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 .
Withdrawn Rejections:
Applicant's amendments and arguments filed on 06/30/2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below is herein withdrawn.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
The application is examined in view of linseed oil as specific oil; isobutyl methacrylate as specific acrylate polymer; the reaction product of specific oil and isobutyl methacrylate polymer as specific hydrophobic polymer; rhamnolipid as specific surfactant and polycitronellol acetate as specific solvent. Claims 1, 9-15, 28 and 30 read on the elected species and are under examination; Claims 16-17, 19, 21-27 and 29 do not read on the elected specie and are withdrawn from consideration.
Claims 1, 9-17 and 19-30 are pending; claims 1, 9-15, 28 and 30 are under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/28/2026 and 07/14/2026 is being considered by the examiner.
Terminal Disclaimer
The terminal disclaimer filed on 06/30/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US patent application 18544283, 18544195, 18654223 and 18544254 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Claim Rejections - 35 USC § 103
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1, 9-15, 28 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Mitra et al. (US20220249342) in view of DeSanto (US20080213194) and Cavaco Paulo (US20230414478) and Lorentz et al. (US20110020249).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Mitra et al. teaches A cosmetic cleansing composition includes a cosmetic carrier system, and a cleansing coagulant system that includes at least one of each of an oil and a viscosity modifier, the viscosity modifier selected from synthetic (including petrochemical based) and natural polymers. The coagulant system can congeal and form a viscoelastic fluid to bind and remove sebum, makeup, dirt, pollution, dead skin and other unwanted material from skin (abstract). In various embodiments, the disclosure provides a cosmetic cleansing composition comprising: (a) cleansing coagulant system comprising: i. an oil component; and ii. a polymer component; and (b) a cosmetic carrier system comprising one or more phases selected from the group consisting of a water phase, an oil phase, and combinations thereof. The coagulant system can congeal and form a viscoelastic fluid to bind and remove sebum, makeup, dirt, pollution, dead skin and other unwanted material from skin. In some embodiments, the cleansing coagulant system that includes at least one of each of an oil and a viscosity modifier includes a natural based or food derived oil, such as linseed oil, and a methacrylate polymer components, such as poly(isobutyl methacrylate). In some embodiments, the cleansing coagulant system is prepared as a reaction product of an oil component selected from the group consisting of glycerides, fatty acids, alkenes, and alkynes, with a polymer component, for example a synthetic polymer component such as a methacrylate or acrylate polymer component. In some embodiments, the cleansing coagulant system is prepared as a homogenous thermal reaction product. In some other embodiments, the reaction product may be produced using other reaction components that drive the formation of the reaction product that forms the cosmetic coagulant system ([0008-0014]). In accordance with the various embodiments, the at least one oil in the cleansing coagulant system is present in a range from about 30% to about 45%, by weight, based on the weight of the cleansing coagulant system, and the at least one polymer is present in a range from about 0.1% to about 20%, by weight, based on the weight of the cleansing coagulant system. In some embodiments, the cleansing coagulant system is present in the cosmetic cleansing composition in a range from about 1% to about 25%, by weight, based on the weight of the cosmetic cleansing composition, and the cosmetic carrier system is present in the range from about 75% to about 99%, by weight, based on the weight of the cosmetic cleansing composition ([0022-0023]). The cosmetic cleansing composition may be any suitable cosmetic cleansing composition, such as, but not limited to, an anhydrous cleansing oil, foaming cleanser, a cleansing milk, lotion or cream, an emulsion such as a water-in-oil or oil-in-water emulsion, or a multi-phase composition comprising at least one water phase, and is easy on the skin, efficiently removes makeup, sebum, dirt and skin debris without smudging, and provides a soft and smooth skin feel after use. The cosmetic cleansing composition in any of the product forms may be either a leave-on or a rinse-off formulation ([0033]). In some embodiments, the cosmetic cleansing compositions may include one or more polar emollient. Emollients are oil-phase ingredients selected from esters, triglycerides, ethers, carbonates, alcohols, oils, butters, fatty acids, and their combinations thereof. The amount of each of the at least one polar emollient, when present, is present in the cosmetic cleansing composition in a range of from about 1% to about 12% by weight ([0080-0084]). In accordance with some embodiments, water may be present in the cosmetic cleansing compositions in a range from about 1% to about 90%, or any suitable combination, sub-combination, range, or sub-range thereof by weight, based on the weight of the cosmetic cleansing composition ([0089]). The pH of the cosmetic cleansing composition is not limited but is generally between 3.0 and 7.0 ([0091]). In some embodiments, the cosmetic cleansing composition may optionally include one or more surfactant in a range from about 1% to about 5%, based on the weight of the cosmetic cleansing composition ([0101-0102]). One of ordinary skill in the art, however, will appreciate that other ranges are within the scope of the invention ([0105]).
DeSanto teaches rhamnolipid-based formulations to clean, disinfect, deodorize, and act as an antimicrobial and antifungal agent for living and working environments. In addition, the present invention relates to the use of rhamnolipids to create a bio-film when applied to a surface, which prevents the growth of bacteria and fungus (abstract). The majority of the surfactants used by the prior art are derived from petroleum sources. These chemical surfactants pose significant environmental risks because they form harmful compounds from incomplete biodegradation in water or soil. In recent years, the prior art is showing an increase in the use of bio-surfactants, because they are an environmentally friendly alternative to petroleum-derived surfactants and their potential use in different areas, such as the food industry, agriculture, pharmaceuticals, cosmetic, and oil industries. Rhamnolipid bio-surfactant secreted from Pseudomonas Aeruginosa, is a naturally occurring extracellular glycolipid that is found in the soil and on plants. Rhamnolipids are powerful bio-surfactants that provide a great antibacterial and antifungal activity, and low toxicity levels, which make them an attractive alternative to the known petroleum derived surfactant used in the pharmaceutical industry, the petroleum industry, agriculture, personal care products, animal cleaning products, and other applications ([0005-0007]). After intense research and development, the present inventor discovered that rhamnolipids can be used to clean, disinfect, deodorize, and act as an antimicrobial and an antifungal agent for living and working environments. In addition, the present inventor discovered that rhamnolipids can also be used in cleaning solutions for humans and animals ([0019]). The personal care product may be a deodorant, sunscreen lotion, cosmetic composition, soap, cleanser, toothpaste, or mouthwash ([0032]). In general, the rhamnolipid preparation (“crude” or partially purified therefrom) is diluted to a final concentration of less than 70%. In various embodiments of the invention, the final formulations contain in the range of about 5% to about 70% rhamnolipid preparation, with preferred formulations being about 65%, or about 35%, or about 25%, or about 10% or about 5% or less of the rhamnolipid preparation in the final formulation ([0043]). Furthermore, the present invention provides rhamnolipid formulations and methods for their use in personal hygiene and care products. Rhamnolipids act as an antimicrobial agent and a surfactant in personal care products ([0069]).
Cavaco Paulo teaches a hair cleanser composition for cleansing and repairing hair (abstract). In some embodiments, the one or more cosmetically or dermatologically acceptable excipients is an emollient selected from: isopropyl lauroyl sarcosinate, phenethyl benzoate, C12-15 alkyl benzoate, caprylic/capric triglyceride, cetyl octanoate, octyldodecanol, dilinoleic acid/propanediol copolymer, isoamyl laurate, oleic acid, isohexadecane, squalane, isopropyl palmitate, polycitronellol, diheptyl succinate, capryloyl glycerin/sebacic acid copolymer, PPG-3 benzyl ether ethylhexanoate, hydrogenated vegetable oil, triheptanoin, diisopropyl sebacate, diisopropyl adipate, propylene glycol dibenzoate, propoxytetramethyl piperidinyl dimethicone, castor oil/IPDI copolymer, butylene glycol cocoate, butylene glycol dicaprylate/dicaprate (dispersant), propylene glycol dicaprylate/dicaprate, triolein (algae oil), propylene glycol dicaprylate/dicaprate, phytosteryl/octyldodecyl lauroyl glutamate, C10-18 triglycerides, isostearyl alcohol, diisostearyl malate, isoamyl laurate, *isoamyl cocoate, hemisqualane, polycitronellol acetate, ethyl macadamiate, coco-caprylate/caprate, coconut alkanes, C9-12 alkane, C13-15 alkane, C13-16 isoalkane, neopentyl glycol diheptanoate, hydrogenated ethylhexyl olivate, hydrogenated olive oil unsaponifiables, undecane, tridecane, isododecane, caprylyl caprylate/caprate, cetyl stearate, cetearyl stearate, decyl oleate, glyceryl stearate, glyceryl adipate, glyceryl arachidate, glyceryl arachidonate, glyceryl behenate, glyceryl caprate, glyceryl caprylate, glyceryl caprylate/caprate, glyceryl citrate/lactate/linoleate/oleate, glyceryl cocoate, glyceryl diarachidate, glyceryl dibehenate, glyceryl dierucate, glyceryl dihydroxystearate, glyceryl diisopalmitate, glyceryl diisostearate, glyceryl dilaurate, glyceryl dilinoleate, glyceryl dimyristate, glyceryl dioleate, glyceryl dipalmitate, glyceryl dipalmitoleate, glyceryl diricinoleate, glyceryl distearate, glyceryl erucate, glycol stearate, isocetyl stearate, isopropyl myristate, isopropyl palmitate, isopropyl stearate, isostearyl stearate, octyl palmitate, octyl stearate, propylene glycol dicaprylate/dicaprate, sorbitan benzoate, sorbitan caprylate, sorbitan isostearate, sorbitan laurate, sorbitan tristearate, stearyl stearate, tocopheryl linoleate, olive oil, avocado oil, coconut oil, sunflower oil, jojoba oil, argan oil, castor oil, almond oil, Sesamum indicum (sesame) seed oil, Prunus areniaca (apricot) kernel oil, Crambe abyssinica seed oil, Oryza sativa (rice) bran oil, Vitis vinifera (grape) seed oil, Passiflora edulis seed oil, meadowfoam seed oil, Butyrospermum parkii (shea) butter, Shorea robusta seed butter, murumuru butter, and any combinations thereof ([0080]).
Lorentz et al. teaches cosmetic composition for skin and hair (abstract). The cosmetic compositions may also contain polymers exhibiting film-forming properties such as acrylate polymer ([0175]). The droplets of the emulsion may be large in size to a lesser or greater degree. Reference may thus be made to microemulsions, miniemulsions or macroemulsions. In the present application, the term “emulsion” covers in particular all these types of emulsions. Without wishing to be bound by any theory, it is specified that microemulsions are generally thermodynamically stable systems, generally comprising large quantities of emulsifying agents. The other emulsions are generally systems in a nonthermodynamically stable state, which preserve for a certain period, in a metastable state, the mechanical energy provided during the emulsification. These systems generally comprise smaller quantities of emulsifying agents ([0188]). According to a particular embodiment, the emulsion is a microemulsion, in which the size of the droplets is less than 0.15 μm. The size of the droplets of microemulsion may be measured on an emulsion prepared prior to its introduction into the cosmetic composition, by dynamic light scattering (DQEL), for example as described below. The apparatus used for example consists of a Spectra-Physics 2020 laser, a Brookhaven 2030 correlator and the associated computing ([0191-0192]). According to an advantageous embodiment, the microemulsion is transparent. The microemulsion may for example exhibit a transmittance of at least 90%, preferably of at least 95%, at a wavelength of 600 nm, measured for example with the aid of a Lambda 40 UV-Vis spectrometer at a concentration of 0.5% by weight in water ([0194]).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
The difference between the instant application and Mitra et al. is that Mitra et al. do not expressly teach rhamnolipid and polycitronellol acetate as well as droplet size of 10 nm to about 2 um. This deficiency in Mitra et al. is cured by the teachings of DeSanto, Cavaco Paulo and Lorentz et al..
Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Mitra et al., as suggested by DeSanto, Cavaco Paulo and Lorentz et al., and produce the instant invention.
Mitra et al. teaches a cosmetic cleanser composition comprising cleansing coagulant system comprising a reaction product of specific oil and isobutyl methacrylate polymer; 1-5% of surfactant and 1-12% of emollient in the form of oil in water emulsion. Mitra et al. is silent about rhamnolipid and polycitronellol acetate
One of ordinary skill in the art would have been motivated to include rhamnolipid in the cleanser composition because rhamnolipid is a suitable surfactant in the cleanser composition. MPEP 2144.07. Under guidance from Mitra et al. teaching surfactant in the cleanser composition; DeSanto teaching rhamnolipid as environmentally friendly surfactant in cleanser composition; since it is advantage to have environmentally friendly surfactant, it is obvious to have rhamnolipid in the cleanser composition and produce instant claimed invention with reasonable expectation of success.
One of ordinary skill in the art would have been motivated to include polycitronellol acetate because polycitronellol acetate is a suitable ingredient in cleanser composition. MPEP 2144.07. Under guidance from Mitra et al. teaching emollient in the cleanser composition, Cavaco Paulo teaching polycitronellol acetate as emollient in cleanser composition, it is obvious for one of ordinary skill in the art to include polycitronellol acetate and produce instant claimed invention with reasonable expectation of success.
One of ordinary skill in the art would have been motivated to have droplet of O/W emulsion less than 0.15um because this is optimization under prior art condition or through routing experimentation. MPEP 2144.05. Under guidance from Lorentz et al. teaching cosmetic composition in form of microemulsion having droplet size less than 0.15um as thermodynamically stable transparent systems, since it is advantage to have thermodynamically stable transparent systems, it is obvious for one of ordinary skill in the art to have O/W emulsion in the form of microemulsion with droplet less than 0.15um.
Regarding claims 1, 10-15 and 28, prior art teaches cosmetic cleanser composition comprising cleansing coagulant system comprising a reaction product of specific oil and isobutyl methacrylate polymer; about 1-5% of rhamnolipid as surfactant and 1-12% of polycitronellol acetate (also as solvent) as emollient, water at about 1% to about 90%, in the form of oil in water emulsion as microemulsion with droplet size less than 0.15um. Furthermore, Mitra et al. teaches one oil in the cleansing coagulant system is present in a range from about 30% to about 45%, by weight, based on the weight of the cleansing coagulant system, and the at least one polymer is present in a range from about 0.1% to about 20%, by weight, based on the weight of the cleansing coagulant system. In some embodiments, the cleansing coagulant system is present in the cosmetic cleansing composition in a range from about 1% to about 25%, by weight. When the linseed oil is 45%, isobutyl methacrylate is 15%, the linseed oil in the reaction product of oil and polymer is 45/(45+15)=75%, and the isobutyl methacrylate is 25%. When the cleansing coagulant system is 10% of final cosmetic cleansing composition, the amount of reaction product of oil and polymer is 10%x (45%+15%)=6%.
Regarding the limitation of “stable at 45ºC for 2 months”, prior art teaches microemulsion with droplet size less than 0.15um, which is thermodynamically stable. Since prior art teaches the same or substantially same emulsion with fine droplet size, this prior art emulsion is expected to have the same stability such as stable at 45C for 2 months. MPEP 2112, "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Regarding claim 9, polycitronellol acetate is the elected solvent, which has a distance (Ra) less than 13.4 MPa0.5 according to applicant’s specification (Table 1). Furthermore, applicants submitted that the elected polycitronellol acetate read on claim 9 in response to election on 02/10/2026, then elected polycitronellol acetate must have the property cited in claim 9. "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Regarding claim 30, this is considered as product by process. With respect to the USC 103 rejection above, please note that in product-by-process claims, “once a product appearing to be substantially identical is found and a 35 U.S.C. 102/103 rejection [is] made, the burden shifts to the applicant to show an unobvious difference.” MPEP 2113. This rejection under 35 U.S.C. 102/103 is proper because the “patentability of a product does not depend on its method of production.” In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985). As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972). Please note that the Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether Applicants’ hydrated (vitrified matrix) collagen gel differs and, if so, to what extent, from that of the discussed reference. Therefore, with the showing of the reference, the burden of establishing non-obviousness by objective evidence is shifted to the Applicants.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Argument:
Applicants argue that Mitra is not concerned with applicant’s invention, not teaching droplet size of 10nm to about 2um.
In response to this argument: this is not persuasive. The test of obvious rejection is not whether the prior art is concerned about applicant’s purpose; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). As discussed in the above 103 rejection, the combination of prior art teaches each limitation of applicant’s claimed invention including droplet size of 10nm to about 2 um. One of ordinary skill in the art would have been motivated to have droplet of O/W emulsion less than 0.15um because this is optimization under prior art condition or through routing experimentation. MPEP 2144.05. Under guidance from Lorentz et al. teaching cosmetic composition in form of microemulsion having droplet size less than 0.15um as thermodynamically stable transparent systems, since it is advantage to have thermodynamically stable transparent systems, it is obvious for one of ordinary skill in the art to have O/W emulsion in the form of microemulsion with droplet less than 0.15um. Therefore, the 103 rejection is still proper.
Applicants argue that Mitra seems to discourage surfactant.
In respoken to this argument: this is not persuasive. Mitra clearly teaches surfactant in one embodiment.
Applicants argue that Mitra also teaches anhydrous system and teaching of water range of 1-90% is too broad over claimed 40-95%.
In response to this argument: this is not persuasive. Mitra clearly teaches O/W emulsion in one embodiment, then O/W emulsion is obvious no matter how many other formulations are recited because the recitation of other formulation does not make any particular formulation including O/W emulsion less obvious. Prior art teaching of 1-90% overlaps with claimed range of 40-95%, In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). Therefore, the 103 rejection is still proper.
Applicants argue about Emulsion A, B and C in the specification not stable and not transparent.
In response to this argument: this is not persuasive. As discussed in the above 103 rejection, it is within skill of one artisan to optimize and have droplet less than 0.15um to have a stable and transparent microemulsuion, and there is no evidence to show this micoremulsion is any difference from applicant’s claimed invention including claim 30. Thus, the 103 rejection is still proper.
MPEP 2141 III states: “The proper analysis is whether the claimed invention would have been obvious to one of ordinary skill in the art after consideration of all the facts.” Respectfully, after weighing all the evidence, the Examiner has reached a determination that the instant claims are not patentable in view of the preponderance of evidence and consideration of all the facts which is more convincing than the evidence which has been offered in opposition to it.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIANFENG SONG. Ph.D. whose telephone number is (571)270-1978. The examiner can normally be reached M-F 8-5.
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/JIANFENG SONG/Primary Examiner, Art Unit 1613
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