DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Summary
Claims 16-35 are pending in this office action. Claims 1-15 are cancelled. All pending claims are under examination in this application.
Priority
The current application was filed on July 21, 2023 is a 371 of PCT/EP2022/050583 filed January 13, 2022. The current application claims foreign priority to DE102021200621.3 filed January 25, 2020.
Information Disclosure Statement
Receipt of the Information Disclosure Statement filed on October 2, 2023 and is acknowledged. A signed copy of the document is attached to this office action.
Claim Objections
Claims 16-33 are objected to because of the following informalities:
Claim 16 has the acronym DMDM. Please describe this in full. Once this is defined, thereafter, the acronym within the claims can be used.
Dependent claims 17-33 fail to cure the defect of claim 16.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 16, 25, and 27-31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Database GNPD ‘589 (Cold Cream, 2019).
Database GNPD ‘589 is the closest prior art as it teaches Biolane Creme Visage Nutri-Protective (Nutri-Protective Cold Cream) and is said to provide purity and softness, while intensely hydrating dry, sensitive and reactive areas of baby face skin. Its formula has a sweet almond oil and beeswax base, which allows it to efficiently fight against local dryness and to reinforce the natural skin balance. It features a dome applicator that guarantees a practical use and an optimal hygiene, for skin that is protected from external aggressions and soothed from twinges and irritations, restoring its softness and comfort. The hypoallergenic product contains 98% natural origin ingredients, is free from paraben, has been dermatologically tested and retails in a 50ml pack (see product description).
Regarding instant claim 16, Database GNPD ‘589 teaches a cosmetic water-in-oil (W/O) emulsion. The necessary citations of Database GNPD ‘589 that pertain to instant claim 1 are presented in Table I.
Table I
Instant Claim 16
Database GNPD ‘589 Citations
A cosmetic water-in-oil (W/O) emulsion, wherein the emulsion comprises
Database GNPD ‘589 discloses a W/O emulsion for the disclosed cold cream (see ingredient list within Database GNPD ‘589).
(a) polyglyceryl-4 diisostearate/polyhydroxystearate/sebacate and (b) hydrogenated castor oil,
Database GNPD ‘589 discloses the full ingredient list. The cold cream contains both emulsifier ingredients identified within the instant claim 1 limitation (see ingredient list within Database GNPD ‘589).
emulsion being free from mineral oil, paraffin wax, microcrystalline wax, shellac wax, polyethylene wax, polyacrylates, acrylate/C10-C30 alkyl acrylate crosspolymers, vinylpyrrolidone/hexadecene copolymers, 3-(4-methylbenzylidene)camphor, 2-hydroxy- 4-methoxybenzophenone, 2-ethylhexyl 4-methoxycinnamate, ethylhexyl 2-cyano-3,3- diphenylacrylate, parabens, methylisothiazolinone, chloromethylisothiazolinone, DMDM hydantoin, polyethylene glycol ethers, polyethylene glycol esters.
Database GNPD ‘589 discloses the absence of all ingredients taught by this limitation (see ingredient list within Database GNPD ‘589).
Database GNPD ‘589 discloses the full ingredient list of the cold cream which includes the following: Aqua, Prunus Amygdalus Dulcis Oil, Cocoglycerides, Coco-caprylate, Polyglyceryl-4 Diisostearate/polyhydroxvstearate/sebacate, Glycerin, Magnesium Sulfate, Parfum, Beeswax, Hydrogenated Castor Oil (Hydrogenated), Cetyl Palmitate, Butyrospermum Parkii Butter, Levulinic Acid, Rosa Damascena Flower Water, Sodium Gluconate, Sodium Levulinate, Tocopherol, O-Cymen-5-Ol, Sodium Dehydroacetate, Helianthus Annuus Seed Oil (see ingredient list within Database GNPD ‘589).
Regarding instant claims 25 and 27-31, Database GNPD ‘589 teaches the inclusion of the ingredient of choice. Please see the full ingredient list within instant claim 1 (Table I) for the necessary rejection text (see ingredient list within Database GNPD ‘589; also see PTO-892 NPL X).
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 non-obviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 16-23 and 32-35 are rejected under 35 U.S.C. 103 as being unpatentable over Database GNPD ‘589 in view of Yardley et al. (WO2019/136351A1), Dobler et al. (Cosmetics, 2019), Pesaro et al. (US2019/0282478A1), and Chenery (Organic Cosmetics for Natural Beauty, 2004).
[The Examiner is going to introduce each new reference and then combine them where appropriate to reject the instant claims.]
1. Yardley et al.
Yardley et al. teach personal care compositions (see title). In addition, Yardley et al. disclose that described herein are personal care compositions and methods of making and using same. A personal care composition comprising: a cannabinoid; a PPAR-a agonist; a terpene; and a cosmetically acceptable carrier (see abstract).
2. Dobler et al.
Dobler et al. teach the impact of selected cosmetic ingredients on common
microorganisms of healthy human skin (see title). Also, Dobler et al. disclose that human skin is a complex ecosystem and is host to a large number of microorganisms.
When the bacterial ecosystem is balanced and differentiated, skin remains healthy. However, the use of cosmetics can change this balance and promote the appearance of skin diseases. The skin’s microorganisms can utilize some cosmetic components, which either promote their growth, or produce metabolites that influence the skin environment. In this study, we tested the ability of the Malassezia species and some bacterial strains to assimilate substances frequently used in dermal formulations. The growth capability of microorganisms was determined and their lipase activity was analyzed. The growth of all Malassezia spp. in the presence of free acids, free acid esters, and fatty alcohols with a fatty chain length above 12 carbon atoms was observed. No growth was observed in the presence of fatty alcohol ethers, secondary fatty alcohols, paraffin- and silicon-based substances, polymers, polyethylene glycols, quaternary ammonium salts, hydroxy fatty acid esters, or fatty acids and fatty acid esters with a fatty chain length shorter than 12 carbon atoms. The hydrolysis of esters by Malassezia lipases was detected using High Performance Thin Layer Chromatography (HPTLC). The production of free fatty acids as well as fatty alcohols was observed. The growth promotion or inhibition of bacterial strains was only found in the presence of a few ingredients. Based on these results, formulations containing microbiome inert ingredients were developed (see abstract).
3. Pesaro et al.
Pesaro et al. teach antimicrobial compositions (see title). Additionally, Pesaro et al. disclose that the present invention is the use of a compound of formula (I) or a (pharmaceutically) acceptable salt thereof, wherein (a) X denotes CH=CH or CZ1=CZ2, wherein if Z1 is H then Z2 denotes a radical selected from the group consisting of OH, NH2, NHMe, NMe2 , OMe and OEt and if Z2 is H then Z1 denotes a radical selected from the group consisting of OH, NH2, NHMe, NMe2 , OMe and OEt, Y denotes a
radical selected from the group consisting of NH2, NHMe, NMe2 , NHEt, O-(CH2)n-OH, wherein n is 2 to 5 and R denotes a radical selected from the group consisting of H,
OH, Me, Et, OMe, OEt, NH2, NHMe, NMe2, NHEt and NEt2, or (b) X denotes 0, Y denotes a radical selected from the group consisting of NH2, NHMe, NMe2, NHEt,
O-(CH2)n-OH and OMe, wherein n is 2 to 5 and R denotes H, OH, Me, Et, OMe, OEt, NH2, NHMe, NMe2, NHEt, NEt2 as anti-microbial agent as well as to composition
comprising said agent (see abstract).
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4. Chenery
Chenery teaches organic cosmetics for natural beauty (see title). Furthermore, Chenery discloses as the number of people who are concerned about toxins in our environment grows, more and more skin care companies are jumping on the natural and organic bandwagon. But what does natural and organic mean when we see them on a product label? How do we know what we are buying is really natural and organic? What are the natural alternatives to chemicals? And is natural really better for us?
Our skin is the largest eliminatory organ in the body. It is a two-way membrane. Toxins are eliminated through the skin via perspiration and absorbed through the skin into the body’s circulation system, through hair follicles and sebaceous glands, but not through the sweat glands. One square inch of skin contains approximately 65 hairs, 100 sebaceous glands and 650 sweat glands.
Skin care manufacturers are not supposed to claim that their products penetrate the skin. If they did, the products would then be labelled as “drugs” and would be governed by much stricter regulations. However, it is now recognized that the skin does absorb many ingredients in skin care preparations. This is both good and bad. Good, because it means our skin can be nourished from the outside with some wonderful
ingredients. Bad, because some skin care manufacturers can use harmful ingredients that would never be allowed to be taken orally, but are still absorbed into our system, through our skin (see page 1, left column).
The teachings of Database GNPD ‘589 are presented in the 35 U.S.C. §102 Section above. Furthermore, the claim limitations of instant claim 1 are taught in full by Database GNPD ‘589.
Combination of Database GNPD ‘589, Yardley et al., and Chenery
Regarding instant claim 17, Database GNPD ‘589, Yardley et al., and Chenery
teach wherein the emulsion comprises from 0.3 % to 1.0 % by weight of (b), based on a total weight of the emulsion. Yardley et al. disclose a cosmetic (see title and abstract within Yardley et al.) comprising an emulsifier such as hydrogenated castor oil (see page 17, line 3 within Yardley et al.) at 0.1-5% by weight (see Table 5 within Yardley et al.).
Regarding instant claims 19-21, Database GNPD ‘589, Yardley et al., and Chenery teach wherein the emulsion comprises from 0.2 % to 2.0 % by weight of (a), based on a total weight of the emulsion. Yardley et al. disclose a cosmetic (see title and abstract within Yardley et al.) comprising an emulsifier such as polyglyceryl-4 diisostearate/polyhydroxystearate/sebacate (see page 27, line 23 within Yardley et al.) at 0.1-5% by weight (see Table 5 within Yardley et al.).
Regarding instant claims 24 and 26, Database GNPD ‘589, Yardley et al., and Chenery teach the inclusion of one or more triglycerides and one or more palmitates. Please see the full ingredient list for the cold cream within instant claim 1 (Table I) for the necessary rejection text (see ingredient list within Database GNPD ‘589; also see PTO-892 NPL X). Also, Yardley et al. disclose the use of additional triglycerides (see paragraph [0066] within Yardley et al.) and palmitates (see paragraph [0066] within Yardley et al.).
Therefore, it would be within the scope of a skilled artisan (POSITA; person of ordinary skill in the art) to add one or more triglycerides and one or more palmitates to the cosmetic emulsion.
Combination of Database GNPD ‘589, Yardley et al., Dobler et al., and Chenery
Regarding instant claim 18, Database GNPD ‘589, Yardley et al., Dobler et al., and Chenery teach wherein the emulsion further comprises diisostearoyl polyglyceryl-3 dimer dilinoleate. Dobler et al. disclose the use of the emulsifier diisostearoyl polyglyceryl-3 dimer dilinoleate which is commonly used in skincare and cosmetic products (see page 3, Table 1 within Dobler et al.; also see PTO-892 NPL 2U).
Regarding instant claims 22-23 and 35, Database GNPD ‘589, Yardley et al., Dobler et al., and Chenery teach wherein the emulsion comprises from 0.2 % to 2.0 % by weight of diisostearoyl polyglyceryl-3 dimer dilinoleate, based on a total weight of the emulsion. Dobler et al. disclose the use of the emulsifier diisostearoyl polyglyceryl-3 dimer dilinoleate (see instant claim 18). Dobler et al. does not disclose a specific weight percent range for the use of the of the emulsifier diisostearoyl polyglyceryl-3 dimer dilinoleate. However, Yardley et al. disclose a cosmetic (see title and abstract within Yardley et al.) comprising a wide variety of emulsifiers at 0.1-5% by weight (see Table 5 within Yardley et al.). Therefore, a skilled artisan (POSITA) would have a reasonable level of success employing the wt% range supplied by Yardley et al. for their emulsifiers, with diisostearoyl polyglyceryl-3 dimer dilinoleate supplied by Dobler et al.
Regarding instant claim 34, Database GNPD ‘589, Yardley et al., Dobler et al., and Chenery teach a cosmetic water-in-oil (W/O) emulsion, wherein the emulsion comprises, based on a total weight of the emulsion, from 0.2 % to 2.0 % by weight of (a) polyglyceryl-diisostearate/polyhydroxystearate/sebacate, from 0.3 % to 1.0 % by weight of (b) hydrogenated castor oil, and from 0. 2 % to 2.0 % by weight of (c) diisostearoyl polyglyceryl-3 dimer dilinoleate, the emulsion being free from mineral oil, paraffin wax, microcrystalline wax, shellac wax, polyethylene wax, polyacrylates, acrylate/C10-C30 alkyl acrylate crosspolymers, vinylpyrrolidone/hexadecene copolymers, 3-(4-methylbenzylidene)camphor, 2-hydroxy- 4-methoxybenzophenone, 2-ethylhexyl 4-methoxycinnamate, ethylhexyl 2-cyano-3,3- diphenylacrylate, parabens, methylisothiazolinone, chloromethylisothiazolinone, DMDM hydantoin, polyethylene glycol ethers, polyethylene glycol esters. Please see the discussion and citations within instant claims 1, 17-19, and 22 for the relevant rejection text.
A skilled artisan (POSITA) could incorporate the necessary instant claim limitations to afford the desired cosmetic composition of instant claim 34.
Combination of Database GNPD ‘589, Yardley et al., Dobler et al., Pesaro et al. and Chenery
Regarding instant claim 32, Database GNPD ‘589, Yardley et al., Dobler et al., Pesaro et al., and Chenery teach wherein the emulsion further comprises potassium sorbate. Pesaro et al. disclose the use of potassium sorbate in a cosmetic (see Table VI within Pesaro et al.).
Regarding instant claim 33, Database GNPD ‘589, Yardley et al., Dobler et al., Pesaro et al., and Chenery teach wherein the emulsion further comprises a mixture of citric acid and sodium citrate. Pesaro et al. disclose the use of citrate buffer (citric acid and sodium citrate) in a cosmetic (see Table XXIV within Pesaro et al.).
In both instances, it would be within the scope of a skilled artisan (POSITA) to add potassium sorbate and citrate buffer into the cosmetic emulsion of the instant application.
Analogous Art
The Database GNPD ‘589, Yardley et al., Dobler et al., Pesaro et al., and Chenery references are directed to the same field of endeavor as the instant claims, that is, a cosmetic water-in-oil (W/O) emulsion as disclosed within instant claim 1.
Obviousness
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the O/W cosmetic disclosed by Database GNPD ‘589, using the teachings of Yardley et al., Dobler et al., Pesaro et al. and further in light of the natural and organic cosmetic ingredients described in Chenery, in order to arrive at the subject matter of the instant claims.
The Database GNPD ‘589, Yardley et al., Dobler et al., Pesaro et al., and Chenery references all have considerable overlap with the preparation of an O/W cosmetic composition. In this instance, both GNPD ‘589 and Yardley et al. supply the O/W cosmetic composition comprising both (a) polyglyceryl-4 diisostearate/polyhydroxystearate/sebacate and hydrogenated castor oil, while Dobler et al. and Pesaro et al. supply cosmetic examples both incorporating the emulsifier diisostearoyl polyglyceryl-3 dimer dilinoleate along with additional claim-specific formulations, respectively. Also, the Chenery reference makes an argument for the use of natural and organic ingredients within cosmetics to benefit consumers. All references are directed to an O/W cosmetic composition and therefore constitute analogous art under MPEP §2141.01(a). A POSITA would have reasonably consulted the five references when seeking to improve or adapt an O/W cosmetic composition.
Starting with Database GNPD ‘589, the skilled person only had to try the necessary claim limitations disclosed by Yardley et al., Dobler et al., Pesaro et al., and Chenery. The combination of Database GNPD ‘589, Yardley et al., Dobler et al., Pesaro et al., and Chenery would allow one to arrive at the present application without employing inventive skill. This combination of the O/W cosmetic emulsion taught by Database GNPD ‘589 along with the use of the necessary claim limitations taught by Yardley et al., Dobler et al., Pesaro et al., and Chenery would allow a research and development scientist (POSITA) to develop the invention taught in the instant application. It would have only required routine experimentation to modify the O/W cosmetic composition disclosed by Database GNPD ‘589 with the use of the necessary claim limitations taught by Yardley et al., Dobler et al., Pesaro et al., and Chenery. Incorporating the disclosure of Database GNPD ‘589 into the O/W cosmetic emulsion presented by Yardley et al., Dobler et al., Pesaro et al., and Chenery represents a predictable use of prior art elements according to their established functions, consistent with MPEP §2143 and KSR.
Furthermore, the additional claim limitations taught by Yardley et al., Dobler et al., Pesaro et al., and Chenery would have been viewed by a POSITA as routine design optimizations or known modifications to improve cosmetic formulations. Implementing these features into Database GNPD ‘589’s O/W cosmetic composition would not require more than ordinary skill or routine experimentation.
Accordingly, the combination of Database GNPD ‘589, supplemented by Yardley et al., Dobler et al., Pesaro et al., and Chenery provides all the elements of the claimed invention. The resulting O/W cosmetic composition constitutes no more than the predictable outcome of combining familiar prior art components, and therefore the claimed subject matter would have been obvious to a POSITA prior to the effective filing date of the invention.
Conclusion
No claims are allowed.
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/JOHN W LIPPERT III/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615