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 .
Status of Claims
Claims 1-12 are pending.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-11, in the reply filed on 21 November 2025 is acknowledged.
Applicant further elected Avena Sativa (Oat) Kernel flour, Avena Sativa (Oat) Kernel oil, and Avena Sativa (Oat) Kernel Extract as the species of ingredients in the first composition, Avena Sativa (Oat) Kernel Flour as the ingredient in the second composition, and balm dosage as the form for the first composition.
Claims 12 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 21 November 2025.
Claims 1-11 are examined herein to the extent that Avena Sativa (Oat) Kernel flour, Avena Sativa (Oat) Kernel oil, and Avena Sativa (Oat) Kernel Extract are the species of ingredients in the first composition, Avena Sativa (Oat) Kernel Flour is the ingredient in the second composition, and balm dosage form is the form for the first composition, e.g., applicant's elected species.
Information Disclosure Statement
The information disclosure statement (IDS) filed 05/22/2023 and 07/14/2023 have been considered by the Examiner. A signed and initialed copy of the IDS is included with the instant Office Action.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Rejections - 35 USC § 112
Scope of Enablement
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.
Claims 1-11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling application of a balm containing glycerin, aqua, cetearyl alcohol, isocetyl alcohol, dimethicone, cetyl alcohol, Avena sativa kernel flour, Avena sativa kernel extract, Avena sativa kernel oil, caprylic/capric triglyceride, ceramide 3, ethylhexylglycerin, p-anisic acid, sodium cetearyl sulfate, palmitic acid, stearic acid, sodium sulfate, sodium chloride, citric acid, dipotassium phosphate, potassium phosphate, sodium hydroxide, tocopherol, benzyl alcohol, benzoic acid, and potassium sorbate; and a wash that contains aqua, glycerin, cocamidopropyl betaine, sodium lauroamphoacetate, coco- glucoside, sodium chloride, hydroxypropyl starch phosphate, Avena sativa kernel flour, Aloe barbadensis leaf juice, Olea europaea leaf extract, Chamomilla recutita extract, Helianthus annuus seed oil, sarcosine, magnesium aspartate, potassium aspartate, polyquaternium-7, polysorbate 20 , sodium cocoyl amino acids, acrylates/C10-30 alkyl acrylate crosspolymer, propylene glycol, citric acid, sodium hydroxide, tocopherol, tocopheryl acetate, sodium benzoate, potassium sorbate, sodium sulfite and parfum, does not reasonably provide enablement for administering any “first composition”. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The factors to be considered in determining whether undue experimentation is required are summarized In re Wands 858 F.2d 731,8 USPQ2nd 1400 (Fed. Cir, 1988). The court in Wands states: "Enablement is not precluded by the necessity for some experimentation such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is 'undue,' not 'experimentation.'" (Wands, 8 USPQ2d 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. "Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations." (Wands, 8 USPQ2d 1404). The factors to be considered in determining whether undue experimentation is required include: (1) the quantity of experimentation necessary, (2) the amount or direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims. While all of these factors are considered, a sufficient amount for a prima facie case are discussed below.
Inventions targeted for disease prevention bear a heavy responsibility to provide supporting evidence because of the unpredictability in biological responses to therapeutic treatments. The standard of enablement is higher for such inventions because effective preventive treatments for disease conditions are relatively rare, and may be unbelievable in the absence of strong supporting evidence. Claims drawn to pharmaceutically acceptable compositions and to methods of administering compounds to humans which would ‘prevent' a condition generally require supporting evidence because of the unpredictability in biological responses to therapeutic treatments.
Wands now requires that one consider the number of working examples presented in the instant specification. It is noted that there is only one an example that comprises a regimen that includes a specific balm and a specific wash. Applicant demonstrated that a regimen that includes a twice daily whole body balm containing glycerin, aqua, cetearyl alcohol, isocetyl alcohol, dimethicone, cetyl alcohol, Avena sativa kernel flour, Avena sativa kernel extract, Avena sativa kernel oil, caprylic/capric triglyceride, ceramide 3, ethylhexylglycerin, p-anisic acid, sodium cetearyl sulfate, palmitic acid, stearic acid, sodium sulfate, sodium chloride, citric acid, dipotassium phosphate, potassium phosphate, sodium hydroxide, tocopherol, benzyl alcohol, benzoic acid, and potassium sorbate; and a daily wash that contains aqua, glycerin, cocamidopropyl betaine, sodium lauroamphoacetate, coco- glucoside, sodium chloride, hydroxypropyl starch phosphate, Avena sativa kernel flour, Aloe barbadensis leaf juice, Olea europaea leaf extract, Chamomilla recutita extract, Helianthus annuus seed oil, sarcosine, magnesium aspartate, potassium aspartate, polyquaternium-7, polysorbate 20 , sodium cocoyl amino acids, acrylates/C10-30 alkyl acrylate crosspolymer, propylene glycol, citric acid, sodium hydroxide, tocopherol, tocopheryl acetate, sodium benzoate, potassium sorbate, sodium sulfite and parfum; provides cumulative incidence of atopic dermatitis of 18.3% in the intervention group and 36.4% in the control group that corresponds to a 50% decreased risk of atopic dermatitis at 6 months in the intervention group (paragraphs [0085-0096], Figure 2). There is no indication in the instant specification that the composition of the instant claims (e.g., any “first composition”) can prevent the onset of or treat atopic dermatitis as recited in claims 1-11. Since there are only working examples a specific balm composition (paragraph [0085]) and a specific wash composition (paragraph [0086]), then one must consider the guidance provided by the instant specification and the prior art of record for preventing the onset of or treating atopic dermatitis.
As the state of the art reflects, there is no 100% prevention the onset of atopic dermatitis. According to Cleveland Clinic (webpage at URL: https://my.clevelandclinic.org/health/diseases/23408-baby-eczema, obtained on 12 December 2025, last reviewed 06/19/2025), because genetic factors contribute to eczema in babies, there’s no way to completely prevent the condition (see page 1/7). Therefore, the unpredictability with composition and regimen for prevention of the onset of atopic dermatitis is established in the state of the art.
While Applicants have shown that a regimen including a twice daily whole body balm containing glycerin, aqua, cetearyl alcohol, isocetyl alcohol, dimethicone, cetyl alcohol, Avena sativa kernel flour, Avena sativa kernel extract, Avena sativa kernel oil, caprylic/capric triglyceride, ceramide 3, ethylhexylglycerin, p-anisic acid, sodium cetearyl sulfate, palmitic acid, stearic acid, sodium sulfate, sodium chloride, citric acid, dipotassium phosphate, potassium phosphate, sodium hydroxide, tocopherol, benzyl alcohol, benzoic acid, and potassium sorbate; and a daily wash that contains aqua, glycerin, cocamidopropyl betaine, sodium lauroamphoacetate, coco- glucoside, sodium chloride, hydroxypropyl starch phosphate, Avena sativa kernel flour, Aloe barbadensis leaf juice, Olea europaea leaf extract, Chamomilla recutita extract, Helianthus annuus seed oil, sarcosine, magnesium aspartate, potassium aspartate, polyquaternium-7, polysorbate 20 , sodium cocoyl amino acids, acrylates/C10-30 alkyl acrylate crosspolymer, propylene glycol, citric acid, sodium hydroxide, tocopherol, tocopheryl acetate, sodium benzoate, potassium sorbate, sodium sulfite and parfum; provides cumulative incidence of atopic dermatitis of 18.3% in the intervention group and 36.4% in the control group that corresponds to a 50% decreased risk of atopic dermatitis at 6 months in the intervention group (paragraphs [0085-0096], Figure 2), Applicants have not provided guidance with regard preventing the onset of or treating atopic dermatitis with any “first composition”. No absolute nexus has been provided within the instant specification as filed between a “first composition”, wherein the “first composition” prevents the onset of or treats atopic dermatitis.
The high degree of unpredictability associated with the claimed method underscores the need to provide teachings in the specification that would provide the skilled artisan with specific treatment regimens that achieve preventative benefit by in vivo therapy; however, the specification does not provide such guidance. Without such guidance in the specification and the lack of correlative working examples, to use the invention as instantly claimed would require an undue amount of experimentation without a predictable degree of success on the part of the skilled artisan. This experimentation would be undue considering the rigorous, time-consuming trial and error protocols which need to be performed in order to ascertain if the composition of the instant claims will actually treat or prevent all viral infection or a symptom thereof.
Therefore, it is suggested that the claims be amended to read that the specific composition in paragraphs [0085] and [0086] which are administered as a regimen to obtain a 50% decreased risk of atopic dermatitis at 6 months in order to overcome this rejection.
In re Fisher, 427 F.2d 833, 166 USPQ 18 (CCPA 1970), held that
"Inventor should be allowed to dominate future patentable inventions of others where those inventions were based in some way on his teachings, since such improvements while unobvious from his teachings, are still within his contribution, since improvement was made possible by his work; however, he must not be permitted to achieve this dominance by claims which are insufficiently supported and, hence, not in compliance with first paragraph of 35 U.S.C. 112; that paragraph requires that scope of claims must bear a reasonable correlation to scope of enablement provided by specification to persons of ordinary skill in the art; in cases involving predictable factors, such as mechanical or electrical elements, a single embodiment provides broad enablement in the sense that, once imagined, other embodiments can be made without difficulty and their performance characteristics predicted by resort to known scientific law; in cases involving unpredictable factors, such as most chemical reactions and physiological activity, scope of enablement varies inversely with degree of unpredictability of factors involved."
Claims 1-6 and 11 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.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, at the time the invention was made, of the specific subject matter claimed. 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 (Fed. Cir. 1997); In re Gostelli, 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.
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co. the court stated:
The factors considered in the Written Description requirement are (1) level of skill and knowledge in the art, (2) partial structure, (3) physical and/or chemical properties, (4) functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the (5) method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient." MPEP § 2163.
In the instant case, the claims are interpreted as being drawn to a method for preventing the onset of or treating atopic dermatitis in a subject that comprises administration of a first composition to the subject at least once a day, wherein the first composition is administered tot the subject starting from within about four days after birth of the subject and continues to at least about two months after birth of the subject.
(1) Level of skill and knowledge in the art:
The level of skill and knowledge in the art is high due to the large amounts of different compositions used to treat atopic dermatitis and no current compositions available that provides absolute prevention of atopic dermatitis.
(2) Partial structure:
The “first composition” and the “second composition” recited in claims 1-6 and 11, respectively, are not limited by any particular ingredients that are present in the “first composition” and the “second composition”.
(3) Physical and/or chemical properties:
The “first composition” and the “second composition” are administered for preventing the onset of or treating atopic dermatitis in a subject.
(4) Functional characteristics:
Different people have different triggers and underlying combinations of genetic and environmental factors causing their atopic dermatitis and need different compositions for treatment.
(5) Method of making the claimed invention:
No particular method is disclosed in the instant specification for making the “first composition” or the “second composition”. The instant specification only discloses the particular ingredients in the “first composition” or the “second composition”. The instant specification discloses that the balm (e.g., “first composition”) contains glycerin, aqua, cetearyl alcohol, isocetyl alcohol, dimethicone, cetyl alcohol, Avena sativa kernel flour, Avena sativa kernel extract, Avena sativa kernel oil, caprylic/capric triglyceride, ceramide 3, ethylhexylglycerin, p-anisic acid, sodium cetearyl sulfate, palmitic acid, stearic acid, sodium sulfate, sodium chloride, citric acid, dipotassium phosphate, potassium phosphate, sodium hydroxide, tocopherol, benzyl alcohol, benzoic acid, and potassium sorbate; and that the daily wash composition (e.g., “second composition”) contains aqua, glycerin, cocamidopropyl betaine, sodium lauroamphoacetate, coco- glucoside, sodium chloride, hydroxypropyl starch phosphate, Avena sativa kernel flour, Aloe barbadensis leaf juice, Olea europaea leaf extract, Chamomilla recutita extract, Helianthus annuus seed oil, sarcosine, magnesium aspartate, potassium aspartate, polyquaternium-7, polysorbate 20 , sodium cocoyl amino acids, acrylates/C10-30 alkyl acrylate crosspolymer, propylene glycol, citric acid, sodium hydroxide, tocopherol, tocopheryl acetate, sodium benzoate, potassium sorbate, sodium sulfite and parfum.
While having written description of administration of balm (e.g., “first composition”) contains glycerin, aqua, cetearyl alcohol, isocetyl alcohol, dimethicone, cetyl alcohol, Avena sativa kernel flour, Avena sativa kernel extract, Avena sativa kernel oil, caprylic/capric triglyceride, ceramide 3, ethylhexylglycerin, p-anisic acid, sodium cetearyl sulfate, palmitic acid, stearic acid, sodium sulfate, sodium chloride, citric acid, dipotassium phosphate, potassium phosphate, sodium hydroxide, tocopherol, benzyl alcohol, benzoic acid, and potassium sorbate; and that the daily wash composition (e.g., “second composition”) contains aqua, glycerin, cocamidopropyl betaine, sodium lauroamphoacetate, coco- glucoside, sodium chloride, hydroxypropyl starch phosphate, Avena sativa kernel flour, Aloe barbadensis leaf juice, Olea europaea leaf extract, Chamomilla recutita extract, Helianthus annuus seed oil, sarcosine, magnesium aspartate, potassium aspartate, polyquaternium-7, polysorbate 20 , sodium cocoyl amino acids, acrylates/C10-30 alkyl acrylate crosspolymer, propylene glycol, citric acid, sodium hydroxide, tocopherol, tocopheryl acetate, sodium benzoate, potassium sorbate, sodium sulfite and parfum, to infant at high-risk of atopic dermatitis to provide a 50% risk of atopic dermatitis at 6 months, the specification is devoid of preventing the onset or treating atopic dermatitis by administering any “first composition” alone or with any “second composition”.
The description requirement of the patent statue 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 fails to provide adequate written description for the genus of the claims 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.
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 1-11 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 1 and dependent claims 2-11 are indefinite for claiming both a composition and a method in a single claim. The term regimen includes a prescribed course of medical treatment, diet, or exercise for the promotion or restoration of health. It is unclear whether infringement occurs when one creates the “first composition” or whether infringement occurs when the “first composition” is administered for preventing or treating atopic dermatitis in a subject. In favor of compact prosecution, the claims are interpreted and examined as method claims.
See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303 (Fed. Cir. 2011). In Katz, a claim directed to “A system with an interface means for providing automated voice messages…to certain of said individual callers, wherein said certain of said individual callers digitally enter data” was determined to be indefinite because the italicized claim limitation is not directed to the system, but rather to actions of the individual callers, which creates confusion as to when direct infringement occurs. In re Katz, 639 F.3d at 1318 (citing IPXL Holdings v. Amazon.com, Inc., 430 F.2d 1377, 1384, 77 USPQ2d 1140, 1145 (Fed. Cir. 2005), in which a system claim that recited “an input means” and required a user to use the input means was found to be indefinite because it was unclear “whether infringement … occurs when one creates a system that allows the user [to use the input means], or whether infringement occurs when the user actually uses the input means.”); < Ex parte Lyell, 17 USPQ2d 1548 (Bd. Pat. App. & Inter. 1990) (claim directed to an automatic transmission workstand and the method of using it held ambiguous and properly rejected under 35 U.S.C. 112, second paragraph). MPEP 2173.05(p).
Claims 3 recites “administered to the whole body of the subject” which makes claim 3 indefinite because it is unclear if the recitation means administration to only skin surfaces or include other parts of the body including eyes, organs, etc.
Claims 4-6 recites “standard routine care” which renders the claims indefinite because it is unclear what “standard routine care” means. The term “standard routine care” is not defined in the instant specification.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 10 recites the broad recitation a first “preferably…” amount for a.-q., and the claim also recites a second “preferably…” amount for a.-q. which is the narrower statement of the range/limitation, respectively. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim Rejections - 35 USC § 102
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.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by CRANE (“The struggle is real: a parent’s guide to caring for kids with eczema”, electronic article from National Eczema Association webpage at URL https://nationaleczema.org/blog/parenting-eczema-kids/, last updated on 13 July 2021, obtained on 12 December 2025).
Regarding instant claim 1, Crane discloses that benefits of moisturizing the skin of high-risk infants as early as two days after birth (e.g., within about four days after birth) has been explored in a published study and that the author of the published study found that daily moisturizing (e.g., at least once a day) with a petroleum- or planted-based emollient (e.g., first composition) reduced AD risk by 50 percent by the time the babies reached 6 months old (e.g., preventing the onset of atopic dermatitis in a subject and at least about two months after birth of the subject).
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.
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 1-3 and 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over CRANE (“The struggle is real: a parent’s guide to caring for kids with eczema”, electronic article from National Eczema Association webpage at URL https://nationaleczema.org/blog/parenting-eczema-kids/, last updated on 13 July 2021, obtained on 12 December 2025) in view of BARNES (US 8,808,759 B1; patent date of 19 August 2014) and OSORIO (US 2019/0374591 A1, publication date of 12 December 2019).
Applicant is reminded that although a claimed invention can be obvious but not anticipated,
it “cannot have been anticipated and not have been obvious.” In re Fracalossi, 681 F.2d 792, 794 [215 USPQ 569] (CCPA 1982) (emphasis added). Indeed, this court has repeatedly emphasized that “a disclosure that anticipates … also renders the claim invalid under §103, for anticipation is the epitome of obviousness.” Connell v. Sears, Roebuck & Co., 722 F.2d 1542, 1548 [220 USPQ 193] (Fed. Cir. 1983).
Crane is primarily directed towards caring for kids with eczema (see entire electronic article).
Regarding instant claim 1, Crane discloses that benefits of moisturizing the skin of high-risk infants as early as two days after birth (e.g., within about four days after birth) has been explored in a published study and that the author of the published study found that daily moisturizing (e.g., at least once a day) with a petroleum- or planted-based emollient (e.g., first composition) reduced AD risk by 50 percent by the time the babies reached 6 months old (e.g., preventing the onset of atopic dermatitis in a subject and at least about two months after birth of the subject).
Crane does not specifically teach that the composition administered comprises Avena sativa (oat) kernel flour, Avena sativa (oat) kernel extract and Avena sativa (oat) kernel oil (e.g., elected species of ingredients in first composition). The deficiencies are made up for by the teachings of Barnes and Osorio.
Barnes is primarily directed towards preparation containing colloidal materials including colloidal oatmeal for treating skin and ameliorating skin disorder symptoms (abstract).
Regarding claims 1 and 7-10, Barnes teaches that colloidal material is characterized by presenting particles which are approximately 10 to 1,000 nanometers is size (column 1, lines 27-29). Barnes teaches colloidal oatmeal, a product processed by grinding of the oat grain has been recommended for including infants in lotions, creams and ointments (paragraph bridging columns 2 and 3). Barnes teaches that Oat derived colloidal oatmeal is devised for external application to the affected area of the body by applying directly to the desired area for treating skin discomforts as well as maintaining normal skin. Barnes teaches that colloidal oatmeal is considered safe at all concentrations as an effective agent for symptomatic relief and treatment of dry skin and the resulting itching (column 3, lines 3-11). Barnes teaches a composition that can be used to treat eczema (column 8, lines 6-7) that comprises more than 1% (w/w) colloidal oatmeal (e.g., Avena sativa (Oat) kernel flour) (column 8, lines 13-14). Barnes teaches adding moisturizing components to the composition in amounts including 0.1 to 5% w/w and that the moisturizing component includes Avena sativa (Oat) kernel extract (column 7, lines 49-54).
Osorio is primarily directed towards topical skincare composition for treating symptoms of including itch, redness, flaking, dryness, and/or roughness of the skin (abstract).
Regarding claims 1 and 7-10, Osorio teaches a topical skincare composition capable of alleviating symptoms associated with including atopic dermatitis that comprises including Avena sativa (oat) kernel extract and Avena sativa (oat) oil (paragraph [0009]). Osorio teaches that Avena (oat) extract relieve symptoms of challenged skin by suppressing nuclear factor-kappaB (NFκB) activation, a transcription factor that activated inflammatory response (paragraph [0032]). Osorio teaches that Avena (oat) extract is present in the topical skincare composition at an amount of from about 0.0001% to about 25% (paragraphs [0041-0042]). Osorio teaches that Avena (oat) extract is selected from a group that includes Avena (oat) kernel extract, Avena (oat) kernel flour and Avena (oat) kernel oil (paragraph [0044]). Thus, the amounts of including Avena sativa (oat) kernel flour, Avena sativa (oat) kernel extract and Avena sativa (oat) kernel oil in the instant claim 10 of “from about 0.0% to about 2.0%”, “from about 0.0% to about 1.0%” and “from about 0.0% to about 1.0%”, respectively, are rendered prima facie obvious. See In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See also MPEP 2144.05.
Regarding claim 2, Osorio teaches applying the topical composition to the portion of the skin in need thereof that is repeated at least once within a twenty-four hour time period (paragraph [0102]).
Regarding claim 3, Osorio teaches that the skin in need includes the skin all over the body (paragraph [0099]).
It would have been prima facie obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to substitute in Avena sativa (oat) kernel extract including Avena (oat) extract is selected from a group that includes Avena (oat) kernel extract, Avena (oat) kernel flour and Avena (oat) kernel oil as the moisturizer in a topical composition to administer to a baby as early as two days after birth up to at least 6 months to reduce the risk of atopic dermatitis or treat atopic dermatitis of the baby; wherein the amount of the Avena sativa (oat) kernel extract including Avena (oat) extract is selected from a group that includes Avena (oat) kernel extract, Avena (oat) kernel flour and Avena (oat) kernel oil Avena sativa (oat) kernel extract including Avena (oat) extract is selected from a group that includes Avena (oat) kernel extract, Avena (oat) kernel flour and Avena (oat) kernel oil is from about 0.0001% to about 25%. The person of ordinary skill in the art would have been motivated to make those modifications in order to provide additional effects by using Avena sativa (oat) kernel extract including Avena (oat) extract is selected from a group that includes Avena (oat) kernel extract, Avena (oat) kernel flour and Avena (oat) kernel oil which in addition to providing moisturization also provides relief of symptoms of challenged skin by suppressing nuclear factor-kappaB (NFκB) activation, a transcription factor that activated inflammatory response and is safe. The person of ordinary skill in the art would have reasonably expected success because Crane discloses that benefits of moisturizing the skin of high-risk infants as early as two days after birth (e.g., within about four days after birth) has been explored in a published study and that the author of the published study found that daily moisturizing (e.g., at least once a day) with a petroleum- or planted-based emollient (e.g., first composition) reduced AD risk by 50 percent by the time the babies reached 6 months old (e.g., preventing the onset of atopic dermatitis in a subject and at least about two months after birth of the subject). Barnes teaches that Oat derived colloidal oatmeal is devised for external application to the affected area of the body by applying directly to the desired area for treating skin discomforts as well as maintaining normal skin. Barnes teaches that colloidal oatmeal is considered safe at all concentrations as an effective agent for symptomatic relief and treatment of dry skin and the resulting itching (column 3, lines 3-11). Barnes teaches a composition that can be used to treat eczema (column 8, lines 6-7) that comprises more than 1% (w/w) colloidal oatmeal (e.g., Avena sativa (Oat) kernel flour) (column 8, lines 13-14). Barnes teaches adding moisturizing components to the composition in amounts including 0.1 to 5% w/w and that the moisturizing component includes Avena sativa (Oat) kernel extract (column 7, lines 49-54). Osorio teaches a topical skincare composition capable of alleviating symptoms associated with including atopic dermatitis that comprises including Avena sativa (oat) kernel extract and Avena sativa (oat) oil (paragraph [0009]). Osorio teaches that Avena (oat) extract relieve symptoms of challenged skin by suppressing nuclear factor-kappaB (NFκB) activation, a transcription factor that activated inflammatory response (paragraph [0032]). Osorio teaches that Avena (oat) extract is present in the topical skincare composition at an amount of from about 0.0001% to about 25% (paragraphs [0041-0042]). Osorio teaches that Avena (oat) extract is selected from a group that includes Avena (oat) kernel extract, Avena (oat) kernel flour and Avena (oat) kernel oil (paragraph [0044]). Osorio teaches a topical skincare composition capable of alleviating symptoms associated with including atopic dermatitis that comprises including Avena sativa (oat) kernel extract and Avena sativa (oat) oil (paragraph [0009]). Osorio teaches that Avena (oat) extract relieve symptoms of challenged skin by suppressing nuclear factor-kappaB (NFκB) activation, a transcription factor that activated inflammatory response (paragraph [0032]). Osorio teaches that Avena (oat) extract is present in the topical skincare composition at an amount of from about 0.0001% to about 25% (paragraphs [0041-0042]). Osorio teaches that Avena (oat) extract is selected from a group that includes Avena (oat) kernel extract, Avena (oat) kernel flour and Avena (oat) kernel oil (paragraph [0044]).
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Crane in view of Barnes and Osorio as applied to claims 1-3 and 7-10 above, and further in view of CAPONE (US 2020/0360259 A1, publication date of 19 November 2020, cited in IDS filed 05/22/2023), IFTIKHAR (“Oatmeal Baths for Babies: How-To, Benefits, and More”, electronic article at healthline.com, URL: https://www.healthline.com/health/baby/oatmeal-bath-for-babies, medically reviewed 17 September 2020, obtained on 12 December 2025) and NORTHWESTERN MEDICINE (“Newborn Hygiene”, electronic publication at www.nm.org, URL: https://www.nm.org/conditions-and-care-areas/pediatrics/pediatric-infant-and-newborn-care/hygiene, oldest capture from Wayback Machine is 27 June 2019, obtained on 12 December 2025; hereafter Northwestern).
Regarding claims 4-5, the method of claim 1 is described above in section 15.
Regarding claims 4, Barnes teaches adding moisturizing components includes Avena sativa (Oat) kernel extract (column 7, lines 49-54). Osorio teaches that Avena (oat) extract relieve symptoms of challenged skin by suppressing nuclear factor-kappaB (NFκB) activation, a transcription factor that activated inflammatory response (paragraph [0032]). Osorio teaches that Avena (oat) extract is selected from a group that includes Avena (oat) kernel extract, Avena (oat) kernel flour and Avena (oat) kernel oil (paragraph [0044]).
Crane, Barnes and Osorio do not specifically teach administering a second composition to the subject in accordance with standard routine care; wherein the standard routine care is administration two to three times a week. The deficiency is made up for by the teachings of Capone, Iftikhar and Northwestern.
Capone is primarily directed towards method of selecting skin treatment regimens, ingredients and compositions (abstract).
Regarding claim 4, Capone teaches mild infant wash with addition of lotion routine best help improve microbial richness, which may contribute to overall skin barrier health by providing the right environment for healthy skin microbes to flourish (paragraph [0023]).
Iftikhar is primarily directed towards oatmeal baths for babies (see entire copy of the electronic article).
Regarding claim 4, Iftikhar teaches that adding oatmeal to baby’s bath can help remedy dry, flaky, or itchy skin (see page 1 of the copy of the electronic article).
Northwestern is primarily directed towards newborn hygiene care (see entire copy of the electronic article).
Regarding claim 5, Northwestern teaches that newborn babies should be bathed one to two times a week because bathing more than this can dry out their skin (see first page of the copy of the electronic article).
It would have been prima facie obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to administer a topical composition comprising Avena sativa (oat) kernel extract including Avena (oat) extract is selected from a group that includes Avena (oat) kernel extract, Avena (oat) kernel flour and Avena (oat) kernel oil, to a baby as early as two days after birth up to at least 6 months to reduce the risk of atopic dermatitis or treat atopic dermatitis of the baby; and further include bathing the baby with a second composition that contains Avena (oat) extract is selected from a group that includes Avena (oat) kernel extract, Avena (oat) kernel flour and Avena (oat) kernel oil; wherein the amount of the Avena sativa (oat) kernel extract including Avena (oat) extract is selected from a group that includes Avena (oat) kernel extract, Avena (oat) kernel flour and Avena (oat) kernel oil Avena sativa (oat) kernel extract including Avena (oat) extract is selected from a group that includes Avena (oat) kernel extract, Avena (oat) kernel flour and Avena (oat) kernel oil is from about 0.0001% to about 25%; wherein the second composition is used to bath the baby one to two times a week. The person of ordinary skill in the art would have been motivated to make those modifications to: 1) improve microbial richness on the skin of the baby by including bath, which Capone teaches help improve microbial richness when used along with a lotion; 2) include an oat material including Avena (oat) extract is selected from a group that includes Avena (oat) kernel extract, Avena (oat) kernel flour and Avena (oat) kernel oil in the bath composition to further provide including moisturization; and 3) bath the baby only one to two times to avoid opposing effect of causing dry skin by bathing too much. The person of ordinary skill in the art would have reasonably expected success because Barnes teaches adding moisturizing components includes Avena sativa (Oat) kernel extract (column 7, lines 49-54). Osorio teaches that Avena (oat) extract relieve symptoms of challenged skin by suppressing nuclear factor-kappaB (NFκB) activation, a transcription factor that activated inflammatory response (paragraph [0032]). Osorio teaches that Avena (oat) extract is selected from a group that includes Avena (oat) kernel extract, Avena (oat) kernel flour and Avena (oat) kernel oil (paragraph [0044]). Capone teaches mild infant wash with addition of lotion routine best help improve microbial richness, which may contribute to overall skin barrier health by providing the right environment for healthy skin microbes to flourish (paragraph [0023]). Iftikhar teaches that adding oatmeal to baby’s bath can help remedy dry, flaky, or itchy skin (see page 1 of the copy of the electronic article). Northwestern teaches that newborn babies should be bathed one to two times a week because bathing more than this can dry out their skin (see first page of the copy of the electronic overview).
Claims 4 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Crane in view of Barnes and Osorio as applied to claims 1-3 and 7-10 above, and further in view of CAPONE (US 2020/0360259 A1, publication date of 19 November 2020, cited in IDS filed 05/22/2023) and IFTIKHAR (“Oatmeal Baths for Babies: How-To, Benefits, and More”, electronic article at healthline.com, URL: https://www.healthline.com/health/baby/oatmeal-bath-for-babies, medically reviewed 17 September 2020, obtained on 12 December 2025).
Regarding claims 4 and 6, the method of claim 1 is described above in section 15.
Regarding claims 4, Barnes teaches adding moisturizing components includes Avena sativa (Oat) kernel extract (column 7, lines 49-54). Osorio teaches that Avena (oat) extract relieve symptoms of challenged skin by suppressing nuclear factor-kappaB (NFκB) activation, a transcription factor that activated inflammatory response (paragraph [0032]). Osorio teaches that Avena (oat) extract is selected from a group that includes Avena (oat) kernel extract, Avena (oat) kernel flour and Avena (oat) kernel oil (paragraph [0044]).
Crane, Barnes and Osorio do not specifically teach administering a second composition to the subject in accordance with standard routine care, wherein the standard routine care is administration daily. The deficiency is made up for by the teachings of Capone and Iftikhar.
Capone is primarily directed towards method of selecting skin treatment regimens, ingredients and compositions (abstract).
Regarding claim 4, Capone teaches mild infant wash with addition of lotion routine best help improve microbial richness, which may contribute to overall skin barrier health by providing the right environment for healthy skin microbes to flourish (paragraph [0023]).
Regarding claim 6, Capone teaches applying skin treatment regimen (e.g., wash + lotion) at least once daily (paragraph [0098]).
Iftikhar is primarily directed towards oatmeal baths for babies (see entire copy of the electronic article).
Regarding claim 4, Iftikhar teaches that adding oatmeal to baby’s bath can help remedy dry, flaky, or itchy skin (see page 1 of the copy of the electronic article).
It would have been prima facie obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to administer a topical composition comprising Avena sativa (oat) kernel extract including Avena (oat) extract is selected from a group that includes Avena (oat) kernel extract, Avena (oat) kernel flour and Avena (oat) kernel oil, to a baby as early as two days after birth up to at least 6 months to reduce the risk of atopic dermatitis or treat atopic dermatitis of the baby; and further include bathing the baby with a second composition that contains Avena (oat) extract is selected from a group that includes Avena (oat) kernel extract, Avena (oat) kernel flour and Avena (oat) kernel oil; wherein the amount of the Avena sativa (oat) kernel extract including Avena (oat) extract is selected from a group that includes Avena (oat) kernel extract, Avena (oat) kernel flour and Avena (oat) kernel oil Avena sativa (oat) kernel extract including Avena (oat) extract is selected from a group that includes Avena (oat) kernel extract, Avena (oat) kernel flour and Avena (oat) kernel oil is from about 0.0001% to about 25%; wherein the second composition is used to bath the baby daily. The person of ordinary skill in the art would have been motivated to make those modifications to: 1) improve microbial richness on the skin of the baby by including bath, which Capone teaches help improve microbial richness when used along with a lotion; and 2) include an oat material including Avena (oat) extract is selected from a group that includes Avena (oat) kernel extract, Avena (oat) kernel flour and Avena (oat) kernel oil in the bath composition to further provide including moisturization. The person of ordinary skill in the art would have reasonably expected success because Barnes teaches adding moisturizing components includes Avena sativa (Oat) kernel extract (column 7, lines 49-54). Osorio teaches that Avena (oat) extract relieve symptoms of challenged skin by suppressing nuclear factor-kappaB (NFκB) activation, a transcription factor that activated inflammatory response (paragraph [0032]). Osorio teaches that Avena (oat) extract is selected from a group that includes Avena (oat) kernel extract, Avena (oat) kernel flour and Avena (oat) kernel oil (paragraph [0044]). Capone teaches mild infant wash with addition of lotion routine best help improve microbial richness, which may contribute to overall skin barrier health by providing the right environment for healthy skin microbes to flourish (paragraph [0023]). Iftikhar teaches that adding oatmeal to baby’s bath can help remedy dry, flaky, or itchy skin (see page 1 of the copy of the electronic article).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Crane in view of Barnes and Osorio as applied to claims 1-3 and 7-10 above, and further in view of ROCKETPURE (“Balm, Cream or Lotion. What’s the Difference?”, electronic article at rocketpure.com, URL: https://rocketpure.com/blogs/news/balm-lotion-or-cream-what-s-the-difference#:~:text=Balm:%20Balms%20are%20typically%20plant,job%20at%20nourishing%20your%20skin., 31 January 2020, obtained on 12 December 2025).
Regarding claim 11, the method of claim 1 is described above in section 15.
Crane, Barnes and Osorio do not specifically teach that the composition is in the form of a balm. The deficiency is made up for by the teachings of Rocketpure.
Rocketpure is primarily directed towards use of lotion, cream or balm for skin (see entire copy of the electronic article).
Regarding claim 11, Rocketpure teaches that balm is recommended over cream and lotion because balm is thicker, provides soothing consistency and does not contain alcohol which dries out the skin (third page, of the copy of the electronic article).
It would have been prima facie obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to administer a topical composition comprising Avena sativa (oat) kernel extract including Avena (oat) extract is selected from a group that includes Avena (oat) kernel extract, Avena (oat) kernel flour and Avena (oat) kernel oil, to a baby as early as two days after birth up to at least 6 months to reduce the risk of atopic dermatitis or treat atopic dermatitis of the baby; wherein the amount of the Avena sativa (oat) kernel extract including Avena (oat) extract is selected from a