DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Rejections - 35 USC § 102
3. 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.
4. Claims 13, 16, 19, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Maxim U.S. 5,887,437 (herein referred to as “Maxim”).
5. Regarding Claim 13, Maxim teaches a method of alleviating skin inflammation (Figs. 1 and 2, abstract), the method comprising the steps of:
a. providing a chillable gel pack (Figs. 1 and 2, ref num 12 defining ref num 22/24; Col. 3, lines 4-5 and 15-17, “A cooling agent 24 is positioned within the cold pack volume 22… gels or other well known coolable materials can be employed as the cooling agent 24”) and an adhesive applicator (Fig. 2, ref nums 32, 34, 36) wherein said adhesive applicator having an adhesive lining (Fig. 2, ref num 36) and a pressure adhesive layer (Fig. 2, ref num 34);
b. chilling said chillable gel pack (Col. 4, lines 1-3, “The user can place the self-adhering cold pack 10 in a conventional freezer until the cooling agent 24 is completely solidified”);
c. removing said adhesive lining from said adhesive applicator (Col. 3, lines 55-65);
d. exposing said pressure adhesive layer of said adhesive applicator (see Fig. 2, when ref num 36 is removed, ref num 34 is exposed);
e. affixing said adhesive applicator to the skin of a user (Col. 3, lines 46-49 and 56-58, “The bandage adhesive 34 is a hypo-allergenic adhesive for temporary adhesion of the mounting tabs 26 to the skin surface of a patient… the bandage adhesive 34 in operating condition until application of the self-adhering cold pack 10 to the patient”); and
f. applying said chillable gel pack to said adhesive applicator (Fig. 2, ref num 12 is applied to ref num 32/34).
6. Regarding Claim 16, Maxim teaches freezing the chillable gel pack (Col. 4, lines 1-3, “The user can place the self-adhering cold pack 10 in a conventional freezer until the cooling agent 24 is completely solidified”).
7. Regarding Claim 19, Maxim teaches the chillable gel pack has a freezing agent for freezing said chillable gel pack (Col 1, lines 45-48, “The cold pack in accordance with the invention has an envelope containing a cooling agent. The cooling agent can be a material, such as water, that can be readily frozen in a conventional freezer”).
8. Regarding Claim 20, Maxim teaches the chillable gel pack has an adhesive layer on a rear surface (Fig. 2, ref num 32 is on rear surface, ref num 26).
Claim Rejections - 35 USC § 103
9. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
10. Claims 1, 4, 6, 7, 10, 12, 14, and 15 rejected under 35 U.S.C. 103 as being unpatentable over Maxim and in view of Biser U.S. 8,784,391 (herein referred to as “Biser”), Kingsley U.S. 8,257,752 (herein referred to as “Kingsley”), Mitra U.S. 2009/0287168 (herein referred to as “Mitra”), Reinstein U.S. 2008/0300529 (herein referred to as “Reinstein”), and Barman U.S. 2014/0079686 (herein referred to as “Barman”.
11. Regarding Claims 1, 7, 14, and 15, Maxim teaches a skincare kit for alleviating skin inflammation (Col. 1, lines 10-12, “to apply cold packs to the skin surface of a patient that has undergone trauma. The cold pack can reduce pain and prevent or reduce swelling”) comprising:
a. a chillable gel pack (Figs. 1 and 2, ref num 12 defining ref num 22/24; Col. 3, lines 4-5 and 15-17, “A cooling agent 24 is positioned within the cold pack volume 22… gels or other well known coolable materials can be employed as the cooling agent 24”);
b. an adhesive applicator (Fig. 2, ref nums 32, 34, 36) having an adhesive lining (Fig. 2, ref num 36) and a pressure adhesive layer (Fig. 2, ref num 34); and
c. the chillable gel pack including a composition of materials (Col. 3, lines 4-17).
However, Maxim fails to teach the chillable gel pack includes:
Claims 1 and 14—20%-30% w/w aloe vera gel extract, 15%-25% w/w chamomile extract, 15%-25% w/w green tea extract, 15%-25% w/w cucumber extract, 1%-10% w/w menthol, 1%-10% w/w Vitamin C extract, and 1%-10% w/w allantoin;
[OR]
Claims 7 and 15— 10%-20% w/w aloe vera gel extract, 5%-15% w/w chamomile extract, 15%-25% w/w green tea extract, 25%-35% w/w cucumber extract, 10%-20% w/w menthol, 1%-10% w/w Vitamin C extract, and 1%-10% w/w allantoin.
The following chart outlines various references of analogous that contain the above materials:
REFERENCE
MATERIAL(S)
%WEIGHT (if applicable)
FIGURES/SPECIFICATION
Biser U.S. 8,784,391
Allantoin, Green Tea extract, Aloe Vera, Chamomile extract, cucumber extract
Col. 18, lines 56-59
Kingsley U.S. 8,257,752
Menthol, Vitamin C, Aloe Vera Extract, Green Tea Extract
%volume described for menthol at about 0.5% to 10%
Col. 2, lines 33-42; Col. 5, lines 7-13; Table 1
Mitra U.S. 2009/0287168
Allantoin, Menthol, Vitamin C
%weight for active agent described as being up to 25% and Vitamin C is listed as an active ingredient
Para 0165; Table 2
Reinstein U.S. 2008/0300529
Allantoin, Aloe, Green Tea, Menthol, Vitamin C
Para 0035, 0038, 0046-0048
Biser teaches a gel pack of analogous art (Fig. 1, ref num 202), wherein the gel pack includes substances, such as allantoin, green tea extract, Aloe Vera, Chamomile extract, cucumber extract (Col. 18, lines 56-59). These materials provide therapeutic benefit to the user’s body (Col. 19, line 37-40).
Kingsley teaches a solution to be applied to a user of analogous art (Col. 8, lines 35-48), such that the solution includes Menthol, Vitamin C, Aloe Vera Extract, Green Tea Extract (Col. 2, lines 33-42; Col. 5, lines 7-13; Table 1). This composition reduces inflammation in the skin of a user (Col. 8, lines 35-48).
Mitra teaches a skin care composition that contains Allantoin, Menthol, Vitamin C (para 0165, Table 2), wherein the active agent may be up to 25% by weight, such that the active agent selected may be vitamin C (para 0165).
Reinstein teaches a skin care composition that contains Allantoin, Aloe, Green Tea, Menthol, Vitamin C (Para 0035, 0038, 0046-0048). This materials provide protectants for the skin, moisturizing effects, and therapeutic effects (para 0035, 0038, 0046-0048).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to use these materials mentioned above within the chillable gel pack, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. These materials provide the benefit of therapeutic effects to reducing skin inflammation, as described by Biser, Kingsley, Mitra, and Reinstein.
While some of the references explain the percentages weights of various materials, each %weight of the materials is not explicitly stated. However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to have these different materials within the desired %weight ranges, 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. In re Aller, 105 USPQ 233. This is taught by Barman, such that gels are typical made with ingredients that are classified as safe with concentrations per the FDA (para 1020-1021, “The hydrogel was formulated with approximately 90% water, using excipients that are classified as GRAS (generally recognized as safe) in the concentration range used in the formulation and for topical use, as per the FDA Inactive Ingredients Database”).
12. Regarding Claims 4 and 10, Maxim teaches the chillable gel pack has a freezing agent for freezing said chillable gel pack (Col 1, lines 45-48, “The cold pack in accordance with the invention has an envelope containing a cooling agent. The cooling agent can be a material, such as water, that can be readily frozen in a conventional freezer”).
13. Regarding Claims 6 and 12, Maxim teaches the chillable gel pack has an adhesive layer on a rear surface (Fig. 2, ref num 32 is on rear surface, ref num 26).
14. Claims 2 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Maxim, Biser, Kingsley, Mitra, Reinstein, Barman, and further in view of Mitroo U.S. 2016/0128950 (herein referred to as “Mitroo”).
15. Regarding Claims 2 and 8, Maxim fails to teach the kit further comprises a plurality of sanitizing wipes, further that there are also Vitamin E wipes.
Mitroo teaches a kit of analogous art that includes a product in which relieves the user and is adhesively applied to the skin (see Fig. 1; abstract). This kit also comprises sanitizing wipes (para 0048, “The tape may also be provided as part of a kit for providing pain relief. The kit can include the tape 100 as well as a cleaning element to clean the skin where the tape is to be applied. A cleaning element, such as a cloth, may contain solvents to remove water-soluble and/or lipid—solvable debris and dirt from the skin”). The sanitizing wipes are provided in order to clean the skin where the product is to be applied (para 0048). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Maxim to include sanitizing wipes in order to clean the skin before application.
16. Claims 3 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Maxim, Biser, Kingsley, Mitra, Reinstein, Barman, and further in view of Mitroo and Non-Patent Literature, ‘Vitamin E in human skin: Functionality and topical products (herein referred to as “Vitamin E in human skin”).
17. Regarding Claims 3 and 9, while Maxim as modified by Mitroo fails to teach vitamin E wipes, it is widely known that vitamin E is used topically in order to provide antioxidant and moisturizing properties (Vitamin E in human skin, abstract). This can protect the skin as well reduce inflammation of the skin (Vitamin E in human skin, pg. 2, last paragraph in ‘Introduction’ section). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Maxim and included vitamin E wipes.
18. Claims 5 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Maxim, Biser, Kingsley, Mitra, Reinstein, Barman, and further in view of Scheja U.S. 2015/0165231 (herein referred to as “Scheja”).
19. Regarding Claims 5 and 11, Maxim teaches the chillable gel pack has an outer covering layer (Fig. 2, ref num 12), but fails to teach the outer covering layer is transparent.
Scheja teaches a gel pack of analogous art (Fig. 1), wherein the gel pack comprises an outer covering layer (Fig. 1, ref num 101/102) that is transparent (para 0051, “the first layer 101 may be substantially transparent”). This allows the user to see the contents within the gel pack (para 0058). It would have been obvious to one having ordinary skill in the art at the time the invention was made to have the outer covering layer be transparent, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
20. Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Maxim and in view of Mitroo.
21. Regarding Claim 17, Maxim fails to teach wiping the skin of the user with a sanitizing wipe prior to affixing said adhesive applicator to the skin of a user.
Mitroo teaches a method of analogous art that includes a product in which relieves the user and is adhesively applied to the skin (see Fig. 1; abstract). This method also comprises wiping the skin of the user prior to application with sanitizing wipes (para 0048, “The tape may also be provided as part of a kit for providing pain relief. The kit can include the tape 100 as well as a cleaning element to clean the skin where the skin where the tape is to be applied. A cleaning element, such as a cloth, may contain solvents to remove water-soluble and/or lipid—solvable debris and dirt from the skin”). The sanitizing wipes are provided in order to clean the skin where the product is to be applied (para 0048). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Maxim to wipe the skin of the user with sanitizing wipes in order to clean the skin before application.
22. Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Maxim and in view of Mitroo and Non-Patent Literature, ‘Vitamin E in human skin: Functionality and topical products.
23. Regarding Claim 18, Maxim teaches removing said adhesive applicator from the skin of the user (Col. 3, lines 46-49, “The bandage adhesive 34 is a hypo-allergenic adhesive for temporary adhesion of the mounting tabs 26 to the skin surface of a patient”; temporary adhesion indicates that the adhesive applicator would be removed). While Maxim as modified by Mitroo fails to teach vitamin E wipes, it is widely known that vitamin E is used topically in order to provide antioxidant and moisturizing properties (Vitamin E in human skin, abstract). This can protect the skin as well reduce inflammation of the skin (Vitamin E in human skin, pg. 2, last paragraph in ‘Introduction’ section). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Maxim and included vitamin E wipes to wipe the skin of the user.
Conclusion
24. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure are as follows:
Polster U.S. 11,717,437: a compress including skin-cooling ingredients such as aloe vera, Vitamin E, chamomile, and Vitamin C (Col. 1, lines 63-64; Col. 7, lines 3-15);
Mohammadi U.S. 2021/0205125: a cosmetic pad that may include agents such as allantoin, aloe vera, chamomile, menthol, vitamin C (para 0124, 0147, 0161, 0162);
Howard U.S. 2017/0087010: a garment with adhesive application that has a cooling pack in order to reduce inflammation (abstract; para 0012-0013);
Non-Patent Literature, Earth Therapeutics (website page found as early as November 22, 2019): Hydrogel Under-Eye Recovery Patch that includes all of the ingredients as claimed in the present application (see INGREDIENTS)
Non-Patent Literature, IncideCoder (website page found as early as January 17, 2021): explanation of ingredient lists, and how the %weight is related to the order in which ingredients are listed for cosmetic products.
25. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNIE L SHOULDERS whose telephone number is (571)272-3846. The examiner can normally be reached Monday-Friday (alternate Fridays) 8AM-5PM EST.
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/ANNIE L SHOULDERS/Examiner, Art Unit 3794