF protection for scar prevention as the prior art discloses witch hazel, aloe vera and zinc oxide as possible active agents in a patch.
Applicant has not provided sufficient evidence that modifying Kivivuori to include the active agents listed in Wittmayer would be unobvious.
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.
Claim 5 is 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. Claim 1 already requires the backing sheet to be made of polyurethane, so claim 5 does not further limit claim 1. Applicants 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.
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.
Claim(s) 1, 5-6, 8-13 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2023/0038483 (Kivivuori et al.) in view of US 2024/0033129 (Wittmayer) and US 2021/0386630 (Lee et al.).
Regarding claim 1, Kivivuori discloses a treatment patch configured to relieve insect-bite-induced pruritus for use on a patient's skin (An adhesive body dressing 10 is interpreted as a treatment patch; [0071], [0084] – [0086]. The adhesive body dressing 10 is capable of relieving insect-bite-induced pruritus as the dressing improves or prevents any skin related medical or aesthetic concern; [0002]. Where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation. See MPEP 2111.02(II).), comprising:
a first surface comprising a printed polyurethane backing sheet (A backing layer B is interpreted as a first surface and comprises a printed polyurethane backing sheet; Fig. 4; [0043]. The recitation “printed” is considered a product-by-process limitation. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. See MPEP 2113(I).);
a second surface comprising a hydrocolloid layer (A hydrocolloid adhesive material layer 30 is interpreted as a second surface comprising a hydrocolloid layer.),
wherein the hydrocolloid layer comprises a self-adhesive dressing configured to adhere the treatment patch to the patient at the second surface (The hydrocolloid adhesive material layer 30 comprises a self-adhesive dressing configured to adhere the dressing 10 to the patient at the adhesive 30; [0090].).
Kivivuori does not disclose wherein the hydrocolloid layer comprises a combination of aloe barbadensis leaf and witch hazel together embedded within, wherein said combination is configured to attenuate the pruritic itch-scratch cycle associated with insect bites; and wherein the treatment patch comprises an ultraviolet protection factor (UPF) of at least 15 to improve scarring of the skin resulting from insect bites.
However, Wittmayer discloses a patch which is analogous to the adhesive body dressing 10 of Kivivuori. Wittmayer discloses an adhesive layer that is hydrocolloid-based which is analogous to the hydrocolloid adhesive material layer 30 of Kivivuori; Wittmayer [0018]. The adhesive layer of Wittmayer comprises active agents including topical pain-relieving agents, topical antibiotics, prescription, and over-the-counter drugs; [0019]. Active agents that can be added to the patch include witch hazel and aloe vera; [0106] – [0143].
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to modify the adhesive 30 of Kivivuori to include aloe vera and witch hazel dispersed within as taught by Wittmayer. A skilled artisan would have been motivated to do so because Wittmayer teaches these materials may both be added to a hydrocolloid adhesive to be released to the skin of the patient because they are listed as agents that are advantageous in pain relief patches ([0605]) and for the sustained release of the agents ([0013]). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to treatment patches. Kivivuori in view of Wittmayer teaches wherein said combination is configured to attenuate the pruritic itch-scratch cycle associated with insect bites because a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art to patentably distinguish the claimed invention from the prior art. If the prior art structure can perform the intended use, then it meets the claim. See MPEP 2114(II).
Kivivuori in view of Wittmayer still does not disclose wherein the treatment patch comprises an ultraviolet protection factor (UPF) of at least 15 to improve scarring of the skin resulting from insect bites.
However, Lee discloses an ultraviolet protection patch which is analogous to the adhesive body dressing 10 of Kivivuori. The ultraviolet protection patch comprises an ultraviolet protection agent including both an organic ultraviolet protection agent and an inorganic ultraviolet protection agent; [0010], [0017]. By adding 55 parts by weight of an organic and inorganic ultraviolet protection agent, the patch has a UPF of more than 50; table 4.
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to modify the backing layer B of Kivivuori to include an organic and inorganic ultraviolet protection agent as taught by Lee. A skilled artisan would have been motivated to do so because Lee teaches that the organic and inorganic ultraviolet protection agents provide ultraviolet protection to the patch; [0044]. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the amount of organic and inorganic ultraviolet protection agents to result in at least 15 UPF, since it has been held that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The organic and inorganic ultraviolet protection agents’ amount is a result-effective variable wherein the result is a change in UPF. A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to treatment patches. Kivivuori in view of Wittmayer teaches improve scarring of the skin resulting from insect bites because a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art to patentably distinguish the claimed invention from the prior art. If the prior art structure can perform the intended use, then it meets the claim. See MPEP 2114(II).
Regarding claim 5, Kivivuori, in view of Wittmayer and Lee discloses the treatment patch of claim 1, wherein the backing sheet is made of polyurethane (A backing layer B is interpreted as a first surface and comprises a printed polyurethane backing sheet; Fig. 4; [0043].).
Regarding claim 6, Kivivuori in view of Wittmayer and Lee discloses the treatment patch of claim 1.
Kivivuori, in view of Wittmayer and Lee, as applied above, does not disclose wherein the backing sheet is transparent.
However, Lee further discloses that the ultraviolet protection patch has excellent transparency and thus does not degrade visibility of an adherend when being attached to skin; [0009].
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to modify the backing layer B of Kivivuori to be transparent as taught by Lee. A skilled artisan would have been motivated to do so because Lee teaches that transparency allows for visibility of the underlying skin; [0009]. A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to treatment patches.
Regarding claim 8, Kivivuori, in view of Wittmayer and Lee discloses the treatment patch of claim 1, wherein the treatment patch is configured to adhere to the skin for 5 days (The dressing 10 can be adhered to the skin for 5 days. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art to patentably distinguish the claimed invention from the prior art. If the prior art structure can perform the intended use, then it meets the claim. See MPEP 2114(II).).
Regarding claim 9, Kivivuori in view of Wittmayer and Lee discloses the treatment patch of claim 1, wherein the hydrocolloid layer further comprises menthol (Wittmayer includes menthol as an active agent of the adhesive layer; Wittmayer [0019]. It would be obvious to add menthol to the adhesive 30 of Kivivuori for the same reasons it is obvious to add aloe vera and witch hazel.).
Regarding claim 10, Kivivuori in view of Wittmayer and Lee discloses the treatment patch of claim 1, wherein the hydrocolloid layer further comprises capsaicin (Wittmayer includes capsaicin as an active agent of the adhesive layer; Wittmayer [0019]. It would be obvious to add capsaicin to the adhesive 30 of Kivivuori for the same reasons it is obvious to add aloe vera and witch hazel.).
Regarding claim 11, Kivivuori in view of Wittmayer and Lee discloses the treatment patch of claim 1, wherein the hydrocolloid layer further comprises calendula (Wittmayer includes calendula as an active agent of the adhesive layer; Wittmayer [0209]. It would be obvious to add calendula to the adhesive 30 of Kivivuori for the same reasons it is obvious to add aloe vera and witch hazel.).
Regarding claim 12, Kivivuori in view of Wittmayer and Lee discloses the treatment patch of claim 1, wherein the hydrocolloid layer further comprises hydrocortisone (Wittmayer includes hydrocortisone as an active agent of the adhesive layer; Wittmayer [0639]. It would be obvious to add hydrocortisone to the adhesive 30 of Kivivuori for the same reasons it is obvious to add aloe vera and witch hazel.).
Regarding claim 13, Kivivuori in view of Wittmayer and Lee discloses the treatment patch of claim 1, wherein the witch hazel is diluted in water (Wittmayer includes water as an additive; Wittmayer [0508]. It would be obvious to add water to the adhesive 30 of Kivivuori for the same reasons it is obvious to add aloe vera and witch hazel. This results in the witch hazel being diluted in water. The recitation “diluted in water” is considered a product-by-process limitation. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. See MPEP 2113(I).).
Regarding claim 15, Kivivuori in view of Wittmayer and Lee discloses the treatment patch of claim 1, wherein the hydrocolloid layer further comprises zinc oxide configured to increase the ultraviolet protection factor of the treatment patch (Lee includes zinc oxide as an inorganic ultraviolet protection agent; Lee [0045].).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2023/0038483 (Kivivuori et al.) in view of US 2024/0033129 (Wittmayer) and US 2021/0386630 (Lee et al.), and further in view of US 2015/0157758 (Blücher).
Regarding claim 2, Kivivuori in view of Wittmayer and Lee discloses the treatment patch of claim 1.
Kivivuori in view of Wittmayer and Lee does not disclose wherein the hydrocolloid layer comprises a thickness of about 12 mm to about 18 mm.
However, Blücher discloses a wound dressing which is particularly suitable for therapeutically dressing wounds and consists of a multi-layered structure comprising at least one layer containing at least one hydrocolloid. See the abstract. [0073] – “As regards the dimensions of the layer containing at least one hydrocolloid, preferably collagen, this preferably has a thickness in the range from 0.01 to 100 mm, in particular 0.02 to 50 mm, preferably 0.05 to 10 mm. Depending on the severity of the wound to be treated and the degree of wound exudation, it is advantageous--particularly in case of heavy secretion of wound fluids (particularly for example in the exudative phase of wound healing)--if the layer containing a hydrocolloid, preferably collagen, is made especially thick.”
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention for the thickness of the hydrocolloid layer of Kivivuori to be about 12 mm to about 18 mm as taught by Blücher, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See MPEP 2144.05. A skilled artisan would have been motivated to do so because Blücher teaches that the thickness depends on the severity of the wound to be treated and the degree of wound exudation ([0073]). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to dressings with hydrocolloid adhesives.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2023/0038483 (Kivivuori et al.) in view of US 2024/0033129 (Wittmayer) and US 2021/0386630 (Lee et al.), and further in view of US 6,710,100 (Lipman).
Regarding claim 3, Kivivuori, in view of Wittmayer and Lee discloses the treatment patch of claim 1.
Kivivuori in view of Wittmayer and Lee does not disclose wherein the self-adhesive dressing comprises a 90° peel adhesion of about 35.19 oz/in to about 49.98 oz/in.
However, Lipman discloses a fluid absorbing, adhesive hydrocolloid composition that is suitable as primary dressings. See the abstract. Example 4 of the Lipman’s hydrocolloid is described in Col. 9, Lns. 14-35 and has a 90° peel adhesion of 10.4 N/in in table 4. 10.4 N/in is equal to about 37.4 oz/in.
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the hydrocolloid of Kivivuori to be the Example 4 hydrocolloid of Lipman and for the 90° peel adhesion to be of about 35.19 oz/in to about 49.98 oz/in, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See MPEP 2144.05. A skilled artisan would have been motivated to do so because Lipman teaches that the increased adhesion strength is important for the prevention of unintentional removal (Col. 10, lns. 10-25). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to dressings with hydrocolloid adhesives.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2023/0038483 (Kivivuori et al.) in view of US 2024/0033129 (Wittmayer) and US 2021/0386630 (Lee et al.), and further in view of US 2016/0074552 (Liu et al.)
Regarding claim 4, Kivivuori in view of Wittmayer and Lee discloses the treatment patch of claim 1.
Kivivuori in view of Wittmayer and Lee does not disclose wherein the treatment patch comprises an absorption percentage of about 131% to about 240% by weight over 24 hours.
However, Liu discloses a discontinuous hydrocolloid article that provides for a high rate of water absorption and a high rate of water vapor transmission. See the abstract. [0049] – “For example, in one embodiment, the hydrocolloid article 100 will absorb at least 100% of its weight within 24 hours. In one embodiment, the hydrocolloid article 100 will absorb at least 200% of its weight within 24 hours. In one embodiment, the hydrocolloid article 100 will absorb at least 300% of its weight within 24 hours.”
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the patch of Kivivuori to be the hydrocolloid article of Liu and for the absorption percentage to be about 131% to about 240% by weight over 24 hours, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See MPEP 2144.05. A skilled artisan would have been motivated to do so because Liu teaches that water absorption allows for the article to absorb fluids from the patient and improves adhesion ([0038]). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn dressings with hydrocolloid adhesives.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2023/0038483 (Kivivuori et al.) in view of US 2024/0033129 (Wittmayer) and US 2021/0386630 (Lee et al.), and further in view of US 5,897,516 (Kadesh et al.).
Regarding claim 7, Kivivuori, in view of Wittmayer and Lee, discloses the treatment patch of claim 1.
Kivivuori, in view of Wittmayer and Lee, does not disclose wherein the backing sheet is opaque.
However, Kadesh discloses an improved wound dressing which comprises a backing layer bearing a reference marking, a hydrocolloid layer, and a release layer. See the abstract. [Col. 3, Ln. 64 – Col. 4, Ln. 13] – “The backing layer 20 of the wound dressing is preferably a suitable polymeric material. It can be of any polymer film, nonwoven material, weave or the like, or combination thereof, known in the art. It is preferably made of thin, flexible, conformable, resilient, supple, limp, or flimsy material that can flex or bend to conform to irregular surfaces or contours, such as those of anatomical body parts. The backing layer 20 is preferably transparent or translucent, or it can be opaque.”
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to make the backing layer of Kivivuori opaque as taught by Kadesh. A skilled artisan would have been motivated to do so because Kadesh teaches that the backing layer may be transparent, translucent, or opaque and Kivivuori is silent with regards to the light passing abilities of the backing layer. One may be motivated to use opaque material for the backing layer if they desire to block light from reaching the underlying tissue. A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to dressings with hydrocolloid adhesives and backing layers.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2023/0038483 (Kivivuori et al.) in view of US 2024/0033129 (Wittmayer) and US 2021/0386630 (Lee et al.), and further in view of US 6,171,594 (Nielsen).
Regarding claim 14, Kivivuori, in view of Wittmayer and Lee, discloses the treatment patch of claim 1.
Kivivuori, in view of Wittmayer and Lee does not disclose herein the aloe barbadensis leaf is purified and chopped into powder.
However, Nielsen discloses an adhesive agent for application to human or animal skin and is useful for wound dressings. See the abstract. [Col. 5, Ln. 66 – Col. 6, Ln. 11] – “The invention also relates to a method of producing an adhesive agent for application to human or animal skin, preferably for use in connection with ostomy or incontinence appliances comprising a pressure sensitive adhesive and optionally additives conventionally used in adhesives of this kind, the adhesive agent comprises parts of or extracts from Aloe vera which method comprises mixing, in a heated mixer, a plastic or elastic matrix-forming adhesive material and a part of a hydrocolloid material, turning off the heating, continuing the mixing for a short while, admixing the remaining part of the hydrocolloid material and Aloe vera and continuing the mixing in vacuo until a homogeneous mixture is obtained.” [Col. 3, Lns. 32-35] – “The basic idea is to add Aloe vera powder (prepared from Aloe vera gel) directly to the adhesive as a component which surprisingly has been found to prevent and alleviate skin problems for users of ostomy appliances.”
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date for the aloe barbadensis leaf to be in powder form when added to the hydrocolloid of Kivivuori as taught by Nielsen. A skilled artisan would have been motivated to do so because Nielsen teaches that the addition of powdered ale vera has been found to prevent and alleviate skin problems for users of ostomy appliances (Col. 3, Lns. 32-35). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to wound dressings comprising hydrocolloid adhesive and aloe vera. The recitations “purified” and “chopped” are considered product-by-process limitations. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. See MPEP 2113(I).
Claim(s) 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2023/0038483 (Kivivuori et al.) in view of US 2024/0033129 (Wittmayer), US 2021/0386630 (Lee et al.), US 6,171,594 (Nielsen), US 2021/0128666 (Naone), and US 2016/0263049 (Daeef).
Regarding claim 16, Kivivuori discloses a method of using a treatment patch (An adhesive body dressing 10 is interpreted as a treatment patch; [0071], [0084] – [0086].), the method comprising:
providing a treatment patch (An adhesive body dressing 10 is interpreted as a treatment patch; [0071], [0084] – [0086].), wherein the treatment patch comprises:
a first surface comprising a printed polyurethane backing sheet (A backing layer B is interpreted as a first surface and comprises a printed polyurethane backing sheet; Fig. 4; [0043]. The recitation “printed” is considered a product-by-process limitation. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. See MPEP 2113(I).),
a second surface comprising the hydrocolloid layer (A hydrocolloid adhesive material layer 30 is interpreted as a second surface comprising a hydrocolloid layer.),
wherein the hydrocolloid layer comprises a self-adhesive dressing configured to adhere the treatment patch to the patient at the second surface (The hydrocolloid adhesive material layer 30 comprises a self-adhesive dressing configured to adhere the dressing 10 to the patient at the adhesive 30; [0090].).
Kivivuori does not disclose using the treatment patch to relieve insect-bite-induced pruritus in a region on a patient's skin, diluting witch hazel in a water solution; purifying aloe barbadensis leaf and chopping the aloe barbadensis leaf into a powder; combining the witch hazel and the aloe barbadensis leaf powder to form a combination configured to attenuate the insect-bite itch-scratch cycle; embedding the witch hazel and the aloe barbadensis leaf combination into the hydrocolloid layer; wherein the treatment patch comprises an ultraviolet protection factor (UPF) of at least 15 to improve scarring of the skin resulting from insect bites; and administering the treatment patch to the patient's skin at the site of an insect bite.
However, Wittmayer discloses a patch which is analogous to the adhesive body dressing 10 of Kivivuori. Wittmayer discloses an adhesive layer that is hydrocolloid-based which is analogous to the hydrocolloid adhesive material layer 30 of Kivivuori; Wittmayer [0018]. The adhesive layer of Wittmayer comprises active agents including topical pain-relieving agents, topical antibiotics, prescription, and over-the-counter drugs; [0019]. Active agents that can be added to the patch include witch hazel and aloe vera; [0106] – [0143]. Wittmayer includes water as an additive; Wittmayer [0508]. Adding both water and witch hazel dilutes the witch hazel in the water.
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to modify the adhesive 30 of Kivivuori to include aloe vera, witch hazel and water combined within as taught by Wittmayer. A skilled artisan would have been motivated to do so because Wittmayer teaches these materials may both be added to a hydrocolloid adhesive to be released to the skin of the patient because they are listed as agents that are advantageous in pain relief patches ([0605]) and for the sustained release of the agents ([0013]). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to treatment patches.
Kivivuori in view of Wittmayer still does not disclose using the treatment patch to relieve insect-bite-induced pruritus in a region on a patient's skin; purifying aloe barbadensis leaf and chopping the aloe barbadensis leaf into a powder; the combination configured to attenuate the insect-bite itch-scratch cycle; wherein the treatment patch comprises an ultraviolet protection factor (UPF) of at least 15 to improve scarring of the skin resulting from insect bites; and administering the treatment patch to the patient's skin at the site of an insect bite.
However, Lee discloses an ultraviolet protection patch which is analogous to the adhesive body dressing 10 of Kivivuori. The ultraviolet protection patch comprises an ultraviolet protection agent including both an organic ultraviolet protection agent and an inorganic ultraviolet protection agent; [0010], [0017]. By adding 55 parts by weight of an organic and inorganic ultraviolet protection agent, the patch has a UPF of more than 50; table 4.
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to modify the backing layer B of Kivivuori to include an organic and inorganic ultraviolet protection agent as taught by Lee. A skilled artisan would have been motivated to do so because Lee teaches that the organic and inorganic ultraviolet protection agents provide ultraviolet protection to the patch; [0044]. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the amount of organic and inorganic ultraviolet protection agents to result in at least 15 UPF, since it has been held that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The organic and inorganic ultraviolet protection agents’ amount is a result-effective variable wherein the result is a change in UPF. A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to treatment patches.
Kivivuori in view of Wittmayer and Lee is still does not disclose using the treatment patch to relieve insect-bite-induced pruritus in a region on a patient's skin; purifying aloe barbadensis leaf and chopping the aloe barbadensis leaf into a powder; the combination configured to attenuate the insect-bite itch-scratch cycle; improving scarring of the skin resulting from insect bites; and administering the treatment patch to the patient's skin at the site of an insect bite.
However, Nielsen discloses an adhesive agent for application to human or animal skin and is useful for wound dressings. See the abstract. [Col. 5, Ln. 66 – Col. 6, Ln. 11] – “The invention also relates to a method of producing an adhesive agent for application to human or animal skin, preferably for use in connection with ostomy or incontinence appliances comprising a pressure sensitive adhesive and optionally additives conventionally used in adhesives of this kind, the adhesive agent comprises parts of or extracts from Aloe vera which method comprises mixing, in a heated mixer, a plastic or elastic matrix-forming adhesive material and a part of a hydrocolloid material, turning off the heating, continuing the mixing for a short while, admixing the remaining part of the hydrocolloid material and Aloe vera and continuing the mixing in vacuo until a homogeneous mixture is obtained.” [Col. 3, Lns. 32-35] – “The basic idea is to add Aloe vera powder (prepared from Aloe vera gel) directly to the adhesive as a component which surprisingly has been found to prevent and alleviate skin problems for users of ostomy appliances.”
While Nielsen does not disclose the method of making the powdered aloe, Naone discloses a topical animal cream (TPA) comprising powdered aloe. [0067] – “Another method of making TPA involves selecting a specimen of Aloe vera from an Aloe plant. de-dusting the Aloe vera specimen; washing the Aloe vera specimen in warm water, the warm water being exposed to the Aloe vera plant for at least five seconds; removing the rind from the Aloe vera specimen; washing the specimen a second time in warm water, the warm water being exposed to the Aloe vera plant for at least five seconds; inserting the specimen into a dehydrating machine for at least twelve hours; examining the Aloe vera specimen and verifying that the specimen is no more than 5% liquid by weight and modifying the specimen if there is more than 5% liquid by dry weight; grinding up the Aloe vera specimen until it is a fine powder of Aloe vera granules”. The washing process is interpreted as a purifying step, and the grinding process is interpreted as a chopping step.
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to purify and chop aloe barbadensis leaf into a powder and add the powder to the hydrocolloid of Kivivuori as taught by Nielsen and Naone. A skilled artisan would have been motivated to do so because Nielsen teaches that the addition of powdered ale vera has been found to prevent and alleviate skin problems for users of ostomy appliances (Col. 3, Lns. 32-35). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to wound dressings comprising hydrocolloid adhesive and aloe vera. Additionally, Naone teaches that the aloe vera powder is useful in the topical treatment of animal wounds ([0067]). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to medical uses for aloe plants and their components.
Kivivuori in view of Wittmayer, Lee, Nielsen and Naone still does not disclose using the treatment patch to relieve insect-bite-induced pruritus in a region on a patient's skin; the combination configured to attenuate the insect-bite itch-scratch cycle; improving scarring of the skin resulting from insect bites; and administering the treatment patch to the patient's skin at the site of an insect bite.
However, all these uses are a result of applying the patch of Kivivuori in view of Wittmayer, Lee, Nielsen, and Naone to an insect bite, which is taught by Daeef. Daeef discloses a kit containing patches that are applied to insect bites; Daeef [0001]. Applying the patch of Kivivuori in view of Wittmayer, Lee, Nielsen and Naone to an insect bite, as taught by Daeef, relieves insect-bite-induced pruritus in a region on a patient's skin; the combination of the powdered aloe and water-diluted witch hazel is configured to attenuate the insect-bite itch-scratch cycle; scarring of the skin resulting from insect bites is improved; and the patch is administered to the patient’s skin at the site of an insect bite.
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to apply the patch of Kivivuori to an insect bite as taught by Daeef. A skilled artisan would have been motivated to do so because Daeef teaches insect bites and stings cause itching, swelling and pain in the affected area; Daeef [0002]. Additionally, Kivivuori discloses that it is used for improving or preventing any skin related medical or esthetic concerns such as wounds, blisters, cold sores, acne, corns, cracked skin, burns, pressure ulcers, eczema, scarring, stretch marks, dermal ulcers, burns and other exudative wounds; Kivivuori [0002]. A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to treatment patches.
Regarding claim 17, Kivivuori in view of Wittmayer, Lee, Nielsen, Naone and Daeef discloses the method of claim 16, wherein the hydrocolloid layer further comprises menthol (Wittmayer includes menthol as an active agent of the adhesive layer; Wittmayer [0019]. It would be obvious to add menthol to the adhesive 30 of Kivivuori for the same reasons it is obvious to add aloe vera and witch hazel.).
Regarding claim 18, Kivivuori in view of Wittmayer, Lee, Nielsen, Naone and Daeef discloses the method of claim 16, wherein the hydrocolloid layer further comprises capsaicin (Wittmayer includes capsaicin as an active agent of the adhesive layer; Wittmayer [0019]. It would be obvious to add capsaicin to the adhesive 30 of Kivivuori for the same reasons it is obvious to add aloe vera and witch hazel.).
Regarding claim 19, Kivivuori, in view of Wittmayer, Lee, Nielsen, Naone and Daeef discloses the method of claim 16, wherein the hydrocolloid layer further comprises calendula (Wittmayer includes calendula as an active agent of the adhesive layer; Wittmayer [0209]. It would be obvious to add calendula to the adhesive 30 of Kivivuori for the same reasons it is obvious to add aloe vera and witch hazel.).
Regarding claim 20, Kivivuori in view of Wittmayer, Lee, Nielsen, Naone and Daeef discloses the method of claim 16, wherein the hydrocolloid layer further comprises zinc oxide (Lee includes zinc oxide as an inorganic ultraviolet protection agent; Lee [0045].).
Conclusion
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.
The following prior art made of record and not relied upon are considered pertinent to applicant's disclosure.
US 2024/0050380 (Jetter)
US 2007/0098671 (Martin)
US 2022/0054535 (Hahn)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Seth Brown whose telephone number is (571)272-5642. The examiner can normally be reached 8:00 AM – 11:00 AM or 1:00 PM – 3:00 PM ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner' s supervisor, Rachael Bredefeld can be reached at (571)270-5237. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SETH R. BROWN/Examiner, Art Unit 3786
/KERI J NELSON/Primary Examiner, Art Unit 3786
