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 .
Withdrawal of Rejections
The response and amendments filed on 07/08/2026 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minor objections and/or minor rejections (i.e., formal matters), not explicitly restated here for brevity, have been withdrawn necessitated by Applicant’s formality correction and/or amendments.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Briefly, the previous claim rejections under 35 U.S.C. 112(b) for indefiniteness have been withdrawn necessitated by Applicant’s amendments.
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 07/08/2026 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 § 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 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 Castiel (US 2009/0068160; Date of Publication: March 12, 2009 – previously cited) and Siew (Semi-Solid Dosage Forms; 2015 – 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 inherently contains oligosaccharides (see, e.g., Smilowitz, Background, pg. 2), was finger-fed (i.e., applied to the skin of a caregiver) to the infants (see, e.g., Smilowitz, “Study Design”, pg. 3). The instant specification does not define “surrounding skin” nor does the specification define whether the “surrounding skin” is confined to the nipple area; therefore, the Examiner has interpreted this to mean any skin that is surrounding the body, which includes skin directly and indirectly surrounding a nipple.
However, Smilowitz does not teach: or wherein the composition is in the form of an edible semi-solid 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 1).
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 administration of the composition, Castiel teaches that compositions comprising the Bifidobacterium microorganisms (see, e.g., Castiel, [0059]), 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]). Additionally, Castiel teaches that the composition can be orally administered (see, e.g., Castiel, [0080]); therefore, one of ordinary skill in the art would understand that this composition is edible. 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]). Furthermore, Castiel also teaches that a composition comprising B. infantis can be orally administered using a food support such as “Milk, yoghurt, cheese, fermented milks, milk-based products, ice creams, fermented cereal-based products, milk-based powders, infant and baby formulae, food products of confectionery, chocolate or cereal type, animal feed in particular for pets, tablets, gel capsules or lozenges, oral supplements in dry form and oral supplements in liquid form (see, e.g., Castiel, [0032], [0100]).
Siew’s general disclosure relates to types and mechanisms for semi-solid topical formulations (see, e.g., Siew, pg. 1). Siew teaches that semi-solid topical formulations have advantages, such as “very little systemic exposure”, wherein “a high drug load can be applied on the actual site where the drug is required, with a reduced risk of unwanted side effects” and wherein “topical products are easy for the patient to apply” (see, e.g., Siew, pg. 2). Moreover, Siew teaches that semi-solid ointments are “less irritating to sensitive skin than water-based formulations” (see, e.g., Siew, pg. 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer Smilowitz’s B. infantis composition as an edible, semi-solid, as taught by Castiel. One would have been motivated to do so because Castiel teaches formulation of a Bifidobacterium composition as a semi-solid in order to produce a lotion or cream product to apply to one’s skin (see, e.g., Castiel, [0085], [0087], and claim 19). Additionally, Castiel teaches that compositions can be produced for oral administration of B. infantis, wherein B. infantis can be mixed with infant and baby formulae (see, e.g., Castiel, [0032], [0100]). Moreover, Smilowitz teaches topically applying B. infantis mixed with breast milk to the finger of a caregiver for administration to an infant (see, e.g., Smilowitz, “Study Design”, pg. 3). Siew teaches that semi-solid topical formulations are advantageous because they can be easily applied directly to the desired site (see, e.g., Siew, pg. 2), which one of ordinary skill in the art would understand is desirable for a caregiver when applying the B. infantis composition for administration to an infant because this would allow the caregiver to apply the composition directly to where they want the infant to feed from. One would have expected success because Smilowitz and Castiel both teach production of topical and edible B. infantis formulations. Additionally, Smilowitz, Castiel, and Siew teach topical formulations for administration of products or drugs to individuals.
Claims 5-6 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Smilowitz, Castiel and Siew as applied to claims 1-4 above, and in view of Frese (WO 2019/246316; Date of Publication: December 26, 2019 – previously cited).
The references of Smilowitz, Castiel and Siew are discussed above.
However, the references do 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 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 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 Smilowitz, Castiel, and Siew’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, Smilowitz 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 these teachings, 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 Smilowitz, Castiel, and Siew’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, Smilowitz teaches adding a sachet of B. infantis to breast milk, followed by administration to an infant (see, e.g., Smilowitz, Study Design, pg. 3). Therefore, based on these teachings, it would have been obvious to produce a Bifidobacterium composition so that it can be easily supplemented into various foods, such as breast milk. One would have expected success because Smilowitz Castiel, and Frese all teach administration of compositions comprising Bifidobacterium. Additionally, Smilowitz, Castiel, and Siew teach topical formulations for administration of products or drugs to individuals.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Smilowitz, Castiel and Siew as applied to claims 1-4 above, and in view of Garcia-Rodenas (US 2018/0220691; Date of Publication: August 9, 2018 – previously cited).
The references of Smilowitz, Castiel, and Siew are discussed above.
However, the references do 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 Smilowitz, Castiel, and Siew’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]). Moreover, Smilowitz teaches topical administration of B. infantis for subsequent oral administration to an infant (see, e.g., Smilowitz, Study Design, pg. 3). Therefore, producing a composition containing Bifidobacterium infantis in a lactose-free composition would allow for Bifidobacterium infantis to be administered to infants without the risk of developing a cow’s milk allergy. One would have expected success because Smilowitz, Castiel and Garcia-Rodenas all teach compositions for administration that include Bifidobacteria.
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Smilowitz, Castiel and Siew as applied to claim 1-4 above, and in view of Kyle (WO 2021/021746; Date of Publication: February 4, 2021 – previously cited).
The references of Smilowitz, Castiel and Siew are discussed above.
However, these references do 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 Smilowitz and 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, Smilowitz teaches administration of a composition comprising B. infantis and breast milk, wherein B. infantis stimulates anti-inflammatory and inhibition of pro-inflammatory cytokines by intestinal cells (see, e.g., Smilowitz, Background, pg. 2). Therefore, based on these teachings, it would have been obvious to produce a Bifidobacterium composition, wherein the composition also contains vitamins, because both the vitamins and B. infantis exhibit anti-inflammatory properties within the gut. One would have been motivated to do so because Smilowitz, Castiel, and Kyle all teach compositions for administration that include Bifidobacterium. Additionally, Smilowitz, Castiel, and Siew teach topical formulations for administration of products or drugs to individuals.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Smilowitz and Castiel as applied to claims 1-4 above, and in view of Singh (US 2020/0246454; Date of Publication: August 6, 2020 – previously cited).
The references of Smilowitz and Castiel are discussed above.
However, these references do 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 Smilowitz and Castiel’s Smilowitz, Castiel, and Siew’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, and the allergen can be administered with prebiotics/probiotics (see, e.g., Singh, [0106]). Additionally, Singh teaches that the allergens added to the composition can be protein allergens, seed allergens, plant allergens, food allergens, insect allergens, animal dander, or saliva (see, e.g., Singh, [0108]). Moreover, Smilowitz teaches topical administration of B. infantis for subsequent oral administration to an infant (see, e.g., Smilowitz, Study Design, pg. 3). Therefore, based on these teachings, it would have been obvious to produce a composition containing Bifidobacterium and a prebiotic, wherein the composition also contains an allergen because this would allow for the composition to exhibit many beneficial effects on human health, as well as induce tolerance to specific allergens upon administration. One would have expected success because Smilowitz, Castiel, and Singh all teach compositions for administration that include Bifidobacteria and prebiotics. Additionally, Smilowitz, Castiel, and Siew teach topical formulations for administration of products or drugs to individuals.
Claims 11 and 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Smilowitz, Castiel and Siew as applied to claims 1-4 above, and in view of Valla (WO 2012/021432; Date of Publication: February 16, 2012 – previously cited).
The references of Smilowitz, and Castiel Smilowitz, Castiel, and Siew are discussed above.
However, these references do 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 Smilowitz, Iannitti, and 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, Castiel teaches that softgels are used as an ingestible pharmaceutical support when administering a Bifidobacteria compositions orally (see, e.g., Castiel, [0100]-[0101]). , based on these teachings, it would have been obvious to produce a composition containing Bifidobacteria and a prebiotic into a softgel capsule because this would prolong stability of the composition as well as support oral administration of the Bifidobacteria composition. One would have expected success because Smilowitz, Castiel and Valla all teach compositions for administration that include Bifidobacterium. Additionally, Smilowitz, Castiel, and Siew teach topical formulations for administration of products or drugs to individuals.
Claims 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Smilowitz, Castiel and Siew as applied to claims 1-4 above, and further in view of Blanchard (US 2019/0029306; Date of Publication: January 31, 2019 – previously cited).
The references of Smilowitz, Castiel and Siew are discussed above.
Regarding claims 18-19 pertaining to the composition, Smilowitz teaches a composition comprising B. infantis and oligosaccharides (see, e.g., Smilowitz, “Study Design”, pg. 3).
However, the references do 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 Smilowitz, Castiel, and Siew’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, Smilowitz teaches administration of a composition comprising B. infantis mixed with breastmilk and oligosaccharides to infants (see, e.g., Smilowitz, “Study Design”, pg. 3). Additionally, 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) and Siew teaches that topical semi-solid formulations are desirable because they are easy to apply, are applied directly to actual site where the drug is required, and are not irritating (see, e.g., Siew, pg. 1).Therefore, based on these teachings, 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 while being applied directly to where the drug is required. One would have expected success because Smilowitz, Castiel, and Blanchard all teach compositions for administration that include Bifidobacterium. Additionally, Smilowitz, Castiel, Siew, and Blanchard all teach topical formulations.
Examiner’s Response to Arguments
Applicant's arguments filed 07/08/2026 have been fully considered but they are not persuasive.
Regarding Applicant’s argument that the references do not teach the claimed administration route (remarks, pages 5-6), this argument is not persuasive for multiple reasons:
First, Castiel teaches a Bifidobacterium composition, wherein the Bifidobacterium species can be Bifidobacterium infantis (see, e.g., Castiel, abstract & [0059]), and wherein the composition can be topically administered to the skin of an individual (see, e.g., Castiel, [0085]). Therefore, this is motivation that a composition comprising Bifidobacterium infantis can be administered to the skin surrounding a nipple since Castiel teaches topical administration to the skin. Moreover, Castiel teaches that the B. infantis composition can be formulated into infant and baby formula (see, e.g., Castiel, [0100]); further supporting that this composition can be administered to babies.
Secondly, the combined prior art of Smilowitz and Castiel teaches and provides motivation for the instantly claimed invention. 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). Therefore, Smilowitz teaches that one can apply a B. infantis composition to the skin of a caregiver and administer this composition to an infant. Additionally, as discussed above, the instant specification does not define what “surrounding skin” is, nor does it define this as the skin confined to the nipple area; therefore, the Examiner has interpreted this to mean any skin on the body, including skin directly and indirectly surrounding the nipple of a caregiver. Smilowitz reads upon these claim limitations since the art teaches administration of B. infantis to an infant via skin on a finger. Furthermore, as discussed above, Castiel teaches a Bifidobacterium composition, wherein the Bifidobacterium species can be Bifidobacterium infantis (see, e.g., Castiel, abstract & [0059]), and wherein the composition can be topically administered to the skin of an individual as a semi-solid formulation (see, e.g., Castiel, [0085]), which can include the skin directly or indirectly surrounding a nipple. Siew teaches that semi-solid topical formulations have advantages, such as wherein “a high drug load can be applied on the actual site where the drug is required, with a reduced risk of unwanted side effects” and wherein “topical products are easy for the patient to apply” (see, e.g., Siew, pg. 2). Moreover, Siew teaches that semi-solid ointments are “less irritating to sensitive skin than water-based formulations” (see, e.g., Siew, pg. 4). This would be advantageous for a caregiver because this allows the caregiver to easily apply the Bifidobacterium composition directly to where they want the infant to feed from on the caregiver. Furthermore, Castiel also teaches that a composition comprising B. infantis can be orally administered using a food support such as “Milk, yoghurt, cheese, fermented milks, milk-based fermented products, ice creams, fermented cereal-based products, milk-based powders, infant and baby formulae, food products of confectionery, chocolate or cereal type, animal feed in particular for pets, tablets, gel capsules or lozenges, oral supplements in dry form and oral supplements in liquid form” (see, e.g., Castiel, [0032], [0100]). One would have been motivated to administer a B. infantis composition to infants because 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 Applicant’s argument that Castiel is directed to an entirely different purpose (remarks, page 6), this argument is not persuasive because Castiel was cited to show that B. infantis can be topically and orally administered (see, e.g., Castiel, [0032], [0100]), and can be combined with infant and baby formulae (see, e.g., Castiel, [0100]), further supporting that this can be administered to infants. Additionally, Castiel is analogous art to Smilowitz because the references teach oral administration of Bifidobacterium. Therefore, Castiel is not directed to an entirely different purpose compared to the references of Smilowitz. Moreover, Applicant is arguing against references individually one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Additionally, Applicant argues that Castiel is directed to an entirely different purpose compared to the instantly claimed invention; however, instant claims 18 and 19 are directed to the composition being suitable for improving skin barrier function, moisturization, soothing irritated skin, and protecting against skin irritation, all of which pertains to the purpose of Castiel (see, e.g., Castiel, abstract, [0029], [0033]).
Regarding Applicant’s argument that there is no articulated reason to combine the references (remarks, page 7), as previously stated above, Applicant arguing against references individually and one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. Furthermore, the teachings of Smilowitz and Castiel are discussed above, and it would have been obvious to one of ordinary skill in the art to apply the B. infantis composition to the skin of a caregiver in order to easily administer the composition to an infant. One would have been motivated to do so because 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).Furthermore, Castiel teaches that the B. infantis composition can be formulated using infant and baby formulae (see, e.g., Castiel, [0100]), which further support oral administration of this composition to babies. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). The prior art references of Smilowitz and Castiel are analogous art teaching oral administration of Bifidobacterium infantis, as well as topical administration of Bifidobacterium infantis compositions, which are combined to teach the instantly claimed invention, and are not combined based on improper hindsight reasoning. Smilowitz teaches topically applying B. infantis to the skin of a caregiver in order to administer the composition to an infant, and Castiel was merely relied upon to teach that B. infantis topical compositions can be formulated as semi-solids, such as lotions or creams, which would be obvious to one of ordinary skill in the art in order to easily apply the composition to the skin of a caregiver for subsequent administration to an infant.
Regarding Applicant’s argument that Castiel is directed to a bacterial lysate and not alive probiotic organism (see, e.g., remarks, page 7), this argument is not persuasive because the instantly claimed invention does not recite the form that the Bifidobacterium is in (i.e., live vs lysate). Additionally, Castiel teaches “This or these microorganism(s) may therefore be included in the compositions according to the disclosure in a live, semi-active or inactivated, dead form” (see, e.g., Castiel, [0078]); therefore, Applicant’s argument that Castiel only teaches lysates and fractions is not correct. Additionally, the prior art of Smilowitz teaches administration of live B. infantis (see, e.g., Smilowitz, “Study Design”, pg. 3).
Conclusion
Claims 1-11 and 13-19 are rejected.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
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/NATALIE IANNUZO/Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
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