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 .
The Examiner of this application has change from Jackson K. Sweeney to Danielle Johnson.
Claims 1-20, 23, 25, 27, 30-38, 40, 41, 43, 45, 47, 49, 51, 53, 55, 57, 58, 60, 62, 63, 65-69, 71-73, 78 and 91 are pending.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/13/2022, 3/21/2023, 4/14/2025, 12/22/2023 and 8/10/2023 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
Election/Restrictions
Claim 78 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II. Claim 78 is a linking claim of which claim 91 depends which is drawn to a product comprising 1-20% by weight azelaic acid and 1-20% by weight urea dissolved in 30-95% of a non-aqueous solvent selected from polyol, C(3-6)alkanediol, glycol ether, dimethyl ether, or a combination thereof, and optionally one or more additional agents. Election was made without traverse in the reply filed on 8/26/2025.
Applicant’s election without traverse of Group I in the reply filed on 8/26/2025 is acknowledged.
Claims 1-20, 23, 25, 27, 30-38, 40, 41, 43, 45, 47, 49, 51, 53, 55, 57, 58, 60, 62, 63, 65-69, 71-73 and 91 are under examination.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 8-20, 23, 25, 27, 30-34, 38, 40, 41, 43, 45, 47, 49, 51, 53, 55, 57, 60, 62, 63, 65-69, 71, 72 and 91 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 9, 23, 26, 33-35, 38, 41, 44, 46, 48, 50, 54 and 65 of copending Application No. 18/703,024 (herein ‘024). Although the claims at issue are not identical, they are not patentably distinct from each other because the storage stable topical composition requires 1-20% by weight azelaic acid and 1-20% by weight urea dissolved in a non-aqueous solvent selected from diols such as 1,3-propanediol and 1,6-hexandiol, whereas the copending application ‘024 requires 1-30% by weight urea and further comprises an antioxidant selected from 22% or less azelaic acid in dependent claim 9. Copending application ‘024 also claims an emulsion composition comprising in the dispersed phase 56% by weight propanediol, 5% by weight of urea, 5% by weight off azelaic acid, and 5% by weight ascorbic acid and in the continuous phase 0.02% by weight of the retinoid agent, optionally with C10-30 cholesterol/lanosterol esters, bakuchiol, tocopherol and dimethicone and dimethicone/PEG-10/15.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 8-15, 17-20, 23, 25, 27, 30-38, 51, 55, 65-69, 73 and 91 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 17, 19, 20, 22-25, 27-30, 45 and 51 of copending Application No. 18/764,303 (herein ‘303). Although the claims at issue are not identical, they are not patentably distinct from each other because the storage stable topical composition requires 1-20% by weight azelaic acid and 1-20% by weight urea dissolved in a non-aqueous solvent selected from diols such as 1,3-propanediol and 1,6-hexandiol, whereas the copending application ‘303 comprises 10-20% by weight ascorbic acid, 5-10% by weight xylitol, and less than 10% by weight one or more optional ingredients selected from an antioxidant, a skin lightening agent, a chemical exfoliant a moisturizing agent and an anti-inflammatory agent, dissolved in a non-aqueous solvent selected from diols such as 1,3-propanediol and 1,6-hexandiol. Copending application ‘303 claims the skin lightening agent comprises azelaic acid, preferably 5% of azelaic acid (claims 22, 28, 29 and 51) and the moisturizing agent comprises urea (claim 23). Therefore, the present claims would have been prima facie obvious.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-20, 23, 25, 27, 30-38, 40, 41, 43, 45, 47, 49, 51, 53, 55, 57, 58, 60, 62, 63, 65-69, 72, 73 and 91 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 8, 9, 11, 12, 15, 17-27, 30, 34, 37, 39, 41, 43, 45, 47, 48, 50, 52, 53 and 81 of copending Application No. 17/918,823 (herein ‘823). Although the claims at issue are not identical, they are not patentably distinct from each other because the storage stable topical composition requires 1-20% by weight azelaic acid and 1-20% by weight urea dissolved in a non-aqueous solvent selected from diols such as 1,3-propanediol and 1,6-hexandiol, whereas the copending application ‘823 comprises 1-30% by weight urea agent dissolved in a non-aqueous solvent selected from diols such as 1,3-propanediol and 1,6-hexandiol with and external phase comprising 10% or more by weight silicone agent. Copending application ‘823 claims additional agents comprise azelaic acid, preferably 5% of azelaic acid (claims 22, 28, 18, 34 and 81). Claim 81 discloses an anhydrous formulation, free of water, volatile alcohols and monohydric alcohols comprising 49.4% by weight 1,3-propanediol, 5% by weight urea, 5% by weight azelaic acid, 0.1% by weight madecassoside/asiaticoside, 0.5% by weight ferulic acid, 5% by weight ascorbic acid, 1% by weight diglycerin and pinus pinaster bark extract, 10% by weight C12-15 alkyl benzoate, 10% by weight dimethicone and dimethicone/PEG-10/15 crosspolymer, 4% by weight lauryl PEG-9 polydimethylsiloxyethyl dimethicone, 4% by weight C10-30 cholesterol/lanosterol esters, 1% by weight tocopherol, 1% by weight bakuchiol, 1% by weight bis-ethylhexyl hydroxydimethoxy benzylmalonate and 3% by weight retinol and glycerin soja (soybean) oil. Therefore, the present claims would have been prima facie obvious.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 8-11, 13-20, 23, 25, 27, 30-38, 40, 41, 43, 47, 51, 55, 65-69 and 91 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 6, 8, 11, 13, 17, 20, 24, 29, 33 and 70-72 of copending Application No. 18/501,422 (herein ‘422). Although the claims at issue are not identical, they are not patentably distinct from each other because the storage stable topical composition requires 1-20% by weight azelaic acid and 1-20% by weight urea dissolved in a non-aqueous solvent selected from diols such as 1,3-propanediol and 1,6-hexandiol, whereas the copending application ‘422 comprises 5-25% by weight ascorbic acid, 5-20% by weight urea agent, 10% or less by weight one or more optional ingredients dissolved in non-aqueous solvent comprising 1, 3-propanediol. Copending application ‘422 claims 3-10% by weight azelaic acid as the optional ingredient (claim 29). Therefore, the present claims would have been prima facie obvious
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 112
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 14, 15, 32, 35 and 71 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.
Claims 14 and 15 include in paratheses “e.g. demonstrates less than 10 mol % degradation of the urea agent and azelaic acid” which render the claims indefinite. The phrase renders the claim indefinite because it is unclear whether the limitation(s) following “e.g.” are part of the claimed invention. See MPEP § 2173.05(d).
Claim 32 recites one or more optional additional components are selected from azelaic acid which is indefinite because claim 1 requires 1-20% by weight azelaic acid. Therefore, the limitation of azelaic acid being listed as an optional renders the claim indefinite.
Claim 35 recites the limitation "the one or more additional components" in reference to the composition of claim 1. There is insufficient antecedent basis for this limitation in the claim since additional components are not added to claim 1. The rejection can be overcome if the claim is amended to change dependency to claim 31 rather than claim 1.
Claim 71 recites the composition of Table 1 or 2 which renders the claim indefinite. The claim fails to point out what is included or excluded by the claim because the limitation to Tables 1 and 2 in the specification is not read into the claims. Claims are to be complete in themselves. Incorporation by reference to a specific figure or table is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience.’ Ex Parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted). See MPEP § 2173.05(s).
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 34 and 71 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 34 fails to further limit the one or more additional components listed in claim 33. Claim 71 fails to further limit the scope of the composition in claim 65 because it is drawn to Tables 1 and 2 in the specification. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 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.
Claim(s) 1-20, 23, 25, 27, 30-32, 35-37, 40, 41, 45, 57, 58, 60, 62, 63, 65-69, 71, 72 and 91 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang (US 2007/0172436; published July 26, 2007) in view of Lyapunov (RU2012146433, published October 10, 2014).
Applicant claims a storage stable topical composition requires 1-20% by weight azelaic acid and 1-20% by weight urea dissolved in a non-aqueous solvent selected from polyol, C(3-6)alkanediol, glycol ether, dimethyl ether, or a combination thereof, preferably 1,3-propanediol and 1,6-hexanediol. (claim 1)
Applicant claims a product comprising 1-20% by weight azelaic acid and 1-20% by weight urea dissolved in 30-95% of a non-aqueous solvent selected from polyol, C(3-6)alkanediol, glycol ether, dimethyl ether, or a combination thereof, and optionally one or more additional agents. (claim 91)
Claims 13-15 and 19 are drawn to inherent properties of the composition.
With respect to claims 1-20, 23, 25, 27, 30-32, 35-37, 40, 41, 45, 57, 58, 60, 62, 63, 65-69, 71, 72 and 91, Zhang teach nonaqueous ascorbic acid compositions in an alcohol solvent comprising ascorbic acid, a solubilization enhancer, and an oleaginous skin protectant (abstract). The nonaqueous composition is substantially free of water, preferably less than 3% by weight [0025]. The ascorbic acid may be present in an amount of at least 5% by weight to as much as 40% by weight, preferably 10-35% by weight [0031]. Suitable organic solvents suitable for preparing the nonaqueous compositions preferably include polyols selected from 1,3-propanediol, 1,2-propanediol, 1,3-butanediol, 1,5-pentanediol, 1,2-hexanediol, 1,6-hexanediol and glycerol [0032-36]. The non-aqueous solvent is present in an amount of 20-90% by weight of the composition [0037]. The solubilization enhancer is urea and/or urea derivatives, including hydroxyethyl urea in amounts of at least 1% by weight to as much as 40% by weight of the composition [0038-0050]. The oleaginous compounds include antioxidants, such as vitamin E, alpha, beta, delta and gamma tocopherols/tocotrienols and ascorbic acid vitamin A, such as retinol; sunscreens and dermatologically active agents including skin whitening agents such as hydroquinone and 4-methoxyphenol [0053-64]. Other oleaginous agents include silicone oils and are in amounts ranging from 0.01-15% by weight of the composition [0067]. Further ingredients include cholesterol, ceramides and fatty acids including ceramide III (ceramide NP), and fatty acids linolenic acid, linoleic acid, stearic acid, palmitic acid and oleic acid in an amount of at least 0.1% by weight up to 10% by weight of the formulation [0076-82].
With respect to claims 5-7, Zhang et al. teach monohydric alcohols, including ethanol [0032-33]. However, the majority of Examples comprise propylene glycol without the presence of volatile or monohydric alcohol such as ethanol solvent [Examples 1, 2, 5, 6, 8-26 use propylene glycol whereas only Examples 3, 4 and 7 use ethanol]. Additionally, Zhang teach that polyols are especially preferred nonaqueous solvents which are used over monohydric alcohol [0036]. Therefore, the use of polyols as the non-aqueous solvent is preferred over the use of volatile or monohydric alcohols.
With respect to claims 1, 20, 23, 25, 30, 65-68 and 91 Zhang do not specify 1-20% by weight azelaic acid is present in the formulation. With respect to claim 72, Zhang do not teach the composition is in an emulsion further comprising an external phase with 10% or more silicone agent. However, Zhang does teach oleaginous agents include silicone oils in amounts ranging from 0.01-15% by weight of the composition It is for this reason that Lyapunov is joined. Lyapunov teach a topical gel containing azelaic acid as the active ingredient which has antibacterial and depigmenting effects against acne and rosacea (page 1, paragraph 1). The inventive compositions comprises azelaic acid, a hydrophobic component, a non-aqueous solvent, an emulsifier, a gel forming polymer, a preservative and a pH regulator, wherein azelaic acid is 5-20% by weight of the composition (page 4, paragraphs 3 and 4). The hydrophobic component includes synthetic oils combined with dimethicone in concentrations of 0.7-20% by weight the formulation (page 6, paragraph 2). The nonaqueous solvent includes polyols such as glycerol (page 7, paragraph 4). The cream gel forms an oil/water emulsion which maintains a uniform dispersion and stability of the azelaic acid (page 8, paragraph 2).
With respect to claims 1, 20, 23, 25, 30, 65-68 and 91 the teachings of Zhang and Lyapunov render the ranges of azelaic acid, urea agent and non-aqueous solvent obvious because Zhang teach formulations comprising non-aqueous solvent is present in an amount of 20-90% by weight of the composition with urea and/or urea derivatives in amounts of 1-40% by weight of the composition and Lyapunov teach formulations comprising 5-20% azelaic acid which renders the ranges of claims 1, 20, 23, 25, 65-68 and 91 and the weight ratio of claim 30 obvious.
Zhang and Lyapunov are both draw to topical non-aqueous formulations. Therefore, it would have been prima facie obvious to one of ordinary skill to combine the teachings of Zhang and Lyapunov to further include azelaic acid in the formulation with a reasonable expectation of success. One of ordinary skill in the art would have been motivated before the time of filing to include azelaic acid in the formulation because Lyapunov et al. teach azelaic acid has antibacterial and depigmenting effects against acne and rosacea. Therefore, it would have been prima facie obvious to include azelaic acid in the formulation to improve skin appearance.
It would have been prima facie obvious to one of ordinary skill to combine the teachings of Zhang and Lyapunov to further include an external phase comprising 10% or more by weight silicone agent in the formulation with a reasonable expectation of success. One of ordinary skill in the art would have been motivated before the time of filing to include 10% or more of an external phase comprising silicone oil in the formulation because Zhang et al. teach other oleaginous agents include silicone oils in amounts ranging from 0.01-15% by weight of the composition and Lyapunov et al. teach dimethicone in concentrations of 0.7-20% as a hydrophobic agent in the formulation that aids in forming an oil/water emulsion which maintains a uniform dispersion and stability of the azelaic acid. Therefore, it would have been prima facie obvious to include an external phase comprising 10% or more silicone agent in the formulation.
Claim(s) 33, 34, 38 and 55 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang (US 2007/0172436; published July 26, 2007) in view of Lyapunov (RU2012146433, published October 10, 2014), as applied to claims 1-20, 23, 25, 27, 30-32, 35-37, 40, 41, 45, 57, 58, 60, 62, 63, 65-69, 71 and 91 in further view of Elsen-Wahrer et al. (US 2018/0280286; published October 4, 2018).
Applicant claims a storage stable topical composition requires 1-20% by weight azelaic acid and 1-20% by weight urea dissolved in a non-aqueous solvent selected from polyol, C(3-6)alkanediol, glycol ether, dimethyl ether, or a combination thereof, preferably 1,3-propanediol and 1,6-hexanediol.
The teachings of Zhang and Lyapunov are addressed in the above 103 rejection.
With respect to claims 33, 34, 38 and 55, Zhang and Lyapunov do not teach an additional component selected from pinus pinaster bark extract or ferulic acid. It is for this reason that Elsen-Wahrer et al. is joined.
Elsen-Wahrer et al. teach cosmetic treatment compositions to alter hair color (abstract). The treatment comprises an antioxidant selected from ascorbic acid, polyphenols, ferulic acid and pine bark extract and mixtures thereof [0009]. Treatments preferably include 0.1-5% by weight pine bark extract (pinus pinaster bark extract) or 0.1-3% by weight ferulic acid [0012-13, 0043]. Pine bark extract comprise proanthocyanidin compounds which benefit the cardiovascular system and the circulatory health [0052]. Ferulic acid is a strong antioxidant that is very reactive to free radicals and reduces oxidative stress and may have antitumor activity [0053]. The compounds are combined with hydrotropes such as urea and hydroxyethyl urea in amounts of 0.1-20% based on the total composition [0074-75].
Zhang, Lyapunov and Elsen-Wahrer et al. all teach cosmetic formulations. Therefore, it would have been prima facie obvious to one of ordinary skill to combine the teachings of Zhang, Lyapunov and Elsen-Wahrer et al. to further include pinus pinaster bark extract in the formulation with a reasonable expectation of success. One of ordinary skill in the art would have been motivated before the time of filing to include pinus pinaster bark extract in the formulation because Elsen-Wahrer et al. teach that it is an antioxidant compound that comprises proanthocyanidin compounds which benefit the circulatory health. Therefore, it would have been prima facie obvious to include pinus bark extract as an antioxidant compound in the formulation.
It would have been prima facie obvious to one of ordinary skill to combine the teachings of Zhang, Lyapunov and Elsen-Wahrer et al. to further include ferulic acid in the formulation with a reasonable expectation of success. One of ordinary skill in the art would have been motivated before the time of filing to include ferulic acid in the formulation because Elsen-Wahrer et al. teach that it is a strong antioxidant and effectively reduces oxidative stress. Therefore, it would have been prima facie obvious to use ferulic acid as an antioxidant compound in the formulation.
Claim(s) 43 and 53 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang (US 2007/0172436; published July 26, 2007) in view of Lyapunov (RU2012146433, published October 10, 2014), as applied to claims 1-20, 23, 25, 27, 30-32, 35-37, 40, 41, 45, 57, 58, 60, 62, 63, 65-69, 71 and 91 in further view of Ratti (WO 2018/172948; published September 27, 2018).
Applicant claims a storage stable topical composition requires 1-20% by weight azelaic acid and 1-20% by weight urea dissolved in a non-aqueous solvent selected from polyol, C(3-6)alkanediol, glycol ether, dimethyl ether, or a combination thereof, preferably 1,3-propanediol and 1,6-hexanediol.
The teachings of Zhang and Lyapunov are addressed in the above 103 rejection.
With respect to claims 43 and 53, Zhang and Lyapunov do not teach bis-ethylhexyl hydroxydimethoxy benzylmalonate or glycyrrhetinic acid. It is for this reason that Ratti is joined.
Ratti teaches topical compositions for lightening skin and reducing hyperpigmentation (page 1, paragraph 1). The formulation comprises niacinamide, 4-substituted resorcinol and hinokitiol with optional supplements selected from an antioxidant and anti-inflammatory agents (page 3, paragraph 2). The antioxidants include ascorbic acid and bis-ethylhexyl hydroxydimethoxy benzylmalonate (page 7, paragraph 4, claim 16). The compositions also include anti-inflammatory agents that are non-steroidal include glycyrrhetinic acid (page 8, paragraph 1, claim 17).
Zhang, Lyapunov and Ratti all teach formulations used topically to lighten skin. Therefore, it would have been prima facie obvious to one of ordinary skill to combine the teachings of Zhang, Lyapunov and Ratti to further include bis-ethylhexyl hydroxydimethoxy benzylmalonate in the formulation with a reasonable expectation of success. One of ordinary skill in the art would have been motivated before the time of filing to include bis-ethylhexyl hydroxydimethoxy benzylmalonate in the formulation because Ratti teach that it works as an antioxidant similar to ascorbic acid. Therefore, it would have been prima facie obvious to include bis-ethylhexyl hydroxydimethoxy benzylmalonate as an antioxidant compound.
It would have been prima facie obvious to one of ordinary skill to combine the teachings of Zhang, Lyapunov and Ratti to further include glycyrrhetinic acid in the formulation with a reasonable expectation of success. One of ordinary skill in the art would have been motivated before the time of filing to include glycyrrhetinic acid in the formulation because Ratti teach that it works as a non-steroidal anti-inflammatory agent which would aid in reducing inflammation and improve skin appearance.
Claim(s) 47, 49, 51 and 73 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang (US 2007/0172436; published July 26, 2007) in view of Lyapunov (RU2012146433, published October 10, 2014), as applied to claims 1-20, 23, 25, 27, 30-32, 35-37, 40, 41, 45, 57, 58, 60, 62, 63, 65-69, 71 and 91 in further view of Burnam (US 2016/0367676; published December 22, 2016).
Applicant claims a storage stable topical composition requires 1-20% by weight azelaic acid and 1-20% by weight urea dissolved in a non-aqueous solvent selected from polyol, C(3-6)alkanediol, glycol ether, dimethyl ether, or a combination thereof, preferably 1,3-propanediol and 1,6-hexanediol.
The teachings of Zhang and Lyapunov are addressed in the above 103 rejection.
Zhang and Lyapunov do not teach an additional compound selected from bakuchiol, C10-C30 cholesterol/lanosterol esters or madecassoside. With respect to claim 73, Zhang and Lyapunov do not specify a ready-to-use topical preparation in a multi-use container prefilled with the composition with a means of dispensing a single dose of the composition. It is for this reason that Burnam is joined.
Burnam teach petroleum based compositions as a suspension matrix for various active ingredients which form stable emulsions of active ingredients in petroleum (abstract). The petroleum-based composition comprises 80% to greater than 99% petrolatum and generally less than about 1% by weight of active ingredient with 0.1-6% water or another solvent which would inherently include anhydrous formulations [0011-13]. The actives include ascorbic acid, azelaic acid, bakuchiol, C10-30 cholesterol/lanosterol esters and madecassoside and non-water soluble actives are used with non-aqueous solvents [0019]. The formulations are packaged in tubes to analyze stability, appearance and package compatibility for 3-9 months [0124-0127].
With respect to claim 73, Burnam teach suitable containers for ready to use formulations include tubes but does not specify single dose application, however it is well-settled law that combining printed instructions and known product into a kit will not render the claimed invention nonobvious even if the instructions detail a new use for the product. See In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004). Further, the inclusion of a package insert or label showing the "the name of drug, dosage, dosage form, route of administration, indication and direction of use" of a pharmaceutical composition is mandated by 21 CFR 201.57 and is therefore obvious to one of ordinary skill in the art.
Zhang, Lyapunov and Burnam all teach formulations used topically in non-aqueous solvents. Therefore, it would have been prima facie obvious to one of ordinary skill to combine the teachings of Zhang, Lyapunov and Burnam to further include additional optional active ingredients selected from bakuchiol, C10-C30 cholesterol/lanosterol esters and madecassoside in the formulation with a reasonable expectation of success. One of ordinary skill in the art would have been motivated before the time of filing to include bakuchiol, C10-C30 cholesterol/lanosterol esters and madecassoside in the formulation because Burnam teach the compounds are known active ingredients used in cosmetic formulations. Therefore, it would have been prima facie obvious to include bakuchiol, C10-C30 cholesterol/lanosterol esters and madecassoside as optional active compounds.
It would have been prima facie obvious to one of ordinary skill to combine the teachings of Zhang, Lyapunov and Burnam to further include packaging the formulation in a tube container with a reasonable expectation of success. One of ordinary skill in the art would have been motivated before the time of filing to include packaging the formulation in a tube because Burnam teach formulations are packaged in tubes to maintain stability and appearance of the formulation for a period of 3-9 months.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIELLE D JOHNSON whose telephone number is (571)270-3285. The examiner can normally be reached Monday-Friday 9:00 am-5:30 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached at 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
DANIELLE D. JOHNSON
Examiner
Art Unit 1617
Prosecution Insights