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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/18/2025 has been entered.
Withdrawal of Rejections
The response and amendments filed on 12/18/2025 are acknowledged. Any previously applied minor objections and/or minor rejections (i.e., formal matters), not explicitly restated here for brevity, have been withdrawn necessitated by Applicant’s formality correction and/or amendments. For the purposes of clarity of the record, the reasons for the Examiner’s withdrawal, and/or maintaining, if applicable, of the substantive or essential claim rejections are detailed directly below and/or in the Examiner’s Response to Arguments section.
Briefly, the previous 35 U.S.C. 103 rejections have been withdrawn necessitated by Applicant’s amendments; however, new grounds of rejection are set forth below.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/24/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112(b), Indefiniteness
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.
Claims 1-19 and 26 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the nipple”. There is insufficient antecedent basis for this limitation in the claim. No nipple was previously recited.
Claims 2-19 and 26 are included in this rejection for depending on independent claim 1 and failing to rectify the noted deficiency.
Claim Rejections - 35 USC § 103, Obviousness
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-4 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Smilowitz (Safety and tolerability of Bifidobacterium longum subspecies infantis EVC001 supplementation in healthy term breastfed infants: a phase I clinical trial; 2017 – previously cited) in view of Iannitti (Therapeutical use of probiotic formulations in clinical practice; 2010 – previously cited) and Castiel (US 2009/0068160; Date of Publication: March 12, 2009 – newly cited).
Smilowitz’s general disclosure relates to determining the safety and tolerability of supplementing breastfed infants with B. infantis (EVC001). Smilowitz discloses finger-feeding B. infantis mixed with breastmilk and oligosaccharides to infants (see, e.g., Smilowitz, “Study Design”, pg. 3). Moreover, Smilowitz discloses that intestinal Bifidobacterium and B. infantis increases the mRNA expression of intestinal epithelial tight junction proteins, enhances intestinal barrier function through the production of acetate, and promotes the maturation of dendritic cells in intestinal Peyer’s Patches (see, e.g., Smilowitz, Discussion, pg. 8).
Regarding claims 1-4 pertaining to oral delivery of Bifidobacterium infantis to an infant, Smilowitz teaches that B. infantis mixed with breast milk, which contains oligosaccharides, was finger-fed (i.e., applied to the skin of a caregiver) to the infants (see, e.g., Smilowitz, “Study Design”, pg. 3).
However, Smilowitz does not teach: wherein the composition is applied directly to the nipple or surrounding skin of a caregiver (claim 1); or wherein the composition is in the form of an emulsion (claim 1); or wherein the composition comprises an ingredient selected from the group consisting of vegetable oils, fish oil, coconut oil, olive oil, soy oil, nut oil, mineral oil, avocado oil, glyceryl behenate, glyceryl stearate, waxes, beeswax, shea butter, microcrystalline wax, lecithin, esters, polysorbates, stearoyl lactylates, propylene glycol esters, and sucrose esters (claim 26).
Iannitti’s general disclosure relates to a review of “the most significant clinical trials involving the use of probiotic formulations for the treatment of several pathologies” (see, e.g., Iannitti, “Summary”, pg. 701). Moreover, Iannitti discloses that Bifidobacteria naturally occurs on the milk ducts, nipple, and surrounding skin of caregivers (see, e.g., Iannitti, Introduction, pg. 702); therefore, breastfeeding infants are readily exposed to Bifidobacterium. Iannitti discloses that Bifidobacterium is a probiotic and exhibits many benefits on human health, such as low blood cholesterol level, immunomodulatory activity, repression of rotaviruses, production of vitamins, restoration of normal intestinal flora after antibiotic therapy, production of digestive enzymes, inhibition of pathogen growth, and reduction of blood ammonia levels (see, e.g., Iannitti, Figure 7, pg. 707).
Regarding claim 1 pertaining to the nipple or surrounding skin of a caregiver, Iannitti teaches “breast feeding exposes the infant to bacteria, especially Bifidobacteria, from milk ducts, nipple, and surrounding skin” (see, e.g., Iannitti, Introduction, pg. 702). Therefore, based on the teachings of Iannitti, breastfeeding inherently exposes infants to Bifidobacteria.
Castiel’s general disclosure relates to “Cosmetic use of an effective amount of at least one lysate of at least one microorganism of the genus Bifidobacterium species and/or a fraction thereof, for preventing and/or treating a skin disorder in the case of sensitive skin” (see, e.g., Castiel, abstract). Moreover, Castiel discloses “that probiotic microorganisms can have a beneficial effect in regulating skin hypersensitivity reactions such as the inflammatory and allergic reactions that are a matter of an immunological process” (see, e.g., Castiel, [0012]). Additionally, Castiel discloses compositions can comprise Bifidobacterium infantis (see, e.g., Castiel, [0059]), wherein the composition can be for topical or oral administration (see, e.g., Castiel, [0032]).
Regarding claim 1 pertaining to the composition being an emulsion and the composition being applied to the surrounding skin, Castiel teaches that the compositions comprising the Bifidobacterium microorganisms can be “compositions for external topical administration, i.e. to the surface of the skin, they may be aqueous, aqueous-alcoholic or oily solutions, dispersions of the solution type or dispersions of the lotion or serum type, emulsions of liquid or semi-liquid consistency of the milk type, suspensions or emulsions of the cream type, aqueous or anhydrous gels, microemulsions, microcapsules, microparticles, or vesicular dispersions of ionic and/or nonionic type” (see, e.g., Castiel, [0085]). Moreover, since Castiel teaches that compositions comprising Bifidobacteria can be externally applied via topical administration (see, e.g., Castiel, [0085]), one of ordinary skill in the art would understand that this means that this composition can be applied to the surrounding skin of caregivers.
Regarding claim 26 pertaining to the composition comprising an additional ingredient, Castiel teaches that the composition can contain “As fatty substances that may be used in the disclosure, mention may be made of mineral oils, for instance hydrogenated polyisobutene and liquid petroleum jelly, plant oils, for instance a liquid fraction of shea butter, sunflower oil and apricot kernel oil, animal oils, for instance perhydrosqualene, synthetic oils, especially purcellin oil, isopropyl myristate and ethylhexyl palmitate, unsaturated fatty acids and fluoro oils, for instance perfluoropolyethers. It is also possible to use fatty alcohols, fatty acids, for instance stearic acid and, for example, waxes, especially paraffin wax, carnauba wax and beeswax. Silicone compounds may also be used, for instance silicone oils, for example cyclomethicone and dimethicone, silicone waxes, silicone resins and silicone gums” (see, e.g., Castiel, [0093]).
It would have been first obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply Smilowitz’s composition containing B. infantis mixed with breastmilk, to the nipple or surrounding skin of a caregiver, as taught by Iannitti. One would have been motivated to do so because Iannitti teaches that the nipple, milk ducts, and surrounding skin of caregivers contains Bifidobacteria (see, e.g., Iannitti, Introduction, pg. 702), which one of ordinary skill in the art would understand allows infants to be naturally exposed to Bifidobacteria bacteria during breastfeeding. Additionally, Iannitti teaches that Bifidobacterium exhibits many benefits on human health, such as low blood cholesterol level, immunomodulatory activity, repression of rotaviruses, production of vitamins, restoration of normal intestinal flora after antibiotic therapy, production of digestive enzymes, inhibition of pathogen growth, and reduction of blood ammonia levels (see, e.g., Iannitti, Figure 7, pg. 707). Moreover, Smilowitz teaches that “supplementation of infants with B. infantis facilitates maturation of the gut mucosa. This hypothesis is supported by the findings that intestinal Bifidobacterium and B. infantis increase the mRNA expression of intestinal epithelial tight junction proteins [15], enhance intestinal barrier function through the production of acetate [44], and promote the maturation of dendritic cells in intestinal Peyer’s Patches (see, e.g., Smilowitz, Discussion, pg. 8). Therefore, based on the teachings of Smilowitz and Iannitti, it would have been obvious to apply Smilowitz’s composition to the nipple or surrounding area of a caregiver because this would allow for the infant to become exposed to the B. infantis within the composition, as well as Bifidobacteria naturally occurring on the nipple, milk ducts, and surrounding skin of the caregiver. Moreover, based on the teachings of Smilowitz and Iannitti, exposure to Bifidobacterium and B. infantis enhances the gut microbiota, intestinal barrier function, immune responses, and benefits human health. One would have expected success because Smilowitz and Iannitti both teach probiotics containing Bifidobacterium and B. infantis, or enhancing the gut microbiota.
It would have been secondly obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce Smilowitz’s composition containing B. infantis, wherein the composition is in the form of an emulsion, as taught by Castiel. One would have been motivated to do so because Castiel teaches that the emulsions can be formulated for topical administration (see, e.g., Castiel, [0085]) and oral composition (see, e.g., Castiel, [0101]), wherein these compositions have a wide variety of applications (see, e.g., Castiel, [0087], [0089], [0101]). Furthermore, Castiel teaches that the compositions comprising the Bifidobacterium microorganisms can be “compositions for external topical administration, i.e., to the surface of the skin” (see, e.g., Castiel, [0085]); therefore, this composition can be applied to the surrounding skin of a caregiver since Castiel teaches that a composition comprising Bifidobacterium can be topically applied to the surface of skin. Moreover, Smilowitz teaches finger-feeding B. infantis mixed with breastmilk and oligosaccharides to infants (see, e.g., Smilowitz, “Study Design”, pg. 3); therefore, Smilowitz is teaching orally administering B. infantis. Therefore, based on the teachings of Smilowitz and Castiel, it would have been obvious to produce a composition comprising B. infantis into an emulsion.
It would have been thirdly obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce Smilowitz’s composition containing B. infantis, wherein the composition comprises oils, waxes, and/or silicones, as taught by Castiel. One would have been motivated to do so because Castiel teaches “the composition of the disclosure is an emulsion, the proportion of the fatty phase may range from 5% to 80% by weight and preferably from 5% to 50% by weight relative to the total weight of the composition. The oils, emulsifiers and coemulsifiers used in the composition in emulsion form are chosen from those conventionally used in cosmetics and/or dermatology” (see, e.g., Castiel, [0090]). Therefore, from the teachings of Castiel, the oil can be used in the emulsion process. Furthermore, Castiel teaches oral and topical administration of compositions comprising B. infantis, wherein these compositions can be in the form of emulsions (see, e.g., Castiel, [0032], [0059]). Furthermore, Castiel teaches topically applying compositions comprising Bifidobacterium to skin (see, e.g., Castiel, [0085]). Moreover, Smilowitz teaches administration of B. infantis in breastmilk to infants (see, e.g., Smilowitz, “Study Design”, pg. 3). Therefore, based on the teachings of Smilowitz and Castiel, it would have been obvious to add oils, waxes, and/or silicones to a composition comprising B. infantis in order to make it into an emulsion. One would have expected success because Smilowitz and Castiel both teach compositions comprising B. infantis for topical administration to the skin of a caregiver and oral administration to an infant.
Claims 5-6, 12, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Smilowitz, Iannitti, and Castiel as applied to claims 1-4 and 26 above, and in view of Frese (WO 2019/246316; Date of Publication: December 26, 2019 – previously cited).
The teachings of Smilowitz, Iannitti, and Castiel herein referred to as modified-Smilowitz-Iannitti-Castiel, are discussed above as it pertains to administering a composition containing B. infantis to an infant.
However, modified-Smilowitz-Iannitti-Castiel does not teach: wherein the prebiotic is a synthetic molecule functionally equivalent to a natural oligosaccharide (claim 5); wherein the prebiotic is lacto-N-tetraose (LNT) or 2’-fucosyllactose (2’-FL) (claim 6); or wherein the composition is a semisolid (claim 12); or wherein the composition is anhydrous (claim 17).
Frese’s general disclosure relates to “the identification of novel structures in mare’s milk that may be synthesized or otherwise purified for use in a variety of animal and human applications related to the gut microbiome and mammalian health” (see, e.g., Frese, [0001]). Moreover, Frese discloses that the composition contains synthetic prebiotics, such as LNT or 2’-FL (see, e.g., Frese, [0011]), as well as B. infantis (see, e.g., Frese, [0012]).
Regarding claims 5-6 pertaining to the prebiotic being LNT or 2’-FL, Frese teaches both LNT and 2’-FL (see, e.g., Frese, [0011]). Frese teaches that “the oligosaccharides limit the growth of pathogens in the gut and may also reduce stool pH. In even further embodiments, addition of the oligosaccharide structures can alter the growth of the host animal including but not limited to weight gain, distribution of weight gain including lean to fat mass, and vitamin status, etc.” (see, e.g., Frese, [0026]).
Regarding claim 12 pertaining to a semisolid, Frese teaches a gel composition (see, e.g., Frese, [0044]).
Regarding claim 17 pertaining to the composition being anhydrous, Frese teaches that the composition can be a dry powder (see, e.g., Frese, [0044]).
It would have been first obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce modified-Smilowitz-Iannitti-Castiel’s composition containing Bifidobacterium and a prebiotic, wherein the prebiotic is LNT or 2’-FL, as taught by Frese. One would have been motivated to do so because one of ordinary skill in the art would readily understand that LNT and 2’-FL are synthetic molecules that are functionally equivalent to natural oligosaccharides, and Frese teaches that oligosaccharides exhibit “a wide variety of biological roles, with potential prebiotic, antimicrobial, anti-adhesive, and immunomodulatory activity” (see, e.g., Frese, [0003]). Additionally, “the oligosaccharides limit the growth of pathogens in the gut and may also reduce stool pH. In even further embodiments, addition of the oligosaccharide structures can alter the growth of the host animal including but not limited to weight gain, distribution of weight gain including lean to fat mass, and vitamin status, etc.” (see, e.g., Frese, [0026]). Moreover, modified-Smilowitz-Iannitti-Castiel teaches that human milk oligosaccharides “are non-digestible by the human infant and support the competitive growth of protective Bifidobacterial strains within the intestine” (see, e.g., Smilowitz, “Background”, pg. 2). Therefore, based on the teachings of modified-Smilowitz-Iannitti-Castiel and Frese, it would have been obvious to produce a composition containing Bifidobacterium and a prebiotic, wherein the prebiotic is LNT or 2’-FL because these oligosaccharides would exhibit a wide variety of protective biological roles, while supporting the growth of Bifidobacteria, and promoting skin health and hydration.
It would have been secondly obvious to one of ordinary skill in the art to manufacture modified-Smilowitz-Iannitti-Castiel’s composition containing Bifidobacterium and a prebiotic into a gel composition, as taught by Frese. One would have been motivated to do so because Frese teaches that the gel is in a shelf stable format (see, e.g., Frese, [0044]). Moreover, modified-Smilowitz-Iannitti-Castiel teaches “B. infantis 35624 is a probiotic that specifically relieves many of the symptoms of IBS. At a dosage level of 1x108 cfu, it can be delivered by a capsule making it stable, convenient to administer, and amenable to widespread use” (see, e.g., Iannitti, Section 3.2, pg. 716). Therefore, based on the teachings of modified-Smilowitz-Iannitti-Castiel and Frese, it would have been obvious to produce modified-Smilowitz-Iannitti-Castiel’s composition into a gel capsule because this would allow for increased stability of the composition, while having the ability to conveniently administer the composition.
It would have been thirdly obvious to one of ordinary skill in the art to manufacture modified-Smilowitz-Iannitti-Castiel’s composition containing Bifidobacterium and a prebiotic into a dry powder (i.e., anhydrous composition), as taught by Frese. One would have been motivated to do so because Frese teaches that the dry powder containing the oligosaccharides can be added to “human milk, bovine milk, infant formula, follow on formula, weaning foods, baby foods, meal replacers, feeds and feed supplements, beverages, post-surgery recovery drinks” (see, e.g., Frese, [0046]). Moreover, modified-Smilowitz-Iannitti-Castiel teaches that “Probiotics are available in food and dietary supplements (for example, capsules, tablets and powders) and in some other forms as well” (see, e.g., Iannitti, Section 1.3, pg. 703). Therefore, based on the teachings of modified-Smilowitz-Iannitti-Castiel and Frese, it would have been obvious to produce modified-Smilowitz-Iannitti-Castiel’s composition so that it can be easily supplemented into various foods. One would have expected success because modified-Smilowitz-Iannitti-Castiel and Frese both teach compositions comprising B. infantis and oligosaccharide.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Smilowitz, Iannitti, and Castiel as applied to claims 1-4 and 26 above, and in view of Garcia-Rodenas (US 2018/0220691; Date of Publication: August 9, 2018 – previously cited).
The teachings of Smilowitz, Iannitti, and Castiel herein referred to as modified-Smilowitz-Iannitti-Castiel, are discussed above as it pertains to administering a composition containing B. infantis to an infant.
However, modified-Smilowitz-Iannitti-Castiel does not teach: wherein the composition is lactose free (claim 7).
Garcia-Rodenas’ general disclosure relates to nutritional compositions for infants comprising a specific probiotic for inducing a gut microbiota that is close to the one of infants fed exclusively on human breast milk (see, e.g., Garcia-Rodenas, [0001]). Moreover, Garcia-Rodenas discloses that the infant formulation comprises oligosaccharides (see, e.g., Garcia-Rodenas, [0070]) and teaches that “galacto-oligosaccharides (GOS) and/or certain fructo-oligosaccharides (FOS) can promote the growth and prevalence of Bifidobacteria in the gut, especially in infants” (see, e.g., Garcia-Rodenas, [0010]).
Regarding claim 7 pertaining to the composition being lactose free, Garcia-Rodenas teaches a composition wherein whey protein hydrolysates are used for infants believed to be at risk of developing a cow’s milk allergy because the whey fraction used as the starting material is substantially lactose free (see, e.g., Garcia-Rodenas, [0155]).
It would have been obvious to one of ordinary skill in the art to produce modified-Smilowitz-Iannitti-Castiel’s composition containing Bifidobacterium and a prebiotic, wherein the composition is lactose free, as taught by Garcia-Rodenas. One would have been motivated to do so because Garcia-Rodenas teaches that lactose free compositions can be used for infants believed to be at risk of developing a cow’s milk allergy (see, e.g., Garcia-Rodenas, [0155]). Furthermore, Garcia-Rodenas discloses that the infant formulation comprises oligosaccharides (see, e.g., Garcia-Rodenas, [0070]) and teaches that “galacto-oligosaccharides (GOS) and/or certain fructo-oligosaccharides (FOS) can promote the growth and prevalence of Bifidobacteria in the gut, especially in infants” (see, e.g., Garcia-Rodenas, [0010]). Moreover, modified-Smilowitz-Iannitti-Castiel teaches that Bifidobacterium is a probiotic and exhibits many benefits on human health, such as low blood cholesterol level, immunomodulatory activity, repression of rotaviruses, production of vitamins, restoration of normal intestinal flora after antibiotic therapy, production of digestive enzymes, inhibition of pathogen growth, and reduction of blood ammonia levels (see, e.g., Iannitti, Figure 7, pg. 707). Therefore, producing modified-Smilowitz-Iannitti-Castiel’s composition containing Bifidobacterium in a lactose-free composition would allow for Bifidobacterium to exhibit its beneficial properties on infants without the risk of developing a cow’s milk allergy. One would have expected success because modified-Smilowitz-Iannitti-Castiel and Garcia-Rodenas both teach compositions for infants that include oligosaccharides as prebiotics.
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Smilowitz, Iannitti, and Castiel as applied to claim 1-4 and 26 above, and in view of Kyle (WO 2021/021746; Date of Publication: February 4, 2021).
The teachings of Smilowitz, Iannitti, and Castiel herein referred to as modified-Smilowitz-Iannitti-Castiel, are discussed above as it pertains to administering a composition containing B. infantis to an infant.
However, modified-Smilowitz-Iannitti-Castiel does not teach: wherein the composition further comprises an antioxidant (claim 8); or wherein the composition further comprises a vitamin, mineral, or supplement (claim 9).
Kyle’s general disclosure relates to “to compositions and uses of milk fat globule membrane complex (MFGM)-enriched complexes to store, protect and deliver commensal bacteria, milk oligosaccharides, and/or natural or recombinant proteins and enzymes to the gut of a mammal” (see, e.g., Kyle, [001]). Moreover, Kyle discloses that the composition comprises “one or more components including milk fat globule membranes (MFGM) complexes, milk fat globules (MFG), commensal organisms, SIgA, recombinant SIgA (rSIgA), triglycerides or oils, and mammalian milk oligosaccharides (MMO)” (see, e.g., Kyle, [006]).
Regarding claim 8 pertaining to an antioxidant, Kyle teaches that the composition comprises vitamin E, which is an antioxidant (see, e.g., Kyle, [0058]).
Regarding claim 9 pertaining to vitamins, Kyle teaches that the composition comprises vitamins, such as, but not limited to, vitamin A palmitate, vitamin D3, vitamin E acetate, and/or vitamin K (see, e.g., Kyle, [0058]). Kyle teaches that the composition comprising oligosaccharides can further comprise a blend of nutritional components, which includes vitamins and antioxidants (see, e.g., Kyle, [0017]), to aid in restoring the gut microbiome and/or reduce inflammation (see, e.g., Kyle, [0021]).
It would have been obvious to one of ordinary skill in the art to produce modified-Smilowitz-Iannitti-Castiel’s composition containing Bifidobacterium and a prebiotic, wherein the composition contains vitamins and antioxidants, as taught by Kyle. One would have been motivated to do so because Kyle teaches that the composition comprising oligosaccharides can further comprise a blend of nutritional components, which includes vitamins and antioxidants (see, e.g., Kyle, [0017]), to aid in restoring the gut microbiome and/or reduce inflammation (see, e.g., Kyle, [0021]). Moreover, modified-Smilowitz-Iannitti-Castiel teaches that probiotic administration improves bacterial overgrowth and vitamin B12 availability (see, e.g., Iannitti, Section 2.4, pg. 711). Therefore, based on the teachings of modified-Smilowitz-Iannitti-Castiel and Kyle, it would have been obvious to produce modified-Smilowitz-Iannitti-Castiel’s composition, wherein the composition also contains vitamins, because it would allow for gut microbiome restoration and decreased inflammation. One would have been motivated to do so because modified-Smilowitz-Iannitti-Castiel and Kyle both teach compositions for infants that include oligosaccharides as prebiotics.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Smilowitz, Iannitti, and Castiel as applied to claims 1-4 and 26 above, and in view of Singh (US 2020/0246454; Date of Publication: August 6, 2020).
The teachings of Smilowitz, Iannitti, and Castiel herein referred to as modified-Smilowitz-Iannitti-Castiel, are discussed above as it pertains to administering a composition containing B. infantis to an infant.
However, modified-Smilowitz-Iannitti-Castiel does not teach: wherein the composition further comprises a food allergen (claim 10).
Singh’s general disclosure relates to “compositions and methods for treating allergies in subjects, such as subjects who are suffering from allergies after taking antibiotics that disrupt the gut microflora” (see, e.g., Singh, [0002]). Moreover, Singh discloses “a method for inducing/augmenting tolerance, and/or treating, preventing and/or reducing the risk and/or symptoms of allergy in a subject, comprising: identifying a subject suffering from an allergy; administering to the subject a composition comprising of; a) one or more probiotics; b) one or more allergens; and optionally; c) one or more prebiotics” (see, e.g., Singh, [0010]).
Regarding claim 10 pertaining to a food allergen, Singh teaches a composition comprising one or more allergens, wherein the allergens are food allergens (see, e.g., Singh, [0010], [0028]).
It would have been obvious to one of ordinary skill in the art to manufacture modified-Smilowitz-Iannitti-Castiel’s composition containing Bifidobacterium and a prebiotic, wherein the composition contains a food allergen, as taught by Singh. One would have been motivated to do so because Singh teaches that the incorporation of allergens can be used to induce tolerance (see, e.g., Singh, [0106]). Moreover, modified-Smilowitz-Iannitti-Castiel teaches that Bifidobacterium is a probiotic and exhibits many benefits on human health, such as low blood cholesterol level, immunomodulatory activity, repression of rotaviruses, production of vitamins, restoration of normal intestinal flora after antibiotic therapy, production of digestive enzymes, inhibition of pathogen growth, and reduction of blood ammonia levels (see, e.g., Iannitti, Figure 7, pg. 707). Therefore, based on the teachings of modified-Smilowitz-Iannitti-Castiel and Singh, it would have been obvious to produce modified-Smilowitz-Iannitti-Castiel’s composition containing Bifidobacterium and a prebiotic, wherein the composition also contains an allergen, as taught by Singh, because this would allow for the composition to exhibit many beneficial effects on human health, as well as induce tolerance. One would have expected success because modified-Smilowitz-Iannitti-Castiel and Singh both teach compositions comprising oligosaccharide prebiotics and Bifidobacterium.
Claims 11 and 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Smilowitz, Iannitti, and Castiel as applied to claims 1-4 and 26 above, and in view of Valla (WO 2012/021432; Date of Publication: February 16, 2012).
The teachings of Smilowitz, Iannitti, and Castiel herein referred to as modified-Smilowitz-Iannitti-Castiel, are discussed above as it pertains to administering a composition containing B. infantis to an infant.
However, modified-Smilowitz-Iannitti-Castiel does not teach: wherein the composition is contained in a soft gel (claim 11); or wherein the composition is stable for at least 3-24 months when stored at 25-65% relative humidity (claims 13-16).
Valla’s general disclosure relates to a process of manufacturing a softgel capsule containing microencapsulated probiotic bacteria, wherein the product is stable at room temperature of at least 24 months (see, e.g., Valla, [0002]). Moreover, Valla discloses that microencapsulation steps are: “(a) providing microencapsulated probiotic bacteria with at least one coating comprising at least one vegetable lipid having a melting point of between 35°C and 75°C; (b) suspending the microencapsulated probiotic bacteria in a suspending formulation to make a fill; (c) mixing the fill at low intensity and low temperature to make a mixed fill; (d) reducing agglomerates of the microencapsulated probiotic bacteria in the mixed fill to make a de- agglomerated fill; and (e) encapsulating the de-agglomerated fill in a softgel capsule, wherein the integrity of the coating of the microencapsulated probiotic bacteria is maintained” (see, e.g., Valla, [0016]).
Regarding claim 11 pertaining to a soft gel, Valla teaches “a softgel capsule containing microencapsulated probiotic bacteria” (see, e.g., Valla, [0002]).
Regarding claims 13-16 pertaining to stability of the composition, Valla teaches that the “microencapsulated softgel capsule is stable for at least about 24 months at room temperature” (see, e.g., Valla, [0047]), wherein room temperature is “between about 15°C to about 30°C, more preferably about 20°C to about 25°C and a humidity between about 20% and about 75%, and more preferably about 50% to about 60%” (see, e.g., Valla, [0047]).
It would have been obvious to one of ordinary skill in the art to manufacture modified-Smilowitz-Iannitti-Castiel’s composition containing Bifidobacterium and a prebiotic into a soft gel, as taught by Valla. One would have been motivated to do so because Valla teaches that a softgel can be used to enhance the viability and shelf life of probiotic bacteria (see, e.g., Valla, [0007]). Additionally, Valla teaches that Valla teaches that prolonging the shelf life of compositions at room temperature will enhance the commercialization process (see, e.g., Valla, [0005]-[0008]). Moreover, modified-Smilowitz-Iannitti-Castiel teaches “B. infantis 35624 is a probiotic that specifically relieves many of the symptoms of IBS. At a dosage level of 1x108 cfu, it can be delivered by a capsule making it stable, convenient to administer, and amenable to widespread use” (see, e.g., Iannitti, Section 3.2, pg. 716). Therefore, based on the teachings of modified-Smilowitz-Iannitti-Castiel and Valla, it would have been obvious to produce modified-Smilowitz-Iannitti-Castiel’s composition containing Bifidobacteria and a prebiotic into a softgel capsule because this would prolong stability of the composition.
Claims 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Smilowitz, Iannitti, and Castiel as applied to claims 1-4 and 26 above, and further in view of Blanchard (US 2019/0029306; Date of Publication: January 31, 2019 – previously cited).
The teachings of Smilowitz, Iannitti, and Castiel herein referred to as modified-Smilowitz-Iannitti-Castiel, are discussed above as it pertains to administering a composition containing B. infantis to an infant.
Regarding claims 18-19 pertaining to the composition, modified-Smilowitz-Iannitti-Castiel teaches a composition comprising B. infantis and oligosaccharides (see, e.g., Smilowitz, “Study Design”, pg. 3).
However, modified-Smilowitz-Iannitti-Castiel does not teach: wherein the composition further comprises an ingredient suitable for skin in need of improving skin barrier function and/or moisturization (claim 18); or wherein the composition further comprises an ingredient suitable to soothe irritated skin or protect against skin irritation (claim 19).
Blanchard’s general disclosure relates to “a composition comprising oligosaccharide, for use in the prevention and/or treatment of skin conditions and/or skin diseases by increasing SCFA, in particular colonic propionate and butyrate” (see, e.g., Blanchard, abstract). Moreover, Blanchard discloses that “the administration of a mixture of specific oligosaccharides is particularly effective in the prevention and/or treatment of skin conditions and skin diseases, and in particular in the prevention and/or treatment of atopic dermatitis, and/or in the promotion of skin health” (see, e.g., Blanchard, [0016]). Additionally, Blanchard discloses that the composition for prevention and/or treating of skin conditions or disease contains prebiotic synthetic oligosaccharides like LNT and 2’-FL (see, e.g., Blanchard, [0019]).
Regarding claims 18-19 pertaining to skin barrier, skin irritation, and moisturization, Blanchard teaches that oligosaccharides can promote skin health, enhance skin hydration, and prevent and/or treat of skin conditions and skin diseases (see, e.g., Blanchard, [0016], [0019], [0281]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to manufacture modified-Smilowitz-Iannitti-Castiel’s composition containing Bifidobacterium, wherein the composition contains oligosaccharides for treatment of skin irritation and promotion of skin health, as taught by Blanchard. One would have been motivated to do so because Blanchard teaches the administration of a mixture of specific oligosaccharides is particularly effective in the prevention and/or treatment of skin conditions and skin diseases, and in particular in the prevention and/or treatment of atopic dermatitis, and/or in the promotion of skin health” (see, e.g., Blanchard, [0016]). Moreover, modified-Smilowitz-Iannitti-Castiel teaches administration of a composition comprising B. infantis mixed with breastmilk and oligosaccharides to infants (see, e.g., Smilowitz, “Study Design”, pg. 3). Additionally, modified-Smilowitz-Iannitti-Castiel teaches that compositions comprising B. infantis can be used for topical administration in order to “preventing and/or treating a skin disorder in the case of sensitive skin” (see, e.g., Castiel, abstract). Therefore, based on the teachings of modified-Smilowitz-Iannitti-Castiel and Blanchard, it would have been obvious to produce a composition comprising B. infantis and oligosaccharides because both B. infantis and oligosaccharides have the ability to treat skin diseases and improve barrier function. One would have expected success because modified-Smilowitz-Iannitti-Castiel and Blanchard both teach compositions comprising oligosaccharides for treatment of skin diseases.
Examiner’s Response to Arguments
Applicant's arguments filed 12/18/2025 have been fully considered but they are not persuasive.
Applicant has traversed the previous 35 U.S.C 103 rejections in view of Smilowitz, Iannitti, Frese, Garcia-Rodenas, Kyle, Singh, Valla, and Blanchard, in light of the amendment of claim 1 which introduces new limitations (remarks, pages 4-7). As discussed above, all rejections have been withdrawn and new rejections are presented due to Applicant’s amendment on 12/18/2025. While Smilowitz, Iannitti, Frese, Garcia-Rodenas, Kyle, Singh, Valla, and Blanchard are relied upon in the above-presented rejection, they are not relied upon for teaching that the composition is in the form of an emulsion. As such, Applicant’s arguments regarding the teachings of Smilowitz, Iannitti, Frese, Garcia-Rodenas, Kyle, Singh, Valla, and Blanchard are moot.
Conclusion
Claims 1-19 and 26 are rejected.
No claims are allowed.
Correspondence Information
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/NATALIE IANNUZO/Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653