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 .
Claim Objections
Claim 22 is objected to because of the following informalities: the term
“further” should be immediately recited prior to the term “comprising.” 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 16, 26, 27, and 29-31 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 16 recites the limitation "the straight-chain and/or branched fatty alcohols" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 6 depends from claim 15 which recites “one or more straight-chain and/or branched fatty alcohols.” It is unclear whether “the straight-chain and/or branched fatty alcohols” refers to some or to all of the “one or more straight-chain and/or branched fatty alcohols” of the claim from which it depends.
Claims 26, 27, 29, and 31 recite elements of a Markush group. However, each claim lacks the conjunction term “and” for a proper Markush type limitation. Therefore, it is not clear if the Markush group is complete or if there are additional suitable elements not disclosed in the claim. Claims 29 and 30 recite the limitation " the triglycerides" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 6 depends from claim 15 which recites “one or more triglycerides.” It is unclear whether “the triglycerides” refers to some or to all of the “one or more triglycerides” of the claim from which it depends.
Further, claim 30 recites wherein the triglycerides comprise hydrogenated rapeseed oil, rapeseed oil, caprylic/capric acid triglycerides, sunflower oil, hydrogenated coco glycerides, hydrogenated castor oil, shea butter. The claim is missing a conjugative term. The claim is indefinite since it is unclear whether the composition requires each of the triglycerides or only one of the triglycerides.
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.
(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.
(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 13-14, 18, 20, 22, 24-29, and 31-32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Evonik Nutrition & Care GmbH (ISOLAN® 17 MB, February 2019) (hereinafter Evonik).
Evonik discloses ISOLAN® 17 MB which is a W/O emulsifier comprising Caprylic/Capric Triglyceride (i.e., one or more triglycerides) and Diisostearoyl Polyglyceryl-3 Dimer Dilinoleate (page 1, INCI (PCPC name)). In an exemplary Guideline Formulation, a W/O Pampering Body Cream (H 6/16-10) is prepared using ISOLAN® 17 MB (i.e., one or more triglycerides), 6% sweet almond oil, 0.4% hydrogenated castor oil, 4.4% caprylic/capric triglyceride (i.e., two or more triglycerides with total weight 10.8%), tocopheryl acetate, citric acid, 5% glycerin (i.e., glycerol), tocopheryl acetate (page 5, Pampering Body Cream (H 6/16-10)). Give Your Body A Natural Treat Lotion (BR 7/16-13) is an exemplary Guideline Formulation which is a W/O lotion comprising 4.5% ISOLAN® 17 MB (i.e., one or more triglycerides), 0.6% hydrogenated castor oil, 0.4% cera alba, 10% sweet almond oil, 3% jojoba seed oil, alcohol, and panthenol (page 5, Give Your Body A Natural Treat Lotion (BR 7/16-13)). Natural Liquid Foundation (SZ 9/17-2) is an exemplary Guideline Formulation which is a W/O emulsion comprising ISOLAN® 17 MB (i.e., one or more triglycerides), hydrogenated lecithin, and magnesium sulfate heptahydrate (page 4, Natural Liquid Foundation (SZ 9/17-2)). ISOLAN® 17 MB is suitable for the formulation of cosmetic W/O butters, creams, lotions, sprays and aerosols. As typical usage concentration 1.5 – 5.0% ISOLAN® 17 MB are recommended depending on the type of formulation. In general no coemulsifiers are needed to obtain stable emulsions. For lotions the typical oil phase contents of 20-30% can be formulated (i.e., 70-80% by weight of aqueous phase and 20-30% by weight of oil phase) (page 1, Application Characteristics).
Accordingly, Evonik anticipates the instant claims insofar as disclosing a W/O emulsion comprising Caprylic/Capric Triglyceride (i.e., one or more triglycerides) and is free of mineral oil, paraffin wax, microcrystalline wax, shellac wax, polyethylene waxes, polyacrylates, crosslinked acrylate/C10O-C30 alkyl acrylate polymers, vinylpyrrolidone/hexadecene copolymers, 3-(4-methylbenzylidene)camphor, 2-hydroxy-4-methoxybenzophenone, 2-ethylhexyl 4- methoxycinnamate, ethylhexyl 2-cyano-3 ,3 -diphenylacrylate, parabens, methylisothiazolinone, chloromethyl-isothiazolinone, DMDM hydantoin, polyethylene glycol ethers, and polyethylene glycol esters (page 5, Pampering Body Cream (H 6/16-10)).
Regarding claim 14, the exemplary Guideline Formulation Pampering Body Cream (H 6/16-10) does not comprise aliphatic and aromatic hydrocarbons. Accordingly, the teachings of Evonik anticipate the limitations of claim 14.
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.
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 19 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Evonik Nutrition & Care GmbH (ISOLAN® 17 MB, February 2019) (hereinafter Evonik).
The teaching of Evonik are discussed above and do not teach wherein the emulsion comprises from 1.5 % by weight to 2.5 % by weight of diisostearoyl polyglyceryl-3 dimer dilinoleate or from 20 % by weight to 27 % by weight of triglycerides.
However, as discussed above, Evonik teaches ISOLAN® 17 MB is a W/O emulsifier comprising Diisostearoyl Polyglyceryl-3 Dimer Dilinoleate and is typically used in a concentration between 1.5 – 5.0% depending on the formulation. Accordingly, one of ordinary skill in the art would have been capable of arriving at a composition comprising from 1.5 % by weight to 2.5 % by weight of diisostearoyl polyglyceryl-3 dimer dilinoleate through routine experimentation based on the amount of emulsifier needed for the desired formulation type, as taught by Evonik. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See MPEP 2144.05.
Regarding claim 21, as discussed above, Evonik discloses formulations comprising
4.5% ISOLAN® 17 MB (i.e., comprising one or more triglycerides), 0.6% hydrogenated castor oil, 0.4% cera alba, 10% sweet almond oil, 3% jojoba seed oil, totaling about 18.5% by weight of triglycerides, which is close to the claimed range of from 20 % by weight to 27 % by weight of triglycerides. A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See MPEP 2144.05.
Claims 15-17 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Evonik Nutrition & Care GmbH (ISOLAN® 17 MB, February 2019) (hereinafter Evonik) in view of Bleckman et al., (US 2003/0017176 A1, Jan. 23, 2003) (hereinafter Bleckman).
As discussed above Evonik discloses the limitations of claim 13 but does not teach wherein the emulsion additionally comprises one or more straight-chain and/or branched fatty alcohols comprising one or more of octyldodecanol, cetyl alcohol or stearyl alcohol from 0.3 % to 2.5 % by weight, or wherein the triglycerides comprise hydrogenated rapeseed oil, rapeseed oil, sunflower oil, hydrogenated coco glycerides, shea butter.
However, Bleckman discloses water-in-oil emulsions (a) with a content of water and optionally water-soluble substances and with a content of lipids, emulsifiers and lipophilic constituents, (b) whose oil phase is chosen from the group of lipids or lipid mixtures, where the total polarity of the lipid phase is between 20 and 30 mN/m (Claim 1). Table 1 lists moderately polar lipids which are advantageous as individual substances or else as mixtures with one another to ensure that the total polarity of the oil phase is in the claimed range ([0037]), including octyldodecanol (i.e., a branched fatty alcohols) (Table 1, [0038]). Fatty and/or wax components which are to be used in the oil phase include shea butter ([0041]), hydrogenated coconut fatty glycerides or other hydrogenated vegetable oils ([0042]). The oil phase may also comprise sunflower oil and rapeseed oil (i.e., a vegetable oil) ([0040]). Example 8 teaches the use of octyldodecanol in 2% by weight.
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Evonik discloses wherein the W/O composition comprises alcohol. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated octyldodecanol (i.e., a branched fatty alcohol) in 2% by weight into the composition of Evonik it is known and effective alcohol and weight for W/O emulsions as taught by Bleckmann.
In regards to the composition comprising hydrogenated rapeseed oil, rapeseed oil, sunflower oil, hydrogenated coco glycerides, shea butter, since Evonik discloses formulations comprising multiple triglycerides in the oil phase, the use of the individual species in combination would have been obvious since it is prima facie obvious to combine two compositions, each of which is taught by Bleckmann to be useful for the same purpose, in order to form a third composition to be used for the very same purpose; the idea for combining them flows logically from their having been individually taught in the prior art. See MPEP 2144.06. Further Bleckmann teaches the use of hydrogenated vegetable oils as suitable oil phase components and that rapeseed oil (i.e., a vegetable oil) is a suitable oil phase component. Accordingly, it would have been obvious to one of ordinary skill in the art to have selected hydrogenated rapeseed oil as a suitable oil phase component.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Evonik Nutrition & Care GmbH (ISOLAN® 17 MB, February 2019) (hereinafter Evonik) in view of Nielsen et al., (US 2004/0037797 A1, Feb. 26, 2004) (hereinafter Nielsen).
As discussed above Evonik discloses the limitations of claim 13 but does not teach from 0.0005 % to 0.1 % by weight of lecithin.
However, Nielsen discloses a cosmetic or dermatological water-in-oil emulsion, comprising up to 10% by weight of one or more emulsifiers (Claim 1). The composition comprises caprylic/capric triglyceride in the lipid phase ([0039]). Suitable naturally occurring emulsifiers include lecithin ([0077]). The cosmetic or topical dermatological compositions can be used for creams or lotions ([0147]).
As discussed above, Evonik discloses water in oil emulsions comprising hydrogenated lecithin. Accordingly, it would have been obvious to one of ordinary skill in the art to formulate the emulsion of Evonik comprising up to 10% by weight of lecithin since this is a known and effective weight of lecithin used in water in oil emulsions as taught by Nielsen.
Conclusion
Claims 13-32 are rejected.
No Claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Samantha J Knight whose telephone number is (571)270-3760. The examiner can normally be reached Monday - Friday 8:30 am to 5:00 pm ET.
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/S.J.K./ Examiner, Art Unit 1614
/ALI SOROUSH/ Supervisory Patent Examiner, Art Unit 1614