FINAL 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
Receipt is acknowledged of the claim amendments filed on 18 May 2026.
Claims 1, 3-6, 10 have been amended.
Claims 2, 7-9 and 11-12 are cancelled.
Claims 13-17 have been added.
Claims 13 and 17 are withdrawn from consideration for being drawn to nonelected species.
Claims 1, 3-6, 10 and 14-16 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.
Specification
The amendment to the specification filed 18 May 2026 contains an error for the amendment on page 28, which includes “doi.org/10.1111/jdv.17675.1” but should actually be “doi.org/10.1111/jdv.17675.6”.
Rejections Withdrawn
The rejection of claims 1-11 under 35 U.S.C. 112(a), for scope of enablement, is withdrawn in view of the claim amendments filed on 18 May 2026.
The rejection of claims 1-6 and 11 under 35 U.S.C. 112(a), as failing to comply with the written description requirement, is withdrawn in view of the claim amendments filed on 18 May 2026.
The rejection of claims 1-9 and 11 under U.S.C. 112(b), as being indefinite, is withdrawn in view of the claim amendments filed on 18 May 2026.
The rejection of claim 1 under 35 U.S.C. 102(b) 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https://nationaleczema.org/blog/parenting-eczema-kids/, last updated on 13 July 2021, obtained on 12 December 2025), is withdrawn in view of the claim amendments filed on 18 May 2026.
Rejections Modified and Maintained as Necessitated by the Claim Amendments
Claim Rejections - 35 USC § 112
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 10 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.
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 amount range for ingredients a.-q., and the claim also recites a “preferably…” amount for ingredients 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 § 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 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), OSORIO (US 2019/0374591 A1, publication date of 12 December 2019) and 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).
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., reducing the risk of atopic dermatitis in a subject and at least about two months after birth of the subject) (third paragraph on page 2/7).
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). Crane does not specifically teach that the composition is in the form of a balm. The deficiencies are made up for by the teachings of Barnes, Osorio and Rocketpure.
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 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 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. 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]).
Rocketpure is primarily directed towards use of lotion, cream or balm for skin (see entire copy of the electronic article).
Regarding claim 1, 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 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%; and wherein the topical composition is in the form of a balm. 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; and to obtain a treatment with enhanced efficiency including is thicker and provides soothing consistency by using a balm formulation, as taught by Rocketpure. 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., reducing the risk of atopic dermatitis in a subject and at least about two months after birth of the subject) (third paragraph on page 2/7). 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]). 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).
Claims 4-5 and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Crane in view of Barnes, Osorio and Rocketpure as applied to claims 1, 3 and 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 and 14-16, the method of claim 1 is described above in section 10.
Regarding claims 4 and 16, 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, Osorio and Rocketpure 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 claims 4 and 15, 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 claims 4 and 16, 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).
Regarding claim 14, 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., results in a 50% decreased risk of atopic dermatitis at 6 months) (third paragraph on page 2/7).
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).
Regarding claim 14, 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., results in a 50% decreased risk of atopic dermatitis at 6 months) (third paragraph on page 2/7). Therefore, in light of the disclosure by Crane and the teachings of Barnes, Osorio, Rocketpure, Capone, Iftikhar and Northwestern, 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 (third paragraph on page 2/7 of Crane; column 3, lines 3-11; column 8, lines 6-7; column 8, lines 13-14; column 7, lines 49-54 of Barnes; paragraphs [0009], [0032], [0041-0042] and [0044] of Osorio [0009]); third page, of the copy of the electronic article of Rocketpure; column 7, lines 49-54 of Barnes; paragraphs [0032] and [0044]) of Osorio; paragraph [0023] of Capone; page 1 of the copy of the electronic article of Iftikhar; and first page of the copy of the electronic overview of Northwestern); which appears to be the same as the prior art, absent a showing of unobvious differences. The office does not have the facilities and resources to provide the factual evidence needed in order to establish that the composition of the prior art does not possess the same material, structural and steps-like characteristics of the claimed composition. In the absence of evidence to the contrary, the burden is on Applicant to prove that the claimed composition is different from that taught by the prior art and to establish patentable differences. See In re Best 562F .2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2nd 1992 (PTO Bd. Pat. App. & Int. 1989).
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Claims were directed to a titanium alloy containing 0.2-0.4% Mo and 0.6-0.9% Ni having corrosion resistance. A Russian article disclosed a titanium alloy containing 0.25% Mo and 0.75% Ni but was silent as to corrosion resistance. The Federal Circuit held that the claim was anticipated because the percentages of Mo and Ni were squarely within the claimed ranges. The court went on to say that it was immaterial what properties the alloys had or who discovered the properties because the composition is the same and thus must necessarily exhibit the properties.). MPEP 2112.01 (I).
Claims 4, 6 and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Crane in view of Barnes, Osorio and 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, 6 and 14-16, the method of claim 1 is described above in section 10.
Regarding claims 4 and 16, 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, Osorio and Rocketpure do not specifically teach administering a second composition to the subject. 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 claims 4, 6 and 15, 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]). 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 claims 4 and 16, 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).
Regarding claim 14, 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., results in a 50% decreased risk of atopic dermatitis at 6 months) (third paragraph on page 2/7). Therefore, in light of the disclosure by Crane and the teachings of Barnes, Osorio, Rocketpure, Capone and Iftikhar, 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 (third paragraph on page 2/7 of Crane; column 3, lines 3-11; column 8, lines 6-7; column 8, lines 13-14; column 7, lines 49-54 of Barnes; paragraphs [0009], [0032], [0041-0042] and [0044] of Osorio [0009]); third page, of the copy of the electronic article of Rocketpure; column 7, lines 49-54 of Barnes; paragraphs [0032] and [0044]) of Osorio; paragraph [0023] of Capone; and page 1 of the copy of the electronic article of Iftikhar); which appears to be the same as the prior art, absent a showing of unobvious differences. The office does not have the facilities and resources to provide the factual evidence needed in order to establish that the composition of the prior art does not possess the same material, structural and steps-like characteristics of the claimed composition. In the absence of evidence to the contrary, the burden is on Applicant to prove that the claimed composition is different from that taught by the prior art and to establish patentable differences. See In re Best 562F .2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2nd 1992 (PTO Bd. Pat. App. & Int. 1989).
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Claims were directed to a titanium alloy containing 0.2-0.4% Mo and 0.6-0.9% Ni having corrosion resistance. A Russian article disclosed a titanium alloy containing 0.25% Mo and 0.75% Ni but was silent as to corrosion resistance. The Federal Circuit held that the claim was anticipated because the percentages of Mo and Ni were squarely within the claimed ranges. The court went on to say that it was immaterial what properties the alloys had or who discovered the properties because the composition is the same and thus must necessarily exhibit the properties.). MPEP 2112.01 (I).
Response to Arguments
Applicant argues that the cited reference do not teach or suggest regimens as instantly claimed which reduce the risk of incidence of atopic dermatitis. Applicant argues that the instant specification reflects that the scientific and medical literature is inconsistent, with multiple large, randomized studies showing no preventive effect of early emollient use in infants and meta-analyses concluding that such interventions do not reduce the onset of atopic dermatitis. Applicant argues that a person of ordinary skill in the art would lack any reasonable expectation that modifying Crane’s general teaching with the composition ingredients of Barnes and Osario would achieve the claimed effect. Applicant argues that Barnes and Osorio are directed to treatment or alleviation of skin symptoms and do not disclose or suggest reducing the risk of atopic dermatitis.
Applicant's arguments filed on 18 May 2026 have been fully considered but they are not persuasive. In response, 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., reducing the risk of atopic dermatitis in a subject and at least about two months after birth of the subject) (third paragraph on page 2/7). 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 selected from a group that includes Avena (oat) kernel extract, Avena (oat) kernel flour and Avena (oat) kernel oil (paragraph [0044]). 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). 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). Therefore, in light of the disclosure of Crane and the teachings of Barnes, Osoria, Capone and Iftikhar, 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%. 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, as taught by Barnes and Osoria, respectively; to obtain a treatment with enhanced efficiency including is thicker and provides soothing consistency by using a balm formulation, as taught by Rocketpure; to 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 provide moisturization to the wash by including 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.
Further, 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., reducing the risk of atopic dermatitis in a subject and at least about two months after birth of the subject) (third paragraph on page 2/7). Therefore, Crane provides a teaching of the claimed effect of reducing the risk of atopic dermatitis in a subject as early as two days after birth (e.g., within about four days after birth) to including 6 months (e.g., at least about two months after birth of the subject) and there is a reasonable expectation that daily moisturizing of high-risk infants as early as two days after birth (e.g., within about four days after birth) to including 6 months (e.g., at least about two months after birth of the subject) and washing with a wash that 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; would reduce atopic dermatitis risk in the infants.
Applicant is reminded that objective evidence must be factually supported by an appropriate affidavit or declaration to be of probative value includes evidence of unexpected results, commercial success, solution of a long-felt need, inoperability of the prior art, invention before the date of the reference, and allegations that the author(s) of the prior art derived the disclosed subject matter from the applicant. See, for example, In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984).
The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965). Examples of attorney statements which are not evidence and which must be supported by an appropriate affidavit or declaration include statements regarding unexpected results, commercial success, solution of a long-felt need, inoperability of the prior art, invention before the date of the reference, and allegations that the author(s) of the prior art derived the disclosed subject matter from the applicant. See MPEP 716.01(c).
Thus, for the reasons of record and for the reasons presented above claims 1, 3-6, 10 and 14-16 are rejected under 35 U.S.C. 103(a).
Conclusion and Correspondence
No claims are 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 extension fee 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 date of this final action.
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/JOHN P NGUYEN/
Examiner, Art Unit 1619
/ANNA R FALKOWITZ/Primary Examiner, Art Unit 1600
