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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09/14/2026 has been entered.
Status of the Claims
The claim set filed 08/17/2026 is hereby being considered. Claims 1-33, 37-38, 40, and 52 are cancelled. Claims 34, 39, 41, 43, 46, and 50 are currently amended. Claims 35-36, 42-45, 47-49, 51, and 53 are previously presented. Claims 34-36,39,41-51 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Rejections/Objections withdrawn
All 35 USC § 112(a) rejections imposed in the previous correspondence filed 06/17/2026 are hereby withdrawn due to applicant’s amendments of removing the term “derivative” from the claim set.
All 35 USC § 112(b) rejections imposed in the previous correspondence filed 06/17/2026 are hereby withdrawn due to applicant’s amendments of removing the term “derivative” from the claim set.
Claim Objection
Claim 41 is objected to for mentioning repeated items in the group including tretinoin, triclosan and octopirox.
Claim 42 is objected to for “amellia japonica”, which is properly spelled “camellia japonica”.
Claim 42 is objected to for “hoellen” which is properly spelled as “hoelen”.
Appropriate correction is required.
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.
Claim 41 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 contains the trademark/trade name octopirox (mentioned twice in the claim). Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe piroctone olamine and, accordingly, the identification/description is 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.
Rejections modified in view of amendments: prior arts unchanged yet rearranged (i.e., Fares, Winn, and Sengupta now combined to form a single rejection), claim mappings unchanged yet rearranged, obviousness statements unchanged yet rearranged.
Claims 34-36, 39, and 41-44, 46-48 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. 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 (per claims 34 and 46) 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).
However, Fares et al. and Winn collectively fail to teach the personal care composition containing saccharide isomerate (per claims 34 and 46) and lipoic acid (per claim 46).
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 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.
Additionally, 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 and 49 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 Sengupta et al. (US20220288086A1) in further view of Krutmann et al. (US10780042B2).
Fares et al, Winn, and Sengupta et al. collectively teach the required limitations of claims 34-36, 39, and 41-44, 46-48.
However, Fares et al, Winn, and Sengupta et al. collectively fail to teach the personal care composition according further comprising licorice extract (per claims 45 and 49).
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, protection, 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, Winn, and Sengupta et al. This is because Fares et al, Winn, and Sengupta et al. 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 et al, Winn, and Sengupta et al. 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, claim mapping added, obviousness statement unchanged.
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 at concentrations ranging from 0.0001% to 7% w/w (paragraphs 209-210). 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 at concentrations ranging from 1% to 25% w/w (paragraphs 182-184). 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 maintained in view of amendments: prior arts unchanged, prior art mapping unchanged, obviousness statement unchanged.
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 50-51.
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: Co-pending claims rearranged to teach the amended present claims.
Claims 34-36, 39, and 42-45 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, 2, 5, 6, 8, 12, and 13 (for present claim 34); 6 (for present claim 35); 7 (for present claim 36); 3 (for present claim 39); 12 (for present claim 42); 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 08/17/2026 have been fully considered but they are not persuasive.
Regarding applicants’ arguments (p. 8, ¶¶4-5; p. 9, ¶1) that Winn and Fares fail to teach or provide motivation for the amended composition of claim 34 and uses improper hindsight:
These arguments are not persuasive in view of the amended rejection. The rejection has now been modified to rely on Fares in view of Winn and Sengupta. Fares teaches combined AHA/BHA topical compositions and concentrations within the presently claimed ranges, Winn teaches oleyl adapalate for topical skin treatment and expressly contemplates use of adapalene esters with hydroxy acids, and Sengupta teaches saccharide isomerase as a moisturizing agent of topical skin care compositions. Thus, the claimed components are not selected solely upon applicant’s disclosure, but are combined according to their established skin-care functions with a reasonable expectation of success. Applicant’s repeated characterization of the amended acid ranges as 5-25 wt.% is also noted; However, the current claims recited 5-20 wt.% and the present rejection addresses the claim language.
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).
Regarding applicants’ arguments (p. 9, ¶2-8) that claim 34 has unexpected results:
The evidence is insufficient to establish unexpected synergy. The cited biomarker results compare the tested composition primarily against an untreated control and therefore demonstrate biological activity, not an unexpected superior result relative to the closest prior art. Applicant has not provided comparative controls isolating the contribution of oleyl adapalate, the hydroxy acids, or saccharide isomerate, nor evidence suggesting the criticality throughout the claimed 5-20 wt.% ranges. Moreover, the formulation contains additional ingredients, including lipoic acid and licorice extract, such that the asserted results have not been shown to be attributed to the breadth of claim 34.
Regarding applicants’ arguments (p. 10, ¶¶2-5; p. 11, ¶¶1-4) for claims 41-44 that all limitations of amended claim 34 must be considered and that Fares, Winn, and Sengupta do not teach the exact claimed multi-component compositions, and that there is no motivation to combine such references:
All limitations have been considered. The modified rejection expressly accounts for the newly incorporated limitations of claim 34, while Sengupta additionally teaches the claimed anti-acne agents, antioxidants, humectants, and humectant concentration teachings relied upon the dependent claims. Obviousness does not require any single reference to expressly disclose the complete claimed formulation where the combined teachings provide the claimed elements together with an articulated reason and predictable use.
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). As previously stated in the 35 USC 103 rejection above, all references are directed to the same field of endeavor (i.e., topical skin compositions), with all three references teaching the claimed components of the composition and their respective concentrations for their established functions. One would have therefore been motivated to combine the teachings of Winn, Fares, and Sengupta to obtain the additive benefits of each component for skincare applications.
Regarding applicants’ arguments (p. 11, ¶5; p. 12, ¶¶1-6) of unexpected results for claims 41-44:
The evidence does not establish unexpected results commensurate with the scope of these claims. Applicant again relies on comparisons with untreated controls rather than the closest prior art and provides no component-by-component comparative control to establish synergy. Further, based on applicant’s own identification of the example 1 ingredients, the tested formulation does not appear to contain an antioxidant species recited by claim 42 or an additional humectant presently recited by amended claim 43. Accordingly, applicant has not established that the experimental composition is representative of the full scope of claims 41-44.
Regarding applicants’ arguments (p. 13, ¶¶3-6; p. 14, ¶¶1-3) for claim 45 that the recited references provide no motivation to add licorice extract to the amended claim 34 composition:
The rejection has been modified to rely on Fares in view of Winn and Sengupta, in further view of Krutmann. Krutmann does not merely list licorice extract arbitrarily, but teaches licorice extract for its known skin-lightening functions in topical cosmetic compositions. Thus, an ordinarily skilled artisan would have had reason to incorporate licorice extract into the otherwise obvious skin-care composition to obtain its known skin-lightening benefit.
Regarding applicants’ arguments (p. 14, ¶¶4-6; p. 15, ¶¶1-4) for claim 45 justifying its claims for unexpected results:
The evidence does not establish that the additional licorice extract limitation produces unexpected result. Applicant provides no comparison between otherwise identical compositions with and without licorice extract. Demonstrating beneficial results for a formulation that happens to contain licorice extract does not establish that inclusion of licorice extract unexpectedly causes those results.
Regarding applicants’ arguments (p. 16, ¶¶3-6; p. 17, ¶¶1-2) for claims 46-48 that Sengupta and Winn require impermissible hindsight and fail to provide motivation for the claimed composition:
The rejection has been modified to collectively rely on Sengupta, Winn, and Fares. Sengupta teaches AHA, lipoic acid, and saccharide isomerate as suitable functional components of topical skin care formulations, Winn teaches oleyl adapalate for topical treatment and expressly contemplates hydroxy acids with lipophilic adapalene esters, and Fares teaches topical AHA concentrations within the amended 5-20 wt.% range. The use and motivation for each component is recited in the aforementioned 35 USC 103 rejection above. The combination therefore follows the known functions of the cited components rather than applicant’s disclosure. Applicant’s unsupported assertion that such a formulation would not reasonably have been expected to be stable or non-irritating is not supported by comparative technical evidence or teaching away in the cited art.
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).
Regarding applicants’ arguments (p. 17, ¶¶3-6; p. 18, ¶¶1-4) of unexpected results for claims 46-48:
The evidence remains insufficient. Example 1 contains additional components, including BHA (salicylic acid) and licorice extract, which are not required by independent claim 46, and applicant has not shown through appropriate controls that the reported biological effects arise from the additional ingredients. Nor has applicant compared the claimed formulation with the closest prior art composition or established unexpected performance throughout the claimed AHA range and genus.
Regarding applicants’ arguments (p. 18, ¶¶6-8; p. 19, ¶¶1-5; p. 20, ¶¶1-2) for claim 49 that the selection of licorice extract from Krutmann constitutes hindsight:
This argument is not persuasive. The rejection is modified to rely on Sengupta, Winn, Fares, and Krutmann, and Krutmann expressly identifies licorice extract for a known skin-care function. Selection of an expressly taught ingredient for its stated skin-lightening benefit provides a reason grounded in the prior art independent of applicant’s disclosure.
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).
Regarding applicants’ arguments (p. 20, ¶¶3-7; p. 21, ¶¶1-2) of unexpected results for claim 49:
Applicant has not demonstrated that addition of licorice extract produces an unexpected result because no sufficient comparative control formulation lacking licorice extract is presented. The same untreated control, nexus, and commensurateness deficiencies discussed above therefore remain applicable.
Regarding applicants’ arguments (p. 21, ¶¶4-6; p. 22, ¶¶3-7; p. 23, ¶¶1-4) for claims 50-51 that Fernandez merely contains broad ingredient lists and that combining Fernandez with Winn is hindsight, wherein the references have no clear teaching or suggestion or motivation to combine:
This argument is not persuasive. Fernandez expressly teaches topical personal care compositions containing retinoids, skin lighteners, desquamation actives, and combinations thereof; specifically teaches adapalene, Bakuchiol at concentrations encompassing the claimed range, and AHAs at concentrations encompassing the claimed range. Winn supplies the expressly claimed oleyl adapalate species and teaches its use in topical compositions, including compositions containing hydroxy acids. Thus, selection of Winn’s oleyl adapalate as Fernandez’s known retinoid component is supported by the prior art itself rather than hindsight. Ernandez additionally teaches multiple AHA species recited in dependent claim 51.
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).
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 particularly 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). As previously stated in the 35 USC 103 rejection above, both references are directed to the same field of endeavor (i.e., topical skin compositions), with both references collectively teaching the claimed components of the composition and their respective concentrations for their established functions. One would have therefore been motivated to combine the teachings of Fernandez and Winn to obtain the additive benefits of each component for skincare applications.
Regarding applicants’ arguments (p. 23, ¶¶5-7; p. 24, ¶¶1-6; p. 25, ¶1) for claim 53 that Fernandez, Winn, and Farez do not teach the claimed low pH composition and that reliance on Farez improperly requires combining formulations with improper hindsight and no clear motivation:
The argument improperly focuses on bodily incorporation of the complete Fares formulation. Fares is relied upon for teaching that hydroxy-acid topical compositions are suitably formulated for acidic pH and for its exemplary compositions having a pH within the claimed 2.5-4.5 range. An ordinarily skilled artisan would therefore have had a reason to formulate the Fernandez/Winn AHA-containing composition at the known acidic pH taught by Fares to obtain the known hydroxy acid exfoliating effect, without requiring wholesale incorporation of Fares’ PVP formulation.
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 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). As previously stated in the 35 USC 103 rejection above, all references are directed to the same field of endeavor (i.e., topical skin compositions), with all three references collectively teaching the claimed components of the composition and their respective concentrations for their established functions. One would have therefore been motivated to combine the teachings of Fernandez, Winn, and Farez to obtain the additive benefits of each component for skincare applications.
Regarding applicants’ arguments (p. 25, ¶¶2-7) of unexpected results for claim 53:
The evidence does not establish unexpected results attributable to the presently claimed composition pH range. Applicant repeatedly identifies the composition tested in example 3 and 4 elsewhere in the response as example 1, which applicant describes as containing AHA, BHA, oleyl adapalate, saccharide isomerate, lipoic acid, and licorice extract, rather than Bakuchiol. To the extent the cited data were generated from that example 1 composition, they lack nexus to claim 53, which requires Bakuchiol. In any event, applicant provides no controlled comparison establishing that bakuchiol or the claimed pH range causes an unexpected result relative to the closest prior art, nor comparative evidence with sufficient control demonstrating the criticality of the claimed pH range.
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
Prosecution Insights