DETAILED ACTION
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 .
Status of the Claims
Claims 1-33 are cancelled. Claims 34-53 are new, pending, and under examination.
Priority
This application claims the benefit of priority from U.S. Provisional Patent Application No. 63/489,017, filed March 8, 2023, and entitled, “Personal Care Compositions,”.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 03/08/2024 and 09/12/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 50, 51 and 53 are rejected under 35 U.S.C. 101 because the claimed subject matter is directed to products of nature and includes no additional elements that amount to more than that. Claim 50 recites products that are naturally occurring substances including retinoids, bakuchiol, and alpha hydroxy acids, with a cosmetically acceptable carrier. Retinoids can include naturally occurring retinols found in the human body. Bakuchiol is a plant-based retinol found in Psoralea corylifolia (also known as babchi) plants. Claim 50 also recites a “cosmetically acceptable carrier”, which according to the specifications may be water or ethanol (paragraph 101) ––both of which are also naturally occurring substances. Alpha Hydroxy acids can include naturally occurring ones such as malic acid and lactic acid. Claim 51 further limits claim 50 by stating that the alpha hydroxy acid may be selected from a list that includes malic acid and lactic acid, both similarly being products found in nature (such as the human body). Such natural acids naturally lower pH. Additionally, there is no indication that one of the above naturally occurring elements provide an additional benefit to the composition or to the other elements within the composition than what each product of nature would individually contribute on their own. Claim 53 also limits the pH range of claim 50, which is a natural characteristic to the above claimed products found in nature. Furthermore, the preamble of these claims (i.e., “personal care composition”) is directed towards intended use (MPEP 2111.02), and does not impose a structural limitation.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 41 and 52 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 41 Recites “azelaic acid and its derivatives”. However, The specification fails to provide adequate written description to support the genus “azelaic acid and its derivatives”. The disclosure does not describe any specific azelaic acid derivative species, structural features, substitution patterns, attachment groups, representative members, or guidance defining the scope of the claimed derivative of the genus. While Azelaic acid may be listed, its “derivatives” is merely stated and not elaborated upon with a definition or description of adequate species. The specification does not describe functional groups, or structural variations by which such derivatives would be formed, nor does it identify any common structural characteristics sufficient to discern the boundaries of the claimed genus.
Claim 52 Recites “oleyl adapalate, or a derivative thereof”. However, The specification fails to provide adequate written description to support the genus “oleyl adapalate, or a derivative thereof”. The disclosure does not describe any specific oleyl adapalate derivative species, structural features, substitution patterns, attachment groups, representative members, or guidance defining the scope of the claimed derivative of the genus. While oleyl adapalate may be listed, its “derivatives” is merely stated and not elaborated upon with a definition or description of adequate species. The specification does not describe functional groups, or structural variations by which such derivatives would be formed, nor does it identify any common structural characteristics sufficient to discern the boundaries of the claimed genus.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 41 and 52 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 41 Recites “azelaic acid and its derivatives”. However, the term “derivative” renders the scope unclear, because the claim does not specify which structural modifications qualify as derivatives of azelaic acid. The disclosure does not describe any specific azelaic acid derivative species, structural features, substitution patterns, attachment groups, representative members, or guidance defining the scope of the claimed derivative of the genus. While Azelaic acid may be listed, its “derivatives” is merely stated and not elaborated upon with a definition or description of adequate species. The specification does not describe functional groups, or structural variations by which such derivatives would be formed, nor does it identify any common structural characteristics sufficient to discern the boundaries of the claimed genus. As a result, a person of ordinary skill in the art would not be able to determine with reasonable certainty which compounds are encompassed by the claim, rendering it indefinite.
Claim 52 Recites “oleyl adapalate, or a derivative thereof”. However, the term “derivative” renders the scope unclear, because the claim does not specify which structural modifications qualify as derivatives of oleyl adapalate. The disclosure does not describe any specific oleyl adapalate derivative species, structural features, substitution patterns, attachment groups, representative members, or guidance defining the scope of the claimed derivative of the genus. While oleyl adapalate may be listed, its “derivatives” is merely stated and not elaborated upon with a definition or description of adequate species. The specification does not describe functional groups, or structural variations by which such derivatives would be formed, nor does it identify any common structural characteristics sufficient to discern the boundaries of the claimed genus. As a result, a person of ordinary skill in the art would not be able to determine with reasonable certainty which compounds are encompassed by the claim, rendering it indefinite.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 34-40 are rejected under 35 U.S.C. 103 as being unpatentable over Fares et al. (US20120093748A) in view of Winn (US20220211597A1).
Fares et al. discloses topical compositions that have 0.5% or more of at least one personal care or pharmaceutical acid, and lightly- to moderately-crosslinked PVP, which is an effective thickener in the low pH systems (abstract). Fares et al. teaches that the composition can be used for personal care, or prescriptive or non-prescriptive medication indications for use on the skin, hair, scalp, foot, or lips (abstract). Fares et al. teaches that In preferred embodiments, the acid is a hydroxy acid such as alpha hydroxy acids and beta hydroxy acids (paragraph 48), which can respectively be used for skin penetration and exfoliation (paragraph 49 and 51). Fares et al. teaches that examples of beta hydroxy acids used for the compositions are salicylic acid, beta hydroxybutanoic acid, and trethocanic acid (paragraph 51). Fares et al. teaches that the alpha hydroxy acids such as mandelic acid, lactic acid, tartaric acid can be included in this composition (paragraph 49 and claim 13). Fares et al. further teaches that the alpha hydroxy acids such as malic acid can also be included in this composition (paragraph 52 and claim 13). Fares et al. teaches the compositions having 0.5% w/w or more of at least one personal care acid or pharmaceutical acid (paragraph 2), which wholly overlaps with the claimed range of 5% to 25% w/w. Fares et al. teaches that the composition may have at least one additional ingredient including active ingredients and humectants (claim 17). Fares et al. further teaches that the composition may have at least one additional ingredient including antioxidants, conditioning agents, and bleaching (or skin lightening) agents at concentrations ranging from 0% to 20% w/w (paragraph 68). In a single embodiment (paragraph 135, example 7), Fares et al. teaches the use of multiple ingredient classes in an acne gel formulation––including a carrier (water and ethanol), humectants (Lubrajel ® Oil), alpha hydroxy acids (glycolic acid) as an active ingredient, and beta hydroxy acids (salicylic acid) as an active ingredient––thus providing a point of reference to modify such skin-care compositions.
However, Ferris et al. fails to teach the addition of oleyl adapalate in the personal care composition.
Winn discloses external compositions containing one or more lipophilic naphthoic acid retinoid compounds (abstract). Winn teaches that the external compositions are applied to the skin where they stimulate skin repair and visibly improve skin damage caused by photoaging and acne (abstract). Winn teaches that the compositions contain a lipophilic adapalene ester as an active agent for the purpose of eliminating signs of photoaging and acne, such as reducing aging spots, discoloration spots, redness, blemishes, fine lines, and wrinkles (paragraph 23). In an embodiment (example 2), Winn teaches the synthesis of Adapalene Oleyl Ester (also known as oleyl adapalene, oleyl adapalate) as an example of such lipophilic adapalene ester active agents (paragraph 27). In another embodiment (example 4), Winn teaches the Adapalene Oleyl Ester active agent being incorporated in topical skin care compositions (paragraph 29).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to arrive at the claimed compositions by combining the teachings of Fares et al. and Winn. This is because Fares already teaches topical personal care compositions suitable for application to the skin, which comprises many of the claimed alpha and beta hydroxy acids at concentrations also overlapping with those claimed––for the purpose of skin penetration and exfoliation. Fares further teaches that such compositions may include additional and conventional formulation components including active agents, humectants, and antioxidants. Concurrently, Winn teaches the use of oleyl adapalene as a topical skin-active agent for multiple purposes such as wrinkle and redness reduction. Thus, a person of ordinary skill in the art would have been motivated to incorporate the oleyl adapalene teachings of Winn into the personal care compositions taught by Fares to obtain the additive benefits of wrinkle reduction, redness reduction, skin penetration, and exfoliation. Furthermore, because each component performs a well-established function in conventional skincare compositions, a person of ordinary skill in the art would have had a reasonable expectation of success formulating them together to reach the claimed invention, as the combinations represent no more than routine and predictable use of known elements according to their established functions.
Claims 41-44 are rejected under 35 U.S.C. 103 as being unpatentable over Fares et al. (US20120093748A) in view of Winn (US20220211597A1) in further view of Sengupta et al. (US20220288086A1).
Fares et al. and Winn collectively teach the previous limitations, including a personal care composition comprising: oleyl adapalate; a beta hydroxy acid and/or a salt thereof; and a humectant.
However, Fares et al. and Winn collectively fail to teach The personal care composition according to claim 34, further comprising an anti- acne agent selected from keratolytics, retinoids, tretinoin, adapalene, tazarotene, lipoic acid, benzoyl peroxide, triclosan, chlorhexidine gluconate, octopirox, tetracycline, 2,4,4'-trichloro-2'- hydroxy diphenyl ether, 3,4,4'-trichlorobanilide, nicotinamide, tea tree oil, rofecoxib, azelaic acid and its derivatives, phenoxyethanol, phenoxypropanol, phenoxisopropanol, ethyl acetate, clindamycin, erythromycin, meclocycline, sebostats, Minocycline, Moxifloxacin, N-acetylcystein, Nadifloxacin, octopirox, Prulifloxacin, Sitafloxacin, sodium sulfacetamide, spirinolactone, sulfacetamide, sulfur, tazarotene, tretinoin, triclosan, ulifloxacin, metronidazole, ornidazole, urea, and a combination of two or more thereof.
Additionally, Fares et al. and Winn collectively fail to teach the personal care composition according to further comprising an antioxidant selected from amellia japonica extract, quercetin, green tea, soy, milk thistle, algae, aloe, angelica, bitter orange, coffee, goldthread, grapefruit, hoellen, honeysuckle, Job's tears, lithospermum, mulberry, peony, puerarua, rice, safflower, and a combination of two or more thereof.
Additionally, Fares et al. and Winn collectively fail to teach the personal care composition containing the humectant selected from sorbitol, butylene glycol,1,3-propanediol, glycerin, polyoxyethylene glycol, polyglutamic acid, saccharide isomerate, and a combination of two or more thereof at concentrations overlapping with 0.01% to 5% w/w.
Sengupta et al. discloses novel molecules, compositions, and formulations for treatment of bacterial infections in general and more specifically to bacterial infections with antibiotic resistant pathogens. Sengupta et al. teaches that the composition may be an anti-bacterial composition in the form of a skin care composition (paragraph 167). Sengupta et al. teaches that the term “skin care composition” refers to materials applied topically to the skin that benefit, improve, or enhance the condition of the skin, or treat skin suffering from an infectious or diseased condition (paragraph 167). Sengupta et al. teaches that the composition can contain active agents (paragraph 109). Sengupta et al. teaches that the active agent may be keratolytics, retinoids, tretinoin, adapalene, tazarotene, lipoic acid, benzoyl peroxide, triclosan, chlorhexidine gluconate, octopirox, tetracycline, 2,4,4'-trichloro-2'- hydroxy diphenyl ether, 3,4,4'-trichlorobanilide, nicotinamide, tea tree oil, rofecoxib, azelaic acid and its derivatives, phenoxyethanol, phenoxypropanol, phenoxisopropanol, ethyl acetate, clindamycin, erythromycin, meclocycline, sebostats, and combinations thereof (paragraph 61). Sengupta et al. further teaches that additional active agent can be included in the formulation including Minocycline, Moxifloxacin, N-acetylcystein, Nadifloxacin, octopirox, Prulifloxacin, Sitafloxacin, sodium sulfacetamide, spirinolactone, sulfacetamide, sulfur, tazarotene, tretinoin, triclosan, ulifloxacin, metronidazole, ornidazole, urea, and combinations thereof (paragraph 64). Sengupta et al. further teaches that the composition may include anti-aging agents such as quercetin, green tea, soy, milk thistle, algae, aloe, angelica, bitter orange, coffee, goldthread, grapefruit, hoellen, honeysuckle, Job's tears, lithospermum, mulberry, peony, puerarua, rice, safflower, and mixtures thereof (paragraph 112), which are antioxidants. Sengupta et al. teaches that the composition can contain humectants (e.g., polyhydric alcohols, water soluble and alkoxylated nonionic polymer) at concentrations ranging from 0.1% to 20% w/w (paragraph 228). Sengupta et al. teaches that examples of such polyhydric alcohol humectants are glycerin, sorbitol, and butylene glycol (paragraph 229). Sengupta et al. teaches that examples of water soluble alkoxylated nonionic polymers include polyethylene glycols (known as polyoxyethylene glycols) (paragraph 230). Sengupta et al. teaches that a single or combination of moisturizing agents such as saccharide isomerate can be included in the composition at concentrations ranging from 0.01% to 50% w/w (paragraph 235). In a single embodiment (paragraph 483, example 3), Sengupta et al. teaches a topical formulation containing many of the claimed classes of ingredients––including a compatible delivery vehicle, an active agent, a humectant, an anti-oxidant, and an alpha hydroxy acid as a pH modifier––thus providing a point of reference to modify such compositions.
It would have been obvious for a person of ordinary skill in the art, before the effective filing date of the claimed invention, to incorporate the active agent, antioxidant, and humectant teachings taught by Sengupta et al. into the composition teachings jointly taught by Fares et al. and Winn. This is because Fares and Winn conjointly teach the use of skincare compositions with the ability to include additional components such as humectants, anti-oxidants, and active agents. Concurrently, Sengupta teaches that many of the claimed species of the above components can be added to skincare compositions––with humectants notably being at concentrations overlapping with those in the present claims. Thus, a person of ordinary skill in the art would have been motivated to incorporate such species of active agents, anti-oxidants, and humectants taught by Sengupta into the skincare compositions jointly taught by Fares and Winn to obtain their additive benefits including anti-acne effects, free radical neutralization, and moisturization. Furthermore, because each component performs a well-established function in conventional skincare compositions, a person of ordinary skill in the art would have had a reasonable expectation of success formulating them together to reach the claimed invention, as such combinations represent no more than routine and predictable use of known elements according to their established functions.
Claim 45 is rejected under 35 U.S.C. 103 as being unpatentable over Fares et al. (US20120093748A) in view of Winn (US20220211597A1) in further view of Krutmann et al. (US10780042B2).
Fares et al. and Winn collectively teach the previous limitations, including a personal (or skin) care composition comprising: oleyl adapalate; a beta hydroxy acid and/or a salt thereof; and a humectant.
However, Fares et al. and Winn collectively fail to teach the personal care composition according further comprising licorice extract.
Krutmann et al. discloses is a cosmetic composition comprising an anti-pollution agent (abstract). Krutmann et al. teaches that the compositions according to the present inventions are selected from the group of products for treatment, protecting, care and cleansing of the skin and/or hair or as a make-up product, preferably as a leave-on product (column 31, lines 33-36). Krutmann et al. teaches that such skin compositions may include licorice extract as a skin lightening agent (column 21, line 12).
It would have been obvious for a person of ordinary skill in the art, before the effective filing date of the claimed invention, to incorporate the licorice extract teachings taught by Krutmann et al. into the composition teachings jointly taught by Fares et al. and Winn. This is because Fares and Winn conjointly teach the use of skincare compositions that may include bleaching (or skin lightening) agents as additives. Concurrently, Krutmann teaches that licorice extract can be added in skincare compositions as a skin-lightening agent. Thus, a person of ordinary skill in the art would have been motivated to incorporate the licorice extract taught by Krutmann into the skincare composition jointly taught by Fares and Winn to obtain its skin-lightening benefits. Furthermore, because these components perform a well-established purpose in conventional skincare compositions, a person of ordinary skill in the art would have had a reasonable expectation of success formulating them together to reach the claimed invention, as such combinations represent no more than routine and predictable use of known elements according to their conventional functions.
Claims 46-48 are rejected under 35 U.S.C. 103 as being unpatentable over Sengupta et al. (US20220288086A1) in view of Winn (US20220211597A1).
Sengupta et al. discloses novel molecules, compositions, and formulations for treatment of bacterial infections in general and more specifically to bacterial infections with antibiotic resistant pathogens (abstract). Sengupta et al. teaches that the composition may be an anti-bacterial composition in the form of a skin care composition (paragraph 167). Sengupta et al. teaches that the term “skin care composition” refers to materials applied topically to the skin that benefit, improve, or enhance the condition of the skin, or treat skin suffering from an infectious or diseased condition (paragraph 167). Sengupta et al. teaches that the composition can contain active agents or a combination thereof (paragraph 109). Sengupta et al. teaches that examples of such active agents include penetration enhancers, bleaching (or skin lightening) agents, anti-aging agents, anti-acne agents, soothing agents, and regenerative agents (paragraph 110). Sengupta et al. teaches that mandelic acid, lactic acid, malic acid, and tartaric acid can be used in the composition as anti-aging active ingredients (paragraph 112). Sengupta et al. teaches that lipoic acid and salicylic acid can be used in the composition as an anti-acne agent (paragraph 127). Sengupta et al. teaches that saccharide isomerate can be used in the composition as a moisturizing agent (paragraph 235). In a single embodiment (paragraph 483, example 3), Sengupta et al. teaches a topical formulation containing many of classes of ingredients––including a compatible delivery vehicle, an active agent, a humectant (or moisturizer), an anti-oxidant, and an alpha hydroxy acid as a pH modifier––thus providing a point of reference to modify such compositions.
However, Sengupta et al. fails to teach the addition of oleyl adapalate in the personal care composition.
Winn discloses external compositions containing one or more lipophilic naphthoic acid retinoid compounds (abstract). Winn teaches that the external compositions are applied to skin where they stimulate skin repair and visibly improve skin damage caused by photoaging and acne (abstract). Winn teaches that the compositions contain a lipophilic adapalene ester as an active agent for the purpose of eliminating signs of photoaging and acne, such as reducing aging spots, discoloration spots, redness, blemishes, fine lines, and wrinkles (paragraph 23). In an embodiment (example 2), Winn teaches the synthesis of Adapalene Oleyl Ester (also known as oleyl adapalene, oleyl adapalate) as an example of such lipophilic adapalene ester as an active agent (paragraph 27). In another embodiment (example 4), Winn teaches the Adapalene Oleyl Ester active agent being incorporated in such topical skin care compositions (paragraph 29).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to arrive at the claimed compositions by combining the teachings of Sengupta et al. and Winn. This is because Sengupta already teaches topical personal care compositions suitable for application to the skin, which comprises many of the alpha and beta hydroxy acids listed in the present claims for the purpose of anti-aging, in addition to the claimed lipoic and salicylic acid for anti-acne, and the claimed saccharide isomerate for moisturization. Sengupta further teaches that such skincare compositions may include additional active agents that reduce aging, promote regeneration, and enhance soothing (which can reduce redness). Concurrently, Winn teaches the use of oleyl adapalene as a topical skin-active agent for improving conditions such as skin damage, aging, and redness. Thus, a person of ordinary skill in the art would have been motivated to incorporate the oleyl adapalene teachings of Winn into the personal care compositions taught by Sengupta in order to obtain the additive benefits of anti-aging, anti-redness, skin regeneration, anti-acne, and moisturization. Furthermore, because each of these components perform a well-established purpose in conventional skincare compositions, a person of ordinary skill in the art would have had a reasonable expectation of success formulating them together to reach the claimed invention, as such combinations represent no more than routine and predictable use of known elements according to their conventional functions.
Claim 49 is rejected under 35 U.S.C. 103 as being unpatentable over Sengupta et al. (US20220288086A1) in view of Winn (US20220211597A1) in further view of Krutmann et al. (US10780042B2).
Sengupta et al. and Winn collectively teach the limitations above, including personal care composition comprising oleyl adapalate; an alpha hydroxy acid and/or salt thereof; lipoic acid and/or a salt thereof; and saccharide isomerate.
However, Sengupta et al. and of Winn collectively fail to teach the personal care composition according further comprising licorice extract.
Krutmann et al. discloses is a cosmetic composition comprising an anti-pollution agent (abstract). Krutmann et al. teaches that the compositions according to the present inventions are selected from the group of products for treatment, protecting, care and cleansing of the skin and/or hair or as a make-up product, preferably as a leave-on product (column 31, lines 33-36). Krutmann et al. teaches that such skin compositions may include licorice extract as a skin lightening agent (column 21, line 12).
It would have been obvious for a person of ordinary skill in the art, before the effective filing date of the claimed invention, to incorporate the licorice extract teachings taught by Krutmann et al. into the composition teachings jointly taught by Sengupta et al. and Winn. This is because Sengupta and Winn conjointly teach the use of skincare compositions that may include bleaching (or skin lightening) agents as an additive. Concurrently, Krutmann teaches that licorice extract can be added in skincare compositions as a skin-lightening agent. Thus, a person of ordinary skill in the art would have been motivated to incorporate the licorice extract taught by Krutmann into the skincare composition jointly taught by Fares and Winn to obtain its skin-lightening benefits. Furthermore, because these components perform a well-established purpose in conventional skincare compositions, a person of ordinary skill in the art would have had a reasonable expectation of success formulating them together to reach the claimed invention, as such combinations represent no more than routine and predictable use of known elements according to their conventional functions.
Claims 50-51 are rejected under 35 U.S.C. 103 as being unpatentable over Fernandez et al. (US20130336903A1).
Fernandez et al. discloses a personal care composition comprising a pH tunable gellant (abstract). Fernandez et al. teaches that “personal care composition” means compositions suitable for topical application on keratinous tissue (paragraph 9). Fernandez et al. teaches that the term “keratinous tissue” includes, but is not limited to, skin, lips, hair, and nails (paragraph 11). Fernandez et al. teaches that the composition may include one or more active ingredient including retinoids (paragraph 102). Fernandez et al. teaches that the composition may comprise a skin lightening agent including bakuchiol (paragraph 210). Fernandez et al. teaches that the composition may comprise a compatible carrier (paragraph 46). Fernandez et al. teaches that the composition may contain one or more desquamation (or exfoliation) actives including malic acid, mandelic acid, tartaric acid, and lactic acid (paragraph 183 and 184). Fernandez et al. teaches that the composition may contain one or more anti-wrinkle actives or anti-atrophy actives including phytic acid (paragraph 129). Fernandez et al. teaches that the personal care composition may include one or more additional active agent such as anti-inflammatory agents and anti-wrinkle agent (which is a form of anti-aging agent) (paragraph 102).
It would have been obvious for a person of ordinary skill in the art, before the effective filing date of the claimed invention, to arrive at the claimed composition based on the teachings of Fernandez et al. This is because Fernandez teaches topical personal care compositions applicable to the skin that may include retinoids as an anti-acne active, bakuchiol as a skin lightening agent, and all of the alpha hydroxy acids listed in the present claims as desquamation (or exfoliation) agents and anti-wrinkle agents, and an acceptable carrier for delivery. A person of ordinary skill in the art would have thus been motivated to formulate the claimed personal care composition in order to achieve additive effects of addressing multiple skin improvement objectives including skin lightening, acne treatment, exfoliation, and wrinkle reduction, with the components delivered by a compatible carrier. Furthermore, because each of these components perform a well-established purpose in conventional skincare compositions, a person of ordinary skill in the art would have had a reasonable expectation of success formulating them together to reach the claimed invention, as such combinations represent no more than routine and predictable use of known elements according to their conventional functions.
Claim 52 is rejected under 35 U.S.C. 103 as being unpatentable over Fernandez et al. (US20130336903A1) in view of Winn (US20220211597A1).
Fernandez et al. teaches all of the limitations previously stated, including a composition comprising: a retinoid; bakuchiol; an alpha hydroxy acid, or a salt thereof; and a cosmetically acceptable carrier.
However, Fernandez et al. fails to teach the addition of oleyl adapalate in the personal care composition.
Winn discloses external compositions containing one or more lipophilic naphthoic acid retinoid compounds (abstract). Winn teaches that the external compositions be applied to skin where they stimulate skin repair and visibly improve skin damage caused by photoaging and acne (abstract). Winn teaches that the compositions contain a lipophilic adapalene ester as an active agent for the purpose of eliminating signs of photoaging and acne, such as reducing aging spots, discoloration spots, redness, blemishes, fine lines, and wrinkles (paragraph 23). In an embodiment (example 2), Winn teaches the synthesis of Adapalene Oleyl Ester (also known as oleyl adapalene, oleyl adapalate) as an example of such lipophilic adapalene ester as an active agent (paragraph 27). In another embodiment (example 4), Winn teaches the Adapalene Oleyl Ester active agent being incorporated in such topical skin care compositions (paragraph 29).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to arrive at the claimed composition by combining the teachings of Fernandez et al. and Winn. This is because Fernandez already teaches topical personal care compositions suitable for application to the skin, which comprises many of the previously claimed elements including retinoids, bakuchiol, a carrier, and alpha hydroxy acids. Fernandez further teaches that such skincare compositions may include additional anti-inflammatory agents (which reduces redness) and anti-wrinkle agents. Concurrently, Winn teaches the use of oleyl adapalene as a topical skin-active retinoid for improving conditions such as wrinkles and redness. Thus, a person of ordinary skill in the art would have been motivated to incorporate the oleyl adapalene teachings of Winn into the personal care compositions taught by Fernandez in order to obtain the additive benefits of wrinkle and redness reduction. Furthermore, because each of these components perform a well-established purpose in conventional skincare compositions, a person of ordinary skill in the art would have had a reasonable expectation of success formulating them together to reach the claimed invention, as such combinations represent no more than routine and predictable use of known elements according to their conventional functions.
Claim 53 is rejected under 35 U.S.C. 103 as being unpatentable over Fernandez et al. (US20130336903A1) in view of Fares et al. (US20120093748A).
Fernandez et al. teaches all of the limitations previously stated, including a composition comprising: a retinoid; bakuchiol; an alpha hydroxy acid, or a salt thereof; and a cosmetically acceptable carrier.
However, Fernandez et al. fails to teach the personal care composition having a pH of from about 2.5 to about 4.5.
Fares et al. discloses topical compositions that have 0.5% or more of at least one personal care or pharmaceutical acid, and lightly- to moderately-crosslinked PVP, which is an effective thickener in the low pH systems (abstract). Fares et al. teaches that the composition can be used for personal care, or prescriptive or non-prescriptive medication indications for use on the skin, hair, scalp, foot, or lips (abstract). Fares et al. teaches that alpha hydroxy acids such as mandelic acid, lactic acid, and tartaric acid can be included in this composition (paragraph 49 and claim 13). Fares et al. further teaches that the alpha hydroxy acids such as malic acid can also be included in this composition (paragraph 52 and claim 13). Fares et al. teaches that alpha hydroxy acids are exfoliation agents used in skincare compositions such as lotions and the like (paragraph 49). Fares et al. teaches that these compositions ideally have an acidic pH, especially a pH less than 6, and more preferably a pH less than 4, and especially preferably less than 2 (paragraph 2). Fares et al teaches that due to the low pH of such topical compositions, they may be expected to provide a skin exfoliation effect (also known as keratolysis) (paragraph 129). In a single embodiment (paragraph 135, example 7), Fares et al. teaches the use of multiple ingredient classes in an acne gel formulation––including a carrier (water and ethanol), humectants (Lubrajel ® Oil), alpha hydroxy acids (glycolic acid), beta hydroxy acids (salicylic acid) ––thus providing a point of reference to modify such skin-care compositions.
It would have been obvious for a person of ordinary skill in the art, before the effective filing date of the claimed invention, to incorporate the low pH teachings of Fares et al. into the composition teachings of Fernandez et al. This is because Fernandez teaches topical skincare compositions comprising retinoids, bakuchiol, a carrier, and alpha hydroxy acids. Concurrently, Fares teaches that topical skincare formulations containing alpha hydroxy acids may be formulated to have an acidic pH, preferably below 6, and more preferably less than 4 in order to potentially achieve exfoliating effects, which completely overlaps with the claimed pH range of 2.5-4.5. A person of ordinary skill in the art would have thus been motivated to adjust the pH of the compositions taught by Fernandez to be within the acidic range taught by Fares in order to optimize the exfoliating effects of the alpha hydroxy acids. This would be done with a reasonable expectation of success, as pH adjustment is a routine formulation parameter that could be optimized using conventional result-effective variables such as acids.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 34-45 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the following claims of U.S. Patent No. 18/962,927 (referred to as co-pending ‘927): 1, 6, and 13 (for present claim 34); 6 (for present claim 35); 7 (for present claim 36); 8 (for present claim 37); 2(for present claim 38); 3 (for present claim 39); 5 (for present claim 40); 14 (for present claim 43); 13 (for present claim 44); and 12 (for present claim 45)––In view of Winn (US20220211597A1).
Each of the above claims (or group of claims) of co-pending ‘927 teach all limitations of
their corresponding claim(s) listed in the present application, except for the following difference: present claim 34 teaches the personal care composition to contain oleyl adapalate, which is not taught in co-pending ‘927. Winn remedies this deficiency by teaching that Adapalene Oleyl Ester (also known as oleyl adapalene, oleyl adapalate) is a third-generation retinoid that can be added to such personal care compositions to reduce wrinkles and redness, thus making it a conventional agent. The selection, inclusion, or exclusion of retinoids to personal care (e.g., skincare) compositions is a routine formulation choice that would have been obvious to a person of ordinary skill in the art before the effective filing date of this claimed invention, since retinoids are well-known to be interchangeable based on many factors such as stability, solubility, efficacy, irritation profile, cost, and compatibility with the carrier system. Thus, adjusting a personal care (e.g., skincare) composition by adding or omitting a conventional retinoid represents no more than a routine and predictable variation using known components for their established functions, made with a reasonable expectation of success. Accordingly, the present claims differ from the claims of co-pending ‘927 only by an obvious variation that does not impart a patentable distinction.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusions
No claim is found allowable.
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Arya A. Bazargani, Ph.D.
Patent Examiner
Art Unit 1613
/MARK V STEVENS/ Primary Examiner, Art Unit 1613