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 Status
Applicant’s response to the restriction requirement filed on June 30, 2026 has been received and entered. Claims 2-4, 6-7, 10-12, 25, and 29 have been cancelled, and not clams have been newly added. Claims 1, 5, 8, 9, 13-24, 26, and 28 are pending in this instant application.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1, 5, 8, 9, 13-20, 24, and 26 drawn to an oil-in-water emulsion for topic use the reply filed on June 30, 2026 is acknowledged.
Claims 21-23 and 27-28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 1, 5, 8, 9, 13-20, and 24-26 are under consideration.
The election/restriction requirement is deemed proper and made FINAL.
Priority
Applicant has made a claim for priority to the filing dates of PCT Application CA2022/05248; filed on February 22, 2022. However, the Certified Copy of the Foreign Priority Paper has not been filed.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on August 22, 2024 and June 30, 2026 are in compliance with the provisions of 37 CFR 1.97, except where noted. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 24 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because “Use” claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101. In re Moreton, 288 F.2d 708, 709, 129 USPQ 227, 228 (CCPA 1961)(“one cannot claim a new use per se, because it is not among the categories of patentable inventions specified in 35 U.S.C. § 101”). In this instance use of a method of claim 21 to formulate an oil-in-water emulsion is not directed to the method or a composition, but rather the use of the method to formulate the emulsion.
Claim Rejections - 35 USC § 112 (a) Written Description
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1, 5, 8, 9, 13-20, and 24-26 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 1 and 26 include an oil-in-water emulsion for topical use having a viscosity of 4.5 to 8 centipoise, which comprises by weight, based on total weight of the emulsion, one or more oils in the total amount of 15- 20% by weight, and one or more surfactants, the ratio of total oils:total surfactants being in the range of 3.8-7.5 :1, without providing an particular oils, surfactants, or product by process language that produces the instantly claimed range of a viscosity of 4.5 to 8 cps. Similarly, dependent claims, require a moisturizing factor, a specific gravity range, oil phase particles having a specific DV50, range, stability at specific temperatures over 18 weeks, and ranges of decrease in Trans-Epidermal Water Loss when the emulsion is applied daily without providing an particular oils, surfactants, or product by process language that produces the instantly claimed range or stability.
Rather the specification discloses examples of a specific formulation comprising 1.00 wt% BRIJ IC20-70, 2.00 wt% FLUIDIFEEL EASY, 15.00 wt% SQUALINE, 0.075116 wt% PURAC ULTRAPURE 90, 0.05 wt% WATER HYALO-REPAIR, 5.00 wt% PRODEW 500 HYGROLEX V, 0.48 wt% PHYSIOGENYL PF, 1.00 wt% HYGROPLEX V, and 1.00 wt% ISCAGUARD CPP (Fig. 1 and Table 1) produced by microfluidics for high-pressure homogenization, in order to create nano-emulsions [0008], utilize wherein the formulation is prepared in three core phases (PHASE A, B, and C) [0026]. Applicant does not include examples other than the instant formulation, or wherein the formulation is not prepared in three core phases, or other methods besides high-pressure homogenization. The singular example found in table 1 of the specification does not reasonably representative of the genus in its claimed scope. PAIK et al. (PUB No. US 2015/0238403, Pub. date; August 27, 2015) discloses that low viscosity cosmetic compositions (abstract) in the form of oil-in water emulsions with viscosity of less than 1,000cps has poor stability [0015]. JIN (Pub. No.: US 2017/0367937; Pub Date Dec. 28, 2017) discloses stabilization of emulsion formulations require excessive amount of surfactant and decrease the flowability of emulsion particles as the viscosity is increased [0003]. Sono (EP 1,250,907; Pub. date: October 19, 2023 discloses an oil in water emulsion [0005] prepared by high shear emulsification produces microdroplets [0030] having a size range of 0.01 to 0.2 um but with a viscosity of 200 to 1,000,000 cps [0030]-[0035]. The state of the art, at the time of filing, was poorly developed with regard to achieving stable low viscosity oil in water emulsions with properties of the particles of instantly claimed size and amounts of surfactants, as confirmed by the lack examples and the state of the art. Accordingly, the specification does not appear to adequately describe the claimed genus.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004).
Vas-Cath Inc. V. Mahurkar, 19 USPQ2d 1111, states that Applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The courts have stated:
“To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (1997); In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (" [T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.” Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing characteristics of the genus. The factors to be considered include disclosure of structures, formulas, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. A description of a genus may be achieved by means of a recitation of a representative number of species falling within the scope of the genus or of a recitation of structural features common to the members of the genus, which features constitute a substantial portion of the genus.
In Regents of the University of California v. Eli Lilly & Co. the court stated:
“A written description of an invention involving a chemical genus, like a description of a chemical species, ‘requires a precise definition, such as by structure, formula, [or] chemical name,’ of the claimed subject matter sufficient to distinguish it from other materials.” Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) (“In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus …”) Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP does state that for generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. MPEP 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP 2163. Although the MPEP does not define what constitute a sufficient number of representative species, the Courts have indicated what do not constitute a representative number of species to adequately describe a broad generic. In Gostelli, the Court determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872 F.2d at 1012, 10 USPQ2d at 1618.
The Guidelines for Examination of Patent Applications Under 35 USC 112, ¶1, “Written Description” Requirement (Federal Register, Vol. 66, No. 4, pg. 1105, column 3), in accordance with MPEP § 2163, specifically state that for each claim drawn to a genus the written description requirement may be satisfied through sufficient description of a representative number of species by a) actual reduction to practice; b) reduction to drawings or structural chemical formulas; c) disclosure of relevant, identifying characteristics (ie. structure) by functional characteristics coupled with a known or disclosed correlation between function and structure.
The claims lack written description because the genus of compounds has substantial variance while the specification lacks sufficient variety of species to reflect the variance within the genus, and because of the lack of common structural attributes of the claimed genus/subgenus, combined with a correlation between structure and function. The specification does not tell one of ordinary skill what structural variation is permitted in the in each of the phases or the acceptable methods to obtain the instantly claimed properties. The different classes of chemical compounds that can be found in the phases would not be expected to act similarly. Applicant’s assumption that the very structurally different compounds will work the same way is scientifically unreasonable. As, different types of polymers have different complexities, different degrees of hydrophobicity and hydrophilicity, different functional groups, which result in different release profiles and efficacy it is scientifically unreasonable to conclude that every type of hydrophobic polymer and “hydrophilic polymer can be used in a polymeric nanocarrier.
In applications directed to inventions in arts where the results are unpredictable, the disclosure of a single species usually does not provide an adequate basis to support generic claims. In re Soll, 97 F.2d 623, 624, 38 USPQ 189, 191 (CCPA 1938).
A need for greater disclosure derives from the fact it is not obvious from the disclosure of one species, what other species will work. Generally speaking, the Courts recognize that predictability in chemical arts is low enough to require a highly detailed disclosure. Unpredictability arises in chemical arts because subtle changes in molecular structure may greatly impact a compound's structure-activity relationship, pharmacologic activity, and/or biologic profile. In drug development, the skilled artisan would not be able to easily extrapolate the biological activity from a single example or limited disclosure without more instruction. These considerations support a requirement for a disclosure with a high level of detail. In cases involving unpredictable factors, such as most chemical reactions and physiological activity, more may be required.
The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does "little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate"). Accordingly, it is deemed that the specification does not describe in sufficient detail the genus of compounds in the claims and how to make them and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
Applicant has shown possession of the singular formulation found in Table 1 produced in the manner disclosed for the formulation as set forth in the specification. Applicant has failed to show possession of the claimed an oil-in-water emulsion for topical use having a viscosity of 4.5 to 8 centipoise, which comprises by weight, based on total weight of the emulsion, one or more oils in the total amount of 15- 20% by weight, and one or more surfactants, the ratio of total oils:total surfactants being in the range of 3.8-7.5 :1, without providing an particular oils, surfactants, or product by process language that produces the instantly claimed range of a viscosity of 4.5 to 8 cps.
See also MPEP 2163 for a detailed discussion of guidelines concerning analysis of written description issues.
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 24 is 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 24 is directed to the use of the method of claim 21 for the formulation of an oil-in-water elusion composition. It is unclear to what statutory class this claim is direct to. “Use” is not a statutory class under 35 U.S.C. 101, the claim additionally incorporates both the method steps of claim 21 and the composition of the nanoparticles. It is unclear which statutory class this claim is directed to. Moreover, applicant elected the composition claim and the method claim of 24 is withdrawn. The metes and bounds of this claim cannot be determined.
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 1, 5, 8 and 26 are rejected under 35 U.S.C. 102(a)(1)as being anticipated by SCHAMBIL et al. (Pub No.: WO 89/11907; Pub Date: Dec. 14, 1989). While the SCHABIL EP publication relied upon for prior art is German and English translation has been provided. However, citations to figures and tables will be from the EP publication.
Regarding claims 1 and 5, SCHAMBIL discloses a stable low viscosity oil in water emulsion (title and abstract) for skin and hair treatment (page 3 bottom paragraph), wherein the composition comprises a surfactant of a non-ionic ethylene oxide added aliphatic alcohol or ester, and a co-emulsifier (page 3 paragraphs 6 to 10) wherein the weight of the oil in the composition is 20% and the weight of surfactant is 4% resulting in a weight ratio of oil to surfactant of Decyl oleate: stearyl alcohol 5:1 (Examples 2 and 3 as found in Tables 1 and II), which is within the instantly claimed range; and wherein the composition has a viscosity of 8 MPas (8 cps) (Table 2 formula 2) and 3% by weight of the natural moisturizer cetyl-stearyl alcohol (Table 1 formula 2).
Regarding claim 8, SCHAMBIL discloses a water in oil of claim 1 as set forth above with 20 wt% decyl oleate which has a density of 0.826 g/cm3 (Chemical Book),4 wt% stearyl alcohol which has a density of 0.812 g/cm3 (Chemical Book), 3 wt/% cetyl stearyl alcohol which has a density of 0.8 g/cm3 (Chemical Book) and 73 wt% water density 1 g/cm3. Utilizing the formula Density of the mixture = (total mass of solution)/(total volume); the total mass is the sum of mass of each component is (wt % x density). Accordingly the density of the mixture is .95168 g/cm3, when divided by the density of water 1 g/cm3 it equals a specific gravity of .95168 which is in the range of 0.95.
Regarding claim 26, this is a composition claim directed to an oil-in-water emulsion for use as a leave in product to remain on the keratinous tissue of the scalp. SCHAMBIL discloses an oil-on-water emulsion wherein the weight of the oil in the composition is 20% and the weight of surfactant is 4% resulting in a weight ratio of oil to surfactant of 5:1 (Examples 2 and 3 as found in Tables 1 and II), which is within the instantly claimed range; and wherein the composition has a viscosity of 8 MPas (8 cps) (Table 2 formula 2) for skin and hair treatment (page 3 bottom paragraph). As SCHAMBIL discloses an identical oil-in-water emulsion composition, it must necessarily be able to function as a leave in hair product that can be placed on the scalp. Applicant should note that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNA R FALKOWITZ whose telephone number is (571)270-3386. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/ANNA R FALKOWITZ/ Primary Examiner, Art Unit 1600
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