DETAILED ACTION
This is a Non-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 .
Claim Rejections - 35 USC § 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 8-13 and 15 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 2024/0033129 (Wittmayer).
Regarding claim 1, Wittmayer discloses a treatment patch for use on a patient’s skin (Abstract – “The subject invention relates to a therapeutic patch, its manufacture and use wherein the patch comprises: a fabric layer made of synthetic fibers stretchable in both directions along a substantially orthogonal transverse axis of the patch, an adhesive layer on said face side of the base layer, an active agent dispersed in said adhesive layer, and optionally, a penetration enhancing agent in said adhesive layer.”), comprising:
a first surface comprising a backing sheet (The fabric layer is interpreted as a backing sheet and comprise a first surface.);
a second surface comprising a hydrocolloid layer ([0078] – “The adhesive can be an acrylic based adhesive, or any other form well known in the art of patch technology and it can be applied/coated to the fabric layer via any suitable method. In an advantageous embodiment, a medical grade acrylic-based, silicone-based, hydrocolloid-based, or hydrogel-based adhesive is used.” [0080] – “Hydrocolloid PSA's are often used for acne treatment and wound dressings that are occlusive and adhesive and can form a gel with water.” The adhesive layer is a hydrocolloid and comprises a second surface.),
wherein the hydrocolloid layer comprises a self-adhesive dressing configured to adhere the treatment patch to the patient at the second surface ([0078] – “The adhesive can be an acrylic based adhesive, or any other form well known in the art of patch technology and it can be applied/coated to the fabric layer via any suitable method. In an advantageous embodiment, a medical grade acrylic-based, silicone-based, hydrocolloid-based, or hydrogel-based adhesive is used.”),
wherein the hydrocolloid layer comprises aloe barbadensis leaf and witch hazel embedded within ([0654] – “Inactive agents of the patch optionally include one or more of:”; [656] – “Aloe Barbadensis (Aloe Vera) Leaf Juice”; [0709] – “Active agents of the skin care patch can include one or more of:”; [0748] – “Witch Hazel”.); and
wherein the treatment patch comprises an ultraviolet protection factor (UPF) to improve scarring of the skin ([0623] – “Active agents of a pain relief patch can include one or more of:”; [0652] – “Zinc Oxide”. Zinc oxide is known to provide UPF protection.).
Regarding claim 8, Wittmayer discloses the treatment patch of claim 1, wherein the treatment patch is configured to adhere to the skin for 5 days ([0076] – “The patch also has strong shear adhesion, or holding power, with the skin. Shear adhesion or shear resistance is defined as the ability to resist flow/movement when shear forces are applied. For a patch to perform well, the shear adhesion or shear resistance property has to guarantee that the adhesive will remain attached to the skin for a specific period of time despite stresses caused by both body movements and cloth frictions.” The patch is capable of being adhered to the skin for 5 days.).
Regarding claim 9, Wittmayer discloses the treatment patch of claim 1, wherein the hydrocolloid layer further comprises menthol ([0019] – “Active agents of the adhesive layer can include topical pain-relieving agents such as lidocaine, menthol, hemp oil extract or CBD, and capsaicin.”).
Regarding claim 10, Wittmayer discloses the treatment patch of claim 1, wherein the hydrocolloid layer further comprises capsaicin ([0019] – “Active agents of the adhesive layer can include topical pain-relieving agents such as lidocaine, menthol, hemp oil extract or CBD, and capsaicin.”).
Regarding claim 11, Wittmayer discloses the treatment patch of claim 1, wherein the hydrocolloid layer further comprises calendula ([0144] – “The patches of the subject invention can include one or more of the following:”; [0209] – “Calendula”.).
Regarding claim 12, Wittmayer discloses the treatment patch of claim 1, wherein the hydrocolloid layer further comprises hydrocortisone ([0623] – “Active agents of a pain relief patch can include one or more of:”; [0639] – “Hydrocortisone”.).
Regarding claim 13, Wittmayer discloses the treatment patch of claim 1, wherein the witch hazel is diluted in water ([0144] – “The patches of the subject invention can include one or more of the following:”; [0508] – “Water”; [0514] – “Witch Hazel”. In an embodiment with both water and witch hazel, the witch hazel is diluted in the water.).
Regarding claim 15, Wittmayer 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 ([0623] – “Active agents of a pain relief patch can include one or more of:”; [0652] – “Zinc Oxide”.).
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) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2024/0033129 (Wittmayer) in view of US 6,710,100 (Lipman).
Regarding claim 3, Wittmayer discloses the treatment patch of claim 1.
Wittmayer 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, modifying the peel adhesion strength is within the skills of one of ordinary skill in the art and taught by Lipman.
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 Wittmayer 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 dressings with hydrocolloid adhesives.
As a result, Lipman teaches that it would have been obvious for Wittmayer to comprise wherein the self-adhesive dressing comprises a 90° peel adhesion of about 35.19 oz/in to about 49.98 oz/in (In view of Lipman, the hydrocolloid adhesive of Wittmayer has a 90° peel adhesion of about 35.19 oz/in to about 49.98 oz/in.).
Claim(s) 4 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2024/0033129 (Wittmayer) in view of US 2016/0074552 (Liu et al.).
Regarding claim 4, Wittmayer discloses the treatment patch of claim 1.
Wittmayer does not disclose wherein the treatment patch comprises an absorption percentage of about 131% to about 240% by weight over 24 hours.
However, modifying the absorption percentage of the patch of Wittmayer is within the skill of one of ordinary skill in the art and taught by Liu.
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 Wittmayer 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.
As a result, Liu teaches that it would have been obvious for Wittmayer to comprise wherein the treatment patch comprises an absorption percentage of about 131% to about 240% by weight over 24 hours (In view of Liu, the patch absorbs about 131% to about 240% by weight over 24 hours.).
Regarding claim 6, Wittmayer discloses the treatment patch of claim 1.
Wittmayer does not disclose wherein the backing sheet is transparent.
However, modifying the backing sheet to be transparent is within the skill of one of ordinary skill in the art and taught by Liu.
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. [0039] – “In one embodiment, an additional backing 150 is included on a side of the hydrocolloid article 100. The backing 150 may be a single or multilayer structure. In some embodiments, a backing that is transparent is desirable to allow for viewing of the underlying skin or medical device. ”
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to modify the backing of Wittmayer to be transparent as taught by Liu. A skilled artisan would have been motivated to do so because Liu teaches that the transparency is desirable to allow for viewing of the underlying skin ([0039]). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn dressings with hydrocolloid adhesives.
As a result, Liu teaches that it would have been obvious for Wittmayer to comprise wherein the backing sheet is transparent (In view of Liu, the backing sheet of Wittmayer is transparent.).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2024/0033129 (Wittmayer) in view of US 5,897,516 (Kadesh et al.).
Regarding claim 7, Wittmayer discloses the treatment patch of claim 1.
Wittmayer does not disclose wherein the backing sheet is opaque.
However, modifying the backing sheet of Wittmayer to be opaque is within the skill of one of ordinary skill in the art and taught by Kadesh.
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 a 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 Wittmayer 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 Wittmayer is silent with regards to the light passing abilities of the backing layer. One may be motivated to use an 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 dressings with hydrocolloid adhesives and backing layers.
As a result, Kadesh teaches that it would have been obvious for Wittmayer to comprise wherein the backing sheet is opaque (In view of Kadesh, the backing layer of Wittmayer is opaque.).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2024/0033129 (Wittmayer) in view of US 6,171,594 (Nielsen).
Regarding claim 14, Wittmayer discloses the treatment patch of claim 1.
Wittmayer doers not disclose wherein the aloe barbadensis leaf is purified and chopped into powder.
However, using aloe barbadensis leaf in its powdered form is within the skill of one of ordinary skill in the art and taught by Nielsen.
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 Wittmayer 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 wound dressings comprising hydrocolloid adhesive and aloe vera.
As a result, Nielsen teaches that it would have been obvious for Wittmayer to comprise wherein the aloe barbadensis leaf is purified and chopped into powder (In view of Nielsen, the aloe is provided in a powered form. 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 2024/0033129 (Wittmayer) in view of US 6,171,594 (Nielsen) and US 2021/0128666 (Naone).
Regarding claim 16, Wittmayer discloses a method of using a treatment patch to relieve a region on a patient’s skin (Abstract – “The subject invention relates to a therapeutic patch, its manufacture and use wherein the patch comprises: a fabric layer made of synthetic fibers stretchable in both directions along a substantially orthogonal transverse axis of the patch, an adhesive layer on said face side of the base layer, an active agent dispersed in said adhesive layer, and optionally, a penetration enhancing agent in said adhesive layer.”), the method comprising:
diluting witch hazel in a water solution ([0144] – “The patches of the subject invention can include one or more of the following:”; [0508] – “Water”; [0514] – “Witch Hazel”. In an embodiment with both water and witch hazel, the witch hazel is diluted in the water.);
embedding the witch hazel and the aloe barbadensis leaf into a hydrocolloid layer ([0654] – “Inactive agents of the patch optionally include one or more of:”; [656] – “Aloe Barbadensis (Aloe Vera) Leaf Juice”; [0709] – “Active agents of the skin care patch can include one or more of:”; [0748] – “Witch Hazel”.);
providing a treatment patch (Abstract – “The subject invention relates to a therapeutic patch, its manufacture and use wherein the patch comprises: a fabric layer made of synthetic fibers stretchable in both directions along a substantially orthogonal transverse axis of the patch, an adhesive layer on said face side of the base layer, an active agent dispersed in said adhesive layer, and optionally, a penetration enhancing agent in said adhesive layer.”), wherein the treatment patch comprises:
a first surface comprising a backing sheet (The fabric layer is interpreted as a backing sheet and comprise a first surface.),
a second surface comprising the hydrocolloid layer ([0078] – “The adhesive can be an acrylic based adhesive, or any other form well known in the art of patch technology and it can be applied/coated to the fabric layer via any suitable method. In an advantageous embodiment, a medical grade acrylic-based, silicone-based, hydrocolloid-based, or hydrogel-based adhesive is used.” [0080] – “Hydrocolloid PSA's are often used for acne treatment and wound dressings that are occlusive and adhesive and can form a gel with water.” The adhesive layer is a hydrocolloid and comprises a second surface.),
wherein the hydrocolloid layer comprises a self-adhesive dressing configured to adhere the treatment patch to the patient at the second surface ([0078] – “The adhesive can be an acrylic based adhesive, or any other form well known in the art of patch technology and it can be applied/coated to the fabric layer via any suitable method. In an advantageous embodiment, a medical grade acrylic-based, silicone-based, hydrocolloid-based, or hydrogel-based adhesive is used.”), and
wherein the treatment patch comprises an ultraviolet protection factor (UPF) to improve scarring of the skin ([0623] – “Active agents of a pain relief patch can include one or more of:”; [0652] – “Zinc Oxide”. Zinc oxide is known to provide UPF protection.); and
administering the treatment patch to the patient’s skin ([0017] – “wherein said adhesive layer attaches the patch to the skin of the user and provides sustained release of the active agent to the skin.”).
Wittmayer does not disclose purifying aloe barbadensis leaf and chopping the aloe barbadensis leaf into a powder.
However, purifying aloe barbadensis leaf and chopping the aloe barbadensis leaf into a powder is within the skill of one of ordinary skill in the art and taught by Nielsen and Naone.
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 particular 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 adding the powder to the hydrocolloid of Wittmayer 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 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 medical uses for aloe plants and its components.
As a result, Nielsen and Naone teaches that it would have been obvious for Wittmayer to comprise purifying aloe barbadensis leaf and chopping the aloe barbadensis leaf into a powder (In view of Naone, powdered aloe barbadensis leaf may be made via a purifying and chopping step and Nielsen teaches using the aloe powder in a hydrocolloid of Wittmayer.).
Regarding claim 17, Wittmayer in view of Nielsen and Naone discloses the treatment patch of claim 16, wherein the hydrocolloid layer further comprises menthol ([0019] – “Active agents of the adhesive layer can include topical pain-relieving agents such as lidocaine, menthol, hemp oil extract or CBD, and capsaicin.”).
Regarding claim 18, Wittmayer in view of Nielsen and Naone discloses the treatment patch of claim 16, wherein the hydrocolloid layer further comprises capsaicin ([0019] – “Active agents of the adhesive layer can include topical pain-relieving agents such as lidocaine, menthol, hemp oil extract or CBD, and capsaicin.”).
Regarding claim 19, Wittmayer in view of Nielsen and Naone discloses the treatment patch of claim 16, wherein the hydrocolloid layer further comprises calendula ([0144] – “The patches of the subject invention can include one or more of the following:”; [0209] – “Calendula”.).
Regarding claim 20, Wittmayer in view of Nielsen and Naone discloses the treatment patch of claim 16, wherein the hydrocolloid layer further comprises zinc oxide ([0623] – “Active agents of a pain relief patch can include one or more of:”; [0652] – “Zinc Oxide”.).
Claim(s) 1 and 5 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). This rejection is in addition to the 102 rejection of claim 1 and does not replace the prior rejection.
Regarding claim 1, Kivivuori discloses a treatment patch for use on a patient’s skin ([abstract] – “An adhesive body dressing includes a hydrocolloid adhesive layer (H) and a backing layer (B) provided on a first side of the hydrocolloid adhesive layer (H). The backing layer (B) is made of biodegradable polymer material.”), comprising:
a first surface comprising a backing sheet (a backing layer (B));
a second surface comprising a hydrocolloid layer (a hydrocolloid adhesive layer (H)),
wherein the hydrocolloid layer comprises a self-adhesive dressing configured to adhere the treatment patch to the patient at the second surface ([0069] – “In one embodiment, the adhesive body dressing comprises a first removable covering layer provided on a second side of the hydrocolloid adhesive layer. The first removable covering layer protects the adhesive surface of the hydrocolloid adhesive layer or the adhesive body dressing before placing the adhesive body dressing on skin of a user.”).
Kivivuori does not disclose wherein the hydrocolloid layer comprises aloe barbadensis leaf and witch hazel embedded within; and wherein the treatment patch comprises an ultraviolet protection factor (UPF) to improve scarring of the skin.
However, adding aloe barbadensis leaf, witch hazel and an ultraviolet protection factor (UPF) to a hydrocolloid is within the skill of one of ordinary skill in the art and taught by Wittmayer.
Wittmayer discloses [0654] – “Inactive agents of the patch optionally include one or more of:”; [656] – “Aloe Barbadensis (Aloe Vera) Leaf Juice”; [0709] – “Active agents of the skin care patch can include one or more of:”; [0748] – “Witch Hazel”; [0623] – “Active agents of a pain relief patch can include one or more of:”; [0652] – “Zinc Oxide”. Zinc oxide is known to provide UPF protection.
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to add aloe barbadensis leaf, witch hazel and an ultraviolet protection factor (UPF) to the hydrocolloid of Kivivuori as taught by Wittmayer. A skilled artisan would have been motivated to do so because Wittmayer teaches 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 advantageous in pain relief patches ([0605]). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn wound dressing with hydrocolloid adhesive layers.
As a result, Wittmayer teaches that it would have been obvious for Kivivuori to comprise wherein the hydrocolloid layer comprises aloe barbadensis leaf and witch hazel embedded within; and wherein the treatment patch comprises an ultraviolet protection factor (UPF) to improve scarring of the skin (in view of Wittmayer, the hydrocolloid of Kivivuori comprises aloe barbadensis leaf, witch hazel, and zinc oxide.).
Regarding claim 5, Kivivuori in view of Wittmayer discloses the treatment patch of claim 1, wherein the backing sheet is made of polyurethane ([0044] – “The backing layer or the surface backing material layer is made of biodegradable biopolyesters, the biodegradable biopolyesters comprising one or more of the following: polyhydroxyalkanoates, polylactides, polyglycolide, polycaprolactones, polyesteramides, polyurethane, aliphatic copolyesters and aromatic copolyesters.”).
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 further in view of US 2015/0157758 (Blücher).
Regarding claim 2, Kivivuori in view of Wittmayer discloses the treatment patch of claim 1.
Kivivuori in view of Wittmayer does not disclose wherein the hydrocolloid layer comprises a thickness of about 12 mm to about 18 mm.
However, modifying the thickness of the hydrocolloid layer is within the skill of one of ordinary skill in the art and taught by Blücher.
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 dressings with hydrocolloid adhesives.
As a result, Blücher teaches that it would have been obvious for Kivivuori in view of Wittmayer to comprise wherein the hydrocolloid layer comprises a thickness of about 12 mm to about 18 mm (In view of Blücher, the thickness of the hydrocolloid of Kivivuori is about 12 mm to about 18 mm.).
Conclusion
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/SETH R. BROWN/Examiner, Art Unit 3786
/RACHAEL E BREDEFELD/Supervisory Patent Examiner, Art Unit 3786