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, 37, and 52 are cancelled. Claims 34 and 50 are currently amended. Claims 35-36, 38-49, 51, and 53 are previously presented. pending, and under examination. Claims 34-36, 38-51, and 53 are 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,”.
Rejections withdrawn
The 35 USC § 101 rejection imposed in the previous correspondence has been withdrawn due to applicants’ amendments of incorporating oleyl adapalate into the independent claim 50.
As this rejection is withdrawn, applicant’s arguments toward this rejection are moot.
Maintained Claim Rejections -Modified in View of Amendments- 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, 50-51 and 53 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.
Claims 50-51 and 53 after amendment to import limitation of claim 52 into claim 50 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- Modified in view of Amendments - 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, 50-51 and 53 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 50 (amended) 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.
Claims 51 and 53 are rejected as being dependent on a now indefinite claim.
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.
Rejections maintained in view of amendments: Prior art unchanged, mapping of prior art unchanged, obviousness statement unchanged.
Claims 34-36 and 38-40 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.
Rejections modified in view of amendments: prior arts unchanged yet rearranged, claim mappings unchanged yet rearranged, obviousness statements unchanged yet rearranged.
Claims 50-51 are rejected under 35 U.S.C. 103 as being unpatentable over Fernandez et al. (US20130336903A1) in view of Winn (US20220211597A1).
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).
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.
Rejections modified in view of amendments: prior arts unchanged yet rearranged, prior art mapping unchanged yet rearranged, obviousness statement modified.
Claim 53 is rejected under 35 U.S.C. 103 as being unpatentable over Fernandez et al. (US20130336903A1) in view of Winn (US20220211597A1) in further view of Fares et al. (US20120093748A).
Fernandez et al. and Winn collectively teach all required limitations of claim 50-52.
However, Fernandez et al. and Winn fail to collectively teach all required limitations of claim 53.
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. and Winn. This is because Fernandez and Winn collectively teach topical skincare compositions comprising retinoids, oleyl adapalate, 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 and Winn 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.
Double patenting rejection maintained in view of amendments and arguments:
Claims 34-36 and 38-45 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 non-statutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed on 04/21/2026 have been fully considered but they are not persuasive.
With regards to applicants’ arguments against the 112 (a) written description rejections in the instant applications:
It is emphasized that no particular azelaic acid or oleyl adapalate "derivative" species, structural characteristics, substitution patterns, attachment groups, representative members, or guidelines defining the extent of the claimed derivative of the genus are described in the disclosure. Although oleyl adapalate and azelaic acid are mentioned, their "derivatives" are only mentioned without an applicant specified definition or description of a sufficient number of suitable species to provide ownership of the genre provided with “derivatives”. The specification does not identify any common structural traits that would allow one to distinguish the boundaries of the claimed genus, nor does it describe functional groups or structural variations by which such derivatives would be formed. Per MPEP § 2106: The claimed invention as a whole may not be adequately described if the claims require an essential or critical feature which is not adequately described in the specification and which is not conventional or known in the art. Consider the claim “A gene comprising SEQ ID NO:1.” The claim may be construed to include specific structures in addition to SEQ ID NO:1, such as a promoter, a coding region, or other elements. Although SEQ ID NO:1 is fully disclosed, there may be insufficient description of other structures embraced by the claim (e.g., promoters, enhancers, coding regions, and other regulatory elements)”.
With regards to applicants’ arguments against the 112 (b) Indefiniteness rejections in the instant applications:
It is reiterated the term “derivative” renders the scope unclear, as the claim does not specify which structural modifications qualify as derivatives of azelaic acid or oleyl adapalate. 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 and 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. Thus, numerous structures could count as a derivate as long as the original form was azelaic acid or oleyl adapalate. a person of ordinary skill in the art would therefore not be able to determine with reasonable certainty which compounds are encompassed by the claim, rendering it indefinite.
With regards to applicants’ arguments that the claimed combination of oleyl adapalate and 5-25 wt.% BHA achieves the promotion of regeneration and improved healing (Specification, paragraph [0105]) that are not taught by Winn or Fares, which thus makes the results unexpected, per claims 34-36 and 38-40:
As applicant has noted in their argument, Winn already teaches that retinoid compounds "stimulate skin repair and visibly improve skin damage caused by photoaging or acne" (Winn, paragraph [0002]), while also combining retinoid compounds with BHAs (claim 18). As stated in the 35 U.S.C. 103 rejection above, Winn also teaches that such retinoid compounds include oleyl adapalate. Thus, the claimed benefits of skin repair (e.g., wound healing) exerted by such retinoids was already established before the instant application was filed, and combining such retinoids with BHA was already established for skin application. Thus, any wound-healing effects (i.e., triggering the synthesis of growth factors like VEGF and TGFB2 or promoting restorative pathways such as AQP3) claimed by applicant would have been inherent to such retinol formulations when applied to the skin. Additionally, applicant’s data (i.e., examples 1 & 3; figures 1& 2) fails to provide sufficient-- control––including the wound-healing effects of oleyl adapalate when used alone, or the wound healing effects of combining oleyl adapalate with BHA at concentrations other than those claimed--–– to show that any unexpected “synergy” actually occurred. Thus, the combination of BHA with oleyl adapalate remains a matter of mere additive effects, with BHA simply providing exfoliation of the skin, while oleyl adapalate provides accelerated wound healing following the exfoliation–– with such combinations and motivations to combine already taught by Winn and Fares.
Regarding Applicant’s arguments against the teachings of Sengupta against claims 41-44:
As previously stated, applicant has failed to demonstrate unexpected results stemming from synergy in using the BHA and oleyl adapalate in a single formulation––the results are merely additive effects of combing BHA and oleyl adapalate to achieve exfoliation followed by healing-- for skin formulations––with such combinations and their benefits already taught by Winn and Fares. Sengupta meanwhile teaches all required components of claims 41-44 for skincare formulations in addition to clear motivation to add them to the teachings of Winn and Fares (i.e., additive anti-acne effects, free radical neutralization, and moisturization). Thus, the teachings of Sengupta yet maintain the previous rejections imposed on claims 41-44.
In response to applicant’s arguments against Krutmann for obviating claim 45:
Once again, as previously stated, applicant has failed to demonstrate unexpected results stemming from synergy in using the BHA and oleyl adapalate in a single formulation––the results are merely additive effects of combing BHA and oleyl adapalate to achieve exfoliation followed by healing-- for skin formulations––with such combinations and their benefits already taught by Winn and Fares. Furthermore, Krutmann may teach skincare compositions for treating skin conditions induced by air pollution. However, Krutmann does not explicitly limit such compositions to its disclosed components, which would thus allow for ingredients such as BHA and oleyl adapalate to also exploit their aforementioned benefits while treating skin conditions induced by pollution. Furthermore, It teaches licorice extract can be added to such composition as a skin lightening agent, which thus motivates adding it to the composition taught by Winn and Fares to utilize its effects. Thus, the teachings of Krutmann maintain the previous rejections imposed on claim 45.
In response to applicant’s traversal of the rejections for claims 46-49
As applicant has noted in their argument, Winn already teaches that retinoid compounds "stimulate skin repair and visibly improve skin damage caused by photoaging or acne" (Winn, paragraph [0002]), while teaching that such retinoid compounds include oleyl adapalate. Concurrently, Sengupta teaches that AHAs such as lactic acid can be used as anti-ageing agents for skincare compositions in conjunction with regenerative agents (e.g., oleyl adapalate). Thus, the claimed benefits of skin repair (e.g., wound healing) exerted by such retinoids was already established before the instant application was filed, and combining such retinoids with AHA was already established for skin application. Therefore, any wound-healing effects (i.e., triggering the synthesis of growth factors like VEGF and TGFB2 or promoting restorative pathways such as AQP3) claimed by applicant would have been inherent to such retinol formulations when applied to the skin. Additionally, applicant’s data (i.e., examples 1 & 3; figures 1& 2) fails to provide sufficient-- control––including the wound-healing effects of oleyl adapalate when used alone–– to show that any unexpected “synergy” actually occurred. Thus, the combination of AHA with oleyl adapalate remains a matter of mere additive effects, with AHA simply providing anti-ageing of the skin, while oleyl adapalate provides skin repair–– with such combinations and motivations to combine already taught by Winn and Fares.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Saccharide isomerate would be added to moisturize, lipoic acid would be added as an antioxidant to compliment the anti-ageing effects of AHA taught by, Sengupta and the skin repairing effects of oleyl adapalate as taught by Winn. This formulation would be further enhanced by the skin-lightning effects of adding licorice per the teachings of Krutmann.
Applicant’s arguments that there is no teaching, suggestion, or motivation to select from the disclosed alternatives is not persuasive. The cited prior art expressly provides a finite number of identified, predictable options for achieving the claimed objective. Where the prior art discloses a limited number of know alternatives, selection of one of those alternatives amounts to routine optimization within the level of one of ordinary skill in the art (see MPEP 2143; MPEP 2144.05 (II) – Obvious to try when a finite number of identified, predictable solutions are found in the prior art). A person of ordinary skill in the art would have been motivated to pursue these known options with a reasonable expectation of success particular when each of the alternatives is taught as suitable for the same purposes (see MPEP 2143 and MPEP 2144.06). The claimed selection, therefore, represents no more than the predictable use of prior art elements according to their established functions, and does not confer patentable distinction (see MPEP 2143; KSR Int’l Co v Teleflex Inc).
In response to applicant’s traversal of the rejections for claims 50-51, and 53:
Claim 52 was previously rejected under U.S.C. 103 as being unpatentable over Fernandez in view of Winn. In the present amendments, applicant moved the limitations of claim 52 to claim 50. Consequently, per the updated U.S.C. 103s above, Claims 50 and 51 are now rejected under U.S.C. 103 as being unpatentable over Fernandez in view of Winn to remedy the new deficiency of oleyl adapalate. Applicant is reminded that as previously stated, no unexpected result was proven for the claimed compositions because AHA (an exfoliant) and oleyl adapalate (skin-repairing agent) were not demonstrated to have novel synergistic effects, but rather merely an additive effect of their established functions as already taught by Fernandez in view of Winn.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In this case, the prior art provides motivations for the combinations as provided above.
Applicant’s arguments that there is no teaching, suggestion, or motivation to select from the disclosed alternatives is not persuasive. The cited prior art expressly provides a finite number of identified, predictable options for achieving the claimed objective. Where the prior art discloses a limited number of know alternatives, selection of one of those alternatives amounts to routine optimization within the level of one of ordinary skill in the art (see MPEP 2143; MPEP 2144.05 (II) – Obvious to try when a finite number of identified, predictable solutions are found in the prior art). A person of ordinary skill in the art would have been motivated to pursue these known options with a reasonable expectation of success particular when each of the alternatives is taught as suitable for the same purposes (see MPEP 2143 and MPEP 2144.06). The claimed selection, therefore, represents no more than the predictable use of prior art elements according to their established functions, and does not confer patentable distinction (see MPEP 2143; KSR Int’l Co v Teleflex Inc).
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the composition would include oleyl adapalate for skin repair (per Winn), lactic acid for exfoliation (per Fernandez), bakuchiol as a skin lightener (per Fernandez), and a low pH to enhance exfoliation (per Fares), all formulated in a suitable carrier for proper delivery.
Regarding applicant’s argument against non-statutory double patenting:
In light of the above reasonings which conclude that applicant has failed to show any non-obviousness, criticality, or unexpected results, the non-statutory double patenting rejection over co-pending ‘927 is maintained.
Conclusions
No claim is found allowable.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARYA AHMADI BAZARGANI whose telephone number is (571)272-0211. The examiner can normally be reached Monday - Friday 9:00AM - 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian-Yong Kwon can be reached at (571) 272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Arya A. Bazargani, Ph.D.
Patent Examiner
Art Unit 1613
/MARK V STEVENS/Primary Examiner, Art Unit 1613
Prosecution Insights